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.

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

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

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

Does variation among provincial drug formulary antimicrobial listings in Canada influence prescribing rates?

PubMed

Glass-Kaastra, Shiona K; Finley, Rita; Hutchinson, Jim; Patrick, David M; Weiss, Karl; Conly, John

2014-01-01

The financial accessibility of antimicrobial drugs to the outpatient community in Canada is governed at the provincial level through formularies. Each province may choose to list particular drugs or impose restriction criteria on products in order to guide prescribing and/or curtail costs. Although changes to formularies have been shown to change patterns in the use of individual products and alter costs, no comparison has been made among the provincial antimicrobial formularies with regards to flexibility/stringency, or an assessment of how these formularies impact overall antimicrobial use in the provinces. To summarize provincial antimicrobial formularies and assess whether their relative flexibility/stringency had a statistical impact upon provincial prescription volume during a one year period. Provincial drug plan formularies were accessed and summarized for all prescribed antimicrobials in Canada during 2010. The number of general and restricted benefits for each plan was compiled by antimicrobial classification. Population-adjusted prescription rates for all individual antimicrobials and by antimicrobial class were obtained from the Canadian Integrated Program for Antimicrobial Resistance Surveillance. Correlations between the number of general benefits, restricted benefits, and total benefits with the prescription rate in the provinces were assessed by Spearman rank correlation coefficients. Formularies varied considerably among the Canadian provinces. Quebec had the most flexible formulary, offering the greatest number of general benefits and fewest restrictions. In contrast, Saskatchewan's formulary displayed the lowest number of general benefits and most restrictions. Correlation analyses detected a single significant result; macrolide prescription rates decreased as the number of general macrolide benefits increased. All other rates of provincial antimicrobial prescribing and measures of flexibility/stringency revealed no significant correlations

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.

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.

Formulary management.

PubMed

Scroccaro, G

2000-10-01

The hospital formulary is not only a list of drugs, but also a policy that involves several complex processes and activities. Formularies are developed based on cost-effectiveness evaluation, but maintaining cost-effectiveness requires educational strategies. The clinical pharmacist plays an active role in formulary processes. These processes are discussed in this paper. There is a need for studies on the cost-effectiveness of clinical pharmacy services in support of the hospital formulary.

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.

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

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.

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

INTEGRATING HEALTH TECHNOLOGY ASSESSMENT PRINCIPLES IN FORMULARY MANAGEMENT.

PubMed

Teng, Monica; Khoo, Ai Leng; Zhao, Ying Jiao; Lin, Liang; Lim, Boon Peng

2016-01-01

Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore. A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary. Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists' proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management. Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

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.

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.

Results of our national survey. Current formulary decision-making strategies and new factors influencing the process.

PubMed

1995-08-01

Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.

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

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

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.

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

Use of a geriatric formulary in long-term care.

PubMed

Babington, M A

1997-01-01

The use of drug formularies in nursing facilities (NFs) is a fairly new idea. A large long-term care pharmacy provider prepared a formulary specific to a geriatric population. This open formulary is contained within a handbook of clinical monographs, complete with dosing information, cost comparisons, and references to NF regulations affecting the use of particular drugs.

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.

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.

Implementation of a formulary management process.

PubMed

Karel, Lauren I; Delisle, Dennis R; Anagnostis, Ellena A; Wordell, Cindy J

2017-08-15

The application of lean methodology in an initiative to redesign the formulary maintenance process at an academic medical center is described. Maintaining a hospital formulary requires clear communication and coordination among multiple members of the pharmacy department. Using principles of lean methodology, pharmacy department personnel within a multihospital health system launched a multifaceted initiative to optimize formulary management systemwide. The ongoing initiative began with creation of a formulary maintenance redesign committee consisting of pharmacy department personnel with expertise in informatics, automation, purchasing, drug information, and clinical pharmacy services. The committee met regularly and used lean methodology to design a standardized process for management of formulary additions and deletions and changes to medications' formulary status. Through value stream analysis, opportunities for process and performance improvement were identified; staff suggestions on process streamlining were gathered during a series of departmental kaizen events. A standardized template for development and dissemination of monographs associated with formulary additions and status changes was created. In addition, a shared Web-based checklist was developed to facilitate information sharing and timely initiation and completion of tasks involved in formulary status changes, and a permanent formulary maintenance committee was established to monitor and refine the formulary management process. A clearly defined, standardized process within the pharmacy department was developed for tracking necessary steps in enacting formulary changes to encourage safe and efficient workflow. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

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

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.

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.

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.

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

Attitude and opinion towards essential medicine formulary.

PubMed

Sharma, Sangeeta; Kh, Reeta; Chaudhury, R Roy

2010-06-01

The Delhi State Drug Policy was adopted in 1994 following which the first Essential Medicines List (EML) was developed in 1996. The Delhi State Essential Medicines Formulary was brought out in 1997. A need was felt to revise the formulary to match with the EML as the EML is renewed every 2 years. A survey was undertaken to elicit the opinions of the doctors practicing in the state on the usefulness of the formulary before revising and printing the updated version. The survey covered dispensaries, 10-20 bedded hospitals, 100-bedded hospitals and two tertiary care hospitals. Discussions were focused on questionnaires on attitudes toward adopting Essential Medicines Formulary using a 10-point scale. Of the 200 doctors approached, only 90 doctors completed the questionnaire. Sixty-nine respondents (76.6%) had received the copy of the formulary. Most practitioners welcomed the formulary and were satisfied with the coverage and selection of the medicines. Most respondents (76.9%) agreed that a well-developed formulary would improve the quality of the public health care system, although they had reservations about the authority, relevance and effect on professional autonomy. About 74% of the respondents used the formulary in clinical practice as a source of medicine information, which makes its regular revision necessary.

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.

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

Attitude and opinion towards essential medicine formulary

PubMed Central

Sharma, Sangeeta; Kh, Reeta; Chaudhury, R. Roy

2010-01-01

Objective: The Delhi State Drug Policy was adopted in 1994 following which the first Essential Medicines List (EML) was developed in 1996. The Delhi State Essential Medicines Formulary was brought out in 1997. A need was felt to revise the formulary to match with the EML as the EML is renewed every 2 years. Materials and Methods: A survey was undertaken to elicit the opinions of the doctors practicing in the state on the usefulness of the formulary before revising and printing the updated version. The survey covered dispensaries, 10–20 bedded hospitals, 100-bedded hospitals and two tertiary care hospitals. Discussions were focused on questionnaires on attitudes toward adopting Essential Medicines Formulary using a 10-point scale. Results: Of the 200 doctors approached, only 90 doctors completed the questionnaire. Sixty-nine respondents (76.6%) had received the copy of the formulary. Most practitioners welcomed the formulary and were satisfied with the coverage and selection of the medicines. Most respondents (76.9%) agreed that a well-developed formulary would improve the quality of the public health care system, although they had reservations about the authority, relevance and effect on professional autonomy. Conclusion: About 74% of the respondents used the formulary in clinical practice as a source of medicine information, which makes its regular revision necessary. PMID:20871765

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.

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.

Overview of the hospital formulary systems in Hong Kong. Princess Margaret Hospital as a baseline.

PubMed

Chang, S; Wong, J W; Wong, C W; Chiu, H C; Raymond, K

1997-12-01

To investigate the popularity of formulary systems in all Hong Kong hospitals and to compare these with the newly introduced formulary system in a major government hospital, the Princess Margaret Hospital (PMH), as the baseline. Questionnaire and selected interviews by pharmacy students. All hospital pharmacies in Hong Kong. Department managers (directors of pharmacy services) of hospital pharmacies. The popularity of the hospitals' formulary systems and their formulary decision-making strategies. Calculations of cost savings of the new formulary system in PMH and a comparison of the PMH system with the US standards were also made. Among 38 responding hospitals, 35 (92%) had a formulary handbook and 21 (55.3%) claimed to have a formulary system. The evaluation processes and formulary decision-making procedures were found to be inadequate because basic components in drug evaluation (e.g., standardized criteria for drug evaluation) were not used regularly. However, the formulary system in PMH was found to be comparable with the US standards. Substantial cost savings were made through rejection of less cost-effective drugs by the Formulary Subcommittee in PMH. In general, comprehensive formulary systems are still not popular in Hong Kong. This may be due to insufficient staffing and lack of administrative and physicians' support. The new formulary system in PMH can be used as a model to develop a successful formulary system in which hospital pharmacists can prove their expertise for the benefit of both hospitals and patients in Hong Kong.

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

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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

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

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.

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.

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.

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.

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

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

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.

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.

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.

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 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

Effect of electronic prescribing with formulary decision support on medication tier, copayments, and adherence

PubMed Central

2014-01-01

between formulary decision support usage and adherence. Conclusion Interruptive formulary decision support shifted prescribing toward preferred tiers, but these medications were only minimally less expensive in the studied patient population. In this context, formulary decision support did not significantly increase adherence. To impact cost-related non-adherence, formulary decision support will likely need to be paired with complementary drug benefit design. Formulary decision support should be studied further, with particular attention to its effect on adherence in the setting of different benefit designs. PMID:25167807

Effect of electronic prescribing with formulary decision support on medication tier, copayments, and adherence.

PubMed

Pevnick, Joshua M; Li, Ning; Asch, Steven M; Jackevicius, Cynthia A; Bell, Douglas S

2014-08-28

support usage and adherence. Interruptive formulary decision support shifted prescribing toward preferred tiers, but these medications were only minimally less expensive in the studied patient population. In this context, formulary decision support did not significantly increase adherence. To impact cost-related non-adherence, formulary decision support will likely need to be paired with complementary drug benefit design. Formulary decision support should be studied further, with particular attention to its effect on adherence in the setting of different benefit designs.

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

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

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

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.

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

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.

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.

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.

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.

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

Should medical students learn to develop a personal formulary?

PubMed Central

Daniels, J. M. A.; Mulder, C. W.; Groot, O. A.; Wewerinke, L.; Barnes, K. I.; Bakathir, H. A.; Hassan, N. A. G. M.; Van Bortel, L.; Kriska, M.; Santoso, B.; Sanz, E. J.; Thomas, M.; Ziganshina, L. E.; Bezemer, P. D.; Van Kan, C.; Richir, M. C.; Hogerzeil, H. V.

2008-01-01

Objective This study was performed to determine whether students who are trained in developing a personal formulary become more competent in rational prescribing than students who have only learned to use existing formularies. Methods This was a multicentre, randomised, controlled study conducted in eight universities in India, Indonesia, the Netherlands, the Russian Federation, Slovakia, South Africa, Spain and Yemen. Five hundred and eighty-three medical students were randomised into three groups: the personal formulary group (PF; 94), the existing formulary group (EF; 98) and the control group (C; 191). The PF group was taught how to develop and use a personal formulary, whereas e the EF group was taught how to review and use an existing formulary. The C group received no additional training and participated only in the tests. Student’s prescribing skills were measured by scoring their treatment plans for written patient cases. Results The mean PF group score increased by 23% compared with 19% for the EF group (p < 0.05) and 6% for controls (p < 0.05). The positive effect of PF training was only significant in universities that had a mainly classic curriculum. Conclusion Training in development and use of a personal formulary was particularly effective in universities with a classic curriculum and with traditional pharmacology teaching. In universities with a general problem-based curriculum, pharmacotherapy teaching can be based on either existing or personal formularies. PMID:18338161

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

Effect of Misalignment between Hospital and Provincial Formularies on Medication Discrepancies at Discharge: PPITS (Proton Pump Inhibitor Therapeutic Substitution) Study

PubMed Central

Chua, Doson; Chu, Eric; Lo, Angela; Lo, Melissa; Pataky, Fruzina; Tang, Linda; Bains, Ajay

2012-01-01

Background Medication discrepancies may occur on admission, transfer, or discharge from hospital. Therapeutic interchange within a drug class is a common practice in hospitals, and orders for specific proton pump inhibitors (PPIs) are often substituted with the hospital’s formulary PPI through therapeutic interchange protocols. Rabeprazole is the PPI on the formulary of the British Columbia PharmaCare program. However, different PPIs may appear on the formularies of the province’s hospitals. This misalignment and use of therapeutic interchange may lead to increased rates of medication discrepancies at the time of discharge. Objective To evaluate the effect of formulary misalignment for PPIs between St Paul’s Hospital in Vancouver and the British Columbia PharmaCare program and use of therapeutic interchange on the occurrence of medication discrepancies at discharge. Methods A cohort chart review was performed to compare discharge discrepancy rates for PPI orders between 2 periods: June 2006 to June 2008, when the same PPI appeared on the hospital and provincial formularies, and July 2008 to July 2010, when the designated PPIs differed between the hospital and provincial formularies. Data for the first study period were used to establish the baseline discharge discrepancy rate, and data for the later period represented the discharge discrepancy rate in the presence of misalignment between the hospital and PharmaCare formularies. Results The discharge discrepancy rate for PPIs was 27.3% (24/88) when the 2 formularies were aligned and 49.1% (81/165) when the formularies were misaligned. This represents an absolute increase of 21.8 percentage points in the risk of discharge discrepancies (95% confidence interval 9.8–33.9 percentage points; p < 0.001) when the hospital and provincial formularies were misaligned and the hospital’s therapeutic interchange protocol was used. Conclusions Misalignment between the PPIs specified in the hospital and provincial

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

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.

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.

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.

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

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

Using National Drug Codes and drug knowledge bases to organize prescription records from multiple sources.

PubMed

Simonaitis, Linas; McDonald, Clement J

2009-10-01

The utility of National Drug Codes (NDCs) and drug knowledge bases (DKBs) in the organization of prescription records from multiple sources was studied. The master files of most pharmacy systems include NDCs and local codes to identify the products they dispense. We obtained a large sample of prescription records from seven different sources. These records carried a national product code or a local code that could be translated into a national product code via their formulary master. We obtained mapping tables from five DKBs. We measured the degree to which the DKB mapping tables covered the national product codes carried in or associated with the sample of prescription records. Considering the total prescription volume, DKBs covered 93.0-99.8% of the product codes from three outpatient sources and 77.4-97.0% of the product codes from four inpatient sources. Among the in-patient sources, invented codes explained 36-94% of the noncoverage. Outpatient pharmacy sources rarely invented codes, which comprised only 0.11-0.21% of their total prescription volume, compared with inpatient pharmacy sources for which invented codes comprised 1.7-7.4% of their prescription volume. The distribution of prescribed products was highly skewed, with 1.4-4.4% of codes accounting for 50% of the message volume and 10.7-34.5% accounting for 90% of the message volume. DKBs cover the product codes used by outpatient sources sufficiently well to permit automatic mapping. Changes in policies and standards could increase coverage of product codes used by inpatient sources.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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...

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…

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".

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.

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.

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.

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

National Drug IQ Challenge

MedlinePlus

... del coeficiente intelectual (CI) sobre las drogas y el alcohol 2016 National Drug IQ Challenge 2016 Reto ... del coeficiente intelectual (CI) sobre las drogas y el alcohol 2015 National Drug IQ Challenge 2015 Reto ...

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...

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

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.

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

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.

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

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.

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

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

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.

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.

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.

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

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

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.

National Drug Control Strategy.

ERIC Educational Resources Information Center

Office of National Drug Control Policy, Washington, DC.

This report presents a comprehensive blueprint for new direction and effort in the national fight against illegal drug use. It is the result of an intensive review of federal anti-drug efforts to date and incorporates advice and recommendations from hundreds of interested and involved anti-drug leaders outside the federal government. The…

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.

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...

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).

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.

National Drug Control Strategy. 2008 Annual Report

ERIC Educational Resources Information Center

Office of National Drug Control Policy, 2008

2008-01-01

This report presents the 2008 National Drug Control Strategy of the White House Office of National Drug Control Policy. The overarching goal of the President's Strategy is to reduce drug use in America through a balanced approach that focuses on stopping use before it starts, healing America's drug users, and disrupting the market for illegal…

Drug Testing: A National Controversy.

ERIC Educational Resources Information Center

Stone, Karen; Thompson, Judith R.

1989-01-01

Addresses some of the controversies and illustrates the historical background of drug testing and what the different drug tests are. Also outlines some national statistics and opinions on drug testing and the results of a survey taken of a Louisiana population dealing with this issue. (NB)

Different policy outcomes of the new drugs and currently listed drugs under the positive list system in South Korea.

PubMed

Lee, Eui-Kyung; Kim, Bo-Yeon; Lim, Jae-Young; Park, Mi-Hai

2012-01-01

Four years have passed since the positive list system was implemented in South Korea. The system was received well because it has fulfilled its intended objective of enhancing the cost-effectiveness of new drugs. With regard to currently listed drugs, however, debate has lingered since the reevaluation of the cost-effectiveness by therapeutic group. This study intended to review the lessons learned and compromises reached in implementing an evidence-based national formulary. Currently listed drugs are very different from new drugs. In terms of effectiveness, the level of existing evidence tends to be lower for currently listed drugs. Also, the evaluation plan was quite delayed because of the vast amount of literature. In the political decision-making process, a coalition was formed by the pharmaceutical companies with physicians, and the government had difficulty responding because of the strong resistance against the reevaluation of currently listed drugs. Although idealistic, it was an attempt to apply the same standard of cost-effectiveness for currently listed drugs as that for new drugs. To successfully implement the system, however, some factors that need to be considered were limitation of available evidence on currently listed drugs and specific strategies employed against political resistance. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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.

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.

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.

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

National Drug Control Strategy, 2006

ERIC Educational Resources Information Center

The White House, 2006

2006-01-01

This report presents a summary of the Fiscal Year 2007 Budget for the National Drug Control Strategy within the three key priority areas; education and community action, treatment and intervention, and disruption in the illegal drug market. The first chapter, "Stopping Drug Use Before It Starts," outlines the Administration's work to prevent the…

National Drug Control Strategy, 2011

ERIC Educational Resources Information Center

Office of National Drug Control Policy, 2011

2011-01-01

In May of 2010, President Obama released the Administration's inaugural "National Drug Control Strategy". Based on the premise that drug use and its consequences pose a threat not just to public safety, but also to public health, the 2010 "Strategy" represented the first comprehensive rebalancing of Federal drug control policy in the nearly 40…

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.

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.

2007 national roadside survey of alcohol and drug use by drivers : drug results.

DOT National Transportation Integrated Search

2009-12-01

This report presents the first national prevalence estimates for drug-involved driving derived from the recently : completed 2007 National Roadside Survey (NRS). The NRS is a national field survey of alcohol- and drug-involved : driving conducted pri...

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.

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.

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...

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...

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.

National Drug Control Strategy. FY 2009 Budget Summary

ERIC Educational Resources Information Center

The White House, 2008

2008-01-01

The National Drug Control Budget Summary identifies resources and performance indicators for programs within the Executive Branch that are integral to the President's National Drug Control Strategy. The Strategy, which is the Administration's plan for reducing drug use and availability, is based on three pillars: (1) Stopping Use Before It Starts,…

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.

Validating Self-Reports of Illegal Drug Use to Evaluate National Drug Control Policy: A Reanalysis and Critique

ERIC Educational Resources Information Center

Magura, Stephen

2010-01-01

Illicit drug use remains at high levels in the U.S. The federal Office of National Drug Control Policy evaluates the outcomes of national drug demand reduction policies by assessing annual changes in drug use from several federally sponsored annual national surveys. Such survey methods, relying exclusively on drug use as self-reported on…

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.

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.

National Drug Control Strategy. Update

ERIC Educational Resources Information Center

Office of National Drug Control Policy, 2005

2005-01-01

The first National Drug Control Strategy set ambitious two and five-year performance based goals: (1) to lower the rate of drug use by 10 percent over 2 years among both youth and adults; and (2) to lower the rate by 25 percent over 5 years. The chapters in this updated version are keyed to the strategies three priorities: (1) Stopping Use Before…

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.

Pulse Check: National Trends in Drug Abuse.

ERIC Educational Resources Information Center

Hunt, Dana

This Pulse Check is a report of national trends in illicit drug abuse and drug markets in the United States. The report draws on conversations with ethnographers and epidemiologists working in the drug field, law enforcement agents, and drug treatment providers across the United States. Information from each of these sources is summarized in…

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

Breaking the Cycle of Drug Abuse. 1993 Interim National Drug Control Strategy.

ERIC Educational Resources Information Center

Office of National Drug Control Policy, Washington, DC.

This Interim Drug Strategy is intended to give a new sense of direction and to reinvigorate the nation's efforts against drug trafficking and abuse. The preface to the report lists eight new strategies that the Administration will implement: (1) make drug policy a cornerstone of domestic and social policy; (2) target pregnant women, children, and…

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.

National drug control policy and prescription drug abuse: facts and fallacies.

PubMed

Manchikanti, Laxmaiah

2007-05-01

In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects

Results from the 2002 National Survey on Drug Use and Health: National Findings.

ERIC Educational Resources Information Center

Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Office of Applied Studies.

This report presents the first information from the 2002 National Survey on Drug Use and Health (NSDUH), an annual survey of the civilian, noninstitutionalized population of the United States aged 12 years old or older. Prior to 2002, the survey was called the National Household Survey on Drug Abuse (NHSDA). This initial report on the 2002 data…

76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-23

... National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... Alcoholism and National Advisory Council on Drug Abuse. Date: September 12, 2011. Open: September 12, 2011...

76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-20

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS...

75 FR 80511 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Development of Alternate Drug Delivery Dosage Forms for Drug Abuse Studies. Date: January 7, 2011... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug...

United States National Library of Medicine Drug Information Portal.

PubMed

Hochstein, Colette; Goshorn, Jeanne; Chang, Florence

2009-01-01

The Drug Information Portal is a free Web resource from the National Library of Medicine (NLM) that provides a user-friendly gateway to current information for more than 15,000 drugs. The site guides users to related resources of NLM, the National Institutes of Health (NIH), and other government agencies. Current drug-related information regarding consumer health, clinical trials, AIDS, MeSH pharmacological actions, MEDLINE/PubMed biomedical literature, and physical properties and structure is easily retrieved by searching on a drug name. A varied selection of focused topics in medicine and drugs is also available from displayed subject headings. This column provides background information about the Drug Information Portal, as well as search basics.

77 FR 22581 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001...

75 FR 71712 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Cutting... Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug...

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.

Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines.

PubMed

Dumbreck, Siobhan; Flynn, Angela; Nairn, Moray; Wilson, Martin; Treweek, Shaun; Mercer, Stewart W; Alderson, Phil; Thompson, Alex; Payne, Katherine; Guthrie, Bruce

2015-03-11

To identify the number of drug-disease and drug-drug interactions for exemplar index conditions within National Institute of Health and Care Excellence (NICE) clinical guidelines. Systematic identification, quantification, and classification of potentially serious drug-disease and drug-drug interactions for drugs recommended by NICE clinical guidelines for type 2 diabetes, heart failure, and depression in relation to 11 other common conditions and drugs recommended by NICE guidelines for those conditions. NICE clinical guidelines for type 2 diabetes, heart failure, and depression Potentially serious drug-disease and drug-drug interactions. Following recommendations for prescription in 12 national clinical guidelines would result in several potentially serious drug interactions. There were 32 potentially serious drug-disease interactions between drugs recommended in the guideline for type 2 diabetes and the 11 other conditions compared with six for drugs recommended in the guideline for depression and 10 for drugs recommended in the guideline for heart failure. Of these drug-disease interactions, 27 (84%) in the type 2 diabetes guideline and all of those in the two other guidelines were between the recommended drug and chronic kidney disease. More potentially serious drug-drug interactions were identified between drugs recommended by guidelines for each of the three index conditions and drugs recommended by the guidelines for the 11 other conditions: 133 drug-drug interactions for drugs recommended in the type 2 diabetes guideline, 89 for depression, and 111 for heart failure. Few of these drug-disease or drug-drug interactions were highlighted in the guidelines for the three index conditions. Drug-disease interactions were relatively uncommon with the exception of interactions when a patient also has chronic kidney disease. Guideline developers could consider a more systematic approach regarding the potential for drug-disease interactions, based on epidemiological

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.

Self-Monitoring of Blood Glucose: Impact of Quantity Limits in Public Drug Formularies on Provincial Costs Across Canada.

PubMed

Knowles, Sandra R; Lee, Kathy; Paterson, J Michael; Shah, Baiju R; Mamdani, Muhammad M; Juurlink, David N; Gomes, Tara

2017-04-01

For most patients with diabetes, routine use of blood glucose test strips (BGTS) has not been shown to be beneficial, yet the economic implications of broad publicly funded reimbursement for BGTS are substantial. We assessed the potential impact of BGTS quantity limits on utilization and costs for 6 publicly funded drug plans across Canada. A cross-sectional analysis was conducted in 6 provinces (Alberta, Saskatchewan, Manitoba, Nova Scotia, Newfoundland and Labrador and Prince Edward Island) for patients who received at least 1 prescription for BGTS in 2014 through the public drug program. We determined the number of BGTS that would have exceeded the quantity limits and the associated costs to the provincial drug program. A total of $38,051,026 was spent on BGTS reimbursed through public drug programs among the 6 provinces. In provinces where BGTS use is largely restricted to patients using insulin, the potential annual savings were minimal, ranging from 0.4% to 2.3%, whereas in provinces with more liberal listings, potential savings ranged from 12.4% to 19.8%. Combining these results with data from a previous analysis in Ontario and British Columbia, the cost savings associated with BGTS quantity limits for 8 provinces across Canada (capturing approximately three-quarters of the Canadian population) is estimated to be $30.3 million annually. The national implementation of a quantity limit policy for BGTS that aligns with evidence of efficacy, optimal prescribing and patient safety can lead to considerable savings for most public drug plans across Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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

Cancer Drugs: An International Comparison of Postlicensing Price Inflation.

PubMed

Savage, Philip; Mahmoud, Sarah; Patel, Yogin; Kantarjian, Hagop

2017-06-01

The cost of cancer drugs forms a rising proportion of health care budgets worldwide. A number of studies have examined international comparisons of initial cost, but there is little work on postlicensing price increases. To examine this, we compared cancer drug prices at initial sale and subsequent price inflation in the United States and United Kingdom and also reviewed relevant price control mechanisms. The 10 top-selling cancer drugs were selected, and their prices at initial launch and in 2015 were compared. Standard nondiscounted prices were obtained from the relevant annual copies of the RED BOOK and the British National Formulary. At initial marketing, prices were on average 42% higher in the United States than in the United Kingdom. After licensing in the United States, all 10 drugs had price rises averaging an overall annual 8.8% (range, 1.4% to 24.1%) increase. In comparison, in the United Kingdom, six drugs had unchanged prices, two had decreased prices, and two had modest price increases. The overall annual increase in the United Kingdom was 0.24%. Cancer drug prices are rising substantially, both at their initial marketing price and, in the United States, at postlicensing prices. In the United Kingdom, the Pharmaceutical Price Regulation Scheme, an agreement between the government and the pharmaceutical industry, controls health care costs while allowing a return on investment and funds for research. The increasing costs of cancer drugs are approaching the limits of sustainability, and a similar government-industry agreement may allow stability for both health care provision and the pharmaceutical industry in the United States.

76 FR 3913 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse... individual investigators. Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns... Psychologist, Clinical Pharmacology Branch, Intramural Research Program, National Institute on Drug Abuse...

The right drug, but from whose perspective? A framework for analysing the structure and activities of drug and therapeutics committees.

PubMed

Hoffmann, Mikael

2013-05-01

During the last five decades drug and therapeutics committees (DTCs), have evolved from mainly hospital-based groups of experts in pharmacotherapy and drug logistics into an arena for healthcare professionals employing evidence-based methods of promoting rational drug use. The purpose of this study was to suggest a framework for analysing the structure and activities of DTCs. A literature search was carried out in the Medline, Cinahl and Web of Sciences databases for the period 1993-2012. A total of 207 articles were included. Based on these articles a framework for the analysis of the DTCs based on the role of the DTC, target groups, budget perspective and type of economic decisions could be suggested. In order to respond to future demands the DTCs will have to develop their skill in pharmacoeconomics. Their processes will have to be standardised and made more transparent in order to be better adapted to evidence-based decision-making. They will also have to embrace the possibilities created by electronic health records in both influencing the decisions of physicians, and in improving quality assurance programmes and longitudinal follow-up of drug therapy and outcomes. They will have to find new ways of interacting with the public and policy makers in order to get the resources needed for their work. Finally, they will have to handle the conflict among national, regional and local decision-making processes and the relationship between formularies and therapeutic guidelines.

76 FR 65517 - National Institute on Drug Abuse Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

78 FR 55265 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

2011 National Drug Control Strategy. Executive Summary

ERIC Educational Resources Information Center

Office of National Drug Control Policy, 2011

2011-01-01

In May of 2010, President Obama released the Administration's inaugural "National Drug Control Strategy", a comprehensive approach to combat the public health and safety consequences posed by drug use. Now, a year later, the Administration is releasing its update building upon that initial "Strategy". The "Strategy" establishes ambitious goals to…

77 FR 27075 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel....D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH... . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel NIDA B/START Small Grant...

76 FR 22715 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-22

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Blending..., Training and Special Projects Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse... Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health...

77 FR 27075 - National Institute on Drug Abuse Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Regulatory..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001... Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes...

75 FR 80512 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...D, Scientific Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse... limitations imposed by the review and funding cycle. Name of Committee: National Institute on Drug Abuse...

76 FR 3916 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel..., Scientific Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Seek, Test...

78 FR 73866 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-09

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Center... Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

78 FR 13362 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIH Pathway..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH..., Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: February 20...

75 FR 14175 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401... Federal Domestic Assistance Program Nos. 93.279, Drug Abuse and Addiction Research Programs, National...

78 FR 58320 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Strategic..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

76 FR 31968 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Technical... Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

75 FR 63498 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Statistical... Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard... Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated...

77 FR 22581 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Multi-site... Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd... Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes...

78 FR 64960 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH... . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; CEBRA: Cutting-Edge Basic...

78 FR 63994 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Substance Use...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

War on Drugs: Reauthorization of the Office of National Drug Control Policy

DTIC Science & Technology

2005-06-01

Authorization of the Office of National Drug Control Policy (ONDCP) expired on September 30, 2003. Located in the Executive Office of the President...Counter-Drug Technology Assessment Center. The office was created in 1988 and reauthorized twice since then. A bill has been introduced in the House (H.R...Congress as it prepares to consider reauthorization of the office of the drug czar. This report will be updated as legislative activity occurs.

21 CFR 1401.2 - The Office of National Drug Control Policy-organization and functions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false The Office of National Drug Control Policy-organization and functions. 1401.2 Section 1401.2 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY PUBLIC AVAILABILITY OF INFORMATION § 1401.2 The Office of National Drug Control Policy—organization and functions. (a) The Office of National Drug...

76 FR 81952 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Training and... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4245, MSC 9550, 6001 Executive Blvd... Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated...

78 FR 27410 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; R13..., Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Committee: National Institute on Drug Abuse Special Emphasis Panel; PA-11-197 NIH Pathway to Independence...

75 FR 54348 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse.... [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, NIDA B/Start... Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Blvd., Bethesda...

75 FR 36429 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Medications..., National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Blvd., Bethesda, MD 20892. 301-451-3086. [email protected] . Name of Committee: National Institute on Drug Abuse Special...

75 FR 42102 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-07-20

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Research..., lf33c.nih.gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug...

78 FR 56238 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Multisite... Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550... review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; I...

76 FR 11252 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Initial Review Group..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4245, MSC 9550, 6001.... Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA-K Conflicts. Date...

75 FR 42104 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-20

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Systems... Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401... review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel 2010...

78 FR 25460 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Committee: National Institute on Drug Abuse Special Emphasis Panel; Cohort Studies of HIV/AIDS and Substance...

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.

76 FR 24893 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

The relationship between the prescription of psychotropic drugs and suicide rates in older people in England and Wales.

PubMed

Shah, Ajit; Zhinchin, Galina; Zarate-Escudero, Sofia; Somyaji, Manjunath

2014-02-01

Several studies have reported an inverse correlation between general population and elderly suicide rates and antidepressant prescribing rates. Correlations between general population and elderly suicide rates and prescribing rates of other psychotropic drugs have also been reported. All studies of elderly suicide rates have used data over a decade old. The relationship between elderly suicide rates and prescription rates of psychotropic drugs by the broad British National Formulary (BNF) categories, for individual psychotropic drug groups within the BNF categories (e.g. SSRIs), and for individual psychotropic drugs was examined over a 12-year period (1995-2006) using Spearman's rank correlation. All data were ascertained from the archives of the National Statistics Office. There was an absence of significant correlations between elderly suicides rates and rates of prescriptions of psychotropic drugs in the broad BNF categories, individual psychotropic drug groups and individual psychotropic drugs. The findings may be due to methodological flaws. However, if they are genuine, then the following approaches require consideration to further reduce suicide rates: (1) development of strategies to ensure continued prescription of psychotropic drugs at the current level; (2) development of strategies to improve non-pharmacological measures, including improved mental health services provision for older people, improved assessment of suicide risk, increased availability of psychosocial interventions and restricting the availability of methods of suicide; and (3) development of strategies to implement improvement in distal risk (e.g. societal socio-economic status) and protective (e.g. societal educational attainment) factors for suicide at a societal level.

78 FR 25460 - National Institute on Drug Abuse; Notice of Closed Meetings

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2013-05-01

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel..., National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892- 9550, (301) 435-1439, [email protected] . Name of Committee: National Institute on Drug Abuse Special...

76 FR 59414 - National Institute on Drug Abuse; Notice of Closed Meetings

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2011-09-26

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76 FR 31967 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-06-02

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; N01DA-11-7777.... Ruiz, PhD, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse....: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: May 26...

78 FR 57166 - National Institute on Drug Abuse; Notice of Closed Meetings

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2013-09-17

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77 FR 3480 - National Institute on Drug Abuse, Notice of Closed Meetings

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2012-01-24

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76 FR 51381 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4238, MSC 9550, 6001 Executive Blvd., Bethesda, MD 20892-9550, 301-402-6626, [email protected] . Name of Committee: National Institute on Drug Abuse...

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

77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

Drugs and the Nation's High School Students: Five Year National Trends. 1979 Highlights.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

The current prevalence of drug use among American high school seniors, and trends in drug use since 1975, were investigated as part of the program entitled "Monitoring the Future: A Continuing Study of the Lifestyles and Values of Youth," funded by the National Institute on Drug Abuse. The basic research design involved data collection from high…

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.

Drug resistance in Mexico: results from the National Survey on Drug-Resistant Tuberculosis.

PubMed

Bojorquez-Chapela, I; Bäcker, C E; Orejel, I; López, A; Díaz-Quiñonez, A; Hernández-Serrato, M I; Balandrano, S; Romero, M; Téllez-Rojo Solís, M M; Castellanos, M; Alpuche, C; Hernández-Ávila, M; López-Gatell, H

2013-04-01

To present estimations obtained from a population-level survey conducted in Mexico of prevalence rates of mono-, poly- and multidrug-resistant strains among newly diagnosed cases of pulmonary tuberculosis (TB), as well as the main factors associated with multidrug resistance (combined resistance to isoniazid and rifampicin). Study data came from the National Survey on TB Drug Resistance (ENTB-2008), a nationally representative survey conducted during 2008-2009 in nine states with a stratified cluster sampling design. Samples were obtained for all newly diagnosed cases of pulmonary TB in selected sites. Drug susceptibility testing (DST) was performed for anti-tuberculosis drugs. DST results were obtained for 75% of the cases. Of these, 82.2% (95%CI 79.5-84.7) were susceptible to all drugs. The prevalence of multidrug-resistant TB (MDR-TB) was estimated at 2.8% (95%CI 1.9-4.0). MDR-TB was associated with previous treatment (OR 3.3, 95%CI 1.1-9.4). The prevalence of drug resistance is relatively low in Mexico. ENTB-2008 can be used as a baseline for future follow-up of drug resistance.

76 FR 70463 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

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75 FR 16815 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Mechanism for Time-Sensitive Drug Abuse Research. Date: April 8, 2010. Time: 12 p.m. to 3 p.m. Agenda: To review and..., Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6101...

75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...

76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health... Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-89550, (301...

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.

77 FR 22579 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel E... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4229, MSC 9550... Drug Abuse Special Emphasis Panel Rapid Portable Devices to Measure Drug Use (1206). Date: May 1, 2012...

78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... on Drug Abuse. Date: September 4, 2013. Closed: 8:30 AM to 10:30 AM. Agenda: To review and evaluate... program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center...

Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings

ERIC Educational Resources Information Center

Substance Abuse and Mental Health Services Administration, 2011

2011-01-01

This report presents a first look at results from the 2010 National Survey on Drug Use and Health (NSDUH), an annual survey of the civilian, noninstitutionalized population of the United States aged 12 years old or older. The report presents national estimates of rates of use, numbers of users, and other measures related to illicit drugs, alcohol,…

Development and economic trends in cancer therapeutic drugs: a 5-year update 2010-2014.

PubMed

Savage, P; Mahmoud, S

2015-03-17

Over the past 20 years, the mechanisms of action, duration of benefits and economic costs of newly licenced cancer drugs have changed significantly; however, summary data on these characteristics are limited. In this study, using historical copies of the British National Formulary and relevant contemporary publications, we have documented for each new cancer drug the year of introduction, therapeutic classification, initial indication, median duration of treatment and the cost of treatment at introduction relative to the then current UK GDP per capita. Before 2000, there were 69 cancer treatment drugs available, of which 50 (72.5%) were classical cytotoxic drugs. In the subsequent 15 years, there have been 63 more new cancer treatment drugs added, including 20 kinase inhibitors and 11 monoclonal antibodies. The average median duration of treatment with a new drug has risen from 181 days in 1995-1999 to 263 days in 2010-2014. The average cost of treatment has also risen from £3036.91 (20.6% of UK per capita GDP) in 1995-1999 to £20 233 (89.0%) in 2005-2009 and now to £35 383 (141.7%) in 2010-2014. The last 5 years has seen 33 new cancer drugs. These drugs deliver significant benefits in patient outcomes and are taken for increasing lengths of time. Alongside these clinical benefits, the direct costs of new treatments have increased significantly over the past decade.

76 FR 23828 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD....279, Drug Abuse and [[Page 23829

75 FR 49946 - National Drug Intelligence Center: Agency Information Collection Activities: Proposed Extension...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF JUSTICE [OMB Number 1105-0087] National Drug Intelligence Center: Agency Information...), National Drug Intelligence Center (NDIC), will be submitting the following information collection request... Kevin M. Walker, General Counsel, National Drug Intelligence Center, Fifth Floor, 319 Washington Street...

Factors influencing the difference between forecasted and actual drug sales volumes under the price-volume agreement in South Korea.

PubMed

Park, Sun-Young; Han, Euna; Kim, Jini; Lee, Eui-Kyung

2016-08-01

This study analyzed factors contributing to increases in the actual sales volumes relative to forecasted volumes of drugs under price-volume agreement (PVA) policy in South Korea. Sales volumes of newly listed drugs on the national formulary are monitored under PVA policy. When actual sales volume exceeds the pre-agreed forecasted volume by 30% or more, the drug is subject to price-reduction. Logistic regression assessed the factors related to whether drugs were the PVA price-reduction drugs. A generalized linear model with gamma distribution and log-link assessed the factors influencing the increase in actual volumes compared to forecasted volume in the PVA price-reduction drugs. Of 186 PVA monitored drugs, 34.9% were price-reduction drugs. Drugs marketed by pharmaceutical companies with previous-occupation in the therapeutic markets were more likely to be PVA price-reduction drugs than drugs marketed by firms with no previous-occupation. Drugs of multinational pharmaceutical companies were more likely to be PVA price-reduction drugs than those of domestic companies. Having more alternative existing drugs was significantly associated with higher odds of being PVA price-reduction drugs. Among the PVA price-reduction drugs, the increasing rate of actual volume compared to forecasted volume was significantly higher in drugs with clinical usefulness. By focusing the negotiation efforts on those target drugs, PVA policy can be administered more efficiently with the improved predictability of the drug sales volumes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

75 FR 5798 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug..., Targeted Library Synthesis and Screening at Novel Targets for Potential Drug Addiction (R21/R33). Date... Panel, Diversity-promoting Institutions' Drug Abuse Research Development Program. Date: February 25...

78 FR 43890 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-07-22

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76 FR 59415 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-09-26

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78 FR 63996 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-10-25

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78 FR 40755 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-07-08

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76 FR 35227 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-06-16

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78 FR 22892 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-04-17

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77 FR 75179 - National Institute on Drug Abuse; Notice of Closed Meetings

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2012-12-19

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78 FR 37835 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-06-24

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78 FR 19499 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-04-01

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75 FR 16815 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-04-02

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75 FR 9606 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-03-03

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76 FR 4928 - National Institute on Drug Abuse; Amended Notice of Meeting

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2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory Council on Drug Abuse, February 2, 2011, 8:30 a.m. to 2:45 p.m., National Institutes of Health...

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

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.

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

77 FR 44640 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-30

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Rodent Testing...: Lyle Furr, Contract Review Specialist, Office of Extramural Affairs, National Institute on Drug Abuse..., lf33c.nih.gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction...

77 FR 75179 - National Institute on Drug Abuse Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse... Institute on Drug Abuse, NIH, Room 4228, MSC 9550, 6001 Executive Blvd., Bethesda, MD 20892-9550, (301) 451-3086, [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel...

75 FR 21006 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, 6101 Executive Blvd., Rm. 213, MSC.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

78 FR 63995 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel R13 Conference... Officer, Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

78 FR 6126 - National Institute on Drug Abuse; Notice of Closed Meetings

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2013-01-29

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550, 6001 Executive Blvd., Bethesda, MD 20892- 9550, 301-443-9511, [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis...

76 FR 81954 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-12-29

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Confirming Compliance with Experimental Pharmacotherapy Treatment of Drug Abuse (2227) Date: January 17, 2012. Time: 9 a..., National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550, 6001 Executive Blvd., Bethesda, MD 20892...

75 FR 13136 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-03-18

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Institute on Drug Abuse, NIH. DHHS, Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892- 8401... Assistance Program Nos. 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health...

75 FR 25277 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, May 11, 2010, 1:30 p.m. to May 11, 2010, 3 p.m., National...

78 FR 69858 - National Institute on Drug Abuse; Notice of Closed Meetings

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2013-11-21

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel..., [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Seek... on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4245, MSC 9550, Bethesda, MD 20892-9550, 301-451...

75 FR 6042 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-02-05

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Blvd., Bethesda, MD 20892-8401, 301... Assistance Program Nos. 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health...

77 FR 69640 - National Institute on Drug Abuse; Notice of Closed Meetings

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2012-11-20

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550, 6001... Institute on Drug Abuse Special Emphasis Panel CEBRA Conflict Review. Date: November 29, 2012. Time: 4:00 p...

Young Men and Drugs--A Nationwide Survey. National Institute on Drug Abuse Research Monograph Series 5.

ERIC Educational Resources Information Center

O'Donnell, John A.; And Others

Results of a national survey of drug use among young males (19-30) are reported. For most drugs, half or more of the users used the drug less than 10 times. The data suggest a possible decline in the use of cigarettes. Several implications of the drug epidemic of the late 1960's are noted. Differences of drug use between blacks and whites seem to…

Results from the 2006 National Survey on Drug Use and Health: National Findings

ERIC Educational Resources Information Center

Substance Abuse and Mental Health Services Administration, 2007

2007-01-01

This updated report from Substance Abuse and Mental Health Services Administration's (SAMHSA's) Office of Applied Studies presents the first information from the 2006 National Survey on Drug Use and Health (NSDUH) and is the primary source of information on the prevalence, patterns, and consequences of alcohol, tobacco, and illegal drug use and…

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.

Implementation of a national anti-tuberculosis drug resistance survey in Tanzania

PubMed Central

Chonde, Timothy M; Doulla, Basra; van Leth, Frank; Mfinanga, Sayoki GM; Range, Nyagosya; Lwilla, Fred; Mfaume, Saidi M; van Deun, Armand; Zignol, Matteo; Cobelens, Frank G; Egwaga, Saidi M

2008-01-01

Background A drug resistance survey is an essential public health management tool for evaluating and improving the performance of National Tuberculosis control programmes. The current manuscript describes the implementation of the first national drug resistance survey in Tanzania. Methods Description of the implementation process of a national anti-tuberculosis drug resistance survey in Tanzania, in relation to the study protocol and Standard Operating Procedures. Results Factors contributing positively to the implementation of the survey were a continuous commitment of the key stakeholders, the existence of a well organized National Tuberculosis Programme, and a detailed design of cluster-specific arrangements for rapid sputum transportation. Factors contributing negatively to the implementation were a long delay between training and actual survey activities, limited monitoring of activities, and an unclear design of the data capture forms leading to difficulties in form-filling. Conclusion Careful preparation of the survey, timing of planned activities, a strong emphasis on data capture tools and data management, and timely supervision are essential for a proper implementation of a national drug resistance survey. PMID:19116022

Implementation of a national anti-tuberculosis drug resistance survey in Tanzania.

PubMed

Chonde, Timothy M; Doulla, Basra; van Leth, Frank; Mfinanga, Sayoki G M; Range, Nyagosya; Lwilla, Fred; Mfaume, Saidi M; van Deun, Armand; Zignol, Matteo; Cobelens, Frank G; Egwaga, Saidi M

2008-12-30

A drug resistance survey is an essential public health management tool for evaluating and improving the performance of National Tuberculosis control programmes. The current manuscript describes the implementation of the first national drug resistance survey in Tanzania. Description of the implementation process of a national anti-tuberculosis drug resistance survey in Tanzania, in relation to the study protocol and Standard Operating Procedures. Factors contributing positively to the implementation of the survey were a continuous commitment of the key stakeholders, the existence of a well organized National Tuberculosis Programme, and a detailed design of cluster-specific arrangements for rapid sputum transportation. Factors contributing negatively to the implementation were a long delay between training and actual survey activities, limited monitoring of activities, and an unclear design of the data capture forms leading to difficulties in form-filling. Careful preparation of the survey, timing of planned activities, a strong emphasis on data capture tools and data management, and timely supervision are essential for a proper implementation of a national drug resistance survey.

75 FR 3239 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Rapid Assessment for Drug Abuse and Risky Sex (5556). Date: February 16, 2010. Time: 1:30 p.m. to..., Contract Review Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room...

75 FR 3239 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse; Special... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard... Drug Abuse, Special Emphasis Panel, P30 Centers Review. Date: February 22, 2010. Time: 8 a.m. to 5 p.m...

76 FR 65517 - National Institute on Drug Abuse Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Review Officer, Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

2013–2014 National Roadside Study of alcohol and drug use by drivers: drug results.

DOT National Transportation Integrated Search

2017-05-01

This was a nationally representative study to estimate the prevalence of alcohol and other drug use among drivers. : Drugs studied included 98 over-the-counter, prescription, and illegal substances. Drivers were randomly selected at : 60 sites (300 l...

78 FR 66948 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus, Baltimore, MD, 21223... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Board of...

76 FR 35226 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel... of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4229, MSC 9550, 6001... Institute on Drug Abuse Special Emphasis Panel, R01 and R34 Review. Date: June 30, 2011. Time: 11 a.m. to 2...

75 FR 9606 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-03

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard... Drug Abuse Special Emphasis Panel NIDA CEBRA R21 Review. Date: March 17, 2010. Time: 9 a.m. to 5 p.m...

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

Testimony of Edwin Meese III, Attorney General and Chairman, National Drug Policy Board, before U.S. Senate Committee on the Judiciary, Regarding Coordination of National Drug Policy and Strategy.

ERIC Educational Resources Information Center

Department of Justice, Washington, DC.

The testimony of the United States Attorney General which appears in this document concentrates on three areas: (1) the coordination of federal drug control efforts and the reorganization of the National Drug Policy Board; (2) the performance of the National Drug Policy Board; and (3) the Administration's views on the proposed "Drug…

77 FR 63843 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of changes in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 2, 2012, 1:00 p.m. to October 2, 2012, 4:00 p.m...

76 FR 71986 - National Institute on Drug Abuse Amended; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse Amended; Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, December 13, 2011, 9 a.m. to December 13, 2011, 5 p.m...

76 FR 3916 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, February 22, 2011, 8 a.m. to February 25, 2011, 5 p.m...

77 FR 64117 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of changes in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 2, 2012, 8:30 a.m. to October 2, 2012, 1:00 p.m...

Changes in Retail Prices of Prescription Dermatologic Drugs From 2009 to 2015.

PubMed

Rosenberg, Miranda E; Rosenberg, Steven P

2016-02-01

Physicians from many specialties as well as primary care prescribe dermatologic medications; as insurance formularies become increasingly restrictive and more patients are covered with high-deductible insurance plans, many patients are forced to pay high retail prices to obtain their medications. To determine the changes in the prices of commonly prescribed dermatologic medications since 2009 and to identify trends in price increases for different classes of drugs. Four national chain pharmacies received surveys requesting price data on commonly prescribed dermatologic drugs in 2009, 2011, 2014, and 2015. The initial survey requested information on 72 brand-name drugs. Subsequent surveys increased to eventually include 120 additional brand-name drugs and their generic alternatives when available. Owing to the frequency of prescription, diseases treated, or unusual price increases, 19 brand-name drugs surveyed in all 4 years were selected for final price trend analysis, which was conducted from August 1 to 15, 2015. Retail prices of topical and systemic drugs for the treatment of various dermatologic conditions. Prices of surveyed brand-name drugs increased rapidly between 2009 and 2015. Of the 19 brand-name drugs analyzed, the retail prices of 7 drugs more than quadrupled during the study period. Among these 19 drugs, the mean price increase was 401% during the 6-year survey period, with the majority of the price increases occurring after 2011. Prices of topical antineoplastic drugs had the greatest mean absolute and percentage increase ($10,926.58 [1240%]). Prices of drugs in the antiinfective class had the smallest mean absolute increase ($333.99); prices of psoriasis medications had the smallest mean percentage increase (180%). Prices of acne and rosacea medications increased a mean of 195%, and prices of topical corticosteroids increased a mean of 290% during the study period. Selected generic drugs surveyed in 2011 and 2014 also increased a mean of 279% during

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

Investing in Our Nation's Youth. National Youth Anti-Drug Media Campaign: Phase II (Final Report).

ERIC Educational Resources Information Center

Office of National Drug Control Policy, Washington, DC.

This publication presents the findings from an evaluation of Phase II of the National Youth Anti-Drug Media Campaign. The number one goal of the campaign was to educate youth to reject illegal drugs. This report evaluates Phase II and focuses on the effect of paid television advertising on awareness of anti-drug messages among youth, teens, and…

78 FR 64962 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 15, 2013, 9:00 a.m. to October 15, 2013, 11:00 p.m...

78 FR 64966 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 15, 2013, 11:00 a.m. to October 15, 2013, 2:00 p.m...

78 FR 64965 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 16, 2013, 08:00 a.m. to October 16, 2013, 05:00 p.m...

78 FR 64958 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 15, 2013, 2:00 p.m. to October 16, 2013, 1:00 p.m...

78 FR 64966 - National Institute on Drug Abuse; Amended Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, October 17, 2013, 08:00 a.m. to October 17, 2013, 05:00 p.m...

A national database for essential drugs in South Africa.

PubMed

Zweygarth, M; Summers, R S

2000-06-01

In the process of drafting standard treatment guidelines for adults and children at hospital level, the Secretariat of the National Essential Drugs List Committee made use of a database designed with technical support from the School of Pharmacy, MEDUNSA. The database links the current 697 drugs on the Essential Drugs List with Standard Treatment Guidelines for over 400 conditions. It served to streamline the inclusion of different drugs and dosage forms in the various guidelines, and provided concise, updated information to other departments involved in drug procurement. From information on drug prices and morbidity, it can also be used to calculate drug consumption and cost estimates and compare them with actual figures.

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.

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.

Surveillance of Physicians Causing Potential Drug-Drug Interactions in Ambulatory Care: A Pilot Study in Switzerland

PubMed Central

Bucher, Heiner C.; Achermann, Rita; Stohler, Nadja; Meier, Christoph R.

2016-01-01

Objectives We analysed potential drug-drug interactions (DDI) in ambulatory care in Switzerland based on claims data from three large health insurers in 2010 to identify physicians with peculiar prescription behaviour differing from peers of the same specialty. Methods We analysed contraindicated or potentially contraindicated DDI from the national drug formulary and calculated for each physician the ratios of the number of patients with a potential DDI divided by the number of patients at risk and used a zero inflated binomial distribution to correct for the inflated number of observations with no DDI. We then calculated the probability that the number of caused potential DDI of physicians was unlikely (p-value < 0.05 and ≥0.01) and very unlikely (p-value <0.01) to be due to chance. Results Of 1'607'233 females and 1'525'307 males 1.3% and 1.2% were exposed to at least one potential DDI during 12 months. When analysing the 40 most common DDI, 598 and 416 of 18,297 physicians (3.3% and 2.3%) were causing potential DDI in a frequency unlikely (p<0.05 and p≥0.01) and very unlikely (p<0.01) to be explained by chance. Patients cared by general practitioners and cardiologists had the lowest probability (0.20 and 0.26) for not being exposed to DDI. Conclusions Contraindicated or potentially contraindicated DDI are frequent in ambulatory care in Switzerland, with a small proportion of physicians causing potential DDI in a frequency that is very unlikely to be explained by chance when compared to peers of the same specialty. PMID:26808430

76 FR 14980 - National Institute on Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of Meeting Pursuant to section 10(a... meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Advisory Council.... Name of Committees: National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory...

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

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

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

Driving after drug or alcohol use : findings from the 1996 national household survey on drug abuse

DOT National Transportation Integrated Search

1998-12-01

Author's abstract: This report contains findings from questions included in the 1996 National Household Survey on Drug Abuse (NHSDA). The data presented describe the prevalence and patterns of driving following drug use and/or alcohol use by 11,847 N...

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.

75 FR 29354 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-25

... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA... Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Blvd...

78 FR 14562 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... Emphasis Panel; Synthesis and Distribution of Drugs of Abuse and Related Compounds (7784). Date: April 11... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as...

Do national drug control laws ensure the availability of opioids for medical and scientific purposes?

PubMed Central

Brown, Marty Skemp; Maurer, Martha A

2014-01-01

Abstract Objective To determine whether national drug control laws ensure that opioid drugs are available for medical and scientific purposes, as intended by the 1972 Protocol amendment to the 1961 Single Convention on Narcotic Drugs. Methods The authors examined whether the text of a convenience sample of drug laws from 15 countries: (i) acknowledged that opioid drugs are indispensable for the relief of pain and suffering; (ii) recognized that government was responsible for ensuring the adequate provision of such drugs for medical and scientific purposes; (iii) designated an administrative body for implementing international drug control conventions; and (iv) acknowledged a government’s intention to implement international conventions, including the Single Convention. Findings Most national laws were found not to contain measures that ensured adequate provision of opioid drugs for medical and scientific purposes. Moreover, the model legislation provided by the United Nations Office on Drugs and Crime did not establish an obligation on national governments to ensure the availability of these drugs for medical use. Conclusion To achieve consistency with the Single Convention, as well as with associated resolutions and recommendations of international bodies, national drug control laws and model policies should be updated to include measures that ensure drug availability to balance the restrictions imposed by the existing drug control measures needed to prevent the diversion and nonmedical use of such drugs. PMID:24623904

78 FR 73552 - National Institute On Alcohol Abuse and Alcoholism; National Institute On Drug Abuse; and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute On Alcohol Abuse and Alcoholism; National Institute On Drug Abuse; and National Cancer Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the...

77 FR 69869 - National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board; Notice of Joint Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given o...

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

Analysis of National Drug Code Identifiers in Ambulatory E-Prescribing.

PubMed

Dhavle, Ajit A; Ward-Charlerie, Stacy; Rupp, Michael T; Amin, Vishal P; Ruiz, Joshua

2015-11-01

Communication of an accurate and interpretable drug identifier between prescriber and pharmacist is critically important for realizing the potential benefits of electronic prescribing (e-prescribing) while minimizing its risk. The National Drug Code (NDC) is the most commonly used codified drug identifier in ambulatory care e-prescribing, but concerns have been raised regarding its use for this purpose.  To (a) assess the frequency of NDC identifier transmission in ambulatory e-prescribing; (b) characterize the type of NDC identifier transmitted (representative, repackaged, obsolete, private label, and unit dose); and (c) assess the level of agreement between drug descriptions corresponding to NDC identifiers in electronic prescriptions (e-prescriptions) and the free-text drug descriptions that were entered by prescribers.  We analyzed a sample of 49,997 e-prescriptions that were transmitted by ambulatory care prescribers to outlets of a national retail drugstore chain during a single day in April 2014. The First Databank MedKnowledge drug database was used as the primary reference data base to assess the frequency and types of NDC numbers in the e-prescription messages. The FDA's Comprehensive NDC Standard Product Labeling Data Elements File and the National Library of Medicine's RxNorm data file were used as secondary and tertiary references, respectively, to identify NDC numbers that could not be located in the primary reference file. Three experienced reviewers compared the free-text drug description that had been entered by the prescriber with the drug description corresponding to the NDC number from 1 of the 3 reference database files to identify discrepancies. Two licensed pharmacists with residency training and ambulatory care experience served as final adjudicators. A total of 42,602 e-prescriptions contained a value in the NDC field, of which 42,335 (84.71%) were found in 1 of the 3 study reference databases and were thus considered to be valid NDC

Drugs Cheaper Than Threepenny: The Market of Extremely Low-Priced Drugs within the National Health Insurance in Taiwan

PubMed Central

Chou, Li-Fang

2014-01-01

While most drug policy researches paid attention to the financial impact of expensive drugs, the market situation of low-priced drugs in a country was seldom analyzed. We used the nationally representative claims datasets to explore the status within the National Health Insurance (NHI) in Taiwan. In 2007, a total of 12,443 distinct drug items had been prescribed 853,250,147 times with total expenditure of 105,216,950,198 new Taiwan dollars (NTD). Among them, 7,366 oral drug items accounted for 701,353,383 prescribed items and 68,133,988,960 NTD. Besides, 2,887 items (39.2% of oral drug items) belonged to cheap drugs with the unit price ≤1 NTD (about 0.03 of US dollar). While the top one item among all oral drugs had already a market share of 5.0%, 30 items 30.3% and 107 items 50.0%, the cheap drugs with aggregate 332,893,462 prescribed items (47.5% of all prescribed oral drug items) only accounted for 2,750,725,433 NTD (4.0% of expenditure for oral drugs and 2.6% of total drug expenditure). The drug market of Taiwan's NHI was abundant in cheap drugs. The unreasonably low prices of drugs might not guarantee the quality of pharmaceutical care and the sustainability of a healthy pharmaceutical industry in the long run. PMID:24719568

Drugs cheaper than threepenny: the market of extremely low-priced drugs within the National Health Insurance in Taiwan.

PubMed

Wang, Bih-Ru; Chou, Chia-Lin; Hsu, Chia-Chen; Chou, Yueh-Ching; Chen, Tzeng-Ji; Chou, Li-Fang

2014-01-01

While most drug policy researches paid attention to the financial impact of expensive drugs, the market situation of low-priced drugs in a country was seldom analyzed. We used the nationally representative claims datasets to explore the status within the National Health Insurance (NHI) in Taiwan. In 2007, a total of 12,443 distinct drug items had been prescribed 853,250,147 times with total expenditure of 105,216,950,198 new Taiwan dollars (NTD). Among them, 7,366 oral drug items accounted for 701,353,383 prescribed items and 68,133,988,960 NTD. Besides, 2,887 items (39.2% of oral drug items) belonged to cheap drugs with the unit price ≤ 1 NTD (about 0.03 of US dollar). While the top one item among all oral drugs had already a market share of 5.0%, 30 items 30.3% and 107 items 50.0%, the cheap drugs with aggregate 332,893,462 prescribed items (47.5% of all prescribed oral drug items) only accounted for 2,750,725,433 NTD (4.0% of expenditure for oral drugs and 2.6% of total drug expenditure). The drug market of Taiwan's NHI was abundant in cheap drugs. The unreasonably low prices of drugs might not guarantee the quality of pharmaceutical care and the sustainability of a healthy pharmaceutical industry in the long run.

Prevalence of Potential and Clinically Relevant Statin-Drug Interactions in Frail and Robust Older Inpatients.

PubMed

Thai, Michele; Hilmer, Sarah; Pearson, Sallie-Anne; Reeve, Emily; Gnjidic, Danijela

2015-10-01

A significant proportion of older people are prescribed statins and are also exposed to polypharmacy, placing them at increased risk of statin-drug interactions. To describe the prevalence rates of potential and clinically relevant statin-drug interactions in older inpatients according to frailty status. A cross-sectional study of patients aged ≥65 years who were prescribed a statin and were admitted to a teaching hospital between 30 July and 10 October 2014 in Sydney, Australia, was conducted. Data on socio-demographics, comorbidities and medications were collected using a standardized questionnaire. Potential statin-drug interactions were defined if listed in the Australian Medicines Handbook and three international drug information sources: the British National Formulary, Drug Interaction Facts and Drug-Reax(®). Clinically relevant statin-drug interactions were defined as interactions with the highest severity rating in at least two of the three international drug information sources. Frailty was assessed using the Reported Edmonton Frail Scale. A total of 180 participants were recruited (median age 78 years, interquartile range 14), 35.0% frail and 65.0% robust. Potential statin-drug interactions were identified in 10% of participants, 12.7% of frail participants and 8.5% of robust participants. Clinically relevant statin-drug interactions were identified in 7.8% of participants, 9.5% of frail participants and 6.8% of robust participants. Depending on the drug information source used, the prevalence rates of potential and clinically relevant statin-drug interactions ranged between 14.4 and 35.6% and between 14.4 and 20.6%, respectively. In our study of frail and robust older inpatients taking statins, the overall prevalence of potential statin-drug interactions was low and varied significantly according to the drug information source used.

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.

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

77 FR 55087 - National Alcohol and Drug Addiction Recovery Month, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-06

... Vol. 77 Thursday, No. 173 September 6, 2012 Part IV The President Proclamation 8850--National Alcohol and Drug Addiction Recovery Month, 2012 Proclamation 8851--National Childhood Cancer Awareness Month, 2012 Proclamation 8852--National Childhood Obesity Awareness Month, 2012 Proclamation 8853...

The Research Plan: Closing the ExMC Med02 "Pharmacy" Gap

NASA Technical Reports Server (NTRS)

Daniels, Vernie; Bayuse, Tina; Mulcahy, Robert; Shah, Ronak; Antonsen, Erik

2017-01-01

HRP Human Research Roadmap: Risk and Gap Risk of Adverse Health Outcomes and Decrements in Performance due to Inflight Medical Conditions. Med02 "Pharmacy" Gap: We do not have the capability to provide a safe and effective medication formulary for exploration missions delivering a recommendation for a chemically stable, safe, and effective medication formulary that will support the operational needs of exploration space missions research strategy evidence-based formulary and models innovative analytical tools and methodologies novel treatments and preventive measures Planned review by a panel of experts from the pharmaceutical industry, regulatory, and academic scientific communities Formulary Selection Formulary Potency and Shelf life Formulary Safety and Toxicity Novel Technology Proof-of-Concept Portable real-time chemical analysis Innovative drug development / design

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.

76 FR 2697 - National Institute on Drug Abuse; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

... Drug Abuse. The meeting will be open to the public as indicated below, with attendance limited to space... on Drug Abuse. Date: February 2, 2011. Closed: 8:30 a.m. to 12 p.m. Agenda: To review and evaluate... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive...

Drugs and Pregnancy: The Effects of Nonmedical Use of Drugs on Pregnancy, Childbirth, and Neonates. National Institute on Drug Abuse Research Issues 5.

ERIC Educational Resources Information Center

Ferguson, Patricia, Ed.; And Others

The National Institute on Drug Abuse presents this report as the fifth in a series intended to summarize the empirical research findings and major theoretical approaches relating to the the issues of drug use and abuse. Included in this volume are summaries of the major research findings concerning the effects of nonmedical drug use on pregnancy.…

2013-2014 National Roadside Study of alcohol and drug use by drivers : alcohol results.

DOT National Transportation Integrated Search

2016-12-01

This report describes the alcohol results from the 20132014 National Roadside Survey (NRS), a national field study to : estimate the prevalence of alcohol-, drug-, and alcohol-plus-drug-involved driving, primarily among nighttime weekend : drivers...

Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK

PubMed Central

Ward, Derek J; Martino, Orsolina I; Simpson, Sue; Stevens, Andrew J

2013-01-01

Objective To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development. Design Retrospective observational study. Setting and data source Database of new preparations added annually to the British National Formulary (BNF). Main outcome measures The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF. Results There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period. Conclusions The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective. PMID:23427198

78 FR 9065 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; The Diversity-promoting Institutions Drug Abuse Research Program (DIDARP). Date: March 26, 2013. [[Page 9066

2013–2014 national roadside study of alcohol and drug use by drivers : methodology.

DOT National Transportation Integrated Search

2016-07-01

This report describes the methodology for the National Roadside Study (NRS), a national field study to estimate the prevalence of alcohol-, drug-, and alcohol-plus-drug-involved driving primarily among nighttime weekend drivers, but also daytime Frid...

Retail prescription drug spending in the National Health Accounts.

PubMed

Smith, Cynthia

2004-01-01

Recent rapid spending growth for retail drugs has largely arisen from increased use of new drugs, rather than from increasing prices of existing drugs. A sizable shift in the payment from consumers to third parties has also contributed to faster growth. Strategies such as negotiating for rebates and using tiered copayments have sought to slow spending growth but simultaneously have complicated the estimation of spending in the National Health Accounts (NHA). NHA estimates show that retail pharmaceuticals' share of health spending is not much different than it was in 1960, although its share of gross domestic product (GDP) has tripled.

75 FR 71711 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892-8401... Institute on Drug Abuse Special Emphasis Panel Video Game Targeting Relapse Prevention in Youth with...

78 FR 4421 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

...: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852... contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

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.

77 FR 47654 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse... Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892- 9550, (301) 435-1439, lf33c.nih.gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse...

National Institute on Drug Abuse Training Grants Directory.

ERIC Educational Resources Information Center

Mitchell, Lonnie E.

This catalog lists for individuals, universities and colleges, and Single State Agency directors training grants supported by the National Institute on Drug Abuse. The four different types of grants described are developmental, career teacher, individual fellowship, and institutional research training grants. Each section is divided alphabetically…

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.

Mexicans' use of illicit drugs in an era of drug reform: national comparative analysis by migrant status.

PubMed

Guerrero, Erick G; Villatoro, Jorge Ameth; Kong, Yinfei; Gamiño, Marycarmen Bustos; Vega, William A; Mora, Maria Elena Medina

2014-05-01

Although rates of illicit drug use are considerably lower in Mexico than in the United States, rates in Mexico have risen significantly. This increase has particular implications for Mexican women and US migrants, who are considered at increased risk of drug use. Due to drug reforms enacted in Mexico in 2008, it is critical to evaluate patterns of drug use among migrants who reside in both regions. We analysed a sample of Mexicans (N=16,249) surveyed during a national household survey in 2011, the Encuesta Nacional de Adicciones (National Survey of Addictions). Comparative analyses based on Mexicans' migrant status - (1) never in the United States, (2) visited the United States, or (3) lived in the United States (transnationals) - featured analysis of variance and Chi-square global tests. Two multilevel regressions were conducted to determine the relationships among migrant status, women, and illicit drug use. Comparative findings showed significant differences in type and number of drugs used among Mexicans by migrant status. The regression models showed that compared with Mexicans who had never visited the United States, Mexican transnationals were more likely to report having used drugs (OR=2.453, 95% CI=1.933, 3.113) and using more illicit drugs (IRR=2.061, 95% CI=1.626, 2.613). Women were less likely than men to report having used drugs (OR=0.187, 95% CI=0.146, 0.239) and using more illicit drugs (IRR=0.153, 95% CI=0.116, 0.202). Overall, the findings support further exploration of risk factors for illicit drug use among Mexican transnationals, who exhibit greater drug use behaviours than Mexicans never in the United States. Because drug reform mandates referrals to treatment for those with recurrent issues of drug use, it is critical for the Mexican government and civic society to develop the capacity to offer evidence-based substance abuse treatment for returning migrants with high-risk drug behaviours. Copyright © 2014 Elsevier B.V. All rights reserved.

Mexicans’ Use of Illicit Drugs in an Era of Drug Reform: National Comparative Analysis by Migrant Status

PubMed Central

Villatoro, Jorge Ameth; Kong, Yinfei; Gamiño, Marycarmen Bustos; Vega, William A.; Mora, Maria Elena Medina

2014-01-01

Although rates of illicit drug use are considerably lower in Mexico than in the United States, rates in Mexico have risen significantly. This increase has particular implications for Mexican women and U.S. migrants, who are considered at increased risk of drug use. Due to drug reforms enacted in Mexico in 2008, it is critical to evaluate patterns of drug use among migrants who reside in both regions. We analysed a sample of Mexicans (N = 16,249) surveyed during a national household survey in 2011, the Encuesta Nacional de Adicciones (National Survey of Addictions). Comparative analyses based on Mexicans’ migrant status—(1) never in the United States, (2) visited the United States, or (3) lived in the United States (transnationals)—featured analysis of variance and chi-square global tests. Two multilevel regressions were conducted to determine the relationships among migrant status, women, and illicit drug use. Comparative findings showed significant differences in type and number of drugs used among Mexicans by migrant status. The regression models showed that compared with Mexicans who had never visited the United States, Mexican transnationals were more likely to report having used drugs (OR = 2.453, 95% CI = 1.933, 3.113) and using more illicit drugs (IRR = 2.061, 95% CI = 1.626, 2.613). Women were less likely than men to report having used drugs (OR = 0.187, 95% CI = 0.146, 0.239) and using more illicit drugs (IRR = 0.153, 95% CI = 0.116, 0.202). Overall, the findings support further exploration of risk factors for illicit drug use among Mexican transnationals, who exhibit greater drug use behaviours than Mexicans never in the United States. Because drug reform mandates referrals to treatment for those with recurrent issues of drug use, it is critical for the Mexican government and civic society to develop the capacity to offer evidence-based substance abuse treatment for returning migrants with high-risk drug behaviours. PMID:24816376

75 FR 25278 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; N44DA-10-5542... Institute on Drug Abuse, NIH, 6101 Executive Blvd., Room 220, MSC 8401, Bethesda, MD 20852, 301-435-1432, [email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and...

78 FR 27411 - National Institute on Drug Abuse Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse... on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4238, MSC 9550, Bethesda, MD 20892-9550, 301-402... on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4238, MSC 9550, Bethesda, MD 20892-9550, 301-402...

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

Parent ads in the National Youth Anti-Drug Media Campaign.

PubMed

Stephenson, Michael T; Quick, Brian L

2005-12-01

The National Youth Anti-Drug Media Campaign aims not only to reduce drug use by teens and preteens, but also to arm parents with knowledge about specific parenting practices known to reduce the risk of teen drug use. Among the documented successes of the campaign to date was a small, but direct effect on some parenting practices, including parent-child discussions about drug use. To reach a deeper understanding about the substance of the parental ads, we content analyzed the message strategies employed in the campaign's parent ads over the inaugural 5 years of the campaign. Each ad was coded for its major theme, minor subtheme, and featured drug. Among seven possible major themes, the parental anti-drug ads largely featured four: enhance the risk of their child's drug use, encourage monitoring practices, promote parent-child discussions about drug use, or advocate positive involvement behaviors. Moreover, most parental messages addressed marijuana use or addressed drug use in general. Marijuana and inhalant ads largely were risk based, while general drug messages focused on monitoring, parent-child discussions or positive involvement practices.

Drug user organizations in the Nordic countries--local, national, and international dimensions.

PubMed

Frank, Vibeke Asmussen; Anker, Jørgen; Tammi, Tuukka

2012-04-01

The article focuses on drug user organizations that represent and advocate for active "hard drug" users in the Nordic countries. It discusses the opportunities and challenges that these organizations face in their search for legitimacy and political influence. The comparative perspective points at similarities and differences in national contexts that both support and challenges the existence of drug user organizations, including drug policy, social welfare policy, trends in drug use, and organizational conditions. The article also discusses the importance of international network and transnational organizations that support drug user organizations.

78 FR 19499 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel PAR-12-297: Mechanism for Time-Sensitive Drug Abuse Research. Date: April 9, 2013. Time: 12:00 p.m. to 2:00 p.m. Agenda... Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4226, MSC 9550, Bethesda, MD 20892-9550, 301...

2007 National Roadside Survey of Alcohol and Drug Use by Drivers: Methodology

DOT National Transportation Integrated Search

2009-12-01

This report describes the methodology for the 2007 U.S. national field study to estimate the prevalence of alcohol-, drug-, and alcohol-and-drug-involved driving, primarily among nighttime weekend drivers, but also daytime Friday drivers. This study ...

National Rules for Drug–Drug Interactions: Are They Appropriate for Tertiary Hospitals?

PubMed Central

2016-01-01

The application of appropriate rules for drug–drug interactions (DDIs) could substantially reduce the number of adverse drug events. However, current implementations of such rules in tertiary hospitals are problematic as physicians are receiving too many alerts, causing high override rates and alert fatigue. We investigated the potential impact of Korean national DDI rules in a drug utilization review program in terms of their severity coverage and the clinical efficiency of how physicians respond to them. Using lists of high-priority DDIs developed with the support of the U.S. government, we evaluated 706 contraindicated DDI pairs released in May 2015. We evaluated clinical log data from one tertiary hospital and prescription data from two other tertiary hospitals. The measured parameters were national DDI rule coverage for high-priority DDIs, alert override rate, and number of prescription pairs. The coverage rates of national DDI rules were 80% and 3.0% at the class and drug levels, respectively. The analysis of the system log data showed an overall override rate of 79.6%. Only 0.3% of all of the alerts (n = 66) were high-priority DDI rules. These showed a lower override rate of 51.5%, which was much lower than for the overall DDI rules. We also found 342 and 80 unmatched high-priority DDI pairs which were absent in national rules in inpatient orders from the other two hospitals. The national DDI rules are not complete in terms of their coverage of severe DDIs. They also lack clinical efficiency in tertiary settings, suggesting improved systematic approaches are needed. PMID:27822925

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.

Report from the National Institute of Allergy and Infectious Diseases workshop on drug allergy.

PubMed

Wheatley, Lisa M; Plaut, Marshall; Schwaninger, Julie M; Banerji, Aleena; Castells, Mariana; Finkelman, Fred D; Gleich, Gerald J; Guttman-Yassky, Emma; Mallal, Simon A K; Naisbitt, Dean J; Ostrov, David A; Phillips, Elizabeth J; Pichler, Werner J; Platts-Mills, Thomas A E; Roujeau, Jean-Claude; Schwartz, Lawrence B; Trepanier, Lauren A

2015-08-01

Allergic reactions to drugs are a serious public health concern. In 2013, the Division of Allergy, Immunology, and Transplantation of the National Institute of Allergy and Infectious Diseases sponsored a workshop on drug allergy. International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology, and pharmacogenomics discussed the current state of drug allergy research. These experts were joined by representatives from several National Institutes of Health institutes and the US Food and Drug Administration. The participants identified important advances that make new research directions feasible and made suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy. The workshop summary and recommendations are presented herein. Published by Elsevier Inc.

National Institute on Drug Abuse symposium report: drugs of abuse, dopamine, and HIV-associated neurocognitive disorders/HIV-associated dementia.

PubMed

Purohit, Vishnudutt; Rapaka, Rao; Frankenheim, Jerry; Avila, Albert; Sorensen, Roger; Rutter, Joni

2013-04-01

The National Institute on Drug Abuse organized a symposium on drugs of abuse, dopamine, and HIV-associated neurocognitive disorders (HAND)/HIV-associated dementia (HAD) in Rockville, Maryland, October 4, 2011. The purpose of this symposium was to evaluate the potential role of dopamine in the potentiation of HAND/HAD by drugs of abuse. A summary of the symposium has been presented in this report.

The fourth national anti-tuberculosis drug resistance survey in Viet Nam.

PubMed

Nhung, N V; Hoa, N B; Sy, D N; Hennig, C M; Dean, A S

2015-06-01

Viet Nam's Fourth National Anti-Tuberculosis Drug Resistance Survey was conducted in 2011. To determine the prevalence of resistance to the four main first-line anti-tuberculosis drugs in Viet Nam. Eighty clusters were selected using a probability proportion to size approach. Drug susceptibility testing (DST) against the four main first-line anti-tuberculosis drugs was performed. A total of 1629 smear-positive tuberculosis (TB) patients were eligible for culture. Of these, DST results were available for 1312 patients, including 1105 new TB cases, 195 previously treated TB cases and 12 cases with an unknown treatment history. The proportion of cases with resistance to any drug was 32.7% (95%CI 29.1-36.5) among new cases and 54.2% (95%CI 44.3-63.7) among previously treated cases. The proportion of multidrug-resistant TB (MDR-TB) cases was 4.0% (95%CI 2.5-5.4) in new cases and 23.3 (95%CI 16.7-29.9) in previously treated cases. The fourth drug resistance survey in Viet Nam found that the proportion of MDR-TB among new and previously treated cases was not significantly different from that in the 2005 survey. The National TB Programme should prioritise the detection and treatment of MDR-TB to reduce transmission of MDR-TB in the community.

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

3 CFR 8701 - Proclamation 8701 of August 31, 2011. National Alcohol and Drug Addiction Recovery Month, 2011

Code of Federal Regulations, 2012 CFR

2012-01-01

... our 2011 National Drug Control Strategy, which supports successful, long-term recoveries through... Alcohol and Drug Addiction Recovery Month, 2011 8701 Proclamation 8701 Presidential Documents Proclamations Proclamation 8701 of August 31, 2011 Proc. 8701 National Alcohol and Drug Addiction Recovery Month...

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.

77 FR 63843 - National Institute on Drug Abuse; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

...: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center... of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

21 CFR 1405.400 - What are my responsibilities as a(n) Office of National Drug Control Policy awarding official?

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Responsibilities of Office of National Drug Control Policy Awarding Officials § 1405.400 What are my... 21 Food and Drugs 9 2010-04-01 2010-04-01 false What are my responsibilities as a(n) Office of National Drug Control Policy awarding official? 1405.400 Section 1405.400 Food and Drugs OFFICE OF NATIONAL...

75 FR 25278 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

..., MD 21224, (410) 550-1547. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and...

Problems with drugs in Croatia.

PubMed

Vrhovac, B

1997-01-01

Croatia has 4.8 million inhabitants, 11,800 physicians, 2000 pharmacists, two now shareholding, pharmaceutical companies (about 6500 employees, total sales of about 350 million US dollars). There are a number of problems due to the war (GNP fell from 3800 to about 1500 US dollars), occupation of 25% of its territory, 0.5 million refugees and lack of resources (139 US dollars/capita for health, about 40 US dollars i.e. 30%!! for drugs)--about three times less than before the aggression. The drug situation is controlled with the help of: (1) donations (approximate value of 600 million US dollars since 1991 from Europe and US), (2) (essential) drug formularies--250 for outpatients, and 580 generic names for various levels of hospital use, (3) special efforts to purchase drugs of good quality at a reasonable price (a kind of tender), (4) control of prescribing (prescriptions, specialists referral) especially by GPs. A new Medicines Act is in preparation and about 1000 generic names are on the market. DRUG EDUCATION: Pharmaca: the Croatian journal of pharmacotherapy has been published since 1962, there are several Drug bulletins (one published since 1975); special chapters on clinical pharmacology in textbooks, translation of three editions of Laurence's textbook with special commentary and adaptation to local needs; ADR spontaneous and intensive monitoring (WHO programme) with a personal feedback to the reporters and regular articles on drug use in a number of periodicals. Data on drug consumption indicates that there is room for improvement of prescribing. There is an enthusiasm for 'vasoactive drugs'--after dipirydamole came oxpentifylline and antimicrobials are always overprescribed. All these problems will hopefully decrease when the war finally stops and when industry (especially tourism) starts being fruitful again. In any case the importance of teaching of pharmacotherapy at the under- and postgraduate level should be recognized. Copyright 1997 by John Wiley

Novel Phenotype Issues Raised in Cross-National Epidemiological Research on Drug Dependence

PubMed Central

Anthony, James C.

2010-01-01

Stage-transition models based on the American Diagnostic and Statistical Manual (DSM) generally are applied in epidemiology and genetics research on drug dependence syndromes associated with cannabis, cocaine, and other internationally regulated drugs (IRD). Difficulties with DSM stage-transition models have surfaced during cross-national research intended to provide a truly global perspective, such as the work of the World Mental Health Surveys (WMHS) Consortium. Alternative simpler dependence-related phenotypes are possible, including population-level count process models for steps early and before coalescence of clinical features into a coherent syndrome (e.g., zero-inflated Poisson regression). Selected findings are reviewed, based on ZIP modeling of alcohol, tobacco, and IRD count processes, with an illustration that may stimulate new research on genetic susceptibility traits. The annual National Surveys on Drug Use and Health can be readily modified for this purpose, along the lines of a truly anonymous research approach that can help make NSDUH-type cross-national epidemiological surveys more useful in the context of subsequent genome wide association (GWAS) research and post-GWAS investigations with a truly global health perspective. PMID:20201862

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

Human neuroscience at National Institute on Drug Abuse: Implications for genetics research

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gordon, H.W.

It is becoming clear that there is a genetic component to drug abuse. Family studies, adoption studies, and critical twin studies have all pointed to some genetic vulnerability or risk factors for an individual to abuse psychoactive drugs depending on certain psychopathologies in the biological parents and/or parents` own drug use. The question for the next generation of research at the National Institute on Drug Abuse (NIDA) is to apply the rapidly developing technology in molecular genetics in an effort to determine the candidate genes contributing to the risk. 19 refs.

Evaluation of rational drug use based on World Health Organization core drug use indicators in selected public hospitals of eastern Ethiopia: a cross sectional study.

PubMed

Sisay, Mekonnen; Mengistu, Getnet; Molla, Bereket; Amare, Firehiwot; Gabriel, Tesfaye

2017-02-23

stock while only 19(63.3%) of key drugs had adequate labeling. On average, selected key drugs were out of stock for 30 days per year. All of the hospitals included in the study used the national drug list, formulary and standard treatment guidelines but none of them had their own drug list or guideline. Majority of WHO stated core drug use indicators were not met by the three hospitals included in the study.

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

Treatment Programs in the National Drug Abuse Treatment Clinical Trials Network

PubMed Central

McCarty, Dennis; Fuller, Bret; Kaskutas, Lee Ann; Wendt, William W.; Nunes, Edward V.; Miller, Michael; Forman, Robert; Magruder, Kathryn M.; Arfken, Cynthia; Copersino, Marc; Floyd, Anthony; Sindelar, Jody; Edmundson, Eldon

2008-01-01

Drug abuse treatment programs and university-based research centers collaborate to test emerging therapies for alcohol and drug disorders in the National Drug Abuse Treatment Clinical Trials Network (CTN). Programs participating in the CTN completed organizational (n = 106 of 112; 95% response rate) and treatment unit surveys (n = 348 of 384; 91% response rate) to describe the levels of care, ancillary services, patient demographics, patient drug use and co-occurring conditions. Analyses describe the corporations participating in the CTN and provide an exploratory assessment of variation in treatment philosophies. A diversity of treatment centers participate in the CTN; not for profit organizations with a primary mission of treating alcohol and drug disorders dominate. Compared to N-SSATS (National Survey of Substance Abuse Treatment Services), programs located in medical settings are over-represented and centers that are mental health clinics are under-represented. Outpatient, methadone, long-term residential and inpatient treatment units differed on patients served and services proved. Larger programs with higher counselor caseloads in residential settings reported more social model characteristics. Programs with higher social model scores were more likely to offer self-help meetings, vocational services and specialized services for women. Conversely, programs with accreditation had less social model influence. The CTN is an ambitious effort to engage community-based treatment organizations into research and more fully integrate research and practice. PMID:17875368

National Clearinghouse for Drug Abuse Information Report Series, Series 16, No. 1.

ERIC Educational Resources Information Center

National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

Concerned with clarifying some of the more complex issues in drug abuse, the National Clearinghouse for Drug Abuse Information has prepared this special report on psilocybin. Background information is provided through a summary of its history, legal status, and the opinions of authorities in the field. Significant research on the subject is…

National Clearinghouse for Drug Abuse Information Report Series, Series 18, No. 1.

ERIC Educational Resources Information Center

National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

Concerned with clarifying some of the more complex issues in drug abuse, the National Clearinghouse for Drug Abuse Information has prepared this special report on methaqualone. Background information is provided through a summary of its history, legal status, and the opinions of authorities in the field. Significant research on the subject is…

ASHP national survey of hospital-based pharmaceutical services--1992.

PubMed

Crawford, S Y; Myers, C E

1993-07-01

The results of a national mail survey of pharmaceutical services in community hospitals conducted by ASHP during summer 1992 are reported and compared with the results of earlier ASHP surveys. A simple random sample of community hospitals (short-term, nonfederal) was selected from community hospitals registered by the American Hospital Association. Questionnaires were mailed to each director of pharmacy. The adjusted gross sample size was 889. The net response rate was 58% (518 usable replies). The average number of hours of pharmacy operation per week was 105. Complete unit dose drug distribution was offered by 90% of the respondents, and 67% offered complete, comprehensive i.v. admixture programs. A total of 73% of the hospitals had centralized pharmaceutical services. Some 83% provided services to ambulatory-care patients, including clinic patients, emergency room patients, patients being discharged, employees, home care patients, and the general public. A computerized pharmacy system was present in 75% of the departments, and 86% had at least one microcomputer. More than 90% participated in adverse drug reaction, drug-use evaluation, drug therapy monitoring, and medication error management programs. Two thirds of the respondents regularly provided written documentation of pharmacist interventions in patients' medical records, and the same proportion provided patient education or counseling. One third provided drug management of medical emergencies. One fifth provided drug therapy management planning, and 17% provided written histories. Pharmacokinetic consultations were provided by 57% and nutritional support consultations by 37%; three fourths of pharmacist recommendations were adopted by prescribers. A well-controlled formulary system was in place in 51% of the hospitals; therapeutic interchange was practiced by 69%. A total of 99% participated in group purchasing, and 95% used a prime vendor. The 1992 ASHP survey revealed a continuation of the changes in

21 CFR 1404.635 - May the Office of National Drug Control Policy settle a debarment or suspension action?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false May the Office of National Drug Control Policy settle a debarment or suspension action? 1404.635 Section 1404.635 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General Principles Relating to Suspension and Debarment Actions § 1404.635...

National estimates of exposure to prescription drugs with addiction potential in community-dwelling elders.

PubMed

Simoni-Wastila, Linda; Zuckerman, Ilene H; Singhal, Puneet K; Briesacher, Becky; Hsu, Van Doren

2005-03-01

The use of prescription drugs with addiction potential is an overlooked and growing problem among today's elderly. This paper provides national prevalence estimates of exposure to prescription drugs with addiction potential among community-dwelling elders and explores risk factors for such exposure. Using the Medicare Current Beneficiary Survey, a nationally-representative database of Medicare eligibles, we calculated the prevalence of abusable prescription drug use, overall, by therapeutic class, and by drug. Nearly 22% (7.22 million) of all community-dwelling Medicare elders used at least one prescription medication with addiction potential. Opioid analgesics were used most frequently (14.9%; 95% CI 14.0, 15.8%); central nervous system (CNS) depressants were used by 10.4% of the nation's elders (95% CI 9.5, 10.8%). Using logistic regression analysis, we examined the association of explanatory variables with three outcome variables: any controlled substances use, any opioid analgesic use, and any CNS depressant use. We found that females, whites, those aged 65-79, and those with non-spousal others, were significantly more likely to use one or more prescription drugs with addiction potential, controlling for health status and severity-of-illness. The significance and magnitude of several explanatory variables, including age, race, ethnicity, living arrangement, and health status, varied by therapeutic category. This paper provides an important first step in acknowledging the widespread use of abusable prescription drugs in elders, and provides a foundation for future research and practical solutions to preventing subsequent problem use of prescription drugs.

The impact of alternative pricing methods for drugs in California Workers' Compensation System: Fee-schedule pricing.

PubMed

Wilson, Leslie; Turkistani, Fatema A; Huang, Wei; Tran, Dang M; Lin, Tracy Kuo

2018-01-01

California's Workers' Compensation System (CAWCS) Department of Industrial Relations questioned the adequacy of the current Medi-Cal fee-schedule pricing and requested analysis of alternatives that maximize price availability and maintain budget neutrality. To compare CAWCS pharmacy-dispensed (PD) drug prices under alternative fee schedules, and identify combinations of alternative benchmarks that have prices available for the largest percentage of PD drugs and that best reach budget neutrality. Claims transaction-level data (2011-2013) from CAWCS were used to estimate total annual PD pharmaceutical payments. Medi-Cal pricing data was from the Workman's Compensation Insurance System (WCIS). Average Wholesale Prices (AWP), Wholesale Acquisition Costs (WAC), Direct Prices (DP), Federal Upper Limit (FUL) prices, and National Average Drug Acquisition Costs (NADAC) were from Medi-Span. We matched National Drug Codes (NDCs), pricing dates, and drug quantity for comparisons. We report pharmacy-dispensed (PD) claims frequency, reimbursement matching rate, and paid costs by CAWCS as the reference price against all alternative price benchmarks. Of 12,529,977 CAWCS claims for pharmaceutical products 11.6% (1,462,814) were for PD drugs. Prescription drug cost for CAWCS was over $152M; $63.9M, $47.9M, and $40.6M in 2011-2013. Ninety seven percent of these CAWCS PD claims had a Medi-Cal price. Alternative mechanisms provided a price for fewer claims; NADAC 94.23%, AWP 90.94%, FUL 73.11%, WAC 66.98%, and DP 14.33%. Among CAWCS drugs with no Medi-Cal price in PD claims, AWP, WAC, NADAC, DP, and FUL provided prices for 96.7%, 63.14%, 24.82%, 20.83%, and 15.08% of claims. Overall CAWCS paid 100.52% of Medi-Cal, 60% of AWP, 97% of WAC, 309.53% of FUL, 103.83% of DP, and 136.27% of NADAC. CAWCS current Medi-Cal fee-schedule price list for PD drugs is more complete than all alternative fee-schedules. However, all reimbursement approaches would require combinations of pricing benchmarks