Fixed and flexible formularies as cost-control mechanisms.

PubMed

Dewa, Carolyn S; Hoch, Jeffrey S

2003-06-01

The purpose of this review is to consider the prevalent types of fixed and flexible formularies, the general economic principles on which they are based and the evidence for their effectiveness in controlling rising drug expenditures. The principal-agent relationship and economic model underlying the various types of formularies are described. The principal-agent model describes a relationship where there is an asymmetry of information between two parties involved in a particular task. As a result of this asymmetry of information, the party with less information (the principal) allows the party with more information (the agent) to make decisions about that task or activity for them. In the case of formularies and cost-control, the principal is the payer. Depending on the incentives offered by the formulary, the agent can alternately be the prescriber, dispenser or patient. The success of a formulary type to control costs is dependent on two main factors. First, the payer (the principal) must identify the agent for whom it is reasonable to create incentives that incorporate the financial risks associated with use of the drugs. Second, the payer must develop a structure that best aligns the principal and agent objectives. The principal-agent framework serves as the vehicle through which the authors examine five major types of formularies (i.e., closed, best available price, reference-based pricing, tiered and open formularies) and their inherent incentives and limitations. The evidence for their effectiveness as cost-control mechanisms is reviewed and the system factors that can affect formulary success will be discussed. Finally, the authors' observations are summarized and interpreted, and suggested implications for future use of formularies in controlling the costs of pharmaceutical use are offered.

Variation in formulary adherence in general practice over time (2003-2007).

PubMed

van Dijk, Liset; de Jong, Judith D; Westert, Gert P; de Bakker, Dinny H

2011-12-01

To study trends and variation in adherence to the main national formulary for the 20 most prevalent health problems in Dutch general practice over a 5-year period (2003-07). Routine electronic medical records from a pool of 115 representative general practices were linked to the main national formulary. Analyses included over 2 million prescriptions for 246 391 patients. The outcome variable was whether or not the prescribed medication was congruent with recommendations in the national formulary. Trends and variation were analysed using three-level multilevel logistic regression analyses (general practice, patient, and prescription). The percentage of formulary adherent prescriptions for the 20 most prevalent health problems was 73-76% between 2003 and 2007. The percentage varied considerably between guidelines. Lowest adherence rates were found for acute bronchitis and acute upper respiratory infection. Interpractice variation was constant over time. General practice information networks are useful for monitoring general patterns of formulary on a year-to-year basis. Formulary adherence is stable over time but varies across diagnoses, patients and general practices. In the past decade, efforts have been made to increase the level of formulary adherent prescribing. These general efforts managed to stabilize (variation in) adherence in a field where many other initiatives (e.g. by pharmaceutical companies) are undertaken to influence prescribing behaviour.

Perampanel

PubMed Central

Cada, Dennis J.; Levien, Terri L.; Baker, Danial E.

2013-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service.Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The April 2013 monograph topics are alogliptin, crofelemer, lomitapide, ponatinib, and sumatriptan iontophoretic transdermal. The DUE/MUE is on alogliptin. PMID:24421482

Introducing a drug formulary to general practice — effects on practice prescribing costs

PubMed Central

Beardon, P.H.G.; Brown, S.V.; Mowat, D.A.E.; Grant, J.A.; McDevitt, D.G.

1987-01-01

A drug formulary comprising 249 preparations of 132 drugs and drug combinations was prepared by the partners in a three-doctor general practice serving more than 5000 patients. No attempt was made to change to generic prescribing nor were repeat prescription drugs altered. Introduction of the formulary in September 1981 was followed by an increase in the proportion of prescriptions containing drugs from the formulary from about 55% to more than 60% for both repeat and non-repeat prescriptions. The proportion of formulary drugs on non-repeat prescriptions reached a maximum of 78% within the first year with the additional influence of information feedback. Over the first year the level of formulary drugs used for both repeat and nonrepeat prescribing levelled off at about 62%. Even with these modest changes, when compared with the costs of general practice prescribing in Scotland as a whole, the introduction of the formulary resulted in savings of approximately 10% within the practice for the mean ingredient costs both per patient and per prescription. PMID:3449632

The use of pharmacoeconomic data in formulary selection.

PubMed

Hatoum, H T; Freeman, R A

1994-01-01

Pharmacists are encouraged to improve their knowledge and use of pharmacoeconomic data in formulary selection. The formulary selection process has changed significantly in recent years. Among its most significant uses is its potential for cost containment strategies. An overview is presented of the origin as well as the potential impact of pharmacoeconomic data. The need to balance the economic benefit with the clinical advantages for any proposed new drug for formulary inclusion remains the most critical decision to be made by pharmacists.

From A to Z: Medication Cost-Management Strategies for Disproportionate Share Hospitals

PubMed Central

Henry, Andrea; Erowele, Goldina Ikezuagu; Ndefo, Uche Anadu; Milton-Brown, Jackie; Anassi, Enock; Green, Wendy; Alvidrez, Adriana; Okpara, Alphonsus U.

2011-01-01

Background Harris County Hospital District, Houston, TX, is a publicly funded hospital system that provides care to residents of Harris County with a need-based payment system. The Harris County Hospital District pharmacy department, with a drug budget of more than $75 million in fiscal year 2010, utilizes a closed formulary system that is managed by the Formulary Management and Pharmacoeconomics Service, along with the medical staff. This service is comprised of clinical pharmacists whose goal is to provide a comprehensive, safe, and cost-effective formulary. Objective To describe the unique formulary management process at a county hospital system and what makes this process cost-effective, which may benefit pharmacy departments in institutions serving an indigent patient population. Summary The Harris County Hospital District drug formulary is overseen by the Pharmacy & Therapeutics committee, which is supported by 5 therapeutic subcommittees, including antimicrobials, cardiovascular, general formulary, central nervous system, and oncology. The Pharmacy & Therapeutics Committee consists of a medical staff committee that is supported by clinical pharmacists, who serve as the facilitators of these 5 subcommittees. Their responsibilities include the provision of drug information for formulary decisions, providing parameters to govern the use of certain medications, communicating changes to the formulary, conducting class reviews and medication utilization evaluations, coordinating annual pharmaceutical bids, reviewing and writing medication use policies and procedures, facilitating the use of cost-effective medications, and monitoring the use of medications in the hospital system. Conclusion The processes incorporated by Harris County Hospital District in its formulary management are cost-effective and may be beneficial to other pharmacy departments, especially those institutions that serve an indigent patient population and are interested in cost-effective management strategies. PMID:25126349

Factors that influence patient response to requests to change to a unified restrictive formulary.

PubMed

Smetana, Gerald W; Davis, Roger B; Phillips, Russell S

2004-12-01

To determine factors that influence patient willingness to accept a medication change to a unified, restrictive formulary. Prospective cohort study. University-affiliated hospital-based primary care internal medicine practice. Two hundred ninety-seven members of a managed care plan who had received a prescription for a nonformulary medication in the previous 4 months and whose primary care physician approved a conversion to a formulary medication. Clinical nurses invited patients to change to a formulary medication at the time of a telephone refill request based on a standard script. The overall conversion rate to the formulary medication was 59.8%. Seventy-four percent of patients who requested a refill by telephone converted to the formulary (odds ratio [OR], 2.24; 95% confidence interval [CI], 1.02 to 4.72). Patient age (OR, 1.03; CI, 1.01 to 1.05) and male gender (OR, 2.00; CI, 1.09 to 3.67) were each significant correlates of conversion. After adjustment in a multivariable model, only telephone refill request (adjusted OR, 2.31; CI, 1.07 to 4.97) and age (adjusted OR, 1.03; CI, 1.01 to 1.06) remained significant. Among the patients who made a telephone refill request, those who converted were more likely to completely trust their physician's judgment (P=.04) and to trust their physician to put their health over cost concerns (P=.05). Formulary conversion reduced costs beginning 3 months after the conversion date. A protocol for encouraging conversion to a unified formulary at the point of a telephone refill request increases formulary compliance rates and reduces medication costs. Patients who decline to convert medications are less likely to trust their physician.

The new medicare drug benefit: formularies and their potential effects on access to medications.

PubMed

Huskamp, Haiden A; Keating, Nancy L

2005-07-01

During congressional debate over the Medicare Part D prescription drug benefit, much attention was focused on nominal benefit design. Relatively little attention was paid to details about how plans would operate, such as the design of drug formularies. Yet, formularies will be important tools for controlling costs, and may be as important as nominal benefit design in determining enrollees' access to medications and out-of-pocket costs. We describe Part D plan incentives and how they may influence formulary design, and then provide recommendations for Part D formulary implementation. We encourage the Centers for Medicare & Medicaid Services (CMS) to develop standardized tools to provide physicians and patients with up-to-date and easily accessible information about covered drugs on each plan's formulary (perhaps via a central website) and a national set of easy-to-follow procedures for reconsideration and appeals. Such efforts should reduce administrative burden and better allow physicians to help patients obtain needed medications.

Weighing the evidence: trends in managed care formulary decision making.

PubMed

de Lissovoy, Gregory

2003-01-01

Health plans, pharmacy benefit managers, and other organizations use drug formularies to promote quality care while controlling costs. However, restrictive formularies are often viewed as constraints on physician practice and potential barriers to optimal patient care. Reluctance to add new drugs to an established formulary is rational economic behavior. Innovative compounds may have unknown properties with uncertain outcomes and therefore may impose costs in the form of risk. Products that seemingly duplicate drugs already on formulary may increase transaction costs without additional benefit. In evaluating new products, formulary managers face the task of identifying, assembling, and synthesizing a wide range of complex information. Manufacturers, who may be in the best position to supply that information, have been severely restricted by U.S. Food and Drug Administration (FDA) regulations that limited marketing communications to findings from well-controlled clinical trials. The FDA Modernization Act of 1997 eased these restrictions somewhat by acknowledging that sophisticated purchasers such as organized health plans were capable of weighing the quality and impartiality of manufacturer-supplied evidence. The Academy of Managed Care Pharmacy (AMCP) created a standardized template that formularies can use to request comprehensive information about specific drugs from manufacturers. Widespread adoption of the AMCP format by health plans and manufacturers will greatly increase access to information about new drugs, speeding the process of formulary committee deliberation, and instilling greater confidence in the outcome of those decisions. Wider access to new drugs may result.

Incentive formularies and changes in prescription drug spending.

PubMed

Landon, Bruce E; Rosenthal, Meredith B; Normand, Sharon-Lise T; Spettell, Claire; Lessler, Adam; Underwood, Howard R; Newhouse, Joseph P

2007-06-01

To examine the impact of incentive formularies on prescription drug spending shifts in formulary compliance, use of generic medications, and mail-order fulfillment in the year after introduction of a new pharmacy benefit strategy. Pre-post comparison study with matched concurrent control group (difference-indifferences analysis). Study subjects were continuously enrolled patients from a single large health plan in the northeastern United States. Health plan administrative data were used to determine the total, health plan, and out-of-pocket spending in the year before and the year after the introduction of 12 different benefit changes, including 1 in which copayments decreased. Overall, changing from a single-tier or 2-tier formulary to a 3-tier formulary was associated with a decrease in total drug spending of about 5% to 15%. Plan spending decreased more dramatically, about 20%, whereas out-of-pocket spending that resulted from higher copayments increased between 20% and >100%. Changing to an incentive formulary with higher copayments was accompanied by a small but inconsistent decrease in use of nonformulary selections and a concomitant increase in both generic and formulary preferred utilization. Mail-order fulfillment doubled, albeit from a low baseline level. Switching to incentive formulary arrangements with higher levels of copayments generally led to overall lower drug costs and vice versa. These effects varied with the degree of change, level of baseline spending, and magnitude of the copayments. Whether these effects are beneficial overall depends on potential health effects and spillover effects on medical spending.

Medicare Part D formulary coverage since program inception: are beneficiaries choosing wisely?

PubMed

Jackson, E Anne; Axelsen, Kirsten J

2008-11-01

To evaluate how Medicare Part D formulary composition has changed since program inception, including comparison of plans eligible for full premium subsidy (ie, benchmark plans) with their counterparts. The study used publicly available data released by the Centers for Medicare & Medicaid Services to generate snapshots of formulary coverage and enrollment levels in each plan year. The analysis included all Part D plans and tracked formulary coverage of 152 of the most common brand name and generic drugs prescribed to seniors. Since 2006, the number of products available without restriction has increased and the number of drugs not on formulary has decreased. However, it appears that beneficiaries (subsidized beneficiaries in particular) may not be using their open-enrollment periods to reevaluate the available plan offerings. Beneficiaries need to reevaluate the Part D options available on an annual basis to maintain enrollment with the most appropriate plan available. Although all plans meet the proscribed formulary requirements, some plans offer richer drug coverage with more drugs available on an unrestricted basis. Benchmark plan status allows Part D plans to maintain or gain significant Medicare enrollment from year to year. Careful oversight should be provided to ensure that the level of formulary coverage offered at benchmark and other plans remains consistent.

Disparity in the "time to patient access" to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian Society of Medical Oncology (AIOM).

PubMed

Gori, Stefania; Di Maio, Massimo; Pinto, Carmine; Alabiso, Oscar; Baldini, Editta; Barbato, Enrico; Beretta, Giordano Domenico; Bravi, Stefano; Caffo, Orazio; Canobbio, Luciano; Carrozza, Francesco; Cinieri, Saverio; Cruciani, Giorgio; Dinota, Angelo; Gebbia, Vittorio; Giustini, Lucio; Graiff, Claudio; Molino, Annamaria; Muggiano, Antonio; Pandoli, Giuliano; Puglisi, Fabio; Tagliaferri, Pierosandro; Tomao, Silverio; Venturini, Marco

2011-01-01

In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the "time to patient access" to new anti-cancer drugs in Italian regions. In March 2010, we analyzed the availability of 17 new anti-cancer drugs at a regional level, specifically the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency (AIFA). In the regions with pharmaceutical formularies, we analyzed the characteristics of technical-scientific committees for the evaluation of inclusion of hospital drugs in these formularies. We also analyzed the time from EMA (CMPH) authorization to AIFA marketing authorization, the time from AIFA marketing authorization to patient availability, and the total time from EMA (CMPH) authorization to patient availability of the drugs in all Italian regions, for 11 of these drugs. Some drugs were included in all the regional pharmaceutical formularies, without restrictions, whereas other drugs were not included in one and others were not included in more than one formulary. Median time from EMA to AIFA was 11.2 months (range, 2.9-17.1). Median time from AIFA to patient availability was 1.4 months (range, 0.0-50.5) in regions with drug formularies versus 0.0 months in regions without drugs formularies. Median total time from EMA to patient availability was longer in regions with formularies (13.3 months; range, 2.9-65.3) than in regions without formularies (11.2 months; range, 2.9-24.0), where drugs are immediately available after AIFA marketing authorization. Moreover, the interval was very long (range, 2.9-65.3) for some drugs in regions with formularies. The analysis confirmed that the presence of multiple hierarchical levels of drug evaluation can create disparity in drug availability for Italian citizens.

77 FR 38019 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Retail...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... prescriptions approved through the non-formulary special approval process that validates the medical necessity... the process for formulary placement of newly approved drugs; streamline the process for updating... clarify the process for formulary placement of newly approved drugs by the Food and Drug Administration...

Pricing strategies for combination pediatric vaccines based on the lowest overall cost formulary.

PubMed

Behzad, Banafsheh; Jacobson, Sheldon H; Sewell, Edward C

2012-10-01

This paper analyzes pricing strategies for US pediatric combination vaccines by comparing the lowest overall cost formularies (i.e., formularies that have the lowest overall cost). Three pharmaceutical companies compete pairwise over the sale of monovalent and combination vaccines. Particular emphasis is placed on examining the price of Sanofi Pasteur's DTaP-IPV/HIb under different conditions. The main contribution of the paper is to provide the lowest overall cost formularies for different prices of DTaP-IPV/HIb and other Sanofi Pasteur vaccines. The resulting analysis shows that DTaP-IPV/HIb could have been more competitively priced compared with the combination vaccine DTaP-HepB-IPV, for federal contract prices in 2009, 2010 and 2011. This study also proposes the lowest overall cost formularies when shortages of monovalent vaccines occur.

Evidence-based and value-based formulary guidelines.

PubMed

Neumann, Peter J

2004-01-01

Health plans and hospitals have long used drug formularies, but the processes by which formulary committees made decisions have typically lacked transparency and scientific rigor. A growing number of organizations have begun implementing formulary guidelines issued by the Academy of Managed Care Pharmacy (AMCP). These guidelines call for health plans to request formally that drug companies present a standardized "dossier" that contains detailed information not only on the drug's effectiveness and safety but also on its economic value relative to alternative therapies. This paper describes the guidelines, reviews progress to date, and analyzes several critical issues for the future.

Sharing resources to create a district drug formulary: a countywide controlled trial.

PubMed Central

Hill-Smith, I

1996-01-01

BACKGROUND: Creating a drug formulary takes considerable time, but merely adopting one lacks local perspective and ownership. Sharing resources between several practices treads a middle path between these extremes, but is it effective? AIM: The aim of the study was to audit the influence of a district primary care drug formulary on prescribing by general practitioners. METHOD: A controlled trial was carried out to compare prescribing by 50 general practitioners from 11 urban and semirural practices in south Bedfordshire that participated in creating a district drug formulary with prescribing by all other general practitioners in the county. RESULTS: The proportion of prescription items that were for drugs listed in the formulary rose significantly in three therapeutics groups: cardiovascular (by 7-12% above control practice values); musculoskeletal (by 1-11% above control practice values); and obstetrics and gynaecology (by 6-9% above control practice values). The number of items prescribed per prescribing unit fell significantly in three therapeutic groups: musculoskeletal (by 1-7% below control practice values); nervous (by 7-12% below control practice values); and nutrition and blood (by 15-21% below control practice values). The estimated saving resulting from the creation of the formulary was 150,000 pounds (3000 pounds per doctor) per year. CONCLUSIONS: Sharing resources between practices to create a district-wide primary care drug formulary can lead to changes in prescribing and reduce costs sustained over 3 years. PMID:8762741

Angiotensin receptor blockers on the formularies of Medicare drug plans.

PubMed

Gellad, Walid F; Huskamp, Haiden A; Phillips, Kathryn A; Haas, Jennifer S

2007-08-01

The presence of angiotensin receptor blockers (ARBs) on the formularies of Medicare Part D prescription drug plans (PDPs) is vitally important to the health of seniors who cannot tolerate angiotensin-converting enzyme (ACE) inhibitors. To determine whether ARBs are present on the formularies of PDPs and how the prescription cost-sharing for ARBs under Part D compares to cost-sharing before Part D. Cross-sectional analyses of March 2006 Medicare Part D formularies (n = 1,446) and of ARB utilization and cost-sharing for adults over the age of 64 included in the nationally representative Medical Expenditure Panel Survey. (1) Presence of ARBs on Part D formularies. (2) Average out-of-pocket costs for 30-day supply of ARBs before and after Part D (both in 2006 dollars). All PDP formularies included at least 1 ARB. Most plans covered 2 ARBs (41%) and 35% covered all 7. The average monthly copay for the most commonly used ARB, valsartan, is $28 under part D, $14 before Part D for individuals with prescription coverage, and $53 before Part D for individuals without coverage. Whereas ARBs are present on all Part D formularies, many seniors will pay more for these drugs under Part D. Any savings in copayments under Part D may be erased by the monthly premium and by more expensive cost-sharing when seniors reach the 'donut hole'.

Effects of Guideline and Formulary Changes on Statin Prescribing in the Veterans Affairs.

PubMed

Markovitz, Adam A; Holleman, Rob G; Hofer, Timothy P; Kerr, Eve A; Klamerus, Mandi L; Sussman, Jeremy B

2017-12-01

To compare the effects of two sequential policy changes-the addition of a high-potency statin to the Department of Veterans Affairs (VA) formulary and the release of the American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines-on VA provider prescribing. Retrospective analysis of 1,100,682 VA patients, 2011-2016. Interrupted time-series analysis of changes in prescribing of moderate-to-high-intensity statins among high-risk patients and across high-risk subgroups. We also assessed changes in prescribing of atorvastatin and other statin drugs. We estimated marginal effects (ME) of formulary and guideline changes by comparing predicted and observed statin use. Data from VA Corporate Data Warehouse. The use of moderate-to-high-intensity statins increased by 2 percentage points following the formulary change (ME, 2.4, 95% confidence interval [CI], 2.2 to 2.6) and less than 1 percentage point following the guideline change (ME, 0.8, 95% CI, 0.6 to 0.9). The formulary change led to approximately a 12 percentage-point increase in the use of moderate-to-high-intensity atorvastatin (ME, 11.5, 95% CI, 11.3 to 11.6). The relatively greater provider response to the formulary change occurred across all patient subgroups. Addition of a high-potency statin to formulary affected provider prescribing more than the ACC/AHA guidelines. © Health Research and Educational Trust.

The British National Formulary: Checking, medicines and clinicians.

PubMed

Dickson, Jane

2015-01-01

The British National Formulary underpins the way medical practice is made safe in the UK. Its move from book to digital product has been identified as welcome but with problematic aspects. This chapter describes and investigates the current use of the formulary in order to examine how a rapid, well-targeted project is designed and executed.

42 CFR 423.578 - Exceptions process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... request is the therapeutic equivalent, as defined in § 423.100, of any other drug on the plan's formulary... sponsor required to cover a non-preferred drug at the generic drug cost-sharing level if the plan... provided for a non-formulary drug. (3) If the Part D plan sponsor covers a non-formulary drug, the cost(s...

42 CFR 423.578 - Exceptions process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... request is the therapeutic equivalent, as defined in § 423.100, of any other drug on the plan's formulary... sponsor required to cover a non-preferred drug at the generic drug cost-sharing level if the plan... provided for a non-formulary drug. (3) If the Part D plan sponsor covers a non-formulary drug, the cost(s...

Institutional formularies: the relevance of pharmacoeconomic analysis to formulary decisions.

PubMed

Lipsy, R J

1992-04-01

Formularies, in one form or another, have been in existence for nearly 100 years. Beginning simply as a list of available agents, the formulary has evolved into a complex system which acts as a guide to prescribing practices. As the importance of the formulary has increased, so has the need for formulary managers to make an appropriate decision about each drug's formulary status. Several systematic approaches to drug evaluations have been developed to aid in the decision process. However, while some reviews of drug utilisation contain fairly rigorous analyses of their clinical efficacy, very few include an economic evaluation that goes beyond the cost of drug acquisition, preparation, distribution and administration. This is surprising, since formulary managers rank economic data second only to clinical data when making formulary decisions. In the past this apparent oversight has been due, in part, to the absence of a sophisticated model which can both approximate a drug's true economic impact and express cost and quality in similar terms. The explosion of new and very expensive biotechnology drugs into the market has the potential to improve patient care significantly. Such drugs also have the potential to increase institutional pharmacy budgets significantly; with some analysts predicting a spending of $US60 million yearly for these drugs by the year 2000, critical evaluation will be mandatory. Fortunately, advances in the relatively new science of pharmacoeconomics have made it possible to conduct appropriate estimates of the true economic impact of new drug therapies. Pharmacoeconomic studies can be very useful in evaluating drugs for formulary inclusion and in assessing the effects of formulary changes on institutional budgets. Cost-effectiveness and cost-benefit analyses, utilising decision analysis models and/or data gathered from clinical studies, are used most frequently. Relatively simple models can be used to evaluate drugs within the same class if sufficient published data on their clinical efficacy and safety are available. More complex analyses are necessary when comparing dissimilar agents or when comparing agents with non-drug therapy. Pharmacoeconomic studies have frequently been used to demonstrate that very substantial direct costs of drug therapy are often offset by equal or greater reductions in other institutional direct and indirect patient care costs. Pharmacoeconomic studies have also been used to calculate the relative cost-effectiveness of drug therapies for different disease states, although such evaluations are more useful to governmental and regulatory agencies than to individual institutions.(ABSTRACT TRUNCATED AT 400 WORDS)

Simeprevir Capsules

PubMed Central

Levien, Terri L.; Baker, Danial E.

2014-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The April 2014 monograph topics are dapagliflozin, tasimelteon, treprostinil diolamine, avarofloxacin, and idelalisib. The DUE/MUE is on dapagliflozin. PMID:24958945

Doxylamine Succinate/Pyridoxine Hydrochloride

PubMed Central

Cada, Dennis J.; Demaris, Kendra; Levien, Terri L.; Baker, Danial E.

2013-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available online. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The October 2013 monograph topics are afatinib, ferric carboxymaltose, cangrelor, vedolizumab, and albiglutide. The DUE/MUE is on afatinib. PMID:24421551

Sacubitril/Valsartan

PubMed Central

Cada, Dennis J.; Baker, Danial E.; Leonard, James

2015-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The December 2015 monograph topics are rolapitant, insulin degludec, flibanserin, coagulation factor IX (recombinant), and grazoprevir/elbasvir. The Safety MUE is on rolapitant. PMID:27621510

Suvorexant

PubMed Central

Cada, Dennis J.; Levien, Terri L.; Baker, Danial E.

2015-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The January 2015 monograph topics are ledipasvir/sofosbuvir, eliglustat, naloxegol, pembrolizumab, and dulaglutide injection. The Safety MUE is on ledipasvir/sofosbuvir. PMID:25684802

Assessment of formulary development in a small hospital.

PubMed

Holt, R T; Larson, D S; Scheil, E S

1988-07-01

The development of a formulary system in a 138 bed hospital is evaluated. A description of the process used in completing the formulary is provided as well as the assertion that the small hospital has advantages in initiating this process. The results of the study show a 40% decrease in the number of drug line items and a $14,901 (36%) reduction in inventory. Improvement in departmental organization is noted as well as a positive psychological impact. As the prospective payment system increases the need to control costs and improve efficiency, the formulary system is seen as an important step in addressing these concerns.

How to develop a proactive formulary system.

PubMed

Crane, V S; Gonzalez, E R; Hull, B L

1994-10-01

To develop a quality formulary system, a proactive approach is necessary. This approach incorporates a prospective product and concurrent product analyses. A prospective product analysis, in turn, involves a review of current formulary agents, those likely to enter the marketplace shortly, and the formation of an expert review panel. This panel's tasks are to examine therapeutic, economic, and humanistic aspects of therapy and to set initial parameters for appropriate and cost-effective use of accepted products. Keys to a successful formulary system are to continuously monitor drug use and compliance with criteria and to work collaboratively with all institutional professionals in the development, implementation, and monitoring of the system.

Using RxNorm for cross-institutional formulary data normalization within a distributed grid-computing environment.

PubMed

Wynden, Rob; Anderson, Nick; Casale, Marco; Lakshminarayanan, Prakash; Anderson, Kent; Prosser, Justin; Errecart, Larry; Livshits, Alice; Thimman, Tim; Weiner, Mark

2011-01-01

Within the CTSA (Clinical Translational Sciences Awards) program, academic medical centers are tasked with the storage of clinical formulary data within an Integrated Data Repository (IDR) and the subsequent exposure of that data over grid computing environments for hypothesis generation and cohort selection. Formulary data collected over long periods of time across multiple institutions requires normalization of terms before those data sets can be aggregated and compared. This paper sets forth a solution to the challenge of generating derived aggregated normalized views from large, distributed data sets of clinical formulary data intended for re-use within clinical translational research.

Access to new cardiovascular therapies in Canadian hospitals: a national survey of the formulary process.

PubMed

Shalansky, Stephen J; Virk, Roohina; Ackman, Margaret; Jackevicius, Cynthia; Kertland, Heather; Tsuyuki, Ross; Humphries, Karin

2003-02-01

Access to new therapies in hospitals depends upon both clinical trial evidence and local Pharmacy and Therapeutics (P&T) committee approval. The process of formulary evaluation by P&T committees is not well-understood. To describe the formulary decision-making process in Canadian hospitals for cardiovascular medications recently made available on the Canadian market. Postal survey of hospital pharmacy directors in all Canadian hospitals with more than 50 beds. Target drugs included abciximab, enoxaparin, dalteparin, clopidogrel, eptifibatide and tirofiban. Of 428 surveys mailed, responses were received from 164 P&T committees representing 350 hospitals for an effective response rate of 82%. While physicians make up the largest proportion of committee membership, pharmacists play an influential role. Information most commonly cited as influencing formulary decisions included published clinical trials (97%), regional guidelines (90%), pharmacoeconomic data (84%), decisions at peer hospitals (73%) and local opinion leaders (60%). However, this information was often not required on formulary applications. Approval timelines varied widely for target medications but there were no regional, hospital or P&T committee characteristics that were independent predictors of early formulary application or approval. There is wide variability in the time taken for Canadian institutions to adopt new cardiovascular therapies, which is not explained by regional, hospital or P&T committee characteristics. Standardization of the formulary application and evaluation processes, including sharing of information amongst institutions, would lead to broader understanding of the applicable issues, more objectivity and improved efficiency.

Do drug formulary policies reflect evidence of value?

PubMed

Neumann, Peter J; Lin, Pei-Jung; Greenberg, Dan; Berger, Marc; Teutsch, Steven; Mansley, Edward; Weinstein, Milton C; Rosen, Allison B

2006-01-01

To investigate the extent to which preferred drug lists and tiered formularies reflect evidence of value, as measured in published cost-utility analyses (CUAs). Using 1998-2001 data from a large registry of cost-effectiveness analyses, we examined the 2004 Florida Medicaid preferred drug list and the 2004 Harvard Pilgrim Pharmacy Program 3-tier formulary, and compared cost-utility ratios (standardized to 2002 US dollars) of drugs with preferred and nonpreferred status. Few drugs on the formularies had any cost-utility data available. Of those that did, median cost-utility ratios were somewhat higher (less favorable) for Florida's preferred drugs compared with the nonpreferred drugs (25,465 dollars vs 13,085 dollars; P = .09). Ratios did not differ for drugs on tiers 1 and 2 of the Harvard Pilgrim formulary, although they were higher for tier 3 and for excluded drugs (18,309 dollars, 18,846 dollars, 52,119 dollars, and 22,580 dollars, respectively; P = .01). Among therapies reported to be cost-saving or to have cost-utility ratios below 50,000 dollars, 77% had favored status in Florida Medicaid and 73% in Harvard Pilgrim. Among dominated drug interventions (reported to be more costly and less effective than alternatives), 95% had favored status in Florida Medicaid and 56% in Harvard Pilgrim. This study underscores the paucity of published cost-utility data available to formulary committees. Some discrepancies prevail between the value of drugs, as reflected in published cost-utility ratios, and the formulary placement policies of 2 large health plans.

Comparison of tiered formularies and reference pricing policies: a systematic review

PubMed Central

Morgan, Steve; Hanley, Gillian; Greyson, Devon

2009-01-01

Objectives To synthesize methodologically comparable evidence from the published literature regarding the outcomes of tiered formularies and therapeutic reference pricing of prescription drugs. Methods We searched the following electronic databases: ABI/Inform, CINAHL, Clinical Evidence, Digital Dissertations & Theses, Evidence-Based Medicine Reviews (which incorporates ACP Journal Club, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, Database of Abstracts of Reviews of Effectiveness, Health Technology Assessments and NHS Economic Evaluation Database), EconLit, EMBASE, International Pharmaceutical Abstracts, MEDLINE, PAIS International and PAIS Archive, and the Web of Science. We also searched the reference lists of relevant articles and several grey literature sources. We sought English-language studies published from 1986 to 2007 that examined the effects of either therapeutic reference pricing or tiered formularies, reported on outcomes relevant to patient care and cost-effectiveness, and employed quantitative study designs that included concurrent or historical comparison groups. We abstracted and assessed potentially appropriate articles using a modified version of the data abstraction form developed by the Cochrane Effective Practice and Organisation of Care Group. Results From an initial list of 2964 citations, 12 citations (representing 11 studies) were deemed eligible for inclusion in our review: 3 studies (reported in 4 articles) of reference pricing and 8 studies of tiered formularies. The introduction of reference pricing was associated with reduced plan spending, switching to preferred medicines, reduced overall drug utilization and short-term increases in the use of physician services. Reference pricing was not associated with adverse health impacts. The introduction of tiered formularies was associated with reduced plan expenditures, greater patient costs and increased rates of non-compliance with prescribed drug therapy. From the data available, we were unable to examine the hypothesis that tiered formulary policies result in greater use of physician services and potentially worse health outcomes. Conclusion The available evidence does not clearly differentiate between reference pricing and tiered formularies in terms of policy outcomes. Reference pricing appears to have a slight evidentiary advantage, given that patients’ health outcomes under tiered formularies have not been well studied and that tiered formularies are associated with increased rates of medicine discontinuation. PMID:21603047

Variation in Formulary Management Practices Within the Department of Veterans Affairs Health Care System.

PubMed

Radomski, Thomas R; Good, Chester B; Thorpe, Carolyn T; Zhao, Xinhua; Marcum, Zachary A; Glassman, Peter A; Lowe, John; Mor, Maria K; Fine, Michael J; Gellad, Walid F

2016-02-01

All Department of Veterans Affairs Medical Centers (VAMCs) operate under a single national drug formulary, yet substantial variation in prescribing and spending exists across facilities. Local management of the national formulary may differ across VAMCs and may be one cause of this variation. To characterize variation in the management of nonformulary medication requests and pharmacy and therapeutics (P&T) committee member perceptions of the formulary environment at VAMCs nationwide. We performed an online survey of the chief of pharmacy and an additional staff pharmacist and physician on the P&T committee at all VAMCs. Respondents were asked questions regarding criteria for use for nonformulary medications, specific procedures for ordering nonformulary medications in general and specific lipid-lowering and diabetes agents, the appeals process, and the formulary environment at their VAMCs. We compared responses across facilities and between chiefs of pharmacy, pharmacists, and physicians. A total of 212 chief pharmacists (n = 80), staff pharmacists (n = 78), and physicians (n = 54) responded, for an overall response rate of 49%. In total, 107/143 (75%) different VAMCs were represented. The majority of VAMCs reported adhering to national criteria for use, with 38 (36%) being very adherent and 69 (65%) being mostly adherent. There was substantial variation between VAMCs regarding how nonformulary drugs were ordered, evaluated, and appealed. The nonformulary lipid-lowering drugs ezetimibe, rosuvastatin, and atorvastatin were viewable to providers in the order entry screen at 67 (63%), 67 (63%), and 64 (60%) VAMCs, respectively. The nonformulary diabetes medication pioglitazone was only viewable at 58 (55%) VAMCs. In the remaining VAMCs, providers could not order these nonformulary drugs through the normal order-entry process. For questions about the formulary environment, physician respondent perceptions differed from those of staff pharmacists and chief pharmacists. Compared with pharmacy chiefs and staff pharmacists, physicians were less likely to agree that providers at their VAMC prescribed too many nonformulary medications (47% and 44% vs. 12%, P < 0.001), more likely to agree that providers must jump through too many hoops to prescribe nonformulary medication (5% and 3% vs. 25%, P < 0.001), and more likely to agree that providers make an effort to convert new patients from nonformulary to formulary lipid-lowering (65% and 73% vs. 94%, P <0.02) and diabetic medications (49% and 50% vs. 88%, P < 0.001). Although the Department of Veterans Affairs (VA) operates under a single national formulary, we found significant differences among VAMCs regarding their management of nonformulary medication requests. We also found differences among formulary leaders regarding their perception of the environment in which their VAMC's formulary is managed. These findings have important implications not just for VA, but for any organization that develops, implements, and manages drug formularies across multiple facilities.

Oritavancin diphosphate.

PubMed

Cada, Dennis J; Baker, Danial E

2014-12-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The December 2014 monograph topics are olodaterol, peginterferon beta-1a, testosterone nasal gel, ferric citrate corredination complex, and safinamide. The Safety MUE is on olodaterol.

Formulary evaluation of third-generation cephalosporins using decision analysis.

PubMed

Cano, S B; Fujita, N K

1988-03-01

A structured, objective approach to formulary review of third-generation cephalosporins using the decision-analysis model is described. The pharmacy and therapeutics (P&T) committee approved the evaluation criteria for this drug class and assigned priority weights (as percentages of 100) to those drug characteristics deemed most important. Clinical data (spectrum of activity, pharmacokinetics, adverse effects, and stability) and financial data (cost of acquisition and cost of therapy per day) were used to determine ranking scores for each drug. Total scores were determined by multiplying ranking scores by the assigned priority weights for the criteria. The two highest-scoring drugs were selected for inclusion in the formulary. By this decision-analysis process, the P&T committee recommended that all current third-generation cephalosporins (cefotaxime, cefoperazone, and moxalactam) be removed from the institutions's formulary and be replaced with ceftazidime and ceftriaxone. P&T committees at other institutions may structure their criteria differently, and different recommendations may result. Using decision analysis for formulary review may promote rational drug therapy and achieve cost savings.

Integrating clinical pharmacists into the primary health care team: a framework for rational and cost-effective prescribing.

PubMed

Hamley, J H; MacGregor, S H; Dunbar, J A; Cromarty, J A

1997-02-01

A recent Audit Commission report into general practice prescribing identifies areas where general practitioner and pharmacist collaboration could be beneficial. Two such areas are formulary development and repeat prescribing review. Increased generic prescribing is encouraged in the report and in central priorities for Scottish Health Boards. This study was designed to develop and assess the effects on prescribing, of a practice formulary and a procedure for change to generic name prescribing. A practice formulary, standards for generic name prescribing and an approach to prescribing review were agreed, developed and implemented. Formulary compliance and the extent of prescribing generically and of changes to generic prescriptions were assessed by prospective prescription monitoring. Consultations resulting in a prescription reduced from 69% to 59% and 80% of acute prescribing events were met from 144 formulary medicines. Rapid change to generic name prescriptions was achieved without patient complaints and the overall generic prescribing level increased from 57% to 68%. Eighty percent of all new prescriptions were generic.

Factors associated with prescribing restriction on oncology formulary drugs in Malaysia.

PubMed

Fatokun, Omotayo; Olawepo, Michael N

2016-10-01

Background Drugs listed on formularies are often subjected to a variety of utilization restriction measures. However, the degree of restriction is influenced by multiple factors, including the characteristics and attributes of the listed drugs. Objective To identify the factors that are associated with the levels of prescribing restriction on oncology formulary drugs in Malaysia. Setting Oncology formulary in Malaysia. Method The Malaysia Drug Code assigned to each of the drug products on the Malaysia Ministry of Health (MOH) drug formulary was used to identify oncology drugs belonging to WHO ATC class L (antineoplastic and immunomodulating agents). Main outcome measures Categories of prescribing restrictions, therapeutic class, drug type, administration mode, number of sources and the post-approval use period. Results Oncology drugs having a shorter post-approval use period (p < 0.001), biologic oncology drugs (p = 0.01) and oncology drugs belonging to immunosuppressant therapeutic class (p = 0.03) were all significantly associated with a greater likelihood of being subjected to a higher level of prescribing restriction. Conclusion This study suggests that safety concerns, costs and potentials for inappropriate use were the important considerations influencing a higher level of prescribing restriction placement on oncology drugs in the Malaysia MOH drug formulary.

Effects of electronic prescribing on formulary compliance and generic drug utilization in the ambulatory care setting: a retrospective analysis of administrative claims data.

PubMed

Ross, S Michael; Papshev, Diana; Murphy, Erin L; Sternberg, David J; Taylor, Jeffrey; Barg, Ronald

2005-06-01

Electronic prescribing (e-prescribing) provides formulary information at the point of care. The objective of this study was to assess the effects of e-prescribing on formulary compliance and generic utilization. This was a retrospective analysis of pharmacy claims data from a large national managed care organization. A sample of 95 providers using predominantly e-prescribing was randomly selected (e-prescriber group). A matched sample of 95 traditional prescribers was selected (traditional prescriber group), matched to the e-prescriber group by zip code and medical specialty. A total of 110,975 paid pharmacy claims, for the 12 months from August 1, 2001, through July 31, 2002, were analyzed to assess the effect of e-prescribing on formulary compliance and generic utilization. All paid pharmacy claims were examined for each group; for the e-prescriber group, this included all claims, not just those prescribed using an e-prescribing device. A written qualitative survey was distributed to physicians and office managers to assess e-prescribing usage, sources of formulary information, and effects of e-prescribing on office resources. Both predominantly e-prescribers and traditional prescribers demonstrated high levels of formulary compliance, 83.2% versus 82.8%, respectively (P=0.32). Formulary compliance for these groups did not differ from the overall prescriber population (82.0%). There was not a difference in generic drug utilization rates between e-prescribers and traditional prescribers (absolute rates 37.3% versus 36.9%, P=0.18). Qualitative survey responses supported previously reported research indicating reductions in calls both to and from pharmacies for prescription orders. An examination of paid pharmacy claims from a large, national managed care organization demonstrated no differences between predominantly e-prescribers and traditional prescribers in measures of formulary compliance or generic drug utilization. Future studies should examine keystroke data at the point of care to observe more detail about drug selection methods.

Formulary Drug Review: Betrixaban.

PubMed

Baker, Danial E

2018-02-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Formulary Drug Review: Ocrelizumab.

PubMed

Ali, Zaynah K; Baker, Danial E

2017-10-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Formulary Drug Reviews: Glecaprevir/Pibrentasvir.

PubMed

Levien, Terri L; Baker, Danial E

2018-04-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Formulary Drug Review: Edaravone.

PubMed

Ali, Zaynah K; Baker, Danial E

2017-12-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

The arrival of economic evidence in managed care formulary decisions: the unsolicited request process.

PubMed

Neumann, Peter J

2005-07-01

Managed care plans have traditionally resisted using economic evidence explicitly in drug formulary decisions, even as they used ever more aggressive and sophisticated processes for managing care. In recent years, this has changed as health plans have begun to adopt evidence-based and value-based formulary submission guidelines. The guidelines have the potential to serve as a national unifying template for pharmacy and therapeutics committees to consider clinical and economic information in a systematic and rigorous fashion. However, many questions remain about their use and about the nature of communications (called "unsolicited requests") from plans to drug companies for information. This article describes the unsolicited request process and its potential impact on the use of economic evidence in formulary decisions.

Implementing CER: what will it take?

PubMed

Biskupiak, Joseph E; Dunn, Jeffrey D; Holtorf, Anke-Peggy

2012-06-01

Comparative effectiveness research (CER) is undeniably changing how drugs are developed, launched, priced, and reimbursed in the United States. But most organizations are still evaluating what CER can do for them and how and when they can utilize the data. A roundtable of stakeholders, including formulary decision makers, evaluated CER's possible effects on managed care organizations (MCOs) and what it may take to fully integrate CER into decision making. To examine the role of CER in current formulary decision making, compare CER to modeling, discuss ways CER may be used in the future, and describe CER funding sources. While decision makers from different types of organizations, such as pharmacy benefit management (PBM) companies and MCOs, may have varying definitions and expectations of CER, most thought leaders from a roundtable of stakeholders, including formulary decision makers, see value in CER's ability to enhance their formulary decision making. Formulary decision makers may be able to use CER to better inform their coverage decisions in areas such as benefit design, contracting, conditional reimbursement, pay for performance, and other alternative pricing arrangements. Real-world CER will require improvement in the health information technology infrastructure to better capture value-related information. The federal government is viewed as a key driver and funding source behind CER, especially for infrastructure and methods development, while industry will adapt the clinical development and create increasing CER evidence. CER then needs to be applied to determining value (or cost efficacy). It is expected that CER will continue to grow as a valuable component of formulary decision making. Future integration of CER into formulary decision making will require federal government and academic leadership, improvements in the health information technology infrastructure, ongoing funding, and improved and more consistent methodologies.

The effect of three-tier formulary adoption on medication continuation and spending among elderly retirees.

PubMed

Huskamp, Haiden A; Deverka, Patricia A; Landrum, Mary Beth; Epstein, Robert S; McGuigan, Kimberly A

2007-10-01

To assess the effect of three-tier formulary adoption on medication continuation and spending among elderly members of retiree health plans. Pharmacy claims and enrollment data on elderly members of four retiree plans that adopted a three-tier formulary over the period July 1999 through December 2002 and two comparison plans that maintained a two-tier formulary during this period. We used a quasi-experimental design to compare the experience of enrollees in intervention and comparison plans. We used propensity score methods to match intervention and comparison users of each drug class and plan. We estimated repeated measures regression models for each class/plan combination for medication continuation and monthly plan, enrollee, and total spending. We estimated logit models of the probability of nonpersistent use, medication discontinuation, and medication changes. We used pharmacy claims to create person-level drug utilization and spending files for the year before and year after three-tier adoption. Three-tier formulary adoption resulted in shifting of costs from plan to enrollee, with relatively small effects on medication continuation. Although implementation had little effect on continuation on average, a small minority of patients were more likely to have gaps in use and discontinue use relative to comparison patients. Moderate cost sharing increases from three-tier formulary adoption had little effect on medication continuation among elderly enrolled in retiree health plans with relatively generous drug coverage.

77 FR 34356 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary. Meeting Agenda 1. Sign-In. 2. Welcome and Opening Remarks. 3. Public Citizen Comments. 4. Scheduled Therapeutic...

76 FR 50720 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary. Meeting Agenda 1. Sign-In. 2. Welcome and Opening Remarks. 3. Public Citizen Comments. 4. Scheduled Therapeutic Class...

77 FR 50088 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-20

... Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary. Meeting Agenda: 1. Sign-In. 2. Welcome and Opening Remarks. 3. Public Citizen Comments. 4. Scheduled Therapeutic...

78 FR 33074 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary. Meeting Agenda 1. Sign-In 2. Welcome and Opening Remarks 3. Public Citizen Comments 4. Scheduled Therapeutic...

78 FR 74120 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

... Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary. Meeting Agenda 1. Sign-In 2. Welcome and Opening Remarks 3. Public Citizen Comments 4. Scheduled Therapeutic...

Formulary Drug Review: Naldemedine.

PubMed

Baker, Danial E

2017-07-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The September 2017 monograph topics are brigatinib, durvalumab, edaravone, midostaurin, and sarilumab. The MUE is on sarilumab.

The Effect of Three-Tier Formulary Adoption on Medication Continuation and Spending among Elderly Retirees

PubMed Central

Huskamp, Haiden A; Deverka, Patricia A; Landrum, Mary Beth; Epstein, Robert S; McGuigan, Kimberly A

2007-01-01

Objective To assess the effect of three-tier formulary adoption on medication continuation and spending among elderly members of retiree health plans. Data Sources Pharmacy claims and enrollment data on elderly members of four retiree plans that adopted a three-tier formulary over the period July 1999 through December 2002 and two comparison plans that maintained a two-tier formulary during this period. Study Design We used a quasi-experimental design to compare the experience of enrollees in intervention and comparison plans. We used propensity score methods to match intervention and comparison users of each drug class and plan. We estimated repeated measures regression models for each class/plan combination for medication continuation and monthly plan, enrollee, and total spending. We estimated logit models of the probability of nonpersistent use, medication discontinuation, and medication changes. Data Collection/Extraction Methods We used pharmacy claims to create person-level drug utilization and spending files for the year before and year after three-tier adoption. Principal Findings Three-tier formulary adoption resulted in shifting of costs from plan to enrollee, with relatively small effects on medication continuation. Although implementation had little effect on continuation on average, a small minority of patients were more likely to have gaps in use and discontinue use relative to comparison patients. Conclusions Moderate cost sharing increases from three-tier formulary adoption had little effect on medication continuation among elderly enrolled in retiree health plans with relatively generous drug coverage. PMID:17850526

A P&T Committee’s Transition to a Complete Electronic Meeting System—A Multisite Institution Experience

PubMed Central

Al-Jedai, Ahmed H.; Algain, Roaa A.; Alghamidi, Said A.; Al-Jazairi, Abdulrazaq S.; Amin, Rashid; Bin Hussain, Ibrahim Z.

2017-01-01

Purpose In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. Summary We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. Conclusion The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites. PMID:29018301

A P&T Committee's Transition to a Complete Electronic Meeting System-A Multisite Institution Experience.

PubMed

Al-Jedai, Ahmed H; Algain, Roaa A; Alghamidi, Said A; Al-Jazairi, Abdulrazaq S; Amin, Rashid; Bin Hussain, Ibrahim Z

2017-10-01

In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites.

Pricing of multiple dosage prescription medications: an analysis of the Ontario Drug Benefit Formulary.

PubMed

Lexchin, Joel

2009-07-01

This paper investigates the pricing strategy (perfect flat pricing, perfect monotonic pricing, intermediate) used for multiple dosage medications listed in the Ontario Drug Benefit Formulary. All multiple dosage solid medications containing a single active ingredient newly listed in the Ontario Drug Benefit Formulary between 1996 and 2005 were identified. The relationship between price and dosage was calculated using a previously developed method. Seventy-three multiple dosage medications were introduced. Where medications were equivalent to existing ones in most cases companies followed the pricing strategy used by therapeutically equivalent drugs already in the formulary. Where there were no equivalent products companies did not adopt any particular pricing strategy. There was no difference in the way that companies priced scored tablets versus unscored tablets and capsules or in the way that they priced drugs that had objective measurements of efficacy/effectiveness, for example blood pressure, versus those that did not have these measurements. When Monotonic pricing is used it leads to higher expenditures whereas flat pricing results in lower expenditures and offers more predictability in expenditures. Provincial governments should consider requiring flat pricing in return for formulary listing.

Assessing the impact of wastage on pediatric vaccine immunization formulary costs using a vaccine selection algorithm.

PubMed

Jacobson, Sheldon H; Karnani, Tamana; Sewell, Edward C

2004-06-02

Pediatric immunization is an important factor in providing protection against numerous common preventable diseases. The success of the pharmaceutical industry in developing new pediatric vaccines has resulted in a crowded recommended immunization schedule requiring several clinic visits over the first 12 years of life. Operations research models have been developed and used to make economically sound procurement choices from among a growing number of competing vaccine products. One factor that has not been incorporated into such models is the economic impact of wastage on such decisions. This paper reports results obtained from a vaccine selection algorithm that incorporates vaccine wastage data. The lowest overall cost formularies comparing no wastage costs with wastage costs are presented. A sensitivity analysis of the vaccine formulary with respect to the wastage rates associated with each available vaccine is provided. The maximum permissible wastage rate for each vaccine is determined for which the vaccine earns a place in the lowest overall cost formulary. This research provides health maintenance organizations and healthcare providers information that can be used to gain a better understanding of wastage and its impact on pediatric formulary costs.

Impact of a transition to more restrictive drug formulary on therapy discontinuation and medication adherence.

PubMed

Shirneshan, E; Kyrychenko, P; Matlin, O S; Avila, J P; Brennan, T A; Shrank, W H

2016-02-01

There is conclusive evidence demonstrating that formulary restrictions are associated with reduced utilization and pharmacy spending of the restricted drugs. However, prior efforts to implement restrictive formularies have been associated with inconsistent rates of therapy discontinuation and mixed impacts on adherence to therapy. Also, the impact of transferring patients from an already restrictive formulary to a more aggressive model has not been previously examined. This study evaluated the impact of implementation of a more restrictive formulary on therapy disruption, adherence rates, pharmacy costs and generic utilization among patients with common chronic conditions. In 2014, CVS Health implemented Value Formulary (VF), a restrictive benefit design with the aim of reducing spending while preserving access to and adherence to essential therapy, was used. A retrospective cohort study was conducted to assess changes in therapy disruption rates, pharmacy costs and generic dispensing rate (GDR) (for continuers) and medication adherence (for initiators) following the implementation of VF. The study group was selected from members of three existing employer clients transitioned from standard formulary (SF) to VF on January 2014. The control population was a matched group of six employers with the same preperiod formulary structure, business unit, adherence programmes and patient out-of-pocket cost as the study group. The control group retained SF in 2014. To assess therapy disruption after VF implementation, we categorized patients by their subsequent medication use into three groups: (i) therapy stopped, (ii) therapy continued and (iii) therapy switched. Medication adherence was measured as monthly proportion of days covered (PDC). Pharmacy cost and GDR were measured per utilizer per month (PUPM). Rates of therapy disruption in study and control groups were compared using the chi-square test. Differences in monthly PDC between matched groups were evaluated using multivariate linear regression. Impact of VF on pharmacy cost and GDR was measured through segmented regression of interrupted time series data with generalized estimating equations. A transition from SF to VF influenced drug coverage for approximately 13% of members (as their medications were either no longer covered, or covered restrictively under VF). Compared to patients whose plan sponsors retained SF, the patients that transitioned to VF had a modest (1·3%) but statistically significant increase in therapy discontinuation rates. This was offset by similarly modest improvements in adherence; patients who initiated therapy under VF demonstrated a 1·5% higher adherence to medications as compared to SF patients (P < 0·001). Medication costs in the VF group were lower by $20 PUPM (P < 0·001), and GDR was greater by 4·2% (P < 0·001). Transition of patients to a more restrictive drug formulary led to modest therapy discontinuation, similarly modest improvements in medication adherence and substantial prescription drug cost savings. As healthcare payors search for ways to control the rapid rise in spending for medications without compromising quality, the Value Formulary can serve as a useful tool. © 2016 John Wiley & Sons Ltd.

Formulary Drug Review: Etelcalcetide.

PubMed

Baker, Danial E

2017-11-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The November 2017 monograph topics are Ertugliflozin, Glecaprevir / pibrentasvir, Neratinib, Sofosbuvir, velpatasvir, voxilaprevir and SQ C1 esterase inhibitor. The MUE is on glecaprevir, pibrentasvir.

Implementation of an integrated pharmacy supply management strategy.

PubMed

Amerine, Lindsey B; Calvert, Daniel R; Pappas, Ashley L; Lee, Sarah M; Valgus, John M; Savage, Scott W

2017-12-15

Implementation of an integrated pharmacy supply management strategy is described. In 2011, the formulary approval process and supply management for oncology medications were independent of each other at an oncology infusion center. Numerous nonformulary medications were kept on hand and reordered based on inventory levels that were established with inadequate usage information, while some formulary agents did not have on-hand inventory levels and had to be reordered on a patient-specific basis, which required paperwork and then a review by drug information staff per institutional policy. Because there was no true distinction in the ordering of formulary versus nonformulary oncology agents, the medical staff prescribed both in the same manner, leaving the pharmacy staff responsible for ensuring that enough quantities were on hand for many drugs, regardless of formulary status. Using supply chain management principles, a formal analysis of the on-hand inventory was performed. In addition, the formulary process for oncology drugs was restructured to align with how oncology drugs are managed for on-hand inventory levels. The alignment of these processes allowed the operation to have 1 supply strategy for the ambulatory oncology infusion center. As a result, inventory exhaustion rates were reduced by 70% and inventory turn rates improved by 78%. There was also significant time savings in the operational process streamlining, eliminating the rework and inefficiencies caused by an unclear process that was not fully captured in this assessment. Alignment of the formulary review process with inventory analyses that support supply management principles reduced inventory exhaustion while improving inventory turn rates. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Impact of Drug Policy on Regional Trends in Ezetimibe Use

PubMed Central

Lu, Lingyun; Krumholz, Harlan M.; Tu, Jack V.; Ross, Joseph S.; Ko, Dennis T.; Jackevicius, Cynthia A.

2014-01-01

Background Ezetimibe use has steadily increased in Canada during the past decade even in the absence of evidence demonstrating a beneficial effect on clinical outcomes. Among the 4 most populated provinces in Canada, there is a gradient in the restrictiveness of ezetimibe in public-funded formularies (most to least strict: British Columbia, Alberta, Quebec and Ontario). The impact of formulary policy on the utilization of ezetimibe over time is unknown. Methods and Results We conducted a population-level cohort study using IMS Health Canada’s data from June 2003 to December 2012 to examine ezetimibe use in these 4 provinces to better understand the association between use and formulary restrictiveness. We found regional variations in the patterns of ezetimibe use. From June 2003 to December 2012, British Columbia(most restrictive) had the lowest monthly increasing rate from $261 to $21,926 ($190/100,000 population/month), whereas Ontario (least restrictive) had the most rapid monthly increase from $223 to $74,030 ($ 647/100,000 population/month); Quebec from $130 to $59,690 ($522/100,000 population/month) and Alberta from $356 to $ 37604 ($327/100,000 population/month) were intermediate. (P<0.001) Conclusions Ezetimibe use remains common, increasing over the past decade. Use steadily increased in provinces with the most lenient formularies. In contrast, use was lower, plateauing since 2008 in British Columbia and Alberta, which have more restrictive formularies. The gradient in ezetimibe use was related to variability in restrictiveness of the provincial formularies, illustrating the potential of a policy-response gradient that may be used to more effectively manage medication use. PMID:24895451

Medicare Part D Roulette: Potential Implications of Random Assignment and Plan Restrictions

PubMed Central

Patel, Rajul A.; Walberg, Mark P.; Woelfel, Joseph A.; Amaral, Michelle M.; Varu, Paresh

2013-01-01

Background Dual-eligible (Medicare/Medicaid) beneficiaries are randomly assigned to a benchmark plan, which provides prescription drug coverage under the Part D benefit without consideration of their prescription drug profile. To date, the potential for beneficiary assignment to a plan with poor formulary coverage has been minimally studied and the resultant financial impact to beneficiaries unknown. Objective We sought to determine cost variability and drug use restrictions under each available 2010 California benchmark plan. Methods Dual-eligible beneficiaries were provided Part D plan assistance during the 2010 annual election period. The Medicare Web site was used to determine benchmark plan costs and prescription utilization restrictions for each of the six California benchmark plans available for random assignment in 2010. A standardized survey was used to record all de-identified beneficiary demographic and plan specific data. For each low-income subsidy-recipient (n = 113), cost, rank, number of non-formulary medications, and prescription utilization restrictions were recorded for each available 2010 California benchmark plan. Formulary matching rates (percent of beneficiary's medications on plan formulary) were calculated for each benchmark plan. Results Auto-assigned beneficiaries had only a 34% chance of being assigned to the lowest cost plan; the remainder faced potentially significant avoidable out-of-pocket costs. Wide variations between benchmark plans were observed for plan cost, formulary coverage, formulary matching rates, and prescription utilization restrictions. Conclusions Beneficiaries had a 66% chance of being assigned to a sub-optimal plan; thereby, they faced significant avoidable out-of-pocket costs. Alternative methods of beneficiary assignment could decrease beneficiary and Medicare costs while also reducing medication non-compliance. PMID:24753963

Analysis of the drug formulary and the purchasing process at a Moroccan university medical center.

PubMed

Lachhab, Z; Serragui, S; Hassar, M; Cherrah, Y; Errougani, A; Ahid, S

2018-05-31

To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition. This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center. Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value. With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary.

Proton-pump inhibitor utilization associated with the change to nonpreferred formulary status for esomeprazole in the TRICARE formulary.

PubMed

Linton, Andrea; Bacon, Thomas; Peterson, Michael

2009-01-01

inhibitor (PPI) esomeprazole in the third copayment tier on the TRICARE formulary on July 17, 2005. The change to nonpreferred formulary status for esomeprazole included a $13 copayment increase (from $9.00 to $22.00) for either a 30-day supply purchased from a community pharmacy or a 90-day supply purchased from the mail-order pharmacy and a $0 copayment if obtained from a military pharmacy but with a prior authorization (PA) requirement. The change to nonpreferred formulary status was designed to encourage the use of PPIs other than esomeprazole and to increase the use of the mail-order pharmacy for esomeprazole purchases. To quantify changes in (a) the TRICARE beneficiary utilization of esomeprazole relative to other PPIs and (b) the pharmacy settings used for filling esomeprazole prescriptions following implementation of a copayment increase and nonpreferred formulary status for esomeprazole. A census of outpatient pharmacy fill records for prescription acid-reducing medications (PPIs, histamine-2 blockers, misoprostol, and sucralfate) obtained by beneficiaries aged 18 years or older from January 1, 2005, through December 31, 2006, was examined. Interrupted time series regression analyses without a control group were used to compare the utilization of esomeprazole relative to other PPIs, as well as the pharmacy setting used to obtain esomeprazole, in the months before and after the formulary change. The rates of continued esomeprazole use, switching to other prescription PPIs (lansoprazole, omeprazole, pantoprazole, and rabeprazole), switching to non-PPI prescription acid-reducing drugs, and discontinued prescription acid-reducing medication use among existing esomeprazole users (i.e., beneficiaries who obtained esomeprazole as the last PPI fill before the formulary change) were calculated overall and for each pharmacy setting used prior to the formulary change. Over the 24-month study period from January 1, 2005, through December 31, 2006, the total numbers of PPI fills and PPI users increased by 8.5% and 9.0%, respectively, and the number of esomeprazole users decreased by 4.6%. Of esomeprazole users, the percentages of individuals obtaining esomeprazole from military pharmacies and community pharmacies, respectively, decreased from 1.7% to 1.1% and from 89.7% to 81.7%, while the percentage of individuals obtaining esomeprazole from the mail-order pharmacy increased from 8.8% to 17.6%. Time series analysis yielded a positive, statistically significant growth in esomeprazole fills (beta1=0.114; P=0.012) during the 6-month pre-intervention period (January through June 2005) and a significant reduction in August 2005 (beta2=-5.0%; P<0.001), the month immediately following the formulary change. During the 17-month post-intervention period (August 2005 through December 2006), no statistically significant change in trend for esomeprazole fills (beta3=-0.0265; P=0.534) was observed, although a small increase in the raw number of esomeprazole fills was noted. Among the 117,801 existing esomeprazole users, 86,386 (73.3%) continued using esomeprazole, 17,676 (15.0%) switched to other prescription PPIs, 679 (0.6%) used only non- PPI prescription therapy, and 13,060 (11.1%) discontinued all prescription acid-reducing pharmacotherapy after the formulary change. Significantly higher PPI switching and acid-reducing therapy discontinuation rates were observed among men aged 18-44 years and in TRICARE enrollees relative to women, those over 45 years of age, and those who used other health insurance (P<0.001). Individuals who used military pharmacies, where a PA requirement was implemented, were more likely to change pharmacy settings to obtain esomeprazole (43.8%) than were users of community pharmacies (11.9%) or the mail-order pharmacy (22.8%). Mail-order pharmacy users were less likely to discontinue acid-reducing pharmacotherapy (4.9%) than were community (11.9%) or military (12.9%) pharmacy users (P<0.05). After adjustment for serial correlation, the formulary change was associated with a migration of approximately 5% of all PPI fills and 25% of esomeprazole fills to the preferred PPIs in the first post-intervention month. Over the 17-month post-intervention period, the trend toward increased esomeprazole use was slowed and use of the mail-order pharmacy for esomeprazole fills nearly doubled. Our observed PPI switch rate of 15.0% resembled the rate observed for another insured population that experienced a similar formulary restructuring, but was substantially lower than the rates reported for more sizeable formulary changes. Thus, the present study's copayment differentials for third-tier medications ($19 compared with tier 1 and $13 compared with tier 2 copayments) may be less than the threshold amount required to optimize switching to preferred PPIs.

75 FR 51984 - Federal Advisory Committee; Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

... and Therapeutics Committee regarding the Uniform Formulary. Meeting Agenda Sign-In; Welcome and Opening Remarks; Public Citizen Comments; Scheduled Therapeutic Class Reviews--Ophthalmic Agents...; Panel Discussions and Vote; and comments following each therapeutic class review. Meeting Accessibility...

Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

PubMed

Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y

2018-02-01

The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

Formulary decision-making about cephalosporins with similar therapeutic uses.

PubMed

Mabe, Don M

2003-05-15

The various costs and intangible factors that enter into formulary decisions in an era of increasingly frequent drug product shortages that can adversely affect patient care and increase treatment costs are described. Pharmacy administration at Carolinas HealthCare System analyzed the costs associated with making a formulary switch from the third-generation cephalosporin ceftriaxone to cefotaxime, which recently became available in generic form and has a similar spectrum of antimicrobial activity and therapeutic uses. Hard dollar costs for purchasing drugs and the supplies needed to administer them; soft dollar costs for staff time spent acquiring, preparing, and administering doses; and intangible factors were considered. A reliable supply of drug product from the manufacturer was an important intangible factor because of frequent drug shortages in the past few years and the adverse effect on patient care and the increased soft dollar costs associated with these shortages. Administrators at Carolinas HealthCare System decided not to make the proposed formulary change after weighing the many factors and costs.

Antimicrobial formulary management: meeting the challenge in the community hospital.

PubMed

Rush, D R

1991-01-01

We established a casework approach to develop an antibiotic formulary for a large community hospital. The program consists of a combination of comprehensive clinical and administrative strategies designed to reduce antimicrobial expenditures and improve the quality of antibiotic prescribing. Strategies included a background document summarizing each pharmacologic group of antimicrobial drugs and formulary preferences, presentations to medical and surgical departments, development of drug use evaluation strategies that complement the development of the formulary, and a monitoring program for nonformulary antibiotic use. The development of a customized microbiologic/antibiotic susceptibility report card specific to the institution's inpatient and outpatient microflora was an integral part of the program. This tool also allowed for the continuous compilation of comparison data and development of prescribing tips. Predetermined criteria were established providing physicians with microorganism susceptibility reports and preferred treatment alternatives linked to pharmacoeconomic concerns. These strategies can be implemented with or without direct clinical pharmacotherapy specialist involvement at the individual patient care level.

The formulary process from a risk management perspective.

PubMed

Raber, Jack H

2010-06-01

During their evolution over the past 6 decades, hospital formularies have become more than a list of drugs that an institution keeps in stock. Today, an agent under formulary consideration must be examined not only in light of its relative efficacy, safety, and acquisition cost, but consideration must also be given to the potential indirect costs that accompany its use. Federal regulations have, for some drugs, added layers of administrative actions that must be followed to ensure their appropriate use. Examples of this are risk evaluation and mitigation strategies (REMS) and duties that may be implied or expressly addressed in the black-box warnings associated with some classes of agents and, in isolated instances, specific drugs within a given class. Regulatory interpretation of these programs and warnings has often led to the expectation that the institution providing the agent will implement effective protocols and procedures to minimize the risk of adverse events to a patient in addition to or in accordance with required programs such as REMS. The consequences for failing to meet this expectation can lead to regulatory sanctions; the potential also exists for liability exposure. Risk management principles apply to all levels of the decision-making process for evaluating a new agent for formulary inclusion or when reevaluating an agent's formulary status. Pharmacists play an important role in mitigating these risks by carefully evaluating every agent from a broader perspective.

Creating a Shared Formulary in 7 Critical Access Hospitals

ERIC Educational Resources Information Center

Wakefield, Douglas S.; Ward, Marcia M.; Loes, Jean L.; O'Brien, John; Abbas, Nancy

2010-01-01

Purpose: This paper reports a case study of 7 Critical Access Hospitals' (CAH) and 1 rural referral hospital's successful collaboration to develop a shared formulary. Methods: Study methods included document reviews, interviews with key informants, and use of descriptive statistics. Findings: Through a systematic review and decision process, CAH…

Use of multiattribute utility theory for formulary management in a health system.

PubMed

Chung, Seonyoung; Kim, Sooyon; Kim, Jeongmee; Sohn, Kieho

2010-01-15

The application, utility, and flexibility of the multiattribute utility theory (MAUT) when used as a formulary decision methodology in a Korean medical center were evaluated. A drug analysis model using MAUT consisting of 10 steps was designed for two drug classes of dihydropyridine calcium channel blockers (CCBs) and angiotensin II receptor blockers (ARBs). These two drug classes contain the most diverse agents among cardiovascular drugs on Samsung Medical Center's drug formulary. The attributes identified for inclusion in the drug analysis model were effectiveness, safety, patient convenience, and cost, with relative weights of 50%, 30%, 10%, and 10%, respectively. The factors were incorporated into the model to quantify the contribution of each attribute. For each factor, a utility scale of 0-100 was established, and the total utility score for each alternative was calculated. An attempt was made to make the model adaptable to changing health care and regulatory circumstances. The analysis revealed amlodipine besylate to be an alternative agent, with the highest total utility score among the dihydropyridine CCBs, while barnidipine hydrochloride had the lowest score. For ARBs, losartan potassium had the greatest total utility score, while olmesartan medoxomil had the lowest. A drug analysis model based on the MAUT was successfully developed and used in making formulary decisions for dihydropyridine CCBs and ARBs for a Korean health system. The model incorporates sufficient utility and flexibility of a drug's attributes and can be used as an alternative decision-making tool for formulary management in health systems.

Multiattribute evaluation in formulary decision making as applied to calcium-channel blockers.

PubMed

Schumacher, G E

1991-02-01

The use of multiattribute utility theory (MAUT) to make a formulary decision involving calcium-channel blockers (CCBs) is described. The MAUT method is a procedure for identifying, characterizing, and comparing the many variables that may affect a decision. Although applications in pharmacy have been infrequent, MAUT should be particularly appealing to formulary committees. The steps of the MAUT method are (1) determine the viewpoint of the decision makers, (2) identify the decision alternatives, (3) identify the attributes to be evaluated, (4) identify the factors to be used in evaluating the attributes, (5) establish a utility scale for scoring each factor, (6) transform the values for each factor to its utility scale, (7) determine weights for each attribute and factor, (8) calculate the total utility score for each decision alternative, (9) determine which decision alternative has the greatest total score, and (10) perform a sensitivity analysis. The viewpoint of a formulary committee in a health maintenance organization was simulated to develop a model for using the MAUT method to compare CCBs for single-agent therapy of chronic stable angina in ambulatory patients for one year. The attributes chosen were effectiveness, safety, patient acceptance, and cost and weighted 36%, 29%, 21%, and 14%, respectively, as contributions to the evaluation. The rank order of the decision alternatives was (1) generic verapamil, (2) brand-name verapamil, (3) diltiazem, (4) nicardipine, and (5) nifedipine. The MAUT method provides a standardized yet flexible format for comparing and selecting among formulary alternatives.

Impact of Maine's Medicaid drug formulary change on non-Medicaid markets: spillover effects of a restrictive drug formulary.

PubMed

Wang, Y Richard; Pauly, Mark V; Lin, Y Aileen

2003-10-01

Market penetration of HMOs affect physician practice styles for non-HMO patients. To study the impact of a restrictive Medicaid drug formulary on prescribing patterns for other patients, ie, so-called spillover effects. A before-and-after, 3-state comparison study. On January 1, 2001, Maine's Medicaid program implemented a restrictive drug formulary for the proton pump inhibitor class, with pantoprazole as the only preferred drug. The Medicaid and non-Medicaid market shares of pantoprazole in Maine (vs New Hampshire and Vermont and among Maine physicians with different Medicaid share of practice. After 3 months, the market share of pantoprazole in Maine (vs 2 control states) increased 79% among Medicaid prescriptions (vs 1%-2%), 10% among cash prescriptions (vs 3%), and 7% among other third-party payer prescriptions (vs 1%). The market shares increased more among Maine physicians with a higher Medicaid share of practice (high vs middle vs low [market]: 16% vs 8% vs 5% [cash]; 11% vs 5% vs 4% [other third-party payers]). Linear regression results indicate that practicing medicine in Maine leads to a 72% increase in pantoprazole share among Medicaid prescriptions (P < .001). In addition, for each 10% Medicaid share of practice in Maine, the share of pantoprazole increases 1.8% among cash prescriptions (P = .01) and 1.4% among other third-party payer prescriptions (P < .001). Maine's Medicaid drug formulary generated spillover effects in cash and other third-party payer markets, with somewhat stronger effects in the cash market.

The effect of incentive-based formularies on prescription-drug utilization and spending.

PubMed

Huskamp, Haiden A; Deverka, Patricia A; Epstein, Arnold M; Epstein, Robert S; McGuigan, Kimberly A; Frank, Richard G

2003-12-04

Many employers and health plans have adopted incentive-based formularies in an attempt to control prescription-drug costs. We used claims data to compare the utilization of and spending on drugs in two employer-sponsored health plans that implemented changes in formulary administration with those in comparison groups of enrollees covered by the same insurers. One plan simultaneously switched from a one-tier to a three-tier formulary and increased all enrollee copayments for medications. The second switched from a two-tier to a three-tier formulary, changing only the copayments for tier-3 drugs. We examined the utilization of angiotensin-converting-enzyme (ACE) inhibitors, proton-pump inhibitors, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins). Enrollees covered by the employer that implemented more dramatic changes experienced slower growth than the comparison group in the probability of the use of a drug and a major shift in spending from the plan to the enrollee. Among the enrollees who were initially taking tier-3 statins, more enrollees in the intervention group than in the comparison group switched to tier-1 or tier-2 medications (49 percent vs. 17 percent, P<0.001) or stopped taking statins entirely (21 percent vs. 11 percent, P=0.04). Patterns were similar for ACE inhibitors and proton-pump inhibitors. The enrollees covered by the employer that implemented more moderate changes were more likely than the comparison enrollees to switch to tier-1 or tier-2 medications but not to stop taking a given class of medications altogether. Different changes in formulary administration may have dramatically different effects on utilization and spending and may in some instances lead enrollees to discontinue therapy. The associated changes in copayments can substantially alter out-of-pocket spending by enrollees, the continuation of the use of medications, and possibly the quality of care. Copyright 2003 Massachusetts Medical Society

Impact of 3-tier formularies on drug treatment of attention-deficit/hyperactivity disorder in children.

PubMed

Huskamp, Haiden A; Deverka, Patricia A; Epstein, Arnold M; Epstein, Robert S; McGuigan, Kimberly A; Muriel, Anna C; Frank, Richard G

2005-04-01

Expenditures for medications used to treat attention-deficit/hyperactivity disorder (ADHD) in children have increased rapidly. Many employers and health plans have adopted 3-tier formularies in an attempt to control costs for these and other drugs. To assess the effect of copayment increases associated with 3-tier formulary adoption on use and spending patterns for ADHD medications for children. Observational study using quasi-experimental design to compare effects on ADHD medication use and spending for children enrolled as dependents in an employer-sponsored plan that made major changes to its pharmacy benefit design and a comparison group of children covered by the same insurer. The plan simultaneously moved from a 1-tier (same copayment required for all drugs) to a 3-tier formulary and implemented an across-the-board copayment increase. The plan later moved 3 drugs from tier 3 to tier 2. An intervention group of 20 326 and a comparison group of 15 776 children aged 18 years and younger. Monthly probability of using an ADHD medication; plan, enrollee, and total ADHD medication spending; and medication continuation. A 3-tier formulary implementation resulted in a 17% decrease in the monthly probability of using medication (P<.001), a 20% decrease in expected total medication expenditures, and a substantial shifting of costs from the plan to families (P<.001). Intervention group children using medications in the pre-period were more likely to change to a medication in a different tier after 3-tier adoption, relative to the comparison group (P = .08). The subsequent tier changes resulted in increased plan spending (P<.001) and decreased patient spending (P = .003) for users but no differences in continuation. The copayment increases associated with 3-tier formulary implementation by 1 employer resulted in lower total ADHD medication spending, sizeable increases in out-of-pocket expenditures for families of children with ADHD, and a significant decrease in the probability of using these medications.

Management of Hospital Formularies in Ontario: Challenges within a Local Health Integration Network.

PubMed

Burke, Natasha; Bowen, James M; Troyan, Sue; Jegathisawaran, Jathishinie; Gosse, Carolyn; Tonkin, Marita; Kagoma, Sandra; Goeree, Ron; Holbrook, Anne

2016-01-01

Expenditures on drugs dispensed and administered to patients in Canadian hospitals have been estimated at $2.4 billion per year. Pharmacy and therapeutics (P&T) committees play a key role in the evaluation and management of drug therapies in this setting. Hospitals differ with respect to the composition of these committees, their members' expertise, and the processes used for making formulary decisions. To examine the current processes for formulary drug review from the perspective of P&T committees and their individual members, and to examine the needs and preferences of these stakeholders related to evidence review and potential collaborative drug review processes within a large Local Health Integration Network (LHIN) in Ontario. Twenty-three sites within 10 hospital corporations in LHIN 4 (Hamilton Niagara Haldimand Brant) were recruited. A 2-part questionnaire was developed and pretested for clarity and comprehensiveness. The institution profile section of the questionnaire was to be completed by pharmacy directors and the P&T section by committee members. Ten pharmacy directors and 28 committee members representing 10 P&T committees responded. A mean of 6.4 new drug requests were reviewed annually by each P&T committee. Across the LHIN, the workload associated with reviewing submissions for new drugs to be added to the formulary represented 0.84 full-time equivalent. The quality of clinical evidence in the drug submissions was rated more favourably than the quality of economic evidence; furthermore, the use of economic evidence was limited by a lack of health economics expertise within the committees. A centralized review process for the LHIN was perceived as beneficial to improve efficiency, the quality of review, and standardization, and also to reduce costs. Across the Hamilton Niagara Haldimand Brant LHIN, considerable time and resources are spent on the review of potential new drugs for addition to the hospitals' formularies. A standardized formulary review process, with greater use of provincial and national drug reviews, would likely benefit all LHINs.

Economic Outcomes Associated with a Pharmacist-Adjudicated Formulary Consult Service in a Veterans Affairs Medical Center.

PubMed

Britt, Rachel B; Hashem, Mohamed G; Bryan, William E; Kothapalli, Radhika; Brown, Jamie N

2016-09-01

Several cost analysis studies have been conducted looking at clinical and economic outcomes associated with clinical pharmacist services in a variety of health care settings. However, there is a paucity of data regarding the economic impact of clinical pharmacist involvement in formulary management at the hospital level. To evaluate economic outcomes of a pharmacist-adjudicated formulary management consult service in a Veterans Affairs (VA) medical center offering outpatient and inpatient services. This VA medical center uses a pharmacist-adjudicated formulary management system for review of restricted drug consults. A retrospective review of electronic medical records was conducted to identify restricted drug consults at this institution between January 1, 2014, and March 31, 2014. Only restricted drug consults that were not approved were included for evaluation in order to best characterize the effects of formulary interventions by pharmacists. Economic outcomes were determined as direct cost savings by comparing the cost of requested drug with the recommended drug and accounting for the cost of pharmacist review. Characteristics of consults that were not approved and pharmacist rationale were also evaluated. Of 1,802 restricted drug consults adjudicated by a pharmacist during the study period, 198 consults in 190 individual patients met criteria for inclusion and were evaluated. The most commonly requested indications were dyslipidemia, pain, and diabetes, while the most commonly requested drugs were rosuvastatin, insulin pens, tamsulosin, varenicline, ezetimibe, and rivaroxaban. The majority of consults were requested for outpatient use. Total cost savings among 195 evaluable consults was $420,324.05, while mean cost savings per consult was $2,229.43 (range: -$3,009.27-$65,982.36). The highest cost savings were seen with outpatient use. A pharmacist-adjudicated formulary consult service in a VA medical center was associated with a substantial cost savings after adjustment for cost of pharmacist review. Future research should assess clinical outcomes associated with a restrictive formulary management system. No outside funding supported this study. None of the authors report any financial interests or potential conflict of interest with regard to this work. Study concept and design were created by all authors. Data were collected and interpreted by Britt, with input from all authors. The manuscript was written by Britt and revised by all authors.

An application of a proposed framework for formulary listing in low-income countries: the case of Côte d'Ivoire.

PubMed

Diaby, Vakaramoko; Lachaine, Jean

2011-11-01

The General Mutual Benefit Fund for Civil Servants and State Employees of Côte d'Ivoire (MUGEFCI; Mutuelle Générale des Fonctionnaires et Agents de l'État de Côte d'Ivoire) is a health mutual fund providing coverage (medical consultations, laboratory tests and treatment) for its enrolees (government officials and agents). This organization aims to improve its current drug reimbursement process because of budgetary constraints. One method of achieving this is to implement a formulary-listing framework specifically developed for low-income countries. The aim of this study was to evaluate the feasibility of developing a new formulary for the MUGEFCI in Côte d'Ivoire, by implementing a formulary-listing framework specifically designed for under-researched settings. The application of this formulary-listing framework (based on multi-criteria decision analysis [MCDA]) consisted of four steps. First, relevant formulary-listing criteria and their levels of variation were identified and weighted according to their importance in the decision making around drug reimbursement. Second, a set of priority treatments to be assessed was determined. Once the treatments eligible for reimbursement were determined, scores were assigned to these treatments according to their performance on the formulary-listing criteria levels. Finally, a composite league table (weighted matrix) was constructed to rank the set of treatments by priority order of reimbursement. A budget-impact analysis (BIA) was also conducted to appraise the economic implications of the new composite drugs league table. The extent to which the new priority list of reimbursable drugs was affordable for the MUGEFCI was then measured. Policy makers in Côte d'Ivoire considered severity of disease and cost effectiveness of treatment to be the most significant criteria for priority reimbursement of drugs. This translated into a general preference for antimalarials, treatments for asthma and antibacterials for urinary tract infection. Moreover, the results of the BIA suggest that the new priority list of reimbursable drugs would be affordable if the real economic impact of drugs per member is less than $US66. Over this threshold, the MUGEFCI would have to select reimbursable drugs according to their rank in the priority list and their respective budget impact per patient (cost per patient). This selection would start from the first treatment, going down the list until the $US66 per patient is exhausted. It was possible to use MCDA to simultaneously consider different decision criteria for drug reimbursement in Côte d'Ivoire; therefore, it is feasible to use MCDA to establish a formulary for low-income countries. The application of this method is a step towards transparency in policy making.

Assessment of the Level of Satisfaction and Unmet Data Needs for Specialty Drug Formulary Decisions in the United States.

PubMed

Choi, Yoonyoung; Navarro, Robert P

2016-04-01

Formulary management within a limited budget is critical, especially for specialty drugs, which are used for serious medical conditions and are very expensive. Despite attempts to summarize the pertinent evidence, it is uncertain whether data needs of formulary decision makers for specialty drugs are satisfied. To assess the level of satisfaction of specialty drug formulary decision makers with regards to the strength of current available data sources and unmet needs regarding clinical, economic, and unpublished evidence. This study targeted pharmacists and physicians involved with formulary decision making at health plans or pharmacy benefit management companies at the national, large regional, and local levels. 95 individuals were invited to participate (without compensation) in a 21-item, web-based survey (Qualtrics), which was open from June 14 to July 31, 2014. The responses were coded for descriptive and statistical analysis. Statistical analyses included the Kruskal-Wallis test, analysis of variance, and the Mann-Whitney-Wilcoxon test. Of 95 pharmacists or physicians, 40 respondents initiated the survey, and 33 respondents completed the survey (response rate = 34.7%). Drug formulary decision makers infrequently rated data evidence strength (17.1% "always"). Clinical data evidence strength was rated highest with published randomized controlled trials (RCTs; mean [SD] = 4.06 [0.87] of 5.0), while participant organizations' internal data were rated highest for economic data evidence strength (mean [SD] = 3.91 [1.07] of 5.0). Decision makers rated the highest unmet need as more data generated from head-to-head RCTs (mean [SD] = 2.94 [0.25] of 3.0) and cost-effectiveness analyses (mean [SD] = 2.53 [0.67] of 3.0). The participants believed manufacturers might be in the best position to satisfy their desire for head-to-head RCTs (mean [SD] = 4.31 [1.09] of 5.0). Despite a variety of data sources, drug formulary decision makers continue to rely on published RCTs or internal economic analyses as having the strongest evidence strength. The study respondents believed that pharmaceutical manufacturers would be best able to satisfy the greatest clinical data unmet need, that is, head-to-head RCTs in specialty drug formulary decisions. This study was not funded by any company or pharmaceutical manufacturer. Navarro has worked as a consultant for Biogen, Purdue Pharma, and Novartis and has offered expert testimony on behalf of AstraZeneca. The authors declare no other potential conflicts of interest. Study design was contributed primarily by Navarro, along with Choi. Choi took the lead in data collection and interpretation, assisted by Navarro. Both authors contributed equally to manuscript writing and revision.

Pharmacogenetics and rational drug use around the world.

PubMed

Roederer, Mary W; Sanchez-Giron, Francisco; Kalideen, Kusha; Kudzi, William; McLeod, Howard L; Zhang, Wei

2011-06-01

The WHO embraces evidence-based medicine to formulate an essential medicines list (EML) considering disease prevalence, drug efficacy, drug safety and cost-effectiveness. The EML is used by developing countries to build a national formulary. As pharmacogenetics in developed countries evolves, the Pharmacogenetics for Every Nation Initiative (PGENI) convened with representatives from China, Mexico, Ghana and South Africa in August 2009 to evaluate the use of human pharmacogenetics to enhance global drug use policy. The diseases causing mortality, the lack of integration of pharmacovigilance at the national formulary level, the pharmacogenetics research agenda and pharmacogenetics clinician education did not differ greatly among the countries. While there are many unanswered questions, systematically incorporating pharmacogenetics at the national formulary level promises to improve global drug use.

The Influence of Socioeconomic Status on Selection of Anticoagulation for Atrial Fibrillation.

PubMed

Sholzberg, Michelle; Gomes, Tara; Juurlink, David N; Yao, Zhan; Mamdani, Muhammad M; Laupacis, Andreas

2016-01-01

Without third-party insurance, access to marketed drugs is limited to those who can afford to pay. We examined this phenomenon in the context of anticoagulation for patients with nonvalvular atrial fibrillation (NVAF). To determine whether, among older Ontarians receiving anticoagulation for NVAF, patients of higher socioeconomic status (SES) were more likely to switch from warfarin to dabigatran prior to its addition to the provincial formulary. Population-based retrospective cohort study of Ontarians aged 66 years and older, between 2008 and 2012. Socioeconomic status, as approximated by median neighborhood income. We identified two groups of older adults with nonvalvular atrial fibrillation: those who appeared to switch from warfarin to dabigatran after its market approval but prior to its inclusion on the provincial formulary ("switchers"), and those with ongoing warfarin use during the same interval ("non-switchers"). We studied 34,797 patients, including 3183 "switchers" and 31,614 "non-switchers". We found that higher SES was associated with switching to dabigatran prior to its coverage on the provincial formulary (p<0.0001). In multivariable analysis, subjects in the highest quintile were 50% more likely to switch to dabigatran than those in the lowest income quintile (11.3% vs. 7.3%; adjusted odds ratio 1.50; 95% CI 1.32 to 1.68). Following dabigatran's addition to the formulary, the income gradient disappeared. We documented socioeconomic inequality in access to dabigatran among patients receiving warfarin for NVAF. This disparity was eliminated following the drug's addition to the provincial formulary, highlighting the importance of timely reimbursement decisions.

A Psychiatric Formulary for Long-Duration Spaceflight.

PubMed

Friedman, Eric; Bui, Brian

2017-11-01

Behavioral health is essential for the safety, well-being, and performance of crewmembers in both human spaceflight and Antarctic exploration. Over the past five decades, psychiatric issues have been documented in orbital spaceflight. In Antarctica, literature suggests up to 5% of wintering crewmembers could meet criteria for a psychiatric illness, including mood disorders, stressor-related disorders, sleep-wake disorders, and substance-related disorders. Experience from these settings indicates that psychiatric disorders on deep space missions must be anticipated. An important part of planning for the psychological health of crewmembers is the onboard provision of psychotropic drugs. These medications have been available on orbital missions. A greater variety and supply of these drugs exist at Antarctic facilities. The size and diversity of a deep space psychiatric formulary will be greater than that provided on orbital missions. Drugs to be provisioned include anxiolytics, antidepressants, mood stabilizers, antipsychotics, and hypnotics. Each drug category should include different medications, providing diverse pharmacokinetic, pharmacodynamic, and side effect profiles. The formulary itself should be rigorously controlled, given the abuse potential of some medications. In-flight treatment strategies could include psychological monitoring of well-being and early intervention for significant symptoms. Psychiatric emergencies would be treated aggressively with behavioral and pharmacological interventions to de-escalate potentially hazardous situations. On long-duration space missions, a robust psychiatric formulary could provide crewmembers autonomy and flexibility in treating a range of behavioral issues from depression to acute psychosis. This will contribute to the safety, health, and performance of crewmembers, and to mission success.Friedman E, Bui B. A psychiatric formulary for long-duration spaceflight. Aerosp Med Hum Perform. 2017; 88(11):1024-1033.

Vision 2010: Pharmacy Executive Leadership Skills and Associated Competencies in the Department of Defense

DTIC Science & Technology

2002-01-01

management , drug therapy management , pharmacy benefit management , and leadership . During the Delphis second phase, respondents provided...of the top 15 rated SKA items came from the drug therapy management , leadership , and formulary management domains. Results indicate that the issues... management and technology, financial resources, formulary management , drug therapy management , pharmacy benefit management , and leadership . During

The relationship between pediatric combination vaccines and market effects.

PubMed

Behzad, Banafsheh; Jacobson, Sheldon H; Jokela, Janet A; Sewell, Edward C

2014-06-01

We explored market factors that affect pediatric combination vaccine uptake in the US public-sector pediatric vaccine market. We specifically examined how Pediarix and Pentacel earned a place in the 2009-2012 lowest overall cost formulary. Direct competition between Pediarix and Pentacel is driven by the indirect presence of the Merck Haemophilus influenzae type b vaccine and the Recommended Childhood Immunization Schedule requirement for a hepatitis B birth dose. The resulting analysis suggests that Pentacel would never have earned a place in the lowest overall cost formulary for 2009-2012 federal contract prices for any cost of an injection unless the Merck H influenzae type b advantage was ignored and the hepatitis B birth dose administration cost was recognized by health care providers in designing the lowest overall cost formularies.

Designing pediatric vaccine formularies and pricing pediatric combination vaccines using operations research models and algorithms.

PubMed

Jacobson, Sheldon H; Sewell, Edward C; Allwine, Daniel A; Medina, Enrique A; Weniger, Bruce G

2003-02-01

The National Immunization Program, housed within the Centers for Disease Control and Prevention in the USA, has identified several challenges that must be faced in childhood immunization programs to deliver and procure vaccines that immunize children from the plethora of childhood diseases. The biomedical issues cited include how drug manufacturers can combine and formulate vaccines, how such vaccines are scheduled and administered and how economically sound vaccine procurement can be achieved. This review discusses how operations research models can be used to address the economics of pediatric vaccine formulary design and pricing, as well as how such models can be used to address a new set of pediatric formulary problems that will surface with the introduction of pediatric combination vaccines into the US pediatric immunization market.

The Relationship Between Pediatric Combination Vaccines and Market Effects

PubMed Central

Behzad, Banafsheh; Jokela, Janet A.; Sewell, Edward C.

2014-01-01

We explored market factors that affect pediatric combination vaccine uptake in the US public-sector pediatric vaccine market. We specifically examined how Pediarix and Pentacel earned a place in the 2009–2012 lowest overall cost formulary. Direct competition between Pediarix and Pentacel is driven by the indirect presence of the Merck Haemophilus influenzae type b vaccine and the Recommended Childhood Immunization Schedule requirement for a hepatitis B birth dose. The resulting analysis suggests that Pentacel would never have earned a place in the lowest overall cost formulary for 2009–2012 federal contract prices for any cost of an injection unless the Merck H influenzae type b advantage was ignored and the hepatitis B birth dose administration cost was recognized by health care providers in designing the lowest overall cost formularies. PMID:24825198

The effect of a three-tier formulary on antidepressant utilization and expenditures.

PubMed

Hodgkin, Dominic; Parks Thomas, Cindy; Simoni-Wastila, Linda; Ritter, Grant A; Lee, Sue

2008-06-01

Health plans in the United States are struggling to contain rapid growth in their spending on medications. They have responded by implementing multi-tiered formularies, which label certain brand medications 'non-preferred' and require higher patient copayments for those medications. This multi-tier policy relies on patients' willingness to switch medications in response to copayment differentials. The antidepressant class has certain characteristics that may pose problems for implementation of three-tier formularies, such as differences in which medication works for which patient, and high rates of medication discontinuation. To measure the effect of a three-tier formulary on antidepressant utilization and spending, including decomposing spending allocations between patient and plan. We use claims and eligibility files for a large, mature nonprofit managed care organization that started introducing its three-tier formulary on January 1, 2000, with a staggered implementation across employer groups. The sample includes 109,686 individuals who were continuously enrolled members during the study period. We use a pretest-posttest quasi-experimental design that includes a comparison group, comprising members whose employer had not adopted three-tier as of March 1, 2000. This permits some control for potentially confounding changes that could have coincided with three-tier implementation. For the antidepressants that became nonpreferred, prescriptions per enrollee decreased 11% in the three-tier group and increased 5% in the comparison group. The own-copay elasticity of demand for nonpreferred drugs can be approximated as -0.11. Difference-in-differences regression finds that the three-tier formulary slowed the growth in the probability of using antidepressants in the post-period, which was 0.3 percentage points lower than it would have been without three-tier. The three-tier formulary also increased out-of-pocket payments while reducing plan payments and total spending. The results indicate that the plan enrollees were somewhat responsive to the changed incentives, shifting away from the drugs that became nonpreferred. However, the intervention also resulted in cost-shifting from plan to enrollees, indicating some price-inelasticity. The reduction in the proportion of enrollees filling any prescriptions contrasts with results of prior studies for non-psychotropic drug classes. Limitations include the possibility of confounding changes coinciding with three-tier implementation (if they affected the two groups differentially); restriction to continuous enrollees; and lack of data on rebates the plan paid to drug manufacturers. The results of this study suggest that the impact of the three-tier formulary approach may be somewhat different for antidepressants than for some other classes. Policymakers should monitor the effects of three-tier programs on utilization in psychotropic medication classes. Future studies should seek to understand the reasons for patients' limited response to the change in incentives, perhaps using physician and/or patient surveys. Studies should also examine the effects of three-tier programs on patient adherence, quality of care, and clinical and economic outcomes.

Formulary considerations in selection of beta-blockers.

PubMed

Yedinak, K C

1993-08-01

Selection of beta-adrenergic blockers for formulary addition can be a difficult task, especially with the increasing availability of new beta-blockers, as well as the numerous differences in pharmacodynamic and pharmacokinetic properties of currently available agents. Nevertheless, appropriate evaluation of the important characteristics of beta-blockers should allow selection of the most cost-effective agents for formulary addition. Most importantly, differences in efficacy, product formulation and cost should be carefully considered when making formulary decisions. Notably, evidence from clinical trials indicates differences in efficacy among beta-blockers for post-myocardial infarction prophylaxis, situational anxiety, essential tremor, thyrotoxicosis, migraine prophylaxis and prevention of bleeding associated with oesophageal varices. For many clinical situations, it is also important to select an effective agent that is available in both an oral and intravenous formulation, especially for cardioprotection after acute myocardial infarction and for use in supraventricular arrhythmias. In addition, availability of sustained release products and generic formulations should be considered for their potential to increase compliance and decrease cost, respectively. Comparative drug costs, as well as costs associated with decreased compliance, should also be carefully evaluated. Differences in beta-receptor selectivity, duration of action and presence of intrinsic sympathomimetic activity (ISA) are also important considerations in the selection of beta-blockers for formulary consideration. Although degree of selectivity is relative, beta 1-selective agents may be less likely to induce bronchospasm in patients with chronic obstructive pulmonary disease (COPD) and may be less likely to affect glucose homeostasis in patients with diabetes mellitus. Duration of action of a beta-blocker is an important consideration for evaluation of efficacy throughout the recommended dosage interval. In addition, beta-blockers with a long duration of action can often be administered once or twice daily, potentially leading to increased compliance and thereby improved effectiveness and economic efficiency. The presence of ISA is an important consideration because certain beta-blockers with ISA may be less effective than those without ISA for certain indications. Factors considered to be less important when making formulary decisions of choice of beta-blockers include the route of elimination, lipophilicity and presence of membrane stabilising activity.

Drug formulary review process for sargramostim and filgrastim: focus on analysis of adverse drug reactions.

PubMed

Kellihan, M J

1993-01-01

Selection of a drug for formulary inclusion involves evaluation of safety, efficacy, and cost. The colony-stimulating factors (CSFs) sargramostim and filgrastim have a broad range of potential indications and represent a costly formulary addition when acquisition price alone is considered; their comparative safety is unclear. These factors suggest that the CSFs should be closely scrutinized prior to formulary addition. In the absence of direct comparative studies, an assessment of the safety of CSFs involves evaluation of information provided in the product circular, official drug compendia, adverse biologic reports submitted to the United States Food and Drug Administration, and data from key clinical trials. Data in the product circulars report on adverse events in small numbers of patients treated for chemotherapy-induced neutropenia (filgrastim) or neutropenia subsequent to bone marrow transplantation (sargramostim). The official compendia and clinical trials include experience with CSFs produced in a variety of expression systems; these data are not limited to sargramostim and filgrastim. Importantly, there was a similar incidence of adverse events in patients who received sargramostim or filgrastim and in those who took placebo reported in the product circulars and the pivotal trials, suggesting that the underlying disease may have an important role in determining the side-effect profile of these agents. Adverse biologic reports represent experience with sargramostim and filgrastim obtained under actual clinical conditions and suggest that the same types of adverse events are seen with sargramostim as with filgrastim. This analysis suggests that a decision to select filgrastim over sargramostim for formulary inclusion based on the safety profile is not appropriate because currently available data are equivocal and that such decisions would more appropriately be based on efficacy and cost.

The AMCP Format for Formulary Submissions: Welcome to Version 4.0.

PubMed

2016-05-01

Managed care pharmacists are increasingly presented with complex considerations related to prescription drug formulary management. As prescription drug spending soars, and new effective, but expensive drugs rush to the market, pharmacists and other health care decision makers must evaluate a myriad of important clinical and economic considerations in determining the relative value and, subsequently, the appropriate placement of a product within a formulary. The AMCP Format for Formulary Submissions, Version 4.0, is the next iteration of the Format, which was first released in 2000. Version 4.0, developed by pharmacists from health plan, manufacturer, and academic perspectives, provides updated recommendations on acquiring and evaluating clinical and economic evidence to inform formulary and medical policy decisions. It also includes new guidance related to emerging special topic considerations such as biosimilars, specialty pharmacy products, and companion diagnostic tests. Version 4.0 has been modified to improve the usability of the Format, with clarifying guidance related to logistical considerations such as a recommended time frame for implementation of Version 4.0, as well as dossier updates and ongoing communication between manufacturers and health care decision makers. The Format should be used as a framework for ongoing evidence-based dialogue between manufacturers and payers. The evolving health care landscape will require new levels of collaboration and communication among key stakeholders to successfully navigate the challenges of this new environment. The Format provides a framework to support these critical interactions related to product value by facilitating an evidence-based, transparent approach. This document was prepared by Jeff Lee, PharmD, FCCP, on behalf of the AMCP Format Executive Committee. Committee members reviewed and provided feedback on the final draft. No conflicts of interest, financial or otherwise, were reported.

Sugammadex

PubMed Central

Cada, Dennis J.; Levien, Terri L.; Baker, Danial E.

2016-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The July 2016 monograph topics are pimavanserin, venetoclax, defibrotide, lifitegrast ophthalmic solution 5%, and atezolizumab. The Safety MUE is on pimavanserin. PMID:27559192

Eteplirsen.

PubMed

Baker, Danial E

2017-04-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The April 2017 monograph topics are deflazacort, plecanatide, delafloxacin, oxymetazoline hydrochloride 1% cream, and betrixaban. The DUE is on plecanatide.

Lixisenatide.

PubMed

Baker, Danial E; Levien, Terri L

2017-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The January 2017 monograph topics are bezlotoxumab, buprenorphine buccal, deflazacort, dupilumab, and olaratumab. The DUE is on buprenorphine buccal.

Insulin Degludec/Liraglutide.

PubMed

Baker, Danial E

2017-05-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The May 2017 monograph topics are brodalumab, etelcalcetide, guselkumab, ribociclib, and sirukumab. The MUE is on ribociclib.

Irinotecan Liposome Injection.

PubMed

Baker, Danial E; Levien, Terri L

2017-02-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The February 2017 monograph topics are bezlotoxumab, binimetinib, broadalumab, deuterabenazine, prasterone vaginal, and valbenazine. The DUE is on bezlotoxumab.

Sugammadex.

PubMed

Cada, Dennis J; Levien, Terri L; Baker, Danial E

2016-07-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The July 2016 monograph topics are pimavanserin, venetoclax, defibrotide, lifitegrast ophthalmic solution 5%, and atezolizumab. The Safety MUE is on pimavanserin.

Daclizumab.

PubMed

Kim, Anne P; Baker, Danial E

2016-12-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The December 2016 monograph topics are ozenoxacin cream, ocrelizumab, naldemedine, eteplirsen, and abaloparatide. The Safety MUE is on buprenorphine buccal.

Elbasvir/Grazoprevir.

PubMed

Cada, Dennis J; Kim, Anne P; Baker, Danial E

2016-09-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The September 2016 monograph topics are barictinib, buprenorphine implants, sarilumab, sofosbuvir/velpatasvir, and cholera vaccine, live, oral. The Safey MUE is on sofosbuvir/velpatasvir.

Defibrotide

PubMed Central

Baker, Danial E.; Demaris, Kendra

2016-01-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The November 2016 monograph topics are apaziquone, crisaborole, irinotecan liposome, plecanatide, and telotristat. The Safety MUE is on methylnaltrexone PO. PMID:27928191

Bezlotoxumab.

PubMed

Baker, Danial E

2017-03-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The March 2017 monograph topics are crisaborole, insulin degludec/liraglutide, inclusion glargine/lixisenatide, nusimersen, and rucaparib. The MUE is on insulin GLP-1 combo.

Defibrotide.

PubMed

Baker, Danial E; Demaris, Kendra

2016-11-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The November 2016 monograph topics are apaziquone, crisaborole, irinotecan liposome, plecanatide, and telotristat. The Safety MUE is on methylnaltrexone PO.

Drug formularies--good or evil? A view using prescribing analyses and cost trends data.

PubMed

Chapman, S

1994-01-01

In the UK, the drugs bill has almost trebled in the last 10 years and is consuming an increasing proportion of the total National Health Service spend. If the drugs bill can be limited, greater funds will be available for other areas of the health service. Therefore, cost containment measures which include prescribing from a formulary or generic prescribing are now widely encouraged. Prescribing analyses and cost trends data generated from pharmacists sending dispensed general practitioners' prescriptions to a central point for reimbursement are a valuable tool in the assessment of prescribing habits and can be used by general practitioners when preparing a formulary. In the West Midlands, such data have been used to identify areas of growth in cardiovascular drugs and problem areas where prescribing an expensive formulation has led to a dramatic increase in costs.

Structure and activities of pharmacy and therapeutics committees among public hospitals in South Africa; findings and implications.

PubMed

Matlala, Moliehi; Gous, Andries Gs; Godman, Brian; Meyer, Johanna C

2017-11-01

The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used. The findings were converged during the interpretation phase. Expert commentary: Most professionals were represented in the PTCs, with variations across hospitals. Membership of PTCs included a pharmacist, who in the majority of cases was the secretary. PTC activities included dissemination of decisions (100%) and formulary management (89.5%). However, reporting of adverse drug reactions (ADRs) and medication errors was typically poor at all hospital levels. Lack of expertise of pharmacoeconomic analysis and evidence-based decision-making in formulary management was identified as a key challenge in formulary management. In conclusion, future programmes should strengthen PTCs in specialised aspects of formulary management. Further training in the principles of pharmacovigilance is needed to enhance ADR reporting, as well as to ensure compliance with both WHO and provincial guidelines.

Drug policy in Nicaragua, between need-oriented activities and aggression.

PubMed

Laporte, J R; Tognoni, G

1985-01-01

In this case study from Nicaragua, an account is given of how the Essential Drugs Program developed in a context which relectss exceptional political, economic and military pressures. The overall picture could provide a useful guide to the issues behind such an apparently simple concept as the essential drugs list. The criteria for including drugs in the National Formulary were those of the WHO report on essential drugs: proven efficacy, acceptable risks associated with their use, favorable cost, and need. A proposal of the basic list of drugs, classified in therapeutic groups and according to their priority and level of use, was prepared by a central Committee for the National Drug Formulary. An annotated Formulary was prepared to ensure consistency with rigorous scientific standards and to meet the needs of daily practice. The annotated therapeutic formulary has been distributed to all physicians, other health workers responsible for peripheral health centers, pharmacists, and medical students. It has been adopted as the main reference textbook for teaching clinical pharmacology and therapeutics to medical students. A training program in clinical pharmacology has been started at the University Autonoma de Barcelona. It pays particular attention to drug evaluation, drug epidemiology methods, and retrieval and preparation of drug information for health workers.

Potential Savings of Harmonising Hospital and Community Formularies for Chronic Disease Medications Initiated in Hospital

PubMed Central

Lapointe-Shaw, Lauren; Fischer, Hadas D.; Newman, Alice; John-Baptiste, Ava; Anderson, Geoffrey M.; Rochon, Paula A.; Bell, Chaim M.

2012-01-01

Background Hospitals in Canada manage their formularies independently, yet many inpatients are discharged on medications which will be purchased through publicly-funded programs. We sought to determine how much public money could be saved on chronic medications if hospitals promoted the initiation of agents with the lowest outpatient formulary prices. Methods We used administrative databases for the province of Ontario to identify patients initiated on a proton pump inhibitor (PPI), angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) following hospital admission from April 1st 2008-March 31st 2009. We assessed the cost to the Ontario Drug Benefit Program (ODB) over the year following initiation and determined the cost savings if prescriptions were substituted with the least expensive agent in each class. Results The cost for filling all PPI, ACE inhibitor and ARB prescriptions was $ 2.48 million, $968 thousand and $325 thousand respectively. Substituting the least expensive agent could have saved $1.16 million (47%) for PPIs, $162 thousand (17%) for ACE inhibitors and $14 thousand (4%) for ARBs over the year following discharge. Interpretation In a setting where outpatient prescriptions are publicly funded, harmonising outpatient formularies with inpatient therapeutic substitution resulted in modest cost savings and may be one way to control rising pharmaceutical costs. PMID:22761882

Potential savings of harmonising hospital and community formularies for chronic disease medications initiated in hospital.

PubMed

Lapointe-Shaw, Lauren; Fischer, Hadas D; Newman, Alice; John-Baptiste, Ava; Anderson, Geoffrey M; Rochon, Paula A; Bell, Chaim M

2012-01-01

Hospitals in Canada manage their formularies independently, yet many inpatients are discharged on medications which will be purchased through publicly-funded programs. We sought to determine how much public money could be saved on chronic medications if hospitals promoted the initiation of agents with the lowest outpatient formulary prices. We used administrative databases for the province of Ontario to identify patients initiated on a proton pump inhibitor (PPI), angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) following hospital admission from April 1(st) 2008-March 31(st) 2009. We assessed the cost to the Ontario Drug Benefit Program (ODB) over the year following initiation and determined the cost savings if prescriptions were substituted with the least expensive agent in each class. The cost for filling all PPI, ACE inhibitor and ARB prescriptions was $ 2.48 million, $968 thousand and $325 thousand respectively. Substituting the least expensive agent could have saved $1.16 million (47%) for PPIs, $162 thousand (17%) for ACE inhibitors and $14 thousand (4%) for ARBs over the year following discharge. In a setting where outpatient prescriptions are publicly funded, harmonising outpatient formularies with inpatient therapeutic substitution resulted in modest cost savings and may be one way to control rising pharmaceutical costs.

The Pathway to a Safe and Effective Spaceflight Medication Formulary: Expert Review Panel Recommendations

NASA Technical Reports Server (NTRS)

Daniels, V. R.; Bayuse, T. M.; Mulcahy, R. A.; McGuire, R. K. M.; Antonsen, E. L.

2018-01-01

Exploration spaceflight poses several challenges to the provision of a comprehensive medication formulary. This formulary must accommodate the size and space limitations of the spacecraft, while addressing individual medication needs and preferences of the crew, consequences of a degrading inventory over time, the inability to resupply used or expired medications, and the need to forecast the best possible medication candidates to treat conditions that may occur. The Exploration Medical Capability (ExMC) Element's Pharmacy Project Team has developed a research plan (RP) that is focused on evidence-based models and theories as well as new diagnostic tools, treatments, or preventive measures aimed to ensure an available, safe, and effective pharmacy sufficient to manage potential medical threats during exploration spaceflight. Here, we will discuss the ways in which the ExMC Pharmacy Project Team pursued expert evaluation and guidance, and incorporated acquired insight into an achievable research pathway, reflected in the revised RP.

The role of the microbiology laboratory in guiding formulary decisions.

PubMed

Stratton, C W

1988-08-01

Typically, P & T Committee antibiotic selection criteria have included such factors as cost, pharmacokinetics, side effects profile, spectrum of activity, and relative activity against specific pathogens. The microbiology laboratory can provide the P & T Committee with other useful information to help guide them in making even more appropriate and cost-effective formulary decisions. This information includes specific susceptibility data (including prevalence of pathogens, source of infection [community or nosocomial], anatomical site of isolates, specific unit or service where isolated, type of culture specimen, total number of pathogens in the hospital), resistance trends data, an evaluation of microbiologic data presented in published studies, further data regarding an antimicrobial's spectrum of activity and activity against specific pathogens, and the relevance and limitations of in vitro data. With this information in hand, P & T Committee should be in a much better position to optimize formulary decision-making.

The Pathway to a Safe and Effective Medication Formulary for Exploration Spaceflight

NASA Technical Reports Server (NTRS)

Daniels, V. R.; Bayuse, T. M.; Mulcahy, R. A.; Mcguire, R. K. M.; Antonsen, E. L.

2017-01-01

PURPOSE: Exploration space missions pose several challenges to providing a comprehensive medication formulary designed to accommodate the size and space limitations of the spacecraft; while addressing the individual medications needs and preferences of the Crew; the negative outcome of a degrading inventory over time, the inability to resupply before expiration dates; and the need to properly forecast the best possible medication candidates to treat conditions that will occur in the future. METHODS: The Pharmacotherapeutics Discipline has partnered with the Exploration Medical Capabilities (ExMC) Element to develop and propose a research pathway that is comprehensively focused on evidence-based models and theories, as well as on new diagnostic tools and treatments or preventive measures aimed at closure of the Med02 “Pharmacy” Gap; defined in the Human Research Program’s (HRP) risk-based research strategy. The Med02 Gap promotes the challenge to identify a strategy to ensure that medications used to treat medical conditions during exploration space missions are available, safe, and effective. It is abundantly clear that pharmaceutical intervention is an essential component of risk management planning for astronaut healthcare during exploration space. However, the quandary still remains of how to assemble a formulary that is comprehensive enough to prevent or treat anticipated medical events; and is also chemically stable, safe, and robust enough to have sufficient potency to last for the duration of an exploration space mission. In cases where that is not possible, addressing this Gap requires exploration of novel drug development techniques, dosage forms, and dosage delivery platforms that enhance chemical stability as well as therapeutic effectiveness. RESULTS: The proposed research pathway outlines the steps, processes, procedures, and a research portfolio aimed at identifying a capability that will provide a safe and effective pharmacy for any specific exploration Design Reference Mission (DRM). The proposed approach to building this research portfolio is to seek research projects that concentrate on four major focus areas; (1) Formulary selection, (2) Formulary potency and shelf life, (3) Formulary safety and toxicity, and (4) Novel technology and innovation such as portable real-time chemical analysis innovative drug therapies and dosage and delivery platforms. CONCLUSION: The research pathway has been completed and presented to the HRP. In spring 2017, it is scheduled to be reviewed by a panel of pharmaceutical and clinical experts that will evaluate the scientific merit and operational feasibility of the research pathway, as well as make suggestions for any warranted additions or improvements. Once finalized, the ExMC Element will proceed with the execution of this research pathway with the goal of gathering as much data, and learning as much as possible, to provide a safe and effective pharmaceutical formulary for use during exploration missions.

Impact of Modified System of Objectified Judgement Analysis (SOJA) methodology on prescribing costs of ACE inhibitors.

PubMed

Alabbadi, Ibrahim; Crealey, Grainne; Scott, Michael; Baird, Simon; Trouton, Tom; Mairs, Jill; McElnay, James

2006-01-01

System of Objectified Judgement Analysis (SOJA) is a structured approach to the selection of drugs for formulary inclusion. How- ever, while SOJA is a very important advance in drug selection for formulary purposes, it is hospital based and can only be applied to one indication at a time. In SOJA, cost has been given a primary role in the selection process as it has been included as a selection criterion from the start. Cost may therefore drive the selection of a particular drug product at the expense of other basic criteria such as safety or efficacy. The aims of this study were to use a modified SOJA approach in the selection of ACE inhibitors (ACEIs) for use in a joint formulary that bridges primary and secondary care within a health board in Northern Ireland, and to investigate the potential impact of the joint formulary on prescribing costs of ACEIs in that health board. The modified SOJA approach involved four phases in sequence: an evidence-based pharmacotherapeutic evaluation of all available ACEI drug entities, a separate safety/risk assessment analysis of products containing agents that exceeded the pharmacotherapeutic threshold, a budget-impact analysis and, finally, the selection of product lines. A comprehensive literature review and expert panel judgement informed the selection of criteria (and their relative weighting) for the pharmacotherapeutic evaluation. The resultant criteria/scoring system was circulated (in questionnaire format) to prescribers and stakeholders for comment. Based on statistical analysis of the latter survey results, the final scoring system was developed. Drug entities that exceeded the evidence threshold were sequentially entered into the second and third phases of the process. Five drug entities (11 currently available in the UK) exceeded the evidence threshold and 22 of 26 submitted product lines containing these drug entities satisfied the safety/risk assessment criteria. Three product lines, each containing a different drug entity, were selected for formulary inclusion after budget impact analysis was performed. The estimated potential annual cost savings for ACEIs (based on estimated annual usage in defined daily doses) for this particular health board was 42%. The modified SOJA approach has a significant contribution to make in containing the costs of ACEIs. Applying modified SOJA as a practical method for all indications will allow the development of a unified formulary that bridges secondary and primary care.

Differences in the availability of new anti-cancer drugs for Italian patients treated in different regions. Results of analysis conducted by the Italian Society Of Medical Oncology (AIOM).

PubMed

Gori, Stefania; Di Maio, Massimo; Pinto, Carmine; Alabiso, Oscar; Baldini, Editta; Beretta, Giordano Domenico; Caffo, Orazio; Caroti, Cinzia; Crinò, Lucio; De Laurentiis, Michelino; Dinota, Angelo; Di Vito, Francesco; Gebbia, Vittorio; Giustini, Lucio; Graiff, Claudio; Guida, Michele; Lelli, Giorgio; Lombardo, Marco; Muggiano, Antonio; Puglisi, Fabio; Romito, Sante; Salvagno, Luigi; Tagliaferri, Pierosandro; Terzoli, Edmondo; Venturini, Marco

2010-01-01

Italy is divided into 20 regions. As a consequence of local autonomy, following marketing authorization by the Italian Medicines Agency, each drug for hospital use is not immediately available, because its approval needs to undergo further steps that can be different among regions. The Italian Society of Medical Oncology conducted the present study to describe the impact of the existence of sub-national pharmaceutical formularies on the disparity of access to new anti-cancer drugs among patients treated in different Italian regions. The availability of 8 new anti-cancer drugs at a regional level and the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency were analyzed as of April 2009. Fourteen regions and autonomous province of Trento have a regional pharmaceutical formulary. In most cases, the regional pharmaceutical formularies include the eight analyzed drugs, with therapeutic indications coherent with national marketing authorization indications. Five drugs (bevacizumab, trastuzumab, rituximab, erlotinib, sunitinib) were included in all the existing regional pharmaceutical formularies, without restrictions, whereas three drugs (cetuximab, sorafenib, pemetrexed) were found to have restrictions in some regions. The presence of multiple hierarchical levels of drug evaluation creates a potential element of disparity in the access to pharmacological therapies for Italian citizens.

Using health outcomes data to inform decision-making: formulary committee perspective.

PubMed

Janknegt, R

2001-01-01

When healthcare resources are limited, decisions about the treatments to fund can be complex and difficult to make, involving the careful balancing of multiple factors. The decisions taken may have far-reaching consequences affecting many people. Clearly, decisions such as the choice of products on a formulary must be taken using a selection process that is fully transparent and that can be justified to all parties concerned. Although everyone would agree that drug selection should be a rational process that follows the guidelines of evidence-based medicine, many other factors may play a role in decision-making. Although some of these are explicit and rational, others are less clearly defined, and decision-makers may be unaware of the influence exerted by some of these factors. In order to facilitate transparent decision-making that makes rational use of health outcomes information, the System of Objectified Judgement Analysis (SOJA) has been developed by the author. SOJA includes interactive software that combines the quality advantages of the 'top-down' approach to drug selection, based on a thorough literature review, with the compliance advantages of a 'bottom-up' approach, where the final decision is made by the individual formulary committee and not by the authors of the review. The SOJA method, based on decision-making processes in economics, ensures that health outcomes information is given appropriate weight. Such approaches are valuable tools in discussions about product selection for formularies.

A Comprehensive List of Items to be Included on a Pediatric Drug Monograph

PubMed Central

Ito, Shinya; Woods, David; Nunn, Anthony J.; Taketomo, Carol; de Hoog, Matthijs; Offringa, Martin

2017-01-01

OBJECTIVES Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph. METHODS Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed. RESULTS Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties. CONCLUSIONS Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development. PMID:28337081

A Comprehensive List of Items to be Included on a Pediatric Drug Monograph.

PubMed

Kelly, Lauren E; Ito, Shinya; Woods, David; Nunn, Anthony J; Taketomo, Carol; de Hoog, Matthijs; Offringa, Martin

2017-01-01

Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph. Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed. Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties. Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development.

Multi-indication Pharmacotherapeutic Multicriteria Decision Analytic Model for the Comparative Formulary Inclusion of Proton Pump Inhibitors in Qatar.

PubMed

Al-Badriyeh, Daoud; Alabbadi, Ibrahim; Fahey, Michael; Al-Khal, Abdullatif; Zaidan, Manal

2016-05-01

The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring model that is based on comparatively weighted multiple indications and no reports of PPI selection in Qatar or the Middle East. This study aims to compare first-line use of the PPIs that exist in Qatar. The economic effect of the study recommendations was also quantified. A comparative, evidence-based multicriteria decision analysis (MCDA) model was constructed to follow the multiple indications and pharmacotherapeutic criteria of PPIs. Literature and an expert panel informed the selection criteria of PPIs. Input from the relevant local clinician population steered the relative weighting of selection criteria. Comparatively scored PPIs, exceeding a defined score threshold, were recommended for selection. Weighted model scores were successfully developed, with 95% CI and 5% margin of error. The model comprised 7 main criteria and 38 subcriteria. Main criteria are indication, dosage frequency, treatment duration, best published evidence, available formulations, drug interactions, and pharmacokinetic and pharmacodynamic properties. Most weight was achieved for the indications selection criteria. Esomeprazole and rabeprazole were suggested as formulary options, followed by lansoprazole for nonformulary use. The estimated effect of the study recommendations was up to a 15.3% reduction in the annual PPI expenditure. Robustness of study conclusions against variabilities in study inputs was confirmed via sensitivity analyses. The implementation of a locally developed PPI-specific comparative MCDA scoring model, which is multiweighted indication and criteria based, into the Qatari formulary selection practices is a successful evidence-based cost-cutting exercise. Esomeprazole and rabeprazole should be the first-line choice from among the PPIs available at the Qatari government hospital health services. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Analysis of nonformulary use of PPIs and excess drug cost in a Veterans Affairs population.

PubMed

Ajumobi, Adewale B; Vuong, Ronald; Ahaneku, Hycienth

2012-01-01

In the Veterans Affairs (VA) health care system, a formulary-based approach without beneficiary cost-share incentives is used to limit the pharmacy cost of proton pump inhibitors (PPIs). However, the effectiveness of this approach in reducing the cost of PPIs is unknown. To (a) compare cost differences between the formulary PPI (generic omeprazole) and nonformulary PPIs and (b) evaluate reasons for nonformulary PPI use in order to identify opportunities to increase formulary drug use and discourage unnecessary use of nonformulary PPIs. A list of patients with receipt of PPIs from July 1, 2008, through June 30, 2009, was obtained from the Loma Linda VA Healthcare System pharmacy. Subjects with receipt of at least 120 units (capsules or tablets) of any PPI in the study period were considered long-term users. Demographic information was collected. Pharmacy consult records were reviewed to identify reasons for nonformulary use and dosing regimen of the formulary PPI prior to the switch. Cost analysis was done based on the VA contract prices for the drugs at the time of the study. Of 58,605 unique patients seen in this VA health care system in the 12-month period from July 1, 2008, through June 30, 2009, 13,713 (23.4%) received a PPI, and of these, 10,483 (76.4%) received at least 120 PPI units and were defined as long-term users. Of the long-term users, 9,462 (90.3%) were on the formulary PPI generic omeprazole, and 1,021 were nonformulary PPI users. Use of nonformulary PPIs (esomeprazole, pantoprazole, lansoprazole, rabeprazole) accounted for 10.5% of the PPI units and 9.7% of the users but 57.3% of total PPI cost. This pattern resulted in $570,263 in excess spending (i.e., $570,263 would have been saved in the study period if the nonformulary PPI users had used the formulary drug). The most common reason for nonformulary long-term PPI use was persistent symptoms (n=901, 88.2%). Adverse reaction was cited by 111 (10.9%) of nonformulary PPI users, 33.3% (n=37) of whom reported diarrhea. Of those who switched to a nonformulary PPI due to persistent symptoms, 363 (40.3%) were on once-daily dosing prior to the switch; 379 (42.1%) were on twice-daily dosing; and 159 (17.6%) were transfers from other places in which prior dosing information was not available in the hospital pharmacy records. One-year PPI use prevalence was 23% in this VA population, and long-term use prevalence was 18%. Nonformulary PPI use accounted for 10.5% of the PPI units and 9.7% of the users but 57.3% of total PPI drug cost. Opportunities to reduce nonformulary PPI use in order to reduce overall expenditures on PPIs include verification of optimal formulary PPI use, titration to twice-daily dosing, and confirmation of adverse reaction as being attributable to PPI use.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

PubMed

Griffith, Niesha; McBride, Ali; Stevenson, James G; Green, Larry

2014-10-01

Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions' information technology systems.

A medical economic fairy tale: Jack, the magic beans, Medicare and the US FDA.

PubMed

Nusbaum, Neil J

2006-01-01

The US Medicare programme, through its new Part D programme, now offers limited coverage for prescription medicines. The coverage is provided via a variety of drug plans and their respective formularies. The federal regulatory scheme generally requires that the formularies contain drugs representative of the various therapeutic classes. On the other hand, the federal government has generally refrained from making specific decisions that specific drug entities are the most cost effective and therefore must be included in the formularies. With the dawn of Medicare Part D in the US, the federal government will be increasingly involved in supporting the cost of medicines, and will need to confront this challenge in the face of tight overall economic constraints on the federal budget. Any spending on medications of questionable efficacy will inevitably compromise the ability to deliver more cost-effective healthcare measures. Laxity in the approval process for ineffective drugs may therefore result in lack of funds to support acquisition of more useful medicines for the elderly.

Antimicrobial formulary management: a case study in a teaching hospital.

PubMed

Wright, D B

1991-01-01

The role of the formulary system for effective cost containment is becoming increasingly important. With antimicrobial agents taking up a large proportion of most pharmaceutical budgets, this group of agents is an obvious target for cost reduction. The responsible interchange of selected antimicrobial agents offers a promising method to achieve this goal. The Pharmacy and Therapeutics Committee at Henry Ford Hospital implemented the formulary replacement of cefoxitin with cefotetan on a cost basis after the agents were evaluated and considered to be therapeutically equivalent. Drug usage guidelines were developed to implement this change. Educational materials were distributed to the medical staff, and lectures on the appropriate use of cefotetan were given to the house staff. On implementation, all orders written for cefoxitin were automatically changed to cefotetan in the appropriate dosage. After the first 12 months of cefotetan usage no unanticipated problems with treatment failures or adverse effects were noted. Based on analysis of cefotetan use for the first year, a savings of +4F229,811 was achieved with this interchange.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists

PubMed Central

McBride, Ali; Stevenson, James G.; Green, Larry

2014-01-01

Abstract Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions’ information technology systems. PMID:25477613

Decision analysis in formulary decision making.

PubMed

Schechter, C B

1993-06-01

Although decision making about what drugs to include in an institutional formulary appears to lend itself readily to quantitative techniques such as decision analysis and cost-benefit analysis, a review of the literature reveals that very little has been published in this area. Several of the published decision analyses use non-standard techniques that are, at best, of unproved validity, and may seriously distort the underlying issues through covert under-counting or double-counting of various drug attributes. Well executed decision analyses have contributed to establishing that drug acquisition costs are not an adequate measure of the total economic impact of formulary decisions and that costs of labour and materials associated with drug administration must be calculated on an institution-specific basis to reflect unique staffing patterns, bulk purchasing practices, and the availability of surplus capacity within the institution which might be mobilised at little marginal cost. Clinical studies of newly introduced drugs frequently fail to answer the questions that weigh most heavily on the structuring of a formal assessment of a proposed formulary acquisition. Studies comparing a full spectrum of therapeutically equivalent drugs are rarely done, and individual studies of particular pairs of drugs can rarely be used together because of differences in methodology or patient populations studied. Gathering of institution-specific economic and clinical data is a daunting, labour-intensive task. In many institutions, incentive and reward structures discourage behaviour that takes the broad institutional perspective that is intrinsic to a good decision analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

Technology assessment and the drug use process.

PubMed

Solomon, D K; Gourley, D R; Brown, J R; Gourley, G A; Humma, L M

1999-02-01

This activity is designed for pharmacists, physicians, physician assistants, nurses, and other healthcare team members, payers for health services, and healthcare executives. Upon completion of this activity, the participant should be able to: 1. Describe the rationale behind, the development of, and the advantages arising from the formulary process, and discuss the health professionals involved in the creation of formularies. 2. Describe the impact of new drug development and technology on the drug use process. 3. Discuss the functions of the pharmacy and therapeutics committee. 4. Describe the impact of consumers on the drug use process.

The Effect of Formulary Restrictions on Patient and Payer Outcomes: A Systematic Literature Review.

PubMed

Park, Yujin; Raza, Syed; George, Aneesh; Agrawal, Rumjhum; Ko, John

2017-08-01

Formulary restrictions are implemented to reduce pharmacy costs and ensure appropriate use of pharmaceutical products. As adoption of formulary restrictions increases with rising pharmacy costs, there is a need to better understand the potential effect of formulary restrictions on patient and payer outcomes. To conduct a systematic literature review that assesses the effect of formulary restrictions on the following outcomes: medication adherence, clinical outcomes, treatment satisfaction, drug utilization, health care resource utilization, and economic outcomes. Studies published in 2005 or later were identified from the MEDLINE, Embase, and Cochrane databases and the National Health Service Economic Evaluation Database, using 2 sets of search terms. A total of 17 formulary restriction terms (e.g., step therapy [ST] and prior authorization [PA]) and 55 outcome terms were included, resulting in 935 unique search term combinations. Two reviewers independently conducted analyses of the titles, abstracts, and full-text articles. The search was limited to English-language articles that evaluated the effect of ST and/or PA placed by U.S. third-party payers on the following outcomes: patient outcomes (medication adherence, clinical outcomes, and treatment satisfaction) and payer outcomes (drug utilization, health care resource utilization, and economic outcomes). Of 2,321 reviewed articles, 59 articles met the study inclusion criteria. The included studies assessed the effect of ST (n = 18), PA (n = 35), or both (n = 6) on medication adherence (n = 14), clinical outcomes (n = 12), treatment satisfaction (n = 2), drug utilization (n = 39), health care resource utilization (n = 18), and economic outcomes (n = 42). The 59 articles measured 164 outcomes across the patient, health care resource utilization, and economic outcome categories of interest. Of the total number of outcomes, 50.6% (n = 83) were negative in direction or were unfavorable, whereas 40.2% (n = 66) were positive in direction or were favorable, when the perspectives of patients and payers were considered. Of the total number of drug utilization outcomes reported (n = 46), the majority showed lower drug utilization (> 90%). However, in some of the articles, pharmacy cost savings resulting from lower drug utilization appeared to be offset by increased medical costs. Formulary coverage decisions may have unintended consequences on patient and payer outcomes despite lower drug utilization and pharmacy cost savings; therefore, careful evaluation of restrictions before policy implementation and continued reevaluation after implementation is warranted. This study was funded by Novartis Pharmaceuticals. Park and Ko are employed by Novartis Pharmaceuticals in East Hanover, New Jersey, and Ko holds stock in Novartis. Raza, George, and Agrawal are employed by Novartis Healthcare in Hyderabad, India. Study concept and design were contributed primarily by Park and Ko, along with the other authors. Raza, George, and Agrawal collected the data, along with Park and Ko. Data interpretation was performed by Agrawal, Raza, George, Park, and Ko. The manuscript was written and revised by Raza, George, and Park, along with Ko and Agrawal. Results from this systematic literature review were presented at the AMCP Annual Meeting 2016; San Francisco, California; April 19-22, 2016.

Bringing liraglutide to market: a CER case study.

PubMed

Oderda, Gary; Sifford-Wilson, S Monet

2012-06-01

Faced with competition from other drugs and therapies, drug manufacturers may be able to use comparative effectiveness research (CER) to help reduce barriers to a new drug's adoption and integration into formularies. But few examples exist to show how CER can be used effectively and whether the data can make a difference. To examine how CER can help strengthen a new drug's entry into the market and integration into formularies, and how ongoing CER might be valuable as a drug is implemented in the real world. A roundtable of 9 representatives from health plans, including formulary decision makers, evaluated how CER in phase 3 development of a new drug can add to the drug's strength of evidence, helping decision makers understand how and where to integrate that drug into a formulary. The round table participants viewed, as a case study, the development of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist for adults with type 2 diabetes that was approved by the FDA in January 2010. With this drug, CER was incorporated into an extensive type 2 diabetes clinical development program, comparing how the drug worked in comparison with other established therapies. Although there are many antidiabetic drugs available for use, patients with type 2 diabetes often need additional agents. The FDA approved liraglutide with the conclusion that benefits of the drug outweighed potential risks but noted the association with pancreatitis in humans and animal data that showed rare medullary thyroid cancer associated with liraglutide. Roundtable participants agreed that while pre-launch CER can be valuable, ongoing real-world research is also important for confirming expected results, identifying additional uses and indications and managing risks. The participants also suggested opportunities for additional CER studies and made recommendations for manufacturers. Roundtable thought leaders agreed that well-planned trial designs incorporating CER result in high-quality evidence that may provide sufficient data to support adoption of a new therapy onto the formulary. When more real-world data become available and confirm the phase 3 clinical trial results, decision makers may be able to use the results to change the drug's position and either lessen or extend its use.

National Drug Formulary review of statin therapeutic group using the multiattribute scoring tool

PubMed Central

Ramli, Azuana; Aljunid, Syed Mohamed; Sulong, Saperi; Md Yusof, Faridah Aryani

2013-01-01

Purpose HMG-CoA reductase inhibitors (statins) are extensively used in treating hypercholesterolemia. The statins available in Malaysia include atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, and fluvastatin. Over the years, they have accumulated in the National Drug Formulary; hence, the need for review. Effective selection of the best drugs to remain in the formulary can become complex due to the multiple drug attributes involved, and is made worse by the limited time and resources available. The multiattribute scoring tool (MAST) systematizes the evaluation of the drug attributes to facilitate the drug selection process. In this study, a MAST framework was developed to rank the statins based on their utilities or benefits. Methods Published literature on multicriteria decision analysis (MCDA) were studied and five sessions of expert group discussions were conducted to build the MAST framework and to review the evidence. The attributes identified and selected for analysis were efficacy (clinical efficacy, clinical endpoints), safety (drug interactions, serious side effects and documentation), drug applicability (drug strength/formulation, indications, dose frequency, side effects, food–drug interactions, and dose adjustments), and cost. The average weights assigned by the members for efficacy, safety, drug applicability and cost were 32.6%, 26.2%, 24.1%, and 17.1%, respectively. The utility values of the attributes were scored based on the published evidence or/and agreements during the group discussions. The attribute scores were added up to provide the total utility score. Results Using the MAST, the six statins under review were successfully scored and ranked. Atorvastatin scored the highest total utility score (TUS) of 84.48, followed by simvastatin (83.11). Atorvastatin and simvastatin scored consistently high, even before drug costs were included. The low scores on the side effects for atorvastatin were compensated for by the higher scores on the clinical endpoints resulting in a higher TUS for atorvastatin. Fluvastatin recorded the lowest TUS. Conclusion The multiattribute scoring tool was successfully applied to organize decision variables in reviewing statins for the formulary. Based on the TUS, atorvastatin is recommended to remain in the formulary and be considered as first-line in the treatment of hypercholesterolemia. PMID:24353428

Pharmacist recognition of and adherence to medication-use policies and safety practices.

PubMed

Saad, Aline H; Sweet, Burgunda V; Stumpf, Janice L; Gruppen, Larry; Oh, Mary; Stevenson, James G

2007-10-01

Pharmacist recognition of and adherence to medication-use policies and safety practices were assessed. Simulation testing was used to assess the performance of pharmacists in hypothetical scenarios simulating real-life situations. Fifty test case medication orders were developed, some requiring specific intervention and some requiring no special action. Orders were classified into four categories: those posing safety concerns n ( = 16), those with formulary and product standardization issues (n = 4), those with pharmacy and therapeutics (P&T) committee restrictions (n = 4), and those requiring no special action (n = 26). Potential barriers to compliance were identified by the project team and the orders categorized accordingly. The orders were processed by 25 pharmacists using a simulation testing procedure. Data were analyzed by pharmacists' demographics, order category, and perceived barriers to compliance. Pharmacists were correctly able to recognize 77.3% of test orders: 67.3% with safety concerns, 98.9% with formulary issues, and 98.5% with restrictions. Appropriate action was taken with 74.2% of test orders: 64.5% of safety orders, 96.6% of formulary orders, and 92.4% of restriction orders. There was no correlation between pharmacists' performance and demographic characteristics. The two barriers to correct response identified most often were ambiguous responsibility and low perceived level of importance. Pharmacists generally recognized and took appropriate action with simulated medication orders that contained problems related to formulary or P&T committee restrictions. They were less able to recognize and act appropriately on orders with safety-related problems. Ambiguous responsibility and low perceived importance were the most significant factors contributing to noncompliance with P&T committee policies and guidelines.

Medicare Part D: Pharmacists and formularies--whose job is it to address copays?

PubMed

Khan, Shamima

2014-09-01

To explore pharmacists' perceived responsibility to assist Part D patients in the community in managing their out-of-pocket (OOP) costs as well as pharmacists' overall experience with Medicare Part D. Cross-sectional analysis. Maine, New Jersey, New York, Massachusetts, Maryland, and Pennsylvania. 272 pharmacists. 37-question online survey. Perceived responsibility to assist Part D patients in managing their OOP costs and pharmacists' overall experience with Medicare Part D. Of the 4,888 online surveys, 1,108 were assumed to have reached the intended recipients, of which 272 responded (adjusted response rate 25.0%). Fifty-seven percent, 43.3%, and 41.9% of pharmacists reported that it was not their responsibility to address Part D patients' copayment/cost issue, prior authorization issues, or dispense preferred formulary medications, respectively. However, 43.2% reported that their most time-consuming task in reference to Part D were addressing formulary and copayment issues. In reference to overall experience with Part D, 42.9% reported that the impact on pharmacy's workflow was negative or very negative. A significant difference was observed between pharmacists' practice settings, the state in which they practiced, and reporting of negative impact of Part D on workflow (χ² = 4.9, P = 0.028; χ² = 6.16, P = 0.013, respectively). Most community pharmacists reported that it was not their responsibility to address patients' OOP costs issues, though a majority reported that the most time-consuming task in reference to Part D was addressing formulary and copayment issues. Almost half of the pharmacists also reported that the impact of Part D on workflow was negative.

Literature review on the structure and operation of Pharmacy and Therapeutics Committees.

PubMed

Durán-García, Esther; Santos-Ramos, Bernardo; Puigventos-Latorre, Francesc; Ortega, Ana

2011-06-01

To review the literature on the structure and operation of hospital Pharmacy and Therapeutics Committees from an international point of view and examine the factors that influence decision-making of these committees. We performed a literature search in the Medline and Embase databases from 1997 to January 2009 with the search terms: formulary system decision making, pharmacy and therapeutics committee, formularies hospital, drug formulary, survey, drug selection and outcome assessment health care. Inclusion criteria were the following: studies analyzing Pharmacy and Therapeutics Committees published in English or Spanish from 1997 to January 2009. Exclusion criteria were: publications which were editorials or opinion pieces, studies relating to one hospital, and studies where full text could not be attained. The analysis was divided into structural/organizational data and data on factors affecting the decision-making process. Seventeen studies met the inclusion criteria. Pharmacy and Therapeutics Committees and formularies were present in more than 90% of the hospitals in four of the five countries examined. Therapeutic interchange programs existed only in two of these countries. The mean number of committee members ranged between six and eight. More than 89% of the committees included a pharmacist. Standard operating procedures were implemented by 89% of the committees. The most influential factors in the decision-making were clinical trial results or drug costs rather than pharmacoeconomic studies. Other local organization-dependent factors were also important. The structure and operating procedures of Hospital Pharmacy and Therapeutics Committees are similar in select Western countries. Information from clinical trials is the most influential factor in the decision-making process.

Elucidation of Islamic drugs in Hui Hui Yao Fang: a linguistic and pharmaceutical approach.

PubMed

Kong, Y C; Chen, D S

1996-11-01

Hui Hui Yao Fang, an Islamic formulary, was probably the official formulary of the Mongolian administration during the Yuan dynasty (13th-14th century) in China. In the three chapters of prescriptions that remain extant today, there are 517 Islamic drugs carrying Arabic or Persian names, each with its Chinese transliteration. Chapter 12 deals with the 'wind' diseases, containing 199 Islamic drugs. In this research, 129 items were identified, and each of which was assigned to a definite taxon; these are the most frequently cited drugs in the formulary. Identifications were corroborated by botanical, pharmacological and phonetic considerations. This exercise demonstrates the inherent affinity between Islamic and Chinese medicines. The reciprocal influence between them greatly enriched the content of these two important bodies of drug science, thus, setting a pattern for the synthesis of drug knowledge and the regulation of therapeutic substances. Recognition of different bodies of ethnomedicine is necessary in view of the fact that there is an increasing mobility of people today, who tend to bring with them their drug knowledge.

The menu-setting problem and subsidized prices: drug formulary illustration.

PubMed

Olmstead, T; Zeckhauser, R

1999-10-01

The menu-setting problem (MSP) determines the goods and services an institution offers and the prices charged. It appears widely in health care, from choosing the services an insurance arrangement offers, to selecting the health plans an employer proffers. The challenge arises because purchases are subsidized, and consumers (or their physician agents) may make cost-ineffective choices. The intuitively comprehensible MSP model--readily solved by computer using actual data--helps structure thinking and support decision making about such problems. The analysis uses drug formularies--lists of approved drugs in a plan or institution--to illustrate the framework.

The evolution of the cancer formulary review in Canada: Can centralization improve the use of economic evaluation?

PubMed

Wranik, W Dominika; Gambold, Liesl; Hanson, Natasha; Levy, Adrian

2017-04-01

Public reimbursement of drugs is a costly proposition for health care systems. Decisions to add drugs to the public formulary are often guided by review processes and committees. The evolution of the formulary review process in Canada's publicly funded health system is characterized by increased centralization and systematization. In the past, the review of evidence and recommendation was conducted at the regional level, but was replaced with the pan-Canadian Oncology Drug Review in 2011. We assess the extent to which centralization and systematization of the review process have responded to past challenges, focusing on the use of economic evaluation in the process. Past challenges with economic evaluation experienced by regionalized review committees were identified from literature and qualitative data collected in the province of Nova Scotia. We categorize these using a typology with a macro-, meso, and micro-level hierarchy, which provides a useful framework for understanding at which level change is required, and who has the authority to influence change. Using grounded theory methods, we identify approaches used by Nova Scotia past committee members to compensate for perceived shortcomings of the process. These include an undue reliance on other committee members, on the multidisciplinarity of the committee, and on past decisions. Using a policy analysis approach, we argue that centralization and systematization of the review process only partially address the shortcomings of the previous regionalized process. Lessons from Canada can inform policy discussions across all health systems, where similar challenges with the formulary review process have been identified. © 2016 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd. © 2016 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd.

Public Drug Plan Coverage for Children Across Canada: A Portrait of Too Many Colours

PubMed Central

Ungar, Wendy J; Witkos, Maciej

2005-01-01

Background: As debate continues regarding pharmacare in Canada, little discussion has addressed appropriate drug plan coverage for vulnerable populations, such as children. The primary objective of this study was to determine the extent of medication coverage for children in publicly administered programs in each province across Canada. Methods: Data were collected on provincial, territorial and federal government drug plans, and 2003 formulary updates were obtained. A simulation model was constructed to demonstrate costs to a low-income family with an asthmatic child in each province. Programs were compared descriptively. The extent of interprovincial variation in 2003 formulary approvals was summarized statistically. Results: There was 39% variation between provinces with respect to 2003 formulary approvals (chi-square p < 0.0001) and 48% variation for 2003 paediatric-labelled products (chi-square p < 0.0001). Across Canada, only 8% of 2003 formulary approvals were indicated primarily for paediatric conditions. In the simulation model, costs were less than or equal to 3% of household income in provinces with plans for low-income families, catastrophic costs (Ontario) or for the population. Families who failed to qualify for low income plans or who resided in New Brunswick or Newfoundland faced costs up to 7% of household income. Interpretation: With regard to pharmaceutical benefits for children, provincial drug programs vary considerably in terms of whom they cover, what drugs are covered and how much subscribers must pay out of pocket. Unlike seniors and social assistance recipients, the provinces do not agree on the importance of providing comprehensive coverage for all children. For many Canadian children, significant financial barriers exist to medication access. PMID:19308106

Effect of electronic prescribing with formulary decision support on medication use and cost.

PubMed

Fischer, Michael A; Vogeli, Christine; Stedman, Margaret; Ferris, Timothy; Brookhart, M Alan; Weissman, Joel S

2008-12-08

Electronic prescribing (e-prescribing) with formulary decision support (FDS) prompts prescribers to prescribe lower-cost medications and may help contain health care costs. In April 2004, 2 large Massachusetts insurers began providing an e-prescribing system with FDS to community-based practices. Using 18 months (October 1, 2003, to March 31, 2005) of administrative data, we conducted a pre-post study with concurrent controls. We first compared the change in the proportion of prescriptions for 3 formulary tiers before and after e-prescribing began, then developed multivariate longitudinal models to estimate the specific effect of e-prescribing when controlling for baseline differences between intervention and control prescribers. Potential savings were estimated using average medication costs by formulary tier. More than 1.5 million patients filled 17.4 million prescriptions during the study period. Multivariate models controlling for baseline differences between prescribers and for changes over time estimated that e-prescribing corresponded to a 3.3% increase (95% confidence interval, 2.7%-4.0%) in tier 1 prescribing. The proportion of prescriptions for tiers 2 and 3 (brand-name medications) decreased correspondingly. e-Prescriptions accounted for 20% of filled prescriptions in the intervention group. Based on average costs for private insurers, we estimated that e-prescribing with FDS at this rate could result in savings of $845,000 per 100,000 patients. Higher levels of e-prescribing use would increase these savings. Clinicians using e-prescribing with FDS were significantly more likely to prescribe tier 1 medications, and the potential financial savings were substantial. Widespread use of e-prescribing systems with FDS could result in reduced spending on medications.

Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

PubMed

Uppal, Navjeet K; Dupuis, Lee L; Parshuram, Christopher S

2008-01-01

To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

The timing of drug funding announcements relative to elections: a case study involving dementia medications.

PubMed

Gill, Sudeep S; Gupta, Neeraj; Bell, Chaim M; Rochon, Paula A; Austin, Peter C; Laupacis, Andreas

2013-01-01

Following initial regulatory approval of prescription drugs, many factors may influence insurers and health systems when they decide whether to add these drugs to their formularies. The role of political pressures on drug funding announcements has received relatively little attention, and elections represent an especially powerful form of political pressure. We examined the temporal relationship between decisions to add one class of drugs to publicly funded formularies in Canada's ten provinces and elections in these jurisdictions. Dates of provincial formulary listings for cholinesterase inhibitors, which are drugs used to treat Alzheimer's disease and related dementias, were compared to the dates of provincial elections. Medical journal articles, media reports, and proceedings from provincial legislatures were reviewed to assemble information on the chronology of events. We tested whether there was a statistically significant increase in the probability of drug funding announcements within the 60-day intervals preceding provincial elections. Decisions to fund the cholinesterase inhibitors were made over a nine-year span from 1999 to 2007 in the ten provinces. In four of ten provinces, the drugs were added to formularies in a time period closely preceding a provincial election (P = 0.032); funding announcements in these provinces were made between 2 and 47 days prior to elections. Statements made in provincial legislatures highlight the key role of political pressures in these funding announcements. Impending elections appeared to affect the timing of drug funding announcements in this case study. Despite an established structure for evidence-based decision-making, drug funding remains a complex process open to influence from many sources. Awareness of such influences is critical to maintain effective drug policy and public health decision-making.

The Impact of Coverage Restrictions on Antipsychotic Utilization Among Low-Income Medicare Part D Enrollees.

PubMed

Roberto, Pamela N; Brandt, Nicole; Onukwugha, Eberechukwu; Perfetto, Eleanor; Powers, Christopher; Stuart, Bruce

2017-11-01

Prior research demonstrates substantial access problems associated with utilization management and formulary exclusions for antipsychotics in Medicaid, but the use and impact of coverage restrictions for these medications in Medicare Part D remains unknown. We assess the effect of coverage restrictions on antipsychotic utilization in Part D by exploiting a unique natural experiment in which low-income beneficiaries are randomly assigned to prescription drug plans with varying levels of formulary generosity. Despite considerable variation in use of coverage restrictions across Part D plans, we find no evidence that these restrictions significantly deter utilization or reduce access to antipsychotics for low-income beneficiaries.

Pharmacy costs associated with nonformulary drug requests.

PubMed

Sweet, B V; Stevenson, J G

2001-09-15

Pharmacy costs associated with handling nonformulary drug requests were studied. Data for all nonformulary drug orders received at a university hospital between August 1 and October 31, 1999, were evaluated to determine their outcome and the cost differential between the nonformulary drug and formulary alternative. Two sets of data were used to analyze medication costs: data from nonformulary medication request forms, which allowed the cost of nonformulary drugs and their formulary alternatives to be calculated, and data from the pharmacy computer system, which enabled actual nonformulary drug use to be captured. Labor costs associated with processing these requests were determined through time analysis, which included the potential for orders to be received at different times of the day and with different levels of technician and pharmacist support. Economic analysis revealed that the greatest cost saving occurred when converting nonformulary injectable products to formulary alternatives. Interventions were least costly during normal business hours, when all the satellite pharmacies were open and fully staffed. Pharmacists' interventions in oral product orders resulted in a net increase in expenditures. Incremental pharmacy costs associated with processing nonformulary medication requests in an inpatient setting are greater than the drug acquisition cost saving for most agents, particularly oral medications.

US payer perspectives on evidence for formulary decision making.

PubMed

Wang, Anthony; Halbert, Ronald J; Baerwaldt, Tiffany; Nordyke, Robert J

2012-05-01

The perspective of commercial payers on comparative effectiveness research (CER) has not been well researched. This study aims to describe how US commercial payers use and value CER for formulary decision making in different disease states. We recruited 20 medical and pharmaceutical directors from national and regional plans who are involved in pharmaceutical and therapeutics committees to participate in the study. We conducted in-depth qualitative interviews with the payers and asked them to rate the usefulness of CER study types across various disease states and market conditions. The results were analyzed for thematic content. Our findings indicate that payers are interested in a broad range of CER study types, are unsatisfied with the current state of CER, and would like to partner with research groups to develop research and treatment guidelines to better leverage CER. Payers value CER less in oncology than in other disease states because of limitations in their ability to manage oncology therapies. To improve formulary design processes and support payers in providing more effective healthcare, policy makers should consider involving commercial payers in the development of CER as well as in the creation of research and treatment guidelines.

Formulary decisions and health economics.

PubMed

Glazer, W M

1998-01-01

Because of increasing concerns about health care costs, physicians must consider the cost-effectiveness of a treatment strategy, as well as its efficacy and safety. The question of whether the greater expense of a newer drug is justified over the cost of a generic drug deserves a comprehensive evaluation. The determination of effectiveness and tolerability of the newer antipsychotics should be expanded to include quality-of-life issues, reintegration of the patient into the community, resource utilization, and medical costs. There are clear indications that patients who take atypical antipsychotics utilize fewer medical resources than patients who take typical antipsychotics; however, the positive outcomes of the newer drugs must be translated into cost benefits if formularies are to be intelligently controlled.

Impact of formulary restriction with prior authorization by an antimicrobial stewardship program

PubMed Central

Reed, Erica E.; Stevenson, Kurt B.; West, Jessica E.; Bauer, Karri A.; Goff, Debra A.

2013-01-01

In an era of increasing antimicrobial resistance and few antimicrobials in the developmental pipeline, many institutions have developed antimicrobial stewardship programs (ASPs) to help implement evidence-based (EB) strategies for ensuring appropriate utilization of these agents. EB strategies for accomplishing this include formulary restriction with prior authorization. Potential limitations to this particular strategy include delays in therapy, prescriber pushback, and unintended increases in use of un-restricted antimicrobials; however, our ASP found that implementing prior authorization for select antimicrobials along with making a significant effort to educate clinicians on criteria for use ensured more appropriate prescribing of these agents, hopefully helping to preserve their utility for years to come. PMID:23154323

Impact of formulary restriction with prior authorization by an antimicrobial stewardship program.

PubMed

Reed, Erica E; Stevenson, Kurt B; West, Jessica E; Bauer, Karri A; Goff, Debra A

2013-02-15

In an era of increasing antimicrobial resistance and few antimicrobials in the developmental pipeline, many institutions have developed antimicrobial stewardship programs (ASPs) to help implement evidence-based (EB) strategies for ensuring appropriate utilization of these agents. EB strategies for accomplishing this include formulary restriction with prior authorization. Potential limitations to this particular strategy include delays in therapy, prescriber pushback, and unintended increases in use of un-restricted antimicrobials; however, our ASP found that implementing prior authorization for select antimicrobials along with making a significant effort to educate clinicians on criteria for use ensured more appropriate prescribing of these agents, hopefully helping to preserve their utility for years to come.

Saccharomyces boulardii for the prevention of hospital onset Clostridium difficile infection.

PubMed

Flatley, Elizabeth A; Wilde, Ashley M; Nailor, Michael D

2015-03-01

Probiotics, including Saccharomyces boulardii, have been advocated for the prevention of Clostridium difficile infection. The aim of this project was to evaluate the effects of the removal of S. boulardii from an automatic antibiotic order set and hospital formulary on hospital onset C. difficile infection rates. A retrospective chart review was performed on all patients with hospital onset C. difficile infection during the 13 months prior (control group) and the 13 months after (study group) removal of an automatic order set linking S. boulardii capsules to certain broad spectrum antibiotics. A large 800+ bed tertiary hospital. Among all hospitalized patients, the rate of hospital onset C. difficile infection was 0.99 per 1000 patient days while the S. boulardii protocol was active compared with 1.04 per 1000 patient days (p=0.10) after S. boulardii was removed from the formulary. No difference in the rate of hospital onset C. difficile infection was detected in patients receiving the linked broad spectrum antibiotics during and after the removal of the protocol (1.25% vs. 1.51%, respectively; p=0.70). Removal of S. boulardii administration to patients receiving broad spectrum antibiotics and the hospital formulary did not impact the rate of hospital onset C. difficile infection in either the hospital population or patients receiving broad spectrum antibiotics.

Drug-Induced Nephrotoxicity and Dose Adjustment Recommendations: Agreement Among Four Drug Information Sources.

PubMed

Bicalho, Millena Drumond; Soares, Danielly Botelho; Botoni, Fernando Antonio; Reis, Adriano Max Moreira; Martins, Maria Auxiliadora Parreiras

2015-09-09

: Hospitalized patients require the use of a variety of drugs, many of which individually or in combination have the potential to cause kidney damage. The use of potentially nephrotoxic drugs is often unavoidable, and the need for dose adjustment should be evaluated. This study is aimed at assessing concordance in information on drug-induced nephrotoxicity and dose adjustment recommendations by comparing four drug information sources (DRUGDEX(®), UpToDate(®), Medscape(®) and the Brazilian Therapeutic Formulary) using the formulary of a Brazilian public hospital. A total of 218 drugs were investigated. The global Fleiss' kappa coefficient was 0.265 for nephrotoxicity (p < 0.001; CI 95%, 0.211-0.319) and 0.346 for recommendations (p < 0.001; CI 95%, 0.292-0.401), indicating fair concordance among the sources. Anti-infectives and anti-hypertensives were the main drugs cited as nephrotoxic by the different sources. There were no clear definitions for qualitative data or quantitative values for dose adjustments among the four information sources. There was no advice for dosing for a large number of the drugs in the international databases. The National Therapeutic Formulary offered imprecise dose adjustment recommendations for many nephrotoxic drugs. Discrepancies among information sources may have a clinical impact on patient care and contribute to drug-related morbidity and mortality.

eDrug: a dynamic interactive electronic drug formulary for medical students

PubMed Central

Maxwell, Simon R J; McQueen, Daniel S; Ellaway, Rachel

2006-01-01

What is already known about this subject Delivering education about an ever-increasing number of prescribable drugs to medical students represents a major challenge. Drug names are generally not logical or intuitive, and many students find learning them akin to learning a foreign language. Pharmacology and therapeutics teaching is struggling for visibility in some integrated medical curricula. What this study adds Development of electronic tools allowing web delivery of a restricted student formulary facilitates dynamic access to core learning materials, improves the profile of this aspect of the curriculum and is highly appreciated by students. Aims Prescribing drugs is a key responsibility of a doctor and requires a solid grounding in the relevant scientific disciplines of pharmacology and therapeutics (PT). The move away from basic science disciplines towards a more system-based and integrated undergraduate curriculum has created difficulties in the delivery of PT teaching in some medical schools. We aimed to develop a web-based strategy to overcome these problems and improve the PT learning experience. Methods We designed and introduced ‘eDrug’, a dynamic interactive web-based student formulary, as an aid to teaching and learning of PT throughout a 5-year integrated medical curriculum in a UK medical school of 1300 students. This was followed by a prospective observational study of student-reported views about its impact on their PT learning experience. Results eDrug was rated highly by students and staff, with the main benefits being increased visibility of PT in the curriculum, clear identification of core drugs, regular sourcing of drug information via direct links to accredited sources including the British National Formulary, prioritization of learning, immediate access and responsiveness. It has also served as a focus of discussion concerning core PT learning objectives amongst staff and students. Conclusions Web-based delivery of PT learning objectives actively supports learning within an integrated curriculum. PMID:17054667

Mind the Gap: Why Closing the Doughnut Hole Is Insufficient for Increasing Medicare Beneficiary Access to Oral Chemotherapy.

PubMed

Dusetzina, Stacie B; Keating, Nancy L

2016-02-01

Orally administered anticancer medications are among the fastest growing components of cancer care. These medications are expensive, and cost-sharing requirements for patients can be a barrier to their use. For Medicare beneficiaries, the Affordable Care Act will close the Part D coverage gap (doughnut hole), which will reduce cost sharing from 100% in 2010 to 25% in 2020 for drug spending above $2,960 until the beneficiary reaches $4,700 in out-of-pocket spending. How much these changes will reduce out-of-pocket costs is unclear. We used the Medicare July 2014 Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from the Centers for Medicare & Medicaid Services for 1,114 stand-alone and 2,230 Medicare Advantage prescription drug formularies, which represent all formularies in 2014. We identified orally administered anticancer medications and summarized drug costs, cost-sharing designs used by available plans, and the estimated out-of-pocket costs for beneficiaries without low-income subsidies who take a single drug before and after the doughnut hole closes. Little variation existed in formulary design across plans and products. The average price per month for included products was $10,060 (range, $5,123 to $16,093). In 2010, median beneficiary annual out-of-pocket costs for a typical treatment duration ranged from $6,456 (interquartile range, $6,433 to $6,482) for dabrafenib to $12,160 (interquartile range, $12,102 to $12,262) for sunitinib. With the assumption that prices remain stable, after the doughnut hole closes, beneficiaries will spend approximately $2,550 less. Out-of-pocket costs for Medicare beneficiaries taking orally administered anticancer medications are high and will remain so after the doughnut hole closes. Efforts are needed to improve affordability of high-cost cancer drugs for beneficiaries who need them. © 2015 by American Society of Clinical Oncology.

Physicians' opinions about responsibility for patient out-of-pocket costs and formulary prescribing in two Midwestern states.

PubMed

Khan, Shamima; Sylvester, Robert; Scott, David; Pitts, Bruce

2008-10-01

Multi-tier copayment designs in pharmacy benefit plans are intended to steer patients and prescribers to preferred drug therapies that have lower out-of-pocket costs for patients. To describe and assess physicians' prescribing experiences and opinions in a multi-tier, primarily 3-tier formulary environment in 2 Midwestern states. This was a cross-sectional survey of physicians practicing in either Minnesota or North Dakota. A packet consisting of a survey instrument, a cover letter, and a postage-paid return envelope was mailed to a random sample of 690 physician members of the Minnesota Medical Association (n = 460, 5.1% of members) or the North Dakota Medical Association (n = 230, 25.6% of members). Surveys were mailed between March and May 2006. Nonresponders were mailed up to 2 additional surveys. Survey items included practice specialty, sources used to obtain drug information, perceived importance of cost containment actions (e.g., prescribing drug with lowest total cost, prescribing drug that minimizes patient out-of-pocket cost), and how often the physician was personally aware of the following when writing a prescription: identity of the patient's insurer, patient's pharmacy benefit structure, preferred medications on the insurer's formulary, patient's copayment (out-of-pocket cost) responsibility, and list price of the medication. The survey response rate was 49.8% (296 of 594). The results were as follows: 93.5% of respondents agreed that it was important to prescribe the drug that would minimize the patient's out-of-pocket costs, 73.2% agreed that it was important to discuss out-of-pocket medication costs with patients, 81.8% of respondents agreed that it was important to prescribe the drug with the lowest total costs, and 33.3% of respondents believed that it was their responsibility to prescribe a preferred (formulary) medication. According to the survey, 61.6% of respondents were rarely or never aware of their patient's copayment amounts, and 42.4% were rarely or never aware of the list price of the medication. Physician specialty was associated with the awareness of the identity of the patient's insurer (generalists, 41.1% vs. specialists, 19.2%; P = 0.001) and use of personal digital assistant (PDA) when prescribing (generalists, 38.9% vs. specialists, 21.1%; P = 0.005). Physicians who responded to this survey believed that it was important to prescribe drugs that would minimize patients' prescription copayments, but they were often unaware of the preferred medications on the formulary, the patients' copayment amounts, or the price of the drugs prescribed.

Decline in Buprenorphine/Naloxone Prescriptions in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail.

PubMed

Soper, Richard; Appajosyula, Sireesh; Deximo, Christina

2018-04-01

A large, statewide, fee-for-service Medicaid plan recently (October 2015) executed a complete switch from sublingual buprenorphine-naloxone [(SLBN), Suboxone ® ] to buccal buprenorphine-naloxone [(BBN), Bunavail ® ] on its preferred drug formulary. This complete formulary switch provided an opportunity to assess dynamic changes in prescribing patterns, patient/physician acceptance, and indices of potential misuse/diversion. For the period January 1, 2015 through December 31, 2016, two datasets were analyzed: prescriptions and associated costs for buprenorphine-naloxone (BN) products and urine toxicology test results for patients in the Medicaid plan. The dataset comprised 1370 unique providers ordering 643,225 prescriptions for opioid addiction therapy. Patient and order volumes, and the rate of monthly positive laboratory values for opioid molecules and cocaine were reviewed. A targeted survey of physicians treating opioid-dependent patients with state Medicaid plan coverage was also conducted. Upon plan conversion to BBN, there was a rapid increase in monthly BBN prescriptions mirrored by a rapid decrease in SLBN prescriptions. Peak in BBN prescriptions (2633 in November 2015) was approximately 60% lower than peak in SLBN prescriptions (6531 in July 2015). An unexpected finding was a 68% reduction of the overall BN market, indicating that many BN prescriptions were abandoned. The reduction was associated with quarterly cost savings to the Medicaid plan of approximately $3.5 million. Toxicology results indicated a reduction in drug positivity (defined as positivity for cocaine and/or any opioids except buprenorphine and methadone) from 13-16% in 2015 to less than 10% in 2016. Heroin positivity decreased from approximately 9% in December 2015 to an average of less than 1% during the last quarter of 2016, while positivity for norbuprenorphine, the major metabolite of buprenorphine, showed a marked increase in 2016 vs 2015. Among physicians who responded to the targeted survey most rated BBN as more difficult to abuse or misuse than SLBN. The rapid reduction in the overall BN market following a complete formulary switch from SLBN to BBN was associated with quarterly savings of $3.5 million for the state Medicaid plan. Toxicology data suggest that this cost saving was realized in the context of improved physician and patient adherence to treatment protocols. The changing market dynamics can potentially be explained by a number of contributory factors, including a reduction of diversion and illicit distribution of BN following formulary conversion. These results are considered hypothesis-generating and future research should systematically compare the propensity for diversion and abuse of BN products using various epidemiological tracking tools. BioDelivery Sciences International, Inc.

Hospitals' strategies for orchestrating selection of physician preference items.

PubMed

Montgomery, Kathleen; Schneller, Eugene S

2007-06-01

This article analyzes hospitals' strategies to shape physicians' behavior and counter suppliers' power in purchasing physician preference items. Two models of standardization are limitations on the range of manufacturers or products (the "formulary" model) and price ceilings for particular item categories (the "payment-cap" model), both requiring processes to define product equivalencies often with inadequate product comparison data. The formulary model is more difficult to implement because of physicians' resistance to top-down dictates. The payment-cap model is more feasible because it preserves physicians' choice while also restraining manufacturers' power. Hospitals may influence physicians' involvement through a process of orchestration that includes committing to improve clinical facilities, scheduling, and training and fostering a culture of mutual trust and respect.

Summary of 1990 Medicaid drug rebate legislation. ASHP Government Affairs Division.

PubMed

1991-01-01

Provisions of the federal Omnibus Budget Reconciliation Act of 1990 that are designed to control federal and state outlays for prescription drugs by requiring rebates from drug manufacturers to state Medicaid programs are described, and their potential effects on pharmacy practice in organized health-care settings are discussed. As of January 1, 1991, for a manufacturer's drug product line to be eligible for any coverage under Medicaid, the manufacturer must provide rebates to all state Medicaid programs. Health maintenance organizations are exempt from the law. Hospitals that dispense outpatient drugs to Medicaid patients under a formulary system and that bill Medicaid not more than purchase costs are exempt. The law requires no immediate action by hospitals and other organized care settings; action may be required when provisions of the law concerning drug-use review programs and patient counseling become effective. If a state enters a rebate agreement, its Medicaid plan must permit coverage of all of a manufacturer's prescription drug products, but the law does not affect formulary systems of individual health-care institutions. Formulary issues, the scope of hospital exemption, and pharmacist participation in DUR activities and patient counseling need to be clarified as state Medicaid plans are amended to comply with the law; pharmacists in organized health-care settings can best influence these changes through action at the state level.

Pharmacy benefits management in the Veterans Health Administration: 1995 to 2003.

PubMed

Sales, Mariscelle M; Cunningham, Francesca E; Glassman, Peter A; Valentino, Michael A; Good, Chester B

2005-02-01

The Department of Veterans Affairs (VA) Pharmacy Benefits Management Strategic Healthcare Group (VA PBM) oversees the formulary for the entire VA system, which serves more than 4 million veterans and provides more than 108 million prescriptions per year. Since its establishment in 1995, the VA PBM has managed pharmaceuticals and pharmaceutical-related policies, including drug safety and efficacy evaluations, pharmacologic management algorithms, and criteria for drug use. These evidence-based practices promote, optimize, and assist VA providers with the safe and appropriate use of pharmaceuticals while allowing for formulary decisions that can result in substantial cost savings. The VA PBM also has utilized various contracting techniques to standardize generic agents as well as specific drugs and drug classes (eg, antihistamines, angiotensin-converting enzyme inhibitors, alpha-blockers, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [statins]). These methods have enabled the VA to save approximately dollar 1.5 billion since 1996 even as drug expenditures continued to rise from roughly dollar 1 billion in fiscal year (FY) 1996 to more than dollar 3 billion in FY 2003. Furthermore, the VA PBM has established an outcomes research section to undertake quality-improvement and safety initiatives that ultimately monitor and determine the clinical impact of formulary decisions on the VA system nationwide. The experiences of this pharmacy benefits program, including clinical and contracting processes/procedures and their impact on the VA healthcare system, are described.

Using multiple pharmacoeconomic methods to conduct a cost-effectiveness analysis of histamine H2-receptor antagonists.

PubMed

McCoy, S; Blayney-Chandramouli, J; Mutnick, A

1998-12-15

A formulary decision at a health care institution was studied by using two pharmacoeconomic methods. A pharmacoeconomic study was undertaken to assess the impact of a 1995 formulary decision to designate cimetidine as the primary histamine H2-receptor antagonist (H2RA) and to restrict the use of famotidine. Consecutive patients receiving either i.v. cimetidine or famotidine for stress ulcer prophylaxis were reviewed during a two-month period in 1997, and information on demographics, dosage and duration of H2RA therapy, admission date, laboratory test values, and adverse drug reactions was collected. Data for 62 patients (43 cimetidine recipients and 19 famotidine recipients) were evaluated. Therapy was categorized as successful or failed, and the data were then evaluated by decision analysis to evaluate the cost-effectiveness of the agents and by multiattribute utility theory (MAUT) to incorporate a humanistic evaluation of the treatments, namely, the number of doses administered and the number of times dosages were changed. The decision tree revealed that the average cost of receiving cimetidine was $82.01 and the average cost of famotidine therapy was $92.45. The MAUT analysis showed that cimetidine was the preferred agent as long as cost was valued at greater than 60% of the decision-making process and efficacy remained equal between the two agents. Two pharmacoeconomic methods lent support to a formulary decision at a health care institution.

Integrating fluoroquinolones into the hospital formulary.

PubMed

Bertino, J S

2001-10-01

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

77 FR 14769 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... Citizen Comments. 4. Scheduled Therapeutic Class Reviews (Comments will follow each agenda item). a. Attention Deficit Hyperactivity Disorder-Narcolepsy Agents. b. Anti-Platelet Hemorhelogic Agents. c...

76 FR 11212 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... recommendations made to the Director, TRICARE Management Activity, by the Pharmacy and Therapeutics Committee.... Pancreatic Enzymes. b. Inflammatory Bowel Syndrome (IBS)/Inflammatory Bowel Disease (IBD). c. Antilipidemics...

Drug policy: making effective drugs available without bankrupting the healthcare system.

PubMed

Laupacis, Andreas; Anderson, Geoffrey; O'Brien, Bernie

2002-01-01

To the extent possible, drug policy should be based upon good quality evidence. This must extend beyond the traditional focus on efficacy and safety in carefully selected patients, to evidence about real-world effectiveness, cost-effectiveness and safety of drugs. This paper will consider methods of improving the quality of the evidence currently available, and the implications of requiring that evidence. Historically, there has been a direct link between research evidence and policy at the level of licensing - drugs are only made available after they have been shown to be safe and efficacious in well-designed and independently assessed research studies. We propose that this reliance on evidence be logically extended to cover the formulary inclusion and post-marketing surveillance aspects of modern prescription drug policy. More specifically we propose that the decision to initially list a drug on a benefit formulary be based on evidence from relevant head-to-head comparisons and well-designed cost-effectiveness analyses. This evidence would be produced by industry in cooperation with independent peer-reviewed funding agencies. Drugs could only be added to a formulary if they met specific predetermined criteria, and drugs could be removed as superior alternatives became available. The provincial governments are monopsony buyers of medicines, and they wield the power to determine public payer "market access'for medicines. This power (within and across provinces) could be used more effectively to negotiate price in the context of reimbursement. The effect of different methods of influencing prescribing (e.g., 'limited access?) upon drug utilization and patient outcomes should be rigorously assessed, including the randomization of groups of patients or communities to different strategies. We also propose that all drugs on the formulary would be subject to a well-designed post-marketing surveillance program. This program would build on the existing passive reporting of adverse events by adding a proactive system that would systematically describe the use and impact of drugs. The notion of drug safety would be extended to include not only adverse events, but also inappropriate use of drugs that results inpatients receiving drugs that do not benefit them. Inappropriate use wastes resources and can put patients and populations at risk.

Medicare Part D and the Federal Employees Health Benefits Program: A Comparison of Prescription Drug Coverage

PubMed Central

Lovett, Annesha

2013-01-01

Background There is much debate currently about how to restructure the Medicare program to achieve better value for the money. Many have cited the Federal Employees Health Benefits Program (FEHBP) as a model for reform. Objective To compare drug coverage and cost-sharing between Medicare Part D and the FEHBP plans. Methods A cross-sectional comparison was conducted of January 2009 data obtained from the Centers for Medicare & Medicaid Services, the Office of Personnel Management, and 3 health plan websites. Regression analysis and t-tests were used to examine drug coverage, copayment, and coinsurance amounts among Medicare Part D and FEHBP plans. The final study sample of Medicare Part D plans consisted of 19 formularies, covering 63% of total Part D enrollment. These 19 formularies represented 232 stand-alone prescription drug plans. In addition, 5 prescription drug plans or formularies in the FEHBP plans were included, which represents 70% of total FEHBP enrollment. Results The results of this study reveal that formulary coverage of the top drugs dispensed and sold in the United States in 2009 ranged from 72% to 94% (average, 84%) in Medicare Part D plans and from 85% to 99% (average, 94%) in the FEHBP plans (P <.01). The mean copayment for generic drugs in Medicare Part D plans was $4.53 compared with a mean of $7.67 (P <.05) in the FEHBP plans. The difference between the 2 programs in mean copayment for brand-name drugs was nonsignificant. For generic drugs, the mean coinsurance rate was 17% for Medicare Part D plans and a mean of 20% for the FEHBP plans (P <.05). Conclusions This analysis shows that there are differences in prescription drug coverage and cost-sharing among plans within Medicare Part D and the FEHBP. To avoid extreme increases in payroll taxes and other revenues or major cutbacks in services, Medicare must explore ways to change the healthcare system to achieve better value for the money. The experience of the FEHBP suggests a possible means of accomplishing this objective. PMID:24991346

Effects of managerial intervention on drug utilization pattern at King Chulalongkorn Memorial Hospital.

PubMed

Limpanasithikul, Wacharee; Wangsaturaka, Danai; Nantawan, Patra; Itthipanichapong, Chandhanee; Thamaree, Sopit; Wittayalertpanya, Supeecha; Ketcharoen, Aurawan; Taworn, Nongnuch; Kemsri, Wandee; Kusolsomboon, Thammarat; Tangphao, Oranee

2002-06-01

The economic crisis in Thailand since 1997 has a major impact on all sections of the country including health care. There were several suggestions for reducing the drug expenditure budget including restriction of hospital formulary, generic prescribing and generic dispensing. At King Chulalongkorn Memorial hospital, the new hospital formulary was established and implemented in March 1998. The generic dispensing policy was also in place at the same time. This study aimed to evaluate the impact of the new implementation by comparing the prescription patterns in out patient departments (OPDs) of the hospital before and after the new hospital formulary implementation. The prescriptions from several OPDs were systematically stratified samplings 5 weeks before and 5 weeks after March 1st, 1998. The information from the prescriptions including drug category, drug name, amount of dispensed drug, drug cost, etc. was collected and analyzed. The total number of prescriptions and the average number of drug items/prescription before and after the implementation were similar (2,049 vs 2,052, and 2.52 +/- 0.048 vs 2.45 +/- 0.03 respectively). The total cost of the prescription, the cost/prescription and the cost/item seemed to be different (1,690,484 baht vs 1,282,343 baht, 844 +/- 54.04 vs 633 +/- 41.11 and 332.58 +/- 29.59 vs 255.29 +/- 19.98 respectively). After the implementation, physicians in the hospital increasingly prescribed drugs by generic name (37.1% vs 44.85%). Locally made drugs were also prescribed by physicians and received by patients more than before (9.56% vs 84.27% and 28.15% vs 60.72%, respectively). Anti-infective agents were studied in depth as they contribute to significant amount of drug expenditure. The total cost of prescribed anti-infective agents and the cost/prescription were increased after the implementation (223,529 vs 274,435 Baht and 585.38 +/- 102.84 vs 772.71 +/- 147.59). The increased cost mainly came from the cost of anti-HIV drugs. Our data indicate that the new hospital formulary may have played a part on the impact of drug expenditure reduction and may have changed the prescribing attitude of physicians in King Chulalongkorn Memorial Hospital.

American Academy of Dermatology

MedlinePlus

... Center News Advocacy priorities AADA Health System Reform Principles Drug pricing and availability CVS dermatologic formulary restrictions ... Us Media contacts Advertising contacts AAD logo Advertising, marketing and sponsorships Legal notice Copyright © 2017 American Academy ...

75 FR 79344 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Director, TRICARE Management Activity, by the Pharmacy and Therapeutics Committee regarding the Uniform.... Scheduled Therapeutic Class Reviews (Comments will follow each agenda item). a. Non-Insulin Anti-Diabetic...

76 FR 78620 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

... Director of TRICARE Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform.... Scheduled Therapeutic Class Reviews (Comments will follow each agenda item): a. Antidepressants and Non...

78 FR 9037 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... Director of TRICARE Management Activity, by the Pharmacy and Therapeutics Committee, regarding the Uniform... Therapeutic Class Reviews (Comments will follow each agenda item) a. Topical Pain Agents b. Pulmonary--2...

76 FR 28959 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... recommendations made to the Director, TRICARE Management Activity, by the Pharmacy and Therapeutics Committee... Comments 4. Scheduled Therapeutic Class Reviews (Comments will follow each agenda item) Anti-Psychotics a...

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed

Robinson, A

1995-07-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow".

Thrombin products: economic impact of immune-mediated coagulopathies and practical formulary considerations.

PubMed

Voils, Stacy A

2009-07-01

Thrombin has demonstrated utility in aiding surgical hemostasis since its introduction more than 60 years ago. It is used across a wide variety of surgical procedures by virtually every specialty. Only recently have new equally effective and safe products entered the market, causing decision makers to evaluate formulary selection among products with otherwise modest differences. This evaluation includes identifying costs beyond those of acquisition and storage, as well as indirect factors such as monitoring or specialized distribution requirements. One factor to consider specifically in selection of topical thrombin products is the potential for patients to develop an immune-mediated coagulopathy (IMC) after exposure to bovine-derived thrombin. Costs due to adverse drug events fall into the category of indirect costs and, in some instances, can be substantial if bleeding due to IMC occurs.

Implementation of a comprehensive pharmaceutical care program for an underserved population.

PubMed

Mascardo, Lisa A; Spading, Kimberly A; Abramowitz, Paul W

2012-07-15

The implementation of a prescription benefit program for low-income patients emphasizing clinical pharmacist services and strict formulary control is described, with a review of program expenditures and cost avoidance. In 2006, University of Iowa Hospitals and Clinics (UIHC) launched a program to provide a limited prescription benefit to indigent patients under the IowaCare Medicaid demonstration waiver. Sudden dramatic growth in IowaCare enrollment, combined with sharp budget cuts, forced UIHC pharmacy leaders to implement creative cost-control strategies: (1) the establishment of an ambulatory care clinic staffed by a clinical pharmacy specialist, (2) increased reliance on an almost exclusively generic formulary, (3) collaboration with social services staff to help secure medication assistance for patients requiring brand-name drugs, (4) optimized purchasing through the federal 340B Drug Pricing Program, and (5) the imposition of medication copayments and mailing fees for prescription refills. Now in its seventh year, the UIHC pharmacy program has expanded indigent patients' access to pharmaceutical care services while reducing their use of hospital and emergency room services and lowering program medication costs by an estimated 50% (from $2.6 million in fiscal year 2009 to $1.3 million in fiscal year 2010). The UIHC ambulatory care pharmacy implemented a prescription program in collaboration with social service workers to address the medication needs of the state's low-income and uninsured patients in a fiscally responsible manner by managing purchasing contracts, revising a generic formulary, implementing copayments and mailing fees, and reviewing medication profiles.

Evaluating the nondrug costs of formulary coverage restrictions.

PubMed

Abourjaily, Paul; Gouveia, William A; Selker, Harry P; Zucker, Deborah R

2005-08-01

Clinicians often are required to switch prescribed therapy for their patients in response to health plan initiatives for controlling drug expenditures. To explore the effect of these initiatives, we sought clinicians' feedback regarding their practices and processes for switching patients' medications to accommodate insurance coverage. Self-administered Intranet-based survey of clinicians at an urban, tertiary-care hospital. Using survey responses, we calculate nondrug costs induced by formulary cost-saving measures. A total of 91 responses were received from 569 providers who were sent a request to complete the questionnaire via electronic mail (18 percent response rate). It took an average of 11.1, 18.9, and 16.4 minutes for physicians, nurses, and nurse practitioners/physician assistants, respectively, to make the medication switch. The mean number of switches per month ranged from 10.6 to 36.9. More than half the time spent on these switches is not directly reimbursed. Specific switch-induced intervention costs differed for different drug types. The effect on clinician workload tended to be an inconvenience. While the majority of physicians and nurse practitioners/physician assistants did not feel this process damaged patient-provider relations, most nurses did. In response to formulary restrictions, other costs are induced and incurred by providers and patients. The extent of patient costs, including those from adverse drug reactions, needs further study. More research is needed to elucidate costs and burden shifts as all parties involved evaluate and modify plans to moderate prescription drug expenditures.

New Drug Formulary Will Help Expedite Use of Agents in Clinical Trials

Cancer.gov

NCI launched the “NCI Formulary” that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials.

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed Central

Robinson, A

1995-01-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow". Images p86-a PMID:7796380

Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in India: a report from the Global Opioid Policy Initiative (GOPI).

PubMed

Cleary, J; Simha, N; Panieri, A; Scholten, W; Radbruch, L; Torode, J; Cherny, N I

2013-12-01

India is the world's largest democracy with control of opioids divided between the national and state governments. While the global consumption of opioids has increased, the consumption has not increased at the same rate. This is the first comprehensive study of opioid availability and accessibility for cancer patients in India. Data are reported on the availability and accessibility of opioids for the management of cancer pain in 24 of the states that make up India and the Administrative area around Delhi. About 1061 million of the nation's 1189 million people (89%) are covered by this survey. Without exception, opioid availability continues to be low throughout all of India. Even when opioids are on formulary, they are often unavailable. Access is significantly impaired by widespread over-regulation that continues to be pervasive across the nation.

Current treatment of gram-positive infections: focus on efficacy, safety, and cost minimalization analysis of teicoplanin.

PubMed

Crane, V S; Garabedian-Ruffalo, S M

1992-12-01

The current health care environment has had a significant impact on hospital Pharmacy and Therapeutics Committee formulary decisions. In evaluating a new therapy for formulary inclusion, a cost savings along with equivalent or an improvement in patient care and safety is optimal. Teicoplanin is an investigational glycopeptide antimicrobial agent with a spectrum of activity similar to vancomycin. Unlike vancomycin, however, teicoplanin has a long elimination half-life permitting administration once daily, and is well tolerated when given intramuscularly. In addition, teicoplanin is associated with a favorable safety profile. Red man syndrome does not appear to be a significant clinical problem. Results of our cost minimalization analysis using the average acquisition costs of vancomycin revealed that teicoplanin (400 mg), at an average acquisition cost of less than $28.46 when administered intravenously and $30.93 when administered intramuscularly, offers a clinically efficacious, safe, and less expensive alternative to vancomycin therapy.

Pharmacoeconomics and macular degeneration.

PubMed

Brown, Gary C; Brown, Melissa M; Brown, Heidi; Godshalk, Ashlee N

2007-05-01

To describe pharmacoeconomics and its relationship to drug interventions. Pharmacoeconomics is the branch of economics which applies cost-minimization, cost-benefit, cost-effectiveness and cost-utility analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments. Among the four instruments, cost-utility analysis is the most sophisticated, relevant and clinically applicable as it measures the value conferred by drugs for the monies expended. Value-based medicine incorporates cost-utility principles but with strict standardization of all input and output parameters to allow the comparability of analyses, unlike the current situation in the healthcare literature. Pharmacoeconomics is assuming an increasingly important role with regard to whether drugs are listed on the drug formulary of a country or province. It has been estimated that the application of standardized, value-based medicine drug analyses can save over 35% from a public healthcare insurer drug formulary while maintaining or improving patient care.

Budget impact of tegaserod on a managed care organization formulary.

PubMed

Bloom, Michael A; Barghout, Victoria; Kahler, Kristijan H; Bentkover, Judith; Kurth, Hannah; Gralnek, Ian M; Spiegel, Brennan M R

2005-04-01

We sought to develop a budget impact model that assesses the economic effect of adding tegaserod for the management of irritable bowel syndrome (IBS) with constipation to the formulary of a managed care organization (MCO). The model estimates the per patient economic impact and the per member, per month (PMPM) economic impact of patients 6 months before and 6 months after the initiation of tegaserod. Resource utilization data, taken from medical and pharmacy administrative claims data, were based on a retrospective, longitudinal study of 3365 patients administered tegaserod through a large, geographically diverse MCO. Costs were estimated for 2 patient subgroups, women with IBS and other gastrointestinal (GI) diagnoses. Sensitivity analyses were performed by varying several model input parameters. The base-case model resulted in an incremental PMPM budget impact associated with the use of tegaserod of 0.01 dollars. Total per patient budget impact (for all resources, including tegaserod) for a 6-month period was 274.34 dollars for women with IBS and 301.84 dollars for women with other GI diagnoses. Overall, 25.9% (29.0% for women with IBS group and 21.9% for women with other GI diagnoses group) of the cost of tegaserod was offset by decreases in resource utilization. Key drivers of post-tegaserod reductions in resource costs were hospital stays, outpatient office visits, emergency department visits, endoscopic procedures, and nonendoscopic procedures. Tegaserod therapy can decrease GI-related resource utilization, resulting in a significant cost-offset percentage. When the associated budget impact of adding tegaserod to its formulary is absorbed across an entire MCO population, the PMPM impact of tegaserod is small.

A synthesis of drug reimbursement decision-making processes in organisation for economic co-operation and development countries.

PubMed

Barnieh, Lianne; Manns, Braden; Harris, Anthony; Blom, Marja; Donaldson, Cam; Klarenbach, Scott; Husereau, Don; Lorenzetti, Diane; Clement, Fiona

2014-01-01

The use of a restrictive formulary, with placement determined through a drug-reimbursement decision-making process, is one approach to managing drug expenditures. To describe the processes in drug reimbursement decision-making systems currently used in national publicly funded outpatient prescription drug insurance plans. By using the Organisation for Economic Co-operation and Development (OECD) nations as the sampling frame, a search was done in the published literature, followed by the gray literature. Collected data were verified by a system expert within the prescription drug insurance plan in each country to ensure the accuracy of key data elements across countries. All but one country provided at least one publicly funded prescription drug formulary. Many systems have adopted similar processes of drug reimbursement decision making. All but three systems required additional consideration of clinical evidence within the decision-making process. Transparency of recommendations varied between systems, from having no information publicly available (three systems) to all information available and accessible to the public (16 systems). Only four countries did not consider cost within the drug reimbursement decision-making process. There were similarities in the decision-making process for drug reimbursement across the systems; however, only five countries met the highest standard of transparency, requirement of evidence, and ability to appeal. Future work should focus on examining how these processes may affect formulary listing decisions for drugs between countries. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Published by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved.

Funding the new biologics--public policy issues in drug formulary decision making.

PubMed

Lewis, Steven

2002-12-01

One function of drug formularies is to allow health care providers to exert some control over spending. Decisions about whether to include a given medication in a formulary are based on estimates of its costs and effectiveness, relative to other treatment strategies. These decisions are made from a societal perspective, as opposed to that of individual patients, which sometimes results in conflicts. The clinical response to a medication often varies widely among subjects, which means that a small subgroup of patients might benefit dramatically, while others with the same disease do not. The result would be that a drug might appear not to be cost effective in an economic analysis, even though it is of proven value for some patients. New and innovative medications are assessed according to high standards of cost effectiveness, even though established treatments are wasteful of valuable health care resources. Moreover, quality-adjusted life-years (QALYs) discriminate against certain patient groups, including those with diseases that are associated with a high morbidity but a low mortality. Such patients often incur high indirect costs, including loss of employment income and costs incurred by family caregivers that QALYs do not reflect. Therefore, even though QALYs are transparent and widely applicable, they are not necessarily appropriate in the evaluation of a particular therapeutic intervention. A new paradigm should be developed for evaluating emerging therapies. An example would be a risk-sharing approach, whereby the pharmaceutical industry and public insurers share in the costs and rewards of introducing new treatments. This would have implications for the prices charged for new medications.

Quality of clinical and economic evidence in dossier formulary submissions.

PubMed

Colmenero, Fernando; Sullivan, Sean D; Palmer, Jennifer A; Brauer, Carmen A; Bungay, Kathleen; Watkins, John; Neumann, Peter J

2007-07-01

To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions. We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included. Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs. Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices. Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.

Anticonvulsant use after formulary status change for brand-name second-generation anticonvulsants.

PubMed

Patel, Hemal; Toe, Diana C; Burke, Shawn; Rasu, Rafia S

2010-08-01

Anticonvulsant medications are commonly used for off-label indications. However, managed care organizations can restrict utilization of medication to indicated uses only. To evaluate the pattern of off-label use of second-generation anticonvulsants after implementing a formulary change. We did a retrospective analysis of an administrative pharmacy claims database for a managed care plan with more than 1 million members continuously enrolled during 2004-2005. The study evaluated off-label use and explored pharmacy utilization patterns (by physician specialty, region, plan type, age, sex, copayment) across the study population following the formulary change. A total of 10,185 patients had at least 1 pharmacy claim (total of 137,638 claims) for a second-generation anticonvulsant during the study period. Most members were female (68%), and 4.9% were <18 years old. A total of 3986 of 4698 patients (84.8%) and 4600 of 5487 patients (83.8%) had anticonvulsants prescribed for off-label use in 2004 and 2005, respectively (P = .162). The off-label usage pattern varied for individual anticonvulsants in 2004 and 2005 (P <.050), which may have been because of the change to nonpreferred coverage. Primary care physicians accounted for 41.3% of the prescribing of second-generation anticonvulsants for off-label uses, followed by neurologists (9.4%), psychiatrists (2.8%), and other (46.5%). The coverage change resulted in cost savings for the plan of $0.16 per member per month. The off-label usage pattern varied for individual anticonvulsants in 2004 and 2005. Future considerations for controlling off-label use may include requiring prior authorization and provider education.

Evaluation of new antimicrobials for the hospital formulary. Policies restricting antibiotic use in hospitals.

PubMed

Pujol, Miquel; Delgado, Olga; Puigventós, Francesc; Corzo, Juan E; Cercenado, Emilia; Martínez, José Antonio

2013-09-01

In Spain, the inclusion of new antibiotics in hospital formularies is performed by the Infection Policy Committee or the Pharmacy and Therapeutic Committee, although now the decision is moving to a regional level. Criteria for the evaluation of new drugs include efficacy, safety and cost. For antimicrobial drugs evaluation it is necessary to consider local sensibility and impact in bacterial resistance to determinate the therapeutic positioning. There is compelling evidence that the use of antibiotics is associated with increasing bacterial resistance, and a great number of antibiotics are used incorrectly. In order to decrease the inappropriate use of antibiotics, several approaches have been proposed. Limiting the use of antimicrobials through formulary restrictions, often aimed at drugs with a specific resistance profile, shows benefits in improving antimicrobial susceptibilities and decreasing colonization by drug-resistant organisms. However, the restriction of one agent may result in the increased utilization of other agents. By using antibiotic cycling, the amount of antibiotics is maintained below the threshold where bacterial resistance develops, thus preserving highly efficient antibiotics. Unfortunately, cumulative evidence to date suggests that antibiotic cycling has limited efficacy in preventing antibiotic resistance. Finally, although there is still little clinical evidence available on antibiotic heterogeneity, the use of most of the existing antimicrobial classes could limit the emergence of resistance. This review summarizes information regarding antibiotic evaluation and available restrictive strategies to limit the use of antibiotics at hospitals with the aim of curtailing increasing antibiotic resistance. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration.

PubMed

Ezeife, Doreen A; Truong, Tony H; Heng, Daniel Y C; Bourque, Sylvie; Welch, Stephen A; Tang, Patricia A

2015-05-15

The drug approval timeline is a lengthy process that often varies between countries. The objective of this study was to delineate the Canadian drug approval timeline for oncology drugs and to compare the time to drug approval between Health Canada (HC) and the US Food and Drug Administration (FDA). In total, 54 antineoplastic drugs that were approved by the FDA between 1989 and 2012 were reviewed. For each drug, the following milestones were determined: the dates of submission and approval for both the FDA and HC and the dates of availability on provincial drug formularies in Canadian provinces and territories. The time intervals between the aforementioned milestones were calculated. Of 54 FDA-approved drugs, 49 drugs were approved by HC at the time of the current study. The median time from submission to approval was 9 months (interquartile range [IQR], 6-14.5 months) for the FDA and 12 months (IQR, 10-21.1 months) for HC (P < .0006). The time from HC approval to the placement of a drug on a provincial drug formulary was a median of 16.7 months (IQR, 5.9-27.2 months), and there was no interprovincial variability among the 5 Canadian provinces that were analyzed (P = .5). The time from HC submission to HC approval takes 3 months longer than the same time interval for the FDA. To the authors' knowledge, this is the first documentation of the time required to bring an oncology drug from HC submission to placement on a provincial drug formulary. © 2015 American Cancer Society.

21 CFR 172.874 - Hydroxypropyl methylcellulose.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION Multipurpose Additives § 172.874 Hydroxypropyl methylcellulose. The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004...: (a) The additive complies with the definition and specifications prescribed in the National Formulary...

The economic impact of introducing serotonin-noradrenaline reuptake inhibitors into the Brazilian national drug formulary: cost-effectiveness and budget-impact analyses.

PubMed

Machado, Márcio; Iskedjian, Michael; Ruiz, Inés A; Einarson, Thomas R

2007-01-01

To determine the cost effectiveness, from the Brazilian Ministry of Health viewpoint, of three antidepressant classes for major depressive disorder (MDD), and the budget impact of introducing serotonin-noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) into the current Brazilian national drug formulary, assuming a 6-month treatment duration. An existing decision-tree model was adapted to Brazil, based on local guidelines. Clinical data were obtained from published meta-analyses. Patients included adults aged > or =18 years with MDD, diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, third and fourth editions (DSM-III/IV), with moderate-to-severe disease (Hamilton Depression Rating Scale [HAMD] > or =15 or Montgomery-Asberg Depression Rating Scale [MADRS] > or =18), without co-morbidities or co-medications, receiving > or =6 weeks of treatment with SNRIs, selective serotonin reuptake inhibitors (SSRIs) and/or tricyclic antidepressants (TCAs). Clinical outcome was remission (HAMD < or =7 or MADRS < or =12). Direct costs (drugs, physician visits, hospitalisations) were included. Drug costs were obtained from the 2006 Brazilian National Drug Price List, and hospitalisation and physician costs from the 2006 Healthcare System database. Costs were valued in Brazilian Reais ($Brz), year 2006 values ($Brz1 = $US0.47). Univariate and Monte Carlo sensitivity analyses tested model robustness. Expected costs per patient treated were SNRIs $Brz4848; SSRIs $Brz5466; and TCAs $Brz5046, and overall success rates (primary plus secondary treatment across all decision tree branches) were SNRIs 78.1%; SSRIs 74.0%; and TCAs 76.4%. Average costs/success were SNRIs $Brz6209; SSRIs $Brz7385; and TCAs $Brz6602. SNRIs dominated in incremental cost-effectiveness analyses. Monte Carlo analysis confirmed drug classes' relative positions; however, there was considerable uncertainty. Introducing SNRIs into the formulary could generate average savings of 1% of the total budget, with a 52% probability of savings. SNRIs appear to be cost effective against SSRIs and TCAs when prescribed to patients with MDD in Brazil. However, their inclusion into the national drug list would generate minor savings compared with the current formulary of SSRIs and TCAs. Thus, we considered such inclusion as 'cost-neutral', since no major probability of savings or increased expenditures were observed.

Interventions designed to improve the quality and efficiency of medication use in managed care: A critical review of the literature – 2001–2007

PubMed Central

Lu, Christine Y; Ross-Degnan, Dennis; Soumerai, Stephen B; Pearson, Sallie-Anne

2008-01-01

Background Managed care organizations use a variety of strategies to reduce the cost and improve the quality of medication use. The effectiveness of such policies is not well understood. The objective of this research was to update a previous systematic review of interventions, published between 1966 and 2001, to improve the quality and efficiency of medication use in the US managed care setting. Methods We searched MEDLINE and EMBASE for publications from July 2001 to January 2007 describing interventions targeting drug use conducted in the US managed care setting. We categorized studies by intervention type and adequacy of research design using commonly accepted criteria. We summarized the outcomes of well-controlled strategies and documented the significance and magnitude of effects for key study outcomes. Results We identified 164 papers published during the six-year period. Predominant strategies were: educational interventions (n = 20, including dissemination of educational materials, and group or one-to-one educational outreach); monitoring and feedback (n = 22, including audit/feedback and computerized monitoring); formulary interventions (n = 66, including tiered formulary and patient copayment); collaborative care involving pharmacists (n = 15); and disease management with pharmacotherapy as a primary focus (n = 41, including care for depression, asthma, and peptic ulcer disease). Overall, 51 studies met minimum criteria for methodological adequacy. Effective interventions included one-to-one academic detailing, computerized alerts and reminders, pharmacist-led collaborative care, and multifaceted disease management. Further, changes in formulary tier-design and related increases in copayments were associated with reductions in medication use and increased out-of-pocket spending by patients. The dissemination of educational materials alone had little or no impact, while the impact of group education was inconclusive. Conclusion There is good evidence for the effectiveness of several strategies in changing drug use in the managed care environment. However, little is known about the cost-effectiveness of these interventions. Computerized alerts showed promise in improving short-term outcomes but little is known about longer-term outcomes. Few well-designed, published studies have assessed the potential negative clinical effects of formulary-related interventions despite their widespread use. However, some evidence suggests increases in cost sharing reduce access to essential medicines for chronic illness. PMID:18394200

Interventions designed to improve the quality and efficiency of medication use in managed care: a critical review of the literature - 2001-2007.

PubMed

Lu, Christine Y; Ross-Degnan, Dennis; Soumerai, Stephen B; Pearson, Sallie-Anne

2008-04-07

Managed care organizations use a variety of strategies to reduce the cost and improve the quality of medication use. The effectiveness of such policies is not well understood. The objective of this research was to update a previous systematic review of interventions, published between 1966 and 2001, to improve the quality and efficiency of medication use in the US managed care setting. We searched MEDLINE and EMBASE for publications from July 2001 to January 2007 describing interventions targeting drug use conducted in the US managed care setting. We categorized studies by intervention type and adequacy of research design using commonly accepted criteria. We summarized the outcomes of well-controlled strategies and documented the significance and magnitude of effects for key study outcomes. We identified 164 papers published during the six-year period. Predominant strategies were: educational interventions (n = 20, including dissemination of educational materials, and group or one-to-one educational outreach); monitoring and feedback (n = 22, including audit/feedback and computerized monitoring); formulary interventions (n = 66, including tiered formulary and patient copayment); collaborative care involving pharmacists (n = 15); and disease management with pharmacotherapy as a primary focus (n = 41, including care for depression, asthma, and peptic ulcer disease). Overall, 51 studies met minimum criteria for methodological adequacy. Effective interventions included one-to-one academic detailing, computerized alerts and reminders, pharmacist-led collaborative care, and multifaceted disease management. Further, changes in formulary tier-design and related increases in copayments were associated with reductions in medication use and increased out-of-pocket spending by patients. The dissemination of educational materials alone had little or no impact, while the impact of group education was inconclusive. There is good evidence for the effectiveness of several strategies in changing drug use in the managed care environment. However, little is known about the cost-effectiveness of these interventions. Computerized alerts showed promise in improving short-term outcomes but little is known about longer-term outcomes. Few well-designed, published studies have assessed the potential negative clinical effects of formulary-related interventions despite their widespread use. However, some evidence suggests increases in cost sharing reduce access to essential medicines for chronic illness.

Sensitivity of Medication Use to Formulary Controls in Medicare Beneficiaries: A Review of the Literature

PubMed Central

Shenolikar, Rahul; Bruno, Amanda Schofield; Eaddy, Michael; Cantrell, Christopher

2011-01-01

Background Several studies have examined the impact of formulary management strategies on medication use in the elderly, but little has been done to synthesize the findings to determine whether the results show consistent trends. Objective To summarize the effects of formulary controls (ie, tiered copays, step edits, prior authorization, and generic substitution) on medication use in the Medicare population to inform future Medicare Part D and other coverage decisions. Methods This systematic review included research articles (found via PubMed, Google Scholar, and specific scientific journals) that evaluated the impact of drug coverage or cost-sharing on medication use in elderly (aged ≥65 years) Medicare beneficiaries. The impact of drug coverage was assessed by comparing patients with some drug coverage to those with no drug coverage or by comparing varying levels of drug coverage (eg, full coverage vs $1000 coverage or capped benefits vs noncapped benefits). Articles that were published before 1995, were not original empirical research, were published in languages other than English, or focused on populations other than Medicare beneficiaries were excluded. All studies selected were classified as positive, negative, or neutral based on the significance of the relationship (P <.05 or as otherwise specified) between the formulary control mechanism and the medication use, and on the direction of that relationship. Results Included were a total of 47 research articles (published between 1995 and 2009) that evaluated the impact of drug coverage or cost-sharing on medication use in Medicare beneficiaries. Overall, 24 studies examined the impact of the level of drug coverage on medication use; of these, 96% (N = 23) supported the association between better drug coverage (ie, branded and generic vs generic-only coverage, capped benefit vs noncapped benefit, supplemental drug insurance vs no supplemental drug insurance) or having some drug coverage and enhanced medication use. Furthermore, 84% (N = 16) of the 19 studies that examined the effect of cost-sharing on medication use demonstrated that decreased cost-sharing was significantly associated with improved medication use. Conclusion Current evidence from the literature suggests that restricting drug coverage or increasing out-of-pocket expenses for Medicare beneficiaries may lead to decreased medication use in the elderly, with all its potential implications. PMID:25126370

42 CFR 423.600 - Reconsideration by an independent review entity (IRE).

Code of Federal Regulations, 2010 CFR

2010-10-01

... all covered Part D drugs on any tier of the formulary for treatment of the same condition would not be... made by a physician with expertise in the field of medicine that is appropriate for the services at...

21 CFR 178.3700 - Petrolatum.

Code of Federal Regulations, 2014 CFR

2014-04-01

... United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter: Ultraviolet absorbance per centimeter...

Reduction in fluoroquinolone use following introduction of ertapenem into a hospital formulary is associated with improvement in susceptibility of Pseudomonas aeruginosa to group 2 carbapenems: a 10-year study.

PubMed

Cook, Paul P; Gooch, Michael; Rizzo, Shemra

2011-12-01

We examined the effect of the addition of ertapenem to our hospital formulary on the resistance of nosocomial Pseudomonas aeruginosa to group 2 carbapenems (imipenem, meropenem, and doripenem). This was a retrospective, observational study conducted between 1 January 2000 and 31 January 2009 at a large, tertiary-care hospital. Autoregressive integrated moving average (ARIMA) regression models were used to evaluate the effect of ertapenem use on the susceptibility of Pseudomonas aeruginosa to group 2 carbapenems as well as on the use of the group 2 carbapenems, ciprofloxacin, and other antipseudomonal drugs (i.e., tobramycin, cefepime, and piperacillin-tazobactam). Resistance was expressed as a percentage of total isolates as well as the number of carbapenem-resistant bacterial isolates per 10,000 patient days. Pearson correlation was used to assess the relationship between antibiotic use and carbapenem resistance. Following the addition of ertapenem to the formulary, there was a statistically significant decrease in the percentage of Pseudomonas aeruginosa isolates resistant to the group 2 carbapenems (P = 0.003). Group 2 carbapenem use and the number of carbapenem-resistant Pseudomonas aeruginosa isolates per 10,000 patient days did not change significantly over the time period. There was a large decrease in the use of ciprofloxacin (P = 0.0033), and there was a correlation of ciprofloxacin use with the percentage of isolates resistant to the group 2 carbapenems (ρ = 0.47, P = 0.002). We suspect that the improvement in susceptibility of Pseudomonas aeruginosa to group 2 carbapenems was related to a decrease in ciprofloxacin use.

Patterns of use for brand-name versus generic oral bisphosphonate drugs in Ontario over a 13-year period: a descriptive study.

PubMed

Fraser, Lisa-Ann; Albaum, Jordan M; Tadrous, Mina; Burden, Andrea M; Shariff, Salimah Z; Cadarette, Suzanne M

2015-01-01

Bisphosphonates are the first-line therapy for the treatment of osteoporosis. In the province of Ontario, the Ontario Drug Benefit Program funds medications for patients aged 65 years and older. The Ontario Drug Benefit Program has a generic substitution policy that requires lower-cost generic drugs to be dispensed when they are available. However, there is controversy surrounding the efficacy and tolerability of generic bisphosphonates. The objective of this study was to describe patterns in the use of brand-name versus generic formulations when dispensing oral bisphosphonate over a 13-year period. We identified all osteoporotic preparations for alendronate and risedronate that were dispensed through the Ontario Drug Benefit Program from 2001 to 2014. We stratified our sample into community-dwelling residents and residents in long-term care facilities. The number of prescriptions dispensed per month were plotted to illustrate trends over time. We found a rapid switch from brand-name to generic bisphosphonate equivalents immediately after the generic became available on the Ontario Drug Benefit formulary, with generics accounting for > 88% of dispensed drug within 2 months. We also observed a reduction in the number of generic drugs dispensed each time a new brand-name alternative (e.g., monthly risedronate, weekly alendronate plus vitamin D) was introduced to the formulary. The dispensing trends were similar in the community and long-term care settings. The Ontario Drug Benefit Program generic substitution policy resulted in rapid uptake of generic oral bisphosphonates among seniors in Ontario. However, there was a switch away from generic medications to new brand-name alternatives whenever they were introduced to the formulary. Therefore, some patients continued to use brand-name bisphosphonate despite the availability of generic options.

Financial effect of converting ipratropium-albuterol therapy from inhalers to nebulizer treatments at an academic health system.

PubMed

Loborec, Steven M; Johnson, Shawn E; Keating, Ellen A

2016-02-01

The results of a study to assess the financial impact of an automatic formulary substitution of ipratropium-albuterol nebulization solution for ipratropium-albuterol metered-dose inhalers (MDIs) at an academic health system are reported. The study was conducted at a 1242-bed urban academic health system. Data were collected regarding all respiratory medication administrations during a three-month period before the MDI-to-nebulizer substitution (October-December 2012) and the same period of 2013 (after the substitution was implemented). Purchasing data were compared between the two time periods to measure the impact of the formulary substitution on pharmacy department costs, and documented administrations were assessed to evaluate associated changes in respiratory therapist (RT) workload. With 100% prescriber compliance with the formulary substitution, the number of MDI administrations of ipratropium-albuterol declined from 13,667 in October-December 2012 to zero in the same period of 2013. The substitution required expenditures for equipment (vibrating mesh nebulizer technology and patient-specific kits) and RT personnel (one additional RT was hired), but those added costs were substantially outweighed by cost savings resulting from a substantial reduction in overall respiratory drug spending. An automatic substitution of ipratropium-albuterol nebulization solution for MDIs resulted in a three-month savings of $99,359 in drug cost and an extrapolated full-year savings of $397,436. When additional costs associated with the substitution were taken into account, there was an overall savings of $146,806 during the implementation year and a projected savings of $257,936 for each following year. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Cost-effectiveness analysis and formulary decision making in England: findings from research.

PubMed

Williams, Iestyn P; Bryan, Stirling

2007-11-01

In a context of rapid technological advances in health care and increasing demand for expensive treatments, local formulary committees are key players in the management of scarce resources. However, little is known about the information and processes used when making decisions on the inclusion of new treatments. This paper reports research on the use of economic evaluations in technology coverage decisions in England, although the findings have a relevance to other health care systems with devolved responsibility for resource allocation. It reports a study of four local formulary committees in which both qualitative and quantitative data were collected. Our main research finding is that it is an exception for cost-effectiveness analysis to inform technology coverage decisions. Barriers to use include access and expertise levels, concerns relating to the independence of analyses and problems with implementation of study recommendations. Further barriers derive from the constraints on decision makers, a lack of clarity over functions and aims of local committees, and the challenge of disinvestment in medical technologies. The relative weakness of the research-practice dynamics in this context suggests the need for a rethinking of the role of both analysts and decision makers. Our research supports the view that in order to be useful, analysis needs to better reflect the constraints of the local decision-making environment. We also recommend that local decision-making committees and bodies in the National Health Service more clearly identify the 'problems' which they are charged with solving and how their outputs contribute to broader finance and commissioning functions. This would help to establish the ways in which the routine use of cost-effectiveness analysis might become a reality.

Multi-tier drugs assessment in a decentralised health care system. The Italian case-study.

PubMed

Jommi, Claudio; Costa, Enrico; Michelon, Alessandra; Pisacane, Maria; Scroccaro, Giovanna

2013-10-01

To investigate the organisation and decision-making processes of regional and local therapeutic committees in Italy, as a case-study of decentralised health care systems. A structured questionnaire was designed, validated, and self-administered to respondents. Committee members, prioritisation, assessment process and criteria, and transparency of committees were investigated. The respondents represent 100% of the 17 regional committees out of 21 regions (in 4 regions there is not any regional formulary), 88% of the 16 hospital networks and 42% of the 183 public hospitals. The assessment process appears fragmented and may take a long time: drugs inclusion into hospital formularies requires two steps in most regions (regional and local assessment). Most of the therapeutic committees are closed to industry and patients associations involvement. Prioritisation in the assessment is mostly driven by disease severity, clinical evidence, and the absence of therapeutic alternatives. Only 13 out of the 17 regional committees have a public application form for drugs inclusion into regional formulary. Regional and local committees (i) often re-assess the clinical evidence already evaluated at central level and (ii) mostly rely on comparative drug unit prices per DDD and drug budget impact. The level of transparency is quite low. The Italian case-study provides useful insights into an appropriate management of multi-tier drugs assessment, which is particularly complex in decentralised health care systems, but exists also in centralised systems where drugs are assessed by local therapeutic committees. A clear definition of regulatory competences at different levels, a higher collaboration between central, regional and local actors, and increased transparency are necessary to pursue consistency between central policies on price and reimbursement and budget accountability at the regional and local levels. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Evaluation of clinical and financial outcomes of a new no-sting barrier film and barrier cream in a large UK primary care organisation.

PubMed

Stephen-Haynes, Jackie; Stephens, Claire

2013-12-01

The study involves 95 subjects within a UK Primary Care Organisation and was undertaken in two arms. The objective was to determine the clinical outcomes and clinical acceptability of a newly available range of no-sting barrier film and no-sting barrier cream products offering significant financial benefits. The importance of undertaking this study is underpinned by evidence in the literature relating to the use of no-sting barrier preparations within clinical practice. The first part of the study (arm 1) involved extensive evaluation of either the film or cream barrier in 36 patients and was compared to existing standardised barrier protection care within the organisation. The results indicated that the new product range met all the criteria for formulary inclusion and following this the barrier range was further evaluated in arm 2, 33 patients with barrier cream and 26 patients with barrier film. The entire study was conducted over a 3-month period with patient treatment lasting a minimum of 2 days to a maximum 4-week period adhering to the agreed evaluation protocol as approved by clinical governance. In arm 1 (n = 36), the clinical expectation of the product was met in 32 cases relating to ease of use, conformability, no-sting, quick drying, ease of absorption, compatibility with devices, frequency of application, prevention and management including visual skin improvement resulting in a recommendation for formulary listing in 31 of 36 cases. In arm 2 (n = 59), barrier film and barrier cream performance was consistently rated same as, better than or much better than the existing barrier used. A formulary listing recommendation was made in 51 of 59 cases. © 2012 The Authors. International Wound Journal © 2012 John Wiley & Sons Ltd and Medicalhelplines.com Inc.

Use of antimicrobial resistance information and prescribing guidance for management of urinary tract infections: survey of general practitioners in the West Midlands.

PubMed

Ironmonger, Dean; Edeghere, Obaghe; Gossain, Savita; Hawkey, Peter M

2016-05-24

There is a marked variation in both antibiotic prescribing practice and urine sampling rates for diagnostic microbiology across general practices in England. To help understand factors driving this variation, we undertook a survey in 2012/13 to determine sampling protocols and antibiotic formularies used by general practitioners (GPs) for managing urinary tract infections (UTIs) in the West Midlands region of England. Cross-sectional survey of all eligible general practices in the West Midlands region of England undertaken in November 2012. GPs were invited to complete an online survey questionnaire to gather information on policies used within the practice for urine sampling for microbiological examination, and the source of antibiotic formularies used to guide treatment of UTIs. The questionnaire also gathered information on how they would manage five hypothetical clinical scenarios encountered in the community. The response rate was 11.3 % (409/3635 GPs), equivalent to a practice response rate of 26 % (248/950). Only 50 % of GPs reported having a practice policy for urine sampling. Although there was good agreement from GPs regarding collecting specimens in scenarios symbolising treatment failure (98 %), UTI in an adult male (98 %) and asymptomatic UTI in pregnancy (97 %), there was variation in GPs requesting a specimen for the scenarios involving a suspected uncomplicated urinary tract infection (UTI) and an asymptomatic catheterised elderly patient; with 40 and 38 % respectively indicating they would collect a specimen for microbiological examination. Standardised evidence based clinical management policies and antibiotic formularies for GPs should be readily available. This will promote the rational use of diagnostic microbiology services, improve antimicrobial stewardship and aid the interpretation of ongoing antimicrobial resistance surveillance.

The Impact of Price-cap Regulations on Exit by Generic Pharmaceutical Firms.

PubMed

Zhang, Wei; Guh, Daphne; Sun, Huiying; Marra, Carlo A; Lynd, Larry D; Anis, Aslam H

2016-09-01

In 1998, the Province of Ontario in Canada adopted price-cap "70/90" regulations whereby the first generic entrant was required to be priced at ≤70% of the associated brand-name product and subsequent generics were priced at ≤90% of the first generic price. The price-caps were further lowered to 50% in 2006 and 25% in 2010. This study assessed the impact of such price-cap regulations on exit by generic drug firms. Formulary (2003-2012) listings of prescription drugs covered under the Ontario Drug Benefit program were used. The formulary tracks the "status" (on formulary, discontinued by manufacturer, and delisted for other reasons) for each drug. Markets were defined based on unique active ingredient and form within Ontario. Firm exit occurred when a manufacturer discontinued all its generic drugs within a market. The exit rate was defined as the number of generic firm-market exits divided by total generic firm-market follow-up years. Poisson regression was used to compare the exit rates during the 3 policy periods ("25," "50," and "70/90"). A total of 1126 generic manufacturers paired with 290 markets were identified. The exit rate ratio during the 25% price-cap period compared with the 70%/90% period was 2.42 (95% confidence interval, 1.56-3.77). A small manufacturer or a manufacturer in a market with ≥3 competitors or in an older market was more likely to exit. Lowering the price-cap level is associated with a higher incidence of generic firm exit from markets. Continuously reducing price-caps may have the unintended consequence of forcing generic firms to exit.

75 FR 57277 - Agency Information Collection Activities: Proposed Collection: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... patients served, pharmaceuticals prescribed, pricing, and other sources of support to provide AIDS... formulary, eligibility criteria for enrollment, and cost-saving strategies including coordinating with Medicaid). The quarterly report represents the best method for HRSA to determine how ADAP grants are being...

75 FR 36374 - Office of the Secretary

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Meeting of the Uniform Formulary Beneficiary Advisory Panel; Correction AGENCY: Assistant Secretary of Defense (Health Affairs), DoD. ACTION: Notice of meeting; correction. SUMMARY: On May 28, 2010, DoD published a notice (75 FR...

Independent and supplementary prescribing and PGDs.

PubMed

Baird, A

Types of prescribing for non-medical staff are discussed and clarifications made regarding the current overlap in six forms of prescribing and administration of medication. Differences between independent and supplementary prescribing are explored and the distinction between patient group directions and extended formulary nurse prescribing outlined.

21 CFR 178.3700 - Petrolatum.

Code of Federal Regulations, 2013 CFR

2013-04-01

... the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter...

21 CFR 178.3700 - Petrolatum.

Code of Federal Regulations, 2012 CFR

2012-04-01

... the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter...

Formulary evaluation of second-generation cephamycin derivatives using decision analysis.

PubMed

Barriere, S L

1991-10-01

Use of decision analysis in the formulary evaluation of the second-generation cephamycin derivatives cefoxitin, cefotetan, and cefmetazole is described. The rating system used was adapted from one used for the third-generation cephalosporins. Data on spectrum of activity, pharmacokinetics, adverse reactions, cost, and stability were taken from the published literature and the FDA-approved product labeling. The weighting scheme used for the third-generation cephalosporins was altered somewhat to reflect the more important aspects of the cephamycin derivatives and their potential role in surgical prophylaxis. Sensitivity analysis was done to assess the variability of the final scores when the assigned weights were varied within a reasonable range. Scores for cefmetazole and cefotetan were similar and did not differ significantly after sensitivity analysis. Cefoxitin scored significantly lower than the other two drugs. In the absence of data suggesting that the N-methyl thiotetrazole side chains of cefmetazole and cefotetan cause substantial toxicity, these two drugs can be considered the most cost-efficient members of the second-generation cephamycins.

Pharmacy-based distribution system for enteral nutrition products.

PubMed

Craig, S A; Paulson, M F

1985-12-01

A hospital pharmacy department's implementation of enteral nutrition product distribution and its proposal for an enteral nutrition product admixture service are described. Responsibility for the distribution of enteral nutrition formulations was transferred from the central distribution department to the pharmacy after problems with inventory control, billing procedures, and inappropriate administration of enteral nutrition products were recognized by personnel from the central-distribution area and nutrition services. After additional problems were identified using a multi-disciplinary approach, the pharmacy department implemented an enteral nutrition product distribution system and developed an enteral nutrition product formulary. A proposal was developed for a pharmacy-based enteral nutrition admixture service, but implementation of this service was deferred because data from a cost-effectiveness evaluation and random bacteriologic monitoring did not justify adding the service. Pharmacy-based distribution and formulary control of enteral nutrition products alleviated problems with inaccurate patient charges and accumulation of stock on the nursing units. Pharmacists at this hospital hope to develop an enteral nutrition product admixture program that will result in cost savings for the institution.

Getting the cat back in the bag: reforming the way provinces manage drug expenditures to make them manageable.

PubMed

Levy, Adrian R; Gagnon, Yves M

2002-01-01

The fiscal "cat" of healthcare spending - drug expenditures - is out of the bag: drug costs are now the fastest rising component of healthcare expenditures in Canada. Laupacis, Anderson and O'Brien describe the current process of listing drugs on the provincial drug formulary in Ontario, identify factors that may contribute to the rapid growth in drug expenditures, and make a number of recommendations for controlling drug expenditures, including (1) improving the evidence on cost-effectiveness; (2) disseminating the evidence to prescribers; (3) re-evaluating the evidence; and (4) increasing the transparency about the acquisition costs of drugs. These are recommendations that, if implemented, would theoretically help decision-makers make more rational decisions about which drugs to list on provincial formularies. The question of how to implement the recommendations remains to be elucidated, as does an evaluation of the trade-offs between costs and benefits of obtaining better information on cost-effectiveness.

Outcome of a ceftriaxone/cefotaxime interchange programme in a major teaching hospital.

PubMed

Gutensohn, A; Bunz, D; Frighetto, L; Jewesson, P

1991-01-01

A two-stage intervention programme was performed to enable the effective substitution of ceftriaxone for cefotaxime in a teaching hospital with large numbers of transient prescribers. One hundred and sixteen patients with a variety of bacterial infections were randomized to an open, historical control comparative study to determine if ceftriaxone was an acceptable replacement for cefotaxime. For 6 months prior to the intervention, both cephalosporins were available on formulary. Following an initial informational stage, a therapeutic interchange programme was implemented to convert prescriptions for cefotaxime to ceftriaxone. Ceftriaxone and cefotaxime were equivalent in terms of microbiological and clinical efficacy and patient tolerance in 77 evaluable patients. No changes in prescriber service occurred after the changeover. Post-intervention treatment courses required a ceftriaxone/cefotaxime interchange in 28% of the cases. Ceftriaxone appeared to be a suitable and cost-effective alternative to cefotaxime in this hospital. The intervention programme successfully invoked the formulary change with minimal expense and prescriber opposition.

75 FR 43169 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... changes in prescribing practices and the active agreement and participation of physicians, pharmacists and administrators. Physicians and pharmacists may challenge restrictions in formularies and determine that a patient... average wages for physicians ($79.33), pharmacists ($50.13), and medical and health services managers ($42...

26 CFR 54.9812-1 - Parity in mental health and substance use disorder benefits.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Formulary design for prescription drugs; (C) For plans with multiple network tiers (such as preferred providers and participating providers), network tier design; (D) Standards for provider admission to.... (i) Facts. A plan considers a wide array of factors in designing medical management techniques for...

75 FR 60461 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... changes in prescribing practices and the active agreement and participation of physicians, pharmacists and administrators. Physicians and pharmacists may challenge restrictions in formularies and determine that a patient... the mean of the average wages for physicians ($79.33), pharmacists ($50.13), and medical and health...

42 CFR 423.128 - Dissemination of Part D plan information.

Code of Federal Regulations, 2010 CFR

2010-10-01

... tiered formulary structure and utilization management procedures used) functions; (iii) The process for... under § 423.564 et. seq. (8) Quality assurance policies and procedures. A description of the quality assurance policies and procedures required under § 423.153(c), as well as the medication therapy management...

78 FR 57623 - TRICARE Over-the-Counter Drug Demonstration Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-19

... DEPARTMENT OF DEFENSE Office of the Secretary TRICARE Over-the-Counter Drug Demonstration Project AGENCY: Office of the Secretary, DoD. ACTION: Notice of modification to the TRICARE Over-the-Counter Drug...) drugs to be included on the TRICARE uniform formulary. The Department has been engaged in a...

FABS (Formulated Abstracting): An Experiment in Regularized Content Description.

ERIC Educational Resources Information Center

Harris, Brian; Hofmann, Thomas R.

This preliminary report of research conducted at the Linguistics Documentation Centre of the University of Ottawa describes a bilingual experiment into the elaboration of well structured formulary routines for making the writing of abstracts easier, and at the same time standardizing and generally augmenting the information given in them. The…

NRL Plasma Formulary 2009

DTIC Science & Technology

2009-01-01

Knudsen Kn λ/L Hydrodynamic time / collision time Lewis Le κ/D *Thermal conduction/molecular diffusion Lorentz Lo V/c Magnitude of relativistic effects...to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data...44 Relativistic Electron Beams . . . . . . . . . . . . . . . . . . . . 46 Beam Instabilities

78 FR 50049 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

... follow each agenda item) a. Corticosteroids-Immune Modulators b. Self-Monitoring Blood Glucose Systems c... individuals or interested groups to address the Panel. To ensure consideration of their comments, individuals and interested groups should submit written statements as outlined in this notice; but if they still...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - TRICARE Pharmacy Benefits Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

Evaluation of a Computer Simulation in a Therapeutics Case Discussion.

ERIC Educational Resources Information Center

Kinkade, Raenel E.; And Others

1995-01-01

A computer program was used to simulate a case presentation in pharmacotherapeutics. Students (n=24) used their knowledge of the disease (glaucoma) and various topical agents on the computer program's formulary to "treat" the patient. Comparison of results with a control group found the method as effective as traditional case…

Nurse prescribing: how and when.

PubMed

Moreton, J

1992-03-01

Legislation for nurse prescribing now seems destined to be implemented in October 1993, writes Judith Moreton who is on the nurse prescribers formulary subcommittee. A private members bill from Chislehurst MP Roger Sims, received its second reading on the 31 January. It has full government support and should become law in this session of parliament.

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

A Proposed Formulary Based on the Identification of Medications Determined by Diagnoses/Problems in a Troop Medical Clinic During Calendar Year 1983

DTIC Science & Technology

1984-08-01

Simethicone (MYLANTA) Liquid and Tablets Aluminum Hydroxide, Magnesium Trisilicate and Sodium Bicarbonate (GAVISCON) Tablets 56:08 ANTI-DIARRHEAL AGENTS...Diphenoxylate HCl and Atropine Sulfate (LOMOTIL) Tablets Kaolin and Pectin (KAOPECTATE) Suspension 56:10 ANTI-FLATULANTS Simethicone (MYLICON) Tablets

[Textual research on circulation of the Ming edition of Li Heng's Xiu zhen fang (Pocket Formulary)].

PubMed

Yang, Jinping; Liu, Peng; Lu, Mingjing; Lu, Xing; Li, Shaolin; Jin, Xiumei

2015-03-01

Xiu zhen fang (Pocket Formulary) is a recipe book of the Ming Dynasty, inspired and managed by Zhu Su, compiled by Li Heng of liangyisuo (good physician house) in Zhou wangfu (Zhou's royal palace). The book was compiled and published twice during the reigns of the Hongwu and Yongle Emperors of the Ming Dynasty. Because of its high practicability, there were some editions in circulation, and the book was published several times only in the Ming Dynasty. At present, the earliest extanteditionwas the little character version of Yongle, and the version in the 4(th) year of Zhengde Emperor of the Ming Dynasty was a reprinting edition based on the Yongle edition, sharingthe same edition system. Most of the editions appeared after the reign of Zhengtong Emperor of the Ming Dynasty, titled by "kui ben (head version)" and "da quan (complete edition)" were the editionspublished in the local bookshops, which had rather distinct differences from the Yongle edition system not only in the its format but also in its contents.

ADAP faces financial abyss. AIDS Drug Assistance Programs.

PubMed

Link, D

1996-02-01

State AIDS Drug Assistance Programs (ADAPs) are the most heavily utilized AIDS programs in the nation, with over 50,000 people with HIV or AIDS enrolled. Initiated in 1987, the federally-funded programs are now running out of money because of increased caseloads and drug usage, higher drug costs, and more expensive combination therapies coupled with stagnant financial resources. Since 1990, the ADAPs have been funded by the Ryan White CARE Act, with each state administering its own ADAP, so eligibility criteria and formularies vary from state to state. Two states, Colorado and Missouri, have already run out of money and others have cut services, limited enrollment or canceled formulary expansions in the face of growing budget constraints. The National Association of State and Territorial AIDS Directors (NASTAD) surveyed state ADAPs and found that budget gaps ranged from $5.9 million in New York to $15,000 in Nebraska, and calculated that a total of $12 million would be needed just to make up the budget gaps for this fiscal year. The shortfall has led AIDS organizations to press for more funds at the state and Federal levels.

Quality assessment of the visits of pharmaceutical company representatives to hospital pharmacists.

PubMed

Fonzo-Christe, Caroline; Herrmann, François; Bonnabry, Pascal

2005-11-19

To evaluate whether the quality of pharmaceutical company representatives' (PCRs) visits to hospital pharmacists can be improved by written communication of the results of an evaluation of their visits. Pilot study with prospective evaluation of overall visit quality and strength of request for adding drugs to the hospital formulary, and of the scientific quality of products presentations using a standardized form. Two one-year study periods (59 vs. 61 visits) separated by the intervention (global results of the first period sent to each drug company). No difference was observed between both periods in overall visit quality (VAS 0 = null, 10 = excellent: mean 4.7 (2.1 SD) vs. 5.2 (2.1) or strength of request for adding drug to hospital formulary (VAS 0 = null, 10 = extreme: 7.0 [2.6] vs. 7.2 [2.7]). Clarity and scientific value of products' presentations and scientific value of responses were better during the second study period, as a sign of quality improvement. This study suggests that systematic quality evaluation of PCRs visits and communication of results to drug companies may improve the scientific quality of products' presentation.

Pharmaceutical cost containment and innovation in the United States.

PubMed

Kane, N M

1997-09-01

In the United States, government has played a limited role in containing the costs of pharmaceuticals. There are no price controls, no national drug formularies, no universal cost-sharing policies, and perhaps most important, no national coverage of prescription drugs. Rather, pharmaceutical cost containment was historically left to private insurers and managed care companies, while consumers paid out of pocket for close to 62% of all drug expenditures. US utilization has historically been relatively low and prices by far the highest of the four industrialized countries. The major change in pharmaceutical cost containment in the 1990s has been the consolidation of purchaser power at the level of the insurer and managed care companies. These 'whole sale' purchasers now represent 70% of direct manufacturer sales, and they are demanding and receiving deeper price discounts. Meanwhile these same players are implementing formulary policies, utilization controls, and disease management programs, the outcomes of which have not yet been systematically evaluated. Failure to pass on savings to consumers, cost shifting by manufacturers to vulnerable consumer groups, and potential under-utilization of cost-effective drugs remain of concern.

Pharmacy benefit forecast for a new interferon Beta-1a for the treatment of multiple sclerosis: development of a first-line decision tool for pharmacy-budget planning using administrative claims data.

PubMed

Meyer, Christina M; Phipps, Robert; Cooper, Deborah; Wright, Alan

2003-01-01

To estimate the incremental change in pharmacy per-member-permonth (PMPM) costs, according to various formulary designs, for a new interferon beta-1a product (IB1a2) using administrative claims data. Cross-sectional sex- and age-specific disease prevalence and treatment rates for relapsing, remitting multiple sclerosis (RRMS) patients were measured using integrated medical and pharmacy claims data from a 500,000- member employer group in the southern United States. Migration to IB1a2 from other drugs in the class was based on market-share data for new and existing RRMS patients. Duration of therapy was estimated by analyzing claims for current RRMS therapies. Daily therapy cost was provided by the manufacturer of IB1a2, adjusted for migration from other therapies, and multiplied by estimated volume to predict incremental and total PMPM cost impact. Market-share estimates were used to develop a PMPM cost forecast for the next 2 years. PMPM cost estimates were calculated for preferred (copayment tier 2) and nonpreferred (copayment tier 3) formulary designs with and without prior authorization (PA). One-way sensitivity analysis was performed to assess the influence of product pricing, duration of therapy, and other market factors. Annual incremental PMPM change was $0.047 for the scenario of third copayment tier with PA. The incremental change was greatest for those aged 55 to 65 years ($0.056 PMPM) and did not vary greatly by benefit design. Duration of therapy had the greatest impact on the PMPM estimate across benefit designs. IB1a2 will not cause a significant change in managed care pharmacy budgets under a variety of formulary conditions, according to this crosssectional analysis of current care-seeking behavior by RRMS patients. Economic impact may differ if IB1a2 expands RRMS patients. treatment-seeking behavior.

Variation in Prescription Drug Coverage for Triptans: Analysis of Insurance Formularies.

PubMed

Minen, Mia T; Lindberg, Kate; Langford, Aisha; Loder, Elizabeth

2017-09-01

To analyze triptan coverage by insurers to examine (1) possible disparities in coverage for different formulations (oral, intranasal, etc) and (2) quantity limits and stepped care requirements to obtain triptans. Triptans are FDA approved migraine abortive medications. Patients frequently state that they have difficulty accessing triptans prescribed to them. We searched the 2015 drug formularies of commercial and government health insurers providing coverage in NY State. We created a spreadsheet with all of the commercially available triptans and included information about covered formulations, tier numbers and quantity limits for each drug. We then calculated the number of listed plans that cover or do not cover each triptan or triptan formulation, the total number of medications not covered by an insurance provided across all of its plans, as well as the percentage of plans offered by individual companies and across all companies that covered each drug. We also calculated the number and proportion of plans that imposed quantity limits or step therapy for each drug. Of the 100 formularies searched, generic sumatriptan (all formulations), naratriptan, and zolmitriptan tablets were covered by all plans, and rizatriptan tablets and ODTs were covered by 98% of plans. Brand triptans were less likely to be covered: 4/36 Medicaid plans covered brand triptans. Commercial insurers were more likely to cover brand triptans. All plans imposed quantity limits on 1+ triptan formulations, with >80% imposing quantity limits on 14/19 formulations studied. Almost all plans used tiers for cost allocation for different medications. Generic triptans were almost always in Tier 1. Brand triptans were most commonly in Tier 3. Approximately 40% of brand triptans required step therapy, compared with 11% of generic triptans. There are substantial variations in coverage and quantity limits and a high degree of complexity in triptan coverage for both government and commercial plans. © 2017 American Headache Society.

Approaches to the management of agents used for the treatment of multiple sclerosis: consensus statements from a panel of U.S. managed care pharmacists and physicians.

PubMed

Miller, Ross M; Happe, Laura E; Meyer, Kellie L; Spear, Rachel J

2012-01-01

Multiple sclerosis (MS) is a chronic, disabling, and costly disease with several treatment options available; however, there is variability in evidence-based clinical guidelines. Therefore, payers are at a disadvantage when making management decisions without the benefit of definitive guidance from treatment guidelines. To outline approaches for the management of agents used to treat MS, as determined from a group of U.S. managed care pharmacists and physicians. A modified Delphi process was used to develop consensus statements regarding MS management approaches. The panel was composed of experts in managed care and included 8 pharmacy directors and 6 medical directors presently or previously involved in formulary decision making from 12 health plans, 1 specialty pharmacy, and 1 consulting company. These decision makers, who have experience designing health care benefits that include MS treatments, provided anonymous feedback through 2 rounds of web-based surveys and participated in 1 live panel meeting held in December 2010. Consensus was defined as a mean response of at least 3.3 or 100% of responses either "agree" or "strongly agree" (i.e., no panelist answered "disagree" or "strongly disagree") on a 4-item Likert scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). After 3 phases, these managed care representatives reached consensus on 25 statements for management of patients with MS. Consistent with managed care principles, this group of managed care experts found that health plans should consider efficacy, effectiveness, and safety, as well as patient preference, when evaluating MS therapies for formulary placement. Cost and contracting should be considered if efficacy and safety are judged to be comparable between agents. The consensus statements developed by a panel of managed care representatives provide some insight into decision making in formulary and utilization management of MS therapies.

Effect of medication reconciliation on medication costs after hospital discharge in relation to hospital pharmacy labor costs.

PubMed

Karapinar-Çarkit, Fatma; Borgsteede, Sander D; Zoer, Jan; Egberts, Toine C G; van den Bemt, Patricia M L A; van Tulder, Maurits

2012-03-01

Medication reconciliation aims to correct discrepancies in medication use between health care settings and to check the quality of pharmacotherapy to improve effectiveness and safety. In addition, medication reconciliation might also reduce costs. To evaluate the effect of medication reconciliation on medication costs after hospital discharge in relation to hospital pharmacy labor costs. A prospective observational study was performed. Patients discharged from the pulmonology department were included. A pharmacy team assessed medication errors prevented by medication reconciliation. Interventions were classified into 3 categories: correcting hospital formulary-induced medication changes (eg, reinstating less costly generic drugs used before admission), optimizing pharmacotherapy (eg, discontinuing unnecessary laxative), and eliminating discrepancies (eg, restarting omitted preadmission medication). Because eliminating discrepancies does not represent real costs to society (before hospitalization, the patient was also using the medication), these medication costs were not included in the cost calculation. Medication costs at 1 month and 6 months after hospital discharge and the associated labor costs were assessed using descriptive statistics and scenario analyses. For the 6-month extrapolation, only medication intended for chronic use was included. Two hundred sixty-two patients were included. Correcting hospital formulary changes saved €1.63/patient (exchange rate: EUR 1 = USD 1.3443) in medication costs at 1 month after discharge and €9.79 at 6 months. Optimizing pharmacotherapy saved €20.13/patient in medication costs at 1 month and €86.86 at 6 months. The associated labor costs for performing medication reconciliation were €41.04/patient. Medication cost savings from correcting hospital formulary-induced changes and optimizing of pharmacotherapy (€96.65/patient) outweighed the labor costs at 6 months extrapolation by €55.62/patient (sensitivity analysis €37.25-71.10). Preventing medication errors through medication reconciliation results in higher benefits than the costs related to the net time investment.

The fuzzy line between needs, coverage, and excess in the Mexican Formulary List: an example of qualitative market width analysis.

PubMed

Rico-Alba, Israel; Figueras, Albert

2013-04-01

To assess the rationality of the Mexican Formulary List (MEX-LIST). MEX-LIST was compared with the World Health Organization Essential Medicines List (WHO-LIST) to identify drugs classified as unmet needs. For the MEX-LIST rationality evaluation, the assessment of a non-sponsored, systematic and unbiased source (Prescrire Journal) was used for medicines not listed in WHO-LIST. The rating scale of Prescrire classifies medicines as Bravo, Real Advance, Offers an Advance, Possibly Helpful, Nothing New (NN), Judgment Reserved (JR), or Not Acceptable (NA) depending on their comparative therapeutic value. The NN, JR, and NA categories of medicines are further classified as non-added value. The MEX-LIST contains 771 medicines, which is 2.4-fold more than the WHO-LIST (n = 321). Up to 236 medicines in the MEX-LIST perfectly match the WHO-LIST medicines, 40 could be considered as reasonable substitutes, but 45 (14.0 %) present in the WHO-LIST are not present in the MEX-LIST, including an oversupply of 495 medicines. Rationality level could be analyzed for 353 of these: 43.1 % (n = 152) were classified as NN, 12.2 % (n = 43) as NA, and 6.2 % (n = 22) as JR due to limited available information. In summary, 61.5 % of the evaluated medicines present in the MEX-LIST but not included in the WHO-LIST (n = 217) can be considered drugs that do not add substantial therapeutic benefits, this accounts for 28.1 % of the medicines in the MEX-LIST. MEX-LIST is characterized by a twofold irrationality in that essential medicines to treat prevalent diseases are missing and medicines without any rational added value are in oversupply. This type of study can be easily applied to other countries with the aim of providing a forum for further discussion and improvement of the medicines offered by their national formularies.

Comparison of rates of potentially inappropriate medication use according to the Zhan criteria for VA versus private sector medicare HMOs.

PubMed

Barnett, Mitchell J; Perry, Paul J; Langstaff, Jodi D; Kaboli, Peter J

2006-06-01

Inappropriate prescribing in the elderly is common, but rates across different health care systems and the impact of formulary restrictions are not well described. To determine if rates of inappropriate medication use in the elderly differ between the Veterans Affairs (VA) health care system and the private sector Medicare health maintenance organization (HMO) patients. A cross-sectional study design compared administrative pharmacy claims from 10 distinct geographic regions in the United States in the VA health care system and 10 analogous regions for patients enrolled in Medicare HMOs. The cohorts included 123,633 VA and 157,517 Medicare HMO patients aged 65 years and older. Inappropriate medication use was identified using the Zhan modification of the Beers criteria, which categorizes 33 potentially inappropriate drugs into 3 major classifications: "always avoid," "rarely appropriate," and "some indications." Comparisons between the VA health care system and the private sector Medicare HMO were performed for overall differences and stratified by gender and age. The drug formulary status of the Zhan-criteria drugs was known for the VA health system but not for the Medicare HMO patients. Compared with private sector patients, VA patients were less likely to receive any inappropriate medication (21% vs. 29%, P <0.001), and in each classification: always avoid (2% vs. 5%, P <0.001), rarely appropriate (8% vs. 13%, P<0.001), and some indications (15% vs. 17%, P <0.001). The rate of inappropriate drug use was lower in the VA compared with the private sector for males (21% vs. 24%, P <0.001) and females (28% vs. 32%, P <0.001). Differences were consistent when stratified by age. Compared with private sector Medicare HMOs, elderly VA patients were less likely to receive medications defined by the Zhan criteria as potentially inappropriate. A restrictive formulary that excludes 12 of the 33 Zhan criteria drugs may be a factor in the reduction of undesired prescribing patterns in elderly populations.

The System of Objectified Judgement Analysis (SOJA). A tool in rational drug selection for formulary inclusion.

PubMed

Janknegt, R; Steenhoek, A

1997-04-01

Rational drug selection for formulary purposes is important. Besides rational selection criteria, other factors play a role in drug decision making, such as emotional, personal financial and even unconscious criteria. It is agreed that these factors should be excluded as much as possible in the decision making process. A model for drug decision making for formulary purposes is described, the System of Objectified Judgement Analysis (SOJA). In the SOJA method, selection criteria for a given group of drugs are prospectively defined and the extent to which each drug fulfils the requirements for each criterion is determined. Each criterion is given a relative weight, i.e. the more important a given selection criterion is considered, the higher the relative weight. Both the relative scores for each drug per selection criterion and the relative weight of each criterion are determined by a panel of experts in this field. The following selection criteria are applied in all SOJA scores: clinical efficacy, incidence and severity of adverse effects, dosage frequency, drug interactions, acquisition cost, documentation, pharmacokinetics and pharmaceutical aspects. Besides these criteria, group specific criteria are also used, such as development of resistance when a SOJA score was made for antimicrobial agents. The relative weight that is assigned to each criterion will always be a subject of discussion. Therefore, interactive software programs for use on a personal computer have been developed, in which the user of the system may enter their own personal relative weight to each selection criterion and make their own personal SOJA score. The main advantage of the SOJA method is that all nonrational selection criteria are excluded and that drug decision making is based solely on rational criteria. The use of the interactive SOJA discs makes the decision process fully transparent as it becomes clear on which criteria and weighting decisions are based. We have seen that the use of this method for drug decision making greatly aids the discussion in the formulary committee, as discussion becomes much more concrete. The SOJA method is time dependent. Documentation on most products is still increasing and the score for this criterion will therefore change continuously. New products are introduced and prices are also subject to change. To overcome the time-dependence of the SOJA method, regular updates of interactive software programs are being made, in which changes in acquisition cost, documentation or a different weighting of criteria are included, as well as newly introduced products. The possibility of changing the official acquisition cost into the actual purchasing costs for the hospital in question provides a tailor-made interactive program.

77 FR 71178 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... Class Reviews (Comments will follow each agenda item) a. Hepatitis C Agents b. Overactive Bladder Agents...: Notice of meeting. SUMMARY: Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended) and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) the...

75 FR 10789 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... written statements instead of addressing the Panel. Waiver Due to internal DoD difficulties, beyond the... closed to the public. Written Statements Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to the membership of the Panel at any time or in...

78 FR 22523 - Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... Work Meeting will be closed to the public. Written Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to the membership of the Panel at any time or in response to the stated agenda of a planned meeting. Written statements should be...

An Analysis of the Effectiveness of the Retail Pharmacy Utilization Intervention at General Leonard Wood Army Community Hospital

DTIC Science & Technology

2009-04-23

limited to those beneficiaries who filled prescriptions for esomeprazole, clopidogrel, zolpidem, omeprazole, atorvastatin , monteluckast, fexofenadine...formulary. Nexium (esomeprazole) Plavix (clopidogrel) Ambien (zolpidem) Prilosec (omeprazole) Lipitor ( atorvastatin ) Singulair (montelukast...Prilosec (omeprazole) • Topimax (topiramate) • Detrol (tolterodine) Lipitor ( atorvastatin ) We would like to remind you that these medications and many

42 CFR 423.272 - Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.

Code of Federal Regulations, 2013 CFR

2013-10-01

... submitted by potential Part D sponsors. 423.272 Section 423.272 Public Health CENTERS FOR MEDICARE... Approval § 423.272 Review and negotiation of bid and approval of plans submitted by potential Part D... from the formulary. (3) Substantial differences between bids—(i) General. CMS approves a bid only if it...

Counselor Training in Statistical Analysis via Electronic Processing for Research on Local and Regional Student Data. Final Report.

ERIC Educational Resources Information Center

Long, Thomas E.

In this institute, the participants were trained to use peripheral computer related equipment. They were taught Fortran programming skills so they might write and redimension statistical formulary programs, and they were trained to assemble data so they might access computers via both card and punched-tape input. The objectives of the Institute…

Changes in antibiotic usage and susceptibility in nosocomial Enterobacteriaceae and Pseudomonas isolates following the introduction of ertapenem to hospital formulary.

PubMed

Graber, C J; Hutchings, C; Dong, F; Lee, W; Chung, J K; Tran, T

2012-01-01

There is concern that widespread usage of ertapenem may promote cross-resistance to other carbapenems. To analyse the impact that adding ertapenem to our hospital formulary had on usage of other broad-spectrum agents and on susceptibilities of nosocomial Enterobacteriaceae and Pseudomonas isolates, we performed interrupted time-series analyses to determine the change in linear trend in antibiotic usage and change in mean proportion and linear trend of susceptibility pre- (March 2004-June 2005) and post- (July 2005-December 2008) ertapenem introduction. Usage of piperacillin-tazobactam (P=0·0013) and ampicillin-sulbactam (P=0·035) declined post-ertapenem introduction. For Enterobacteriaceae, the mean proportion susceptible to ciprofloxacin (P=0·016) and piperacillin-tazobactam (P=0·038) increased, while the linear trend in susceptibility significantly increased for cefepime (P=0·012) but declined for ceftriaxone (P=0·0032). For Pseudomonas, the mean proportion susceptible to cefepime (P=0·011) and piperacillin-tazobactam (P=0·028) increased, as did the linear trend in susceptibility to ciprofloxacin (P=0·028). Notably, no significant changes in carbapenem susceptibility were observed.

Cost burden of viral respiratory infections: issues for formulary decision makers.

PubMed

Bertino, Joseph S

2002-04-22

Viral respiratory infections (VRIs) are a common malady associated with considerable costs in terms of decreased productivity and time lost from work or school, visits to health-care providers, and the amount of drugs prescribed. Both total respiratory illness and rhinovirus infection peak during the fall and spring seasons, although the average percentage of office visits by patients with a rhinovirus infection is moderately high throughout the year. Most common cold remedies are relatively ineffective and may produce side effects that contribute to increased health-care costs. Antibiotic therapy is widely overused and misused despite evidence that antibiotics fail to treat the cause of VRI or prevent secondary bacterial infections. Increasing use of antibiotics has a significant impact on health-care costs and the emergence of antimicrobial resistance. Reasons for overprescribing antibiotics are varied, but they often involve physician and patient attitudes and expectations. Although treatment of VRIs poses challenges for effective formulary management, several steps can be taken to facilitate the introduction of antiviral agents, including patient and provider education, the development of rapid diagnostic tests, and medical-economics studies to determine the true cost of antiviral therapy.

Comparing patient access to pharmaceuticals in the UK and US.

PubMed

Cohen, Joshua; Cairns, Catherine; Paquette, Cherie; Faden, Laura

2006-01-01

The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified. These pertain to reimbursement and pricing of approved drugs, the so-called fourth and fifth hurdles. We reviewed 38 National Institute for Health and Clinical Excellence (NICE) guidance appraisals carried out between April 1999 and April 2005. These appraisals included 71 recently approved drugs considered to have either high clinical or cost impact. For each drug we first determined its marketing approval date by the British Medicines Healthcare Products Agency (MHRA) or European Medicines Evaluation Agency (EMEA). Secondly, we determined if each drug was approved by the US FDA for marketing and, if so, the date when it was approved. Thirdly, we considered whether and when each drug was recommended for reimbursement and use by NICE, and whether conditions of reimbursement applied. Fourthly, for the subset of FDA-approved drugs, we examined formulary placement, cost sharing and conditions of reimbursement on three-tier formularies used by seven leading US third-party payers serving Medicare beneficiaries. Fifthly, we reviewed each NICE recommendation to determine if cost-effectiveness data were referred to either in the appraisal documentation or in the final recommendation. Sixthly, we asked a spokesperson from each US payer whether cost-effectiveness assessments or rebates played a role in determining formulary placement of drugs in our sample, and whether there was a lag between marketing approval and reimbursement for any of the covered drugs. Of the 71 drugs contained in 38 NICE guidance appraisals, the US FDA approved 64. On average, the subset of 64 drugs received marketing authorisation in the US prior to the UK. On average, US plans covered 87% of the 64 drugs, the same percentage of drugs recommended for NHS reimbursement and use. Cost sharing in the US was significantly higher than in the UK, with wider variation across plans. On average, drugs covered in the US had fewer conditions of reimbursement (15%) than the percentage of drugs given conditions by NICE (46%). US plans were quicker to decide to reimburse drugs following marketing approval than NICE. The US provides faster, more flexible access to most, but not all, of the UK-approved pharmaceuticals in our sample. However, US patients have higher cost sharing than the UK and coverage is less evenly spread across the population. From a policy perspective, our study findings confirm the need to bolster the NICE fast-track initiative to decrease the amount of time it takes to appraise certain new pharmaceuticals. Also, the study findings point to the need in the US for careful monitoring of plan compliance with regulations pertaining to the Medicare drug benefit, particularly with respect to formulary restrictions and limits on cost sharing.

Streamlining the supply chain.

PubMed

Neumann, Lydon

2003-07-01

Effective management of the supply chain requires attention to: Product management--formulary development and maintenance, compliance, clinical involvement, standardization, and demand-matching. Sourcing and contracting--vendor consolidation, GPO portfolio management, price leveling, content management, and direct contracting Purchasing and payment-cycle--automatic placement, web enablement, centralization, evaluated receipts settlement, and invoice matching Inventory and distribution management--"unofficial" and "official" locations, vendor-managed inventory, automatic replenishment, and freight management.

75 FR 30003 - Federal Advisory Committee; Meeting of the Uniform Formulary Beneficiary Advisory Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-28

...: Notice of meeting. SUMMARY: Under the provisions of the Federal Advisory Committee Act of 1972 (title 5, United States Code (U.S.C.), Appendix, as amended) and the Government in the Sunshine Act of 1976 (5 U.S... Accessibility Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, and the...

Critical Advances in Wound Care

DTIC Science & Technology

2011-01-24

Wound Limb Salvage Program WRAMC/NNMC Inpatient Care Wound and Ostomy NNMC and WRAMC Outpatient Care 2 Clinics over 400 complex encounters NNMC and... Ostomy Wound care Skin Care Cleansers Research / EBP Pressure ulcer protocol CPG development Wound education research grant WRNMMC wound care formulary...Algorithm Sibbald, Orstead, Schultz, Coutts, Keast. Preparing the Wound Bed – Focus on Infection and Inflammation. Ostomy Wound Manag 49:24-51

Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone

PubMed Central

Dhalla, Irfan A.; Mamdani, Muhammad M.; Sivilotti, Marco L.A.; Kopp, Alex; Qureshi, Omar; Juurlink, David N.

2009-01-01

Introduction Opioid-related mortality appears to be increasing in Canada. We examined the true extent of the problem and the impact of the introduction of long-acting oxycodone. Methods We examined trends in the prescribing of opioid analgesics in the province of Ontario from 1991 to 2007. We reviewed all deaths related to opioid use between 1991 and 2004. We linked 3271 of these deaths to administrative data to examine the patients’ use of health care services before death. Using time-series analysis, we determined whether the addition of long-acting oxycodone to the provincial drug formulary in January 2000 was associated with an increase in opioid-related mortality. Results From 1991 to 2007, annual prescriptions for opioids increased from 458 to 591 per 1000 individuals. Opioid-related deaths doubled, from 13.7 per million in 1991 to 27.2 per million in 2004. Prescriptions of oxycodone increased by 850% between 1991 and 2007. The addition of long-acting oxycodone to the drug formulary was associated with a 5-fold increase in oxycodone-related mortality (p < 0.01) and a 41% increase in overall opioid-related mortality (p = 0.02). The manner of death was deemed unintentional by the coroner in 54.2% and undetermined in 21.9% of cases. Use of health care services in the month before death was common: for example, of the 3066 patients for whom data on physician visits were available, 66.4% had visited a physician in the month before death; of the 1095 patients for whom individual-level prescribing data were available, 56.1% had filled a prescription for an opioid in the month before death. Interpretation Opioid-related deaths in Ontario have increased markedly since 1991. A significant portion of the increase was associated with the addition of long-acting oxycodone to the provincial drug formulary. Most of the deaths were deemed unintentional. The frequency of visits to a physician and prescriptions for opioids in the month before death suggests a missed opportunity for prevention. PMID:19969578

ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe.

PubMed

Cherny, N I; Sullivan, R; Torode, J; Saar, M; Eniu, A

2017-11-01

The availability and affordability of safe, effective, high-quality, affordable anticancer therapies are a core requirement for effective national cancer control plans. Online survey based on a previously validated approach. The aims of the study were to evaluate (i) the availability on national formulary of licensed antineoplastic medicines across the globe, (ii) patient out-of-pocket costs for the medications, (iii) the actual availability of the medication for a patient with a valid prescription, (iv) information relating to possible factors adversely impacting the availability of antineoplastic agents and (v) the impact of the country's level of economic development on these parameters. A total of 304 field reporters from 97 countries were invited to participate. The preliminary set of data was posted on the ESMO website for open peer review and amendments have been incorporated into the final report. Surveys were submitted by 135 reporters from 63 countries and additional peer-review data were submitted by 54 reporters from 19 countries. There are substantial differences in the formulary availability, out-of-pocket costs and actual availability for many anticancer medicines. The most substantial issues are in lower-middle- and low-income countries. Even among medications on the WHO Model List of Essential Medicines (EML) the discrepancies are profound and these relate to high out-of-pocket costs (in low-middle-income countries 32.0% of EML medicines are available only at full cost and 5.2% are not available at all, and for low-income countries, the corresponding figures are even worse at 57.7% and 8.3%, respectively). There is wide global variation in formulary availability, out-of-pocket expenditures and actual availability for most licensed anticancer medicines. Low- and low-middle-income countries have significant lack of availability and high out-of-pocket expenditures for cancer medicines on the WHO EML, with much less availability of new, more expensive targeted agents compared with high-income countries. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Selection of medicines in Chilean public hospitals: an exploratory study.

PubMed

Collao, Juan F; Smith, Felicity; Barber, Nick

2013-01-07

There is a growing interest in high income countries to control expenditure on medicines by improving the rationale for their selection. However, in middle income countries with differing priorities and needs, little attention has been paid to this issue. In this paper we explore the policies and processes for the selection and use of medicines in a group of hospitals in Chile, a middle income country which has recently joined the OECD. A combination of qualitative and quantitative methods was used. A national survey questionnaire was distributed to investigate the role and operation of PTCs (Pharmacy and Therapeutics Committees). Interviews were conducted with key actors in the selection of medicines in large urban public hospitals. The national survey had an overall response rate of 42% (83 out of 196), whilst 7 out of 14 hospitals participated in the qualitative study. High complexity hospitals are large urban hospitals; all of which claim to have a working PTC. The pharmacy offices are mainly involved in dispensing medicines with little involvement in clinical duties.The interviews conducted suggest that the formulary of all the hospitals visited is no more than a stock list. PTCs are unable to influence the prescribing practices of doctors. Members do not feel prepared to challenge the opinions of specialists requesting a certain drug, and decisions are based primarily on costs. The inclusion of medicines in the clinical practice of hospitals is as a result of doctors bypassing the PTC and requesting the purchase of exceptional items, some of which are included in the formulary if they are widely used. There is an urgent need to develop medicine policies in hospitals in Chile. The procedures used to purchase medicines need to be revised. Central guidance for PTCs could help ensure a more rational use of medicines. PTCs need to be empowered to design formularies which cover all the clinical needs of doctors, training members in the analysis of scientific evidence beyond their own specialities. An influential PTC can take the appropriate measures and design workable policies to enforce a cost effective-use of resources.

ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe

PubMed Central

Cherny, N I; Sullivan, R; Torode, J; Saar, M; Eniu, A

2017-01-01

Abstract Background The availability and affordability of safe, effective, high-quality, affordable anticancer therapies are a core requirement for effective national cancer control plans. Method Online survey based on a previously validated approach. The aims of the study were to evaluate (i) the availability on national formulary of licensed antineoplastic medicines across the globe, (ii) patient out-of-pocket costs for the medications, (iii) the actual availability of the medication for a patient with a valid prescription, (iv) information relating to possible factors adversely impacting the availability of antineoplastic agents and (v) the impact of the country’s level of economic development on these parameters. A total of 304 field reporters from 97 countries were invited to participate. The preliminary set of data was posted on the ESMO website for open peer review and amendments have been incorporated into the final report. Results Surveys were submitted by 135 reporters from 63 countries and additional peer-review data were submitted by 54 reporters from 19 countries. There are substantial differences in the formulary availability, out-of-pocket costs and actual availability for many anticancer medicines. The most substantial issues are in lower-middle- and low-income countries. Even among medications on the WHO Model List of Essential Medicines (EML) the discrepancies are profound and these relate to high out-of-pocket costs (in low-middle-income countries 32.0% of EML medicines are available only at full cost and 5.2% are not available at all, and for low-income countries, the corresponding figures are even worse at 57.7% and 8.3%, respectively). Conclusions There is wide global variation in formulary availability, out-of-pocket expenditures and actual availability for most licensed anticancer medicines. Low- and low-middle-income countries have significant lack of availability and high out-of-pocket expenditures for cancer medicines on the WHO EML, with much less availability of new, more expensive targeted agents compared with high-income countries. PMID:28950323

Selection of medicines in Chilean public hospitals: an exploratory study

PubMed Central

2013-01-01

Background There is a growing interest in high income countries to control expenditure on medicines by improving the rationale for their selection. However, in middle income countries with differing priorities and needs, little attention has been paid to this issue. In this paper we explore the policies and processes for the selection and use of medicines in a group of hospitals in Chile, a middle income country which has recently joined the OECD. Methods A combination of qualitative and quantitative methods was used. A national survey questionnaire was distributed to investigate the role and operation of PTCs (Pharmacy and Therapeutics Committees). Interviews were conducted with key actors in the selection of medicines in large urban public hospitals. Results The national survey had an overall response rate of 42% (83 out of 196), whilst 7 out of 14 hospitals participated in the qualitative study. High complexity hospitals are large urban hospitals; all of which claim to have a working PTC. The pharmacy offices are mainly involved in dispensing medicines with little involvement in clinical duties. The interviews conducted suggest that the formulary of all the hospitals visited is no more than a stock list. PTCs are unable to influence the prescribing practices of doctors. Members do not feel prepared to challenge the opinions of specialists requesting a certain drug, and decisions are based primarily on costs. The inclusion of medicines in the clinical practice of hospitals is as a result of doctors bypassing the PTC and requesting the purchase of exceptional items, some of which are included in the formulary if they are widely used. Conclusions There is an urgent need to develop medicine policies in hospitals in Chile. The procedures used to purchase medicines need to be revised. Central guidance for PTCs could help ensure a more rational use of medicines. PTCs need to be empowered to design formularies which cover all the clinical needs of doctors, training members in the analysis of scientific evidence beyond their own specialities. An influential PTC can take the appropriate measures and design workable policies to enforce a cost effective-use of resources. PMID:23294543

The Design and Analysis of Pediatric Vaccine Formularies: Theory and Practice

DTIC Science & Technology

2006-06-22

Schedule—United States. Morbidity and Mortality Weekly Report; 54(52):Q1-Q4. Centers for Disease Control and Prevention. 2005. Recommended...Childhood and Adolescent Immunization Schedule—United States. Morbidity and Mortality Weekly Report; 53:Q1-Q3. Centers for Disease Control and Prevention... Mortality Weekly Report; 52(RR-1);34-36. Centers for Disease Control and Prevention. 2002. General Recommendations on Immunization. Morbidity and

The Supply of Pharmaceuticals in Humanitarian Assistance Missions: Implications for Military Operations

DTIC Science & Technology

2011-08-01

essential medicines list ( EML ), which provides information The Supply of Pharmaceuticals in Humanitarian Assistance Missions: Implications for...Health Organization (WHO) introduced the concept of the EML to encourage health systems at the country level to focus on a limited number of carefully...be used as a global standard to guide country authorities develop their own national EMLs . 5 In many developing countries, national formularies

Implementation of an Evidence-Based and Content Validated Standardized Ostomy Algorithm Tool in Home Care: A Quality Improvement Project.

PubMed

Bare, Kimberly; Drain, Jerri; Timko-Progar, Monica; Stallings, Bobbie; Smith, Kimberly; Ward, Naomi; Wright, Sandra

Many nurses have limited experience with ostomy management. We sought to provide a standardized approach to ostomy education and management to support nurses in early identification of stomal and peristomal complications, pouching problems, and provide standardized solutions for managing ostomy care in general while improving utilization of formulary products. This article describes development and testing of an ostomy algorithm tool.

Current challenges in European oncology pharmacy practice.

PubMed

Hoppe-Tichy, Torsten

2010-03-01

The demand for pharmacy cancer services is expected to at least double over the next 10 years, as the population ages and new treatments are introduced. Safe and efficient handling of cytotoxic products minimises risks to staff and reduces medication errors. To identify and describe strategies for coping safely and effectively with heavier workloads in the hospital oncology pharmacy, currently and in the future. The PubMed database was searched for literature on approaches to safe handling of antineoplastic agents and to decreasing medication errors in the hospital pharmacy. Articles that were judged to be of prime importance to the hospital oncologist were reviewed. These safety concepts are put into the context of contemporary hospital oncology pharmacy practice through discussion of key issues, including increased demand, the role of the pharmacist in determining the hospital formulary, and growth in patient preferences for oral chemotherapy. Recommendations on best practices are also provided, based on relevant literature and author experience. Efficient, safe hospital pharmacy operations can be aided by capacity planning, dose banding, and knowledge of novel products and procedures that can reduce risks to health while increasing the number of patients who are safely treated. Consideration may also be given to the economic role of oncology pharmacists in formulary development.

Provincial drug plan officials' views of the Canadian drug safety system.

PubMed

Lexchin, Joel; Wiktorowicz, Mary; Moscou, Kathy; Eggertson, Laura

2013-06-01

The Canadian constitution divides the responsibility for pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified.

Military Health System - Governance, Alignment and Configuration of Business Activities Task Group Report

DTIC Science & Technology

2006-09-01

requirements, etc. 2. Enhance the commitment and relationship with Veterans Affairs including shared clinic services and facilities, best evidence - based medicine and...health mission that applies best evidence - based medicine for stakeholders including: – Enhancing the medical readiness of all forces for all missions...hospitals and clinics) and are moving to common equipment, supplies, formularies, etc. • Applying best evidence - based medicine is helping to control supply

An early examination of access to select orphan drugs treating rare diseases in health insurance exchange plans.

PubMed

Robinson, Sandy W; Brantley, Kelly; Liow, Christine; Teagarden, J Russell

2014-10-01

Patients with rare diseases often face significant health care access challenges, particularly since the number of available treatment options for rare diseases is limited. The implementation of health insurance exchanges promises improved access to health care. However, when purchasing a plan, patients with rare diseases need to consider multiple factors, such as insurance premium, access to providers, coverage of a specific medication or treatment, tier placement of drug, and out-of-pocket costs.  To provide an early snapshot of the exchange plan landscape from the perspective of patients with select rare diseases by evaluating the degree of access to medications in a subset of exchange plans based on coverage, tier placement, associated cost sharing, and utilization management (UM) applied.  The selection of drugs for this analysis began by identifying rare diseases with FDA-approved treatment options using the National Institutes of Health Office of Rare Diseases' webpage and further identification of a subset of drugs based on select criteria to ensure a varied sample, including the characteristics and prevalence of the condition. The medications were categorized based on whether alternative therapies have FDA approval for the same indication and whether there are comparators based on class or therapeutic area. The list was narrowed to 11 medications across 7 diseases, and the analysis was based on how these drugs are listed in exchange plan outpatient pharmacy benefit formularies. This analysis focused on 84 plans in 15 states with the highest expected exchange enrollment and included a variety of plan types to ensure that variability in the marketplace was represented. To best approximate plans that will have the greatest enrollment, the analysis focused on silver and bronze plan formularies because consumers in this market are expected to be sensitive to premiums. Data on drug coverage, tier placement, cost, and UM were collected from these plans beginning October 1, 2013, with the launch of the open enrollment period. Coverage and use of UM for selected medications vary within and across states. This study found that bronze plans were far less likely than silver plans to cover the 11 products included in this analysis. Results also showed that select drugs identified as the only FDA-approved product indicated for a certain rare disease experienced relatively robust coverage (at least 65% of plans) but often included some form of UM. However, coverage of selected rare disease therapies also is complicated by the fact that plans cover certain products under the medical benefit versus the pharmacy benefit. At the time of this analysis, transparency of medical benefit coverage for these products in exchange plans was limited.Selected medications are most likely to appear on the highest tiers of 4-tier formularies or are not covered at all. Although there are no requirements to designate certain tiers as "specialty tiers," more than 70% of plans in this study use coinsurance for the highest tiers of their formularies. Rates of coinsurance for medications on highest tiers range from 10% to 50% in silver plans and 15% to 50% in bronze plans. Among those plans utilizing copayments rather than coinsurance, ranges of copayments for these select products vary between $20 and $250 per prescription across both silver plans and bronze plans. This preliminary analysis of access to treatments for patients with select rare diseases revealed the complexities involved for patients with specific needs when selecting a plan with appropriate coverage. For patients with rare diseases, the process of identifying and selecting a plan centers on understanding if and how the plan covers a specific treatment or set of treatments. Access factors will likely vary substantially across plans, as demonstrated by the findings from this analysis. With limited treatment options and the potential for cost sharing and UM barriers, increased data transparency to assist patients in navigating formularies will be a critical step for patients to fully understand their access to needed therapies in each plan.

Deciding which drugs get onto the formulary: a value-based approach.

PubMed

Seigfried, Raymond J; Corbo, Teresa; Saltzberg, Mitchell T; Reitz, Jeffrey; Bennett, Dean A

2013-01-01

Hospitals, physicians, payers, and patients face economic and ethical decisions about the use of biotechnology drugs, commonly called specialty medications. These often target a small population, have data based on smaller clinical trials, are expensive, and may have questionable advantage. This is a result of how the Food and Drug Administration (FDA) approves medications, which is based only on safety and efficacy. Cancer drugs, once approved by the FDA, regardless of cost or value must be covered by Medicare. Some states have laws requiring additional coverage as well. All of this has created an unintended consequence: It has driven up costs with questionable evidence to support the medication's value, placing patients, payers, and providers in an ethical conflict. In this new era of health care transformation, health care leaders must focus on creating value to support a sustainable health system. Christiana Care Health System's Value Institute has designed a new model to evaluate specialty medications, using value as its main criterion. This article describes the process and outcomes using a new value model for evaluating specialty medications for a hospital formulary. It also introduces a new criterion of evaluation entitled "Societal Benefit" that provides a rating on quality- of-life issues. With measurable factors of efficacy, risk, cost, and quality-of-life concerns, our methodology provides a more balanced approach in the evaluation of specialty medications. Specialty medications are the fastest growing segment of drug expense, and it is hard to understand how these medications will be sustainable under health care reforms. Unlike other countries, the United States has no national agency providing cost-effectiveness review; review occurs, if at all, at a local level. Laws governing Medicare and most private insurers' coverage of FDA-approved medication and some clinical quality standards conflict with cost-effectiveness, making this type of review difficult. Finally, because these medications affect the health system as a whole, it is a great example to begin to support health care reform. Hospitals need to challenge the value of specialty medication. Although our model will continue to evolve, value is now our central consideration when selecting specialty medications to be added to the formulary. We share this experience to encourage other hospitals to design their own approach to this vital issue. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Use of pharmacoeconomics in prescribing research. Part 1: costs--moving beyond the acquisition price for drugs.

PubMed

Robertson, J; Lang, D; Hill, S

2003-02-01

This paper addresses pharmacoeconomics in prescribing research and reflects the increasing use of techniques of economic evaluation to aid drug purchasing decisions in a variety of settings -- for national drug subsidization programmes, provincial purchasing plans, insurance programmes, and for hospital and area health authority formulary decisions. First, we focus on the cost component of an economic evaluation and discuss methodological issues that are relevant to all pharmacoeconomic analyses.

Assessment of Thermal Dehydration Using the Human Eye: What is the Potential?

DTIC Science & Technology

2012-01-01

Kenefick a, Neil P. Walsh b, Matthew B. Fortes b, Marieh Esmaeelpour c,d, Samuel N. Cheuvront a,n a US Army Research Institute of Environmental Medicine...anhydrase inhibitors, which are commonly prescribed to glaucoma patients (van der Valk et al., 2005; World Heath Organization; 2009). Both types of...Deposition and thinning of the human tear film. J. Colloid Interface Sci. 184, 44–51. World Heath Organization, 2009. WHO model formulary 2008. WHO

A systematic review of cost-sharing strategies used within publicly-funded drug plans in member countries of the organisation for economic co-operation and development.

PubMed

Barnieh, Lianne; Clement, Fiona; Harris, Anthony; Blom, Marja; Donaldson, Cam; Klarenbach, Scott; Husereau, Don; Lorenzetti, Diane; Manns, Braden

2014-01-01

Publicly-funded drug plans vary in strategies used and policies employed to reduce continually increasing pharmaceutical expenditures. We systematically reviewed the utilization of cost-sharing strategies and physician-directed prescribing regulations in publicly-funded formularies within member nations of the Organization of Economic Cooperation and Development (OECD). Using the OECD nations as the sampling frame, a search for cost-sharing strategies and physician-directed prescribing regulations was done using published and grey literature. Collected data was verified by a system expert within the prescription drug insurance plan in each country, to ensure the accuracy of key data elements across plans. Significant variation in the use of cost-sharing mechanisms was seen. Copayments were the most commonly used cost-containment measure, though their use and amount varied for those with certain conditions, most often chronic diseases (in 17 countries), and by socio-economic status (either income or employment status), or with age (in 15 countries). Caps and deductibles were only used by five systems. Drug cost-containment strategies targeting physicians were also identified in 24 countries, including guideline-based prescribing, prescription monitoring and incentive structures. There was variable use of cost-containment strategies to limit pharmaceutical expenditures in publicly funded formularies within OECD countries. Further research is needed to determine the best approach to constrain costs while maintaining access to pharmaceutical drugs.

Impact of Postoperative Intravenous Acetaminophen on Opioid Requirements and Pain Scores Following Gynecologic Procedures.

PubMed

Stoudenmire, Laura G; Norman, Christy M; Latif, Erin Z

2016-10-01

This study aims to assess the impact of postoperative intravenous (IV) acetaminophen on opioid requirements and pain scores in patients following gynecologic procedures. A retrospective cohort study of patients undergoing gynecologic procedures was conducted to assess the impact of adding scheduled IV acetaminophen to postoperative analgesic regimens. The control group consisted of patients admitted prior to formulary addition of IV acetaminophen; the study group consisted of patients admitted after formulary addition of IV acetaminophen who received scheduled IV acetaminophen for at least the first 24 hours postoperatively. Opioid requirements 0 to 24 hours postoperatively served as the primary end point. Secondary end points included average pain score, cumulative acetaminophen dose, nonopioid analgesic requirements, and rate of adverse events 0 to 24 hours postoperatively. One hundred and thirty-seven patients who underwent a gynecologic procedure from January 2009 to April 2013 were included in this study. Baseline characteristics were similar between the groups. In the first 24 hours postoperatively, there was no difference in opioid requirements between the groups (21 mg [interquartile range, IQR, 15-39.8 mg] vs 32.6 mg [IQR, 16.75-41 mg], P = 0.150). The average pain score and incidence of adverse events did not differ between the 2 groups. Postoperative administration of IV acetaminophen did not provide a significant opioid-sparing effect in patients undergoing gynecologic procedures. © The Author(s) 2015.

Off-label prescribing for children with chronic diseases in Nigeria; findings and implications.

PubMed

Oshikoya, Kazeem Adeola; Oreagba, Ibrahim Adekunle; Godman, Brian; Fadare, Joseph; Orubu, Samuel; Massele, Amos; Senbanjo, Idowu Odunayo

2017-09-01

Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective of this research was to investigate the extent of off-label prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria. Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed. British National Formulary for children and American Hospital Formulary Service Drug information were used as references. 477 patients received 1746 prescriptions. Off-label prescriptions were seen in 7.7% of prescriptions, related to dose (93; 68.9%), indication (22; 16.3%), and age (20; 14.8%). Nervous system (525; 30.1%) and anti-infective (441; 25.2%) medicines were the most prescribed but only 9.5% and 8.2% of the respective prescriptions were off-label. Children with epilepsy received the most number (94; 69.6%) of off-label prescriptions. The three chronic conditions did not associate significantly with the category of off-label medicine prescribed (p = 0.925). Off-label prescribing for children with epilepsy, asthma and sickle cell anaemia occurs. Encouragingly, the overall rate appears low in Nigeria.

NRL (Naval Research Laboratory) plasma formulary, revised

NASA Astrophysics Data System (ADS)

Book, D. L.

Most of the formulas and data in this collection are well known and for all practical purposes are in the public domain. The books and articles cited are intended primarily not for the purpose of giving credit to the original workers, but (1) to guide the reader to sources containing related material and (2) to indicate where derivations, explanations, examples, etc., omitted from this compilation can be found. Additional material can also be found in D.L. Book, NRL Memorandum Report 3332 (1977).

Chemoprophylaxis for HIV prevention: new opportunities and new questions.

PubMed

Mayer, Kenneth H; Venkatesh, Kartik K

2010-12-01

Growing data suggest that antiretrovirals can be used as an effective means of HIV prevention. This article reviews the current status and future clinical prospects of utilizing antiretroviral chemoprophylaxis before and after high-risk HIV exposure to prevent HIV transmission. The discussion about using antiretrovirals as a means of primary HIV prevention has moved to the forefront of public health discourse because of a growing evidence base, the increased tolerability of the medications, the decreased cost, the ever-expanding formulary, and the limitations of other approaches.

Wound care guidelines and formulary for community nurses.

PubMed

Baeyens, T A

2000-03-01

Community nursing is experiencing significant change as a result of developments such as improved technology, care in the community and earlier discharge of patients from hospital. Because of this, increasingly complex clinical care is required in the community, and it has been noted that community nurses are 'under considerable pressure' and show 'evidence of high stress and low morale'. Wound care is one area in which community nurses constantly battle to keep abreast of continual change. Growing product availability and diversity of use, changes in dressing techniques and the ever-increasing costs associated with wound care mean decision-making in wound care is often a complex task. In the Grampian region, a handbook of evidence-based practice guidelines with a product formulary was developed and distributed to all community nurses. The handbook was designed to ease the decision-making process by evaluating evidence-based practice and local preferences to recommend and guide nurses towards effective clinical practice and cost efficiency. All grades of district nurse in the region have been issued with their own copy of the handbook. It is presented in an A5 ring-binder format to make it easy to carry and to facilitate updating using loose-leaf inserts. The use of logos, extra information boxes and colour coding makes it easy for users to find specific areas of interest in the handbook. The success of the handbook has led to debate on the potential for development of a similar resource for use by practice nurses and in local community hospitals.

Influencers of generic drug utilization: A systematic review.

PubMed

Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

2017-08-04

With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

Pharmaceutical Role Expansion and Developments in Pharmacist-Physician Communication.

PubMed

Bergman, Alicia A; Jaynes, Heather A; Gonzalvo, Jasmine D; Hudmon, Karen Suchanek; Frankel, Richard M; Kobylinski, Amanda L; Zillich, Alan J

2016-01-01

Expanded clinical pharmacist professional roles in the team-based patient-centered medical home (PCMH) primary care environment require cooperative and collaborative relationships among pharmacists and primary care physicians (PCPs), but many PCPs have not previously worked in such a direct fashion with pharmacists. Additional roles, including formulary control, add further elements of complexity to the clinical pharmacist-PCP relationship that are not well described. Our objective was to characterize the nature of clinical pharmacist-PCP interprofessional collaboration across seven federally funded hospitals and associated primary care clinics, following pharmacist placement in primary care clinics and incorporation of expanded pharmacist roles. In-depth and semistructured interviews were conducted with 25 practicing clinical pharmacists and 17 PCPs. Qualitative thematic analysis revealed three major themes: (1) the complexities of electronic communication (particularly electronic nonformulary requests) as contributing to interprofessional tensions or misunderstandings for both groups, (2) the navigation of new roles and traditional hierarchy, with pharmacists using indirect communication to prevent PCP defensiveness to recommendations, and (3) a preference for onsite colocation for enhanced communication and professional relationships. Clinical pharmacists' indirect communication practices may hold important implications for patient safety in the context of medication use, and it is important to foster effective communication skills and an environment where all team members across hierarchies can feel comfortable speaking up to reduce error when problems are suspected. Also, the lack of institutional communication about managing drug formulary issues and related electronic nonformulary request processes was apparent in this study and merits further attention for both researchers and practitioners.

A Systematic Review of Cost-Sharing Strategies Used within Publicly-Funded Drug Plans in Member Countries of the Organisation for Economic Co-Operation and Development

PubMed Central

Barnieh, Lianne; Clement, Fiona; Harris, Anthony; Blom, Marja; Donaldson, Cam; Klarenbach, Scott; Husereau, Don; Lorenzetti, Diane; Manns, Braden

2014-01-01

Background Publicly-funded drug plans vary in strategies used and policies employed to reduce continually increasing pharmaceutical expenditures. We systematically reviewed the utilization of cost-sharing strategies and physician-directed prescribing regulations in publicly-funded formularies within member nations of the Organization of Economic Cooperation and Development (OECD). Methods & Findings Using the OECD nations as the sampling frame, a search for cost-sharing strategies and physician-directed prescribing regulations was done using published and grey literature. Collected data was verified by a system expert within the prescription drug insurance plan in each country, to ensure the accuracy of key data elements across plans. Significant variation in the use of cost-sharing mechanisms was seen. Copayments were the most commonly used cost-containment measure, though their use and amount varied for those with certain conditions, most often chronic diseases (in 17 countries), and by socio-economic status (either income or employment status), or with age (in 15 countries). Caps and deductibles were only used by five systems. Drug cost-containment strategies targeting physicians were also identified in 24 countries, including guideline-based prescribing, prescription monitoring and incentive structures. Conclusions There was variable use of cost-containment strategies to limit pharmaceutical expenditures in publicly funded formularies within OECD countries. Further research is needed to determine the best approach to constrain costs while maintaining access to pharmaceutical drugs. PMID:24618721

Financial risk management of pharmacy benefits.

PubMed

Saikami, D

1997-10-01

Financial risk management of pharmacy benefits in integrated health systems is explained. A managed care organization should assume financial risk for pharmacy benefits only if it can manage the risk. Horizontally integrated organizations often do not have much control over the management of drug utilization and costs. Vertically integrated organizations have the greatest ability to manage pharmacy financial risk; virtual integration may also be compatible. Contracts can be established in which the provider is incentivized or placed at partial or full risk. The main concerns that health plans have with respect to pharmacy capitation are formulary management and the question of who should receive rebates from manufacturers. The components needed to managed pharmacy financial risk depend on the type of contract negotiated. Health-system pharmacists are uniquely positioned to take advantage of opportunities opening up through pharmacy risk contracting. Functions most organizations must provide when assuming pharmacy financial risk can be divided into internal and external categories. Internally performed functions include formulary management, clinical pharmacy services and utilization management, and utilization reports for physicians. Functions that can be outsourced include claims processing and administration, provider- and customer support services, and rebates. Organizations that integrate the pharmacy benefit across the health care continuum will be more effective in controlling costs and improving outcomes than organizations that handle this benefit as separate from others. Patient care should not focus on payment mechanisms and unit costs but on developing superior processes and systems that improve health care.

Controlling prescription drug expenditures: a report of success.

PubMed

Miller, David P; Furberg, Curt D; Small, Ronald H; Millman, Franklyn M; Ambrosius, Walter T; Harshbarger, Julia S; Ohl, Christopher A

2007-08-01

To determine whether a multi-interventional program can limit increases in prescription drug expenditures while maintaining utilization of needed medications. Quasi-experimental, pre-post design. The program included formulary changes, quantity limits, and mandatory pill splitting for select drugs implemented in phases. We assessed the short-term effects of each intervention by comparing class-specific drug spending and generic medication use before and after benefit changes. Long-term effects were determined by comparing overall spending with projected spending estimates, and by examining changes in the planwide use of generic medications over time. Effects on medication utilization were assessed by examining members' use of selected classes of chronic medications before and after the policy changes. Over 3 years, the plan and members saved $6.6 million attributed to the interventions. Most of the savings were due to the reclassification of select brand-name drugs to nonpreferred status (estimated annual savings, $941,000), followed by the removal of nonsedating antihistamines from the formulary (annual savings, $565,000), and the introduction of pill splitting (annual savings, $342,000). Limiting quantities of select medications had the smallest impact (annual savings, $135,000). Members' use of generic medications steadily increased from 40% to 57%. Although 17.5% of members stopped using at least 1 class of selected medications, members' total use of chronic medications remained constant. A combination of interventions can successfully manage prescription drug spending while preserving utilization of chronic medications. Additional studies are needed to determine the effect of these cost-control interventions on other health outcomes.

The BC Glomerulonephritis Network: Improving Access and Reducing the Cost of Immunosuppressive Treatments for Glomerular Diseases

PubMed Central

Barbour, Sean; Lo, Clifford; Espino-Hernandez, Gabriela; Gill, Jagbir; Levin, Adeera

2018-01-01

Glomerulonephritis (GN) is a common cause of end-stage renal disease in Canada and worldwide, and results in significant health care resource utilization and patient morbidity. However, GN has not been a traditional priority of provincial renal health care organizations, despite the known benefits to health services delivery and patient outcomes from integrated provincial care in other types of chronic kidney disease. To address this deficiency, the British Columbia (BC) Provincial Renal Agency created the BC GN Network in 2013 to coordinate provincial GN health services delivery informed by robust population-level data capture on all GN patients in the province via the BC GN Registry. This report describes the use of the BC GN Network infrastructure to systematically develop and evaluate a provincial GN drug formulary to improve patient and physician access to evidence-based immunosuppressive treatments for GN in a cost-efficient manner that successfully halted historical trends of increasing medication costs. An example is provided of using the provincial infrastructure to implement and subsequently evaluate an evidence-informed health policy of converting brand to generic tacrolimus for the treatment of GN. The BC GN Network, including the provincial drug formulary and data infrastructure, is an example of the benefits of expanding the mandate of provincial renal health administrative organizations to include the care of patients with GN, and constitutes a viable health delivery model that can be implemented in other Canadian provinces to achieve similar goals. PMID:29581884

Drug selection in French university hospitals: analysis of formularies for nine competitive pharmacological classes.

PubMed

Gallini, Adeline; Juillard-Condat, Blandine; Saux, Marie-Claude; Taboulet, Florence

2011-11-01

To give a panorama of the selectivity and agreement of French university hospitals' drug formularies (HDF) for nine competitive classes. All university hospitals were asked to send their HDF and selection criteria as of January 2009 for nine competitive pharmacological classes (proton pump inhibitors, serotonin antagonists, low molecular weight heparins, erythropoietins, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, statins, α-adrenoreceptor antagonists and selective serotonin re-uptake inhibitors). Selectivity of HDF was estimated by the percentage of drug entities selected by the hospital within the pharmacological class. Agreement between hospitals was assessed with modified kappa coefficients for multi-raters. Twenty-one out of the 29 hospitals agreed to participate. These hospitals selected between 34% and 63% of the drug entities available for the nine classes, which represented 18 to 35 agents. Regarding the nature of chosen drug entities, the overall level of agreement was 'fair' and varied with pharmacological classes. Selection criteria were sent by only 12 hospitals. The technical component was the most important element in all hospitals. The weight of the economic component varied between 20% and 40% in the tender's grade. Large variations were seen in the number and nature of drugs selected by university hospitals which can be attributable to two successive decision-making processes (evaluation by the Drug and Therapeutics Committee followed by the purchasing process). © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

Idarucizumab (Praxbind) Formulary Review.

PubMed

Buchheit, Jessica; Reddy, Prabashni; Connors, Jean M

2016-09-01

Idarucizumab (Praxbind), a humanized monoclonal antibody fragment was granted accelerated approval from the Food and Drug Administration in October 2015 as the first agent to reverse the effects of a novel oral anticoagulant. The drug is indicated for dabigatran reversal in patients requiring emergency surgery/urgent procedures or with life-threatening or uncontrolled bleeding. In a randomized study with healthy volunteers, compared with placebo, idarucizumab reduced the clotting times for all tests assays (assessed pre-, end of-, and 24 hours after infusion), while the results for the placebo group remained unchanged. Another randomized clinical trial assessed the safety and efficacy of idarucizumab in patients with either overt bleeding or undergoing emergency surgery where hemostasis was required. This study is ongoing, but preliminary results showed reversal efficacy demonstrated a reasonable safety profile from the time of the infusion to 90 days after. The wholesale acquisition cost of two 2.5 g vials of idarucizumab is currently $3482.50. To treat 10 or 20 patients per year with a single 5 g dose is estimated to cost $34,825 and $69,650, respectively. In the clinical trial described above, approximately 20% of patients required a second dose, which would further increase the cost of use. In this formulary review for a health system's pharmacy and therapeutics committee, idarucizumab clinical trials and medication package insert were summarized and, after consulting with clinical experts from our institutions, practical recommendations for use were generated to ensure appropriate and safe use of this agent.

Reimbursement-Based Economics--What Is It and How Can We Use It to Inform Drug Policy Reform?

PubMed

Coyle, Doug; Lee, Karen M; Mamdani, Muhammad; Sabarre, Kelley-Anne; Tingley, Kylie

2015-01-01

In Ontario, approximately $3.8 billion is spent annually on publicly funded drug programs. The annual growth in Ontario Public Drug Program (OPDP) expenditure has been limited to 1.2% over the course of 3 years. Concurrently, the Ontario Drug Policy Research Network (ODPRN) was appointed to conduct drug class review research relating to formulary modernization within the OPDP. Drug class reviews by ODPRN incorporate a novel methodological technique called reimbursement-based economics, which focuses on reimbursement strategies and may be particularly relevant for policy-makers. To describe the reimbursement-based economics approach. Reimbursement-based economics aims to identify the optimal reimbursement strategy for drug classes by incorporating a review of economic literature, comprehensive budget impact analyses, and consideration of cost-effectiveness. This 3-step approach is novel in its focus on the economic impact of alternate reimbursement strategies rather than individual therapies. The methods involved within the reimbursement-based approach are detailed. To facilitate the description, summary methods and findings from a recent application to formulary modernization with respect to the drug class tryptamine-based selective serotonin receptor agonists (triptans) used to treat migraine headaches are presented. The application of reimbursement-based economics in drug policy reforms allows policy-makers to consider the cost-effectiveness and budget impact of different reimbursement strategies allowing consideration of the trade-off between potential cost savings vs increased access to cost-effective treatments. © 2015 American Headache Society.

How drug life-cycle management patent strategies may impact formulary management.

PubMed

Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

2016-10-01

Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

Medication-related clinical decision support alert overrides in inpatients.

PubMed

Nanji, Karen C; Seger, Diane L; Slight, Sarah P; Amato, Mary G; Beeler, Patrick E; Her, Qoua L; Dalleur, Olivia; Eguale, Tewodros; Wong, Adrian; Silvers, Elizabeth R; Swerdloff, Michael; Hussain, Salman T; Maniam, Nivethietha; Fiskio, Julie M; Dykes, Patricia C; Bates, David W

2018-05-01

To define the types and numbers of inpatient clinical decision support alerts, measure the frequency with which they are overridden, and describe providers' reasons for overriding them and the appropriateness of those reasons. We conducted a cross-sectional study of medication-related clinical decision support alerts over a 3-year period at a 793-bed tertiary-care teaching institution. We measured the rate of alert overrides, the rate of overrides by alert type, the reasons cited for overrides, and the appropriateness of those reasons. Overall, 73.3% of patient allergy, drug-drug interaction, and duplicate drug alerts were overridden, though the rate of overrides varied by alert type (P < .0001). About 60% of overrides were appropriate, and that proportion also varied by alert type (P < .0001). Few overrides of renal- (2.2%) or age-based (26.4%) medication substitutions were appropriate, while most duplicate drug (98%), patient allergy (96.5%), and formulary substitution (82.5%) alerts were appropriate. Despite warnings of potential significant harm, certain categories of alert overrides were inappropriate >75% of the time. The vast majority of duplicate drug, patient allergy, and formulary substitution alerts were appropriate, suggesting that these categories of alerts might be good targets for refinement to reduce alert fatigue. Almost three-quarters of alerts were overridden, and 40% of the overrides were not appropriate. Future research should optimize alert types and frequencies to increase their clinical relevance, reducing alert fatigue so that important alerts are not inappropriately overridden.

OpenPrescribing: normalised data and software tool to research trends in English NHS primary care prescribing 1998-2016.

PubMed

Curtis, Helen J; Goldacre, Ben

2018-02-23

We aimed to compile and normalise England's national prescribing data for 1998-2016 to facilitate research on long-term time trends and create an open-data exploration tool for wider use. We compiled data from each individual year's national statistical publications and normalised them by mapping each drug to its current classification within the national formulary where possible. We created a freely accessible, interactive web tool to allow anyone to interact with the processed data. We downloaded all available annual prescription cost analysis datasets, which include cost and quantity for all prescription items dispensed in the community in England. Medical devices and appliances were excluded. We measured the extent of normalisation of data and aimed to produce a functioning accessible analysis tool. All data were imported successfully. 87.5% of drugs were matched exactly on name to the current formulary and a further 6.5% to similar drug names. All drugs in core clinical chapters were reconciled to their current location in the data schema, with only 1.26% of drugs not assigned a current chemical code. We created an openly accessible interactive tool to facilitate wider use of these data. Publicly available data can be made accessible through interactive online tools to help researchers and policy-makers explore time trends in prescribing. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pharmacy Benefits Management in the Veterans Health Administration Revisited: A Decade of Advancements, 2004-2014.

PubMed

Aspinall, Sherrie L; Sales, Mariscelle M; Good, Chester B; Calabrese, Vincent; Glassman, Peter A; Burk, Muriel; Moore, Von R; Neuhauser, Melinda M; Golterman, Lori; Ourth, Heather; Valentino, Michael A; Cunningham, Francesca E

2016-09-01

Over the past decade, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services (PBM) has enhanced its formulary management activities and added programs to ensure that the national drug plan continues to meet the pharmacy needs of veterans and to promote safe and appropriate drug therapy in the face of rising medication expenditures. This article describes the broad range of services provided by the VA PBM that work in partnership to deliver a high-quality and sustainable pharmacy benefit for veterans. In support of formulary management, VA PBM pharmacists prepare extensive clinical guidance documents (e.g., drug monographs and criteria for use) that are used by physicians and pharmacists with operational and clinical oversight of the VA national formulary. The VA PBM has utilized various contracting techniques and continually evaluates drug utilization data to identify opportunities for potential savings. Remarkably, since before 2004, the average acquisition cost for a 1-month supply of medication has remained fairly stable at approximately $13-$15. Two new VA PBM programs are the VA Center for Medication Safety (VA MedSAFE) and the Clinical Pharmacy Practice Office (CPPO). VA MedSAFE is a comprehensive pharmacovigilance program focused on the detection, assessment, and prevention of adverse drug events, and CPPO is dedicated to improving safe and appropriate medication use by supporting and expanding clinical pharmacy practice. Moving forward, the VA PBM will consider new initiatives to stay at the forefront of providing quality care while maintaining economic viability. No outside funding supported this research. This work was supported by VA Pharmacy Benefits Management Services (VA PBM), Hines, Illinois, and VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania. Glassman is co-director of the VA Center for Medication Safety, which is part of the VA PBM. He is also part of the Medical Advisory Panel for the VA PMB. All other authors are employed by the VA PBM. The views expressed in this article are those of the authors, and no official endorsement by the U.S. Department of Veteran Affairs or the U.S. government is intended or should be inferred. Study concept and design were contributed by Valentino, Cunningham, Good, Aspinall, and Sales. Calabrese and Ourth took the lead in data collection, along with Good, Cunningham, Aspinall, Sales, Burk, Moore, Neuhauser, and Golterman. Data interpretation was performed by Burk, Newhauser, and Golterman, along with Glassman, Calabrese, Moore, and Ourth. The manuscript was written by Aspinall and Sales, along with Burk, Newhauser, Golterman, Ourth, and Cunningham. Good, Glassman, and Moore revised the manuscript, along with Calabrese, Valentino, and Aspinall.

Developing drug formularies for the "National Medical Holding" JSC.

PubMed

Akhmadyar, N S; Khairulin, B E; Amangeldy-Kyzy, S; Ospanov, M A

2015-01-01

One of the main problems of drug provision of multidisciplinary hospitals is the necessity to improve the efficiency of budget spending. Despite the efforts undertaken in Kazakhstan for improving the mechanism of drug distribution (creation of the Kazakhstan National Formulary, Unified National Health System, the handbook of medicines (drugs) costs in the electronic register of inpatients (ERI), having a single distributor), the number of unresolved issues still remain."National Medical Holding" JSC (NMH) was established in 2008 and unites 6 innovational healthcare facilities with up to 1431 beds (700 children and 731 adults), located in the medical cluster - which are "National Research Center for Maternal and Child Health" JSC (NRCMC), "Republic Children's Rehabilitation Center" JSC (RCRC), "Republican Diagnostic Center" JSC (RDC), "National Centre for Neurosurgery" JSC (NCN), "National Research Center for Oncology and Transplantation" JSC (NRCOT) and "National Research Cardiac Surgery Center" JSC (NRCSC). The main purpose of NMH is to create an internationally competitive "Hospital of the Future", which will provide the citizens of Kazakhstan and others with a wide range of medical services based on advanced medical technology, modern hospital management, international quality and safety standards. These services include emergency care, outpatient diagnostic services, obstetrics and gynecology, neonatal care, internal medicine, neurosurgery, cardiac surgery, transplantation, cancer care for children and adults, as well as rehabilitation treatment. To create a program of development of a drug formulary of NMH and its subsidiaries. In order to create drug formularies of NMH, analytical, software and statistical methods were used.AII subsidiary organizations of NMH (5 out of 6) except for the NRCOT have been accredited by Joint Commission International (JCI) standards, which ensure the safety of patients and clinical staff, by improving the technological infrastructure, management systems, production environments, and developing program for medications management and use (MMU), etc.MMU is the Chapter 7 of the 5th edition of the standard JCI [1] which is an up-to-date recognized international standard for hospital drug supply and includes 7 points of medication management lifecycle for inpatient hospitals: drug management and organization; selection and procurement; storage; prescription; preparation and distribution; administering medications; monitoring.Due to the developed MMU program of subsidiary organizations the drug provision system was rationalized, starting from defining the individual therapy of a patient and ending with the drug procurement strategy. The practical activity was introduced to the use of drugs committeees with reliable evidence-based performance with obligatory consideration of cost-benefit analysis for each diagnosis-related group. Pre-collected applications for drugs for the year 2015 were submitted in a uniform format in accordance with the structure of the Republican form of the drug [2]. In view of the evidence-base physicians-clinical pharmacologists performed discussions and review of 851 drugs included on the uniform format of the list. Totally 51 (6%) positions were excluded from the list; it was suggested that the format of the application for Paracetamol and Ibuprofen in injectable form be revised; the committee revised the sections on the list for "Antianaemia drugs", iron preparations and methods of prevention of venous thromboembolism with oral anticoagulants.On the basis of this work, the new format, consisting of 449 international nonproprietary names was developed, representing 795 positions with pediatric formulations. In view of the exisitng data and the move to bring to the common standards and uniformity prices of drugs purchased for 2016, the NMH program of clinical pharmacology content with on-line and open access to physicians was created. Within 60 days the DSCHC work was carried out with consultations, selection, definition of requirements of generic and therapeutic substitution. Summing up, drug applications for 2016 with dosage forms include 802 positions and the total bid in monetary terms was by 4,7% lower than in 2015.For the establishment of NMH rational and balanced system of medicine provision to patients and in order to increase availability of quality, safe and effective drugs, we need to have an open and transparent program of the MMU, developed in accordance with the standards of JCI, with the NMH drug formulary, indicating the reference price values of the lower units (tablet, capsule, ampoule, vial, etc.), including the drug lists for a single distributor.To improve drug supply of the NMH DSCHC we have to further cooperation with clinical pharmacologists for the rational use of medicines, guided by the principles of evidence-based medicine.

Category Captain Management: a new approach for healthcare suppliers to partner with their hospital customers.

PubMed

Trombetta, Bill

2007-01-01

Hospitals represent a substantial market for pharmaceutical and medical device companies. The typical approach by healthcare manufacturers and suppliers to hospitals is to send representatives or detailers to hospitals and meet with representatives of hospital formularies and purchasing officials. Classic channels systems, and specifically, Category Captain Management ("CCM") may provide more of a sustainable competitive advantage than traditional hospital detailing. The purpose of this article is to discuss how CCM might apply as an approach for healthcare suppliers to truly partner with their hospital customers.

The bias against new innovations in health care: value uncertainty and willingness to pay.

PubMed

Walton, Surrey M; Graves, Philip E; Mueser, Peter R; Dow, Jay K

2002-01-01

This paper offers a model for the bias found in willingness-to-pay valuations against new treatments. For example, this bias provides an explanation for patient preferences that make it difficult for formularies to take treatments off their lists, even when newer treatments would appear to be clearly preferable. The appeal of the model, which is based on imperfect information, is that it is consistent with rational preferences and rational behavior by patients, which are necessary for standard models and methods related to decision theory, cost-effectiveness, and efficiency.

Assessment of new drugs in a tertiary hospital using a standardized tool.

PubMed

González-Bueno, J; Chamorro-de-Vega, E; Alfaro-Lara, E R; Galván-Banqueri, M; Santos-Ramos, B

2013-01-01

To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective. Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports. 63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than ?10,000 per year for our hospital. Highquality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance. The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

Pharma rebates, pharmacy benefit managers and employer outcomes.

PubMed

Ali, Ozden Gür; Mantrala, Murali

2010-12-01

Corporate employers contract with pharmacy benefit managers (PBMs) with the goals of lowering their employee prescription drug coverage costs while maintaining health care quality. However, little is known about how employer-PBM contract elements and brand drugmakers' rebates combine to influence a profit-maximizing PBM's actions, and the impact of those actions on the employer's outcomes. To shed more light on these issues, the authors build and analyze a mathematical simulation model of a competitive pharmaceutical market comprised of one generic and two branded drugs, and involving a PBM contracted by a corporate employer to help it lower prescription drug costs while achieving a minimum desired quality of health care for its employees. The brand drugmakers' rebate offers, the PBM's assignment of drugs to formulary tiers, and the resulting employer outcomes under varying contracts and pharma brand marketing mix environmental scenarios are analyzed to provide insights. The findings include that the pharma brands offer rebates for the PBM's ability to move prescription share away from the unpreferred brand, but reduce these offers when the PBM's contract requires it to proactively influence physicians to prescribe the generic drug alternative. Further, Pareto optimal contracts that provide the highest health benefit for a given employer cost budget for the employer are analyzed to provide managerial implications. They are found to involve strong PBM influence on physician prescribing to discourage unpreferred brands, as well as high patient copayment requirements for unpreferred brands to align the patient prescription fill probability with the formulary, while other copayment requirements provide an instrument to determine the level of desired health benefit-cost tradeoff.

Impact of a Value-based Formulary on Medication Utilization, Health Services Utilization, and Expenditures.

PubMed

Yeung, Kai; Basu, Anirban; Hansen, Ryan N; Watkins, John B; Sullivan, Sean D

2017-02-01

Value-based benefit design has been suggested as an effective approach to managing the high cost of pharmaceuticals in health insurance markets. Premera Blue Cross, a large regional health plan, implemented a value-based formulary (VBF) for pharmaceuticals in 2010 that explicitly used cost-effectiveness analysis (CEA) to inform medication copayments. The objective of the study was to determine the impact of the VBF. Interrupted time series of employer-sponsored plans from 2006 to 2013. Intervention group: 5235 beneficiaries exposed to the VBF. 11,171 beneficiaries in plans without any changes in pharmacy benefits. The VBF-assigned medications with lower value (estimated by CEA) to higher copayment tiers and assigned medications with higher value to lower copayment tiers. Primary outcome was medication expenditures from member, health plan, and member plus health plan perspectives. Secondary outcomes were medication utilization, emergency department visits, hospitalizations, office visits, and nonmedication expenditures. In the intervention group after VBF implementation, member medication expenditures increased by $2 per member per month (PMPM) [95% confidence interval (CI), $1-$3] or 9%, whereas health plan medication expenditures decreased by $10 PMPM (CI, $18-$2) or 16%, resulting in a net decrease of $8 PMPM (CI, $15-$2) or 10%, which translates to a net savings of $1.1 million. Utilization of medications moved into lower copayment tiers increased by 1.95 days' supply (CI, 1.29-2.62) or 17%. Total medication utilization, health services utilization, and nonmedication expenditures did not change. Cost-sharing informed by CEA reduced overall medication expenditures without negatively impacting medication utilization, health services utilization, or nonmedication expenditures.

A survey of Pharmacy and Therapeutic committees across Canada: scope and responsibilities.

PubMed

Mittmann, Nicole; Knowles, Sandra

2009-01-01

Pharmacy and Therapeutics (P&T) committees have traditionally evaluated and developed policies for the clinical use of medications and for ensuring safe and effective drug use and administration. The objective of this study was to determine the current activities of hospital P&T committees across Canada. Surveys were mailed to 856 (693 English, 163 French translations) Canadian hospitals (acute, chronic or rehabilitation) across Canada. Questions consisted of information on P&T membership, scope and responsibilities. Completed surveys were returned by fax. All data was entered into Excel and analyzed for descriptive statistics. 123 surveys were returned, representing 207 hospitals, for an effective response rate of 24%. Four hospitals returned incomplete surveys. Surveys were returned from all areas of Canada, except the territories. On average, P&T committees met six times per year. The average size of the committees was 11 members, with physicians comprising half the membership. Pharmacists and nurses had equal representation; other members were community representatives, dieticians, quality assurance personnel and/or administrators. The top responsibilities of the P&T committee were inpatient formulary management (93% of respondents), drug-use policy making (92%), adverse drug reaction monitoring (83%), patient safety (80%) and drug-use monitoring (80%). Subcommittees were utilized by 46% of P&T committees including antimicrobial (38%), medication safety (25%) and nutrition (14%). Economic evaluations were most frequently completed by a pharmacist who had some previous pharmacoeconomic experience. This survey reports on the current status and responsibilities, namely formulary management and policy making, of P&T committees in Canada.

Ceftaroline fosamil use in hospitalized patients with acute bacterial skin and skin structure infections: Budget impact analysis from a hospital perspective.

PubMed

Huang, Xingyue; Beresford, Eric; Lodise, Thomas; Friedland, H David

2013-06-15

The budgetary impact of adding ceftaroline fosamil to a hospital formulary for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) was evaluated. A three-year hospital budget impact model was constructed with three initial treatment options for ABSSSIs: ceftaroline fosamil, vancomycin plus aztreonam, and other vancomycin-containing regimens. The target population was hospitalized adult patients with an ABSSSI. Clinical cure rates with initial treatment were assumed to be similar to those from ceftaroline fosamil clinical trials. Patients who did not respond to initial treatment were assumed to be treated successfully with second-line antimicrobial therapy. Length of stay and cost per hospital day (by success or failure with initial treatment) were estimated based on a large database from more than 100 U.S. hospitals. Other model inputs included the annual number of ABSSSI admissions, projected annual case growth rate, proportion of ABSSSI target population receiving vancomycin-containing regimen, expected proportion of ABSSSI target population to be treated with ceftaroline fosamil, drug acquisition cost, cost of antibiotic administration, and cost of vancomycin monitoring. Sensitivity analysis using 95% confidence limits of clinical cure rates was also performed. The estimated total cost of care for treating a patient with an ABSSSI was $395 lower with ceftaroline fosamil ($15,087 versus $15,482) compared with vancomycin plus aztreonam and $72 lower ($15,087 versus $15,159) compared with other vancomycin-containing regimens. Model estimates indicated that adding ceftaroline fosamil to the hospital formulary would not have a negative effect on a hospital's budget for ABSSSI treatment.

Using cost-effectiveness analysis to sharpen formulary decision-making: the example of tiotropium at the Veterans Affairs health care system.

PubMed

Onukwugha, Ebere; Mullins, C Daniel; DeLisle, Sylvain

2008-01-01

To identify a cost-saving subset of criteria for the use of tiotropium at a Veterans Affairs Medical Center based on a cost-effectiveness analysis with ipratropium as the comparator. Retrospective analysis of electronic medical records for the calendar year 2004 was conducted. The sample was drawn from a population at the Baltimore Veterans Affairs Medical Center that had a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) and had filled prescriptions for ipratropium. The tiotropium sample was based on a modeled cohort of COPD patients who had received tiotropium. The analysis was conducted from the perspective of the Veterans Affairs Health Care System. The outcome was the incremental cost-effectiveness of tiotropium versus ipratropium. The incremental cost-effectiveness ratio (ICER) was $2360 per avoided exacerbation. Tiotropium cost-effectiveness increased with COPD severity and was cost-saving in patients with very severe disease (ICER = $-1818) and in patients with a previous COPD-related hospitalization (ICER = $-4472). The ICER was most sensitive to the relative effectiveness and price of tiotropium. Results identified the levels of treatment effectiveness and price beyond which tiotropium would become cost-saving relative to ipratropium. The results support the existing Veterans Affairs practice of offering tiotropium to patients with COPD-related hospitalizations. Periodic review of the effectiveness data to determine whether tiotropium would be cost-saving in patients with very severe COPD is suggested. Cost-effectiveness analyses that identify practical criteria-for-use should become an integral part of the formulary process.

Schizophrenia: multi-attribute utility theory approach to selection of atypical antipsychotics.

PubMed

Bettinger, Tawny L; Shuler, Garyn; Jones, Donnamaria R; Wilson, James P

2007-02-01

Current guidelines/algorithms recommend atypical antipsychotics as first-line agents for the treatment of schizophrenia. Because there are extensive healthcare costs associated with the treatment of schizophrenia, many institutions and health systems are faced with making restrictive formulary decisions regarding the use of atypical antipsychotics. Often, medication acquisition costs are the driving force behind formulary decisions, while other treatment factors are not considered. To apply a multi-attribute utility theory (MAUT) analysis to aid in the selection of a preferred agent among the atypical antipsychotics for the treatment of schizophrenia. Five atypical antipsychotics (risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole) were selected as the alternative agents to be included in the MAUT analysis. The attributes identified for inclusion in the analysis were efficacy, adverse effects, cost, and adherence, with relative weights of 35%, 35%, 20%, and 10%, respectively. For each agent, attribute scores were calculated, weighted, and then summed to generate a total utility score. The agent with the highest total utility score was considered the preferred agent. Aripiprazole, with a total utility score of 75.8, was the alternative agent with the highest total utility score in this model. This was followed by ziprasidone, risperidone, and quetiapine, with total utility scores of 71.8, 69.0, and 65.9, respectively. Olanzapine received the lowest total utility score. A sensitivity analysis was performed and failed to displace aripiprazole as the agent with the highest total utility score. This model suggests that aripiprazole should be considered a preferred agent for the treatment of schizophrenia unless found to be otherwise inappropriate.

Investigating the dissolution profiles of amoxicillin, metronidazole, and zidovudine formulations used in Trinidad and Tobago, West Indies.

PubMed

Stuart, Arlene Villarroel; Zuo, Jieyu; Löbenberg, Raimar

2014-10-01

Trinidad and Tobago is a twin-island Republic in the Caribbean and like many developing countries, it has included generic drugs on the national drug formulary to decrease the financial burden of pharmaceutical medications. However, to ensure that medications received by patients are beneficial, generic drugs need to be interchangeable with the innovator which has demonstrated safety, efficacy, and quality. The objective of the study was to compare the dissolution profiles and weight variations for different formulations of amoxicillin, metronidazole, and zidovudine that are on the national drug formulary and marketed in Trinidad and Tobago. All the products investigated are categorized as class 1 drugs according to the Biopharmaceutics Classification System (BCS) and the dissolution profiles were assessed according to the World Health Organization (WHO) criteria for interchangeability between products. The similarity factor, f 2, was used to determine sameness between the products. No generic formulation was found to be similar to Amoxil® 500-mg capsules. The two generic products for metronidazole 200-mg tablets demonstrated more than 85% drug release within 15 min in all three of the buffers; however, their 400-mg counterparts did not fulfill this requirement. The zidovudine 300-mg tablet complied with the requirements in buffer pH 4.5 and simulated gastric fluid (SGF) but not for simulated intestinal fluid (SIF). Some Class 1 pharmaceutical formulations may possess the same active ingredient and amount of drug but may show significant differences to in vitro equivalence requirements. Nevertheless, the dissolution process is suitable to detect these variations.

Coverage of Medications That Treat Opioid Use Disorder and Opioids for Pain Management in Marketplace Plans, 2017.

PubMed

Huskamp, Haiden A; Riedel, Lauren E; Barry, Colleen L; Busch, Alisa B

2018-06-01

Efficacious medications to treat opioid use disorders (OUDs) have been slow to diffuse into practice, and insurance coverage limits may be one important barrier. To compare coverage for medications used to treat OUDs and opioids commonly prescribed for pain management in plans offered on the 2017 Health Insurance Marketplace exchanges. We identified a sample of 100 plans offered in urban and in rural counties on the 2017 Marketplaces, weighting by population. We accessed publicly available plan coverage information on healthcare.gov for states with a federally facilitated exchange, the state exchange website for state-based exchanges, and insurer websites. About 14% of plans do not cover any formulations of buprenorphine/naloxone. Plans were more likely to require prior authorization for any of the covered office-based buprenorphine or naltrexone formulations preferred for maintenance OUD treatment (ie, buprenorphine/naloxone, buprenorphine implants, injectable long-acting naltrexone) than of short-acting opioid pain medications (63.6% vs. 19.4%; P<0.0001). Only 10.6% of plans cover implantable buprenorphine, 26.1% cover injectable naltrexone, and 73.4% cover at least 1 abuse-deterrent opioid pain medication. Many Marketplace plans either do not cover or require prior authorization for coverage of OUD medications, and these restrictions are often more common for OUD medications than for short-acting opioid pain medications. Regulators tasked with enforcement of the Mental Health Parity and Addiction Equity Act, which requires that standards for formulary design for mental health and substance use disorder drugs be comparable to those for other medications, should focus attention on formulary coverage of OUD medications.

Family Physician attitudes about prescribing using a drug formulary

PubMed Central

Suggs, L Suzanne; Raina, Parminder; Gafni, Amiram; Grant, Susan; Skilton, Kevin; Fan, Aimei; Szala-Meneok, Karen

2009-01-01

Background Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers. Methods Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis. Results Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions. Conclusion Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms. PMID:19835601

Pharmacy-enforced outpatient drug treatment protocols: a case study of Medi-Cal restrictions for cefaclor.

PubMed

McCombs, J S; Nichol, M B

1993-02-01

To evaluate whether a pharmacy-enforced treatment protocol successfully limited the use of a high-cost medication to high-risk patients. A case study cost-effectiveness analysis was conducted to evaluate a treatment protocol for cefaclor. Episodes of care were defined, healthcare expenditures for all services were aggregated, and demographic data were retrieved from a five percent random sample of California Medicaid (Medi-Cal) recipients. Data were available for episodes occurring before cefaclor was made available under Medi-Cal. Medi-Cal added cefaclor to its formulary, limiting its use to patients over 50 years of age with lower respiratory tract infections (LRTIs). The unit of analysis was an episode of outpatient antibiotic treatment. Confirmed LRTI episodes and unconfirmed LRTI cefaclor episodes were analyzed, including multiple episodes of treatment for individual patients. A total of 7855 non-cefaclor LRTI episodes and 2556 cefaclor episodes were analyzed. The primary outcome measures were healthcare expenditures three months after the initiation of antibiotic therapy, differentiated by type of service. Physicians directed cefaclor toward higher-risk patients over age 50 years, even in unconfirmed LRTI episodes. Cefaclor use was estimated to reduce posttreatment costs by $388 per patient (p < 0.001), primarily because of reduced hospital expenditures of $366 (p < 0.001). Pharmacy-enforced outpatient drug treatment protocols may be a viable alternative to restrictive formularies and prior authorization. In the case of cefaclor, the Medi-Cal treatment protocol appeared to allow high-risk patients better access to a high-cost medication while reducing total posttreatment costs.

[Compliance with the surgical safety checklist and surgical events detected by the Global Trigger Tool].

PubMed

Menéndez Fraga, M D; Cueva Álvarez, M A; Franco Castellanos, M R; Fernández Moral, V; Castro Del Río, M P; Arias Pérez, J I; Fernández León, A; Vázquez Valdés, F

2016-06-01

The implementing of the WHO Surgical Safety Checklist (SSC) has helped to improve patient safety. The aim of this study was to assess the level of compliance of the SSC, and incorporating the non-compliances as «triggers» in the Global Trigger Tool (GTT). Acute Geriatric Hospital (200 beds). Retrospective study, study period: 2011-2014. The SSC formulary and the methodology of the GTT were used for the analysis of electronic medical records and the compliance with the SSC. The NCCP MERP categories were used to assess the severity of the harm. Out of all the electronic medical records (EMR), a total of 227 (23.6%) discharged patients (1.7% of interventions in the four year study period) were analysed. All (100%) of the EMR included the SSC, with 94.4% of the items being completed, and 28.2% of SSC had all items completed in the 3 phases of the process. Surgical adverse events decreased from 16.3% in 2011 to 9.4% in 2014 (P=.2838, not significant), and compliance with all items of SSC was increased from 18.6% to 39.1% (P=.0246, significant). The GTT systematises and evaluates, at low cost, the triggers and incidents/ AEs found in the EMR in order to assess the compliance with the SSC and consider non-compliance of SSC as «triggers» for further analysis. This strategy has never been referred to in the GTT or in the SCC formulary. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

Applying rapid 'de-facto' HTA in resource-limited settings: experience from Romania.

PubMed

Lopert, Ruth; Ruiz, Francis; Chalkidou, Kalipso

2013-10-01

In attempting to constrain healthcare expenditure growth, health technology assessment (HTA) can enable policy-makers to look beyond budget impact and facilitate more rational decision-making. However lack of technical capacity and poor governance can limit use in some countries. Undertaking de facto HTA by adapting decisions taken in countries with established processes is a method that may be applied while building domestic HTA capacity. We explored the potential for applying this approach in Romania. As part of a review of the basic health benefits available to insured Romanians we examined the listing process and content of the Romanian drug reimbursement formulary. We assessed value for money indirectly by drawing on appraisals by UK's NICE, and for products considered cost effective in the UK, adjusting prices by the ratio of Romanian per capita GDP to UK per capita GDP. We found more than 30 of the top 50 medicines on the Romanian formulary unlikely to be cost-effective, suggesting that existing external reference pricing mechanisms may not be delivering good value for money. While not taking into account local costs or treatment patterns, absent local considerations of value for money, this method offers a guide for both drug selection and pricing. Until robust local HTA processes are established this approach could support further analysis of existing prices and pricing mechanisms. Applied more generally, it is arguably preferable to external reference pricing, product delisting or arbitrary price cuts, and may support the future development of more rigorous, evidence-based decision-making. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Drug approval processes in Australian Paediatric Hospitals.

PubMed

Sinha, Y K; Craig, J C; Barclay, P; Taitz, J; South, M; Coulthard, K; Pearson, C; Erickson, S; Brien, J E

2010-09-01

To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals. Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period. All eight paediatric hospitals in Australia. Eight committee chairs and seven secretaries or delegates. Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes. Total drug expenditure varied from $A1.7 million (US$1.5 million) to $A11.1 million (US$9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%-100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%-100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation. Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

Medicare Part D Claims Rejections for Nursing Home Residents, 2006 to 2010

PubMed Central

Stevenson, David G.; Keohane, Laura M.; Mitchell, Susan L.; Zarowitz, Barbara J.; Huskamp, Haiden A.

2013-01-01

Objectives Much has been written about trends in Medicare Part D formulary design and consumers’ choice of plans, but little is known about the magnitude of claims rejections or their clinical and administrative implications. Our objective was to study the overall rate at which Part D claims are rejected, whether these rates differ across plans, drugs, and medication classes, and how these rejection rates and reasons have evolved over time. Study Design and Methods We performed descriptive analyses of data on paid and rejected Part D claims submitted by 1 large national long-term care pharmacy from 2006 to 2010. In each of the 5 study years, data included approximately 450,000 Medicare beneficiaries living in long-term care settings with approximately 4 million Part D drug claims. Claims rejection rates and reasons for rejection are tabulated for each study year at the plan, drug, and class levels. Results Nearly 1 in 6 drug claims was rejected during the first 5 years of the Medicare Part D program, and this rate has increased over time. Rejection rates and reasons for rejection varied substantially across drug products and Part D plans. Moreover, the reasons for denials evolved over our study period. Coverage has become less of a factor in claims rejections than it was initially and other formulary tools such as drug utilization review, quantity-related coverage limits, and prior authorization are increasingly used to deny claims. Conclusions Examining claims rejection rates can provide important supplemental information to assess plans’ generosity of coverage and to identify potential areas of concern. PMID:23145808

Forecasting Medicaid Expenditures for Antipsychotic Medications.

PubMed

Slade, Eric P; Simoni-Wastila, Linda

2015-07-01

The ongoing transition from use of mostly branded to mostly generic second-generation antipsychotic medications could bring about a substantial reduction in Medicaid expenditures for antipsychotic medications, a change with critical implications for formulary restrictions on second-generation antipsychotics in Medicaid. This study provided a forecast of the impact of generics on Medicaid expenditures for antipsychotic medications. Quarterly (N=816) state-level aggregate data on outpatient antipsychotic prescriptions in Medicaid between 2008 and 2011 were drawn from the Medicaid state drug utilization database. Annual numbers of prescriptions, expenditures, and cost per prescription were constructed for each antipsychotic medication. Forecasts of antipsychotic expenditures in calendar years 2016 and 2019 were developed on the basis of the estimated percentage reduction in Medicaid expenditures for risperidone, the only second-generation antipsychotic available generically throughout the study period. Two models of savings from generic risperidone use were estimated, one based on constant risperidone prices and the other based on variable risperidone prices. The sensitivity of the expenditure forecast to expected changes in Medicaid enrollment was also examined. In the main model, annual Medicaid expenditures for antipsychotics were forecasted to decrease by $1,794 million (48.8%) by 2016 and by $2,814 million (76.5%) by 2019. Adjustment for variable prices of branded medications and changes in Medicaid enrollment only moderately affected the magnitude of these reductions. Within five years, antipsychotic expenditures in Medicaid may decline to less than half their current levels. Such a spending reduction warrants a reassessment of the continued necessity of formulary restrictions for second-generation antipsychotics in Medicaid.

Pharmacotherapy for alcohol dependence: perceived treatment barriers and action strategies among Veterans Health Administration service providers.

PubMed

Harris, Alex H S; Ellerbe, Laura; Reeder, Rachelle N; Bowe, Thomas; Gordon, Adam J; Hagedorn, Hildi; Oliva, Elizabeth; Lembke, Anna; Kivlahan, Daniel; Trafton, Jodie A

2013-11-01

Although access to and consideration of pharmacological treatments for alcohol dependence are consensus standards of care, receipt of these medications by patients is generally rare and highly variable across treatment settings. The goal of the present project was to survey and interview the clinicians, managers, and pharmacists affiliated with addiction treatment programs within Veterans Health Administration (VHA) facilities to learn about their perceptions of barriers and facilitators regarding greater and more reliable consideration of pharmacological treatments for alcohol dependence. Fifty-nine participants from 19 high-adopting and 11 low-adopting facilities completed the survey (facility-level response rate = 50%) and 23 participated in a structured interview. The top 4 barriers to increased consideration and use of pharmacotherapy for alcohol dependence were consistent across high- and low-adopting facilities and included perceived low patient demand, pharmacy procedures or formulary restrictions, lack of provider skills or knowledge regarding pharmacotherapy for alcohol dependence, and lack of confidence in treatment effectiveness. Low patient demand was rated as the most important barrier for oral naltrexone and disulfiram, whereas pharmacy or formulary restrictions were rated as the most important barrier for acamprosate and extended-release naltrexone. The 4 strategies rated across low- and high-adopting facilities as most likely to facilitate consideration and use of pharmacotherapy for alcohol dependence were more education to patients about existing medications, more education to health care providers about medications, increased involvement of physicians in treatment for alcohol dependence, and more compelling research on existing medications. This knowledge provides a foundation for designing, deploying, and evaluating targeted implementation efforts.

Controlling postoperative use of i.v. acetaminophen at an academic medical center.

PubMed

Vincent, William R; Huiras, Paul; Empfield, Jennifer; Horbowicz, Kevin J; Lewis, Keith; McAneny, David; Twitchell, David

2018-04-15

Results of an interprofessional formulary initiative to decrease postoperative prescribing of i.v. acetaminophen are reported. After a medical center added i.v. acetaminophen to its formulary, increased prescribing of the i.v. formulation and a 3-fold price increase resulted in monthly spending of more than $40,000, prompting an organizationwide effort to curtail that cost while maintaining effective pain management. The surgery, anesthesia, and pharmacy departments applied the Institute for Healthcare Improvement's Model for Improvement to implement (1) pharmacist-led enforcement of prescribing restrictions, (2) retrospective evaluation of i.v. acetaminophen's impact on rates of opioid-related adverse effects, (3) restriction of prescribing of the drug to 1 postoperative dose on select patient care services, and (4) guideline-driven pain management according to an enhanced recovery after surgery (ERAS) protocol. Monitored metrics included the monthly i.v. acetaminophen prescribing rate, the proportion of i.v. acetaminophen orders requiring pharmacist intervention to enforce prescribing restrictions, and prescribing rates for select adjunctive analgesics. Within a year of project implementation, the mean monthly i.v. acetaminophen prescribing rate decreased by 83% from baseline to about 6 doses per 100 patient-days, with a decline in the monthly drug cost to about $4,000. Documented pharmacist interventions increased 2.7-fold, and use of oral acetaminophen, ketorolac, and gabapentin in ERAS areas increased by 18% overall. An interprofessional initiative at a large medical center reduced postoperative use of i.v. acetaminophen by more than 80% and yielded over $400,000 in annual cost savings. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Substitution laws, insurance coverage, and generic drug use.

PubMed

Anis, A H

1994-03-01

This study examined the role of various policies (drug product substitution laws) that are usually motivated by cost containment objectives of insurers in facilitating entry by generic firms. Using data for six Canadian provinces over the years 1981-1988, we evaluated the impact of specific aspects of substitution laws on the level of generic use. We find that formularies and the passage of time are not significant determinants of substitution levels. Legal liability, mandatory product selection, deductible and co-payment schemes, and consumer awareness were found to be important variables. Price responsiveness of generic drugs is indicated but the evidence is not strong.

Pharmaceuticals in Australia: priorities in a teaching hospital.

PubMed

Kearney, B J

1993-01-01

In spite of rigorous government programs for control of the pricing and dissemination of pharmaceutical products in Australia, the list of new drugs continues to grow and prices to increase. To regain control over drug usage at Royal Adelaide Hospital, the Hospital Drug Committee developed a rating method that judged drugs on the basis of their cost-benefit to patients. The ratio of a total quality score to a total cost score becomes the determinant of additions to the hospital formulary. The background for the Australian approach to pharmaceuticals and the new evaluation technique at the teaching hospital are described in this report.

Treatment in Kenyan rural health facilities: projected drug costs using the WHO-UNICEF integrated management of childhood illness (IMCI) guidelines.

PubMed Central

Boulanger, L. L.; Lee, L. A.; Odhacha, A.

1999-01-01

Guidelines for the integrated management of childhood illness (IMCI) in peripheral health facilities have been developed by WHO and UNICEF to improve the recognition and treatment of common causes of childhood death. To evaluate the impact of the guidelines on treatment costs, we compared the cost of drugs actually prescribed to a sample of 747 sick children aged 2-59 months in rural health facilities in western Kenya with the cost of drugs had the children been managed using the IMCI guidelines. The average cost of drugs actually prescribed per child was US$ 0.44 (1996 US$). Antibiotics were the most costly component, with phenoxymethylpenicillin syrup accounting for 59% of the cost of all the drugs prescribed. Of the 295 prescriptions for phenoxymethylpenicillin syrup, 223 (76%) were for treatment of colds or cough. The cost of drugs that would have been prescribed had the same children been managed with the IMCI guidelines ranged from US$ 0.16 per patient (based on a formulary of larger-dose tablets and a home remedy for cough) to US$ 0.39 per patient (based on a formulary of syrups or paediatric-dose tablets and a commercial cough preparation). Treatment of coughs and colds with antibiotics is not recommended in the Kenyan or in the IMCI guidelines. Compliance with existing treatment guidelines for the management of acute respiratory infections would have halved the cost of the drugs prescribed. The estimated cost of the drugs needed to treat children using the IMCI guidelines was less than the cost of the drugs actually prescribed, but varied considerably depending on the dosage forms and whether a commercial cough preparation was used. PMID:10593034

Economic evaluation and the Jordan Rational Drug List: an exploratory study of national-level priority setting.

PubMed

Lafi, Rania; Robinson, Suzanne; Williams, Iestyn

2012-01-01

To explore the extent of and barriers to the use of economic evaluation in compiling the Jordan Rational Drug List in the health care system of Jordan. The research reported in this article involved a case study of the Jordan Rational Drug List. Data collection methods included semi-structured interviews with decision makers and analysis of secondary documentary sources. The case study was supplemented by additional interviews with a small number of Jordanian academics involved in the production of economic evaluation. The research found that there was no formal requirement for cost-effectiveness information submitted as part of the decision-making process for the inclusion of new technologies on the Jordan Rational Drug List. Both decision makers and academics suggested that economic evidence was not influential in formulary decisions. This is unusual for national formulary bodies. The study identified a number of barriers that prevent substantive and routine use of economic evaluation. While some of these echo findings of previous studies, others-notably the extent to which the sectional interests of clinical groups and commercial (pharmaceutical) industry exert undue influence over decision making-more obviously result from the specific Jordanian context. Economic evaluation was not found to be influential in the Jordan Rational Drug List. Recommendations for improvement include enhancing capacity in relation to generating, accessing, and/or applying health economic analysis to priority setting decisions. There is a further need to incentivize the use of economic evaluation, and this requires that organizational and structural impediments be removed. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Economic content in medical journal advertisements for medical devices and prescription drugs.

PubMed

Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

2010-01-01

Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

Design, Development and Rationalization of Sarpagandha Ghanvati

PubMed Central

Pundarikakshudu, K.; Bhatt, C. J.

2015-01-01

Sarpagandha ghanvati is a classical Ayurvedic formulation widely prescribed for anxiety and insomnia. It contains Sarpagandha (roots of Rauwolfia serpentina L. (Benth.) Ex Kurz; Family: Apocyanaceae), Khurasani ajowan (Hyocyamus niger L.; Family: Solanaceae) seeds, Jatamansi (Nardostachys jatamansi DC. Family: Valerianaceae) roots and Pipplamul (root of Piper longum L.; Family: Piperaceae). The objective of this study was to make a comparative evaluation of Ghanvatis and tablets of this formulation. Two tablet formulations were prepared; one incorporating only powders of all ingredients; the other with ethanol extracts of the first three ingredients and powder of Piper longum root. Similarly, two types of Sarpagandha ghanvati pills were prepared; one as per Ayurvedic Formulary of India; the other with ethanol extracts of the first three ingredients and powder of Piper longum root. Alcohol extracted 0.22% w/w of total alkaloids as against 0.061% w/w extracted by water. Tablets prepared with powders of all the ingredients had friability more than 3.0% where as those prepared with ethanol extract had very low friability. Ghanvatis, prepared as per the Ayurvedic formulary, did not show reserpine although other alkaloids were present. They showed less content uniformity and lower drug release. Ethanol extracted reserpine along with other alkaloids. Ghanvatis made with the alcoholic extracts exhibited better content uniformity and drug release than the traditional formulation. Tablets prepared with powders or extracts of the ingredients exhibited good content uniformity but the release of alkaloids from the tablets of powders was only 80%. Tablets of the extracts had good content uniformity with 90% release of the total alkaloids. Tablets prepared with alcoholic extracts using 1% polyvinylpyrrolidone as binder and 5% dried starch powder as disintegrating agent confirmed to all the requirements. Thus, the study shows tablets made with the extracts are superior to Ghanvatis and powder tablets. PMID:26798180

Relative importance of attributes of drug benefit plans: Thai civil servants' perspective.

PubMed

Ngorsuraches, Surachat; Wanishayakorn, Tanatape; Tanvejsilp, Pimwara; Udomaksorn, Siripa

2013-01-01

The drug benefit plan of Thailand's Civil Servant Medical Benefit Scheme (CSMBS) must be amended to control increasing costs; to that end, it is important to gather the views of beneficiaries before making changes to the benefit plan. To examine the relative importance of attributes of drug benefit plans from the perspective of CSMBS beneficiaries. Attributes and levels adopted from focus group discussions and a preliminary survey were used to develop a questionnaire concerning hypothetical drug benefit plans. A convenience sample of 650 CSMBS beneficiaries in Songkhla province was asked to rate the drug benefit plans. To determine the beneficiaries' decision models, judgment analysis was used. Policy-capturing analysis was used to examine the beneficiaries' preferences, and cluster analysis was conducted to explore the variability among judgment plans. Judgment policy insight was also examined. The results of the study showed that the beneficiaries weighed on cost-sharing as their most important attribute. The results remained unchanged, although only data from the beneficiaries who used the compensatory model were analyzed. The results of the cluster analysis showed that the largest cluster of beneficiaries weighed mostly on the cost-sharing attribute. The judgment policy insight results not only supported the finding that most beneficiaries focused on the cost-sharing attribute but also revealed that they might have the least understanding of how the formulary attribute affected beneficiaries' decision making. Cost-sharing was the most important attribute for the CSMBS beneficiaries. This study indicated that a possible preferred drug benefit plan should have no cost-sharing, permit access only to drugs listed in a closed formulary, allow beneficiaries to obtain 3 months of drugs, and allow them to obtain drugs from either a community pharmacy or a government hospital. Copyright © 2013 Elsevier Inc. All rights reserved.

Barriers to treatment access for Chagas disease in Mexico.

PubMed

Manne, Jennifer M; Snively, Callae S; Ramsey, Janine M; Salgado, Marco Ocampo; Bärnighausen, Till; Reich, Michael R

2013-01-01

According to World Health Organization (WHO) prevalence estimates, 1.1 million people in Mexico are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease (CD). However, limited information is available about access to antitrypanosomal treatment. This study assesses the extent of access in Mexico, analyzes the barriers to access, and suggests strategies to overcome them. Semi-structured in-depth interviews were conducted with 18 key informants and policymakers at the national level in Mexico. Data on CD cases, relevant policy documents and interview data were analyzed using the Flagship Framework for Pharmaceutical Policy Reform policy interventions: regulation, financing, payment, organization, and persuasion. Data showed that 3,013 cases were registered nationally from 2007-2011, representing 0.41% of total expected cases based on Mexico's national prevalence estimate. In four of five years, new registered cases were below national targets by 11-36%. Of 1,329 cases registered nationally in 2010-2011, 834 received treatment, 120 were pending treatment as of January 2012, and the treatment status of 375 was unknown. The analysis revealed that the national program mainly coordinated donation of nifurtimox and that important obstacles to access include the exclusion of antitrypanosomal medicines from the national formulary (regulation), historical exclusion of CD from the social insurance package (organization), absence of national clinical guidelines (organization), and limited provider awareness (persuasion). Efforts to treat CD in Mexico indicate an increased commitment to addressing this disease. Access to treatment could be advanced by improving the importation process for antitrypanosomal medicines and adding them to the national formulary, increasing education for healthcare providers, and strengthening clinical guidelines. These recommendations have important implications for other countries in the region with similar problems in access to treatment for CD.

Evaluation of conformity of a first prescription of lipid-based formulation of amphotericin B in a university-teaching pediatric hospital.

PubMed

Agogué, Claire; Bussières, Jean-François; Dehaut, Catherine; Lebel, Denis; Brochet, Marie-Sophie

2006-04-01

Invasive fungal infections are an important cause of morbidity and mortality in immunodeficient children. Amphotericin B is an important therapeutic agent for the treatment of invasive fungal infections but is associated with significant toxicities and high acquisition costs. The purpose of this study was to evaluate physician adherence to a local guideline for the use of lipid-based amphotericin B. The study was approved through Pharmacology & Therapeutics (P&T) committee activities. A retrospective drug utilization review (DUR) was conducted. All orders written between January 1, 2003, and December 31, 2004, were reviewed. Demographic and descriptive clinical data were collected as well as variables related to the drug order process. Conformity rates were calculated for the primary objective criteria (authorized prescribers - infectious disease members; recommended drug of choice-Abelcet; accepted indications; and presence of underlying conditions). A total of 109 orders for 70 patients were reviewed by a single research assistant for a 2-year period. Global conformity rate for all four criteria was calculated at 7.3%. Non-conformity was mostly associated with the absence of underlying conditions (e.g., prerenal insufficiency or presence of nephrotoxicity due to amphotericin B desoxycholate) in 84.5% of the cases. Infusionrelated adverse drug reactions partly explained a switch to a non-formulary lipid-based amphotericin B product. External factors (newly published results since the adoption of the guideline and continuous marketing practices) and internal factors (availability of non-formulary process, inefficient DUR process) could have contributed to non-adherence to a local guideline. This study shows low adherence to P&T committee drug guidelines on lipid-based amphotericin B. Continuous and efficient DUR processes should be in place to monitor drug guideline adherence.

Drug rationing in the UK National Health Service. Current status and future prospects.

PubMed

Walley, T; Haycox, A; Barton, S

1997-09-01

There are major problems in attempting to ration drug use in the UK. These include the large indigenous pharmaceutical industry, the nature of funding of drugs within the National Health Service (NHS) and the political sensitivities of rationing. Rationing of services within the NHS has therefore usually been implicit rather than explicit, and there is little public debate about rationing of health services. In relation to drug therapy, prescribing in primary care technically can only be rationed by encouraging the general practitioner (GP) to contain his or her own costs-effectively moving the difficult decision to the GP. Direct incentives to the GP, in the form of incentive payments or by fundholding seem to have some success in containing costs, largely by simple generic substitution. There are established systems in hospitals to control the costs of drugs, including formularies and drug management committees. Hospitals commonly try to transfer drug costs to the GP budget. While in part this is clinically appropriate, it can lead to tensions. Health authorities and GP fundholders now include prescribing, particularly at this interface, in their contracts with hospitals. Economic evaluations currently play little part in aiding decisions about choice of drug. These decisions tend to be dominated by the need for short term cost containment in the UK. Recent reforms of the NHS have moved responsibility for the rationing of services to the local authorities or purchasers; this might in time create an additional, local hurdle for pharmaceutical companies trying to market new drugs. A proposal to introduce a national limited formulary in which drugs will be selected partly on the basis of an economic evaluation seems impractical, although similar ideas might be further developed.

Effect of therapeutic interchange on medication reconciliation during hospitalization and upon discharge in a geriatric population

PubMed Central

Wang, Jessica S.; Fogerty, Robert L.

2017-01-01

Background Therapeutic interchange of a same class medication for an outpatient medication is a widespread practice during hospitalization in response to limited hospital formularies. However, therapeutic interchange may increase risk of medication errors. The objective was to characterize the prevalence and safety of therapeutic interchange. Methods and findings Secondary analysis of a transitions of care study. We included patients over age 64 admitted to a tertiary care hospital between 2009–2010 with heart failure, pneumonia, or acute coronary syndrome who were taking a medication in any of six commonly-interchanged classes on admission: proton pump inhibitors (PPIs), histamine H2-receptor antagonists (H2 blockers), hydroxymethylglutaryl CoA reductase inhibitors (statins), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and inhaled corticosteroids (ICS). There was limited electronic medication reconciliation support available. Main measures were presence and accuracy of therapeutic interchange during hospitalization, and rate of medication reconciliation errors on discharge. We examined charts of 303 patients taking 555 medications at time of admission in the six medication classes of interest. A total of 244 (44.0%) of medications were therapeutically interchanged to an approved formulary drug at admission, affecting 64% of the study patients. Among the therapeutically interchanged drugs, we identified 78 (32.0%) suspected medication conversion errors. The discharge medication reconciliation error rate was 11.5% among the 244 therapeutically interchanged medications, compared with 4.2% among the 311 unchanged medications (relative risk [RR] 2.75, 95% confidence interval [CI] 1.45–5.19). Conclusions Therapeutic interchange was prevalent among hospitalized patients in this study and elevates the risk for potential medication errors during and after hospitalization. Improved electronic systems for managing therapeutic interchange and medication reconciliation may be valuable. PMID:29049325

Worldwide analysis of factors associated with medicines compendia publishing.

PubMed

Arguello, Blanca; Fernandez-Llimos, Fernando

2013-06-01

Medicines compendia, also called formularies, are the most commonly used drug information source among health care professionals. The aim was to identify the countries publishing medicines compendia and the socio-demographic factors associated to this fact. Additionally, we sought to determine the use of foreign compendia in countries lacking their own. Global web-based survey. Healthcare practitioners and researchers from 193 countries worldwide were invited to complete a web-based survey. The questionnaire investigated the existence of a national compendium, or the use of foreign compendia in the absence of one. Demographic and socioeconomic variables were used to predict compendia publishing through a multivariate analysis. Existence of national medicines compendia and foreign compendia used. Professionals from 132 countries completed the survey (response rate at a country level 68.4%, comprising 90.9% global population). Eighty-four countries (63.6%) reported publishing a medicines compendium. In the multivariate analysis, only two covariates had significant association with compendia publishing. Being a member of the Organisation for the Economic Cooperation and Development was the only variable positively associated with compendia publishing (OR = 37.5; 95% CI = 2.3:599.8). In contrast, the countries that listed French as an official language were less likely to publish a compendium (OR = 0.07; 95% CI = 0.007:0.585). Countries without national compendia reported using the British National Formulary most commonly, followed by the Dictionnaire Vidal. Publication of medicines compendia is associated with socio-economic development. Countries lacking a national compendium, use foreign compendia from higher-income countries. Creating an international medicines compendium under the leadership of the World Health Organisation, rather than merely a 'model', would reduce the risks of using information sources not-adapted to the necessities of developing countries.

Comparison of Drug Benefits Provided by Veterans Affairs Canada and the Canadian Forces Health Services Group.

PubMed

Chow, Matthew; Wicks, Charles J; Ma, Janice; Grenier, Sylvain

2017-05-23

Drug benefits are provided at public expense to all actively serving Canadian Armed Forces (CAF) personnel, with ongoing drug coverage offered by Veterans Affairs Canada (VAC) for selected conditions following termination of employment. Differences in drug coverage between these programs could introduce risks for treatment disruption. Work was undertaken to establish a process that would allow systematic comparison of the entire VAC and CAF formularies, and to identify and explain discordant listings in 14 therapeutic categories that pose risk of adverse outcomes with sudden treatment interruption. Lists of medications were created for each program, including regular benefit and restricted use drugs, using files obtained from the claims processor in January 2015. Products were coded using the Anatomic-Therapeutic-Chemical (ATC) system. Degree of alignment within therapeutic categories was assessed based on the percentage of fifth-level ATCs that were covered in common. Discordantly listed drugs in 14 categories of concern were reviewed to identify similarities in product characteristics. A total of 1124 medications were identified in 80 therapeutic categories. Coverage of medications was identical in 11 categories, and overall, almost three-quarters of identified drugs (73.4%, n = 825) were covered in common by both plans. Many discordant listings reflected known differences in the programs' operating procedures. A number of discrepancies were also identified in newer therapeutic categories. There is significant overlap in the medications covered by the CAF and VAC drug benefit programs. Application of the ATC coding system allowed for discrepancies to be readily identified across the entire formulary, and in specific therapeutic categories of concern. © 2017 Journal of Population Therapeutics and Clinical Pharmacology. All rights reserved.

Budget Impact Analysis of Prolonged Half-Life Recombinant FVIII Therapy for Hemophilia in the United States.

PubMed

McMullen, Suzanne; Buckley, Brieana; Hall, Eric; Kendter, Jon; Johnston, Karissa

2017-01-01

Hemophilia A is a factor VIII deficiency, associated with spontaneous, recurrent bleeding episodes. This may lead to comorbidities such as arthropathy and joint replacement, which contribute to morbidity and increased health care expenditure. Recombinant factor VIII Fc fusion protein (rFVIIIFc), a prolonged half-life factor therapy, requires fewer infusions, resulting in reduced treatment burden. Use a budget impact analysis to assess the potential economic impact of introducing rFVIIIFc to a formulary from the perspective of a private payer in the United States. The budget impact model was developed to estimate the potential economic impact of adding rFVIIIFc to a private payer formulary across a 2-year time period. The eligible patient population consisted of inhibitor-free adults with severe hemophilia A, receiving recombinant-based episodic or prophylaxis treatment regimens. Patients were assumed to switch from conventional recombinant factor treatment to rFVIIIFc. Only medication costs were included in the model. The introduction of rFVIIIFc is estimated to have a budget impact of 1.4% ($0.12 per member per month) across 2 years for a private payer population of 1,000,000 (estimated 19.7 individuals receiving treatment for hemophilia A). The introduction of rFVIIIFc is estimated to prevent 124 bleeds across 2 years at a cost of $1891 per bleed avoided. Hemophilia A is a rare disease with a low prevalence; therefore, the overall cost to society of introducing rFVIIIFc is small. Considerations for comprehensively assessing the budget impact of introducing rFVIIIFc should include episodic and prophylaxis regimens, bleed avoidance, and annual factor consumption required under alternative scenarios. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Impact of a Value-Based Formulary on Medication Utilization, Health Services Utilization, and Expenditures

PubMed Central

Yeung, Kai; Basu, Anirban; Hansen, Ryan N.; Watkins, John B.; Sullivan, Sean D.

2016-01-01

Background Value-based benefit design has been suggested as an effective approach to managing the high cost of pharmaceuticals in health insurance markets. Premera Blue Cross, a large regional health plan, implemented a Value-Based Formulary (VBF) for pharmaceuticals in 2010 that explicitly used cost-effectiveness analysis (CEA) to inform medication copayments. Objective To determine the impact of the VBF. Design Interrupted time-series of employer-sponsored plans from 2006 to 2013. Subjects Intervention group: 5,235 beneficiaries exposed to the VBF. Control group: 11,171 beneficiaries in plans without any changes in pharmacy benefits. Intervention The VBF assigned medications with lower value (estimated by CEA) to higher copayment tiers and assigned medications with higher value to lower copayment tiers. Measures Primary outcome was medication expenditures from member, health plan, and member plus health plan perspectives. Secondary outcomes were medication utilization, emergency department visits, hospitalizations, office visits, and non-medication expenditures. Results In the intervention group after VBF implementation, member medication expenditures increased by $2 per member per month (PMPM) (95% CI, $1 to $3) or 9%, while health plan medication expenditures decreased by $10 PMPM (CI, $18 to $2) or 16%, resulting in a net decrease of $8 PMPM (CI, $15 to $2) or 10%, which translates to a net savings of $1.1 million. Utilization of medications moved into lower copayment tiers increased by 1.95 days’ supply (CI, 1.29 to 2.62) or 17%. Total medication utilization, health services utilization and non-medication expenditures did not change. Conclusions Cost-sharing informed by CEA reduced overall medication expenditures without negatively impacting medication utilization, health services utilization or non-medication expenditures. PMID:27579915

Use of benchmarking techniques to justify the evolution of antibiotic management programs in healthcare systems.

PubMed

Schentag, J J; Paladino, J A; Birmingham, M C; Zimmer, G; Carr, J R; Hanson, S C

1995-01-01

To apply basic benchmarking techniques to hospital antibiotic expenditures and clinical pharmacy personnel and their duties, to identify cost savings strategies for clinical pharmacy services. Prospective survey of 18 hospitals ranging in size from 201 to 942 beds. Each was asked to provide antibiotic expenditures, an overview of their clinical pharmacy services, and to describe the duties of clinical pharmacists involved in antibiotic management activities. Specific information was sought on the use of pharmacokinetic dosing services, antibiotic streamlining, and oral switch in each of the hospitals. Most smaller hospitals (< 300 beds) did not employ clinical pharmacists with the specific duties of antibiotic management or streamlining. At these institutions, antibiotic management services consisted of formulary enforcement and aminoglycoside and/or vancomycin dosing services. The larger hospitals we surveyed employed clinical pharmacists designated as antibiotic management specialists, but their usual activities were aminoglycoside and/or vancomycin dosing services and formulary enforcement. In virtually all hospitals, the yearly expenses for antibiotics exceeded those of Millard Fillmore Hospitals by $2,000-3,000 per occupied bed. In a 500-bed hospital, this difference in expenditures would exceed $1.5 million yearly. Millard Fillmore Health System has similar types of patients, but employs clinical pharmacists to perform streamlining and/or switch functions at days 2-4, when cultures come back from the laboratory. The antibiotic streamlining and oral switch duties of clinical pharmacy specialists are associated with the majority of cost savings in hospital antibiotic management programs. The savings are considerable to the extent that most hospitals with 200-300 beds could readily cost-justify a full-time clinical pharmacist to perform these activities on a daily basis. Expenses of the program would be offset entirely by the reduction in the actual pharmacy expenditures on antibiotics.

Barriers to Treatment Access for Chagas Disease in Mexico

PubMed Central

Manne, Jennifer M.; Snively, Callae S.; Ramsey, Janine M.; Salgado, Marco Ocampo; Bärnighausen, Till; Reich, Michael R.

2013-01-01

Background According to World Health Organization (WHO) prevalence estimates, 1.1 million people in Mexico are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease (CD). However, limited information is available about access to antitrypanosomal treatment. This study assesses the extent of access in Mexico, analyzes the barriers to access, and suggests strategies to overcome them. Methods and Findings Semi-structured in-depth interviews were conducted with 18 key informants and policymakers at the national level in Mexico. Data on CD cases, relevant policy documents and interview data were analyzed using the Flagship Framework for Pharmaceutical Policy Reform policy interventions: regulation, financing, payment, organization, and persuasion. Data showed that 3,013 cases were registered nationally from 2007–2011, representing 0.41% of total expected cases based on Mexico's national prevalence estimate. In four of five years, new registered cases were below national targets by 11–36%. Of 1,329 cases registered nationally in 2010–2011, 834 received treatment, 120 were pending treatment as of January 2012, and the treatment status of 375 was unknown. The analysis revealed that the national program mainly coordinated donation of nifurtimox and that important obstacles to access include the exclusion of antitrypanosomal medicines from the national formulary (regulation), historical exclusion of CD from the social insurance package (organization), absence of national clinical guidelines (organization), and limited provider awareness (persuasion). Conclusions Efforts to treat CD in Mexico indicate an increased commitment to addressing this disease. Access to treatment could be advanced by improving the importation process for antitrypanosomal medicines and adding them to the national formulary, increasing education for healthcare providers, and strengthening clinical guidelines. These recommendations have important implications for other countries in the region with similar problems in access to treatment for CD. PMID:24147169

Managing biotechnology in a network-model health plan: a U.S. private payer perspective.

PubMed

Watkins, John B; Choudhury, Sanchita Roy; Wong, Ed; Sullivan, Sean D

2006-01-01

Emerging biotechnology poses challenges to payers, including access, coverage, reimbursement, patient selection, and affordability. Premera Blue Cross, a private regional health plan, developed an integrated cross-functional approach to managing biologics, built around a robust formulary process that is fast, flexible, fair, and transparent to stakeholders. Results are monitored by cost and use reporting from merged pharmacy and medical claims. Utilization management and case management strategies will integrate with specialty pharmacy programs to improve outcomes and cost-effectiveness. Creative approaches to provider reimbursement can align providers' incentives with those of the plan. Redesign of member benefits can also encourage appropriate use of biotechnology.

Moisturizing alcohol hand gels for surgical hand preparation.

PubMed

Jones, R D; Jampani, H; Mulberry, G; Rizer, R L

2000-03-01

With the use of novel formulary technology, unique moisturizing hand gels have been developed that offer significant advantages in perioperative and other health care settings. These advantages include the time-saving capabilities of a waterless formulation, the persistence and effectiveness of a surgical scrub, and the moisturization and protective properties of a lotion. Extensive laboratory and clinical studies, involving in vivo antimicrobial activity against resident and transient flora, skin moisturization on normal and dry skin, and compatibility with latex gloves, have supported these advantages. Nondrying alcohol hand gels can be used for antiseptic hand washing, hand scrubs between procedures (i.e., reentry scrubs), brushless surgical scrubs, moisturizers, and glove-donning aids.

Surfactant replacement therapy: development of criteria for appropriate use. Ohio State University Hospitals.

PubMed

Gardner, D K

1992-08-01

At The Ohio State University (OSU) Hospitals, DUE criteria were established when colfosceril palmitate, a synthetic surfactant, was added to the formulary in January 1991. The DUE criteria were designed to assure appropriate drug use, educate physicians, and establish an effective way to monitor drug use and patient outcome (ie, response rate and complications). The criteria include a mechanism for evaluation and modification of the guidelines, as necessary. In addition, a review process will be used to determine the therapy's cost effectiveness and to serve as a guideline for making recommendations on other surfactant formulations as they become available.

NRL Plasma Formulary

DTIC Science & Technology

2006-01-01

1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law , no...Description SI Gaussian Faraday’s law ∇ × E = −∂B ∂t ∇ × E = − 1 c ∂B ∂t Ampere’s law ∇ × H = ∂D ∂t + J ∇ × H = 1 c ∂D ∂t + 4π c J Poisson equation ∇ · D = ρ...gravitational or V/NL buoyancy force)1/2 Gay– Lussac Ga 1/β∆T Inverse of relative change in volume during heating Grashof Gr gL3β∆T/ν2 Buoyancy force/viscous

NRL (Naval Research Laboratory) Plasma Formulary. Revised.

DTIC Science & Technology

1983-01-01

EQUATIONS Name Rationalized inks Gaussian Faday’s law V xE -- !-s VxE--l1p .aD -l3D 4i" Ampere’slta xH-VxH -- +J VxH -- .- +- J at C at C Poison’s eqution...energy density Froude Fr t V (gL ) 1/2 (Inertial forces/gravitational or VINL buoyancy forces) t/2 Gay- Lussac Ga I/PA T (Relative volume change...112 Alfvin speed a Newton’s- law heat coefficient, k x " aA T aix Volumetric expansion coefficient, dV/ V - )dT r Bulk modulus (units m/it 2 ) AR, A

NRL Plasma Formulary. Revision

DTIC Science & Technology

1990-01-01

Description SI Gaussian 9B 1l0B Faraday’s law V x E -- V x E =-- at c Ot c9D 10D 4wr Ampere’s law V x H + J V x H =- + -J at c Ot c Poisson equation V - D = p...Froude Fr V/(g L) 1/ 2 t(Inertial force/gravitational or V/NL buoyancy force) 1 /2 Gay- Lussac Ga 1/fOAT Inverse of relative change in volume during... law heat coefficient, k = crAT0ax Volumetric expansion coefficient, dV/V = )3dT Bulk modulus (units kg m 1 s - 2) 6R, AV, Ap, AT Imposed difference in

Can we influence prescribing patterns?

PubMed

Sbarbaro, J A

2001-09-15

A variety of programming techniques and methods of training have been employed to change physician behavior. Didactic continuing medical education lectures and clinical guidelines have had minimal impact, although endorsement of national professional guidelines by local opinion leaders appears to have a positive influence on the impact of professional guidelines. Interactive, hands-on workshops, performance reporting, and peer/patient feedback are also effective. Changing prescribing habits has been equally difficult. Drug utilization letters involving both pharmacist and physician have more impact than do letters sent only to the physician. Academic detailing, when properly executed, has been consistently effective. When combined with these strategies, closed formularies become a powerful tool in changing prescribing behavior.

Borates

USGS Publications Warehouse

Crangle, R.D.

2013-01-01

Four minerals represent 90 percent of the borates used by industry worldwide — the sodium borates (tincal and kernite), calcium borate (colemanite) and the sodium-calcium borate (ulexite). Borax is a white crystalline substance, chemically known as sodium tetraborate decahydrate, and is found naturally as the mineral tincal. Boric acid is a colorless crystalline solid sold in technical, national formulary and special quality grades as granules or powder and marketed most often as anhydrous boric acid. Deposits of borates are associated with volcanic activity and arid climates, with the largest economically viable deposits located in the Mojave Desert of the United States near Boron, CA, the Alpide belt in southern Asia and the Andean belt of South America.

A review of medical-grade honey in wound care.

PubMed

Belcher, Judy

In the current healthcare environment, clinicians are increasingly under pressure to use wound care products that are cost effective. This includes products that can be used in a variety of wounds to achieve different outcomes, depending on the wound-bed requirements. Medical-grade honey has emerged as a product that can achieve a variety of outcomes within the wound and is safe and easy to use. This article reviews the use of a medical-grade honey, with a view to including it on the wound care formulary in both primary and secondary care. It featured in a poster presentation at the Wounds UK conference at Harrogate in 2011.

The Effect of Florida Medicaid's State-Mandated Formulary Provision on Prescription Drug Use and Health Plan Costs in a Medicaid Managed Care Plan.

PubMed

Munshi, Kiraat D; Mager, Douglas; Ward, Krista M; Mischel, Brian; Henderson, Rochelle R

2018-02-01

Formulary or preferred drug list (PDL) management is an effective strategy to ensure clinically efficient prescription drug management by managed care organizations (MCOs). Medicaid MCOs participating in Florida's Medicaid program were required to use a state-mandated PDL between May and August 2014. To examine differences in prescription drug use and plan costs between a single Florida Medicaid managed care (MMC) health plan that implemented a state-mandated PDL policy on July 1, 2014, and a comparable MMC health plan in another state without a state-mandated PDL, controlling for sociodemographic confounders. A retrospective analysis with a pre-post design was conducted using deidentified administrative claims data from a large pharmacy benefit manager. The prepolicy evaluation period was January 1 through June 30, 2014, and the postpolicy period was January 1 through June 30, 2015. Continuously eligible Florida MMC plan members were matched on sociodemographic and health characteristics to their counterparts enrolled in a comparable MMC health plan in another state without a state-mandated formulary. Outcomes were drug use, measured as the number of 30-day adjusted nonspecialty drug prescriptions per member per period, and total drug plan costs per member per period for all drugs, with separate measures for generic and brand drugs. Bivariate comparisons were conducted using t-tests. Employing a difference-in-differences (DID) analytic approach, multivariate negative binomial regression and generalized estimating equation models were used to analyze prescription drug use and costs. The final analytical sample consisted of 18,372 enrollees, evenly divided between the 2 groups. In the postpolicy evaluation period, overall and generic use declined, while brand use increased for members in the Florida health plan. Drug costs, especially for brands, significantly increased for Florida health plan members. No significant changes were observed over the same time period in the control health plan members. DID analyses indicated that the decline in overall drug use was 6% lower (P = 0.020), and the increase in plan costs was 27% higher (P = 0.002) among Florida health plan members compared with control group members. Members in a Florida Medicaid health plan with a state-mandated PDL saw declines in overall and generic drug use and an increase in drug plan costs. States considering a state-mandated PDL should take into account potential effects of decreased generic drug use and increases in prescription drug plan costs. Funding for this study was provided internally by Express Scripts Holding Company. The authors and acknowledged contributors are employees of Express Scripts Holding Company. All authors contributed to the study concept, and study design was provided by Munshi, Mager, and Henderson. Munshi and Mager collected the data, and Munshi provided the statistical analysis. Data interpretation was performed by Munshi, Mager, and Henderson. The manuscript was written by Munshi, Henderson, and Mager and revised by Munshi, Ward, Mischel, and Henderson.

Low void content autoclave molded titanium alloy and polyimide graphite composite structures.

NASA Technical Reports Server (NTRS)

Vaughan, R. W.; Jones, R. J.; Creedon, J. F.

1972-01-01

This paper discusses a resin developed for use in autoclave molding of polyimide graphite composite stiffened, titanium alloy structures. Both primary and secondary bonded structures were evaluated that were produced by autoclave processing. Details of composite processing, adhesive formulary, and bonding processes are provided in this paper, together with mechanical property data for structures. These data include -65 F, room temperature, and 600 F shear strengths; strength retention after aging; and stress rupture properties at 600 F under various stress levels for up to 1000 hours duration. Typically, shear strengths in excess of 16 ksi at room temperature with over 60% strength retention at 600 F were obtained with titanium alloy substrates.

[New thoughts on the hypothesis of the origin of the balm of Commander of Pernes: it originated from the balm of Jerusalem].

PubMed

Labrude, Pierre

2006-06-01

The Baume du commandeur appears in France in 1694 in the Histoire générale des drogues... written by Pomet. It is a drug for healing wounds which also has numerous internal uses. Still present in formularies and occasionally used, its invention is attributed to Gaspard de Pernes, commander of the Order of Malta in Toul, in France, at this period. However, some observations have induced me to think that the drug originated in the Ottoman Empire at the end of the XVIlth century, and was derived from the Jerusalem Balsam of the Franciscans of St. Savior Monastery's pharmacy, in Jerusalem.

Bid purchasing of pharmaceuticals.

PubMed

Swift, R G; Ryan, M R

1978-11-01

The effects of bid purchasing of drug products by hospitals and the factors to consider in bid purchasing of pharmaceuticals are reviewed; further, the prices available with bid purchasing to a specific hospital in 1974 and 1977 are presented. Factors important for a successful bid purchasing system of pharmaceuticals are: (1) use of a formulary policy, (2) an effective procedure for handling bid purchasing and (3) criteria for evaluation of drug products. Significant differences were found between prices available with and without bid purchasing for 50 nonproprietary drug products in 1974 and for 19 products in 1977. Although monetary savings to hospitals do exist with bid purchasing of pharmaceuticals, the degree of savings is dependent upon the drug usage for that hospital.

Pharmacoeconomic evaluations of antifungal therapies.

PubMed

Hennen, Cynthia R

2009-07-01

Invasive fungal infections are a growing source of morbidity and mortality in the United States and are associated with excess hospital stay and costs. Although clinicians now have more effective and safe treatment options for invasive candidiasis, evidence confirming the pharmacoeconomic benefits of newer treatment options such as the echinocandins is scarce as few rigorous pharmacoeconomic studies have been completed in the arena of invasive fungal infections. Beyond the cost of drug acquisition, costs associated with ineffective treatment and significant drug-related side-effects must be factored into pharmacoeconomic analysis. Additional administrative costs may need to be considered when a formulary medication switch is undertaken, including those involved with re-education of clinicians unfamiliar with the newer product.

Antineoplastic agents: comparing off-label uses among authoritative drug compendia.

PubMed

Thompson, D F; Keefe, C C

1993-07-01

Unlabeled indications for antineoplastic drugs listed in the American Hospital Formulary-Drug Information, United States Pharmacopeia Dispensing Information-Drug Information for the Health Care Professional (Volume 1), and the American Medical Association-Drug Evaluations were evaluated. Specifically, the total number of unlabeled and unique uses (ie, not listed in either of the other two compendia) of 35 antineoplastic drugs were compared. Using a nonparametric analysis of variance to evaluate the results, significant differences in both the average unlabeled indications per drug and unique unlabeled indications per drug were found among the resources checked. The implications of the study results on reimbursement by private insurance carriers of unlabeled antineoplastic drug use is discussed in this article.

Coverage and prior authorization of psychotropic drugs under Medicare Part D.

PubMed

Huskamp, Haiden A; Stevenson, David G; Donohue, Julie M; Newhouse, Joseph P; Keating, Nancy L

2007-03-01

This study examined formulary coverage and use of utilization management tools for three classes of psychotropic medications (antidepressants, antipsychotics, and anticonvulsants) among Medicare Part D prescription drug plans serving individuals dually eligible for the Medicare and Medicaid programs. Plans must cover "all or substantially all" molecules (distinct drugs) in these classes. Plans serving "dual eligibles" generally covered at least one formulation of all molecules in the three classes. However, certain product formulations were not covered by a number of plans, and use of prior authorization was common for a minority of plans. The effect of Part D will depend on the restrictiveness of the prior authorization and appeals processes, which is currently unknown.

NRL (Naval Research Laboratory) Plasma Formulary. Revised.

DTIC Science & Technology

1987-01-01

ac)- 1 Resistance 4 7r o /Ar (Co//1o ) 1/2 Time 1 c Velocity Ck c- 18 MAXWELL’S EQUATIONS Name or Description SI f Gaussian OB 1lOB Faraday’s law V...x E -- V x E =- D t c Ot OD 1OD 4 -r Ampere’s law V x H = 6 +J x H = -+-J t c Ot c Poisson equation V • D = p V • D = 41rp [Absence of magnetic V...force/gravitational or V/NL buoyancy force) 1/ 2 Gay- Lussac Ga 1/1AT Inverse of relative change in volume during heating Grashof Gr gL S AT/ v

NRL Plasma Formulary

DTIC Science & Technology

2007-01-01

1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law , no...β/α3 (h̄c)−1 Resistance 4πǫ0/α (ǫ0/µ0) 1/2 Time 1 c Velocity α c−1 18 MAXWELL’S EQUATIONS Name or Description SI Gaussian Faraday’s law ∇ × E = −∂B...t ∇ × E = − 1 c ∂B ∂t Ampere’s law ∇ × H = ∂D ∂t + J ∇ × H = 1 c ∂D ∂t + 4π c J Poisson equation ∇ · D = ρ ∇ · D = 4πρ [Absence of magnetic ∇ · B = 0

NRL: Plasma Formulary

DTIC Science & Technology

2004-12-01

Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law , no person...Pressure β/α3 (h̄c)−1 Resistance 4π0/α (0/µ0) 1/2 Time 1 c Velocity α c−1 19 MAXWELL’S EQUATIONS Name or Description SI Gaussian Faraday’s law ∇ × E = −∂B...t ∇ × E = − 1 c ∂B ∂t Ampere’s law ∇ × H = ∂D ∂t + J ∇ × H = 1 c ∂D ∂t + 4π c J Poisson equation ∇ · D = ρ ∇ · D = 4πρ [Absence of magnetic ∇ · B = 0

Design, implementation, and first-year outcomes of a value-based drug formulary.

PubMed

Sullivan, Sean D; Yeung, Kai; Vogeler, Carol; Ramsey, Scott D; Wong, Edward; Murphy, Chad O; Danielson, Dan; Veenstra, David L; Garrison, Louis P; Burke, Wylie; Watkins, John B

2015-04-01

Value-based insurance design attempts to align drug copayment tier with value rather than cost. Previous implementations of value-based insurance design have lowered copayments for drugs indicated for select "high value" conditions and have found modest improvements in medication adherence. However, these implementations have generally not resulted in cost savings to the health plan, suggesting a need for increased copayments for "low value" drugs. Further, previous implementations have assigned equal copayment reductions to all drugs within a therapeutic area without assessing the value of individual drugs. Aligning the individual drug's copayment to its specific value may yield greater clinical and economic benefits. In 2010, Premera Blue Cross, a large not-for-profit health plan in the Pacific Northwest, implemented a value-based drug formulary (VBF) that explicitly uses cost-effectiveness analyses after safety and efficacy reviews to estimate the value of each individual drug. Concurrently, Premera increased copayments for existing tiers. To describe and evaluate the design, implementation, and first-year outcomes of the VBF. We compared observed pharmacy cost per member per month in the year following the VBF implementation with 2 comparator groups: (1) observed pharmacy costs in the year prior to implementation, and (2) expected costs if no changes were made to the pharmacy benefits. Expected costs were generated by applying autoregressive integrated moving averages to pharmacy costs over the previous 36 months. We used an interrupted time series analysis to assess drug use and adherence among individuals with diabetes, hypertension, or dyslipidemia compared with a group of members in plans that did not implement a VBF.  Pharmacy costs decreased by 3% compared with the 12 months prior and 11% compared with expected costs. There was no significant decline in medication use or adherence to treatments for patients with diabetes, hypertension, or dyslipidemia. The VBF and copayment changes enabled pharmacy plan cost savings without negatively affecting utilization in key disease states.

Drugs dispensed at the Division of Neonatology at University Hospital in Río Cuarto, Córdoba, Argentina.

PubMed

Fungo, Marta Stella Maris; Vega, Elena María

2013-04-01

The objective was to analyze the number of drugs dispensed by the Pharmacy Department to the Neonatology Division, to find out if the use of these drugs is described on the package insert approved by the Administración Nacional de Medicamentos, Alimentos y Tecnología, ANMAT (Drug, Food and Technology Administration of Argentina) and to compare such information with that provided by Medical Associations and Commissions. Analytical, observational and retrospective study in which drugs were analyzed based on dosage units, costs and relevance in the 2011 annual budget. We analyzed the information found in ANMAT-approved label inserts, in the Neonatal Pharmacopeia of the Sociedad Argentina de Pediatría and in the Formularies of the Confederación Médica Argentina and the Comisión Nacional del Medicamento (National Medication Commission). A total of 102 drugs (91 drug substances) were dispensed throughout 2011. Drugs most commonly supplied were: antiinfective agents for systemic use (24.51%), agents for the blood and blood forming organs, cardiovascular system, and nervous system (12.72% each). The total expenditure was ARS 263,285.52. Only 21 drugs accounted for 90.73% of the cost. Out of the 14 drugs in this group, only 1 had information related to its use in neonatology in all its labels (package inserts), only 4 in some of their product information and there was no information at all in any of the remaining 9 drugs. The Neonatal Pharmacopeia reported on 12 of the 14 drugs, while the Formularies made a reference to 9 of the 14 drugs. The most widely used drugs were antiinfectives for systemic use. A total of 21 drugs accounted for 90.73% of the annual cost in drugs. Out of 14, only 1 had information of its use in neonatology in all its labels and 9 corresponded to off-label use.

ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe.

PubMed

Cherny, N; Sullivan, R; Torode, J; Saar, M; Eniu, A

2016-08-01

The management of cancer is predicated on the availability and affordability of anticancer therapies, which may be either curative or noncurative. The primary aims of the study were to evaluate (i) the formulary availability of licensed antineoplastic medicines across Europe; (ii) patient out-of-pocket costs for the medications and (iii) the actual availability of the medication for a patient with a valid prescription. The survey tool was based on the previous ESMO studies that addressed the availability and accessibility of opioids for the management of cancer pain. A total of 185 field reporters from 49 countries were invited to participate. The preliminary set of data was posted on the ESMO website for open peer-review, and amendments have been incorporated into the final report. There are substantial differences in the formulary availability, out-of-pocket costs and actual availability for many anticancer medicines. The most profound lack of availability is in countries with lower levels of economic development, particularly in Eastern Europe, and these are largely related to the cost of targeted agents approved in the last 10 years. Discrepancies are less profound among medications on the WHO model essential medicines list (EML) for cancer and in curative settings. However, medicine shortages also affect WHO EML medicines, with relevant therapeutic implications for many patients. The cost and affordability of anticancer treatments with recent market approval is the major factor contributing to inequity of access to anticancer medications. This is especially true with regards to new medications used in the management of EGFR- or ALK-mutated non-small-cell lung cancer, metastatic melanoma, metastatic renal cell cancer, RAS/RAF wild-type metastatic colorectal cancer, HER2 overexpressed breast cancer and castration-resistant metastatic prostate cancer. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Impact of ACA on the Dinner-for-Three Dynamic.

PubMed

Schoonveld, Ed; Coyle, Bill; Markham, Jennifer

2015-04-01

The Patient Protection and Affordable Care Act (ACA) aims to expand coverage to the previously uninsured, improve the quality of coverage, and help eliminate inefficiencies in the health care market. We evaluated the implications of ACA on the drug industry by examining the impact on the "Dinner-for-Three" dynamic in our health care system. We can think of our system as an odd dinner party in which one person pays (the insurer), one orders the meal (the physician), and yet another eats the meal (the patient). This dynamic requires us to examine each stakeholder and how they interact with one another to assess the impact of the ACA. Of the 6.7 million initial exchange enrollees, ~3.8 million subjects were previously uninsured. A higher percentage of these enrollees are using their pharmacy benefit, and they are disproportionately filling prescriptions for specialty drugs relative to those covered in employer-sponsored plans. Formulary designs in exchange plans are passing on higher cost-sharing for prescription drugs to the patient. ACA has also resulted in the development of accountable care organizations (ACOs); these organizations may play a role going forward in the management of drug spending and the development of formularies and protocols that impact drug prescribing. Payers are tightening control over drug spending and are finding physicians and physician groups increasingly less reluctant allies in doing so. Patients are faced by more complexity than ever in the health care system and are expected to take a more active role in responsibly managing the cost of their care. It is increasingly critical that drug manufacturers develop robust value propositions and communicate that value to all stakeholders. They should re-evaluate trial investment decisions and consider changes in price setting, rebates (how much and to whom), copay programs, and physician and patient support programs in light of changing market needs. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Prescription channeling of COX-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs: a population-based case-control study.

PubMed

Moride, Yola; Ducruet, Thierry; Boivin, Jean-François; Moore, Nicholas; Perreault, Sylvie; Zhao, Sean

2005-01-01

This pharmacoepidemiologic study was conducted to determine whether risk factors for upper gastrointestinal bleeding influenced the prescription of cyclo-oxygenase (COX)-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) at the time when COX-2 inhibitors were first included in the formulary of reimbursed medications. A population-based case-control study was conducted in which the prevalence of risk factors and the medical histories of patients prescribed COX-2 inhibitors and traditional nonselective NSAIDs were compared. The study population consisted of a random sample of members of the Quebec drug plan (age 18 years or older) who received at least one dispensation of celecoxib (n = 42,422; cases), rofecoxib (n = 25,674; cases), or traditional nonselective NSAIDs (n = 12,418; controls) during the year 2000. All study data were obtained from the Quebec health care databases. Adjusting for income level, Chronic Disease Score, prior use of low-dose acetylsalicylic acid, acetaminophen, antidepressants, benzodiazepines, prescriber specialty, and time period, the following factors were significantly associated with the prescription of COX-2 inhibitors: age 75 years or older (odds ratio [OR] 4.22, 95% confidence interval [CI] 3.95-4.51), age 55-74 years (OR 3.23, 95% CI 3.06-3.40), female sex (OR 1.52, 95% CI 1.45-1.58), prior diagnosis of gastropathy (OR 1.21, 95% CI 1.08-1.36) and prior dispensation of gastroprotective agents (OR 1.57, 95% CI 1.47-1.67). Patients who received a traditional nonselective NSAID recently were more likely to switch to a coxib, especially first-time users (OR 2.17, 95% CI 1.93-2.43). Associations were significantly greater for celecoxib than rofecoxib for age, chronic NSAID use, and last NSAID use between 1 and 3 months before the index date. At the time of introduction of COX-2 inhibitors into the formulary, prescription channeling could confound risk comparisons across products.

Analytics for vaccine economics and pricing: insights and observations.

PubMed

Robbins, Matthew J; Jacobson, Sheldon H

2015-04-01

Pediatric immunization programs in the USA are a successful and cost-effective public health endeavor, profoundly reducing mortalities caused by infectious diseases. Two important issues relate to the success of the immunization programs, the selection of cost-effective vaccines and the appropriate pricing of vaccines. The recommended childhood immunization schedule, published annually by the CDC, continues to expand with respect to the number of injections required and the number of vaccines available for selection. The advent of new vaccines to meet the growing requirements of the schedule results: in a large, combinatorial number of possible vaccine formularies. The expansion of the schedule and the increase in the number of available vaccines constitutes a challenge for state health departments, large city immunization programs, private practices and other vaccine purchasers, as a cost-effective vaccine formulary must be selected from an increasingly large set of possible vaccine combinations to satisfy the schedule. The pediatric vaccine industry consists of a relatively small number of pharmaceutical firms engaged in the research, development, manufacture and distribution of pediatric vaccines. The number of vaccine manufacturers has dramatically decreased in the past few decades for a myriad of reasons, most notably due to low profitability. The contraction of the industry negatively impacts the reliable provision of pediatric vaccines. The determination of appropriate vaccine prices is an important issue and influences a vaccine manufacturer's decision to remain in the market. Operations research is a discipline that applies advanced analytical methods to improve decision making; analytics is the application of operations research to a particular problem using pertinent data to provide a practical result. Analytics provides a mechanism to resolve the challenges facing stakeholders in the vaccine development and delivery system, in particular, the selection of cost-effective vaccines and the appropriate pricing of vaccines. A review of applicable analytics papers is provided.

Getting clinical trial results into practice: design, implementation, and process evaluation of the ALLHAT Dissemination Project

PubMed Central

Bartholomew, L Kay; Cushman, William C; Cutler, Jeffrey A; Davis, Barry R; Dawson, Glenna; Einhorn, Paula T; Graumlich, James F; Piller, Linda B; Pressel, Sara; Roccella, Edward J; Simpson, Lara; Whelton, Paul K; Williard, Angela

2009-01-01

Background Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted. Purpose To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute’s requirement for dissemination and evaluation of trials with potential immediate public health applicability. Methods ALLHAT’s dissemination plan had two-components: 1) a traditional approach of media coverage, scientific presentation and publication; and 2) a theory-based approach targeting determinants of clinician behavior. Strategies included (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians. Results One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites. Limitations It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing. Conclusions A large multi-method dissemination of clinical trial results is feasible. Planning for dissemination efforts, including evaluation research, should be considered as a part of the funding and design of the clinical trial and should begin early in trial planning. PMID:19587068

Pharmacy executives: leadership issues and associated skills, knowledge, and abilities in the U.S. Department of Defense.

PubMed

Meadows, Andrew B; Finstuen, Kenn; Hudak, Ronald P

2003-01-01

To identify the issues or problems that current and aspiring U.S. Department of Defense (DoD) pharmacy executives will face in the future and to define the skills, knowledge, and abilities (SKAs) required to successfully address these issues. Delphi method for executive decision making. DoD. Ninety-three pharmacists serving in the military grades of lieutenant colonel/commander and colonel/captain, as well as pharmacists selected for promotion to those grades. iterations of the Delphi method for executive decision making separated by an expert panel content analysis. Round 1--participants identified five major issues believed to be of greatest importance to pharmacy executives and reported specific SKAs that might be needed to successfully manage those issues. An expert panel sorted these issues into meaningful domains, then provided an appropriate title for each domain. Round 2--on a 7-point scale, respondents rated the SKA items according to their assessment of how much a future DoD pharmacy executive would need each SKA. Response rates were 44.1% and 46.2% for Delphi rounds 1 and 2, respectively. The first round generated 62 unique issues facing pharmacy executives. The expert panel reviewed and sorted the issues into eight domains and selected an appropriate title for each domain. The domains identified by the panel were human resources, pharmacy operations/business practices, information management and technology, financial resources, formulary management, drug therapy management, pharmacy benefit management, and leadership. During round 2, 73.3% of the top 15 rated SKAs came from the drug therapy management, leadership, and formulary management domains. The three highest-rated SKAs were "ability to see the big picture," "ability to build strong relations with medical staffs," and "skills in both writing and verbal communication." The issues facing future DoD pharmacy executives will require them to expand their clinical abilities as well as their ability to collaborate and communicate with other professionals.

Getting clinical trial results into practice: design, implementation, and process evaluation of the ALLHAT Dissemination Project.

PubMed

Bartholomew, L Kay; Cushman, William C; Cutler, Jeffrey A; Davis, Barry R; Dawson, Glenna; Einhorn, Paula T; Graumlich, James F; Piller, Linda B; Pressel, Sara; Roccella, Edward J; Simpson, Lara; Whelton, Paul K; Williard, Angela; Allhat Collaborative Research Group

2009-08-01

Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted. To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute's requirement for dissemination and evaluation of trials with potential immediate public health applicability. ALLHAT's dissemination plan had two-components: (1) a traditional approach of media coverage, scientific presentation, and publication; and (2) a theory-based approach targeting determinants of clinician behavior. Strategies included: (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians. One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites. It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing. A large multi-method dissemination of clinical trial results is feasible. Planning for dissemination efforts, including evaluation research, should be considered as a part of the funding and design of the clinical trial and should begin early in trial planning.

Independent extended and supplementary nurse prescribing practice in the UK: a national questionnaire survey.

PubMed

Courtenay, Molly; Carey, Nicola; Burke, Joanna

2007-09-01

Nurses are able to prescribe independently from a list of nearly 250 prescription only medicines for a range of over 100 medical conditions or, from the whole British National Formulary as a supplementary prescriber. There is some evidence available on the prescribing practices of district nurses and health visitors and early independent extended prescribers. Little or no attention has focussed on supplementary nurse prescribing. To provide an overview of the prescribing practices of independent extended/supplementary nurse prescribers and the factors that facilitate or inhibit prescribing. National questionnaire survey. United Kingdom. A convenience sample of 868 qualified independent extended/supplementary nurse prescribers self-completed a written questionnaire. A total of 756 (87%) used independent extended prescribing; 304 (35%) used supplementary prescribing to treat a range of chronic conditions (including asthma, diabetes and hypertension); 710 (82%) nurses worked in primary care. Nurses in general practice reported the largest number of reasons preventing prescribing. Reasons included the inability to computer generate prescriptions and to implement the Clinical Management Plan. Nurses in primary care reported more continuing professional development needs. These needs included update on prescribing policy and the treatment management of conditions. A total of 277 (32%) nurses were unable to access continuing professional development. Independent extended/supplementary nurse prescribers work predominantly in primary care and do prescribe medicines. These nurses are highly qualified and have many years clinical experience. Supplementary prescribing is used by a minority of nurses. Implementing the Clinical Management Plan is a barrier preventing the use of this mode of prescribing. The continuing professional development needs of independent extended/supplementary nurse prescribers are frequently unmet. It will become increasingly important that these needs are met once nurses are able to prescribe the full range of medicines included in the British National Formulary, limited only by their area of competence.

Moving branded statins to lowest copay tier improves patient adherence.

PubMed

Chen, Shih-Yin; Shah, Sonali N; Lee, Yuan-Chi; Boulanger, Luke; Mardekian, Jack; Kuznik, Andreas

2014-01-01

Statins are efficacious in reducing the risk of major cardiovascular events for both primary and secondary prevention, yet long-term adherence is poor. Their effectiveness could be compromised in actual practice when patients are not adherent to the treatments. Higher copayments have been shown to be associated with lower adherence to statins. To assess the effect on patient adherence of moving branded atorvastatin and rosuvastatin from the second to the first tier by a Medicare Part D plan sponsor. Pharmacy claims and eligibility records between July 1, 2009, and July 31, 2011, of Medicare Part D members not receiving the low-income subsidy were analyzed. New atorvastatin and rosuvastatin users in January 2010 (2010 cohort) were compared with those in January 2011 (2011 cohort) after this formulary tier change (tier-reduction group). Adherence was defined by the proportion of days covered (PDC) over 6 months. The impact of tier reduction on adherence was evaluated via logistic regression for binary outcome (PDC≥0.8) and generalized linear regression for continuous PDC by comparing the 2011 cohort with the 2010 cohort, adjusting for demographic and clinical characteristics. Other statin users (97% on generic statins) were also analyzed, serving as a nontier-reduction comparator group. We identified 12,437 members in the tier-reduction group. Between the 2010 and 2011 cohorts, mean PDC increased from 0.77 to 0.83, and the proportion of members with high adherence increased from 62.0% to 72.9% (both P < 0.001). After regression adjustment, members in the 2011 cohort were more likely to be adherent (OR=1.68; 95% CI=1.55-1.82) and had a 5.9% increase in PDC (P < 0.05). There was no significant increase in adherence observed in the comparator nontier-reduction group. Findings from this study suggest that financial incentives may improve medication adherence. Future studies should evaluate whether such formulary strategies improve long-term adherence and patient outcomes.

Web-based survey to assess the perceptions of managed care organization representatives on use of copay subsidy coupons for prescription drugs.

PubMed

Nemlekar, Poorva; Shepherd, Marvin; Lawson, Kenneth; Rush, Sharon

2013-10-01

Promotion of prescription drug coupons and vouchers by pharmaceutical manufacturers has increased in recent years. These coupons and vouchers usually subsidize patients' cost-sharing obligations. In other words, drug companies pay for a patient's portion of the drug cost, and the remaining cost is paid by the patient and the patient's health plan. This practice is normally used for brand name drugs but can and has been used for generic drugs. Copayments (also known as copays), and especially high copays for higher cost drugs, are used by managed care organizations (MCOs) to place a higher financial burden on patients and also provide an appreciation of the medication cost. At the same time, tiered copay plans offer incentives, in the form of lower copays, to use available equivalent generic alternatives or lower cost brand name drugs, instead of high cost brand name drugs. With higher tiered copays for brand name drugs being offset by coupons, little is known about MCO representatives' perceptions about the use of copay subsidy coupons for brand name prescription drugs. To assess health plan managers' and pharmacy benefit managers' (PBMs) perceptions about the use of prescription drug copay subsidy coupons. A 28-item online survey instrument was used to collect data from health plan and PBM representatives. A sample of 834 MCO representatives was selected from the Academy of Managed Care Pharmacy membership directory. Pharmacists, managers, directors, and executive officers working in pharmacy, formulary, and clinical pharmacy operations were selected for the survey. Respondents from non-MCO settings and government-sponsored health plans were excluded from the survey. A total of 122 surveys were returned after 3 emails (i.e., an invitation and 2 reminder emails) of which 105 were usable surveys, giving a response rate of 13.7%. A 5-point, 11-item Likert scale (1 = Strongly Disagree and 5 = Strongly Agree) was used to measure respondents' perceptions toward prescription drug coupons. Some items referred to coupons used repeatedly over a year to get copay discounts (i.e., long-term use coupons) whereas some items referred to coupons distributed for trial purposes (i.e., short-term use coupons). Of the 105 respondents, 100 (95.2%) agreed that copay subsidy coupons encouraged nonpreferred brand name drugs over preferred brand name drugs. A total of 102 (97.2%) respondents agreed that brand name drug coupons undermined tiered formulary structure. Ninety-two (87.6%) respondents agreed that short-term use coupons increased plan sponsor's costs while 96 (91.5%) respondents agreed that sponsor cost increased with long-term use coupons. A total of 68 (64.8%) agreed that short-term use coupons should be eliminated whereas 78 (74.3%) respondents agreed that long-term use coupons should be eliminated. Among MCOs' many business activities are efforts to contain rising pharmacy costs. The results of this survey indicate that MCO representatives believe that incentive programs such as prescription drug coupons and vouchers lead to an increase in brand name drug utilization, which undermines their formulary controls and, in turn, can be expected to increase overall health care costs.

Developing a pharmaceutical purchasing strategy.

PubMed

Hynniman, C E

1992-09-01

The process commonly used by group purchasing organizations to contract for multisource pharmaceuticals and a strategic approach for the director of pharmacy in working with the purchasing group and the P & T Committee is described. The pharmacist should be knowledgeable concerning the group's contract commitment requirements, product specifications, terms and conditions and procedures for vendor selection, product award, contract implementation, and performance monitoring. To ensure results that meet the needs of the medical staff, it is important that the P & T Committee actively participate. The P & T Committee should understand the reasons for selecting a particular purchasing group, understand the necessary steps in obtaining the most favorable economic advantage, review products with potential brand interchange concerns, recommend product specifications, and reaffirm formulary procedures regarding the principle of current consent.

Italian drug policy: ethical aims of essential assistance levels.

PubMed

Bernardi, Alessandra; Pegoraro, Renzo

2003-12-01

In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to reimburse without penalizing the rights of the individual and society. This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine).

High dose rivastigmine in the symptom management of Lewy body dementia.

PubMed

Nour, Joseph Marwan; Chouliaras, Leonidas; Hickey, Lilian

2016-11-29

A man presented in late 2004 at the age of 65 with a decline in memory. He was diagnosed with Lewy body dementia and started on 3 mg rivastigmine a day, which made a marked clinical improvement. He lived with the illness for 10 years, over which time the dose of acetylcholinesterase inhibitors (ChEI) he took rose to two 9.5 mg rivastigmine patches and 7.5 mg donepezil, significantly above British National Formulary (BNF) limits. He demonstrated clear clinical response to ChEI and showed improvements in alertness and functioning. He did not exhibit life-threatening cardiac side effects and his death in 2014 was not related to the ChEI. 2016 BMJ Publishing Group Ltd.

The use of medical grade honey in clinical practice.

PubMed

Dunwoody, Gillian; Acton, Claire

In the current healthcare environment, clinicians are increasingly under pressure to use wound care products that are cost-effective. This includes products that can be used in a variety of wounds to achieve different outcomes, depending on the wound-bed requirements. Medical grade honey has emerged as a product that can achieve a variety of outcomes within the wound and is safe and easy to use. This article reviews the use of a medical grade honey (Medihoney) in various clinical applications, with a view to placement on the wound care formulary in both primary and secondary care. It provides an in-depth account of case studies featured in a poster presentation at the 2008 European Wound Management Association meeting in Lisbon, Portugal.

Hospitals' Strategies for Orchestrating Selection of Physician Preference Items

PubMed Central

Montgomery, Kathleen; Schneller, Eugene S

2007-01-01

This article analyzes hospitals' strategies to shape physicians' behavior and counter suppliers' power in purchasing physician preference items. Two models of standardization are limitations on the range of manufacturers or products (the “formulary” model) and price ceilings for particular item categories (the “payment-cap” model), both requiring processes to define product equivalencies often with inadequate product comparison data. The formulary model is more difficult to implement because of physicians' resistance to top-down dictates. The payment-cap model is more feasible because it preserves physicians' choice while also restraining manufacturers' power. Hospitals may influence physicians' involvement through a process of orchestration that includes committing to improve clinical facilities, scheduling, and training and fostering a culture of mutual trust and respect. PMID:17517118

Equivalence studies for complex active ingredients and dosage forms.

PubMed

Bhattycharyya, Lokesh; Dabbah, Roger; Hauck, Walter; Sheinin, Eric; Yeoman, Lynn; Williams, Roger

2005-11-17

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

Improving health visitor emollient prescribing using a CQUIN-based approach.

PubMed

Brooks, Christina; Khatau, Tejas

2015-12-01

Prescribing is an essential element of health visiting practice. This initiative used the payment framework of Commissioning for Quality and Innovation (CQUIN) to develop health visiting practice across a large health visiting workforce in the East Midlands. A focus on emollient prescribing practice was agreed and a guidance booklet regarding preferred emollient products was produced, based on the local formulary Each health visitor benefitted from receiving additional training and was given a guidance booklet to inform their practice. Targets were set for each quarter to demonstrate an improved prescribing adherence to the preferred product list.The targets were achieved for each quarter. Prescribing rates and confidence improved across the service. Therefore, it was demonstrated that specific guidance and ongoing support can improve prescribing practice within the health visiting service.

Evaluation of Subcutaneous Phenobarbital Administration in Hospice Patients.

PubMed

Hosgood, Jessica Richards; Kimbrel, Jason M; McCrate Protus, Bridget; Grauer, Phyllis A

2016-04-01

Phenobarbital is used in hospice and palliative care to treat refractory symptoms. In end-of-life care, Food and Drug Administration approved routes of administration may be unreasonable based on patients' status. In these cases, phenobarbital may be administered subcutaneously for symptom management. However, according to the American Hospital Formulary Service, subcutaneous administration of commercially available injectable phenobarbital is cautioned due to possible skin reactions. This study evaluates the tolerability of phenobarbital administered subcutaneously. Of 69 patients and 774 distinct subcutaneous phenobarbital injections, 2 site reactions were recorded (2.9% of patients; 0.3% of injections). Both were mild, grade 1 reactions. Each patient continued to receive subcutaneous phenobarbital via newly placed ports with no additional reactions. Based on these findings, phenobarbital appears to be well tolerated when administered subcutaneously. © The Author(s) 2014.

Job-based health benefits in 2002: some important trends.

PubMed

Gabel, Jon; Levitt, Larry; Holve, Erin; Pickreign, Jeremy; Whitmore, Heidi; Dhont, Kelley; Hawkins, Samantha; Rowland, Diane

2002-01-01

Based on a national survey of 2,014 randomly selected public and private firms with three or more workers, this paper reports changes in employer-based health insurance from spring 2001 to spring 2002. The cost of health insurance rose 12.7 percent, the highest rate of growth since 1990. Employee contributions for health insurance rose in 2002, from $30 to $38 for single coverage and from $150 to $174 for family coverage. Deductibles and copayments rose also, and employers adopted formularies and three-tier cost-sharing formulas to control prescription drug expenses. PPO and HMO enrollment rose, while the percentage of small employers offering health benefits fell. Because increasing claims expenses rather than the underwriting cycle are the major driver of rising premiums, double-digit growth appears likely to continue.

A critical analysis of studies of state drug reimbursement policies: research in need of discipline.

PubMed

Soumerai, S B; Ross-Degnan, D; Fortess, E E; Abelson, J

1993-01-01

Concerns over pharmaceutical costs and appropriateness of medication use have led state Medicaid programs to restrict drug reimbursement. This article critically reviews 20 years of research on cost sharing, drug reimbursement limits, and administrative limitations on access to particular drugs via formularies, category exclusions, or prior authorization requirements; evaluates their methodological rigor; summarizes the state of current knowledge; and proposes future research directions. Drug reimbursement caps and modest cost sharing can reduce the use of both essential and less important drugs in Medicaid populations; severe reimbursement caps may precipitate serious unintended effects. Limitations on access to particular drugs can cause both rational and irrational drug substitution effects; it is unclear whether such limits reduce expenditures either for drugs or for overall health care.

Estimating the Economic Impact of Adding Panobinostat to a U.S. Formulary for Relapsed and/or Refractory Multiple Myeloma: A Budget Impact and Cost-Benefit Model.

PubMed

Bloudek, Lisa; Roy, Anuja; Kish, Jonathan K; Siegel, David S; Jagannath, Sundar; Globe, Denise; Orloski, Laurie; Kuriakose, Emil T

2016-08-01

Multiple myeloma is an incurable B-cell malignancy with a natural history that involves alternating periods of remission and subsequent relapse. For relapsed and/or refractory multiple myeloma (RRMM), the typical patient currently receives more lines of therapy than has been feasible in the past, translating into longer progression-free survival (PFS). Consequently, cost issues have become more prominent because patients may be offered newer and more expensive therapies during a more prolonged overall treatment course. To estimate the economic impact of adding panobinostat to a U.S. health plan formulary as a treatment option with bortezomib and dexamethasone for patients with RRMM previously treated with a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), using a budget impact and cost-benefit model. Total costs of commonly used salvage therapy regimens were combined with market share data and population prevalence estimates of RRMM to yield the total cost of treatment, from the perspective of a U.S. third-party payer (commercial or Medicare) with a time horizon of 1 year. Comparator treatment regimens included bortezomib-dexamethasone, lenalidomide-dexamethasone, lenalidomide-bortezomib-dexamethasone, carfilzomib monotherapy, carfilzomib-lenalidomide-dexamethasone, and pomalidomide-dexamethasone. Costs (2015 U.S. dollars) included drug costs for oral oncology agents, medical and administration costs for injectable oncology agents, costs of adverse event (AE) prophylaxis and monitoring, and costs of grade 3/4 AEs. In a hypothetical health plan with 1 million members, the annual number of RRMM patients with previous PI and IMiD treatments was estimated at 16 and 118 for a commercial and Medicare plan, respectively. Introduction of panobinostat as part of the panobinostat-bortezomib-dexamethasone regimen was not expected to result in a substantial budget impact to either commercial or Medicare plans, with an incremental cost < $0.01 per member per month. Panobinostat-bortezomib-dexamethasone had a low cost per treated patient per month without progression, owing to the minimal increase in expenditure over existing bortezomib-based regimens and long median PFS, compared with median duration of treatment. Adding panobinostat to a plan formulary as a treatment option is expected to be cost neutral (and potentially cost saving in the context of new and more expensive treatment regimens). With a low cost per month without progression, panobinostat-bortezomib-dexamethasone represents good value for the money. Funding for this study was sponsored by Novartis, East Hanover, New Jersey. Bloudek and Kish are employees of Xcenda, a consulting company contracted by Novartis to conduct this analysis. Roy, Globe, and Kuriakose are employees of Novartis. Siegel is on the advisory boards and speaker's bureau of Celgene, Onyx/Amgen, Millennium/Takeda, and Novartis and is on the advisory boards of Merck. Jagannath is a consultant to Sanofi, Bristol-Meyers Squibb, and Celgene. Orloski is a contractor to Xcenda and provided medical writing support, which was funded by Novartis. Study design and concept were contributed by Bloudek, Roy, and Kish, assisted by Globe. Bloukek took the lead in data collection, along with Kish, and data interpretation was performed by Siegal, Jagannath, Globe, and Kuriakose. The manuscript was written primarily by Orloski, along with Roy and Kish, and revised by Roy, along with Siegal, Jagannath, Globe, Orloski, and Kuriakose.

Insulin lispro: a pharmacoeconomic review of its use in diabetes mellitus.

PubMed

Dunn, Christopher J; Plosker, Greg L

2002-01-01

Insulin lispro is a recombinant insulin analogue with transposed amino acids (proline and lysine) at positions 28 and 29 near the C-terminus of the B-chain. The most prominent practical advantage of insulin lispro over human soluble insulin lies in its very rapid onset of action. This property allows it to be injected immediately before meals and minimises the demands made on patients with type 1 diabetes mellitus, and those with type 2 disease who require insulin, by the ongoing need for careful meal planning and timing. Numerous clinical studies have shown significant improvements in postprandial glycaemic control, with some evidence of reduced rates of severe or nocturnal hypoglycaemia, relative to conventional human insulin in patients receiving lispro-based insulins. Quality-of-life studies show consistent preferences by patients for and increased treatment satisfaction with insulin lispro over human soluble insulin, particularly with variations of the Diabetes Treatment Satisfaction Questionnaire. Willingness of patients and taxpayers to pay additional costs for insulin lispro or a premixed lispro-based formulation over conventional human insulins, and cost benefits favouring formulary inclusion, have been shown in well designed studies carried out in Australia and Canada. Spanish data suggest cost effectiveness in terms of episodes of severe hypoglycaemia avoided, and preliminary German resource utilisation data indicate cost savings related to reduced hospitalisation and general practice costs, with insulin lispro relative to human soluble insulin. Insulin lispro and premixed formulations of lispro-based insulins offer quality-of-life improvements relative to conventional human insulins in patients with diabetes mellitus. Participants in well designed studies have expressed a preference for lispro-based insulins and have been shown to be willing to pay for the advantages they offer, and current cost-benefit data favour the inclusion of these insulins in formularies and their reimbursement by third party payers. Further research into the pharmacoeconomic implications of insulin lispro use in the long term is needed, particularly with respect to effects on indirect costs and those associated with complications of diabetes mellitus.

A novel method of estimating cost of therapy by using patient population characteristics: analysis of fluoroquinolones in various populations with different distributions of renal function.

PubMed

Enzweiler, Kevin A; Bosso, John A; White, Roger L

2003-07-01

Formulary decisions regarding a given drug class are often made in the absence of patient outcome and/or sophisticated pharmacoeconomic data. Analyses that consider factors beyond simple acquisition costs may be useful in such situations. For example, the cost implications of using manufacturers' recommendations for dosing in patients with renal dysfunction may be important, depending on the distribution of various levels of renal function within a patient population. Using four 1000-patient populations representing different renal function distributions and a fifth population of our medical center's distribution, we determined the costs of therapy for intravenous and oral levofloxacin, gatifloxacin, and moxifloxacin for a 10-day course of therapy for community-acquired pneumonia. Costs considered were average wholesale prices (AWPs), 50% of AWP, or same daily price, plus intravenous dose preparation and administration costs when applicable. Costs for each renal function distribution were examined for significant differences with an analysis-of-variance test. Also, costs of failing to adjust dosing regimens for decreased renal function were determined. Differences in fluoroquinolone costs (AWP, 50% AWP, or when matched as the same daily price) among the populations were found. When considering same daily prices, differences among populations ranged from about 35,000 dollars with intravenous gatifloxacin to more than 51,000 dollars for intravenous levofloxacin (all fluoroquinolones, p>0.05). Within a population, differences in costs among the intravenous fluoroquinolones ranged from 47,000-99,000 dollars. Rank orders of the drugs and population costs of therapy were affected by the pricing structure used and varied by the specific population and drug. Differences among the fluoroquinolones or populations were much smaller (<2100 dollars) when considering oral regimens. Costs potentially incurred by failing to adjust dosing for renal function were substantial. Formulary decisions can be facilitated by considering factors such as patient characteristics and related dosing in addition to simple acquisition costs. In our example, consideration of the distribution of renal function within a given patient population and related dosing for these fluoroquinolones revealed potentially important differences within the class.

Using 'big data' to validate claims made in the pharmaceutical approval process.

PubMed

Wasser, Thomas; Haynes, Kevin; Barron, John; Cziraky, Mark

2015-01-01

Big Data in the healthcare setting refers to the storage, assimilation, and analysis of large quantities of information regarding patient care. These data can be collected and stored in a wide variety of ways including electronic medical records collected at the patient bedside, or through medical records that are coded and passed to insurance companies for reimbursement. When these data are processed it is possible to validate claims as a part of the regulatory review process regarding the anticipated performance of medications and devices. In order to analyze properly claims by manufacturers and others, there is a need to express claims in terms that are testable in a timeframe that is useful and meaningful to formulary committees. Claims for the comparative benefits and costs, including budget impact, of products and devices need to be expressed in measurable terms, ideally in the context of submission or validation protocols. Claims should be either consistent with accessible Big Data or able to support observational studies where Big Data identifies target populations. Protocols should identify, in disaggregated terms, key variables that would lead to direct or proxy validation. Once these variables are identified, Big Data can be used to query massive quantities of data in the validation process. Research can be passive or active in nature. Passive, where the data are collected retrospectively; active where the researcher is prospectively looking for indicators of co-morbid conditions, side-effects or adverse events, testing these indicators to determine if claims are within desired ranges set forth by the manufacturer. Additionally, Big Data can be used to assess the effectiveness of therapy through health insurance records. This, for example, could indicate that disease or co-morbid conditions cease to be treated. Understanding the basic strengths and weaknesses of Big Data in the claim validation process provides a glimpse of the value that this research can provide to industry. Big Data can support a research agenda that focuses on the process of claims validation to support formulary submissions as well as inputs to ongoing disease area and therapeutic class reviews.

Brand-name prescription drug use among Veterans Affairs and Medicare Part D patients with diabetes: a national cohort comparison.

PubMed

Gellad, Walid F; Donohue, Julie M; Zhao, Xinhua; Mor, Maria K; Thorpe, Carolyn T; Smith, Jeremy; Good, Chester B; Fine, Michael J; Morden, Nancy E

2013-07-16

Medicare Part D and the U.S. Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas the VA administers its own benefit using a national formulary. To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and the VA. Retrospective cohort. Medicare and the VA, 2008. 1,061,095 Medicare Part D beneficiaries and 510,485 veterans aged 65 years or older with diabetes. Percentage of patients taking oral hypoglycemics, statins, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) who filled brand-name drug prescriptions and percentage of patients taking long-acting insulins who filled analogue prescriptions. Sociodemographic- and health status-adjusted hospital referral region (HRR) brand-name drug use was compared, and changes in spending were calculated if use of brand-name drugs in 1 system mirrored the other. Brand-name drug use in Medicare was 2 to 3 times that in the VA: 35.3% versus 12.7% for oral hypoglycemics, 50.7% versus 18.2% for statins, 42.5% versus 20.8% for ACE inhibitors or ARBs, and 75.1% versus 27.0% for insulin analogues. Adjusted HRR-level brand-name statin use ranged (from the 5th to 95th percentiles) from 41.0% to 58.3% in Medicare and 6.2% to 38.2% in the VA. For each drug group, the 95th-percentile HRR in the VA had lower brand-name drug use than the 5th-percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name drug use matched that of the VA. This analysis cannot fully describe the factors underlying differences in brand-name drug use. Medicare beneficiaries with diabetes use 2 to 3 times more brand-name drugs than a comparable group within the VA, at substantial excess cost.

The Effect of Pharmacy Benefit Design on Patient-Physician Communication About Costs

PubMed Central

Shrank, William H; Fox, Sarah A; Kirk, Adele; Ettner, Susan L; Cantrell, Clairessa H; Glassman, Peter; Asch, Steven M

2006-01-01

BACKGROUND Incentive-based formularies have been widely instituted to control the rising costs of prescription drugs. To work properly, such formularies depend on patients to be aware of financial incentives and communicate their cost preferences with prescribing physicians. The impact of financial incentives on patient awareness of and communication about those costs is unknown. OBJECTIVE To evaluate the relationship between enrollment in incentive-based pharmacy benefit plans and awareness of out-of-pocket costs and rates of communication about out-of-pocket costs. DESIGN A matched telephone survey of patients and their primary care physicians. SETTING Los Angeles County. PARTICIPANTS One thousand nine hundred and seventeen patients aged 53 to 82 (73% response rate). MEASUREMENTS Patient-reported pharmacy benefit design, knowledge of out-of-pocket costs, and discussion of out-of-pocket costs with physicians. RESULTS Sixty-two percent of patients who had prescription drug coverage and were aware of their pharmacy benefit design reported being enrolled in incentive-based plans. The majority of these (54%) were “never” or only “sometimes” aware of their out-of-pocket cost requirements at the time of the physician visit. After controlling for numerous physician and patient level variables, we found that patients enrolled in pharmacy benefit designs requiring no copayments were more likely to report they “never” discuss out-of-pocket costs with physicians compared with patients enrolled in incentive-based pharmacy benefit designs (81% vs 67%, P =.001) and patients with no prescription druginsurance (57%, P <.001). CONCLUSIONS Incentive-based pharmacy benefit plans and lack of insurance are associated with increased rates of discussions about out-of-pocket costs. Nonetheless, most incentive-based enrollees are unaware of out-of-pocket costswhen prescriptions are written and never discuss out-of-pocket costs with their physicians, likely mitigating the effectiveness of financial incentives to guide decision making. Considering that out-of-pocket costs are associated with adherence to medical therapy, interventions to improve patient access to out-of-pocket cost information and the frequency of patient-physician discussions about costs are needed. PMID:16686808

Budget impact model in moderate-to-severe psoriasis vulgaris assessing effects of calcipotriene and betamethasone dipropionate foam on per-patient standard of care costs.

PubMed

Asche, Carl V; Kim, Minchul; Feldman, Steven R; Zografos, Panagiotis; Lu, Minyi

2017-09-01

To develop a budget impact model (BIM) for estimating the financial impact of formulary adoption and uptake of calcipotriene and betamethasone dipropionate (C/BD) foam (0.005%/0.064%) on the costs of biologics for treating moderate-to-severe psoriasis vulgaris in a hypothetical US healthcare plan with 1 million members. This BIM incorporated epidemiologic data, market uptake assumptions, and drug utilization costs, simulating the treatment mix for patients who are candidates for biologics before (Scenario #1) and after (Scenario #2) the introduction of C/BD foam. Predicted outcomes were expressed in terms of the annual cost of treatment (COT) and the COT per member per month (PMPM). At year 1, C/BD foam had the lowest per-patient cost ($9,913) necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared with etanercept ($73,773), adalimumab ($92,871), infliximab ($34,048), ustekinumab ($83,975), secukinumab ($113,858), apremilast ($47,960), and ixekizumab ($62,707). Following addition of C/BD foam to the formulary, the annual COT for moderate-to-severe psoriasis would decrease by $36,112,572 (17.91%, from $201,621,219 to $165,508,647). The COT PMPM is expected to decrease by $3.00 (17.86%, from $16.80 to $13.80). Drug costs were based on Medi-Span reference pricing (January 21, 2016); differences in treatment costs for drug administration, laboratory monitoring, or adverse events were not accounted for. Potentially confounding were the definition of "moderate-to-severe" and the heterogeneous efficacy data. The per-patient cost for PASI-75 response at year 1 was estimated from short-term efficacy data for C/BD foam and apremilast only. The introduction of C/BD foam is expected to decrease the annual COT for moderate-to-severe psoriasis treatable with biologics by $36,112,572 for a hypothetical US healthcare plan with 1 million plan members, and to lower the COT PMPM by $3.00.

Brand-Name Prescription Drug Use Among Veterans Affairs and Medicare Part D Patients With Diabetes

PubMed Central

Gellad, Walid F.; Donohue, Julie M.; Zhao, Xinhua; Mor, Maria K.; Thorpe, Carolyn T.; Smith, Jeremy; Good, Chester B.; Fine, Michael J.; Morden, Nancy E.

2013-01-01

Background: Medicare Part D and the U.S. Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas the VA administers its own benefit using a national formulary. Objective: To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and the VA. Design: Retrospective cohort. Setting: Medicare and the VA, 2008. Patients: 1 061 095 Medicare Part D beneficiaries and 510 485 veterans aged 65 years or older with diabetes. Measurements: Percentage of patients taking oral hypoglycemics, statins, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) who filled brand-name drug prescriptions and percentage of patients taking long-acting insulins who filled analogue prescriptions. Sociodemographic- and health status–adjusted hospital referral region (HRR) brand-name drug use was compared, and changes in spending were calculated if use of brand-name drugs in 1 system mirrored the other. Results: Brand-name drug use in Medicare was 2 to 3 times that in the VA: 35.3% versus 12.7% for oral hypoglycemics, 50.7% versus 18.2% for statins, 42.5% versus 20.8% for ACE inhibitors or ARBs, and 75.1% versus 27.0% for insulin analogues. Adjusted HRR-level brand-name statin use ranged (from the 5th to 95th percentiles) from 41.0% to 58.3% in Medicare and 6.2% to 38.2% in the VA. For each drug group, the 95th-percentile HRR in the VA had lower brand-name drug use than the 5th-percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name drug use matched that of the VA. Limitation: This analysis cannot fully describe the factors underlying differences in brand-name drug use. Conclusion: Medicare beneficiaries with diabetes use 2 to 3 times more brand-name drugs than a comparable group within the VA, at substantial excess cost. Primary Funding Source: U.S. Department of Veterans Affairs, National Institutes of Health, and Robert Wood Johnson Foundation. PMID:19264942

Brand-Name Prescription Drug Use Among Diabetes Patients in the VA and Medicare Part D: A National Comparison

PubMed Central

Gellad, Walid F.; Donohue, Julie M.; Zhao, Xinhua; Mor, Maria K.; Thorpe, Carolyn T.; Smith, Jeremy; Good, Chester B.; Fine, Michael J.; Morden, Nancy E.

2013-01-01

Background Medicare Part D and the Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas VA administers its own benefit using a national formulary. Objective To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and VA. Design Retrospective cohort Setting Medicare and VA Patients National sample in 2008 of 1,061,095 Part D beneficiaries and 510,485 Veterans age 65+ with diabetes. Measurements Percent of patients on oral hypoglycemics, statins, and angiotensin-converting-enzyme inhibitors/angiotensin-receptor-blockers who filled brand-name drugs and percent of patients on long-acting insulin who filled analogues. We compared sociodemographic and health-status adjusted hospital referral region (HRR) brand-name use to examine local practice patterns, and calculated changes in spending if each system’s brand-name use mirrored the other. Results Brand-name use in Medicare was 2–3 times that of VA: 35.3% vs. 12.7% for oral hypoglycemics, 50.7% vs. 18.2% for statins, 42.5% vs. 20.8% for angiotensin-converting-enzyme inhibitors/angiotensin-receptor-blockers, and 75.1% vs. 27.0% for insulin analogues. Adjusted HRR brand-name statin use ranged (5th to 95th percentile) from 41.0%–58.3% in Medicare and 6.2%–38.2% in VA. For each drug group, the HRR at the 95th percentile in VA had lower brand-name use than the 5th percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name use matched the VA for these medications. Limitation This analysis cannot fully describe the factors underlying differences in brand-name use. Conclusions Medicare beneficiaries with diabetes use 2–3 times more brand-name drugs than a comparable group within VA, at substantial excess cost. Primary Funding Sources VA; NIH; RWJF PMID:23752663

Clinical Options for the Treatment of Urinary Tract Infections in Children

PubMed Central

Ramlakhan, Shammi; Singh, Virendra; Stone, Joanne; Ramtahal, Alicia

2014-01-01

Urinary Tract Infections (UTI) are a common cause of childhood febrile illness with 7% of girls and 2% of boys having a symptomatic culture positive UTI by the age of six years. Although there are conflicting views on the long term sequelae of UTI, as well as the place of prophylaxis, the universal aims of treatment of childhood UTI remain those of symptom alleviation, prevention of systemic infection and short and longer term complications. There is good evidence of historical and emerging resistance patterns, therefore rationalisation of prescription patterns by knowledge of sensitivities coupled with re-examination of empirical antibiotic choices is clearly important. Local formularies should reflect geographical resistance patterns along with best evidence on the duration and choice of antibiotic in order to maximize therapeutic effect, while minimizing the development of resistant strains. PMID:25210486

Point-of-Prescription Interventions to Improve Antimicrobial Stewardship

PubMed Central

Hamilton, Keith W.; Gerber, Jeffrey S.; Moehring, Rebekah; Anderson, Deverick J.; Calderwood, Michael S.; Han, Jennifer H.; Mehta, Jimish M.; Pollack, Lori A.; Zaoutis, Theoklis; Srinivasan, Arjun; Camins, Bernard C.; Schwartz, David N.; Lautenbach, Ebbing

2015-01-01

Antimicrobial stewardship is pivotal to improving patient outcomes, reducing adverse events, decreasing healthcare costs, and preventing further emergence of antimicrobial resistance. In an era in which antimicrobial resistance is increasing, judicious antimicrobial use is the responsibility of every healthcare provider. Antimicrobial stewardship programs (ASPs) have made headway in improving antimicrobial prescribing using such “top-down” methods as formulary restriction and prospective audit with feedback; however, engagement of prescribers has not been fully explored. Strategies that include frontline prescribers and other unit-based healthcare providers have the potential to expand stewardship, both to augment existing centralized ASPs and to provide alternative approaches to perform stewardship at healthcare facilities with limited resources. This review discusses interventions focusing on antimicrobial prescribing at the point of prescription as well as a pilot project to engage unit-based healthcare providers in antimicrobial stewardship. PMID:25595748

Access to Care: The Physician's Perspective

PubMed Central

Ruckle, Janessa E; Sultan, Omar S; Kemble, Stephen

2011-01-01

Private practice physicians in Hawai‘i were surveyed to better understand their impressions of different insurance plans and their willingness to care for patients with those plans. Physician experiences and perspectives were investigated in regard to reimbursement, formulary limitations, pre-authorizations, specialty referrals, responsiveness to problems, and patient knowledge of their plans. The willingness of physicians to accept new patients from specific insurance company programs clearly correlated with the difficulties and limitations physicians perceive in working with the companies (p < 0.0012). Survey results indicate that providers in private practice were much more likely to accept University Health Alliance (UHA) and Hawai‘i Medical Services Association (HMSA) Commercial insurance than Aloha Care Advantage and Aloha Quest. This was likely related to the more favorable impressions of the services, payments, and lower administrative burden offered by those companies compared with others. PMID:21308645

Access to care: the physician's perspective.

PubMed

Tice, Alan; Ruckle, Janessa E; Sultan, Omar S; Kemble, Stephen

2011-02-01

Private practice physicians in Hawaii were surveyed to better understand their impressions of different insurance plans and their willingness to care for patients with those plans. Physician experiences and perspectives were investigated in regard to reimbursement, formulary limitations, pre-authorizations, specialty referrals, responsiveness to problems, and patient knowledge of their plans. The willingness of physicians to accept new patients from specific insurance company programs clearly correlated with the difficulties and limitations physicians perceive in working with the companies (p<0.0012). Survey results indicate that providers in private practice were much more likely to accept University Health Alliance (UHA) and Hawaii Medical Services Association (HMSA) Commercial insurance than Aloha Care Advantage and Aloha Quest. This was likely related to the more favorable impressions of the services, payments, and lower administrative burden offered by those companies compared with others. Hawaii Medical Journal Copyright 2011.

Application of artificial intelligence to pharmacy and medicine.

PubMed

Dasta, J F

1992-04-01

Artificial intelligence (AI) is a branch of computer science dealing with solving problems using symbolic programming. It has evolved into a problem solving science with applications in business, engineering, and health care. One application of AI is expert system development. An expert system consists of a knowledge base and inference engine, coupled with a user interface. A crucial aspect of expert system development is knowledge acquisition and implementing computable ways to solve problems. There have been several expert systems developed in medicine to assist physicians with medical diagnosis. Recently, several programs focusing on drug therapy have been described. They provide guidance on drug interactions, drug therapy monitoring, and drug formulary selection. There are many aspects of pharmacy that AI can have an impact on and the reader is challenged to consider these possibilities because they may some day become a reality in pharmacy.

DUE (drug usage evaluation) of ticarcillin and clavulanate potassium: determining appropriate and cost-effective therapeutic options.

PubMed

Lomaestro, B M; Lesar, T S

1988-11-01

The initial 46 patients who were prescribed the combination drug ticarcillin disodium and clavulanate potassium in a 640-bed teaching hospital were evaluated to determine the potential usefulness of the drug in the institution. The review revealed frequent use of the drug for inappropriate indications and in situations for which less expensive antimicrobials were appropriate. The results demonstrate that an increase in costs can occur when an agent that is being considered for formulary addition--because of its cost-saving potential--is not used as expected. In order to optimally utilize the clinical or cost advantages of newer antimicrobials, a program of prescriber education, drug use controls or guidelines, and a concurrent monitoring program may be required and should be implemented at the time of initial drug use within an institution.

Establishing benchmarks and metrics for disruptive technologies, inappropriate and obsolete tests in the clinical laboratory.

PubMed

Kiechle, Frederick L; Arcenas, Rodney C; Rogers, Linda C

2014-01-01

Benchmarks and metrics related to laboratory test utilization are based on evidence-based medical literature that may suffer from a positive publication bias. Guidelines are only as good as the data reviewed to create them. Disruptive technologies require time for appropriate use to be established before utilization review will be meaningful. Metrics include monitoring the use of obsolete tests and the inappropriate use of lab tests. Test utilization by clients in a hospital outreach program can be used to monitor the impact of new clients on lab workload. A multi-disciplinary laboratory utilization committee is the most effective tool for modifying bad habits, and reviewing and approving new tests for the lab formulary or by sending them out to a reference lab. Copyright © 2013 Elsevier B.V. All rights reserved.

From Materia Medica to the Pharmacopoeia: Challenges of Writing the History of Drugs in India

PubMed Central

2016-01-01

Abstract Historians of indigenous medicine in colonial India have looked more closely at the changes, reinventions and reformulations of institutions of Ayurveda and Unani than at the cognitive content of the drugs themselves. The few historians who have examined the changing content of indigenous medicines have conceptualised the creation of materia medica of Indian drugs through two tropes: one of circulation (of specific drugs) through epistemological and geographic boundaries and the second, of marginalisation of certain other drugs either through a lack of textual legitimacy or the lack of the newly discovered ‘active principles’ within each drug. While these approaches have been useful, there is a case to be made for understanding the creation of formularies of Indian drugs in 19th and 20th centuries through the prism of medical praxis in India. PMID:27570491

Antimicrobial stewardship

PubMed Central

Chung, Gladys W.; Wu, Jia En; Yeo, Chay Leng; Chan, Douglas; Hsu, Li Yang

2013-01-01

Antimicrobial stewardship is an emerging field currently defined by a series of strategies and interventions aimed toward improving appropriate prescription of antibiotics in humans in all healthcare settings. The ultimate goal is the preservation of current and future antibiotics against the threat of antimicrobial resistance, although improving patient safety and reducing healthcare costs are important concurrent aims. Prospective audit and feedback interventions are probably the most widely practiced of all antimicrobial stewardship strategies. Although labor-intensive, they are more easily accepted by physicians compared with formulary restriction and preauthorization strategies and have a higher potential for educational opportunities. Objective evaluation of antimicrobial stewardship is critical for determining the success of such programs. Nonetheless, there is controversy over which outcomes to measure and there is a pressing need for novel study designs that can objectively assess antimicrobial stewardship interventions despite the limitations inherent in the structure of most such programs. PMID:23302793

Prospective-pricing strategies for hospital and departmental effectiveness: the pharmacist's response.

PubMed

Gouveia, W A

1985-10-01

Strategies a pharmacy department used to identify product costs and cost of drug therapy by case type are discussed. To define its intermediate products, the pharmacy identified 300 of 7500 line items on the formulary as representing 95% of its drug costs. This information, coupled with workload measures and component costs such as labor and supplies, was used to identify the cost of the pharmacy's products. A retrospective drug-therapy analysis conducted on total-hip-replacement procedures showed that drugs can be indicators of the severity of medical problems and hence good predictors of total hospital cost per case. Intermediate-product costing can be used to determine end-product profitability. Clinical pharmacists can help substantially in trying to determine the total cost of drug therapy, and they can help by developing standard treatment patterns with cost standards for treating patients in specific DRGs.

Reducing pain during the removal of adhesive and adherent products.

PubMed

Denyer, Jacqueline

Silicone Medical Adhesive Removers (SMARs) have proved a valuable addition to formularies. In the absence of SMARs, trauma following removal of adhesive dressings, ostomy products, retention tapes and monitoring equipment can lead to skin stripping or extension of existing wounds. Those at increased risk of skin stripping include groups such as older people, premature infants and neonates and those with skin fragility syndromes. Appeel® Sterile Sachet (CliniMed) is a sterile SMAR in liquid form supplied in a single-use sachet. The addition of this sterile product to the existing Appeel range of wipes and aerosols provides an adhesive remover suitable for use on broken skin. Unlike delivery from an aerosol, Appeel Sterile Sachet does not feel cold on application, a sensation which can be confused with pain. This article discusses the value of SMARs and in particular the advantages of using the single-use Appeel Sterile Sachet.

Ontological approach for safe and effective polypharmacy prescription

PubMed Central

Grando, Adela; Farrish, Susan; Boyd, Cynthia; Boxwala, Aziz

2012-01-01

The intake of multiple medications in patients with various medical conditions challenges the delivery of medical care. Initial empirical studies and pilot implementations seem to indicate that generic safe and effective multi-drug prescription principles could be defined and reused to reduce adverse drug events and to support compliance with medical guidelines and drug formularies. Given that ontologies are known to provide well-principled, sharable, setting-independent and machine-interpretable declarative specification frameworks for modeling and reasoning on biomedical problems, we explore here their use in the context of multi-drug prescription. We propose an ontology for modeling drug-related knowledge and a repository of safe and effective generic prescription principles. To test the usability and the level of granularity of the developed ontology-based specification models and heuristic we implemented a tool that computes the complexity of multi-drug treatments, and a decision aid to check the safeness and effectiveness of prescribed multi-drug treatments. PMID:23304299

Prevalence of antibiotic resistance in adult septic patients of H. Adam Malik central general hospital, Medan under Indonesia’s mandatory health scheme

NASA Astrophysics Data System (ADS)

Tillasman, N. S.; Saragih, R. H.; Umar, N.

2018-03-01

Sepsis is a severe bacterial infection whose treatment still varies in preference. However, for more than 60 years, antibiotics have been regarded as the panacea, as long as they are used wisely and timely. Antibiotic resistance has escalated in recent years, resulting in an accelerating global health security emergency, that is rapidly outpacing available treatment options. In January 2014, the new mandatory health insurance scheme (JKN) was introduced, whose treatments must comply with National Formulary (FORNAS) policy. We aimed to systematically review the prevalence of antibiotic resistance to FORNAS policy’s preferential treatments in adult septic patients who had been in the non-surgical wards. Based on an overall view, 76 out of 90 kinds of antibiotics which had undergone antibiotic susceptibility test (AST) had alarming resistance rate and preferential antibiotics in the current JKN scheme may have become ineffective.

Direct procurement of wound management products.

PubMed

Jenkins, Trevor

2014-03-01

This article describes a collaborative project between Bedfordshire Community Health Services and Primary Care Trusts/Clinical Commissioning Groups to improve provision of dressings to nurses for the patients they treat. Commissioners have facilitated a transformational approach and encouraged development of efficient systems of increased cost-effectiveness rather than a transactional approach based on opportunistic cost improvement plans. Reconfiguration to direct procurement from GP prescribing has reduced wastage, released nurse time from processes to spend on clinical contact time with patients, increased efficiency, and reduced prescription workload for GPs, all without adverse effects on expenditure. Establishing a wound care products formulary placed control under the nurses treating patients and facilitated decision-making based on cost-effectiveness in clinical use. Nurses now manage 60% of expenditure in the local community health economy, and this is increasing. Relationships with the dressings manufacturing industry have also changed in a positive, constructive direction.

Evidence-based decision-making within Australia's pharmaceutical benefits scheme.

PubMed

Lopert, Ruth

2009-07-01

In Australia, most prescription drugs are subsidized through the Pharmaceutical Benefits Scheme (PBS), one of several government programs in which evidence-based decision making is applied to the funding of health technologies. PBS processes are intended to ensure "value for money" for the Australian taxpayer and to support affordable, equitable access to prescription medicines; they are not intended as a mechanism for cost containment. The inclusion of a drug on the national formulary depends on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC), which considers not only the comparative effectiveness but also the comparative cost-effectiveness of drugs proposed for listing. While some decisions have been controversial, the PBS retains strong public support. Moreover, evidence does not suggest that the consideration of cost-effectiveness has created a negative environment for the drug industry: Australia has a high penetration of patented medicines, with prices for some recently approved drugs at U.S. levels.

Improving the delivery of care and reducing healthcare costs with the digitization of information.

PubMed

Noffsinger, R; Chin, S

2000-01-01

In the coming years, the digitization of information and the Internet will be extremely powerful in reducing healthcare costs while assisting providers in the delivery of care. One example of healthcare inefficiency that can be managed through information digitization is the process of prescription writing. Due to the handwritten and verbal communication surrounding prescription writing, as well as the multiple tiers of authorizations, the prescription drug process causes extensive financial waste as well as medical errors, lost time, and even fatal accidents. Electronic prescription management systems are being designed to address these inefficiencies. By utilizing new electronic prescription systems, physicians not only prescribe more accurately, but also improve formulary compliance thereby reducing pharmacy utilization. These systems expand patient care by presenting proactive alternatives at the point of prescription while reducing costs and providing additional benefits for consumers and healthcare providers.

Economic evaluation of interventions for problem drinking and alcohol dependence: cost per QALY estimates.

PubMed

Mortimer, Duncan; Segal, Leonie

2005-01-01

To compare the performance of competing and complementary interventions for prevention or treatment of problem drinking and alcohol dependence. To provide an example of how health maximising decision-makers might use performance measures such as cost per quality adjusted life year (QALY) league tables to formulate an optimal package of interventions for problem drinking and alcohol dependence. A time-dependent state-transition model was used to estimate QALYs gained per person for each intervention as compared to usual care in the relevant target population. Cost per QALY estimates for each of the interventions fall below any putative funding threshold for developed economies. Interventions for problem drinkers appear to offer better value than interventions targeted at those with a history of severe physical dependence. Formularies such as Australia's Medicare should include a comprehensive package of interventions for problem drinking and alcohol dependence.

Antimicrobial stewardship programs: interventions and associated outcomes.

PubMed

Patel, Dimple; Lawson, Wendy; Guglielmo, B Joseph

2008-04-01

Guidelines regarding antimicrobial stewardship programs recommend an infectious diseases-trained physician and an infectious diseases-trained pharmacist as core members. Inclusion of clinical microbiologists, infection-control practitioners, information systems experts and hospital epidemiologists is considered optimal. Recommended stewardship interventions include prospective audit and intervention, formulary restriction, education, guideline development, clinical pathway development, antimicrobial order forms and the de-escalation of therapy. The primary outcome associated with these interventions has been the associated cost savings; however, few published investigations have taken into account the overall cost of the intervention. Over the past 5 years, there has been an increased focus upon interventions intended to decrease bacterial resistance or reduce superinfection, including infections associated with Clostridium difficile colitis. Few programs have been associated with a reduction in antimicrobial drug adverse events. Antimicrobial stewardship programs are becoming increasingly associated with clear benefits and will be integral in the in-patient healthcare setting.

Antimicrobial stewardship: a review of prospective audit and feedback systems and an objective evaluation of outcomes.

PubMed

Chung, Gladys W; Wu, Jia En; Yeo, Chay Leng; Chan, Douglas; Hsu, Li Yang

2013-02-15

Antimicrobial stewardship is an emerging field currently defined by a series of strategies and interventions aimed toward improving appropriate prescription of antibiotics in humans in all healthcare settings. The ultimate goal is the preservation of current and future antibiotics against the threat of antimicrobial resistance, although improving patient safety and reducing healthcare costs are important concurrent aims. Prospective audit and feedback interventions are probably the most widely practiced of all antimicrobial stewardship strategies. Although labor-intensive, they are more easily accepted by physicians compared with formulary restriction and preauthorization strategies and have a higher potential for educational opportunities. Objective evaluation of antimicrobial stewardship is critical for determining the success of such programs. Nonetheless, there is controversy over which outcomes to measure and there is a pressing need for novel study designs that can objectively assess antimicrobial stewardship interventions despite the limitations inherent in the structure of most such programs.

Expanding medicines for neurologic disorders on the WHO Model List.

PubMed

Rimmer, Kathryn; Shah, Hiral; Thakur, Kiran

2017-03-07

The WHO Model List of Essential Medicines is a recommended formulary for high-priority diseases based on public health trends and epidemiology patterns. The biennial publication serves as a guide for countries, particularly low- and lower-middle-income countries, to develop their own national essential medicines list (EML), and many nongovernmental organizations base their medication supplies on the WHO EML. Over the last 40 years, WHO has expanded the EML in response to treatment gaps for infectious diseases, pediatrics, palliative care, and cancer. In contrast, neurotherapeutics are poorly represented on the Model List despite the global burden of neurologic disorders, which have continued to increase in the last decade. It is imperative that the neurology community advocate for more evidence-based neurologic medicines on the WHO EML. Equitable access to essential neurologic medicines is a crucial step toward reducing the treatment gap for high-burden neurologic disorders worldwide. © 2017 American Academy of Neurology.

When do doctors follow patients' orders? Organizational mechanisms of physician influence.

PubMed

Menchik, Daniel A; Jin, Lei

2014-11-01

Physicians, like other professionals, are expected to draw from specialized knowledge while remaining receptive to clients' requests. Using nationally representative U.S. survey data from the Community Tracking Study, this paper examines the degree to which physicians are influenced by patients' requests, and how physicians' workplaces may mediate acquiescence rates through three mechanisms: constraints, protection, and incentives. We find that, based on physicians' reports of their responses to patients' suggestions, patient influence is rare. This influence is least likely to be felt in large workplaces, such as large private practices, hospitals, and medical schools. We find that the protection and incentives mechanisms mediate the relationship between workplace types and physician acquiescence but more prescriptive measures such as guidelines and formularies do not affect acquiescence. We discuss these findings in light of the ongoing changes in the structure of medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

Basics of Compounding with Dilutions and Concentrates.

PubMed

Allen, Loyd V

2017-01-01

Pharmacists use various sources for obtaining the active pharmaceutical ingredient for compounding medications. In many cases, it is the pure drug (United States Pharmacopeia, National Formulary, or similar grade); in some cases, it can be a commercial dosage form; and, in some cases, it may be a dilution or concentrate. If the drug is not present at full strength, then adjustments may be necessary to obtain the required quantity of drug. Also, in many cases, it is necessary to use a dilution or a concentrate of a drug due to safety and quality reasons. Presented within this article are new sources of active pharmaceutical ingredients that are now available to aid pharmacists in meeting future United States Pharmacopeia <800> standards. It is critical that the pharmacist be aware of the strength of the drug and any other excipients that may be available. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Overview of the arthritis Cost Consequence Evaluation System (ACCES): a pharmacoeconomic model for celecoxib.

PubMed

Pettitt, D; Goldstein, J L; McGuire, A; Schwartz, J S; Burke, T; Maniadakis, N

2000-12-01

Pharmacoeconomic analyses have become useful and essential tools for health care decision makers who increasingly require such analyses prior to placing a drug on a national, regional or hospital formulary. Previous health economic models of non-steroidal anti-inflammatory drugs (NSAIDs) have been restricted to evaluating a narrow range of agents within specific health care delivery systems using medical information derived from homogeneous clinical trial data. This paper summarizes the Arthritis Cost Consequence Evaluation System (ACCES)--a pharmacoeconomic model that has been developed to predict and evaluate the costs and consequences associated with the use of celecoxib in patients with arthritis, compared with other NSAIDs and NSAIDs plus gastroprotective agents. The advantage of this model is that it can be customized to reflect local practice patterns, resource utilization and costs, as well as provide context-specific health economic information to a variety of providers and/or decision makers.

The long-term value of the selected list as a method of controlling drug costs in a district general hospital.

PubMed

Upton, D R; Holmes, G K; Fox, P D; Cullen, A M; Poston, J W

1989-02-01

The results of a study aimed at evaluating the long-term effects of the Limited List (now officially referred to as the Selected List Scheme) on inpatient drug costs in a district general hospital (DGH) are presented. Study periods of six months duration were examined before, shortly after, and a further year after implementation of the List on 1 April 1985. Eight therapeutic classes affected by the regulations were examined; in four of these (antacids, expectorants, mucolytics and anxiolytics, hypnotics and sedatives) statistically significant reductions in costs were demonstrated over the study periods. There was no significant change in the costs of the other four classes (vitamins, laxatives, nasal preparations and analgesics). Overall, inpatient expenditure for the hospital showed no significant change. The changes in cost demonstrated can be attributed to the Selected List and occurred despite the prior existence of a local formulary.

Challenges for Managed Care from 340B Contract Pharmacies.

PubMed

Fein, Adam J

2016-03-01

The federal 340B Drug Pricing Program has expanded rapidly, with important yet still unmeasured impact on both managed care practice and policies. Notably, providers increasingly rely on external, contract pharmacies to extend 340B pricing to a broad set of patients. In 2014, 1 in 4 U.S. retail, mail, and specialty pharmacy locations acted as contract pharmacies for 340B-covered entities. This commentary discusses crucial ways in which 340B growth is affecting managed care pharmacy through formulary rebates, profits from managed care paid prescriptions, disruption of retail pharmacy networks, and reduced generic dispensing rates. Managed care should become more engaged in the discussion on how the 340B program should evolve and offer policy proposals to mitigate the challenges being encountered. There is also an urgent need for objective, transparent research on the 340B program's costs, benefits, and implications for managed care pharmacy and practice.

Drug interaction of levothyroxine with infant colic drops.

PubMed

Balapatabendi, Mihirani; Harris, David; Shenoy, Savitha D

2011-09-01

Infacol (Forest Laboratories UK, Kent, UK) is a widely available over-the-counter preparation used to relieve colic symptoms in neonates and infants. The active ingredient is simeticone. No drug interactions with simeticone are documented in the current summary of product characteristics. The authors report the case of an infant with confirmed congenital hypothyroidism on levothyroxine who experienced a possible drug interaction with simeticone. Despite adequate levothyroxine dosage, thyroid stimulating hormone (TSH) was high, suggesting undertreatment. Questioning revealed the child was taking Infacol drops before feeds while on levothyroxine. The colic drops were immediately discontinued and TSH promptly normalised with a reduction in thyroxine requirement to an age appropriate dosage. Drug interaction of thyroxine with simeticone has not been reported previously and is not listed in the British National Formulary for Children. Clinicians and parents need to be aware of this interaction to avoid unnecessary undertreatment and prevent potential long-term neurological sequelae.

Regulating pharmaceutical advertising: What will work?

PubMed Central

Shapiro, M F

1997-01-01

As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public. PMID:9033416

Issues in formulary management: therapeutic interchange. The value, cost, and quality of therapeutic interchange.

PubMed

Mahoney, C D

1992-10-01

Therapeutic interchange is a process of substituting a prescribed medication with one that offers therapeutic and cost benefits. The practice not only provides short-term savings but also is associated with decreases in lengths of stay in hospitals and total hospital drug expenses. There may be medicolegal implications when FDA-approved indications differ for interchanged drugs. The potential for liability is decreased when a standard of care is met, but since standards can change, guidelines should be reviewed regularly. High-tech, high-cost drugs are sometimes appropriate for therapeutic interchange. Pharmacy and therapeutics committees should assure best value by considering indirect expenses, quality, and therapeutic outcome, as well as product cost. Therapeutic interchange programs enable pharmacy managers to neutralize or at least slow the rate of drug cost increases, ensuring appropriate utilization of resources and more favorable patient outcomes.

Key Value Considerations for Consultant Pharmacists.

PubMed

Meyer, Lee; Perry, Ronald G; Rhodus, Susan M; Stearns, Wendy

2016-07-01

Managing the efficiency and costs of residents' drug regimens outside the acute-care hospital and through transitions of care requires a toolbox filled with cost-control tools and careful collaboration among the pharmacy provider(s), facility staff, and the consultant/senior care pharmacist. This article will provide the reader with key long-term care business strategies that affect the profitability of the pharmacy provider in various care settings while, at the same time, ensuring optimal therapy for residents as they transition across levels of care. Readers can take away ideas on how to access critical information, what they can do with this information, and how they can improve the overall care process. Four experts in various aspects of pharmacy management share their insights on pharmacy practice issues including formulary management, performance metrics, short-cycle dispensing challenges/solutions, cost-control measures, facility surveys, billing practices, medication reconciliation, prospective medication reviews, and transitions of care.

A monograph assignment as an integrative application of evidence-based medicine and pharmacoeconomic principles.

PubMed

Law, Anandi V; Jackevicius, Cynthia A; Bounthavong, Mark

2011-02-10

To describe the development and assessment of monographs as an assignment to incorporate evidence-based medicine (EBM) and pharmacoeconomic principles into a third-year pharmacoeconomic course. Eight newly FDA-approved drugs were assigned to 16 teams of students, where each drug was assigned to 2 teams. Teams had to research their drug, write a professional monograph, deliver an oral presentation, and answer questions posed by faculty judges. One team was asked to present evidence for inclusion of the drug into a formulary, while another team presented evidence against inclusion. The teams' average score on the written report was 99.1%; on the oral presentation, 92.5%, and on the online quiz given at the end of the presentations, 77%. Monographs are a successful method of incorporating and integrating learning across different concepts, as well as increasing relevance of pharmacoeconomics in the PharmD curriculum.

A Monograph Assignment as an Integrative Application of Evidence-Based Medicine and Pharmacoeconomic Principles

PubMed Central

Jackevicius, Cynthia A.; Bounthavong, Mark

2011-01-01

Objective To describe the development and assessment of monographs as an assignment to incorporate evidence-based medicine (EBM) and pharmacoeconomic principles into a third-year pharmacoeconomic course. Design Eight newly FDA-approved drugs were assigned to 16 teams of students, where each drug was assigned to 2 teams. Teams had to research their drug, write a professional monograph, deliver an oral presentation, and answer questions posed by faculty judges. One team was asked to present evidence for inclusion of the drug into a formulary, while another team presented evidence against inclusion. Assessment The teams' average score on the written report was 99.1%; on the oral presentation, 92.5%, and on the online quiz given at the end of the presentations, 77%. Conclusions Monographs are a successful method of incorporating and integrating learning across different concepts, as well as increasing relevance of pharmacoeconomics in the PharmD curriculum. PMID:21451753

Regulating pharmaceutical advertising: what will work?

PubMed

Shapiro, M F

1997-02-01

As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.

Assessment of drug use patterns in terms of the WHO patient-care and facility indicators at four hospitals in Southern Ethiopia: a cross-sectional study.

PubMed

Gidebo, Kassa Daka; Summoro, Temesgen Sidamo; Kanche, Zewde Zema; Woticha, Eskinder Wolka

2016-11-10

Patient-centered care is now the goal for virtually all healthcare systems. The aim of this research was to evaluate the patient care quality in regard to drug dispensing in four hospitals in southern Ethiopia namely Wolaita Sodo University teaching and referral hospital (WSUTRH), Tercha zonal hospital (TZH), Sodo Christian hospital (SCH) and Dubo St. Mary's Catholic primary hospital (DSMCPH). A cross sectional study was conducted by using the WHO patient care and facility indicators between September 10 and October 20, 2014. Patients who visited the outpatient departments of the four hospitals were selected by systematic random sampling method and interviewed. In total 384 patients were selected based on a rough estimate of proportion of patients visiting to the four hospitals. Facility indicators including the availability of essential drugs list (EDL), national drug formulary, standard treatment guideline (STG) and key drugs were evaluated. Descriptive statistical calculations were performed using SPSS® version 20.0 software. The mean number of drugs was in the range between 1.9 ± 0.9 to 2.2 ± 2.0. The mean consultation time range was found to be 4.2 ± 1.6 to 4.9 ± 5.0 min whereas the mean dispensing time was ranged from 96.1 ± 52.0 to 152.3 ± 47.6 s. The overall mean number of drug prescribed for the four hospitals was 2.0 ± 1.2 and the mean percentage of medications actually dispensed in the hospitals was thus calculated to be 86.3. The mean percentage of medications clearly labeled was 45.4. Patients who knew their dosage forms accurately were 78.8. Among the four hospitals evaluated only one hospital (25 %) had at least a copy of the Ethiopian essential drug list (EDL), standard treatment guideline for hospitals and drug formulary. The mean availability of key drugs in the hospitals was found to be 65.7 %. The result of the present study indicates that the patient consulting time, medications labeling and availability of key drugs in the hospitals are inadequate. The medication labeling practice in the four hospitals is unacceptably low. These patient care indicators need a special attention for improvement.

Provincial Disparities of Growth Hormone Coverage for Young Adult Survivors of Paediatric Brain Tumours across Canada

PubMed Central

Hasan, Haroon; Howard, Fuchsia; Morgan, Steven G.; Metzger, Daniel L.; Gill, Sabrina; Johnson, Michelle; Lo, Andrea C.; Goddard, Karen

2014-01-01

Background: Young adult survivors of paediatric brain tumours (PBTs) who have been treated with radiation therapy will likely be severely growth hormone–deficient when retested at the achievement of final height. Growth hormone replacement therapy (GHRT) is administered to treat growth hormone deficiency (GHD). Public drug coverage for GHRT falls under the responsibility of provincial governments across Canada. This study sought to determine the extent of public drug coverage and cost in each Canadian province for GHRT to treat GHD during adulthood for young adult survivors of PBTs. Methods: Data were collected from provincial government resources and drug formularies from 2012–2013 on the extent of coverage for GHRT based on a clinical case scenario representative of a young adult survivor of a PBT with childhood-onset radiation-induced GHD, the ingredient cost for GHRT and the applicable provincial public drug plan cost-sharing policies. A model was then created to simulate out-of-pocket costs incurred by a young adult male and a young adult female survivor of a PBT for one year of GHRT in each province with applicable cost-sharing arrangements and levels of low annual individual total income that best represent the majority of young adult survivors of PBTs. Out-of-pocket costs were expressed as a percentage of annual income. Comparisons were made between provinces descriptively, and variation among provinces was summarized statistically. Results: Alberta, Manitoba, Ontario, Quebec, New Brunswick, and Newfoundland and Labrador provide coverage for GHD during adulthood on a case-by-case basis, while British Columbia, Saskatchewan, Nova Scotia and Prince Edward Island provide no coverage. The percentage of annual income to fund GHRT across the provinces without public coverage ranged from 14.4% to 25.5% for males and 21.5% to 38.3% for females, and with public coverage was 0.0% to 4.1% for males and 0.0% to 5.0% for females. Interpretation: There are considerable out-of-pocket costs and variation in coverage provided by provincial public drug plans to fund GHRT for young adult survivors of PBTs with GHD. The implementation of a national drug formulary could potentially prevent undue financial hardship and remove disparities resulting from variations in provincial drug plans. PMID:24726076

Current national initiatives about drug policies and cost control in Europe: the Italy example.

PubMed

Rocchi, Francesca; Addis, Antonio; Martini, Nello

2004-01-01

Pharmaceutical expenditure is a challenge to the financial compatibility of health systems because it is growing faster (+11% per year in the last 5 years in Italy) than any other health sector. In order to curb public pharmaceutical expenditure 2 interventions are commonly used: delisting (de-reimbursement) and reference price, with the difference being paid by patients. The Italian Ministry of Health implemented a set of interventions with the general aim of pharmaceutical governance based on the following criteria: (a) to assure a complete coverage of all clinically and epidemiologically relevant diseases; (b) to provide health professionals with a range of different active drugs with the same therapeutic indications within the same therapeutic class; and (c) to identify a reimbursement threshold in order to save public money by narrowing the (wide) price differentials among drugs with comparable efficacy and safety. In this context, interventions have been undertaken at several levels including drug price reduction, generic drug promotion, delisting of drugs reimbursed, and direct distribution of medicines (by hospital services). Furthermore, a new National Pharmaceutical Formulary has been implemented. Medicines have been classified into homogeneous categories (ie, medicines with the same main indication(s) and with similar clinical efficacy and safety profile). Within each homogeneous category, a reimbursement level (cutoff) was then identified and, accordingly, pharmaceutical companies were asked to adjust their price. This adjustment was based on price per daily drug dose (DDD), cumulative expenditure (at least 50%), and cumulative utilization (at least 60%). This readjustment, at no cost for patients, is expected to save more than Euro 280 million of public money. Seventy-seven percent of this saving will be due to price readjustment of antiulcers, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, and some antibiotics (mainly cephalosporins). The Italian system was able to cover all relevant diseases and ensured citizens and health professionals a choice among a wide range of valid pharmacological therapies. At the same time it was able to save public money by narrowing wide price differentials among drugs with comparable clinical properties. The set of interventions yielded a new national formulary that was able to have a significant influence on the trend of drug expenditure in Italy. This experience can be a useful reference for other European and non-European states.

Non-medical prescribing of chemotherapy: engaging stakeholders to maximise success?

PubMed

Lennan, Elaine

2014-01-01

This study report examines the views and experiences of professional stakeholders about non-medical prescribing (NMP) of chemotherapy. The introduction of open formulary NMP has created opportunities to radically change health-care delivery. For chemotherapy services, the most recent advice from the National Chemotherapy Advisory Group [Department of Health (2009) Chemotherapy Services in England, ensuring quality and safety: a report from the National Chemotherapy Advisory Group, London Her Majesty's Stationary Office] clearly endorses the development of nurse- or pharmacist-led chemotherapy clinics. This is very much welcomed but is based on very limited evidence as to their effectiveness. A fourth-generation evaluation study. A purposeful sample of 23 stakeholders connected with the chemotherapy service was used. A serial data collection technique with individual interviews followed by uni-professional focus groups was adopted. Finally, a multi-professional focus group was held to determine the strategic way forward. Data were collected in 2009-2010. The study illuminated the key features necessary to maximise success of NMP in chemotherapy clinics and captures the importance of good working relationships. Whilst different practice models will emerge, fundamental and core to services is the need for good team working, established and effective communication strategies, and most importantly avoiding isolation in practice. This study additionally reinforced any evaluation takes place within preexisting political contexts and in particular medical dominance. Not all medical colleagues agreed with or wanted NMP for their patients, highlighting difficulties of developing new models of working within a resisting culture. No objections to NMP of chemotherapy were found, but, clearly, the context of practice needs to be agreed and supportedby all professional stakeholders. What is already known about this topicOpen formulary non-medical prescribing has been rapidly introduced over the past decade.Little research has been conducted in acute care and none in the chemotherapy setting.Cancer policy recommends the introduction of nurse-led chemotherapy clinics.What this paper addsNon-medical prescribing (NMP) in chemotherapy is appropriate with the right model of practice.Well-established professional relationships are a key to success.NMP is not appropriate in isolation of the multidisciplinary team (MDT).Implications for practice and/or policyNurses need to demonstrate the value of non-medical prescribing in chemotherapy using available metrics.Models of practice need to ensure good communication channels, MDT working, and transparency of prescribing.

ASP Strategies and Appropriate Antibiotic Use

PubMed Central

Lee, Brian R; Tribble, Alison; Handy, Lori; Gerber, Jeffrey S; Hersh, Adam L; Kronman, Matthew; Terrill, Cindy; Newland, Jason

2017-01-01

Abstract Background The Infectious Diseases Society of America (IDSA) recommends hospitals implement antimicrobial stewardship programs (ASP) in order to decrease inappropriate antibiotic use due to the rise in antibiotic-resistant infections. Data are limited on the extent to which different ASP strategies influence appropriate antibiotic use. Methods We conducted an online survey in 2016 of U.S. Children’s Hospitals to collect hospital-level information on dedicated ASP effort, ASP monitoring activities, use of audit-feedback, formulary restrictions, rapid diagnostics, etc. During the same period the ASP teams at these hospitals completed 3 point prevalence surveys that documented details on all admitted patients 0–17 years receiving any antibiotics, determined what ASP modifications could be made, and if the antibiotic was appropriate. We employed hierarchical, multivariable logit models to examine which ASP-related, hospital-level strategies were associated with appropriate antibiotic use. Results Thirty hospitals participated. A total of 6,921 patients were included, representing 10,068 total antibiotics. Of these orders, 8,554 (85.0%) were categorized as appropriate, though this varied across sites (range: 68-92%). Additionally, 78.2% of antibiotics did not have recommended modifications. Appropriate antibiotic use was significantly higher for hospitals that relied on rapid diagnostics (aOR: 1.6; P < 0.001) or monitored their days of therapy (DOT) rate (aOR: 1.4; P < 0.001), whereas the presence of either audit-feedback (aOR: 1.04; P = 0.75) or formulary restrictions (aOR: 0.83; P = 0.059) were not associated. Having annual education for all prescribers had increased likelihood of antibiotics having no modification recommendations (aOR: 1.45; P = 0.037). Total ASP FTE was not correlated with hospital-level percent appropriate use (corr: −0.05; P = 0.79) or antibiotic modification recommendations (corr: −0.08; P = 0.67). Conclusion Routine monitoring of DOT rates and utilization of rapid diagnostics were associated with appropriate antibiotic use. Additional analysis is needed to understand additional factors that can aid hospitals in developing and maintaining ASPs to reduce inappropriate antibiotic use. Disclosures B. R. Lee, Merck: Grant Investigator, Grant recipient. PCORI: Grant Investigator, Grant recipient. C. Terrill, Merck: Grant Investigator, Research grant Allergan: Grant Investigator, Research grant. J. Newland, Merck: Grant Investigator, Research grant. Allergan: Grant Investigator, Research grant

AMCP Partnership Forum: FDAMA Section 114-Improving the Exchange of Health Care Economic Data.

PubMed

2016-07-01

The Food and Drug Administration Modernization Act (FDAMA) of 1997 included Section 114 as a regulatory safe harbor with the goal of increasing the dissemination of health care economic information (HCEI) to those responsible for formulary decision making. HCEI is typically not included within FDA-approved labeling. Although it has been nearly 20 years since passage and enactment of Section 114, proactive distribution of HCEI has been underutilized by biopharmaceutical companies partly because of (a) vague wording in the statute and (b) the absence of FDA-implementing regulations. Consequently, companies and health care decisions makers have had to speculate about the scope of the provisions. As a result, the biopharmaceutical industry has significant concerns about stepping over the line when using the safe harbor. Also, payers and other "payer-like" decision makers (e.g., self-funded corporate insurers) who are trying to make appropriate coverage and utilization decisions are demanding this information but are not receiving it because of the uncertainties in the statute. Considering this renewed interest by multiple stakeholders regarding the need for revisions and/or guidance pertaining to Section 114, the Academy of Managed Care Pharmacy held a partnership forum on March 1-2, 2016, with a diverse group of health care stakeholders to provide the FDA with considerations for disseminating a guidance document on current thinking for the sharing of HCEI with health care decision makers. Forum participants represented the managed care industry, biopharmaceutical industry, health care providers, pharmacoeconomic experts, policy experts, and patient advocacy groups with specific expertise in the development, use, and dissemination of HCEI. The multistakeholder group represented the key professionals and entities affected by the provisions of Section 114 and present the collective credibility necessary for Congress and the FDA to modernize and operationalize the safe harbor by using the consensus recommendations developed during the forum. Speakers, panelists, and attendees focused on 4 terms in Section 114 that remain open to interpretation by companies and enforcement bodies: (1) the scope of HCEI, (2) the scope of "formulary committee or similar entity," (3) the definition of "competent and reliable scientific evidence (CRSE)," and (4) the parameters of how information "directly relates to an approved indication." Based on the forum results, it was recommended that the safe harbor for companies' proactive dissemination of information under Section 114 should include health care decision makers beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations. Recommendations also suggested expansion to organizations that evaluate HCEI or develop value frameworks and compendia and individuals in such organizations. Forum participants also recommended that HCEI be truthful, and not misleading, and be based on the expertise of professionals in the relevant area. HCEI must also be developed and disclosed in a transparent, reproducible, and accurate manner. Forum participants also discussed and agreed on the types of information, format, and processes by which managed care pharmacy and other health care decision makers seek to receive HCEI from biopharmaceutical companies. Finally, participants encouraged the FDA, Congress, and other stakeholders to find ways to ensure that patients or their representative organizations have appropriate access to a full range of information about their medications and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner. The AMCP Partnership Forum on FDAMA Section 114-Improving the Exchange of Pharmacoeconomic Data and the development of this proceedings document were supported by AbbVie, Amgen, Boehringer Ingelheim Pharmaceuticals, Merck & Co., National Pharmaceutical Council, Pharmaceutical Research and Manufacturers of America, Precision for Value, Pfizer, Takeda Pharmaceuticals, U.S.A., and Xcenda. All sponsors participated in the forum and participated in revising and approving the manuscript.

Evaluation of Patient Migration Patterns and Related Health Care Costs Within a National Medicare Advantage Prescription Drug Plan After Implementation of an Oxycodone HCl Extended-Release Access Restriction.

PubMed

Chen, Chi-Chang; De, Ajita P; Sweet, Brian; Wade, Rolin L

2017-08-01

Health plans use formulary restrictions (e.g., prior authorization, step therapy, tier change, nonformulary status) in an effort to control cost and promote quality, safety, and appropriate prescription utilization. Some Medicare payers perceive that the inclusion of certain agents, such as branded oxycodone HCl extended-release tablets (OERs), on their formularies is associated with attracting high-cost members to the plan. To evaluate disenrollment rates, patient migration, and subsequent health care costs among OER users who disenrolled from a national Medicare Advantage Prescription Drug plan (study-MAPD) in the plan year following OER nonformulary restriction. A retrospective, longitudinal cohort study using IMS pharmacy and medical claims data between July 1, 2011, and December 31, 2014, was conducted. In the study-MAPD, adults aged ≥ 18 years who were chronic OER users with ≥ 2 OER claims 6 months before the nonformulary restriction date on January 1, 2013 (index date) and with continuous activity in pharmacy and medical claims for 6 months pre- and post-index were included in the study. Comparison years of 2012 and 2014 prerestriction/postrestriction were selected. All groups were followed for 6 months postindex. Year-to-year disenrollment rates of OER patients and the overall plan, as well as patient characteristics and costs of those who disenrolled from and those who remained with the plan, were measured. Costs were compared using a difference-in-differences approach. This study identified 2,935 eligible OER users from the study-MAPD population after imposing nonformulary restrictions on OERs on January 1, 2013. Mean age was 62.1 years, and 59.8% were female. The mean Charlson Comorbidity Index score was 1.83 for those 1,001 patients with medical claims data. For comparison years 2012 (prerestriction) and 2014 (postrestriction), 2,248 and 2,222 OER patients were identified, respectively. Patient characteristics were similar across patient cohorts in all 3 study years. Disenrollment rates for OER users (12.9%, 5.5%, and 14.3% for years 2012, 2013, and 2014, respectively) were lower or similar to those of the overall plan (18.3%, 7.6%, and 14.1%, respectively, for the same 3 years). Approximately 40% of OER users who disenrolled from the study-MAPD migrated to plans also imposing a nonformulary restriction on OERs, while about 25% moved to plans with less restrictive OER coverage. The majority (59.9%) of patients continued OER use irrespective of their disenrollment from the study-MAPD in 2013. Although a nonsignificant decrease ($117; P = 0.340) in per patient per month (PPPM) cost was observed among OER patients postrestriction (from 2012 to 2013), the difference-in-difference analysis indicated a net postrestriction increase of $124 (P = 0.461) in PPPM for OER patients. This study found little evidence to support any consistent directional effect on patient enrollment behavior as a result of an OER non-formulary restriction. Implementation of an OER nonformulary restriction did not lead to higher OER patient disenrollment or lower patient costs in the study-MAPD. Funding for this study was provided by Purdue Pharma. De, Chen, and Wade are employees of QuintilesIMS, a for-profit company that was contracted by Purdue Pharma to undertake this research. Sweet was a paid consultant for Purdue Pharma at the time of this study. Study concept and design were contributed by Chen, Wade, and De. Chen, De, and Wade collected the data, which were interpreted by all the authors. The manuscript was written by Chen and De, along with Sweet and Wade, and revised by all the authors.

Functional Integration

NASA Astrophysics Data System (ADS)

Cartier, Pierre; DeWitt-Morette, Cecile

2006-11-01

Acknowledgements; List symbols, conventions, and formulary; Part I. The Physical and Mathematical Environment: 1. The physical and mathematical environment; Part II. Quantum Mechanics: 2. First lesson: gaussian integrals; 3. Selected examples; 4. Semiclassical expansion: WKB; 5. Semiclassical expansion: beyond WKB; 6. Quantum dynamics: path integrals and operator formalism; Part III. Methods from Differential Geometry: 7. Symmetries; 8. Homotopy; 9. Grassmann analysis: basics; 10. Grassmann analysis: applications; 11. Volume elements, divergences, gradients; Part IV. Non-Gaussian Applications: 12. Poisson processes in physics; 13. A mathematical theory of Poisson processes; 14. First exit time: energy problems; Part V. Problems in Quantum Field Theory: 15. Renormalization 1: an introduction; 16. Renormalization 2: scaling; 17. Renormalization 3: combinatorics; 18. Volume elements in quantum field theory Bryce DeWitt; Part VI. Projects: 19. Projects; Appendix A. Forward and backward integrals: spaces of pointed paths; Appendix B. Product integrals; Appendix C. A compendium of gaussian integrals; Appendix D. Wick calculus Alexander Wurm; Appendix E. The Jacobi operator; Appendix F. Change of variables of integration; Appendix G. Analytic properties of covariances; Appendix H. Feynman's checkerboard; Bibliography; Index.

Functional Integration

NASA Astrophysics Data System (ADS)

Cartier, Pierre; DeWitt-Morette, Cecile

2010-06-01

Acknowledgements; List symbols, conventions, and formulary; Part I. The Physical and Mathematical Environment: 1. The physical and mathematical environment; Part II. Quantum Mechanics: 2. First lesson: gaussian integrals; 3. Selected examples; 4. Semiclassical expansion: WKB; 5. Semiclassical expansion: beyond WKB; 6. Quantum dynamics: path integrals and operator formalism; Part III. Methods from Differential Geometry: 7. Symmetries; 8. Homotopy; 9. Grassmann analysis: basics; 10. Grassmann analysis: applications; 11. Volume elements, divergences, gradients; Part IV. Non-Gaussian Applications: 12. Poisson processes in physics; 13. A mathematical theory of Poisson processes; 14. First exit time: energy problems; Part V. Problems in Quantum Field Theory: 15. Renormalization 1: an introduction; 16. Renormalization 2: scaling; 17. Renormalization 3: combinatorics; 18. Volume elements in quantum field theory Bryce DeWitt; Part VI. Projects: 19. Projects; Appendix A. Forward and backward integrals: spaces of pointed paths; Appendix B. Product integrals; Appendix C. A compendium of gaussian integrals; Appendix D. Wick calculus Alexander Wurm; Appendix E. The Jacobi operator; Appendix F. Change of variables of integration; Appendix G. Analytic properties of covariances; Appendix H. Feynman's checkerboard; Bibliography; Index.

An Elective Pharmaceutical Care Course to Prepare Students for an Advanced Pharmacy Practice Experience in Kenya

PubMed Central

Miller, Monica L.; Ogallo, William; Pastakia, Sonak D.

2013-01-01

Objective. To develop a prerequisite elective course to prepare students for an advanced pharmacy practice experience (APPE) in Kenya. Design. The course addressed Kenyan culture, travel preparation, patient care, and disease-state management. Instructional formats used were small-group discussions and lectures, including some Web-based presentations by Kenyan pharmacists on disease states commonly treated in Kenya. Cultural activities include instruction in conversational and medical Kiswahili and reading of a novel related to global health programs. Assessment. Student performance was assessed using written care plans, quizzes, reflection papers, a formulary management exercise, and pre- and post-course assessments. Student feedback on course evaluations indicated that the course was well received and students felt prepared for the APPE. Conclusion. This course offered a unique opportunity for students to learn about pharmacy practice in global health and to apply previously acquired skills in a resource-constrained international setting. It prepares students to actively participate in clinical care activities during an international APPE. PMID:23610478

A Framework for Integrating Biosimilars Into the Didactic Core Requirements of a Doctor of Pharmacy Curriculum.

PubMed

Li, Edward; Liu, Jennifer; Ramchandani, Monica

2017-04-01

Biologic drugs approved via the abbreviated United States biosimilar approval pathway are anticipated to improve access to medications by addressing increasing health care expenditures. Surveys of health care practitioners indicate that there is inadequate knowledge and understanding about biosimilars; this must be addressed to ensure safe and effective use of this new category of products. Concepts of biosimilar development, manufacturing, regulation, naming, formulary, and inventory considerations, as well as patient and provider education should be included within the doctor of pharmacy (PharmD) curriculum as preparation for clinical practice. Based on these considerations, we propose that PharmD graduates be required to have knowledge in the following domains regarding biologics and biosimilars: legal definition, development and regulation, state pharmacy practice laws, and pharmacy practice management. We link these general biosimilar concepts to the Accreditation Council for Pharmacy Education (ACPE) Standards 2016 and Center for the Advancement of Pharmacy Education (CAPE) Outcomes 2013, and provide example classroom learning objectives, in-class activities, and assessments to guide implementation.

Sparing carbapenem usage.

PubMed

Wilson, A Peter R

2017-09-01

Carbapenem resistance in Gram-negative bacteria is increasing in many countries and use of carbapenems and antibiotics to which resistance is linked should be reduced to slow its emergence. There are no directly equivalent antibiotics and the alternatives are less well supported by clinical trials. The few new agents are expensive. To provide guidance on strategies to reduce carbapenem usage. A literature review was performed as described in the BSAC/HIS/BIA/IPS Joint Working Party on Multiresistant Gram-negative Infection Report. Older agents remain active against some of the pathogens, although expectations of broad-spectrum cover for empirical treatment have risen. Education, expert advice on treatment and antimicrobial stewardship can produce significant reductions in use. More agents may need to be introduced onto the antibiotic formulary of the hospital, despite the poor quality of scientific studies in some cases. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Non-antibiotic antimicrobial interventions and antimicrobial stewardship in wound care.

PubMed

Cooper, Rose; Kirketerp-Møller, Klaus

2018-06-02

Control of wound infection today relies largely on antibiotics, but the continual emergence of antibiotic-resistant microorganisms threatens a return to the pre-antibiotic era when physicians used antiseptics to prevent and manage infection. Some of those antiseptics are still used today, and others have become available. A diverse variety of non-antibiotic antimicrobial interventions are found on modern formularies. Unlike the mode of action of antibiotics, which affect specific cellular target sites of pathogens, many non-antibiotic antimicrobials affect multiple cellular target sites in a non-specific way. Although this reduces the likelihood of selecting for resistant strains of microorganisms, some have emerged and cross-resistance between antibiotics and antiseptics has been detected. With the prospect of a post-antibiotic era looming, ways to maintain and extend our antimicrobial armamentarium must be found. In this narrative review, current and emerging non-antibiotic antimicrobial strategies will be considered and the need for antimicrobial stewardship in wound care will be explained.

Designing a strategy to promote safe, innovative off-label use of medications.

PubMed

Ansani, Nicole; Sirio, Carl; Smitherman, Thomas; Fedutes-Henderson, Bethany; Skledar, Susan; Weber, Robert J; Zgheib, Nathalie; Branch, Robert

2006-01-01

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors' strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

HIV, tobacco use, and poverty: a potential cause of disparities in health status by race and socioeconomic status.

PubMed

Sowah, Leonard Anang; Busse, Sarah; Amoroso, Anthony

2013-08-01

Tobacco use in the U.S. has declined significantly since the 1960s, but differentially by socioeconomic status. Current HIV (human immunodeficiency virus) infection rates in the United States are higher in minorities and underprivileged individuals. Effective highly active anti-retroviral therapy (HAART) has changed HIV into a chronic infection. Mortality among HIV patients is now as likely to be due to heart disease and cancers as HIV-related infections. In the current situation, one would expect public insurance plans to focus on interventions targeting lifestyle-associated behaviors such as tobacco use that have been found to be associated with increased risk for heart disease and cancers. Review of the AIDS Drug Assistance Program formularies and the Medicaid Programs of 50 states and the District of Columbia, however, revealed that coverage for smoking cessation is inadequate in most instances. To reduce health disparities, publicly funded programs that serve the nation's most vulnerable should provide coverage for effective tobacco cessation.

How should treatment costs impact on physician's decisions?

PubMed

Neymark, N

1999-01-01

This article first discusses at what level of clinical decision making cost considerations may be most pertinent and important. It is argued that cost assessments will be of most relevance and value at an intermediate level of clinical decision making i.e. at a level where so-called policy decisions are made. These are decisions such as which drugs to include in a hospital formulary or which standard treatment 'protocols' to choose for particular types of patients. The personal encounter between individual patients and physicians will take place within the framework of available treatment options determined by these policy decisions, which must necessarily be based on a prior assessment of the expected costs and benefits of treatments. The article goes on to give a brief introduction to the various methods of economic evaluation that have been developed in order to provide the decision makers with the means to make policy decisions on the basis of the most reliable and pertinent information possible.

Cost-benefit of a clinical services integrated with a decentralized unit dose system.

PubMed

Warrian, K; Irvine-Meek, J

1988-06-01

Clinical pharmacy services are believed to be beneficial to patient care and to have the potential to reduce drug costs. This study was designed to apply cost-benefit analysis techniques to selected clinical pharmacy services provided by staff pharmacists assigned to a mobile decentralized unit-dose drug distribution system. Pharmacists' interventions were identified and recorded by the pharmacists and the investigator over an eight-week period. Interventions, to which a monetary value could be assigned, included non-formulary drug use, drug regimen adjustments, and the duration of drug therapy. A total of 543 interventions were recorded or observed. Of these, 174 (32 percent) fit the criteria for inclusion in the study. Those interventions accepted by physicians (87 percent) were assigned a dollar value and tabulated. Costs to provide the service were the pharmacists' salaries. Benefit to cost ratios of 1.08 and 1.59 demonstrated that the benefits accrued from selected clinical pharmacy services exceeded the costs to the hospital.

Controversies in Antimicrobial Stewardship: Focus on New Rapid Diagnostic Technologies and Antimicrobials

PubMed Central

Wenzler, Eric; Wong, Jordan R.; Goff, Debra A.; Jankowski, Christopher A.; Bauer, Karri A.

2016-01-01

Antimicrobial stewardship programs (ASPs) are challenged with ensuring appropriate antimicrobial use while minimizing expenditures. ASPs have consistently demonstrated improved patient outcomes and significant cost reductions but are continually required to justify the costs of their existence and interventions due to the silo mentality often adopted by hospital administrators. As new technologies and antimicrobials emerge, ASPs are in a constant tug-of-war between providing optimal clinical outcomes and ensuring cost containment. Additionally, robust data on cost-effectiveness of new rapid diagnostic technologies and antimicrobials with subsequent ASP interventions to provide justification are lacking. As the implementation of an ASP will soon be mandatory for acute care hospitals in the United States, ASPs must find ways to justify novel interventions to align themselves with healthcare administrators. This review provides a framework for the justification of implementing a rapid diagnostic test or adding a new antimicrobial to formulary with ASP intervention, reviews approaches to demonstrating cost-effectiveness, and proposes methods for which ASPs may reduce healthcare expenditures via alternative tactics. PMID:27025521

An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system.

PubMed

Zuppa, Athena; Vijayakumar, Sundararajan; Jayaraman, Bhuvana; Patel, Dimple; Narayan, Mahesh; Vijayakumar, Kalpana; Mondick, John T; Barrett, Jeffrey S

2007-09-01

Drug utilization in the inpatient setting can provide a mechanism to assess drug prescribing trends, efficiency, and cost-effectiveness of hospital formularies and examine subpopulations for which prescribing habits may be different. Such data can be used to correlate trends with time-dependent or seasonal changes in clinical event rates or the introduction of new pharmaceuticals. It is now possible to provide a robust, dynamic analysis of drug utilization in a large pediatric inpatient setting through the creation of a Web-based hospital drug utilization system that retrieves source data from our accounting database. The production implementation provides a dynamic and historical account of drug utilization at the authors' institution. The existing application can easily be extended to accommodate a multi-institution environment. The creation of a national or even global drug utilization network would facilitate the examination of geographical and/or socioeconomic influences in drug utilization and prescribing practices in general.

Assessment and non-clinical impact of medical devices.

PubMed

Dervaux, Benoît; Szwarcensztein, Karine; Josseran, Anne; Barna, Alexandre; Carbonneil, Cédric; Chevrie, Karine; Debroucker, Frédérique; Grumblat, Anne; Grumel, Olivier; Massol, Jacques; Maugendre, Philippe; Méchin, Hubert; Orlikowski, David; Roussel, Christophe; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Vicaut, Eric

2015-01-01

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Results of the Arizona Medicaid health information technology pharmacy focus groups.

PubMed

Warholak, Terri L; Murcko, Anita; McKee, Megan; Urbine, Terry

2011-12-01

In 2007, a federal Medicaid Transformation Grant was awarded to design, develop, and deploy a statewide Health Information Exchange and Electronic Health Record in Arizona, United States. To explore the health information technology needs, knowledge, and expectations of Arizona's health care professionals, moderated focus groups were conducted. This article describes the results of the pharmacist focus groups. Focus group activities included a brief presentation, completion of a paper-based survey, and group discussion. The methods included solicitation by invitation, participant selection, meeting content, collaterals, focus group execution, recording, analysis, and discerning comparability among groups. Pharmacy focus group discussions centered on electronic prescribing, including the anticipated advantages: reducing handwriting interpretation errors, improving formulary compliance, improving communication with prescribers, increasing efficiency, and ensuring data accuracy. Disadvantages included: medication errors, inadequate training and knowledge of software applications, and inflated patient expectations. Pharmacists ranked e-prescribing as the highest priority feature of an electronic health system. Copyright © 2011 Elsevier Inc. All rights reserved.

Investigation of the central and peripheral analgesic and anti-inflammatory activity of Draksharishta an Indian Ayurvedic formulation

PubMed Central

Kabir, Ashraf-ul; Samad, Mehdi Bin; D′Costa, Ninadh Malrina; Hannan, Juardar Mohammad

2012-01-01

Rationale: Draksharishta (DRK) is an Ayurvedic formulation approved by the “National formulary of Ayurvedic Medicine 2011”, of Bangladesh. It is widely available in the Bangladeshi market as an effective preparation to treat lumbago, sciatia and arthritic pain of joints. But there are very scientific evidences available to support their common uses. Objectives: Our present studies make an attempt toward identifying probable antinociceptive and anti-inflammatory effect and its mechanisms of DRK. Findings: DRK, at three doses, (10 mL/kg, 20 mL/kg, and 40 mL/kg) showed no involvement of the CNS in antinociceptive activity of the test drug. Both Carrageenan-induced paw edema and acetic acid writhing tests gave significant results (P < 0.05), indicating possible peripheral analgesic and anti-inflammatory action. Formalin-induced paw- licking test showed that DRK had significant effect in suppressing inflammatory pain (P < 0.05) but not neurogenic pain. Conclusions: Hence our study shows anti-inflammatory and peripheral analgesic action for DRK. PMID:24826047

Evaluation of a honey-impregnated tulle dressing in primary care.

PubMed

Stephen-Haynes, Jackie

2004-06-01

Honey has been used for its healing properties for centuries and has been used to dress wounds with favourable results. The emergence of antibiotic resistance and growing interest in "natural" or "complementary" therapies has led to an interest in honey dressings. Much of the research to date has been related to honey's antibacterial properties. However, the healing properties claimed for honey also include stimulating new tissue growth, moist wound healing, fluid handling and promoting epithelialization. Until recently, honey had not been developed as a wound management product and was not a certified pharmaceutical device. Activon Tulle is a sterile, non-adherent dressing impregnated with Leptospermum scoparium hone. The claimed properties of honey dressings would make this a valuable addition to the dressing currently available in the primary care setting. An evaluation was undertaken involving 20 patients with a variety of wounds. A conclusion is drawn that while further research is needed, medical grade honey does appear to be a valuable addition to the wound management formulary.

The Ayurvedic Pharmacopoeia of India, development and perspectives.

PubMed

Joshi, Vinod Kumar; Joshi, Apurva; Dhiman, Kartar Singh

2017-02-02

The Ayurvedic Pharmacopoeia of India (API) is a unique book of standards describing the quality, purity and strength of selected drugs that are manufactured, distributed, and sold by the licensed manufacturers in pan India. It is developed in two parts; the part one comprises of mono-monographs of medicinal substances of natural origin and part two includes selected compound formulations sourced from the schedule - I books under the Drugs and Cosmetics Act, 1940 comprising of popular Ayurvedic classics of different period of times. The first part of the Ayurvedic Formulary of India was published in 1978 and thereafter, the Ayurvedic Pharmacopoeia of India (mono-monograph) Part-I, Vol. I was published in the year 1989 and subsequently, the other volumes were published with their legalized status under Drugs and Cosmetics Act, 1940. The study was aimed to bring out the existing knowledge on the Ayurvedic pharmacopoeia with its chronological development reviewed from the ancient Vedic Compendia with its continuum in Ayurvedic classics of different period of time till recent past. A literary search based on the ancient origin of Ayurveda was carried out. The drug making from the natural resources and utility of the knowledge exist in classical Ayurvedic works of different period of time till composition of the Ayurvedic Pharmacopoeia of India and its importance as official documents of Govt. of India for Standards of Ayurvedic Drugs and its perspectives have been discussed. The present paper reviews on the systemic development and different aspects of drug-making (Pharmacopoeia) with evidence lying in the 5000 years old work of India. During the systematic review of the various works of different period of times (ancient, medieval and modern), it was found that the Ayurvedic Pharmacopoeia of India has its development during 20th Century as an official document of Govt. of India comprising of single drugs monograph and compound formulations. In India, the development of the Indian Pharmacopoeia started in 20th Century on the recommendation of the Col. R.N. Chopra Committee and in 1978 the first part of the Ayurvedic formulary of India was published. Subsequently, the amendment in the drugs and cosmetics Act 1940 was brought in 1964 for regulation of the drugs in Indian Systems of Medicine (Ayurveda, Unani and Siddha). Later on the Ayurvedic Pharmacopoeia of India (Mono-Monograph) Part-I, Volume I, was published in the year 1989 and the other volumes were published subsequently in different years. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Update of the Mexican Health Care Formulary and Supply Catalog in the Context of the Health Technology Assessment.

PubMed

Ríos, Pedro Rizo; Rivera, Aurora González; Oropeza, Itzel Rivas; Ramírez, Odette Campos

2014-12-01

One of the instruments Mexico has available for the optimization of resources specifically allocated to health technologies is the Health Care Formulary and Supply Catalog (Cuadro Básico y Catálogo de Insumos del Sector Salud [CBCISS]). The aim of the CBCISS is to collaborate in the optimization of public resources through the use of technologies (supplies) that have proven their safety, therapeutic efficacy, and efficiency. The importance of the CBCISS lies in the fact that all public institutions within the National Health System must use only the established technologies it contains. The implementation of strategies that strengthen the CBCISS update process allows it to be thought of as an essential regulatory tool for the introduction of health technologies, with relevant contributions to the proper selection of cost-effective interventions. It ensures that each supply included on the list meets the criteria sufficient and necessary to ensure efficacy, safety, effectiveness, and, of course, efficiency, as evidence supporting the selection of suitable technologies. The General Health Council (Consejo de Salubridad General [CSG]) is a collegial body of constitutional origin that-in accordance with its authority-prepares, updates, publishes, and distributes the CBCISS. To perform these activities, the CSG has the CBCISS Inter-institutional Commission. The CBCISS update is performed through the processes of inclusion, modification, and exclusion of supplies approved by the Interior Commission. The CBCISS update process consists of three stages: the first stage involves a test that leads to the acceptance or inadmissibility of the requests, and the other two focus on an in-depth evaluation for the ruling. This article describes the experience of health technology assessment in Mexico, presents the achievements and outlines the improvements in the process of submission of new health technologies, and presents a preliminary analysis of the submissions evaluated until December 2012. During the analysis period, 394 submissions were received. After confirming compliance with the requirements, 59.9% of the submissions passed to the next stage of the process, technology assessment. In the third stage, the committee approved 44.9% of the submissions evaluated. The improvements established in the country in terms of health technology assessment allowed choosing the technologies that give more value for money in a context of public health institutions. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Medication reconciliation in acute care: ensuring an accurate drug regimen on admission and discharge.

PubMed

Rodehaver, Claire; Fearing, Deb

2005-07-01

Several factors contribute to the potential for patient confusion regarding his or her medication regimen, including multiple names for a single drug and formulary variations when the patient receives medications from more than one pharmacy. A 68-year-old woman was discharged from the hospital on a HMG-CoA reductase inhibitor (statin) and resumed her home statin. Eleven days later she returned to the hospital with a diagnosis of severe rhabdomyolysis due to statin overdose. IMPLEMENTING SOLUTIONS: Miami Valley Hospital, Dayton, Ohio, implemented a reconciliation process and order form at admission and discharge to reduce the likelihood that this miscommunication would recur. Initial efforts were trialed on a 44-bed orthopedic unit, with spread of the initiative to the cardiac units and finally to the remaining 22 nursing units. The team successfully implemented initiation of the order sheet, yet audits indicated the need for improvement in reconciling the medications within 24 hours of admission and in reconciling the home medications at the point of discharge. Successful implementation of the order sheet to drive reconciliation takes communication, perseverance, and a multidisciplinary team approach.

Scalable and expressive medical terminologies.

PubMed

Mays, E; Weida, R; Dionne, R; Laker, M; White, B; Liang, C; Oles, F J

1996-01-01

The K-Rep system, based on description logic, is used to represent and reason with large and expressive controlled medical terminologies. Expressive concept descriptions incorporate semantically precise definitions composed using logical operators, together with important non-semantic information such as synonyms and codes. Examples are drawn from our experience with K-Rep in modeling the InterMed laboratory terminology and also developing a large clinical terminology now in production use at Kaiser-Permanente. System-level scalability of performance is achieved through an object-oriented database system which efficiently maps persistent memory to virtual memory. Equally important is conceptual scalability-the ability to support collaborative development, organization, and visualization of a substantial terminology as it evolves over time. K-Rep addresses this need by logically completing concept definitions and automatically classifying concepts in a taxonomy via subsumption inferences. The K-Rep system includes a general-purpose GUI environment for terminology development and browsing, a custom interface for formulary term maintenance, a C+2 application program interface, and a distributed client-server mode which provides lightweight clients with efficient run-time access to K-Rep by means of a scripting language.

Developments in Post-marketing Comparative Effectiveness Research

PubMed Central

S, Schneeweiss

2010-01-01

Physicians and insurers need to weigh the effectiveness of new drugs against existing therapeutics in routine care to make decisions about treatment and formularies. Because Food and Drug Administration (FDA) approval of most new drugs requires demonstrating efficacy and safety against placebo, there is limited interest by manufacturers in conducting such head-to-head trials. Comparative effectiveness research seeks to provide head-to-head comparisons of treatment outcomes in routine care. Health-care utilization databases record drug use and selected health outcomes for large populations in a timely way and reflect routine care, and therefore may be the preferred data source for comparative effectiveness research. Confounding caused by selective prescribing based on indication, severity, and prognosis threatens the validity of non-randomized database studies that often have limited details on clinical information. Several recent developments may bring the field closer to acceptable validity, including approaches that exploit the concepts of proxy variables using high-dimensional propensity scores, within-patient variation of drug exposure using crossover designs, and between-provider variation in prescribing preference using instrumental variable (IV) analyses. PMID:17554243

Ameliorating effects of traditional Chinese medicine preparation, Chinese materia medica and active compounds on ischemia/reperfusion-induced cerebral microcirculatory disturbances and neuron damage

PubMed Central

Sun, Kai; Fan, Jingyu; Han, Jingyan

2015-01-01

Ischemic stroke and ischemia/reperfusion (I/R) injury induced by thrombolytic therapy are conditions with high mortality and serious long-term physical and cognitive disabilities. They have a major impact on global public health. These disorders are associated with multiple insults to the cerebral microcirculation, including reactive oxygen species (ROS) overproduction, leukocyte adhesion and infiltration, brain blood barrier (BBB) disruption, and capillary hypoperfusion, ultimately resulting in tissue edema, hemorrhage, brain injury and delayed neuron damage. Traditional Chinese medicine (TCM) has been used in China, Korea, Japan and other Asian countries for treatment of a wide range of diseases. In China, the usage of compound TCM preparation to treat cerebrovascular diseases dates back to the Han Dynasty. Even thousands of years earlier, the medical formulary recorded many classical prescriptions for treating cerebral I/R-related diseases. This review summarizes current information and underlying mechanisms regarding the ameliorating effects of compound TCM preparation, Chinese materia medica, and active components on I/R-induced cerebral microcirculatory disturbances, brain injury and neuron damage. PMID:26579420

[Innovative medicinal products: the new criteria of the Italian Medicines Agency.

PubMed

Mammarella, Federica; Tafuri, Giovanni

2018-05-01

The Italian Medicines Agency (AIFA), which has the dual function of a regulatory and a reimbursement authority, has recently established new criteria to define innovative medicinal products. Indeed, the decision making process to grant the innovative status is based on the evaluation of the unmet medical need, the added therapeutic value compared to existing therapeutic options and the overall quality of clinical evidence, which is assessed based on the GRADE system. Following this evaluation, if a medicinal product is granted the status of "full innovativeness" for a specific therapeutic indication, its manufacturer can access dedicated yearly funds amounting to 500 million Euros each, depending on the type of medicine (one fund for oncology, the other for all other innovative medicinal products). Alternatively, the product can be granted the status of "conditional innovativeness" which allows immediate access to all Regional formularies, with no additional re-assessments at the local level. The third possible outcome is that no innovativeness is recognized. Starting from January 2018, a full report explaining the rationale for the Agency Committee's decision is made publicly available on the AIFA's website.

Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape.

PubMed

Peterson, Jesse; Budlong, Holly; Affeldt, Tim; Skiermont, Kyle; Kyllo, Gregg; Heaton, Al

2017-12-01

Biosimilars have the potential to greatly reduce medication costs in the United States. As of July 1, 2017, 5 biosimilars have been approved by the FDA, but only 2 are available for purchase. This commentary outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications. We highlight the implementation of a health plan policy and how a health system's formulary committee can encourage use while considering provider perceptions and operational challenges. In addition, we provide our perspective on potential implications for pricing, site of care, and pharmacy dispensing practices based on our experience with regulatory hurdles and market trends. Overall, we believe biosimilars are a good thing for the health care system, but their expected benefit may not be realized for years to come. No outside funding supported this work. Affeldt reports advisory board membership with Janssen, and Skiermont reports membership with Amgen and McKesson. The other authors have nothing to disclose. Peterson and Budlong contributed the study concept and design and wrote the manuscript. Affeldt, Skiermont, Kyllo, and Heaton reviewed and revised the manuscript.

Deeply discounted medications: Implications of generic prescription drug wars.

PubMed

Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

2010-01-01

To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

How should teaching of undergraduates in clinical pharmacology and therapeutics be delivered and assessed?

PubMed Central

Maxwell, Simon R J

2012-01-01

Clinical pharmacology and therapeutics is the academic discipline that informs rational prescribing of medicines. There is accumulating evidence that a significant minority of prescriptions in the UK National Health Service contain errors. This comes at a time when the approach to and success of undergraduate education in this area has been called into question. Various stakeholders are now in agreement that this challenging area of undergraduate education needs to be strengthened. The principles that should form the basis of future educational strategy include greater visibility of clinical pharmacology and therapeutics in the curriculum, clear learning outcomes that are consistent with national guidance, strong and enthusiastic leadership, a student formulary, opportunities to practice prescribing, a robust assessment of prescribing competencies and external quality control. Important new developments in the UK are Prescribe, a repository of e-learning materials to support education in clinical pharmacology and prescribing, and the Prescribing Skills Assessment, a national online assessment designed to allow medical students to demonstrate that they have achieved the core competencies required to begin postgraduate training. PMID:22360965

Specialty medications: traditional and novel tools can address rising spending on these costly drugs.

PubMed

Lotvin, Alan M; Shrank, William H; Singh, Surya C; Falit, Benjamin P; Brennan, Troyen A

2014-10-01

Spending on specialty medications, which represented a small proportion of US pharmacy spending at the beginning of this decade, is growing by more than 15 percent annually. It is expected to account for approximately half ($235 billion) of total annual pharmacy spending by 2018. Among the numerous reasons for the high cost of this heterogeneous group of medications are the increasing size of target patient populations, the high cost of drug development, and a complex and uncoordinated delivery system. In this article we describe the evolution of the specialty market, characterize the current state of specialty medication use, and articulate key challenges and potential solutions. Fully realizing the potential value of the expanding universe of specialty medications will require collaborative efforts to reduce waste and promote value. Those who prescribe, dispense, deliver, and pay for specialty medications will need to employ a combination of traditional and novel management approaches, such as prior authorization, step therapy, tiered formularies, administration at lower-cost sites, and the unique tools being developed for cancer medications. Project HOPE—The People-to-People Health Foundation, Inc.

U.S. pharmacy policy: a public health perspective on safety and cost.

PubMed

Rosenau, Pauline Vaillancourt; Lal, Lincy S; Glasser, Jay H

2009-01-01

A public health perspective based on social justice and a population health point of view emphasizes pharmacy policy innovations regarding safety and costs. Such policies that effectively reduce costs include controlling profits, establishing profit targets, extending prescription providers, revising prescription classification schemes, emphasizing generic medications, and establishing formularies. Public education and universal programs may reduce costs, but co-pays and "cost-sharing" do not. Switching medications to over-the-counter (OTC) status, pill splitting, and importing medication from abroad are poor substitutes for authentic public health pharmacy policy. Where policy changes yield savings, public health insists that these savings should be used to increase access and improve population health. In the future, pharmacy policies may emphasize public health accountability more than individual liberty because of potential cost savings to society. Fear of litigation, as an informal mechanism of focusing manufacturer's attention on safety, is inefficient; public health pharmacy policy regarding safety looks toward a more active regulatory role on the part of government. A case study of direct-to-consumer advertising illustrates the complexity of public health pharmacy policy.

Acute treatment of migraine headaches.

PubMed

Taylor, Frederick R

2010-04-01

Optimum acute treatment of migraine requires prevention of headache as a top priority. Recognition of the multitude of migraine presentations, the frequency of total headache attacks, and number of days of headache disability are critical. Successful treatment requires excellent patient-clinician communication enhancing confidence and mutual trust based on patient needs and preferences. Optimum management of acute migraine nearly always requires pharmacologic treatment for rapid resolution. Migraine-specific triptans, dihydroergotamine, and several antiinflammatories have substantial empirical clinical efficacy. Older nonspecific drugs, particularly butalbital and opioids, contribute to medication overuse headache and are to be avoided. Clinicians should utilize evidence-based acute migraine-specific therapy stressing the imperative acute treatment goal of early intervention, but not too often with the correct drug, formulation, and dose. This therapy needs to provide cost-effective fast results, meaningful to the patient while minimizing the need for additional drugs. Migraine-ACT evaluates 2-hour pain freedom with return to normal function, comfort with treatment, and consistency of response. Employ a thoroughly educated patient, formulary, testimonials, stratification, and rational cotherapy against the race to central sensitization for optimum outcomes. Thieme Medical Publishers.

Developments in post-marketing comparative effectiveness research.

PubMed

Schneeweiss, S

2007-08-01

Physicians and insurers need to weigh the effectiveness of new drugs against existing therapeutics in routine care to make decisions about treatment and formularies. Because Food and Drug Administration (FDA) approval of most new drugs requires demonstrating efficacy and safety against placebo, there is limited interest by manufacturers in conducting such head-to-head trials. Comparative effectiveness research seeks to provide head-to-head comparisons of treatment outcomes in routine care. Health-care utilization databases record drug use and selected health outcomes for large populations in a timely way and reflect routine care, and therefore may be the preferred data source for comparative effectiveness research. Confounding caused by selective prescribing based on indication, severity, and prognosis threatens the validity of non-randomized database studies that often have limited details on clinical information. Several recent developments may bring the field closer to acceptable validity, including approaches that exploit the concepts of proxy variables using high-dimensional propensity scores, within-patient variation of drug exposure using crossover designs, and between-provider variation in prescribing preference using instrumental variable (IV) analyses.

A light on medical practice in 19th-century Canada: the medical manuscripts of Dr. John Mackieson of Charlottetown

PubMed Central

Shephard, D A

1998-01-01

During his long career as a physician in Charlottetown, Dr. John Mackieson (1795-1885) compiled 4 medical manuscripts: 2 sets of case records, a synopsis of the medical conditions that were common in his day and a formulary. As primary sources, these documents provide information about medicine in 19th-century Canada and augment our knowledge of the problems of medical practice in that era. They illustrate aspects of the work of Dr. Mackieson, a generalist with interests in surgery and obstetrics, and they facilitate an understanding of the rationale underlying the treatments that he and his contemporaries used. Although 150 years old, the case records can be appreciated for their relevance to the art of medicine. Two excerpts from the case records, presented in this article, provide a sense of Dr. Mackieson's writings and introduce a discussion on the significance of these manuscripts in relation to the ideas on disease and treatment that governed medical practice, both in Prince Edward Island and elsewhere in Canada, in the 19th century. PMID:9724982

Budget impact model of adding erlotinib to a regimen of gemcitabine for the treatment of locally advanced, nonresectable or metastatic pancreatic cancer.

PubMed

Danese, Mark D; Reyes, Carolina; Northridge, Kelly; Lubeck, Deborah; Lin, Chin-Yu; O'Connor, Paula

2008-04-01

The aim of this study was to determine the budget impact of adding erlotinib to a US health plan insurer's formulary as a combination therapy with gemcitabine for the treatment of nonresectable pancreatic cancer. An Excel-based budget impact model was developed to evaluate the costs for National Comprehensive Cancer Network guideline-recommended treatment options for patients with locally advanced, nonresectable or metastatic pancreatic cancer from the perspective of a US managed care plan. The model compared treatment with gemcitabine alone and in combination with erlotinib, including the costs of treatment, adverse events (AEs), and administration. Inputs for the model were derived from the Surveillance, Epidemiology and End Results Cancer Registry, clinical trials, and publicly available sources and were varied in sensitivity analyses to identify influential inputs. The model addressed first-line use in a single indication and assumed that the proportion of patients aged >or=65 years in a managed care organization was the same as in the general population. The model did not account for patient copayments for oral medications, a factor that could lower a plan's overall cost further than estimated herein. For a hypothetical managed care plan with 500,000 members, the model estimated 43 newly diagnosed pancreatic cancer cases each year, of which 56% (n=24) would be treated with gemcitabine as first-line therapy. Assuming that erlotinib were added to the treatment regimen in 40% (n=10) of gemcitabine-treated patients for 15.7 weeks of therapy per patient, the expected 1-year cost in 2006 dollars would be US $466,700 compared with $346,700 had all patients been treated with gemcitabine alone. Administration costs accounted for 10% to 12% of total costs, while AE management costs made up 14% to 16% of total costs. These estimates corresponded to an incremental cost of $120,000, or $0.020 per member per month (PMPM). The results were relatively insensitive to drug costs, drug administration costs, and costs of treatment of AEs based on sensitivity analyses. In this analysis of the budget impact of adding to the health plan formulary erlotinib to a regimen of gemcitabine as first-line treatment of locally advanced, nonresectable or metastatic pancreatic cancer in the United States, the budget impact was $0.020 PMPM. The relatively low incidence of pancreatic cancer and the assumption of treating only 23% of these patients with erlotinib were likely the principal reasons for the low budgetary impact of erlotinib. In this model and using these reasonable assumptions, the results suggested that the incremental cost impact on a PMPM basis may be small.

Attitudes and experiences of community pharmacists towards paediatric off-label prescribing: a prospective survey

PubMed Central

Stewart, Derek; Rouf, Abdul; Snaith, Ailsa; Elliott, Kathleen; Helms, Peter J; McLay, James S

2007-01-01

What is already known about this subject There are increasing concerns about the safety and efficacy of paediatric off-label medicines. In the UK, each year 26% of children receive an off-label prescription from their general practitioner. The community pharmacist is the final and key professional in the chain, with the responsibility to ensure that medicines are both prescribed and dispensed appropriately. What this study adds The majority of community pharmacists are aware of off-label prescribing, but through work experience rather than undergraduate or postgraduate training or professional development. Community pharmacists, like UK general practitioners, underestimate the levels of paediatric off-label prescribing, and appear unclear as to the most common reasons for a prescription being off label. Most community pharmacists stated that they should inform the prescriber that a medicine was off label; however, when given specific practical examples, less than half would actually appear to do so. The majority of community pharmacists have been asked by the public to sell over-the-counter medicines for paediatric off-label use. Aim To identify community pharmacist experiences of, and attitudes towards paediatric off-label prescribing. Methods A prospective questionnaire-based study, with a 21-item questionnaire issued to 1500 randomly selected community pharmacies throughout the UK during 2005 on three separate occasions. Results Four hundred and eighty-two (32.1%) completed questionnaires were returned. Over 70% of respondents were familiar with the concept of off-label prescribing, primarily through dispensing experience rather than education, although only 40% were aware of having dispensed a paediatric off-label prescription within the previous month. The reasons given for a prescription being off label were younger age than recommended (84.6%, 297/351), primarily for antihistamines, analgesics and β2-agonists, and higher (73.9%, 229/310) or lower than (41%, 103/258) recommended dose, primarily antibiotics and analgesics. Over 60% of respondents had been asked by the public to sell paediatric over-the-counter medicines, such as antihistamines, analgesics and steroid preparations for off-label use. The majority of respondents used the British National Formulary or the Pack Insert rather than specialist formularies or guidelines as a source of specialist paediatric information. Although 78% of respondents believed they had a responsibility to inform the prescriber that a medicine was off label, only 66% believed that they had a similar responsibility to inform parents. Conclusion The community pharmacists who responded to this questionnaire appear to be aware of and concerned by the issues which surround paediatric off-label prescribing. Despite this, most gained relevant knowledge through work experience rather than undergraduate or postgraduate training or professional development. PMID:17324238

Inventory of Drug Samples in a Health Care Institution

PubMed Central

Soucy, Geneviève; Bussières, Jean-François; Tardif, Lyne; Bailey, Benoît

2009-01-01

Background: Few data exist on the presence of drug samples in health care facilities. Although the use of drug samples has potential benefits, this practice is also controversial, as it can contribute to non-optimal drug use. The objective of this study was to evaluate the inventory of drug samples in a health care institution and to determine compliance with existing policies and procedures. Methods: This descriptive observational study was conducted in a university hospital centre from October 18 to November 1, 2007. A standardized data collection form was used for a physical inventory, which was intended to identify all drug samples available in the institution. The following information was recorded: number of locations where drug samples were found, primary patient care activity performed at each location, number of storage areas in the location, type of storage, presence of a lock, location of the key (if a lock was present), medical specialty, number of physicians and nurses likely to use the samples, reasons given for handing out samples, presence of a designated person to manage the samples, physical inventory (i.e., various details for each distribution unit), and declaration of samples to the pharmacy department. The inventory was conducted by 2 research assistants during day shifts. Results: A total of 84 locations were included in the inventory, and drug samples were found in 21 locations (with a total of 31 storage areas). All of the locations were intended for ambulatory patients (outpatient clinics and day centres). No drug samples were found in inpatient care units. The drug samples, which came from 62 different pharmaceutical companies, represented a total of 159 generic entities and 266 different brands. Of the distribution units for drug samples that were identified during this inventory, 59% were not on the hospital’s local formulary. Furthermore, only 3.5% of the distribution units had been declared to the pharmacy department, in accordance with established policy. The sample distribution units, including expired units, totalled 78 955 doses, with a total value of Can$48 783 (based on unit prices in effect in October 2007). Conclusion: This study presents an inventory of drug samples in an urban health care institution and reports compliance with the institution’s policies and procedures regarding drug samples. Samples were found only in outpatient clinics and represented 2.4 times the hospital’s floor stock of medications. Most of the samples inventoried were not listed on the hospital’s formulary. It appears that the use of drug samples is underestimated in hospital settings. Further studies are needed to evaluate the importance of drug samples and the risks associated with their use. PMID:22478908

Using economic evaluations to make formulary coverage decisions. So much for guidelines.

PubMed

Anis, A H; Gagnon, Y

2000-07-01

It is mandatory for drug manufacturers requesting formulary inclusion under the British Columbia (BC) provincial drug plan to submit a pharmacoeconomic analysis according to published guidelines. These submissions are reviewed by the Pharmacoeconomic Initiative (PI) of BC. To assess the compliance of submitted studies with specific criteria outlined in the guidelines, to assess the methodological quality of individual submissions, and to demonstrate the importance of submitting guidelines-compliant pharmacoeconomic analyses. All submissions between January 1996 and April 1999 assessed by the PI of BC were included. Submissions were reviewed according to a checklist to establish compliance with respect to choice of comparator drug, study perspective, sensitivity analysis, analytical horizon and discounting. Submissions were examined for association between analytical technique and author, and between source of submission and compliance. Association between compliance and recommendation for approval was also examined. 95 applications were reviewed. Seven submitted no analyses. There were 25 cost-comparison/consequence, 14 cost-effectiveness, 11 cost-minimisation, 9 cost-utility/benefit and 29 budget-impact analyses. 65 of these 88 submissions failed to comply with guidelines. Of these, 45% used an inappropriate comparator drug, 61% lacked a sensitivity analysis, 73% used a third-party payer and excluded a societal perspective, 66% did not provide a long term evaluation and 25% did not specify any time horizon. 80% of noncompliant studies were cost-comparison/consequence or budget-impact analyses (p < 0.001, Fisher's Exact). Of 25 cost-comparison/consequence and 29 budget-impact analyses, 19 (76%) and 24 (83%), respectively, were industry-conducted, whereas cost-effectiveness (11 of 14) and cost-utility/benefit (6 of 9) analyses were mostly subcontracted to private consultants or academics (p < 0.001, Fisher's Exact). 74% of all submissions (compliant and noncompliant) were not recommended by the PI for listing as a provincial drug plan benefit, 16% received approval for restricted benefit and 9% were recommended as full benefit. 80% of the noncompliant submissions were not recommended (p = 0.06, Fisher's Exact test). Moreover, a strong association between type of analysis and type of recommendation was found (p = 0.03, Fisher's Exact test). Cost-comparison/consequence and budget-impact analyses were less likely to be recommended. IMPLICATIONS OF FINDINGS: Our findings show poor compliance with guidelines, especially among industry-conducted studies. Possible explanations are lack of expertise in pharmacoeconomics and/or scepticism regarding the importance of guidelines and submission quality in decision making. As corroborated by the strong associations between type of recommendation and compliance, and between type of recommendation and type of analysis, these 2 characteristics have a significant impact on decision making.

The cost effectiveness and budget impact of natalizumab for formulary inclusion.

PubMed

Bakhshai, Justin; Bleu-Lainé, Raymond; Jung, Miah; Lim, Jeanne; Reyes, Christian; Sun, Linda; Rochester, Charmaine; Shaya, Fadia T

2010-03-01

Crohn's disease (CD) and multiple sclerosis (MS) are debilitating autoimmune diseases, which represent a substantial cost burden in the context of managed care. As a corollary, there is an unmet pharmacotherapeutic need in patient populations with relapsing forms of MS, in addition to populations with moderately to severely active CD with evidence of inflammation who have experienced an inadequate response to other mainstream therapies. The purpose of this study was to analyze the clinical and economic data associated with natalizumab (Tysabri) and to determine the potential impact of its formulary inclusion in a hypothetical health plan. Regarding MS, the implemented cost-effectiveness and budget-impact models demonstrated an anticipated reduction in relapse rate of 67% over 2 years, and a total therapy cost of $72,120 over 2 years, equating to a cost per relapse avoided of $56,594. With respect to the model assumptions, the market share of natalizumab would experience an increase to 8.5%, resulting in a total per-member, per-month healthcare cost increase of $0.003 ($0.002 for pharmacy costs and $0.001 for medical costs). Regarding CD, over a 2-year period outlined by the model, natalizumab produced the highest average time in remission, steroid-free remission, and remission or response in comparison to the other agents. The mean total costs associated with the initiation of natalizumab, infliximab, and adalimumab were $68,372, $62,090, and $61,796, respectively. Although natalizumab's costs were higher, the mean time spent in remission while on this medication was 4.5 months, as opposed to 2.4 months for infliximab and 2.9 months with adalimumab. This shift in market share was used to estimate the change in total costs (medical + pharmacy), and the per-member per-month change for the model's base case was calculated to be $0.035. The aforementioned cost-effectiveness results for natalizumab in the treatment for CD and MS were limited by the model's predetermined assumptions. These assumptions include anticipated reduction in relapse rate after 2 years of therapy and acquisition costs in the MS model, as well as assuming a certain percentage of patients were primary and secondary failures of TNFalpha inhibitor therapy in the CD model. The evidence presented here demonstrates that natalizumab provides clinical practitioners with another tool in their fight against both MS and CD, albeit by way of a different mechanism of action. After a thorough review of the evidence, the authors find that natalizumab has been shown to be relatively cost effective in the treatment of both conditions from a payer perspective; the therapy adds a new option for those patients for whom conventional treatment was unsuccessful.

Data analyst technician: an innovative role for the pharmacy technician.

PubMed

Ervin, K C; Skledar, S; Hess, M M; Ryan, M

2001-10-01

The development of an innovative role for the pharmacy technician is described. The role of the pharmacy technician was based on a needs assessment and the expertise of the pharmacy technician selected. Initial responsibilities of the technician included chart reviews, benchmarking surveys, monthly financial impact analysis, initiative assessment, and quality improvement reporting. As the drug-use and disease-state management (DUDSM) program expanded, pharmacist activities increased, requiring the expansion of data analyst technician (DAT) duties. These new responsibilities included participation in patient assessment, data collection and interpretation, and formulary enforcement. Most recently, technicians' expanded duties include maintenance of a physician compliance profiling database, quality improvement reporting and graphing, active role in patient risk assessment and database management for adult vaccination, and support of financial impact monitoring for other institutions within the health system. This pharmacist-technician collaboration resulted a threefold increase in patient assessments completed per day. In addition, as the DUDSM program continues to expand across the health system, an increase in DAT resources from 0.5 to 1.0 full-time equivalent was obtained. The role of the DAT has increased the efficiency of the DUDSM program and has provided an innovative role for the pharmacy technician.

Need for "counter-detailing" antibiotics.

PubMed

Hendeles, L

1976-09-01

Selected antibiotic advertisements in medical journals are discussed to illustrate the misleading information that is often disseminated to physicians by the pharmaceutical industry. Laboratory and clinical data are presented to question the validity of selected advertisements which (1) encourage the use of Keflex for severe respiratory infections in children, (2) recommend the use of Keflex for the treatment of bacterial bronchitis, (3) suggest that high tissue penetration is a unique property of Vibramycin, (4) present pooled susceptability data which do not reflect microbial resistance patterns in the patient's hospital, (5) recommend twice-daily administration of Ancef for urinary tract infections but do not clearly state the potential danger of this regimen for other infections, (6) suggest that gentamicin should be given to adults in only two dosage sizes for the treatment of serious Gram-negative infections, and (7) lead the reader to assume that only women need to be treated for Trichomonas infections. It is suggested that as antibiotics are marketed, hospital therapeutics committees should evaluate their advantages and permit formulary additions for only those agents demonstrating increased efficacy, decreased toxicity or decreased cost. Pharmacists who monitor drug therapy can provide information to the physician which will increase his awareness of optimal antibiotic therapy.

Medication safety infrastructure in critical-access hospitals in Florida.

PubMed

Winterstein, Almut G; Hartzema, Abraham G; Johns, Thomas E; De Leon, Jessica M; McDonald, Kathie; Henshaw, Zak; Pannell, Robert

2006-03-01

The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia.

PubMed

Lexchin, Joel; Gleeson, Deborah

2016-10-01

The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A). The article concludes that the TPP could have profound effects on the criteria these countries use to decide on drug safety and effectiveness, how new drugs are approved (or not) for marketing, post-market surveillance and inspection, the listing of drugs on public formularies, and how individual drugs are priced in the future. Furthermore, the TPP, if ratified and enforced, will reduce future policy flexibility to address the increasing challenge of rising drug prices. © The Author(s) 2016.

The role of pharmacoeconomics in current Indian healthcare system.

PubMed

Ahmad, Akram; Patel, Isha; Parimilakrishnan, Sundararajan; Mohanta, Guru Prasad; Chung, HaeChung; Chang, Jongwha

2013-01-01

Phamacoeconomics can aid the policy makers and the healthcare providers in decision making in evaluating the affordability of and access to rational drug use. Efficiency is a key concept of pharmacoeconomics, and various strategies are suggested for buying the greatest amount of benefits for a given resource use. Phamacoeconomic evaluation techniques such as cost minimization analysis, cost effectiveness analysis, cost benefit analysis, and cost utilization analysis, which support identification and quantification of cost of drugs, are conducted in a similar way, but vary in measurement of value of health benefits and outcomes. This article provides a brief overview about pharmacoeconomics, its utility with respect to the Indian pharmaceutical industry, and the expanding insurance system in India. Pharmacoeconomic evidences can be utilized to support decisions on licensing, pricing, reimbursement, and maintenance of formulary procedure of pharmaceuticals. For the insurance companies to give better facility at minimum cost, India must develop the platform for pharmacoeconomics with a validating methodology and appropriate training. The role of clinical pharmacists including PharmD graduates are expected to be more beneficial than the conventional pharmacists, as they will be able to apply the principles of economics in daily basis practice in community and hospital pharmacy.

Case managers and the use of Medicare, Part D.

PubMed

Hensley, Melissa Anne

2011-01-01

The purpose of this study was to examine the experiences and opinions of community-based mental health case managers with the Medicare prescription drug benefit. A qualitative approach, consisting of analysis of data from 3 case manager focus groups, was used to achieve an understanding of the role that case managers played in beneficiaries' access to and use of prescription medicines. Two urban nonprofit community-based mental health agencies. Adults who are disabled by mental illness depend on case managers for information about their prescription drug insurance, help with formulary and plan switching information, and assistance with tasks related to medication adherence in the community. Common themes in the case managers' discussion were managing beneficiary problems, stress for beneficiaries, information and paperwork issues, and cynicism regarding health care reform. The critical role of case managers in the use of Medicare Part D is not well understood or appreciated. Case managers need to be informed about Medicare Part D and ready to advocate for their clients in the community. In addition, it is important for case managers to understand how Medicare Part D affects not only older adults, but also adults living with serious and persistent mental illness.

The impact of hurricanes and flooding disasters on hymenopterid-inflicted injuries.

PubMed

Diaz, James H

2007-01-01

Insect bites and stings, often complicated by allergic reactions or skin infections with community-acquired pathogens, are common sources of morbidity following hurricanes and flooding disasters. The hymenopterids are the most commonly stinging arthropods to cause allergic reactions, and include bees, wasps, and ants. To assess the evolving epidemiology of hymenopterid-inflicted injuries, and the impact of hurricanes and flooding disasters on hymenopterid-inflicted injuries in the United States, an epidemiological analysis of the scientific literature on hymenopterid stings and allergic sting reactions was conducted by MEDLINE search, 1966-2006. The increasing incidence of hymenopterid-inflicted injuries following hurricanes and flooding disasters was described. Common immunological reactions to hymenopterid-inflicted injuries were stratified by clinical severity and outcome. Current recommendations for management, prevention, and prophylaxis of hymenopterid-inflicted injuries were presented. Hymenopterid stings and allergic reactions remain common indications for emergency department visits, especially following hurricanes and flooding disasters. Unrecognized anaphylactic reactions to hymenopterid stings remain significant causes of unanticipated deaths outdoors in young people. Disaster planners and managers are obliged to alert regional healthcare providers of the increased risks of hymenopterid-inflicted injuries following flooding disasters and to assure that emergency drug formularies are properly stocked to treat hymenopterid-inflicted injuries.

Adulteration of Ginkgo biloba products and a simple method to improve its detection.

PubMed

Wohlmuth, Hans; Savage, Kate; Dowell, Ashley; Mouatt, Peter

2014-05-15

Extracts of ginkgo (Ginkgo biloba) leaf are widely available worldwide in herbal medicinal products, dietary supplements, botanicals and complementary medicines, and several pharmacopoeias contain monographs for ginkgo leaf, leaf extract and finished products. Being a high-value botanical commodity, ginkgo extracts may be the subject of economically motivated adulteration. We analysed eight ginkgo leaf retail products purchased in Australia and Denmark and found compelling evidence of adulteration with flavonol aglycones in three of these. The same three products also contained genistein, an isoflavone that does not occur in ginkgo leaf. Although the United States Pharmacopeia - National Formulary (USP-NF) and the British and European Pharmacopoeias stipulate a required range for flavonol glycosides in ginkgo extract, the prescribed assays quantify flavonol aglycones. This means that these pharmacopoeial methods are not capable of detecting adulteration of ginkgo extract with free flavonol aglycones. We propose a simple modification of the USP-NF method that addresses this problem: by assaying for flavonol aglycones pre and post hydrolysis the content of flavonol glycosides can be accurately estimated via a simple calculation. We also recommend a maximum limit be set for free flavonol aglycones in ginkgo extract. Copyright © 2014 Elsevier GmbH. All rights reserved.

How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand.

PubMed

Gleeson, Deborah; Lopert, Ruth; Reid, Papaarangi

2013-10-01

New Zealand's Pharmaceutical Management Agency (PHARMAC) has been highly successful in facilitating affordable access to medicines through a combination of aggressive price negotiations, innovative procurement mechanisms, and careful evaluation of value for money. Recently the US government, through the establishment of a series of bilateral and plurilateral "free" trade agreements, has attempted to constrain the pharmaceutical access programs of other countries in order to promote the interests of the pharmaceutical industry. The Trans Pacific Partnership Agreement (TPPA) represents the latest example; through the TPPA the US is seeking to eliminate therapeutic reference pricing, introduce appeals processes for pharmaceutical companies to challenge formulary listing and pricing decisions, and introduce onerous disclosure and "transparency" provisions that facilitate industry involvement in decision-making around coverage and pricing of medicines (and medical devices). This paper argues that the US agenda, if successfully prosecuted, would be likely to increase costs and reduce access to affordable medicines for New Zealanders. This would in turn be likely to exacerbate known inequities in access to medicines and thus disproportionately affect disadvantaged population groups, including Māori and Pacific peoples. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Access to anti-cancer drugs in India: is there a need to revise reimbursement policies?

PubMed

Haitsma, Gertruud; Patel, Himanshu; Gurumurthy, Parthasarathi; Postma, Maarten J

2018-06-01

The aim of this study was to examine the access of Indian cancer patients to optimum cancer care under selected government schemes by reviewing reimbursement schemes for cancer care in India. All cancer care reimbursement schemes in India were identified and three highly utilized schemes (VAS, RAS, CMCHS) were selected. Quality of breast, colorectal, lung, head & neck, and gastric cancer care was reviewed with respect to NCCN guidelines. Direct medical costs and shortage of budget in reimbursed amounts were calculated for each listed chemotherapy regimen. Medical oncology practice following the schemes' formularies is inferior to recommendations by the NCCN guidelines. Innovative treatment (targeted therapies) like trastuzumab, pertuzumab (breast), bevacizumab, cetuximab, panitumumab (colorectal), erlotinib, gefitinib, crizotinib, and nivolumab (lung) are either not reimbursed (VAS, CMCHS) or partially reimbursed (RAS). Average shortage of budget was found to be 43% (breast), 55% (colorectal), 74% (lung), 7% (head & neck), and 51% (gastric cancer). Policy makers should consider addition of newer treatments, exclusion of sub-optimal treatments, increments in per patient budget and optimization of supportive care, which may contribute to improvements in survival and quality of life for Indian cancer patients.

Cassia fistula: A remedy from Traditional Persian Medicine for treatment of cutaneous lesions of pemphigus vulgaris

PubMed Central

Atarzadeh, Fatemeh; Kamalinejad, Mohammad; Dastgheib, Ladan; Amin, Gholamreza; Jaladat, Amir Mohammad; Nimrouzi, Majid

2017-01-01

Objective: Pemphigus is a rare autoimmune disease that may be fatal without proper medical intervention. It is a blistering disease that involves both the skin and mucus membranes, in which the most important causes of death comprise superimposed opportunistic infections and complications of long-term high-dose corticosteroid therapy or prolonged consumption of immune suppressant drugs. Skin lesions are the most important sources of infection, and any local treatment decreasing the healing time of lesions and reducing the total dosage of drugs is favorable. Materials and Methods: Here, we review the probable mechanism of action of a traditional formulary of Cassia fistula (C. fistula) fruit extract in almond oil as a new topical medication for reducing the duration of treatment of pemphigus vulgaris erosions. Results: C. fistula fruit oil has lupeol, anthraquinone compounds as rhein and flavonoids. Previous in vitro and animal studies on C. fistula fruit have demonstrated wound healing, antioxidative, anti-leukotrienes, anti-inflammatory, antibacterial and antifungal effects of this plant. Conclusion: It is hypothesized that C. fistula L. can be a botanical therapeutic choice for treatment of pemphigus erosions. PMID:28348966

Controlled trials to improve antibiotic utilization: a systematic review of experience, 1984-2004.

PubMed

Parrino, Thomas A

2005-02-01

To review the effectiveness of interventions designed to improve antibiotic prescribing patterns in clinical practice and to draw inferences about the most practical methods for optimizing antibiotic utilization in hospital and ambulatory settings. A literature search using online databases for the years 1975-2004 identified controlled trials of strategies for improving antibiotic utilization. Due to variation in study settings and design, quantitative meta-analysis was not feasible. Therefore, a qualitative literature review was conducted. Forty-one controlled trials met the search criteria. Interventions consisted of education, peer review and feedback, physician participation, rewards and penalties, administrative methods, and combined approaches. Social marketing directed at patients and prescribers was effective in varying contexts, as was implementation of practice guidelines. Authorization systems with structured order entry, formulary restriction, and mandatory consultation were also effective. Peer review and feedback were more effective when combined with dissemination of relevant information or social marketing than when used alone. Several practices were effective in improving antibiotic utilization: social marketing, practice guidelines, authorization systems, and peer review and feedback. Online systems providing clinical information, structured order entry, and decision support may be the most promising approach. Further studies, including economic analyses, are needed to confirm or refute this hypothesis.

Strategic planning for clinical services: St. Joseph Hospital and Health Care Center.

PubMed

Linggi, A; Pelham, L D

1986-09-01

A pharmacy department at a 340-bed community hospital based its strategic plan for developing patient-oriented services on a sound drug distribution system, a credible work-measurement program, and fiscal responsibility. In 1982 the department of pharmacy and i.v. therapy implemented a strategic plan for improving pharmaceutical services. The plan involved developing goals and objectives for the department; marketing the department's services and fiscal management to hospital administrators, medical staff, and nursing staff; building teamwork among the pharmacy staff; and improving the drug distribution system before instituting clinical services. Hiring of additional pharmacy staff was justified on the basis of work-measurement data. By adjusting staffing levels every two weeks based on work-measurement data, the department increased the efficiency of drug distribution activities; the pharmacy also implemented cost-saving programs like selection of therapeutic alternates and formulary restrictions. The savings were then reinvested in labor-intensive patient-oriented pharmaceutical services. A staff development program using staff pharmacists as preceptors expanded the breadth and depth of pharmacists' clinical skills. The planning efforts were successful because the needs of hospital administrators, the pharmacy department, and staff members were addressed.

Accounting for reasonableness: Exploring the personal internal framework affecting decisions about cancer drug funding.

PubMed

Sinclair, Shane; Hagen, Neil A; Chambers, Carole; Manns, Braden; Simon, Anita; Browman, George P

2008-05-01

Drug decision-makers are involved in developing and implementing policy, procedure and processes to support health resource allocation regarding drug treatment formularies. A variety of approaches to decision-making, including formal decision-making frameworks, have been developed to support transparent and fair priority setting. Recently, a decision tool, 'The 6-STEPPPs Tool', was developed to assist in making decisions about new cancer drugs within the public health care system. We conducted a qualitative study, utilizing focus groups and participant observation, in order to investigate the internal frameworks that supported and challenged individual participants as they applied this decision tool within a multi-stakeholder decision process. We discovered that health care resource allocation engaged not only the minds of decision-makers but profoundly called on the often conflicting values of the heart. Objective decision-making frameworks for new drug therapies need to consider the subjective internal frameworks of decision-makers that affect decisions. Understanding the very human, internal turmoil experienced by individuals involved in health care resource allocation, sheds additional insight into how to account for reasonableness and how to better support difficult decisions through transparent, values-based resource allocation policy, procedures and processes.

A Clinical Practice Guideline to Guide a System Approach to Diabetes Care in Hong Kong

PubMed Central

2017-01-01

The Hospital Authority of Hong Kong is a statutory body that manages all the public medical care institutions in Hong Kong. There are currently around 400,000 diabetic patients under its care at 17 hospitals (providing secondary care for 40%) and 73 General Outpatient Clinics (providing primary care for 60%). The patient population has been growing at 6% to 8% per year over the past 5 years, estimated to include over 95% of all diagnosed patients in Hong Kong. In order to provide equitable and a minimal level of care within resources and local system factors constraints, a Clinical Practice Guideline on the management of type 2 diabetes mellitus was drawn in 2013 to guide a system approach to providing diabetes care. There is an algorithm for the use of various hypoglycemic agents. An organizational drug formulary governs that less expansive options have to be used first. A number of clinical care and patient empowerment programs have been set up to support structured and systematic diabetes care. With such a system approach, there have been overall improvements in diabetes care with the percentage of patients with glycosylated hemoglobin <7% rising from 40% in 2010 to 52% in 2015. PMID:28447435

The role of pharmacoeconomics in current Indian healthcare system

PubMed Central

Ahmad, Akram; Patel, Isha; Parimilakrishnan, Sundararajan; Mohanta, Guru Prasad; Chung, HaeChung; Chang, Jongwha

2013-01-01

Phamacoeconomics can aid the policy makers and the healthcare providers in decision making in evaluating the affordability of and access to rational drug use. Efficiency is a key concept of pharmacoeconomics, and various strategies are suggested for buying the greatest amount of benefits for a given resource use. Phamacoeconomic evaluation techniques such as cost minimization analysis, cost effectiveness analysis, cost benefit analysis, and cost utilization analysis, which support identification and quantification of cost of drugs, are conducted in a similar way, but vary in measurement of value of health benefits and outcomes. This article provides a brief overview about pharmacoeconomics, its utility with respect to the Indian pharmaceutical industry, and the expanding insurance system in India. Pharmacoeconomic evidences can be utilized to support decisions on licensing, pricing, reimbursement, and maintenance of formulary procedure of pharmaceuticals. For the insurance companies to give better facility at minimum cost, India must develop the platform for pharmacoeconomics with a validating methodology and appropriate training. The role of clinical pharmacists including PharmD graduates are expected to be more beneficial than the conventional pharmacists, as they will be able to apply the principles of economics in daily basis practice in community and hospital pharmacy. PMID:24991597

Impact of a pharmacy technician-centered medication reconciliation program on medication discrepancies and implementation of recommendations.

PubMed

Kraus, Sarah K; Sen, Sanchita; Murphy, Michelle; Pontiggia, Laura

2017-01-01

To evaluate the impact of a pharmacy-technician centered medication reconciliation (PTMR) program by identifying and quantifying medication discrepancies and outcomes of pharmacist medication reconciliation recommendations. A retrospective chart review was performed on two-hundred patients admitted to the internal medicine teaching services at Cooper University Hospital in Camden, NJ. Patients were selected using a stratified systematic sample approach and were included if they received a pharmacy technician medication history and a pharmacist medication reconciliation at any point during their hospital admission. Pharmacist identified medication discrepancies were analyzed using descriptive statistics, bivariate analyses. Potential risk factors were identified using multivariate analyses, such as logistic regression and CART. The priority level of significance was set at 0.05. Three-hundred and sixty-five medication discrepancies were identified out of the 200 included patients. The four most common discrepancies were omission (64.7%), non-formulary omission (16.2%), dose discrepancy (10.1%), and frequency discrepancy (4.1%). Twenty-two percent of pharmacist recommendations were implemented by the prescriber within 72 hours. A PTMR program with dedicated pharmacy technicians and pharmacists identifies many medication discrepancies at admission and provides opportunities for pharmacist reconciliation recommendations.

Impact of a pharmacy technician-centered medication reconciliation program on medication discrepancies and implementation of recommendations

PubMed Central

2016-01-01

Objectives: To evaluate the impact of a pharmacy-technician centered medication reconciliation (PTMR) program by identifying and quantifying medication discrepancies and outcomes of pharmacist medication reconciliation recommendations. Methods: A retrospective chart review was performed on two-hundred patients admitted to the internal medicine teaching services at Cooper University Hospital in Camden, NJ. Patients were selected using a stratified systematic sample approach and were included if they received a pharmacy technician medication history and a pharmacist medication reconciliation at any point during their hospital admission. Pharmacist identified medication discrepancies were analyzed using descriptive statistics, bivariate analyses. Potential risk factors were identified using multivariate analyses, such as logistic regression and CART. The priority level of significance was set at 0.05. Results: Three-hundred and sixty-five medication discrepancies were identified out of the 200 included patients. The four most common discrepancies were omission (64.7%), non-formulary omission (16.2%), dose discrepancy (10.1%), and frequency discrepancy (4.1%). Twenty-two percent of pharmacist recommendations were implemented by the prescriber within 72 hours. Conclusion: A PTMR program with dedicated pharmacy technicians and pharmacists identifies many medication discrepancies at admission and provides opportunities for pharmacist reconciliation recommendations. PMID:28690691

State policy influence on the early diffusion of buprenorphine in community treatment programs.

PubMed

Ducharme, Lori J; Abraham, Amanda J

2008-06-20

Buprenorphine was approved for use in the treatment of opioid dependence in 2002, but its diffusion into everyday clinical practice in community-based treatment programs has been slow. This study examines the net impact of efforts by state agencies, including provision of Medicaid coverage, on program-level adoption of buprenorphine as of 2006. Interviews were conducted with key informants in 49 of the 50 state agencies with oversight responsibility for addiction treatment services. Information from these interviews was integrated with organizational data from the 2006 National Survey of Substance Abuse Treatment Services. A multivariate logistic regression model was estimated to identify the effects of state efforts to promote the use of this medication, net of a host of organizational characteristics. The availability of Medicaid coverage for buprenorphine was a significant predictor of its adoption by treatment organizations. Inclusion of buprenorphine on state Medicaid formularies appears to be a key element in ensuring that patients have access to this state-of-the-art treatment option. Other potential barriers to the diffusion of buprenorphine require identification, and the value of additional state-level policies to promote its use should be evaluated.

Tennessee health plan tobacco cessation coverage.

PubMed

Kolade, Folasade M

2014-01-01

To evaluate the smoking cessation coverage available from public and private Tennessee health plans. Cross-sectional study. The sampling frame for private plans was a register of licensed plans obtained from the Tennessee Commerce Department. Government websites and reports provided TennCare data. Data were abstracted from plan manuals and formularies for benefit year 2012. Classification of coverage included comprehensive-all seven recommended medications plus individual and group counseling; moderate-at least two forms of nicotine replacement therapy (NRT) plus bupropion and varenicline and one form of counseling; inadequate-at least one treatment, or none-no medications or counseling, or coverage only for pregnant women. Of nine private plans, one provided comprehensive coverage; two, moderate coverage; four, inadequate coverage, as did TennCare; and two plans provided no coverage. Over 362,800 smokers had inadequate access to cessation treatments under TennCare, while 119,094 smokers had inadequate or no cessation coverage under private plans. In 2012, Tennessee fell short of Healthy People goals for total managed care and comprehensive TennCare coverage of smoking cessation. If Tennessee mandates that all health plans provide full coverage, 481,900 smokers may immediately be in a better position to quit. © 2013 Wiley Periodicals, Inc.

Erectile Dysfunction Medication Use in Veterans Eligible for Medicare Part D.

PubMed

Spencer, Samantha H; Suda, Katie J; Smith, Bridget M; Huo, Zhiping; Bailey, Lauren; Stroupe, Kevin T

2016-07-01

Erectile dysfunction (ED) medications are therapeutically effective and associated with satisfaction. Medicare Part D included ED medications on the formulary during 2006 and inadvertently in 2007-2008. To characterize phosphodiesterase-5 inhibitor (PDE-5) medication use among veterans who were dually eligible for Veterans Affairs (VA) and Medicare Part D benefits. Veterans aged > 66 years who received PDE-5 inhibitors between 2005 and 2009 were included. Veterans were categorized by PDE-5 inhibitor claims: VA-only, Part D-only, or dual users of VA and Part D-reimbursed pharmacies. T-tests and chi-square tests were applied as appropriate. From 2005 to 2009, the majority (85.2%) of veterans used VA benefits exclusively for their PDE-5 inhibitors; 11.4% used Medicare Part D exclusively; and 3.4% were dual users. The Part D-only group was older, more frequently not black, had a VA copay, and had a higher income (P < 0.03). The VA group was more likely to have comorbidities, smoke, and have a history of substance abuse (P < 0.001). With the inception of Medicare Part D in 2006, the number of patients filling prescriptions for PDE-5 inhibitors (-68%) and total number of PDE-5 inhibitor 30-day equivalents dispensed (-86.7%) from the VA decreased. Part D prescriptions increased through 2006 (full coverage period) and 2007 (accidental partial coverage) and decreased in 2008. While Part D accounted for only 10% of PDE-5 inhibitor 30-day equivalents, it equaled 29.2% of dispensed tablets. In October 2007, VA PDE-5 inhibitor use returned to 2005 levels. Implementation of Medicare Part D reduced VA PDE-5 inhibitor acquisition. However, after removal of PDE-5 inhibitors from the Part D formulary, use of VA pharmacies for PDE-5 inhibitors resumed. Medication policies outside the VA can affect medication use. Veterans with access to non-VA health care may obtain medications from the private sector because of VA restrictions. This may be especially true for nonformulary and lifestyle medications. The authors received funding support for this research project from the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service as grant IIR 07-165-2. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or Health Services Research and Development Service. Study concept and design were contributed by Smith and Stroupe, assisted by the other authors. Huo, Bailey, and Stroupe took the lead in data collection, assisted by the other authors. Data interpretation was performed by Spencer and Suda, along with Smith and Stroupe and assisted by Huo and Bailey. The manuscript was primarily written by Spencer and Suda, with assistance from the other authors, and revised by Spencer, along with the other authors.

Chemical stability of oseltamivir in oral solutions.

PubMed

Albert, K; Bockshorn, J

2007-09-01

The stability of oseltamivir in oral aqueous solutions containing the preservative sodium benzoate was studied by a stability indicating HPLC-method. The separation was achieved on a RP-18 ec column using a gradient of mobile phase A (aqueous solution of 50 mM ammonium acetate) and mobile phase B (60% (v/v) acetonitrile/40% (v/v) mobile phase A). The assay was subsequently validated according to the ICH guideline Q2(R1). The extemporaneously prepared "Oseltamivir Oral Solution 15 mg/ml for Adults or for Children" (NRF 31.2.) according to the German National Formulary ("Neues Rezeptur-Formularium") was stable for 84 days if stored under refrigeration. After storage at 25 degrees C the content of oseltamivir decreased to 98.4%. Considering the toxicological limit of 0.5% of the 5-acetylamino derivative (the so-called isomer I) the solution is stable for 46 days. Oseltamivir was less stable in a solution prepared with potable water instead of purified water. Due to an increasing pH the stability of this solution decreased to 14 days. Furthermore a white precipitate of mainly calcium phosphate was observed. The addition of 0.1% anhydrous citric acid avoided these problems and improved the stability of the solution prepared with potable water to 63 days. Sodium benzoate was stable in all oral solutions tested.

Pharmacy Benefit Management Companies: Do They Create Value in the US Healthcare System?

PubMed

Lyles, Alan

2017-05-01

Pharmacy benefit management companies (PBMs) perform functions in the US market-based healthcare system that may be performed by public agencies or quasi-public institutions in other nations. By aggregating lives covered under their many individual contracts with payers, PBMs have formidable negotiating power. They influence pharmaceutical insurance coverage, design the terms of coverage in a plan's drug benefit, and create competition among providers for inclusion in a plan's network. PBMs have, through intermediation, the potential to secure lower drug prices and to improve rational prescribing. Whether these potential outcomes are realized within the relevant budget is a function of the healthcare system and the interaction of benefit design and clinical processes-not just individually vetted components. Efficiencies and values achieved in price discounts and cost sharing can be nullified if there is irrational prescribing (over-utilization, under-utilization and mis-utilization), variable patient adherence to medication regimens, ineffective formulary processes, or fraud, waste and abuse. Rising prescription drug costs and the increasing prevalence of 'high deductible health plans', which require much greater patient out-of-pocket costs, is creating a crisis for PBM efforts towards an affordable pharmacy benefit. Since PBM rebate and incentive contracts are opaque to the public, whether they add value by restraining higher drug prices or benefit from them is debatable.

Diuretics: a review.

PubMed

Wile, David

2012-09-01

Diuretics, in one form or another, have been around for centuries and this review sets out to chart their development and clinical use. Starting with the physiology of the kidney, it progresses to explain how diuretics actually work, via symports on the inside of the renal tubules. The different classes of diuretics are characterized, along with their mode of action. The clinical use of diuretics in conditions like congestive cardiac failure and hypertension, as well as some rarer, but clinically important, conditions is then examined. An account is given of the adverse effects of diuretics and how they come about. Common adverse effects like hypokalaemia and hyponatraemia are examined in some detail, and other electrolyte disturbances like hypomagnesaemia also gain a mention. Diuretic use in chronic kidney disease is examined and new guidelines that have been introduced are presented. A section on diuretic abuse is included as this is becoming an all too common clinical scenario, and the sometimes tragic consequences of this abuse are emphasized. Diuretics also find a role in the diagnosis of forms of renal tubular acidosis and this role is explored. Finally, a selection of some of the newer approaches to diuretic therapy are presented, often the consequence of the increasing development of molecular biology, and some of the novel compounds - which may be in drug formularies of the future - are revealed.

Ophthalmic preservatives: focus on polyquaternium-1.

PubMed

Rolando, Maurizio; Crider, Julie Y; Kahook, Malik Y

2011-11-01

Ophthalmic preservatives, such as polyquaternium-1 (PQ-1), are critical for the inhibition of growth of microbial contaminants in multi-dose bottles of topical medications. These antimicrobial agents must have a high efficacy against pathogenic organisms, while maintaining a favorable tolerability and safety profile. This review focuses on the ophthalmic preservative PQ-1. For comparison purposes, the most commonly used preservative, benzalkonium chloride (BAK), is also discussed. This survey focuses primarily on data collected during the past 10 years. Effective drug delivery requires more than just an active ingredient that achieves its desired biological effect on end-target tissues. In addition, drugs must be stable in the containers that they are stored in, and must possess minimal undesired local and systemic side effects that can cause patients to decrease their adherence. In addressing these concerns, specifically in topical ophthalmic drops, one must take into account the active ingredients, vehicle components and preservatives. Medications with fewer adverse effects may lead to enhanced adherence to therapy; therefore, the induction of such adverse outcomes must be considered by physicians when treating patients with chronic ocular disease. Although BAK will continue to be used in ophthalmic medications, due to its familiarity and compatibility with a broad range of topical ocular formulations, PQ-1 is certainly a viable alternative in the preservative formulary armamentarium.

The impact of price-cap regulations on market entry by generic pharmaceutical firms.

PubMed

Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

2017-04-01

In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

Radiation Impact on Pharmaceutical Stability: Retrospective Data Review

NASA Technical Reports Server (NTRS)

Daniels, V. R.; Bayuse, T. M.; McGuire, K. M.; Antonsen, E. L.; Putcha, L.

2017-01-01

Historical studies performed by the JSC Pharmacotherapeutics Discipline suggest that exposure to spaceflight conditions may compromise the safety and efficacy of some medications. Follow-on studies have revealed that affected medications demonstrate reductions in active pharmaceutical ingredient (API) concentrations and altered release characteristics. It was hypothesized that the changes in API potency and release were from the medication's exposure to the harsh environmental conditions of spaceflight. Subsequent review of the spaceflight environmental control records from the time of these studies indicated that temperature and humidity levels aboard all spacecraft remained within United States Pharmacopeia (USP) recommended ranges to maintain optimal pharmaceutical stability. Therefore, space radiation was presumed to be the source of observed drug degradation. The Pharmacotherapeutics Discipline conducted a ground analog radiation experiment in 2006 at the NASA Space Radiation Laboratory (NSRL) at Brookhaven to validate this theory and to characterize the effects of high-energy radioactive particles on pharmaceutical stability. These data were never published. Recently, the Exploration Medical Capability (ExMC) Element finalized a research plan (RP) aimed at providing a safe and effective medication formulary for exploration spaceflight. As ExMC begins to design new flight and ground analog radiation studies, further analysis of the 2006 NSRL study data is essential for the characterization of the impact of radiation on medication potency and efficacy in the exploration spaceflight environment.

Expert knowledge in palliative care on the World Wide Web: palliativedrugs.org.

PubMed

Gavrin, Jonathan

2009-01-01

In my last Internet-related article, I speculated that social networking would be the coming wave in the effort to share knowledge among experts in various disciplines. At the time I did not know that a palliative care site on the World Wide Web (WWW), palliativedrugs.com, already provided the infrastructure for sharing expert knowledge in the field. The Web site is an excellent traditional formulary but it is primarily devoted to "unlicensed" ("off-label") use of medications in palliative care, something we in the specialty often do with little to support our interventions except shared knowledge and experience. There is nothing fancy about this Web site. In a good way, its format is a throwback to Web sites of the 1990s. In only the loosest sense can one describe it as "multimedia." Yet, it provides the perfect forum for expert knowledge and is a "must see" resource. Its existing content is voluminous and reliable, filtered and reviewed by renowned clinicians and educators in the field. Although its origin and structure were not specifically designed for social or professional networking, the Web site's format makes it a natural way for practitioners around the world to contribute to an ever-growing body of expertise in palliative care.

Inter-jurisdictional cooperation on pharmaceutical product listing agreements: views from Canadian provinces.

PubMed

Morgan, Steven G; Thomson, Paige A; Daw, Jamie R; Friesen, Melissa K

2013-01-31

Confidential product listing agreements (PLAs) negotiated between pharmaceutical manufacturers and individual health care payers may contribute to unwanted price disparities, high administrative costs, and unequal bargaining power within and across jurisdictions. In the context of Canada's decentralized health system, we aimed to document provincial policy makers' perceptions about collaborative PLA negotiations. We conducted semi-structured telephone interviews with a senior policy maker from nine of the ten Canadian provinces. We conducted a thematic analysis of interview transcripts to identify benefits, drawbacks, and barriers to routine collaboration on PLA negotiations. Canadian policy makers expressed support for joint negotiations of PLAs in principle, citing benefits of increased bargaining power and reduced inter-jurisdictional inequities in drug prices and formulary listings. However, established policy institutions and the politics of individual jurisdictional authority are formidable barriers to routine PLA collaboration. Achieving commitment to a joint process may be difficult to sustain among heterogeneous and autonomous partners. Though collaboration on PLA negotiation is an extension of collaboration on health technology assessment, it is a very significant next step that requires harmonization of the outcomes of decision-making processes. Views of policy makers in Canada suggest that sustaining routine collaborations on PLA negotiations may be difficult unless participating jurisdictions have similar policy institutions, capacities to implement coverage decisions, and local political priorities.

Performance Equivalence and Validation of the Soleris Automated System for Quantitative Microbial Content Testing Using Pure Suspension Cultures.

PubMed

Limberg, Brian J; Johnstone, Kevin; Filloon, Thomas; Catrenich, Carl

2016-09-01

Using United States Pharmacopeia-National Formulary (USP-NF) general method <1223> guidance, the Soleris(®) automated system and reagents (Nonfermenting Total Viable Count for bacteria and Direct Yeast and Mold for yeast and mold) were validated, using a performance equivalence approach, as an alternative to plate counting for total microbial content analysis using five representative microbes: Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. Detection times (DTs) in the alternative automated system were linearly correlated to CFU/sample (R(2) = 0.94-0.97) with ≥70% accuracy per USP General Chapter <1223> guidance. The LOD and LOQ of the automated system were statistically similar to the traditional plate count method. This system was significantly more precise than plate counting (RSD 1.2-2.9% for DT, 7.8-40.6% for plate counts), was statistically comparable to plate counting with respect to variations in analyst, vial lots, and instruments, and was robust when variations in the operating detection thresholds (dTs; ±2 units) were used. The automated system produced accurate results, was more precise and less labor-intensive, and met or exceeded criteria for a valid alternative quantitative method, consistent with USP-NF general method <1223> guidance.

Room-temperature storage of medications labeled for refrigeration.

PubMed

Cohen, Victor; Jellinek, Samantha P; Teperikidis, Leftherios; Berkovits, Elliot; Goldman, William M

2007-08-15

Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room temperature were collected and compiled in a tabular format. During May and June of 2006, the prescribing information for medications labeled for refrigeration as obtained from the supplier were reviewed for data addressing room-temperature storage. Telephone surveys of the products' manufacturers were conducted when this information was not available in the prescribing information. Medications were included in the review if they were labeled to be stored at 2-8 degrees C and purchased by the pharmacy department for uses indicated on the hospital formulary. Frozen antibiotics thawed in the refrigerator and extemporaneously compounded medications were excluded. Information was compiled and arranged in tabular format. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. Of the 189 medications listed in AHFS Drug Information 2006 for storage in a refrigerator, 89 were present in the pharmacy department's refrigerator. Since six manufacturers were unable to provide information for 10 medications, only 79 medications were included in the review. This table may help to avoid unnecessary drug loss and expenditures due to improper storage temperatures. Information regarding the room-temperature storage of 79 medications labeled for refrigerated storage was compiled.

Availability of antidotes and key emergency drugs in tertiary care hospitals of Punjab and assessment of the knowledge of health care professionals in the management of poisoning cases.

PubMed

Arslan, Naheed; Khiljee, Sonia; Bakhsh, Allah; Ashraf, Muhammad; Maqsood, Iram

2016-03-01

This study was conducted to evaluate the availability of antidotes/key emergency drugs in tertiary care hospitals of the Punjab province, and to assess the knowledge of health care professionals in the stocking and administration of antidotes in the proper management of poisoning cases. Seventeen (n=17) tertiary care hospitals of Punjab Pakistan were selected. Two performas (A and B) were designed for 26 antidotes/key emergency drugs and given to the hospital pharmacists and physicians respectively. It was observed that Activated Charcoal, being the universal antidote was found only in 6 hospitals (41%). Digoxin Immune Fab, Edentate Calcium disodium and Glucagon were not available in emergency department of any hospital and even not included in the formulary of any hospital. About 80% pharmacists were aware of the method of preparation of Activated Charcoal and 85% physicians were familiar with its route of administration. Data showed that tertiary care hospitals of Punjab do not stock antidotes according to national drug policy. Moreover the study strongly suggests the development of health care centers and professional by organizing antidote awareness programs, continuous education and record keeping of poisonous cases and availability of emergency drugs around the clock.

The current capacity and future development of economic evaluation for policy decision-making: a survey among researchers and decision-makers in Thailand.

PubMed

Chaikledkaew, Usa; Lertpitakpong, Chanida; Teerawattananon, Yot; Thavorncharoensap, Montarat; Tangcharoensathien, Viroj

2009-01-01

This study aims to explore the knowledge, experience, and attitudes toward economic evaluation (EE) among decision-makers and researchers in Thailand. Researchers were purposively selected from Thai academics and both public and private research organizations related to EE. Decision-makers at the provincial level were purposively selected from the members of the Management Committees of Provincial Health Offices, and those at hospital level were randomly selected from members of the public and private hospital formulary drug committees throughout Thailand. The self-administered postal questionnaires were distributed. Univariate and bivariate analyses were applied. Of the total 2575 questionnaires distributed, 758 (29.4% response rate) were completed and sent back. The majority of researchers and decision-makers were not familiar with technical terms commonly used in health EE, e.g., incremental cost-effectiveness ratio, discounting, and sensitivity analysis. More decision-makers (70.6%) had never had EE training compared to researchers (50.0%). Both roles indicated that value for money was one of the important issues to consider for health technology adoption. An extensive unmet demand for EE training among Thai researchers and decision-makers still exists. Findings from this study contribute to the short- and long-term plans for research capacity building.

Compendia and anticancer therapy under Medicare.

PubMed

Tillman, Katherine; Burton, Brijet; Jacques, Louis B; Phurrough, Steve E

2009-03-03

In 1993, Congress directed the Medicare program to refer to 3 existing published compendia, American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia Drug Information for the Health Professional (USP-DI), and American Hospital Formulary Service Drug Information (AHFS-DI), to identify unlabeled but medically accepted uses of drugs and biologicals in anticancer chemotherapy regimens. Public discussion during the preceding years had centered on whether to designate unlabeled uses of anticancer treatments as experimental and thus outside the scope of Medicare benefits. American Medical Association Drug Evaluations and USP-DI subsequently ceased publication, and the Medicare program faced increasing calls to revise the list of acceptable compendia, as authorized in the statute. In 2007, the Centers for Medicare & Medicaid Services used its regulatory authority to establish a publicly transparent process to revise the list. The Centers for Medicare & Medicaid Services considered 5 requests in 2008 and added National Comprehensive Cancer Network Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology to the list of compendia. DrugPoints was not added, and AMA-DE was removed. Because of the potential for conflicts of interest to lead to biased judgments, the 2008 Medicare Improvements for Patients and Providers Act has a provision that explicitly prohibits inclusion of compendia that do not have a publicly transparent process for evaluating therapies and identifying potential conflicts of interest.

Medicare part D and the nursing home setting.

PubMed

Stevenson, David G; Huskamp, Haiden A; Newhouse, Joseph P

2008-08-01

The purpose of this article is to explore how the introduction of Medicare Part D is changing the operations of long-term-care pharmacies (LTCPs) and nursing homes, as well as implications of those changes for nursing home residents. We reviewed existing sources of information and interviewed stakeholders across various perspectives. We conducted 31 semistructured telephone interviews with key stakeholders between November 2006 and January 2007. Part D represents a substantial departure from how prescription drugs were previously financed and administered in nursing homes, and nursing home providers and LTCPs have struggled in adapting to some of these changes. Part D increased the variation around formularies and drug management processes for residents at the facility level, creating additional burden on clinical and pharmacy staff and introducing a tension between facilities' need to dispense medications quickly and assuring of coverage for those drugs. Nursing home and LTCP stakeholders perceive wide variation across Part D plans in their ability to meet the needs of nursing home residents. Although LTCPs, nursing homes and their clinicians, and Part D plans will gain experience with the benefit in the nursing home setting over time, stakeholders we interviewed identified a range of longer term issues and questions that merit attention as the benefit proceeds.

Medicare Part D and the Nursing Home Setting

PubMed Central

Stevenson, David G.; Huskamp, Haiden A.; Newhouse, Joseph P.

2008-01-01

Purpose To explore how Medicare Part D's introduction is changing the operations of long-term care pharmacies (LTCPs) and nursing homes, as well as implications of those changes for nursing home residents. Design and Methods We reviewed existing sources of information and interviewed stakeholders across various perspectives. Thirty-one semi-structured, telephone interviews were conducted with key stakeholders between November 2006 and January 2007. Results Part D represents a substantial departure from how prescription drugs were previously financed and administered in nursing homes, and nursing home providers and LTCPs have struggled in adapting to some of these changes. Part D increased the variation around formularies and drug management processes for residents at the facility level, creating additional burden on clinical and pharmacy staff and introducing a tension between facilities' need to dispense medications quickly and assuring coverage for those drugs. Nursing home and LTCP stakeholders perceive wide variation across Part D plans in their ability to meet the needs of nursing home residents. Implications Although LTCPs, nursing homes and their clinicians, and Part D plans will gain experience with the benefit in the nursing home setting over time, stakeholders we interviewed identified a range of longer-term issues and questions that merit attention as the benefit proceeds. PMID:18728293

Computational health economics for identification of unprofitable health care enrollees

PubMed Central

Rose, Sherri; Bergquist, Savannah L.; Layton, Timothy J.

2017-01-01

SUMMARY Health insurers may attempt to design their health plans to attract profitable enrollees while deterring unprofitable ones. Such insurers would not be delivering socially efficient levels of care by providing health plans that maximize societal benefit, but rather intentionally distorting plan benefits to avoid high-cost enrollees, potentially to the detriment of health and efficiency. In this work, we focus on a specific component of health plan design at risk for health insurer distortion in the Health Insurance Marketplaces: the prescription drug formulary. We introduce an ensembled machine learning function to determine whether drug utilization variables are predictive of a new measure of enrollee unprofitability we derive, and thus vulnerable to distortions by insurers. Our implementation also contains a unique application-specific variable selection tool. This study demonstrates that super learning is effective in extracting the relevant signal for this prediction problem, and that a small number of drug variables can be used to identify unprofitable enrollees. The results are both encouraging and concerning. While risk adjustment appears to have been reasonably successful at weakening the relationship between therapeutic-class-specific drug utilization and unprofitability, some classes remain predictive of insurer losses. The vulnerable enrollees whose prescription drug regimens include drugs in these classes may need special protection from regulators in health insurance market design. PMID:28369273

Assessing New Technologies in Aerosol Medicine: Strengths and Limitations.

PubMed

Berlinski, Ariel

2015-06-01

Aerosols are the mainstay of treatment for pulmonary diseases such as asthma, cystic fibrosis, and COPD. In addition, aerosols are also being used for systemic drug delivery. Patients need devices that are safe, reliable, portable, and easy to use; have few steps in their operation; help them keep track of the remaining doses; are not expensive; and provide age-appropriate positive reinforcement and feedback. Computational fluid dynamics, human factor sciences, and quality by design are now applied to device development. Matching patient, drug, and device remains a challenge. Formulary restrictions, the current status of the industry-academia relationship, and the need to use multiple platforms hinder the process. Patients and families need to participate in the selection of a device that is appropriate for them. Practitioners need comparative data to help them choose the right device. New devices and drugs can be compared with the existing technology using in vitro and in vivo methods (lung imaging, pharmacokinetic and pharmacodynamics studies). Drug manufacturers need to be able to justify coverage of new products by third-party payers by showing a positive cost/benefit relationship. Finally, post-market surveillance is necessary for old drugs with new devices or for new drugs and devices to ensure patient safety. Copyright © 2015 by Daedalus Enterprises.

National reimbursement listing determinants of new cancer drugs: a retrospective analysis of 58 cancer treatment appraisals in 2007-2016 in South Korea.

PubMed

Kim, Eun-Sook; Kim, Jung-Ae; Lee, Eui-Kyung

2017-08-01

Since the positive-list system was introduced, concerns have been raised over restricting access to new cancer drugs in Korea. Policy changes in the decision-making process, such as risk-sharing agreement and the waiver of pharmacoeconomic data submission, were implemented to improve access to oncology medicines, and other factors are also involved in the reimbursement for cancer drugs. The aim of this study is to investigate the reimbursement listing determinants of new cancer drugs in Korea. All cancer treatment appraisals of Health Insurance Review and Assessment during 2007-2016 were analyzed based on 13 independent variables (comparative effectiveness, cost-effectiveness, drug-price comparison, oncology-specific policy, and innovation such as new mode of action). Univariate and multivariate logistic analyses were conducted. Of 58 analyzed submissions, 40% were listed in the national reimbursement formulary. In univariate analysis, four variables were related to listing: comparative effectiveness, drug-price comparison, new mode of action, and risk-sharing agreement. In multivariate logistic analysis, three variables significantly increased the likelihood of listing: clinical improvement, below alternative's price, and risk-sharing arrangement. Cancer drug's listing increased from 17% to 47% after risk-sharing agreement implementation. Clinical improvement, cost-effectiveness, and RSA application are critical to successful national reimbursement listing.

Suitability of a liquid chromatography assay of neomycin sulfate to replace the microbiological assay for neomycin in USP Monographs.

PubMed

Hanko, Valoran P; Rohrer, Jeffrey S

2010-01-05

The current USP National Formulary contains 65 Monographs for drug formulations containing neomycin. All 65 Monographs prescribe a bioassay for neomycin assay. This bioassay, based on cell culture, is labor intensive, has poor precision, and cannot be adapted for purity or identification. High-performance anion-exchange chromatography with integrated pulsed amperometric detection (HPAE-IPAD), a liquid chromatography technique, has been shown to be suitable for neomycin purity analysis and neomycin assay of an over-the-counter first aid cream (Hanko and Rohrer [17]). Here we propose that an HPAE-IPAD assay can replace the bioassay in the 65 neomycin-containing Monographs. We applied the HPAE-IPAD assay to four neomycin-containing drug products representing the four classes of formulations found in the 65 Monographs, liquid, solid, suspension, and cream. Each drug was analyzed with two chromatography systems, and on 3 separate days. For all products, HPAE-IPAD measurements were precise and accurate with respect to the label concentrations. There was also high accuracy for spike recovery of neomycin from the four drug products throughout 70-150% of the labeled concentration. These results suggest that an HPAE-IPAD assay would be an accurate assay for neomycin, and would be faster and more precise than the current bioassay.

Emerging importance of geographical indications and designations of origin - authenticating geo-authentic botanicals and implications for phytotherapy.

PubMed

Brinckmann, J A

2013-11-01

Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, and strength of a botanical are developed based on analysis of presumably authenticated botanical reference materials. The specimens should represent the quality traditionally specified for the intended use, which may require different standards for medicinal versus food use. Development of quality standards monographs may occur through collaboration between a sponsor company or industry association and a pharmacopoeial expert committee. The sponsor may base proposed standards and methods on their own preferred botanical supply which may, or may not, be geo-authentic and/or correspond to qualities defined in traditional medicine formularies and pharmacopoeias. Geo-authentic botanicals are those with specific germplasm, cultivated or collected in their traditional production regions, of a specified biological age at maturity, with specific production techniques and processing methods. Consequences of developing new monographs that specify characteristics of an 'introduced' cultivated species or of a material obtained from one unique origin could lead to exclusion of geo-authentic herbs and may have therapeutic implications for clinical practice. In this review, specifications of selected medicinal plants with either a geo-authentic or geographical indication designation are discussed and compared against official pharmacopoeial standards for same genus and species regardless of origin. Copyright © 2012 John Wiley & Sons, Ltd.