Pharmacy Utilization and the Medicare Modernization Act

PubMed Central

Maio, Vittorio; Pizzi, Laura; Roumm, Adam R; Clarke, Janice; Goldfarb, Neil I; Nash, David B; Chess, David

2005-01-01

To control expenditures and use medications appropriately, the Medicare drug coverage program has established pharmacy utilization management (PUM) measures. This article assesses the effects of these strategies on the care of seniors. The literature suggests that although caps on drug benefits lower pharmaceutical costs, they may also increase the use of other health care services and hurt health outcomes. Our review raises concerns regarding the potential unintended effects of the Medicare drug program's PUM policies for beneficiaries. Therefore, the economic and clinical impact of PUM measures on seniors should be studied further to help policymakers design better drug benefit plans. PMID:15787955

42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

Code of Federal Regulations, 2010 CFR

2010-10-01

... PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.153 Drug utilization... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE...

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.

Early access programs: Benefits, challenges, and key considerations for successful implementation

PubMed Central

Patil, Sanjaykumar

2016-01-01

Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation. PMID:26955570

Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

PubMed Central

Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

2014-01-01

Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; Mage = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study results showed no program-related benefits for drug use. Results indicated intervention-related benefits for assertiveness and anxiety management skills and drug use intentions as well as a reduction in detrimental leisure motivations. High program exposure and lesson coverage tended to be connected to intervention benefits. Study findings also documented ways that dosage information provides insight into interventions and their effects. PMID:21053080

42 CFR 423.566 - Coverage determinations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Grievances, Coverage Determinations... sponsor. Each Part D plan sponsor must have a procedure for making timely coverage determinations in accordance with the requirements of this subpart regarding the prescription drug benefits an enrollee is...

The Influence of Drug Testing and Benefit-Based Distribution of Opioid Substitution Therapy on Drug Abstinence.

PubMed

Gabrovec, Branko

2015-01-01

The objective of our research was to discover whether the new approach to urine drug testing has a positive effect on users' abstinence, users' treatment, and their cooperation, while remaining user-friendly, and whether this approach is more cost-effective. The centers are focused on providing high-quality treatment within a cost-efficient program. In this study, we focus on the influence of drug testing and benefit-based distribution of opioid substitution therapy (BBDOST) on drug abstinence. The purpose of this study was to find any possible positive effect of modified distribution of the therapy and illicit drug testing on the number of users who are abstinent from illicit drugs and users who are not abstinent from illicit drugs as well as the users' opinion on BBDOST and testing. We are also interested in a difference in abstinence rates between those on BBDOST and those not receiving BBDOST. In 2010, the method of drug testing at the center was changed (less frequent and random drug testing) to enable its users faster access to BBDOST (take-home therapy). It was found that the number of drug-abstinent program participants has increased from initial 44.5% (2010) to 54.1% (2014). According to the program participants, the new method allows them to achieve and maintain abstinence from drugs more easily. In addition, they are also satisfied with the modified way of drug testing. This opinion does not change with age, gender, and acquired benefits.

School-Based Drug Prevention: What Kind of Drug Use Does It Prevent?

ERIC Educational Resources Information Center

Caulkins, Jonathan P.; Pacula, Rosalie Liccardo; Paddock, Susan; Chiesa, James

School-based drug prevention programs target not only the use of illicit drugs such as marijuana but also licit substances such as alcohol and tobacco. These programs thus have the potential of benefiting society not only by reducing the violence and criminal justice costs associated with abuse of alcohol and cigarettes. This opportunity for…

FY2017 National Defense Authorization Act: Selected Military Personnel Issues

DTIC Science & Technology

2017-01-23

Report RL31664, The Military Survivor Benefit Plan: A Description of Its Provisions, by David F. Burrelli. 13Congressional Budget Office, Cost Estimate...P.L. 114-328 No provision Sec. 702 would modify cost - sharing amounts for the TRICARE pharmacy benefits program for years 2017 through 2025. After...prescription drug acquisition cost parity in the TRICARE pharmacy benefits program. DOD (90 days after pilot program completion) Sec. 744 Pilot program

Benefits of Exercise for the Quality of Life of Drug-Dependent Patients.

PubMed

Giménez-Meseguer, Jorge; Tortosa-Martínez, Juan; de los Remedios Fernández-Valenciano, María

2015-01-01

This study combined quantitative and qualitative research methods to evaluate quality-of-life changes in drug-dependent patients after participation in a group-based exercise program. Quality of life (SF-36) and physical fitness (six-minute Walk Test, Timed Get Up and Go Test, and Chair Stand Test) were quantitatively determined in a group (n=37) of drug-dependent patients before and after a 12-week group exercise program (n=18) or routine care (n=19). Additionally, in-depth interviews were conducted at the end of the program with a subsample of 11 participants from the exercise group. Quantitative results showed improvements in fitness and different aspects of quality of life, such as physical function, mental health, vitality, social function, and general health perception. Qualitative results showed specific physical benefits (decreased injuries and muscle pain, decreased weight, and increased vitality with improvement in activities of daily living), psychological benefits (forgetting about everyday problems, improved mood, decreased stress and anxiety), social benefits, and a reduction in craving. The results of this study provide insight into the importance of exercise for the quality of life and recovery process of drug-dependent patients.

Economic and policy analysis of university-based drug "detailing".

PubMed

Soumerai, S B; Avorn, J

1986-04-01

The cost-effectiveness of quality assurance programs is often poorly documented, especially for innovative approaches. The authors analyzed the economic effects of an experimental educational outreach program designed to reduce inappropriate drug prescribing, based on a four-state randomized controlled trial (N = 435 physicians). Primary care physicians randomized into the face-to-face group were offered two individualized educational sessions with clinical pharmacists, lasting an average of 18 minutes each, concerning optimal use of three drug groups that are often used inappropriately. After the program, expenditures for target drugs prescribed by these physicians to Medicaid patients decreased by 13%, compared with controls (P = 0.002); this effect was stable over three quarters. Implementation of this program for 10,000 physicians would lead to projected drug savings (to Medicaid only) of $2,050,000, compared with resource costs of $940,000. Net savings remain high, even after adjustment for use of substitution medications. Although there was a ninefold difference in average preintervention prescribing levels between the highest and lowest thirds of the sample, all groups reduced target drug expenditures at the same rate. Targeting of higher-volume prescribers would thus further raise the observed benefit-to-cost ratio from approximately 1.8 to at least 3.0. Net benefits would also increase further if non-Medicaid savings were added, or if the analysis included quality-of-care considerations. Although print materials alone may be marginally cost-effective, print plus face-to-face approaches offer greater net benefits. The authors conclude that a program of brief, face-to-face "detailing" visits conducted by academic rather than commercial sources can be a highly cost-effective method for improving drug therapy decisions. Such an approach makes possible the enhancement of physicians' clinical expertise without relying on restriction of drug choices.

Medicare prescription drug discount cards.

PubMed

Bryant, Natasha

2004-01-01

With the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003 came the creation of a Part D drug benefit through Medicare. Until that benefit is implemented, Medicare has established a drug discount card program to help your clients save money on their outpatient prescription drug expenses. In this brief, we discuss the Medicare-approved discount cards--who is eligible, how they work, how your clients can best make important decisions about them, and what help is out there for people with low incomes.

76 FR 21431 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...This final rule makes revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our experience in the administration of the Part C and Part D programs. These latter revisions clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and make other clarifications and technical changes.

Medicare Part D: successes and continuing challenges. Impact of Medicare Part D on Massachusetts health programs and beneficiaries.

PubMed

Thomas, Cindy Parks; Sussman, Jeffrey

2007-05-30

On January 1, 2006, the Centers for Medicare and Medicaid Services (CMS) implemented the Medicare Drug Benefit, or "Medicare Part D." The program offers prescription drug coverage for the one million Medicare beneficiaries in Massachusetts. Part D affects Massachusetts state health programs and beneficiaries in a number of ways. The program: (1) provides prescription drug insurance, including catastrophic coverage, through a choice of private prescription drug plans (PDPs) or integrated Medicare Advantage (MA-PD) health plans; (2) shifts prescription drug coverage for dual-eligible Medicare / Medicaid beneficiaries from Medicaid to Medicare Part D drug plans; (3) requires a maintenance-of-effort, or "clawback" payments from states to CMS designed to capture a portion of states' Medicaid savings to help finance the benefit; (4) offers additional help for premiums and cost sharing to low income beneficiaries through the Low Income Subsidy (LIS); and (5) provides a subsidy to employer groups that maintain their own prescription drug coverage for retired beneficiaries. This paper summarizes the activities involved in implementing Medicare Part D, the impact it has had on Massachusetts health programs, and the experiences of beneficiaries and others conducting outreach and enrollment. The data are drawn from interviews with officials and documents provided by state health programs, CMS and the Social Security Administration, and representatives of provider and advocacy groups involved in the enrollment and ongoing support of Medicare beneficiaries.

42 CFR 423.782 - Cost-sharing subsidy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Cost-sharing subsidy. 423.782 Section 423.782... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost-Sharing Subsidies... cents. (c) When the out-of-pocket cost for a covered Part D drug under a Part D sponsor's plan benefit...

A Political History of Medicare and Prescription Drug Coverage

PubMed Central

Oliver, Thomas R; Lee, Philip R; Lipton, Helene L

2004-01-01

This article examines the history of efforts to add prescription drug coverage to the Medicare program. It identifies several important patterns in policymaking over four decades. First, prescription drug coverage has usually been tied to the fate of broader proposals for Medicare reform. Second, action has been hampered by divided government, federal budget deficits, and ideological conflict between those seeking to expand the traditional Medicare program and those preferring a greater role for private health care companies. Third, the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 reflect earlier missed opportunities. Policymakers concluded from past episodes that participation in the new program should be voluntary, with Medicare beneficiaries and taxpayers sharing the costs. They ignored lessons from past episodes, however, about the need to match expanded benefits with adequate mechanisms for cost containment. Based on several new circumstances in 2003, the article demonstrates why there was a historic opportunity to add a Medicare prescription drug benefit and identify challenges to implementing an effective policy. PMID:15225331

Ontario’s plunging price-caps on generics: deeper dives may drown some drugs

PubMed Central

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product’s price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive. PMID:22046229

Ontario's plunging price-caps on generics: deeper dives may drown some drugs.

PubMed

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product's price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive.

Controlling and policing substance use(rs).

PubMed

White, Tony

2002-01-01

Controlling drug use--a dynamic, global, politicalized process--is reviewed in terms of selected types of drugs, "natural levels" of drug demand and use, drug markets and the drug market environment, types of traffickers, illicit drug trade profits, approaches to drug control ("War on Drugs", "Zero Tolerance" programs and policies, "normalizing" and legalizing selected drugs), including UN's then relatively recent "Balanced Approach" and facets of drug law enforcement (drug prices and purity levels and values of drug seizures), including various rarely noted benefits to intervention programs and control agents. Unresolved issues and needed "tools" are noted while considering the implications of the first UN's World Drug Report data.

42 CFR 423.886 - Retiree drug subsidy amounts.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 3 2014-10-01 2014-10-01 false Retiree drug subsidy amounts. 423.886 Section 423... (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Payments to Sponsors of Retiree Prescription Drug Plans § 423.886 Retiree drug subsidy amounts. (a) Amount of subsidy payment. (1...

42 CFR 423.886 - Retiree drug subsidy amounts.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 3 2012-10-01 2012-10-01 false Retiree drug subsidy amounts. 423.886 Section 423... (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Payments to Sponsors of Retiree Prescription Drug Plans § 423.886 Retiree drug subsidy amounts. (a) Amount of subsidy payment. (1...

42 CFR 423.886 - Retiree drug subsidy amounts.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 3 2013-10-01 2013-10-01 false Retiree drug subsidy amounts. 423.886 Section 423... (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Payments to Sponsors of Retiree Prescription Drug Plans § 423.886 Retiree drug subsidy amounts. (a) Amount of subsidy payment. (1...

42 CFR 423.886 - Retiree drug subsidy amounts.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Retiree drug subsidy amounts. 423.886 Section 423... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Payments to Sponsors of Retiree Prescription Drug Plans § 423.886 Retiree drug subsidy amounts. (a) Amount of subsidy payment. (1) For each...

Phenelzine as a stimulant drug antagonist: a preliminary report.

PubMed

Maletzky, B M

1977-08-01

Phenelzine administration, monitored via a pharmacy-controlled program, was employed in 38 subjects over a 6-month period to prevent amphetamine-type drug abuse, in much the same manner as disulfiram programs are employed against alcohol abuse. Advantages of the program were apparent, with a majority of subjects abstaining during the enforced phenelzine trial. Subjects generally made use of this abstinent period to benefit from a variety of psychotherapeutic modes, and demonstrated enhanced job and school performance and improved marital relationships. Results based on subject and observer reports, reports from dispensing pharmacies, and random urinalyses for drugs were encouraging. However, the study was uncontrolled and observational, and thus results are merely suggestive at present. Potential dangers as well as benefits of administering phenelzine to such a population are discussed.

Public preferences and organized interests in health policy: state pharmacy assistance programs as innovations.

PubMed

Gray, Virginia; Lowery, David; Godwin, Erik K

2007-02-01

While Congress debated prescription drug coverage for more than a decade before amending the Medicare program in 2003, thirty-one states provided such benefits to their citizens. Why were the same special interests that were reputedly so effective in delaying prescription drug coverage at the national level seemingly incapable of stopping the majority of states from passing the same kinds of legislation? To answer this question, we develop and test a number of hypotheses about the determinants of health policy using Heckman models with data on the adoption, revision, and generosity of state prescription drug programs from 1990 through 2001. We find strong evidence that organized interests had little influence on the adoption of state pharmaceutical assistance programs but can influence their likelihood of revision and the generosity of their benefits. We conclude by discussing the balance of public preferences and organized interests' preferences on state health policy.

Reforming private drug coverage in Canada: inefficient drug benefit design and the barriers to change in unionized settings.

PubMed

O'Brady, Sean; Gagnon, Marc-André; Cassels, Alan

2015-02-01

Prescription drugs are the highest single cost component for employees' benefits packages in Canada. While industry literature considers cost-containment for prescription drug costs to be a priority for insurers and employers, the implementation of cost-containment measures for private drug plans in Canada remains more of a myth than a reality. Through 18 semi-structured phone interviews conducted with experts from private sector companies, unions, insurers and plan advisors, this study explores the reasons behind this incapacity to implement cost-containment measures by examining how private sector employers negotiate drug benefit design in unionized settings. Respondents were asked questions on how employee benefits are negotiated; the relationships between the players who influence drug benefit design; the role of these players' strategies in influencing plan design; the broad system that underpins drug benefit design; and the potential for a universal pharmacare program in Canada. The study shows that there is consensus about the need to educate employees and employers, more collaboration and data-sharing between these two sets of players, and for external intervention from government to help transform established norms in terms of private drug plan design. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Impact of HIV prevention programs on drug users in Malaysia.

PubMed

Kamarulzaman, Adeeba

2009-11-01

Faced with a rising HIV epidemic among injecting drug users, harm reduction policies and programs were introduced in Malaysia in 2005. The positive impact seen since the introduction of these programs comprise the inclusion of the health aspects of illicit drug use in the country's drug policies; better access to antiretroviral therapy for injecting drug users who are HIV infected; reduction in HIV-risk behavior; and greater social benefits, including increased employment. Despite these achievements, tension between law enforcement and public health persists, as harm reduction exists alongside an overall drug policy that is based on abstinence and zero tolerance. Unless there is harmonization of this policy, sustainability and scale-up of harm reduction programs will remain a challenge.

Benefit-cost analysis of addiction treatment: methodological guidelines and empirical application using the DATCAP and ASI.

PubMed

French, Michael T; Salomé, Helena J; Sindelar, Jody L; McLellan, A Thomas

2002-04-01

To provide detailed methodological guidelines for using the Drug Abuse Treatment Cost Analysis Program (DATCAP) and Addiction Severity Index (ASI) in a benefit-cost analysis of addiction treatment. A representative benefit-cost analysis of three outpatient programs was conducted to demonstrate the feasibility and value of the methodological guidelines. Procedures are outlined for using resource use and cost data collected with the DATCAP. Techniques are described for converting outcome measures from the ASI to economic (dollar) benefits of treatment. Finally, principles are advanced for conducting a benefit-cost analysis and a sensitivity analysis of the estimates. The DATCAP was administered at three outpatient drug-free programs in Philadelphia, PA, for 2 consecutive fiscal years (1996 and 1997). The ASI was administered to a sample of 178 treatment clients at treatment entry and at 7-months postadmission. The DATCAP and ASI appear to have significant potential for contributing to an economic evaluation of addiction treatment. The benefit-cost analysis and subsequent sensitivity analysis all showed that total economic benefit was greater than total economic cost at the three outpatient programs, but this representative application is meant to stimulate future economic research rather than justifying treatment per se. This study used previously validated, research-proven instruments and methods to perform a practical benefit-cost analysis of real-world treatment programs. The study demonstrates one way to combine economic and clinical data and offers a methodological foundation for future economic evaluations of addiction treatment.

42 CFR 422.156 - Compliance deemed on the basis of accreditation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Quality Improvement § 422...) through (3) of this chapter for MA organizations that offer prescription drug benefit programs. (c...

20 CFR 638.511 - Drug use and abuse.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Drug use and abuse. 638.511 Section 638.511... TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.511 Drug use and abuse. The Job... and education programs related to drug and alcohol use and abuse. ...

20 CFR 638.511 - Drug use and abuse.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Drug use and abuse. 638.511 Section 638.511... TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.511 Drug use and abuse. The Job... and education programs related to drug and alcohol use and abuse. ...

20 CFR 638.511 - Drug use and abuse.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Drug use and abuse. 638.511 Section 638.511... TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.511 Drug use and abuse. The Job... and education programs related to drug and alcohol use and abuse. ...

77 FR 71211 - Request for Information: Establish a Public-Private Collaboration, “Drug Development Initiative...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... clinical trials with the support of the VA Cooperative Studies Program. To identify and test new drug..., ``Drug Development Initiative'' (DDI), for New Pharmacological Treatments for Post-Traumatic Stress... will delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans...

75 FR 71064 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

... and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes... for Contract Year 2012 and Other Proposed Changes'' which was filed for public inspection on November 10, 2010. FOR FURTHER INFORMATION CONTACT: Sabrina Ahmed, (410) 786-7499. SUPPLEMENTARY INFORMATION...

Understanding the Impacts of the Medicare Modernization Act: Concerns of Congressional Staff

ERIC Educational Resources Information Center

Mueller, Keith J.; Coburn, Andrew F.; MacKinney, Clinton; McBride, Timothy D.; Slifkin, Rebecca T.; Wakefield, Mary K.

2005-01-01

Sweeping changes to the Medicare program embodied in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), including a new prescription drug benefit, changes in payment policies, and reform of the Medicare managed-care program, have major implications for rural health care. The most efficient mechanism for research to…

Medicare's Drug Discount Card Program: Beneficiaries' Experience with Choice

PubMed Central

Hassol, Andrea; Wrobel, Marian V.; Doksum, Teresa

2007-01-01

This article describes Medicare beneficiaries' experience with the choice among Medicare drug discount cards and is based primarily on surveys and focus groups with beneficiaries as well as interviews with other stakeholders. Although competition and choice have the potential to reduce cost and enhance quality in the Medicare Program, our findings highlight some of the challenges involved in making choice work in practice. Despite the unique and temporary nature of the drug discount card program, these findings have considerable relevance to the Part D drug benefit and to other Medicare initiatives that rely on choice. PMID:17722747

Demand for a Medicare prescription drug benefit: exploring consumer preferences under a managed competition framework.

PubMed

Cline, Richard R; Mott, David A

2003-01-01

Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit.

The demise of Oregon's Medically Needy program: effects of losing prescription drug coverage.

PubMed

Zerzan, Judy; Edlund, Tina; Krois, Lisa; Smith, Jeanene

2007-06-01

In January 2003, people covered by Oregon's Medically Needy program lost benefits owing to state budget shortfalls. The Medically Needy program is a federally matched optional Medicaid program. In Oregon, this program mainly provided prescription drug benefits. To describe the Medically Needy population and determine how benefit loss affected this population's health and prescription use. A 49-question telephone survey instrument created by the research team and administered by a research contractor. A random sample of 1,269 eligible enrollees in Oregon's Medically Needy Program. Response rate was 35% with 439 individuals, ages 21-91 and 64% women, completing the survey. Demographics, health information, and medication use at the time of the survey obtained from the interview. Medication use during the program obtained from administrative data. In the 6 months after the Medically Needy program ended, 75% had skipped or stopped medications. Sixty percent of the respondents had cut back on their food budget, 47% had borrowed money, and 49% had skipped paying other bills to pay for medications. By self-report, there was no significant difference in emergency department visits, but a significant decrease in hospitalizations comparing 6 months before and after losing the program. Two-thirds of respondents rated their current health as poor or fair. The Medically Needy program provided coverage for a low-income, chronically ill population. Since its termination, enrollees have decreased prescription drug use and increased financial burden. As states make program changes and Medicare Part D evolves, effects on vulnerable populations must be considered.

45 CFR 78.3 - Benefits not denied to rehabilitated offenders.

Code of Federal Regulations, 2010 CFR

2010-10-01

... substances shall be denied Federal benefits relating to long-term drug treatment programs for addiction under... to a long-term treatment program for addiction as defined by § 78.2(b), provided that in the... addiction as defined by § 78.2(b), provided that in the determination of the sentencing court there is a...

45 CFR 78.3 - Benefits not denied to rehabilitated offenders.

Code of Federal Regulations, 2011 CFR

2011-10-01

... substances shall be denied Federal benefits relating to long-term drug treatment programs for addiction under... to a long-term treatment program for addiction as defined by § 78.2(b), provided that in the... addiction as defined by § 78.2(b), provided that in the determination of the sentencing court there is a...

45 CFR 78.3 - Benefits not denied to rehabilitated offenders.

Code of Federal Regulations, 2013 CFR

2013-10-01

... substances shall be denied Federal benefits relating to long-term drug treatment programs for addiction under... to a long-term treatment program for addiction as defined by § 78.2(b), provided that in the... addiction as defined by § 78.2(b), provided that in the determination of the sentencing court there is a...

45 CFR 78.3 - Benefits not denied to rehabilitated offenders.

Code of Federal Regulations, 2012 CFR

2012-10-01

... substances shall be denied Federal benefits relating to long-term drug treatment programs for addiction under... to a long-term treatment program for addiction as defined by § 78.2(b), provided that in the... addiction as defined by § 78.2(b), provided that in the determination of the sentencing court there is a...

45 CFR 78.3 - Benefits not denied to rehabilitated offenders.

Code of Federal Regulations, 2014 CFR

2014-10-01

... substances shall be denied Federal benefits relating to long-term drug treatment programs for addiction under... to a long-term treatment program for addiction as defined by § 78.2(b), provided that in the... addiction as defined by § 78.2(b), provided that in the determination of the sentencing court there is a...

Evaluation of the Maximum Allowable Cost Program

PubMed Central

Lee, A. James; Hefner, Dennis; Dobson, Allen; Hardy, Ralph

1983-01-01

This article summarizes an evaluation of the Maximum Allowable Cost (MAC)-Estimated Acquisition Cost (EAC) program, the Federal Government's cost-containment program for prescription drugs.1 The MAC-EAC regulations which became effective on August 26, 1976, have four major components: (1) Maximum Allowable Cost reimbursement limits for selected multisource or generically available drugs; (2) Estimated Acquisition Cost reimbursement limits for all drugs; (3) “usual and customary” reimbursement limits for all drugs; and (4) a directive that professional fee studies be performed by each State. The study examines the benefits and costs of the MAC reimbursement limits for 15 dosage forms of five multisource drugs and EAC reimbursement limits for all drugs for five selected States as of 1979. PMID:10309857

Cost-Control Mechanisms in Canadian Private Drug Plans

PubMed Central

Kratzer, Jillian; McGrail, Kimberlyn; Strumpf, Erin; Law, Michael R.

2013-01-01

Approximately 68% of Canadians receive prescription drug coverage through an employer-sponsored private plan. However, we have very limited data on the structure of these plans. This study aims to identify and describe the use of cost-control mechanisms in private drug plans in Canada and describe what private coverage looks like for the average Canadian. Using 2010 data from over 113,000 different private drug plans, provided by Applied Management Consultants, we determined the overall use of key cost-control measures, and the cost-control tools that appear to be gaining currency compared to a report on benefits coverage in 1998. We found that the use of common cost-control measures is relatively low among Canadian private benefits programs. Co-insurance is much more common in private coverage plans than co-payments. Deductibles are uncommon in Canada and, when in place, are very small. The use of annual and lifetime maximums is increasing. Canadian private benefits programs use few cost-control measures to respond to increasing costs, particularly in comparison to their public counterparts. These results suggest there are ample opportunities for greater efficiency in private sector drug coverage plans. PMID:23968672

42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Requirements related to qualified prescription drug coverage. 423.104 Section 423.104 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT...

42 CFR 423.886 - Retiree drug subsidy amounts.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Retiree drug subsidy amounts. 423.886 Section 423.886 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Payments to Sponsors of Retiree...

42 CFR 423.165 - Compliance deemed on the basis of accreditation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost..., national accreditation organization approved by CMS; and (2) The accreditation organization uses the...) Access to covered drugs, as provided under §§ 423.120 and 423.124. (2) Drug utilization management...

78 FR 12427 - Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

...This proposed rule would implement medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program under the Patient Protection and Affordable Care Act.

Development of a metrics dashboard for monitoring involvement in the 340B Drug Pricing Program.

PubMed

Karralli, Rusol; Tipton, Joyce; Dumitru, Doina; Scholz, Lisa; Masilamani, Santhi

2015-09-01

An electronic tool to support hospital organizations in monitoring and addressing financial and compliance challenges related to participation in the 340B Drug Pricing Program is described. In recent years there has been heightened congressional and regulatory scrutiny of the federal 340B program, which provides discounted drug prices on Medicaid-covered drugs to safety net hospitals and other 340B-eligible healthcare organizations, or "covered entities." Historically, the 340B program has lacked a metrics-driven reporting framework to help covered entities capture the value of 340B program involvement, community benefits provided to underserved populations, and costs associated with compliance with 340B eligibility requirements. As part of an initiative by a large health system to optimize its 340B program utilization and regulatory compliance efforts, a team of pharmacists led the development of an electronic dashboard tool to help monitor 340B program activities at the system's 340B-eligible facilities. After soliciting input from an array of internal and external 340B program stakeholders, the team designed the dashboard and associated data-entry tools to facilitate the capture and analysis of 340B program-related data in four domains: cost savings and revenue, program maintenance costs, community benefits, and compliance. A large health system enhanced its ability to evaluate and monitor 340B program-related activities through the use of a dashboard tool capturing key metrics on cost savings achieved, maintenance costs, and other aspects of program involvement. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Economic Evaluation of the Juvenile Drug Court/Reclaiming Futures (JDC/RF) Model.

PubMed

McCollister, Kathryn; Baumer, Pamela; Davis, Monica; Greene, Alison; Stevens, Sally; Dennis, Michael

2018-07-01

Juvenile drug court (JDC) programs are an increasingly popular option for rehabilitating juvenile offenders with substance problems, but research has found inconsistent evidence regarding their effectiveness and economic impact. While assessing client outcomes such as reduced substance use and delinquency is necessary to gauge program effectiveness, a more comprehensive understanding of program success and sustainability can be attained by examining program costs and economic benefits. As part of the National Cross-Site Evaluation of JDC and Reclaiming Futures (RF), an economic analysis of five JDC/RF programs was conducted from a multisystem and multiagency perspective. The study highlights the direct and indirect costs of JDC/RF and the savings generated from reduced health problems, illegal activity, and missed school days. Results include the average (per participant) cost of JDC/RF, the total economic benefits per JDC/RF participant, and the net savings of JDC/RF relative to standard JDC.

Low hanging fruit in infectious disease drug development.

PubMed

Kraus, Carl N

2008-10-01

Cost estimates for developing new molecular entities (NME) are reaching non-sustainable levels and coupled with increasing regulatory requirements and oversight have led many pharmaceutical sponsors to divest their anti-microbial development portfolios [Projan SJ: Why is big Pharma getting out of anti-bacterial drug discovery?Curr Opin Microbiol 2003, 6:427-430] [Spellberg B, Powers JH, Brass EP, Miller LG, Edwards JE, Jr: Trends in antimicrobial drug development: implications for the future.Clin Infect Dis 2004, 38:1279-1286]. Operational issues such as study planning and execution are significant contributors to the overall cost of drug development that can benefit from the leveraging of pre-randomization data in an evidence-based approach to protocol development, site selection and patient recruitment. For non-NME products there is even greater benefit from available data resources since these data may permit smaller and shorter study programs. There are now many available open source intelligence (OSINT) resources that are being integrated into drug development programs, permitting an evidence-based or 'operational epidemiology' approach to study planning and execution.

42 CFR 422.6 - Cost-sharing in enrollment-related costs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM General Provisions § 422.6 Cost-sharing in... for the drug benefit). (c) Applicability. The fee assessment also applies to those demonstrations for...

The UIC ICBG (University of Illinois at Chicago International Cooperative Biodiversity Group) Memorandum of Agreement: a model of benefit-sharing arrangement in natural products drug discovery and development.

PubMed

Soejarto, D D; Gyllenhaal, C; Fong, H H S; Xuan, L T; Hiep, N T; Hung, N V; Bich, T Q; Southavong, B; Sydara, K; Pezzuto, J M

2004-02-01

The Convention on Biodiversity mandates a new approach to the discovery of natural product drugs, one that incorporates concepts of national ownership of genetic resources, intellectual property rights in traditional knowledge, and sharing of economic benefits with countries that are the source of new natural products. The International Cooperative Biodiversity Group (ICBG) program was established to support experimentation in implementation of the Convention through development and execution of international agreements for bioprospecting. The agreement of one such ICBG program, between the University of Illinois at Chicago and institutions in Vietnam and Laos, is presented here. The core elements contained in the single, five-way Memorandum of Agreement are the arrangements for intellectual property rights, treatment of informed consent, and plans for benefit-sharing (including the sharing of short- and long-term royalty benefits, capacity building, and community reciprocity). Program participants were able to develop a practical and flexible agreement that satisfies the wishes of all institutions that are parties to it.

Employee benefits managers' opinions about addiction treatment.

PubMed

McFarland, Bentson H; Lierman, Walter K; Penner, Norman R; McCamant, Lynn E; Zani, Brigid G

2003-01-01

Employee benefits managers arrange addictive disease treatment insurance coverage for the majority of people in the United States but little is known about these decision-makers. Managers were surveyed to learn their opinions about addiction treatment. Subjects were 131 people (61 percent female, 94 percent white, average age 46, average of 14 years in the human resources field). Managers were asked to rank health benefits (physical health, dental, alcohol-drug, vision, mental health, employee assistance program, and pharmaceuticals) on 15 dimensions. Managers ranked alcohol-drug abuse treatment worst on fiveitems and second to the worst on another four of the 15 dimensions. On the item considered most important by the managers, respondents noted that employees often (2.8) ask for improved physical health benefits but rarely do so for alcohol and drug (4.1) benefits (p < .001). Education of workers and payers will be needed to change opinions about treatment of addictive disorders.

Evidence-based decision-making within Australia's pharmaceutical benefits scheme.

PubMed

Lopert, Ruth

2009-07-01

In Australia, most prescription drugs are subsidized through the Pharmaceutical Benefits Scheme (PBS), one of several government programs in which evidence-based decision making is applied to the funding of health technologies. PBS processes are intended to ensure "value for money" for the Australian taxpayer and to support affordable, equitable access to prescription medicines; they are not intended as a mechanism for cost containment. The inclusion of a drug on the national formulary depends on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC), which considers not only the comparative effectiveness but also the comparative cost-effectiveness of drugs proposed for listing. While some decisions have been controversial, the PBS retains strong public support. Moreover, evidence does not suggest that the consideration of cost-effectiveness has created a negative environment for the drug industry: Australia has a high penetration of patented medicines, with prices for some recently approved drugs at U.S. levels.

42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

Code of Federal Regulations, 2010 CFR

2010-10-01

... MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Organization Compliance with State Law and Preemption by Federal Law § 423.415 Temporary waivers for entities seeking to offer a prescription drug plan in more...

42 CFR 423.466 - Timeframes for coordination of benefits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 423.466 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination of Part D...) Retroactive claims adjustments, underpayment refunds, and overpayment recoveries. Whenever a sponsor receives...

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement... utilization management programs, quality assurance measures and systems, and medication therapy management... organization (QIO) activities. (f) Compliance deemed on the basis of accreditation. (g) Accreditation...

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement... utilization management programs, quality assurance measures and systems, and medication therapy management... organization (QIO) activities. (f) Compliance deemed on the basis of accreditation. (g) Accreditation...

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements... utilization management programs, quality assurance measures and systems, and medication therapy management... organization (QIO) activities. (f) Compliance deemed on the basis of accreditation. (g) Accreditation...

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement... utilization management programs, quality assurance measures and systems, and medication therapy management... organization (QIO) activities. (f) Compliance deemed on the basis of accreditation. (g) Accreditation...

Promoting universal financial protection: health insurance for the poor in Georgia--a case study.

PubMed

Zoidze, Akaki; Rukhazde, Natia; Chkhatarashvili, Ketevan; Gotsadze, George

2013-11-15

The present study focuses on the program "Medical Insurance for the Poor (MIP)" in Georgia. Under this program, the government purchased coverage from private insurance companies for vulnerable households identified through a means testing system, targeting up to 23% of the total population. The benefit package included outpatient and inpatient services with no co-payments, but had only limited outpatient drug benefits. This paper presents the results of the study on the impact of MIP on access to health services and financial protection of the MIP-targeted and general population. With a holistic case study design, the study employed a range of quantitative and qualitative methods. The methods included document review and secondary analysis of the data obtained through the nationwide household health expenditure and utilisation surveys 2007-2010 using the difference-in-differences method. The study findings showed that MIP had a positive impact in terms of reduced expenditure for inpatient services and total household health care costs, and there was a higher probability of receiving free outpatient benefits among the MIP-insured. However, MIP insurance had almost no effect on health services utilisation and the households' expenditure on outpatient drugs, including for those with MIP insurance, due to limited drug benefits in the package and a low claims ratio. In summary, the extended MIP coverage and increased financial access provided by the program, most likely due to the exclusion of outpatient drug coverage from the benefit package and possibly due to improper utilisation management by private insurance companies, were not able to reverse adverse effects of economic slow-down and escalating health expenditure. MIP has only cushioned the negative impact for the poorest by decreasing the poor/rich gradient in the rates of catastrophic health expenditure. The recent governmental decision on major expansion of MIP coverage and inclusion of additional drug benefit will most likely significantly enhance the overall MIP impact and its potential as a viable policy instrument for achieving universal coverage. The Georgian experience presented in this paper may be useful for other low- and middle-income countries that are contemplating ways to ensure universal coverage for their populations.

42 CFR 423.800 - Administration of subsidy program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Administration of subsidy program. 423.800 Section 423.800 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost...

[Three types of brand name loyalty strategies set up by drug manufacturers].

PubMed

PréMont, Marie-Claude; Gagnon, Marc-André

2014-11-01

The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

Benefits and costs of substance abuse treatment programs for state prison inmates: results from a lifetime simulation model.

PubMed

Zarkin, Gary A; Cowell, Alexander J; Hicks, Katherine A; Mills, Michael J; Belenko, Steven; Dunlap, Laura J; Houser, Kimberly A; Keyes, Vince

2012-06-01

Reflecting drug use patterns and criminal justice policies throughout the 1990s and 2000s, prisons hold a disproportionate number of society's drug abusers. Approximately 50% of state prisoners meet the criteria for a diagnosis of drug abuse or dependence, but only 10% receive medically based drug treatment. Because of the link between substance abuse and crime, treating substance abusing and dependent state prisoners while incarcerated has the potential to yield substantial economic benefits. In this paper, we simulate the lifetime costs and benefits of improving prison-based substance abuse treatment and post-release aftercare for a cohort of state prisoners. Our model captures the dynamics of substance abuse as a chronic disease; estimates the benefits of substance abuse treatment over individuals' lifetimes; and tracks the costs of crime and criminal justice costs related to policing, adjudication, and incarceration. We estimate net societal benefits and cost savings to the criminal justice system of the current treatment system and five policy scenarios. We find that four of the five policy scenarios provide positive net societal benefits and cost savings to the criminal justice system relative to the current treatment system. Our study demonstrates the societal gains to improving the drug treatment system for state prisoners. Copyright © 2011 John Wiley & Sons, Ltd.

BENEFITS AND COSTS OF SUBSTANCE ABUSE TREATMENT PROGRAMS FOR STATE PRISON INMATES: RESULTS FROM A LIFETIME SIMULATION MODEL

PubMed Central

ZARKIN, GARY A.; COWELL, ALEXANDER J.; HICKS, KATHERINE A.; MILLS, MICHAEL J.; BELENKO, STEVEN; DUNLAP, LAURA J.; HOUSER, KIMBERLY A.; KEYES, VINCE

2011-01-01

SUMMARY Reflecting drug use patterns and criminal justice policies throughout the 1990s and 2000s, prisons hold a disproportionate number of society’s drug abusers. Approximately 50% of state prisoners meet the criteria for a diagnosis of drug abuse or dependence, but only 10% receive medically based drug treatment. Because of the link between substance abuse and crime, treating substance abusing and dependent state prisoners while incarcerated has the potential to yield substantial economic benefits. In this paper, we simulate the lifetime costs and benefits of improving prison-based substance abuse treatment and post-release aftercare for a cohort of state prisoners. Our model captures the dynamics of substance abuse as a chronic disease; estimates the benefits of substance abuse treatment over individuals’ lifetimes; and tracks the costs of crime and criminal justice costs related to policing, adjudication, and incarceration. We estimate net societal benefits and cost savings to the criminal justice system of the current treatment system and five policy scenarios. We find that four of the five policy scenarios provide positive net societal benefits and cost savings to the criminal justice system relative to the current treatment system. Our study demonstrates the societal gains to improving the drug treatment system for state prisoners. PMID:21506193

Unique issues raised by drug benefit design.

PubMed

Berndt, Ernst R

2004-01-01

In this Perspective on the preceding paper by Joseph Newhouse, I point out a number of features of the pharmaceutical industry that differentiate it from other health care sectors. These differences help explain why it has proved to be so very difficult to construct policies that simultaneously contain health care costs, provide patients with high-quality care, and generate continued incentives for innovation. I then summarize Newhouse's preferred Medicare prescription drug benefit program and the issues it raises.

Bundling occupational safety with harm reduction information as a feasible method for improving police receptiveness to syringe access programs: evidence from three U.S. cities

PubMed Central

Davis, Corey S; Beletsky, Leo

2009-01-01

Introduction In light of overwhelming evidence that access to sterile injection equipment reduces incidence of injection-attributable bloodborne disease without encouraging drug use, many localities have authorized sterile syringe access programs (SAPs), including syringe exchange and pharmacy-based initiatives. Even where such interventions are clearly legal, many law enforcement officers are unaware of the public health benefits and legal status of these programs and may continue to treat the possession of injection equipment as illegal and program participation as a marker of illegal behavior. Law enforcement practice can impede SAP utilization and may increase the risk of needlestick injury (NSI) among law enforcement personnel. Many SAPs conduct little or no outreach to law enforcement, in part because they perceive law enforcement actors as unreceptive to health-promotion programs targeting drug users. Case description We report on a brief training intervention for law enforcement personnel designed to increase officer knowledge of and positive attitudes towards SAPs by bundling content that addresses officer concerns about infectious disease and occupational safety with information about the legality and public health benefits of these programs. Pilot trainings using this bundled curriculum were conducted with approximately 600 officers in three US cities. Discussion and evaluation Law enforcement officers were generally receptive to receiving information about SAPs through the bundled curriculum. The trainings led to better communication and collaboration between SAP and law enforcement personnel, providing a valuable platform for better harmonization of law enforcement and public health activities targeting injection drug users. Conclusion The experience in these three cities suggests that a harm reduction training curriculum that bundles strategies for increasing officer occupational safety with information about the legality and public health benefits of SAPs can be well received by law enforcement personnel and can lead to better communication and collaboration between law enforcement and harm reduction actors. Further study is indicated to assess whether such a bundled curriculum is effective in changing officer attitudes and beliefs and reducing health risks to officers and injection drug users, as well as broader benefits to the community at large. PMID:19602236

76 FR 54599 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing.... Camille Brown, (410) 786-0274, Marketing issues. SUPPLEMENTARY INFORMATION: I. Background The Balanced... the Secretary to revise the marketing requirements for Part C and Part D plans in several areas. MIPPA...

20 CFR 439.220 - By when must I publish my drug-free workplace statement and establish my drug-free awareness...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false By when must I publish my drug-free workplace...) Requirements for Recipients Other Than Individuals § 439.220 By when must I publish my drug-free workplace... § 439.215, you must publish the statement and establish the program by the time given in the following...

42 CFR 423.772 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost-Sharing Subsidies for Low-Income... 42 Public Health 3 2010-10-01 2010-10-01 false Definitions. 423.772 Section 423.772 Public Health... revision required by that section. Full-benefit dual eligible individual means an individual who, for any...

42 CFR 423.452 - Scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Scope. 423.452 Section 423.452 Public Health... PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription...; establishes waivers for MA-PD plans, employer-sponsored group prescription drug plans, cost plans, and PACE...

California drug courts: outcomes, costs and promising practices: an overview of Phase II in a statewide study.

PubMed

Carey, Shannon M; Finigan, Michael; Crumpton, Dave; Waller, Mark

2006-11-01

The rapid expansion of drug courts in California and the state's uncertain fiscal climate highlighted the need for definitive cost information on drug court programs. This study focused on creating a research design that can be utilized for statewide and national cost-assessment of drug courts by conducting in-depth case studies of the costs and benefits in nine adult drug courts in California. A Transactional Institutional Costs Analysis (TICA) approach was used, allowing researchers to calculate costs based on every individual's transactions within the drug court or the traditional criminal justice system. This methodology also allows the calculation of costs and benefits by agency (e.g., Public Defender's office, court, District Attorney). Results in the nine sites showed that the majority of agencies save money in processing an offender though drug court. Overall, for these nine study sites, participation in drug court saved the state over 9 million dollars in criminal justice and treatment costs due to lower recidivism in drug court participants. Based on the lessons learned in Phases I and II, Phase III of this study focuses on the creation of a web-based drug court cost self-evaluation tool (DC-CSET) that drug courts can use to determine their own costs and benefits.

Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

PubMed Central

Chawla, Anita J; Mytelka, Daniel S; McBride, Stephan D; Nellesen, Dave; Elkins, Benjamin R; Ball, Daniel E; Kalsekar, Anupama; Towse, Adrian; Garrison, Louis P

2014-01-01

Purpose To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. Methods We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. Results The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was −1.80 million LYs, attributable to delayed access to diabetes therapies (−0.18 million LYs) and fewer drugs (−1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. Conclusion The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or forgone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:24892175

Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies.

PubMed

Chawla, Anita J; Mytelka, Daniel S; McBride, Stephan D; Nellesen, Dave; Elkins, Benjamin R; Ball, Daniel E; Kalsekar, Anupama; Towse, Adrian; Garrison, Louis P

2014-03-01

To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was -1.80 million LYs, attributable to delayed access to diabetes therapies (-0 .18 million LYs) and fewer drugs (-1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or for gone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. Copyright © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

42 CFR 423.508 - Modification or termination of contract by mutual consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) Prohibition against Part D program participation by organizations whose owners, directors, or management employees served in a similar capacity with another organization that mutually terminated its Medicare... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT...

42 CFR 422.500 - Scope and definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Application Procedures and Contracts for Medicare Advantage Organizations § 422.500 Scope and definitions. (a) Scope. This subpart sets forth application... requirements of part 423 of this chapter specifically related to the prescription drug benefit. (b) Definitions...

United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

PubMed

Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

2014-05-01

The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Medicare prescription drug coverage: Consumer information and preferences

PubMed Central

Winter, Joachim; Balza, Rowilma; Caro, Frank; Heiss, Florian; Jun, Byung-hill; Matzkin, Rosa; McFadden, Daniel

2006-01-01

We investigate prescription drug use, and information and enrollment intentions for the new Medicare Part D drug insurance program, using a sample of Medicare-eligible subjects surveyed before open enrollment began for this program. We find that, despite the complexity of competing plans offered by private insurers under Part D, a majority of the Medicare population had information on this program and a substantial majority planned to enroll. We find that virtually all elderly, even those with no current prescription drug use, can expect to benefit from enrollment in a Part D Standard plan at the low premiums available in the current market. However, there is a significant risk that many eligible seniors, particularly low-income elderly with poor health or cognitive impairment, will make poor enrollment and plan choices. PMID:16682629

Community-wide reduction in prevalence and intensity of intestinal helminths as a collateral benefit of lymphatic filariasis elimination programs.

PubMed

De Rochars, Madsen Beau; Direny, Abdel N; Roberts, Jacquelin M; Addiss, David G; Radday, Jeanne; Beach, Michael J; Streit, Thomas G; Dardith, Desire; Lafontant, Jack Guy; Lammie, Patrick J

2004-10-01

Annual mass treatment with antifilarial drugs is the cornerstone of the global program to eliminate lymphatic filariasis (LF). Although the primary goal of the program is to interrupt transmission of LF, additional public health benefits also are expected because of the known anthelminthic properties of these drugs. Since rapid re-infection with intestinal helminths occurs following treatment, annual de-worming may not be sufficient to produce a lasting reduction in the prevalence and intensity of these infections. We conducted stool examinations in four sentinel communities before and approximately nine months after each of two rounds of mass drug administration (MDA) with diethylcarbamazine and albendazole in the context of an LF elimination program in Leogane, Haiti. At baseline, overall Ascaris, Trichuris, and hookworm infection prevalences were 20.9%, 34.0%, and 11.2%, respectively (n = 2,716 stools). Nine months after the second MDA, Ascaris, Trichuris and hookworm prevalences had decreased significantly, to 14.1%, 14.6%, and 2.0%, respectively (n = 814 stools). Infection intensity decreased significantly for all three parasites as well. These results demonstrate that substantial reductions in intestinal helminth infections are associated with mass treatment of filariasis in Haiti and are consistent with the conclusion that high levels of coverage for the LF program can decrease transmission of geohelminths.

Medicare program; prohibition of midyear benefit enhancements for Medicare Advantage organizations. Final rule.

PubMed

2008-07-28

This final rule prohibits Medicare Advantage (MA) organizations, including organizations offering MA plans to employer and union group health plan sponsors, from making midyear changes to nonprescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. This final rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors and not open to general enrollment may continue to offer benefit enhancements as they do currently, through means other than midyear benefit enhancements (MYBEs). Programs of all-inclusive care for elderly (PACE) are not subject to the provisions of this final rule and may continue to offer enhanced benefits as specified in our guidance for PACE plans.

Coordination of health coverage for Medicare enrollees: living with HIV/AIDS in California.

PubMed

Eichner, J; Kahn, J G

2001-08-01

Because Medicare does not cover a large part of the health care that its enrollees living with HIV/AIDS require, they need other coverage to supplement Medicare. Medicaid is a major source of that supplemental coverage. In California, Medicare enrollees with HIV/AIDS who were also enrolled in Medi-Cal (California's Medicaid program) had total payments from both programs of $177 million, or an average of $28,956 per person in the fee-for-service-system in 1998. Of that total, Medicare paid for 38 percent, mainly for inpatient visits and ambulatory care, while Medi-Cal paid 62 percent, mainly for prescription drugs. For these dual enrollees, many of Medicare's benefit gaps--including a large share of prescription drugs, nursing facility services and home care--are being filled by Medi-Cal. Data in this Medicare Brief indicate that the incremental cost to the federal government of filling gaps in the Medicare benefits package would be considerably less than the full cost of the additional benefits. Through Medicaid and other programs, the federal government is already paying a substantial part of public program expenditures for dual enrollees with HIV/AIDS. Other issues to consider are how the dual Medicare-Medicaid funding streams affect the programs' cost efficiency, and from the perspective of Medicare enrollees and providers, how well the dual programs coordinate to meet the needs of people with HIV/AIDS and other chronic conditions.

Mass drug administration and the global control of schistosomiasis: successes, limitations and clinical outcomes.

PubMed

Olveda, David U; McManus, Donald P; Ross, Allen G P

2016-12-01

Preventive chemotherapy is advocated for the global control and elimination of schistosomiasis. Despite the well known short-term benefits of treating patients for schistosomiasis, the impact of mass drug administration (MDA) campaigns to control the disease in the long term remains unresolved. Many studies have advocated the success of MDA programs in order to attract donor funds for elimination efforts but such successes are often short-lived given the drug does not alter the life cycle of the organism or prevent reinfection. Within a matter of months to years after halting treatment, the prevalence, intensity of infection and morbidity of disease return to baseline levels. Other mitigating factors contribute to the failings of MDA campaigns namely: poverty, poor drug coverage, poor drug compliance, and, in the case of Asiatic schistosomiasis, zoonotic transmission. Genetic and innate and acquired immunologic mechanisms complicate the epidemiologic picture of schistosomiasis globally, and may contribute indirectly to MDA shortcomings. The possibility of drug resistance is an ever present concern because of the sole reliance on one drug, praziquantel. Preventive chemotherapy is advocated for the global control and elimination of schistosomiasis. The short-term benefits of MDA campaigns are well documented but the long-term benefits are questionable.

42 CFR 423.156 - Consumer satisfaction surveys.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and... Healthcare Providers and Systems (CAHPS) survey vendors to conduct the Medicare CAHPS satisfaction survey of...

42 CFR 423.156 - Consumer satisfaction surveys.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality... as of July of the prior year must contract with approved Medicare Consumer Assessment of Healthcare...

Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA); interpretation of "federal public benefit"--HHS. Notice with comment period.

PubMed

1998-08-04

This notice with comment period interprets the term "Federal public benefit" as used in Title IV of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), Pub. L. 104-193, and identifies the HHS programs that provide such benefits under this interpretation. According to section 401 if PRWORA, aliens who are not "qualified aliens" are not eligible for any "Federal public benefit," unless the "Federal public benefit" falls within a specified exception. A "Federal public benefit" includes "any grant, contract, loan, professional license, or commercial license" provided to an individual, and also "any retirement, welfare, health, disability, public or assisted housing, postsecondary education, food assistance, unemployment benefit, or any other similar benefit for which payments or assistance are provided to an individual, household, or family eligibility unit." Under section 432, providers of a non-exempt "Federal public benefit" must verify that a person applying for the benefit is a qualified alien and is eligible to receive the benefit. The HHS programs that provide "Federal public benefits" and are not otherwise excluded from the definition by the exceptions provided in section 401(b) are: Adoption Assistance Administration on Developmental Disabilities (ADD)-State Developmental Disabilities Councils (direct services only) ADD-Special Projects (direct services only) ADD-University Affiliated Programs (clinical disability assessment services only) Adult Programs/Payments to Territories Agency for Health Care Policy and Research Dissertation Grants Child Care and Development Fund Clinical Training Grant for Faculty Development in Alcohol & Drug Abuse Foster Care Health Profession Education and Training Assistance Independent Living Program Job Opportunities for Low Income Individuals (JOLI) Low Income Home Energy Assistance Program (LIHEAP) Medicare Medicaid (except assistance for an emergency medical condition) Mental Health Clinical Training Grants Native Hawaiian Loan Program Refugee Cash Assistance Refugee Medical Assistance Refugee Preventive Health Services Program Refugee Social Services Formula Program Refugee Social Services Discretionary Program Refugee Targeted Assistance Formula Program Refugee Targeted Assistance Discretionary Program Refugee Unaccompanied Minors Program Refugee Voluntary Agency Matching Grant Program Repatriation Program Residential Energy Assistance Challenge Option (REACH) Social Services Block Grant (SSBG) State Child Health Insurance Program (CHIP) Temporary Assistance for Needy Families (TANF) While all of these programs provide "Federal public benefits" this does not mean that all benefits or services provided under these programs are "Federal public benefits." As discussed in sections II and III below, some benefits or services under these programs may not be provided to an "individual, household, or family eligibility unit" and, therefore, do not constitute "Federal public benefits" as defined by PRWORA.

Health plan approach to operationalizing a specialty drug management program.

PubMed

Tegenu, Mesfin

2008-05-01

Expenditures related to specialty drugs consume a significant percentage of available health care resources. Explain the process of transitioning the management of specialty drugs from medical services to pharmacy services in 2 managed care plans and provide insight into the issues encountered and solutions implemented based on 6 years of experience using traditional and innovative pharmacy utilization management tools to insure appropriate specialty drug use and reimbursement. The level of involvement in a specialty management program varies from managing only products dispensed by the retail, mail, and specialty pharmacy vendor to encompassing a broad list of specialty drugs distributed through a variety of channels. Efficient administrative, operational, and clinical processes are critical to the success of the program. Additionally, an accurate and timely claims processing procedure is also essential for success as is the ability to mine data and effectively report on the use of specialty products. A clinically sound, cost-effective, and patient-friendly program requires input from health plan members, pharmacy service leaders, and physician providers, and must overcome challenges associated with disrupting current relationships and removing competing incentives. A well-constructed and properly funded specialty drug management program results in clinical and financial benefits for the plan.

Cost-benefit analysis of drug treatment services: review of the literature*

PubMed

Cartwright, William S.

2000-03-01

BACKGROUND: How valuable is public investment in treatment for drug abuse and dependency in the real world of everyday practice? Does drug abuse treatment provide benefits and how are they valued? What are the costs of obtaining outcomes and benefits? Cost-benefit analysis attempts to answer these questions in a standard analytic framework. AIMS: This paper reviews cost-benefit analyses with scientific merit so that analysts will have a current picture of the state of the research. It will also give public decision-makers information with regards to the available evidence for policy purposes. METHOD: Bibliographic searches were performed. Studies were obtained through the assistance of the Parklawn Health Library system, a component of the US Public Health Service. Selected studies were from the scientific literature with the exception of eight studies published as governmental reports. RESULTS: Cost-benefit studies have fallen into the following categories: (i) planning models for delivery systems in states and cities; (ii) short-term follow-up studies of individuals, (iii) single individual programs and (iv) state system's monitoring of outcomes. In 18 cost-benefit studies, a persistent finding is that benefits exceed costs, even when not all benefits are accounted for in the analysis. Much variation is found in the implementation of cost-benefit methods, and this is detailed across discussions of effectiveness, benefits and costs. Studies have emphasized the cost savings to society from the reduction in external costs created by the behavioral consequences of addiction and drug use. DISCUSSION: Economic analysis of drug treatment requires sophisticated conceptualization and measurement. Cost-benefit analysis of drug treatment has been a significant analytical exercise since the early 1970s when the public drug treatment system was founded in the United States. CONCLUSION: Drug abuse treatment services may be considered as contributing positive economic returns to society. However, considerable work needs to be done to standardize methods used in the studies. A striking area of omission is the absence of studies for adolescents and only one for women in treatment. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Finding a positive net social benefit should assist policy-makers with decisions related to drug abuse treatment expenditures. Additional work on allocation of budget dollars across various drug treatment services will be needed. IMPLICATIONS FOR HEALTH POLICY FORMULATION: Government agencies and other stakeholders in national health care systems must realize that cost-benefit studies are an important tool for decision-making. Rational strategies can only be addressed by examining alternatives for the efficient allocation and equitable distribution of scarce resources. IMPLICATIONS FOR FURTHER RESEARCH: Future research should focus on standardizing the methods used in the cost-benefit analysis. Extensions should examine methods related to the willingness-to-pay approach. Studies are needed for drug abuse treatment targeted to adolescents and women. More studies should be published in the scientific literature.

Reducing patient drug acquisition costs can lower diabetes health claims.

PubMed

Mahoney, John J

2005-08-01

Concerned about rising prevalence and costs of diabetes among its employees, Pitney Bowes Inc recently revamped its drug benefit design to synergize with ongoing efforts in its disease management and patient education programs. Specifically, based on a predictive model showing that low medication adherence was linked to subsequent increases in healthcare costs in patients with diabetes, the company shifted all diabetes drugs and devices from tier 2 or 3 formulary status to tier 1. The rationale was that reducing patient out-of-pocket costs would eliminate financial barriers to preventive care, and thereby increase adherence, reduce costly complications, and slow the overall rate of rising healthcare costs. This single change in pharmaceutical benefit design immediately made critical brand-name drugs available to most Pitney Bowes employees and their covered dependents for 10% coinsurance, the same coinsurance level as for generic drugs, versus the previous cost share of 25% to 50%. After 2 to 3 years, preliminary results in plan participants with diabetes indicate that medication possession rates have increased significantly, use of fixed-combination drugs has increased (possibly related to easier adherence), average total pharmacy costs have decreased by 7%, and emergency department visits have decreased by 26%. Hospital admission rates, although increasing slightly, remain below the demographically adjusted Medstat benchmark. Overall direct healthcare costs per plan participant with diabetes decreased by 6%. In addition, the rate of increase in overall per-plan-participant health costs at Pitney Bowes has slowed markedly, with net per-plan-participant costs in 2003 at about 4000 dollars per year versus 6500 dollars for the industry benchmark. This recent moderation in overall corporate health costs may be related to these strategic changes in drug benefit design for diabetes, asthma, and hypertension and also to ongoing enhancements in the company's disease management and wellness programs.

42 CFR 423.664 - Authority of hearing officer.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Medicare Contract Determinations and Appeals § 423.664 Authority of hearing officer. In exercising his or her authority, the hearing...

42 CFR 423.2262 - Review and distribution of marketing materials.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D...) Ad hoc enrollee communication materials. Ad hoc enrollee communication materials may be reviewed by...

Comparing employer-sponsored and federal exchange plans: wide variations in cost sharing for prescription drugs.

PubMed

Buttorff, Christine; Andersen, Martin S; Riggs, Kevin R; Alexander, G Caleb

2015-03-01

Just under seven million Americans acquired private insurance through the new health insurance exchanges, or Marketplaces, in 2014. The exchange plans are required to cover essential health benefits, including prescription drugs. However, the generosity of prescription drug coverage in the plans has not been well described. Our primary objective was to examine the variability in drug coverage in the exchanges across plan types (health maintenance organization or preferred provider organization) and metal tiers (bronze, silver, gold, and platinum). Our secondary objective was to compare the exchange coverage to employer-sponsored coverage. Analyzing prescription drug benefit design data for the federally facilitated exchanges, we found wide variation in enrollees' out-of-pocket costs for generic, preferred brand-name, nonpreferred brand-name, and specialty drugs, not only across metal tiers but also within those tiers across plan types. Compared to employer-sponsored plans, exchange plans generally had lower premiums but provided less generous drug coverage. However, for low-income enrollees who are eligible for cost-sharing subsidies, the exchange plans may be more comparable to employer-based coverage. Policies and programs to assist consumers in matching their prescription drug needs with a plan's benefit design may improve the financial protection for the newly insured. Project HOPE—The People-to-People Health Foundation, Inc.

42 CFR 423.586 - Opportunity to submit evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... limited by the short timeframe for making a decision. Therefore, the Part D plan sponsor must inform the... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Grievances, Coverage Determinations...

"Creating hope" and other incentives for drug development for children.

PubMed

Connor, Edward; Cure, Pablo

2011-01-19

Enhancing drug development for pediatric disease is a priority and a public responsibility. The Creating Hope Act of 2010 is important new proposed legislation that adds drugs and biologics for treating rare diseases in children to those for neglected tropical diseases as eligible for a priority review voucher from the U.S. Food and Drug Administration. The Act enhances existing incentive programs through specific financial benefits to companies who seek a pediatric indication for a new drug to treat an orphan disease that occurs specifically in children.

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

PubMed

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

Using a drug facts box to communicate drug benefits and harms: two randomized trials.

PubMed

Schwartz, Lisa M; Woloshin, Steven; Welch, H Gilbert

2009-04-21

Direct-to-consumer prescription drug ads typically fail to provide fundamental information that consumers need to make informed decisions: data on how well the drug works. To see whether providing consumers with a drug facts box-a table quantifying outcomes with and without the drug-improves knowledge and affects judgments about prescription medications. Two randomized, controlled trials conducted between October 2006 and April 2007: a symptom drug box trial using direct-to-consumer ads for a histamine-2 blocker and a proton-pump inhibitor to treat heartburn, and a prevention drug box trial using direct-to-consumer ads for a statin and clopidogrel to prevent cardiovascular events. National sample of U.S. adults identified by random-digit dialing. Adults age 35 to 70 years who completed a mailed survey; the final samples comprised 231 participants with completed surveys in the symptom drug box trial (49% response rate) and 219 in the prevention drug box trial (46% response rate). In both trials, the control group received 2 actual drug ads (including both the front page and brief summary). The drug box group received the same ads, except that the brief summary was replaced by a drug facts box. Choice between drugs (primary outcome of the symptom drug box trial) and accurate perceptions of drug benefits and side effects (primary outcome of the prevention drug box trial). In the symptom drug box trial, 70% of the drug box group and 8% of the control group correctly identified the PPI as being "a lot more effective" than the histamine-2 blocker (P < 0.001), and 80% and 38% correctly recognized that the side effects of the 2 drugs were similar (P < 0.001). When asked what they would do if they had bothersome heartburn and could have either drug for free, 68% of the drug box group and 31% of the control group chose the proton-pump inhibitor, the superior drug (P < 0.001). In the prevention drug box trial, the drug box improved consumers' knowledge of the benefits and side effects of a statin and clopidogrel. For example, 72% of the drug box group and 9% of the control group correctly quantified the benefit (absolute risk reduction) of the statin (P < 0.001). Most of the control participants overestimated this benefit, and 65% did so by a factor of 10 or more. The trials tested drug boxes in only 4 direct-to-consumer ads. If other direct-to-consumer ads were to communicate outcome data better, the effect of the drug box would be reduced. A drug facts box improved U.S. consumers' knowledge of prescription drug benefits and side effects. It resulted in better choices between drugs for current symptoms and corrected the overestimation of benefit in the setting of prevention. National Cancer Institute and Attorney General Consumer and Prescriber Education Program.

78 FR 11939 - Social Security Ruling, SSR 13-2p.; Titles II and XVI: Evaluating Cases Involving Drug Addiction...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... determination or decision. The type and number of CEs we purchase will depend on the claimant's allegations and... decisions relating to the Federal old-age, survivors, disability, supplemental security income, special veterans benefits, and black lung benefits programs. SSRs may be based on determinations or decisions made...

A Cost-Benefit Analysis of the National Guard Youth ChalleNGe Program. Technical Report

ERIC Educational Resources Information Center

Perez-Arce, Francisco; Constant, Louay; Loughran, David S.; Karoly, Lynn A.

2012-01-01

Decades of research show that high school dropouts are more likely than graduates to commit crimes, abuse drugs and alcohol, have children out of wedlock, earn low wages, be unemployed, and suffer from poor health. The ChalleNGe program, currently operating in 27 states, is a residential program coupled with post-residential mentoring that seeks…

42 CFR 423.420 - Solvency standards for non-licensed entities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Organization Compliance with State Law and Preemption by Federal Law § 423.420 Solvency standards for non-licensed...

Behavioral Therapy, Incentives Enhance Addiction Treatment

MedlinePlus

... who are trying to end their addiction to marijuana can benefit from a treatment program that combines motivational incentives with cognitive-behavioral therapy. "Marijuana remains one of the most widely used drugs ...

Controlling prescription drug costs: regulation and the role of interest groups in Medicare and the Veterans Health Administration.

PubMed

Frakt, Austin B; Pizer, Steven D; Hendricks, Ann M

2008-12-01

Medicare and the Veterans Health Administration (VA) both finance large outpatient prescription drug programs, though in very different ways. In the ongoing debate on how to control Medicare spending, some suggest that Medicare should negotiate directly with drug manufacturers, as the VA does. In this article we relate the role of interest groups to policy differences between Medicare and the VA and, in doing so, explain why such a large change to the Medicare drug program is unlikely. We argue that key policy differences are attributable to stable differences in interest group involvement. While this stability makes major changes in Medicare unlikely, it suggests the possibility of leveraging VA drug purchasing to achieve savings in Medicare. This could be done through a VA-administered drug-only benefit for Medicare-enrolled veterans. Such a partnership could incorporate key elements of both programs: capacity to accept large numbers of enrollees (like Medicare) and leverage to negotiate prescription drug prices (like the VA). Moreover, it could be implemented at no cost to the VA while achieving savings for Medicare and beneficiaries.

Managing prescription drug costs: a case study.

PubMed

DuBois, R W; Feinberg, P E

1994-06-01

Pharmacy costs in most private insurance companies and public concerns have risen over the past several years. To address the problem of increased expenditures in its government employee pharmacy program, the State of New York sought bids from outside vendors to help it control pharmaceutical costs. The following is a case study of the tools the state employed in that effort. Over time, both prescription drug coverage and mental health and substance abuse benefits were carved out of the medical plan and are now provided under free-standing programs. In order to participate, an independent pharmacy must accept a discount of 10% off the average wholesale price of brand name drugs and 25% off the average generic price of generic drugs.

Investigating Research Gaps of Pharmaceutical take back Events: An Analysis of take back Program Participants' Socioeconomic, Demographic, and Geographic Characteristics and the Public Health Benefits of take back Programs

NASA Astrophysics Data System (ADS)

Stoddard, K. I.; Hodge, V.; Maxey, G.; Tiwari, C.; Cready, C.; Huggett, D. B.

2017-06-01

Research continues to show that pharmaceutical environmental contamination causes adverse effects to aquatic life. There are also public health risks associated with pharmaceuticals because in-home reserves of medications provide opportunities for accidental poisoning and intentional medication abuse. Pharmaceutical take back programs have been seen as a potential remedy for these issues; however, a thorough review of past programs indicates limited research has been conducted on take back programs. Furthermore, there are significant gaps in take back program research. To address these gaps and ultimately determine if take back programs could improve public health, research was conducted in conjunction with the take back program Denton drug disposal days held in Denton, Texas. Socioeconomic, demographic, and geographic characteristics of Denton drug disposal days participants were investigated using surveys and Geographic Information Systems. Potential impacts of the Denton drug disposal days program on public health were determined by comparing data from Denton drug disposal days events with data supplied by the North Texas Poison Center. Results suggest that Denton drug disposal days events may have prevented accidental poisonings or intentional abuse, however only qualitative comparisons support this statement and there was insufficient empirical evidence to support the conclusion that Denton drug disposal days events were exclusively responsible for public health improvements. An interesting finding was that there was a definitive travel threshold that influenced participation in Denton drug disposal days events. Overall, this study fills some geographic, socioeconomic, and demographic data gaps of take back programs and proposes methods to analyze and improve participation in future take back programs. These methods could also be applied to improve participation in other local environmentally-focused programs such as household hazardous collection events.

Investigating Research Gaps of Pharmaceutical take back Events: An Analysis of take back Program Participants' Socioeconomic, Demographic, and Geographic Characteristics and the Public Health Benefits of take back Programs.

PubMed

Stoddard, K I; Hodge, V; Maxey, G; Tiwari, C; Cready, C; Huggett, D B

2017-06-01

Research continues to show that pharmaceutical environmental contamination causes adverse effects to aquatic life. There are also public health risks associated with pharmaceuticals because in-home reserves of medications provide opportunities for accidental poisoning and intentional medication abuse. Pharmaceutical take back programs have been seen as a potential remedy for these issues; however, a thorough review of past programs indicates limited research has been conducted on take back programs. Furthermore, there are significant gaps in take back program research. To address these gaps and ultimately determine if take back programs could improve public health, research was conducted in conjunction with the take back program Denton drug disposal days held in Denton, Texas. Socioeconomic, demographic, and geographic characteristics of Denton drug disposal days participants were investigated using surveys and Geographic Information Systems. Potential impacts of the Denton drug disposal days program on public health were determined by comparing data from Denton drug disposal days events with data supplied by the North Texas Poison Center. Results suggest that Denton drug disposal days events may have prevented accidental poisonings or intentional abuse, however only qualitative comparisons support this statement and there was insufficient empirical evidence to support the conclusion that Denton drug disposal days events were exclusively responsible for public health improvements. An interesting finding was that there was a definitive travel threshold that influenced participation in Denton drug disposal days events. Overall, this study fills some geographic, socioeconomic, and demographic data gaps of take back programs and proposes methods to analyze and improve participation in future take back programs. These methods could also be applied to improve participation in other local environmentally-focused programs such as household hazardous collection events.

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

PubMed Central

Lovett, Annesha

2013-01-01

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

Perceptions of practicing pharmacists in Idaho about a potential behind-the-counter drug program.

PubMed

Hunt, Timothy L; Culbertson, Vaughn L; Erramouspe, John; Casperson, Kerry

2010-09-01

In late 2007, the Food and Drug Administration (FDA) held public hearings exploring the establishment of a new behind-the-counter (BTC) drug program. However, little is known about the views of pharmacists regarding such a program. To assess the overall perceptions of Idaho's practicing pharmacists about the creation of a formal BTC drug program, the appropriateness of including certain drug categories, specific barriers to its adoption, and the impact of the new program on access to medicines. A survey of practicing pharmacists in Idaho was conducted by mail, utilizing anonymous responses. Key questions exploring the views of pharmacists about the new BTC drug program utilized 5-point Likert scales. Data were also collected on respondent characteristics. A total of 357 practicing pharmacists in Idaho (31% response rate) returned the mail survey; 84% of pharmacists agreed that the FDA should be exploring an expanded BTC program, and 88% of pharmacists agreed that this program would improve access to some prescription-only products and convenience for patients. Almost 71% of pharmacists reported a personal willingness to both initiate and monitor certain BTC drug therapies. When focusing on specific drug categories for BTC status, the highest support was for selected agents within smoking cessation therapies (85%), nasal corticosteroids for allergies (81%), and vaccines (75%). Pharmacists who reported low barriers to the adoption of a new BTC program were significantly more likely to support this program than were those reporting high barriers. Only 39% of pharmacists agreed that adequate facilities were currently available for private evaluation and counseling of BTC patients. Pharmacists in a statewide survey of perceptions regarding a new BTC drug program overwhelmingly believe that patients would benefit. Pharmacists strongly support the development of the new program, and more than two thirds indicate that they would likely participate, given the necessary supporting institutional framework. Perceived barriers are related to willingness to participate and likely can be minimized through education and provision of private consulting areas.

Physicians' views of formularies: implications for Medicare drug benefit design.

PubMed

Landon, Bruce E; Reschovsky, James D; Blumenthal, David

2004-01-01

As Congress considers introducing a drug benefit for Medicare, it will more than likely adopt a program that uses a formulary. We examined data from the Community Tracking Study Physicians Survey, a large, nationally representative study of physicians, to learn about physicians' views of formularies. Our results suggest that several aspects of formularies are associated with physicians' positive views about them. Policymakers should consider imposing limits on the number of competing Medicare formularies operating in a particular area, promoting the adoption and use of information technology, and incorporating financial incentives for physicians to adhere to formularies.

Preventing adolescent drug use: long-term results of a junior high program.

PubMed Central

Ellickson, P L; Bell, R M; McGuigan, K

1993-01-01

OBJECTIVES. Although several studies have reported short-term gains for drug-use prevention programs targeted at young adolescents, few have assessed the long-term effects of such programs. Such information is essential for judging how long prevention benefits last. This paper reports results over a 6-year period for a multisite randomized trial that achieved reductions in drug use during the junior high school years. METHODS. The 11-lesson curriculum, which was tested in 30 schools in eight highly diverse West Coast communities, focused on helping 7th and 8th grade students develop the motivation and skills to resist drugs. Schools were randomly assigned to treatment and control conditions. About 4000 students were assessed in grade 7 and six times thereafter through grade 12. Program effects were adjusted for pretest covariates and school effects. RESULTS. Once the lessons stopped, the program's effects on drug use stopped. Effects on cognitive risk factors persisted for a longer time (many through grade 10), but were not sufficient to produce corresponding reductions in use. CONCLUSIONS. It is unlikely that early prevention gains can be maintained without additional prevention efforts during high school. Future research is needed to develop and test such efforts. PMID:8498624

42 CFR 423.590 - Timeframes and responsibility for making redeterminations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT... redetermination must be made by a physician with expertise in the field of medicine that is appropriate for the...

42 CFR 423.425 - Licensure does not substitute for or constitute certification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Organization Compliance with State Law and Preemption by Federal Law § 423.425 Licensure does not substitute...

Evaluating component effects of a prison-based treatment continuum.

PubMed

Butzin, Clifford A; Martin, Steven S; Inciardi, James A

2002-03-01

A continuum of correctional-based therapeutic community (TC) treatment programs for drug-involved offenders has been functioning for several years in Delaware. Previous evaluations have shown the efficacy of the full continuum for up to three years posttreatment, though there has been some question of the benefits of treatment within prison. The particular focus here is on the relative impact of the within-prison, transitional, and aftercare treatment components upon criminal recidivism and relapse to illicit drug use. The relative benefit of participation in each component is supported, over and above the effects of differences in demographics and histories of criminal behavior and illicit substance use. However, the residential transitional program effects are generally larger and more long lasting. Additionally, the two outcomes appear differentially sensitive to the degree of completion of the continuum. Copyright 2002 Elsevier Science Inc.

The Federal Employees Health Benefits Program: A Model for Competition in Rural America?

ERIC Educational Resources Information Center

Mueller, Keith J.; McBride, Timothy D.; Andrews, Courtney; Fraser, Roslyn; Xu, Liyan

2005-01-01

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) created the Medicare Advantage (MA) program, which promotes the entry of private Preferred Provider Organization (PPO) plans into regions that have not previously had Medicare managed care plans. The assumption that a competitive environment will develop is based on…

The perspectives of structurally vulnerable people who use drugs on volunteer stipends and work experiences provided through a drug user organization: Opportunities and limitations.

PubMed

Bardwell, Geoff; Anderson, Solanna; Richardson, Lindsey; Bird, Lorna; Lampkin, Hugh; Small, Will; McNeil, Ryan

2018-03-01

While drug user organizations (DUO) have received public health attention as a means to potentially reduce the harms associated with drug use, there is a lack of research on the compensation and structural forces that promote or inhibit participation in DUO. Against the backdrop of structural vulnerability experienced by people who use drugs (PWUD), we examined the impact of monetary 'volunteer stipends' provided through a DUO and explore their role in providing low-threshold employment opportunities and shaping participation in DUO. Participants were purposively sampled to reflect a range of perspectives and experiences volunteering at Vancouver Area Network of Drug Users (VANDU) and receiving stipends. Semi-structured qualitative interviews were conducted with 23 members of VANDU. Interview transcripts were coded in Atlas.ti 7 for key a priori themes and emergent categories from the data and analyzed thematically. Stipends provided participants with symbolic and material recognition of the time, effort, and expertise they contribute to the organization, and functioned to facilitate ongoing participation. Payments that rewarded, skills, labour and drug-related knowledge reduced participant's perception of stigma against PWUD. Paid work in VANDU further provided participants with non-material benefits commonly attributed to regular employment, including social connections and a sense of purpose. Participants also identified the low level of pay as a limitation of VANDU's paid participation program. The daily demands of survival (accessing shelter, food, and drugs) posed more complex structural vulnerabilities to participate in VANDU, as small stipends were not sufficient to address these needs. Low threshold employment opportunities within DUO may provide significant individual and public health benefits. However, these benefits are constrained by the small size of stipends. Therefore, to ensure better inclusion of PWUD, our findings recommend the development and expansion of equitable, accessible, well-paying employment programs for PWUD. Copyright © 2018 Elsevier B.V. All rights reserved.

How Management Information Systems Can Enhance the Air Force Drug Testing Program

DTIC Science & Technology

1989-12-01

promising processes to positively identify potential system users (46:401). Scope This study will cover issues concerning the Air Force drug testing...7 Scope....................10 Limitations of the Research . . . 10 Investigative Questions ............ 10 Expected Benefits of the Study . . . . 11...Resource Allocation. ....... 41 M1.>ethodology....................44 The Historical Research Method . . .. 44 The Historical Research Method for this Study

A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multicriteria decision analysis model in the development of combination therapy for overactive bladder.

PubMed

de Greef-van der Sandt, I; Newgreen, D; Schaddelee, M; Dorrepaal, C; Martina, R; Ridder, A; van Maanen, R

2016-04-01

A multicriteria decision analysis (MCDA) approach was developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of overactive bladder (OAB). The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. The MCDA model was developed using efficacy, safety, and tolerability attributes and the results of a phase II factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5+25 and 5+50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for phase III clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. © 2015 The American Society for Clinical Pharmacology and Therapeutics.

Drug-usage evaluation and the patient-care pharmacist: a synergistic combination.

PubMed

Gayman, J; Tapley, D J

1991-07-01

The Joint Commission requires a continuous monitoring program to assure quality pharmaceutical care. The only way to achieve compliance with this standard is to enlist the help of the patient-care pharmacists. Equally important to the pharmacy manager is the way a DUE program can benefit the patient-care pharmacists. The key to an effective program is to assist the patient-care pharmacists in taking responsibility for the quality of drug therapy provided to their patients. Through education, encouragement, and recognition, the DUE Coordinator can elevate the practice of the patient-care pharmacists. The outcome is a synergistic program that enriches the practice of the patient-care pharmacists who, in turn, enrich the quality of pharmaceutical care received by their patients.

The Effect of Drug Treatment on Inmate Misconduct in Federal Prisons.

ERIC Educational Resources Information Center

Langan, Neal P.; Pelissier, Bernadette M. M.

2001-01-01

Evaluates the Federal Bureau of Prisons' substance abuse treatment program's effectiveness in reducing prisoner misconduct. Results show that program graduates are 74 percent less likely to engage in misconduct over a 14-month period than a comparison group. This benefit is shared by male and female inmates alike. (Contains 25 references and 2…

Medicare Part D Enrollment in a Biracial Community-Based Population of Older Adults

ERIC Educational Resources Information Center

Skarupski, Kimberly A.; Mendes de Leon, Carlos F.; Barnes, Lisa L.; Evans, Denis A.

2009-01-01

Purpose: The Medicare Prescription Drug Benefit (Part D) program debuted in January 2006. We ascertained the sociodemographic and health characteristics of Blacks and Whites who enrolled in the early stages of the program. Design and Methods: Data were collected between April 2006 and October 2007 from an ongoing population-based biracial study of…

77 FR 1877 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

... theories under which we might have such authority. Also in the January 12, 2009 Federal Register, we..., and our final rule with comment period set forth three theories under which we might have such authority. These legal theories are described in detail in our January 12, 2009 final rule with comment...

20 CFR 418.3610 - Is there administrative or judicial review for administrative actions that are not initial...

Code of Federal Regulations, 2010 CFR

2010-04-01

...' Benefits SOCIAL SECURITY ADMINISTRATION MEDICARE SUBSIDIES Medicare Part D Subsidies Determinations and the... these sections. For example, changes in your prescription drug program or voluntary disenrollment in the...

The role of media and communication in improving the use of drugs and other technologies.

PubMed

Sitthi-amorn, C; Ngamvithayapongse, J

1998-01-01

Policy makers, health care providers, and the general public need valid information about the benefits and harmful effects of drugs and technologies to be able to make rational choices in their acquisition, distribution, and use. Effective communication is important for quality choices of drugs and other technologies. In effective communication, the choice of messages and media must correspond to the culture and beliefs of the target groups to make them comprehend and adopt the conclusions. Messages must be presented on a regular basis. Most regulatory agencies do not have enough resources to mount effective communication programs. Private advertising agencies and other stakeholders have definite roles. Valid knowledge must be the basis of dialogues to reduce emotional disputes among various benefit groups in society.

Benefits and challenges of a QSP approach through case study: Evaluation of a hypothetical GLP-1/GIP dual agonist therapy.

PubMed

Rieger, Theodore R; Musante, Cynthia J

2016-10-30

Quantitative Systems Pharmacology (QSP) is an emerging science with increasing application to pharmaceutical research and development paradigms. Through case study we provide an overview of the benefits and challenges of applying QSP approaches to inform program decisions in the early stages of drug discovery and development. Specifically, we describe the use of a type 2 diabetes systems model to inform a No-Go decision prior to lead development for a potential GLP-1/GIP dual agonist program, enabling prioritization of exploratory programs with higher probability of clinical success. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

PubMed Central

Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

2014-01-01

Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

Approaches to pharmacy benefit management and the impact of consumer cost sharing.

PubMed

Olson, Bridget M

2003-01-01

Numerous mechanisms have been introduced to deliver prescription drug benefits while controlling pharmaceutical costs. An understanding of the most prominent mechanisms of benefit management is an important step in determining the most effective approach to take in future years. The aims of this review were to illustrate the mechanisms by which managed care has attempted to efficiently and equitably deliver pharmacy benefits and to discuss the impact of such programs, including consumer cost sharing. A review of the literature was conducted using the PreMedline and MEDLINE databases from the years 1966 to 2002, reference lists from relevant articles, and online sources, including news releases, conference materials, and pharmacy benefit management reports. Numerous pharmacy benefit management tools and their impact on utilization, expenditures, and health outcomes are reviewed, including disease state management; utilization management (ie, quantity limitations and prior authorization); drug utilization review; formulary management (ie, open and closed); delivery systems (ie, retail and mail order); and mechanisms for implementing consumer cost sharing (ie, generic incentives, multitiered copayments, and co-insurance). Although there is some evidence to suggest that certain benefit management tools have been successful in reducing health plan expenditures, a more thorough investigation of their potential unintended consequences is needed. Implementing adequate levels of consumer cost sharing is necessary if employers and health plans are to continue offering prescription drug benefits. It is important to remember, however, that quality health care cannot be forfeited for the sake of short-term cost savings.

49 CFR 40.365 - What is the Department's policy concerning starting a PIE proceeding?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.365... constitutes a conflict of interest under this part (e.g., a laboratory that derives a financial benefit from...

42 CFR 423.2260 - Definitions concerning marketing materials.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D..., physicians or other providers). (v) Membership communication materials such as membership rules, subscriber... communications materials, meaning informational materials that— (i) Are targeted to current enrollees; (ii) Are...

42 CFR 423.566 - Coverage determinations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 3 2014-10-01 2014-10-01 false Coverage determinations. 423.566 Section 423.566... (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Grievances, Coverage Determinations, Redeterminations, and Reconsiderations § 423.566 Coverage determinations. (a) Responsibilities of...

Effectiveness of needle/syringe exchange program in Tbilisi.

PubMed

Otiashvili, D; Gambashidze, N; Kapanadze, E; Lomidze, G; Usharidze, D

2006-11-01

IDUs are under the high risk of HIV and other blood born diseases. In Georgia injecting drug use is associated with two third of registered HIV/AIDS cases. Majority of them are also infected with B and C Hepatitis. One of the main components of HIV/AIDS prevention among drug users is considered to be harm reduction programs, among them syringe exchange program. We conducted observational cohort study and performed interviewing participants of syringe exchange program using structured questionnaire. The interviewing was conducted at intake, after 3 months and at the end of the program. During interviewing we used risk assessment questionnaire which we have little adapted (Risk Assessment Battery, Navaline, et al, 1994). The data were statistically analysed using SPPS-11, 5 program. The aim of the study was to assess the efficacy of outreach and needle exchange programs in terms of reduction of HIV risk behavior of injection drug users in Tbilisi. The results of the study show visible reduction in injection risk behavior for clients being in the program for at least three months. There was not seen any significant change in the level of sexual risk behavior, which might suggest the need for targeting this behavior during the further interventions. The results of the study suggest a visible potential benefit to drug users and communities that could be gained through the wide scale implementation of harm reduction programs in Georgia.

Pharmaceutical Advertising and Medicare Part D

PubMed Central

Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

2013-01-01

We explore how and to what extent prescription drug insurance expansions affects incentives for pharmaceutical advertising. When insurance expansions make markets more profitable, firms respond by boosting advertising. Theory suggests this effect will be magnified in the least competitive drug classes, where firms internalize a larger share of the benefits from advertising. Empirically, we find that the implementation of Part D coincides with a 14% to 19% increase in total advertising expenditures. This effect is indeed concentrated in the least competitive drug classes. The additional advertising raised utilization among non-elderly patients outside the Part D program by about 3.6%. This is roughly half of the direct utilization effect of Part D on elderly beneficiaries. The results suggest the presence of considerable spillover effects from publicly subsidized prescription drug insurance on the utilization and welfare of consumers outside the program. PMID:24308884

Pharmaceuticals in Australia: priorities in a teaching hospital.

PubMed

Kearney, B J

1993-01-01

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

Scotland's national naloxone program: The prison experience.

PubMed

Horsburgh, Kirsten; McAuley, Andrew

2018-05-01

Launched in 2011, the Scottish national naloxone program marked an important development in public health policy. Central to its design were strategies to engage prisoners given their elevated risk of drug-related death in the weeks following liberation. Implementation across Scottish prisons has posed particular challenges linked to both operational issues within prison establishments and individual factors affecting staff delivering, and prisoners engaging, with the program. Barriers have been overcome through innovation and partnership working. This commentary has described how the development of the program in prisons has adapted to these challenges to a point where a largely consistent model is in place and where prisoners-on-release are reaping the benefits in terms of reduced opioid-related mortality. © 2017 Australasian Professional Society on Alcohol and other Drugs.

Drug Use among Seniors on Public Drug Programs in Canada, 2012.

PubMed

Proulx, Jeff; Hunt, Jordan

2015-01-01

Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. Although taking multiple medications may be necessary to manage these conditions, it is important to consider the benefits and risks of each medication and the therapeutic goals of the patient. This article provides an in-depth look at the number and types of drugs used by seniors using drug claims data from the CIHI's National Prescription Drug Utilization Information System Database, representing approximately 70% of seniors in Canada. In 2012, almost two-thirds (65.9%) of seniors on public drug programs had claims for five or more drug classes, while 27.2% had claims for 10 or more, and 8.6% had claims for 15 or more. The most commonly used drug class was statins, used by nearly half (46.6%) of seniors. Nearly two-thirds (60.9%) of seniors living in long-term care (LTC) facilities had claims for 10 or more drug classes. Proton pump inhibitors were the most commonly used drug class among seniors living in LTC facilities (used by 37.0% of seniors in LTC facilities), while statins ranked seventh (29.8%).

Addiction Treatment in America: After Money or Aftercare?

PubMed

Miller, David; Miller, Merlene; Blum, Kenneth; Badgaiyan, Rajendra D; Febo, Marcelo

2015-10-21

There are approximately 14,500 clinics and programs in America that provide treatment for all types of addictive behaviors we call "Reward Deficiency Syndrome (RDS)". While most of these have good intentions to provide needed help to the victims of RDS, we propose herein that most of their efforts, especially during periods of aftercare, are not based on the existing scientific evidence. We use "aftercare" to refer to any form of program or therapy following primary treatment including 12-Step programs. Very few programs actually provide any evidenced-based treatment approaches during this most vulnerable period in recovery. In this trieste we are suggesting that a hypodopaminergic trait (genetic) and/or state (epigenetic) is critical in terms of continued motivation to use/abuse of alcohol or other drugs and can lead to relapse. While there is evidence for the approved FDA drugs to treat drug addiction (e.g. alcohol, opiates, nicotine) these drugs favor a short-term benefit by blocking dopamine. We argue instead for the utilization of long-term benefits that induce "dopamine homeostasis", or in simpler terms "normalcy". We suggest that this could be accomplished through a number of holistic modalities including, but not limited to, dopamine-boosting diets, hyper-oxygenation, heavy metal detoxification, exercise, meditation, yoga, and most importantly, brain neurotransmitter balancing with nutraceuticals such as KB220 variants. We embrace 12-step programs and fellowships but not as a stand-alone modality, especially during aftercare. We also provide some scientific basis for why resting state functional connectivity (rsfMRI) is so important and may be the cornerstone in terms of how to treat RDS. We postulate that since drugs, food, smoking, gambling, and even compulsive sexual behavior could reduce rsfMRI then modalities (following required research), that can restore this impaired cross talk between various brain regions (e.g. Nucleus accumbens, cingulate gyrus, hippocampus etc.) should be incorporated into the aftercare plan in all treatment programs in America. Anything less will ultimately lead to the so called "revolving door" for as many as 90% of treatment participants.

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Scope. 423.150 Section 423.150 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements...

42 CFR 423.168 - Accreditation organizations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Accreditation organizations. 423.168 Section 423.168 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality...

Prescription copay reduction program for diabetic employees: impact on medication compliance and healthcare costs and utilization.

PubMed

Nair, Kavita V; Miller, Kerri; Saseen, Joseph; Wolfe, Pamela; Allen, Richard Read; Park, Jinhee

2009-01-01

To examine the impact of a value-based benefit design on utilization and expenditures. This benefit design involved all diabetes-related drugs and testing supplies placed on the lowest copay tier for 1 employer group. The sample of diabetic members were enrolled from a 9-month preperiod and for 2 years after the benefit design was implemented. Measured outcomes included prescription drug utilization for diabetes and medical utilization. Generalized measures were used to estimate differences between years 1 and 2 and the preperiod adjusting for age, gender, and comorbidity risk. Diabetes prescription drug use increased by 9.5% in year 1 and by 5.5% in year 2, and mean adherence increased by 7% to 8% in year 1 and fell slightly in year 2 compared with the preperiod. Pharmacy expenditures increased by 47% and 53% and expenditures for diabetes services increased by 16% and 32% in years 1 and 2, respectively. Increases in adherence and use of diabetes medications were observed. There were no compensatory cost-savings for the employer through lower utilization of medical expenditures in the first 2 years. Adherent patients had fewer emergency department visits than nonadherent patients after the implementation of this benefit design.

How do drug users define their progress in harm reduction programs? Qualitative research to develop user-generated outcomes

PubMed Central

Ruefli, Terry; Rogers, Susan J

2004-01-01

Background Harm reduction is a relatively new and controversial model for treating drug users, with little formal research on its operation and effectiveness. In order to advance the study of harm reduction programs and our understanding of how drug users define their progress, qualitative research was conducted to develop outcomes of harm reduction programming that are culturally relevant, incremental, (i.e., capable of measuring change), and hierarchical (i.e., capable of showing how clients improve over time). Methods The study used nominal group technique (NGT) to develop the outcomes (phase 1) and focus group interviews to help validate the findings (phase 2). Study participants were recruited from a large harm-reduction program in New York City and involved approximately 120 clients in 10 groups in phase 1 and 120 clients in 10 focus groups in phase 2. Results Outcomes of 10 life areas important to drug users were developed that included between 10 to 15 incremental measures per outcome. The outcomes included ways of 1) making money; 2) getting something good to eat; 3) being housed/homeless; 4) relating to families; 5) getting needed programs/benefits/services; 6) handling health problems; 7) handling negative emotions; 8) handling legal problems; 9) improving oneself; and 10) handling drug-use problems. Findings also provided insights into drug users' lives and values, as well as a window into understanding how this population envisions a better quality of life. Results challenged traditional ways of measuring drug users based solely on quantity used and frequency of use. They suggest that more appropriate measures are based on the extent to which drug users organize their lives around drug use and how much drug use is integrated into their lives and negatively impacts other aspects of their lives. Conclusions Harm reduction and other programs serving active drug users and other marginalized people should not rely on institutionalized, provider-defined solutions to problems in living faced by their clients. PMID:15333130

Medicare part D data: major changes on the horizon.

PubMed

Greenwald, Leslie M

2007-10-01

The 3 primary administrative data sets developed by the Centers for Medicare and Medicaid services (CMS) to support the Medicare Part D program implementation represent a valuable source of data for health services researchers. This paper describes the structure of the Medicare Part D program and the related databases, and discusses their utilization for research purposes. The Medicare Part D administrative data include information on plan benefits (integrated into the Health Plan Management System), beneficiary enrollment files, and prescription drug event (PDE) claims-type data. The enrollment data may be of use in investigating the benefits and plan types that appeal to beneficiaries, but their application is limited by the fact that, although individual beneficiaries' enrollment choices are recorded, only summary enrollment data are currently publicly available. PDE data are likely to be of most interest to researchers as they are detailed (including beneficiary identifiers, contract identifiers pharmacy provider information on drugs provided, drug cost, and insurance status), beneficiary-specific (allowing them to be linked to beneficiary characteristics), and an unusual output for a program reimbursed under a capitation-based system. Because PDE data are highly sensitive, only summary data on the number of Part D prescriptions filled are publicly available. Although the data collected in relation to the Medicare Part D program could be applied to many questions of interest to health services researchers, their utility is limited by the sensitive natures of many of these data, making it difficult currently to obtain access for research purposes.

Effectiveness and benefit-cost of peer-based workplace substance abuse prevention coupled with random testing.

PubMed

Miller, Ted R; Zaloshnja, Eduard; Spicer, Rebecca S

2007-05-01

Few studies have evaluated the impact of workplace substance abuse prevention programs on occupational injury, despite this being a justification for these programs. This paper estimates the effectiveness and benefit-cost ratio of a peer-based substance abuse prevention program at a U.S. transportation company, implemented in phases from 1988 to 1990. The program focuses on changing workplace attitudes toward on-the-job substance use in addition to training workers to recognize and intervene with coworkers who have a problem. The program was strengthened by federally mandated random drug and alcohol testing (implemented, respectively, in 1990 and 1994). With time-series analysis, we analyzed the association of monthly injury rates and costs with phased program implementation, controlling for industry injury trend. The combination of the peer-based program and testing was associated with an approximate one-third reduction in injury rate, avoiding an estimated $48 million in employer costs in 1999. That year, the peer-based program cost the company $35 and testing cost another $35 per employee. The program avoided an estimated $1850 in employer injury costs per employee in 1999, corresponding to a benefit-cost ratio of 26:1. The findings suggest that peer-based programs buttressed by random testing can be cost-effective in the workplace.

Injection drug users’ involvement in drug dealing in the downtown eastside of Vancouver: Social organization and systemic violence

PubMed Central

Small, Will; Maher, Lisa; Lawlor, Jeff; Wood, Evan; Shannon, Kate; Kerr, Thomas

2014-01-01

Background Illicit drug markets are a key component of the risk environment surrounding injection drug use. However, relatively few studies have explored how injection drug users’ (IDUs) involvement in drug dealing shapes their experiences of drug market-related harm. This exploratory qualitative study aims to understand IDUs’ dealing activities and roles, as well as the perceived benefits and risks related to participation in illicit drug markets, including experiences of drug market violence. Methods Ten IDUs with extensive involvement in drug dealing activities were recruited from the Vancouver Injection Drug User Study (VIDUS) and participated in semi-structured qualitative interviews, which elicited discussion of experiences dealing drugs, perceived benefits and hazards related to dealing, and understandings of drug market violence. Results Participant's involvement in drug market activities included corporate sales, freelance or independent sales, and opportunistic sales termed “middling” as well as drug market-related hustles entailing selling bogus drugs and robbing dealers. Participants primarily dealt drugs to support their own illicit drug use, and we found that arrest and criminal justice involvement, hazards stemming from drug debts, and drug market-related violence were key risks related to dealing activities. Conclusion The challenges of managing personal consumption while selling drugs exacerbates the hazards associated with drug dealing. Efforts to address drug dealing among IDUs should consider both drug dependency and the material conditions that propel drug users towards dealing activities. Interventions should explore the potential of combining enhanced drug treatment programs with low threshold employment and alternative income generation opportunities. PMID:23664788

Modernizing Medicare's Benefit Design and Low-Income Subsidies to Ensure Access and Affordability.

PubMed

Schoen, Cathy; Davis, Karen; Buttorff, Christine; Andersen, Martin

2015-07-01

Insurance coverage through the traditional Medicare program is complex, fragmented, and incomplete. Beneficiaries must purchase supplemental private insurance to fill in the gaps. While impoverished beneficiaries may receive supplemental coverage through Medicaid and subsidies for prescription drugs, help is limited for people with incomes above the poverty level. This patchwork quilt leads to confusion for beneficiaries and high administrative costs, while also undermining coverage and care coordination. Most important, Medicare's benefits fail to limit out-of-pocket costs or ensure adequate financial protection, especially for beneficiaries with low incomes and serious health problems. This brief, part of a series about Medicare's past, present, and future, presents options for an integrated benefit for enrollees in traditional Medicare. The new benefit would not only reduce cost burdens but also could potentially strengthen the Medicare program and enhance its role in stimulating and supporting innovations throughout the health care delivery system.

Prescription opioid use, illicit drug use, and sexually transmitted infections among participants from a community engagement program in North Central Florida

PubMed Central

Acheampong, Abenaa B.; Striley, Catherine W.; Cottler, Linda B.

2017-01-01

Introduction The purpose of this analysis was to determine the intersection between prescription opioid use, illicit drug use and STIs amongst Alachua County participants. Methods Cross-sectional data come from 2,194 Alachua County community members interviewed by Community Health Workers (CHWs) from HealthStreet, a community engagement program of the University of Florida. Demographic characteristics, health risk factors and health conditions were obtained. Results Among participants, 9.3% reported ever having an STI, 40% reported lifetime use of prescription opioids, and 53% reported ever using an illicit drug. Persons who reported using an illicit drug or an illicit drug plus prescription were 2.89 and 4.12 times as likely to report one or more STIs respectively, compared to those who never used these drugs. Prescription opioid use alone was not statistically related to STIs though female gender (AOR 3.75), lower education (AOR 1.45) and food insecurity (AOR 1.52) were. Discussion Those who report a history illicit drug use with or without prescription opioid use are at increased risk for STIs and could benefit from prevention programs. Those with factors that are proxies for other disparities (lower education, food insecurity) are especially important targets for intervention among women. PMID:29515331

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

PubMed

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

2012-07-15

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

42 CFR 423.1006 - Appeal rights.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 3 2013-10-01 2013-10-01 false Appeal rights. 423.1006 Section 423.1006 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.1006 - Appeal rights.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 3 2014-10-01 2014-10-01 false Appeal rights. 423.1006 Section 423.1006 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.1006 - Appeal rights.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Appeal rights. 423.1006 Section 423.1006 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money Penalties...

42 CFR 423.1006 - Appeal rights.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Appeal rights. 423.1006 Section 423.1006 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money Penalties...

42 CFR 423.1006 - Appeal rights.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 3 2012-10-01 2012-10-01 false Appeal rights. 423.1006 Section 423.1006 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.156 - Consumer satisfaction surveys.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Consumer satisfaction surveys. 423.156 Section 423.156 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality...

42 CFR 423.162 - Quality improvement organization activities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Quality improvement organization activities. 423.162 Section 423.162 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control...

42 CFR 423.774 - Eligibility determinations, redeterminations, and applications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Eligibility determinations, redeterminations, and applications. 423.774 Section 423.774 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... information may include but are not limited to: (A) Medical and pharmaceutical textbooks and reference books... Book) published by the Food and Drug Administration, or any successor to such reference. Generics are...) Cross-sectional or retrospective economic evaluations; (F) Pharmacoeconomic models; (G) Patent...

A critical review of accounting and economic methods for estimating the costs of addiction treatment.

PubMed

Cartwright, William S

2008-04-01

Researchers have been at the forefront of applying new costing methods to drug abuse treatment programs and innovations. The motivation for such work has been to improve costing accuracy. Recent work has seen applications initiated in establishing charts of account and cost accounting for service delivery. As a result, researchers now have available five methods to apply to the costing of drug abuse treatment programs. In all areas of costing, there is room for more research on costing concepts and measurement applications. Additional work would be useful in establishing studies with activity-based costing for both research and managerial purposes. Studies of economies of scope are particularly relevant because of the integration of social services and criminal justice in drug abuse treatment. In the long run, managerial initiatives to improve the administration and quality of drug abuse treatment will benefit directly from research with new information on costing techniques.

Pharmaceutical advertising and Medicare Part D.

PubMed

Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

2013-12-01

We explore how and to what extent prescription drug insurance expansions affect incentives for pharmaceutical advertising. When insurance expansions make markets more profitable, firms respond by boosting advertising. Theory suggests this effect will be magnified in the least competitive drug classes, where firms internalize a larger share of the benefits from advertising. Empirically, we find that the implementation of Part D coincides with a 14-19% increase in total advertising expenditures. This effect is indeed concentrated in the least competitive drug classes. The additional advertising raised utilization among non-elderly patients outside the Part D program by about 3.6%. This is roughly half of the direct utilization effect of Part D on elderly beneficiaries. The results suggest the presence of considerable spillover effects from publicly subsidized prescription drug insurance on the utilization and welfare of consumers outside the program. Copyright © 2013 Elsevier B.V. All rights reserved.

Benefits and Limits of Abuse-Deterrent Painkillers.

PubMed

Hendrikson, Hollie; Hanson, Karmen

2016-02-01

Abuse of opioid prescription products, meant to reduce pain, has been making headlines in recent years as a growing problem not only in rural and urban areas, but also across population groups. Policymakers looking for effective ways to reduce such abuse are employing various strategies, including setting up prescription drug monitoring programs. Another approach gaining attention involves encouraging or requiring the use of prescription drug formulas that can help deter abuse of opioid painkiller products.

Development of Applications about Hazards and Preventions of Drug Based On Android

NASA Astrophysics Data System (ADS)

Hartatik; Febriyanto, F.; Munawaroh, H.

2018-03-01

The number of drug abuse was increase among the younger generation, it caused younger generation fall into drug abuse, and it will lead to physical and mental damage. The lack of knowledge of drugs danger is one of the most potential problems, so in this study we made an application about the types, dangers, and how to avoid its abusement. The application built using PHP programming language with codeiniter framework on admin part, while the parsing data between mobile application server using Javascript Object Notation (JSON). This application has been tested and 85% respondents stated that this application provides positive benefits especially for the socialization of drug abuse.

[Therapeutic benefit of a registered psychoeducation program on treatment adherence, objective and subjective quality of life: French pilot study for schizophrenia].

PubMed

Sauvanaud, F; Kebir, O; Vlasie, M; Doste, V; Amado, I; Krebs, M-O

2017-05-01

In schizophrenic disorders, supportive psychosocial therapies have been used as adjuncts to pharmacotherapy to help alleviate residual symptoms and to improve social functioning and quality of life. Among these therapies, psychoeducational therapies showed a significant efficacy on improving drug adherence and on reducing relapses. However, according to the French Health Agency, fewer than 10% of psychiatric structures in France offer registered psychoeducation programs. Caregiver apprehension of patients' depressive reactions to the awareness of the disease could underlie the underuse of psychoeducation therapies. Indeed, the psychoeducation programs' impact on objective and subjective quality of life is discussed among the literature. In this context, we conducted a retrospective, monocentric, open-labelled and non-controlled pilot study to measure the impact of a registered psychoeducation program on objective and subjective quality of life of patients suffering from schizophrenia. Secondary objectives included measures of the effects on drug observance and awareness of the disease. We included stabilized patients over the age of eighteen suffering from schizophrenia. Referent psychiatrics were asked to inform the patient of the diagnosis and to prescribe psychoeducation therapy. From 2011 to 2014, we offered three ambulatory programs, each program including fifteen two-hour group sessions. The groups were opened for three to six patients and managed by two caregivers. Themes discussed during the sessions included: schizophrenic disease, treatments, relationships to family, diet, social issues, toxics, relaxation. Objective and subjective quality of life were evaluated one month before and one month after the program using respectively the global assessment functioning (GAF) and the subjective quality of life (SQoL) scales. The Medical Adherence Rating Scale (MARS) and the French IQ8 scale evaluated respectively drug adherence and awareness of the disease. All patients gave their written consent for the study. Based on medical records and scales, we compared data before and after the program using the Wilcoxon test, adapted for small samples. Fourteen patients, with a mean age of 37.6 years, were included. All patients had a chronic antipsychotic treatment and four benefitted from a bitherapy with a mood stabilizer. The mean length of disease was 15.3 years, with a mean number of 3.4 hospitalizations before inclusion. The participation rate was nearly twelve sessions out of fifteen. Mean GAF score before the program was 48/100. After the program, mean GAF score was significantly increased to 54/100 (P=0.008). As to SQoL score, we found a significant difference of the sub item psychological well-being from 3.2/5 before the program to 3.8/5 after the program (P=0.03). Global SQoL score and other sub items (self-esteem, resilience, and physical well-being) showed a slight but not significant improvement. The sub items family relationships and sentimental life were diminished, non-significantly. Concerning the drug adherence, the mean MARS score was significantly increased from 6.1 to 6.4/8 (P=0.03). Comparison of the insight IQ8 scale showed a slight but non-significant increase. When asked to note the program, patients were globally very satisfied, with a mean rate of 8.6/10. Of fourteen patients, one needed to be hospitalized three years after program. This retrospective study on a small sample of patients suffering from schizophrenic disorder pointed out a significant improvement on drug adherence, objective quality of life and psychological well-being, after an eight-month registered program of psychoeducational therapy. These results are in line with a recent report from the Cochrane group who reported a significant raise of GAF associated with psychoeducational therapies. The literature data for subjective quality of life are more contradictory. Despite the small sample and evaluation means that need to be corrected in further studies, we reproduced the results described in the literature regarding the improvement on drug adherence. However, the stability of these effects should be checked in the medium and long term. Adjunctive psychoeducation therapy has a positive impact on reducing relapses in schizophrenia. In this study, we showed a significant benefit on drug adherence, objective quality of life and psychological well-being on a small sample of patients and provide arguments for the development of psychoeducation programs which are currently underrepresented in France. Our results encourage conducting a further prospective multicenter controlled study on a larger sample to clarify the benefit of psychoeducational therapy on objective and subjective quality of life in schizophrenia. Copyright © 2016 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

42 CFR 423.1062 - Dismissal for cause.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Dismissal for cause. 423.1062 Section 423.1062 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.1062 - Dismissal for cause.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Dismissal for cause. 423.1062 Section 423.1062 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.160 - Standards for electronic prescribing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Standards for electronic prescribing. 423.160 Section 423.160 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality...

42 CFR 423.773 - Requirements for eligibility.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Requirements for eligibility. 423.773 Section 423.773 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost-Sharing Subsidies...

42 CFR 423.1014 - Charge for transcripts.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Charge for transcripts. 423.1014 Section 423.1014 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.1046 - Conduct of hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Conduct of hearing. 423.1046 Section 423.1046 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

42 CFR 423.44 - Involuntary disenrollment from Part D coverage.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT... this section; or (ii) The individual has engaged in disruptive behavior, as specified under paragraph...) Disruptive behavior—(i) Definition. A PDP enrollee is disruptive if his or her behavior substantially impairs...

42 CFR 423.44 - Involuntary disenrollment from Part D coverage.

Code of Federal Regulations, 2013 CFR

2013-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT... this section; or (ii) The individual has engaged in disruptive behavior, as specified under paragraph...) Disruptive behavior—(i) Definition. A PDP enrollee is disruptive if his or her behavior substantially impairs...

42 CFR 423.2276 - Employer group retiree marketing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Employer group retiree marketing. 423.2276 Section... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing Requirements § 423.2276 Employer group retiree marketing. Part D sponsors may develop marketing materials...

Reference drug programs: effectiveness and policy implications.

PubMed

Schneeweiss, Sebastian

2007-04-01

In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering them. This paper summarizes the mechanism and rationale of RDPs, presents evidence of their economic effectiveness and clinical safety, and concludes with some practical implications of implementing RDP policies.

Reference drug programs: Effectiveness and policy implications☆

PubMed Central

Schneeweiss, Sebastian

2010-01-01

In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering them. This paper summarizes the mechanism and rationale of RDPs, presents evidence of their economic effectiveness and clinical safety, and concludes with some practical implications of implementing RDP policies. PMID:16777256

Health and federal budgetary effects of increasing access to antiretroviral medications for HIV by expanding Medicaid.

PubMed

Kahn, J G; Haile, B; Kates, J; Chang, S

2001-09-01

OBJECTIVES. This study modeled the health and federal fiscal effects of expanding Medicaid for HIV-infected people to improve access to highly active antiretroviral therapy. A disease state model of the US HIV epidemic, with and without Medicaid expansion, was used. Eligibility required a CD4 cell count less than 500/mm3 or viral load greater than 10,000, absent or inadequate medication insurance, and annual income less than $10,000. Two benefits were modeled, "full" and "limited" (medications, outpatient care). Federal spending for Medicaid, Medicare, AIDS Drug Assistance Program, Supplemental Security Income, and Social Security Disability Insurance were assessed. An estimated 38,000 individuals would enroll in a Medicaid HIV expansion. Over 5 years, expansion would prevent an estimated 13,000 AIDS diagnoses and 2600 deaths and add 5,816 years of life. Net federal costs for all programs are $739 million (full benefits) and $480 million (limited benefits); for Medicaid alone, the costs are $1.43 and $1.17 billion, respectively. Results were sensitive to awareness of serostatus, highly active antiretroviral therapy cost, and participation rate. Strategies for federal cost neutrality include Medicaid HIV drug price reductions as low as 9% and private insurance buy-ins. Expansion of the Medicaid eligibility to increase access to antiretroviral therapy would have substantial health benefits at affordable costs.

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

PubMed

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

2002-01-01

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

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

PubMed

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

2005-02-01

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

Health Outcomes for Clients of Needle and Syringe Programs in Prisons.

PubMed

Lazarus, Jeffrey V; Safreed-Harmon, Kelly; Hetherington, Kristina L; Bromberg, Daniel J; Ocampo, Denise; Graf, Niels; Dichtl, Anna; Stöver, Heino; Wolff, Hans

2018-04-12

High levels of drug dependence have been observed in the prison population globally, and the sharing of injecting drug equipment in prisons has contributed to higher prevalence of bloodborne diseases in prisoners than in the general population. Few prison needle and syringe programs (PNSPs) exist. We conducted a systematic review to assess evidence regarding health outcomes of PNSPs. We searched peer-reviewed databases for data relating to needle and syringe programs in prisons. The search methodology was conducted in accordance with accepted guidelines. Five studies met review inclusion criteria, and all presented evidence associating PNSPs with one or more health benefits, but the strength of the evidence was low. The outcomes for which the studies collectively demonstrated the strongest evidence were prevention of human immunodeficiency virus and viral hepatitis. Few negative consequences from PNSPs were observed, consistent with previous evidence assessments. More research is needed on PNSP effectiveness, and innovative study designs are needed to overcome methodological limitations of previous research. Until stronger evidence becomes available, policymakers are urged to recognize that not implementing PNSPs has the potential to cause considerable harm, in light of what is currently known about the risks and benefits of needle and syringe programs and PNSPs and about the high prevalence of human immunodeficiency virus and viral hepatitis in prisons.

Health plans keeping drug cost increases in check with programs that promote generics.

PubMed

2002-07-01

To counter the massive amount of drug company detailing and marketing that is partly responsible for driving up pharmaceutical costs, health plans and some independent practice associations are promoting the use of generics to physicians in their networks. While most physicians in capitated contracts don't directly benefit from the movement to encourage generics unless they have pharmacy risk, some health plans are paying physicians financial incentives to increase generic prescribing.

42 CFR 423.1976 - Judicial review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Judicial review. 423.1976 Section 423.1976 Public...) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings, MAC review, and Judicial Review § 423.1976 Judicial review. (a) Review of ALJ's decision. The enrollee may request judicial...

42 CFR 423.1092 - Revision of reopened decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Revision of reopened decision. 423.1092 Section 423.1092 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Appeal Procedures for Civil Money...

How To Keep Your Schools Safe and Secure.

ERIC Educational Resources Information Center

Gilbert, Christopher B.

1996-01-01

Discusses unforeseen costs (including potential litigation expenses), benefits, and consequences of adopting security measures (such as metal detectors, drug dogs, security cameras, campus police, dress codes, crime watch programs, and communication devices) to counter on-campus violence and gang activity. High-tech gadgetry alone is insufficient.…

42 CFR 423.771 - Basis and scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Basis and scope. 423.771 Section 423.771 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost-Sharing Subsidies for Low...

42 CFR 423.44 - Involuntary disenrollment from Part D coverage.

Code of Federal Regulations, 2011 CFR

2011-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Eligibility and...) The individual has engaged in disruptive behavior, as specified under paragraph (d)(2) of this section...) Disruptive behavior—(i) Definition. A PDP enrollee is disruptive if his or her behavior substantially impairs...

42 CFR 423.2046 - Notice of an ALJ decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... making the determination; (2) The procedures for obtaining additional information concerning the decision... 42 Public Health 3 2010-10-01 2010-10-01 false Notice of an ALJ decision. 423.2046 Section 423... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings, MAC review...

Estimated cost savings associated with the transfer of office-administered specialty pharmaceuticals to a specialty pharmacy provider in a Medical Injectable Drug program.

PubMed

Baldini, Christopher G; Culley, Eric J

2011-01-01

A large managed care organization (MCO) in western Pennsylvania initiated a Medical Injectable Drug (MID) program in 2002 that transferred a specific subset of specialty drugs from physician reimbursement under the traditional "buy-and-bill" model in the medical benefit to MCO purchase from a specialty pharmacy provider (SPP) that supplied physician offices with the MIDs. The MID program was initiated with 4 drugs in 2002 (palivizumab and 3 hyaluronate products/derivatives) growing to more than 50 drugs by 2007-2008. To (a) describe the MID program as a method to manage the cost and delivery of this subset of specialty drugs, and (b) estimate the MID program cost savings in 2007 and 2008 in an MCO with approximately 4.6 million members. Cost savings generated by the MID program were calculated by comparing the total actual expenditure (plan cost plus member cost) on medications included in the MID program for calendar years 2007 and 2008 with the total estimated expenditure that would have been paid to physicians during the same time period for the same medication if reimbursement had been made using HCPCS (J code) billing under the physician "buy-and-bill" reimbursement rates. For the approximately 50 drugs in the MID program in 2007 and 2008, the drug cost savings in 2007 were estimated to be $15.5 million (18.2%) or $290 per claim ($0.28 per member per month [PMPM]) and about $13 million (12.7%) or $201 per claim ($0.23 PMPM) in 2008. Although 28% of MID claims continued to be billed by physicians using J codes in 2007 and 22% in 2008, all claims for MIDs were limited to the SPP reimbursement rates. This MID program was associated with health plan cost savings of approximately $28.5 million over 2 years, achieved by the transfer of about 50 physician-administered injectable pharmaceuticals from reimbursement to physicians to reimbursement to a single SPP and payment of physician claims for MIDs at the SPP reimbursement rates.

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

PubMed

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

2016-09-01

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

The Effect of Pharmaceutical Patent Term Length on Research and Development and Drug Expenditures in Canada

PubMed Central

Grootendorst, Paul; Matteo, Livio Di

2007-01-01

While pharmaceutical patent terms have increased in Canada, increases in patented drug spending have been mitigated by price controls and retrenchment of public prescription drug subsidy programs. We estimate the net effects of these offsetting policies on domestic pharmaceutical R&D expenditures and also provide an upper-bound estimate on the effects of these policies on Canadian pharmaceutical spending over the period 1988–2002. We estimate that R&D spending increased by $4.4 billion (1997 dollars). Drug spending increased by $3.9 billion at most and, quite likely, by much less. Cutbacks to public drug subsidies and the introduction of price controls likely mitigated drug spending growth. In cost–benefit terms, we suspect that the patent extension policies have been beneficial to Canada. PMID:19305720

42 CFR 423.2136 - Judicial review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Judicial review. 423.2136 Section 423.2136 Public...) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings, MAC review, and Judicial Review § 423.2136 Judicial review. (a) General rule. To the extent authorized by sections 1876(c...

42 CFR 423.165 - Compliance deemed on the basis of accreditation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Compliance deemed on the basis of accreditation. 423.165 Section 423.165 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost...

42 CFR 423.780 - Premium subsidy.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Premiums and Cost-Sharing Subsidies for Low... 42 Public Health 3 2010-10-01 2010-10-01 false Premium subsidy. 423.780 Section 423.780 Public...-service plans or 1876 cost plans) in a PDP region in the reference month. (ii) Premium amounts. The...

42 CFR 423.2110 - MAC reviews on its own motion.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false MAC reviews on its own motion. 423.2110 Section 423.2110 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings, MAC review...

42 CFR 423.2276 - Employer group retiree marketing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Employer group retiree marketing. 423.2276 Section 423.2276 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing Requirements § 423.2276 Employer group retiree...

Social Marketing: Its Role in the Delivery of Nutrition Education Programs.

ERIC Educational Resources Information Center

Grondin, Deirdre

Social causes such as "improved nutritional practices" could benefit from marketing-like thinking. The improvement of nutritional practices, like other social concerns such as pollution control, drug abuse, and physical fitness, needs innovative solutions and approaches for gaining public attention and support. Marketing persons, by their…

42 CFR 423.2020 - Time and place for a hearing before an ALJ.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ...-teleconferencing technology is available to conduct the appearance. (2) The ALJ may also offer to conduct a hearing...-teleconferencing technology is not available; or (ii) Special or extraordinary circumstances exist. (c) Notice of...

42 CFR 423.410 - Waiver of certain requirements to expand choice.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Organization Compliance with State Law and Preemption by Federal Law § 423.410 Waiver of certain requirements... than those required by Federal Law. The application by a State of any grounds other than those required...

42 CFR 423.2000 - Hearing before an ALJ: general rule.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings... subject to the restrictions in § 423.2018, examine the evidence used in making the determination under... conducts a de novo review and issues a decision based on the hearing record. (e) If an enrollee waives his...

42 CFR 423.1986 - Good cause for reopening.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the time of the determination or decision; and (ii) May result in a different conclusion; or (2) The evidence that was considered in making the determination or decision clearly shows on its face that an... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Reopening, ALJ Hearings, MAC review...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

32 CFR 199.21 - TRICARE Pharmacy Benefits Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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. Although antimicrobial formulary listings are used to guide prescribing rates within a province, our analysis of one year's data of the impact of the antimicrobial formulary structure did not correlate with antimicrobial prescribing rates, and other factors are likely to be at play.

[How I treat: from specialized pharmacology to drug therapy: a plea for an optimal educational program for rational therapeutics, from decision making to drug prescription].

PubMed

Scheen, A J

2000-09-01

Clinical pharmacology and therapeutics are two complementary disciplines which should lead the medical student, through an optimized training, to a rational prescription of drugs, ultimate and important step of the medical approach. Such a learning should occur progressively throughout the medical education, focusing, first, on the therapeutic reasoning ("why?") and, second, on the practical application leading to the prescription ("how?"). The medical student should learn the difficult task of integrating disease, drug and patient, in order to optimize the benefit/risk ratio, while being informed about new concepts such as "Evidence-Based Medicine" and pharmacoeconomics.

ADATSA Treatment Outcomes: Employment and Cost Avoidance: An Eighteen Month Follow-Up Study of Indigent Persons Served by Washington State's Alcoholism and Drug Addiction Treatment and Support Act. Report No. 4-19.

ERIC Educational Resources Information Center

Longhi, Dario; And Others

This report provides a cost-benefit analysis of a program that provides publicly-funded treatment and support for persons who are addicted to alcohol or other drugs and who are judged to be indigent, unemployable, and incapacitated due to their addiction. The study focused on two client outcomes: (1) determine employment outcomes during an 18…

Qualitative evaluation of a high school yoga program: feasibility and perceived benefits.

PubMed

Conboy, Lisa A; Noggle, Jessica J; Frey, Jessica L; Kudesia, Ravi S; Khalsa, Sat Bir S

2013-01-01

This is the first published qualitative assessment of a yoga program applied in a high school setting. This qualitative interview study was nested in a randomized, controlled trial studying the effects of a yoga program offered in place of a semester of physical education classes at a rural public high school. Student interviews were conducted after taking part in a semester of the yoga program. A formal passive consent with information about the qualitative study was sent home to parents/guardians of all students in the parent study before the interviews. Most students enjoyed the yoga classes and felt benefits. Negative reports of yoga practice were associated with gender as most males sensed peer pressure against practicing yoga. Despite this finding, most students wanted to continue yoga and would continue if it were offered in school. Positive reports include a greater kinesthetic awareness, which some students associated with a greater respect for the body and improved self-image. Among students reporting psychological benefits, many cited stress reduction; many used yoga to manage negative emotions; and some propagated more optimism. Most thought yoga could reduce interest in the use of drugs and alcohol and increase social cohesion with family and peers. We found that a yoga program is feasible in this sample of 9th and 10th graders, especially after benefits are perceived. We also found evidence that yoga may lead to emergent positive benefits in health behaviors not directly prescribed by the program. These results suggest that school-based yoga programs may be appropriate for promoting healthy behaviors at a societal level by focusing on the prevention of negative patterns during the adolescent transition. Copyright © 2013 Elsevier Inc. All rights reserved.

Benefits planning--what you must know: interview with Daniel Fortuno, AIDS Benefits Counselors. Interview by John S. James.

PubMed

Fortuno, D

1996-09-20

Daniel Fortuno, a counselor with AIDS Benefits Counselors (ABC), summarizes key insurance and benefits information for persons living with AIDS (PWAs), particularly those who reside in California. Fortuno explains the managed care concept and basic health insurance terms, such as pre-existing conditions, health maintenance organizations (HMOs), preferred provider organizations (PPOs), contestability, and the Consolidated Omnibus Budget Reconciliation Act (COBRA). Fortuno explains a California law that became effective in July 1993 that greatly restricts the ability of health insurance companies to refuse insurance due to preexisting conditions to small groups of persons. This law, AB 1672, makes health insurance available to the sick with little overall rises in prices. Federal insurance laws and regulations that impact PWAs and HIV-positive individuals are outlined. In the interview, Fortuno also discusses Medicaid/Medi-Cal (California's Medicaid), Social Security programs, State disability, and the AIDS Drug Assistance Program. Fortuno offers suggestions for obtaining good private insurance and evaluates the pros and cons of HMOs, PPOs, and indemnity insurance.

Influence of Peer-Based Needle Exchange Programs on Mental Health Status in People Who Inject Drugs: A Nationwide New Zealand Study.

PubMed

Hay, Bianca; Henderson, Charles; Maltby, John; Canales, Juan J

2016-01-01

Alleviating the personal and social burden associated with substance use disorders requires the implementation of a comprehensive strategy, including outreach, education, community interventions, psychiatric treatment, and access to needle exchange programs (NEP), where peer support may be available. Given that substantial research underscores the potential benefits of peer support in psychiatric interventions, we aimed to conduct a national survey to examine key domains of mental health status in people who inject drugs (PWID) in New Zealand. PWID were recruited from 24 pharmacies and 16 dedicated peer-based needle exchanges (PBNEs) across the country. We focused on two mental health outcomes: (1) affective dysregulation, across the three emotional domains of the Depression Anxiety Stress Scale, due to its role in the maintenance of continued drug use, and (2) positive cognition and effective health- and drug-related information exchange with the provider, using the Satisfaction with Life Scale and an ad hoc questionnaire, respectively, in view of their association with improved mental health outcomes. We hypothesized that access to peer support would be associated with mental health benefits for PWIDs. Remarkably, the results of a multistep regression analysis revealed that irrespective of sex, age, ethnicity, main drug used, length of drug use, and frequency of visits to the NEP, the exclusive or preferential use of PBNEs predicted significantly lower depression and anxiety scores, greater satisfaction with life, and increased health-related information exchange with the service provider. These findings demonstrate for the first time an association between access to peer support at PBNEs and positive indices of mental health, lending strong support to the effective integration of such peer-delivered NEP services into the network of mental health services for PWID worldwide.

Influence of Peer-Based Needle Exchange Programs on Mental Health Status in People Who Inject Drugs: A Nationwide New Zealand Study

PubMed Central

Hay, Bianca; Henderson, Charles; Maltby, John; Canales, Juan J.

2017-01-01

Alleviating the personal and social burden associated with substance use disorders requires the implementation of a comprehensive strategy, including outreach, education, community interventions, psychiatric treatment, and access to needle exchange programs (NEP), where peer support may be available. Given that substantial research underscores the potential benefits of peer support in psychiatric interventions, we aimed to conduct a national survey to examine key domains of mental health status in people who inject drugs (PWID) in New Zealand. PWID were recruited from 24 pharmacies and 16 dedicated peer-based needle exchanges (PBNEs) across the country. We focused on two mental health outcomes: (1) affective dysregulation, across the three emotional domains of the Depression Anxiety Stress Scale, due to its role in the maintenance of continued drug use, and (2) positive cognition and effective health- and drug-related information exchange with the provider, using the Satisfaction with Life Scale and an ad hoc questionnaire, respectively, in view of their association with improved mental health outcomes. We hypothesized that access to peer support would be associated with mental health benefits for PWIDs. Remarkably, the results of a multistep regression analysis revealed that irrespective of sex, age, ethnicity, main drug used, length of drug use, and frequency of visits to the NEP, the exclusive or preferential use of PBNEs predicted significantly lower depression and anxiety scores, greater satisfaction with life, and increased health-related information exchange with the service provider. These findings demonstrate for the first time an association between access to peer support at PBNEs and positive indices of mental health, lending strong support to the effective integration of such peer-delivered NEP services into the network of mental health services for PWID worldwide. PMID:28149282

The Effect of Benefits, Premiums, and Health Risk on Health Plan Choice in the Medicare Program

PubMed Central

Atherly, Adam; Dowd, Bryan E; Feldman, Roger

2004-01-01

Objective To estimate the effect of Medicare+Choice (M+C) plan premiums and benefits and individual beneficiary characteristics on the probability of enrollment in a Medicare+Choice plan. Data Source Individual data from the Medicare Current Beneficiary Survey were combined with plan-level data from Medicare Compare. Study Design Health plan choices, including the Medicare+Choice/Fee-for-Service decision and the choice of plan within the M+C sector, were modeled using limited information maximum likelihood nested logit. Principal Findings Premiums have a significant effect on plan selection, with an estimated out-of-pocket premium elasticity of −0.134 and an insurer-perspective elasticity of −4.57. Beneficiaries are responsive to plan characteristics, with prescription drug benefits having the largest marginal effect. Sicker beneficiaries were more likely to choose plans with drug benefits and diabetics were more likely to pick plans with vision coverage. Conclusions Plan characteristics significantly impact beneficiaries' decisions to enroll in Medicare M+C plans and individuals sort themselves systematically into plans based on individual characteristics. PMID:15230931

Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.

PubMed

Valverde, Ana M; Reed, Shelby D; Schulman, Kevin A

2012-11-01

The 1983 Orphan Drug Act created incentives for the development of orphan drugs. Despite its successes, including a substantial increase in new drugs, approved orphan drugs still treat fewer than 5 percent of registered rare diseases. In addition, concerns have arisen about the high prices of many of these therapies, which can cost hundreds of thousands of dollars per patient each year. In this article, we propose a new "grant-and-access pathway," in which drug developers could opt to compete for federal grants to subsidize the costs of clinical testing. In return for the grant funding, companies would no longer claim orphan drug tax credits and would agree to price caps for marketed products based on the duration and costs associated with drug development, expected market size, and target rate of return. We identify scenarios in which such a policy could provide a net benefit to society.

[Assessment of actual benefits of new drugs by the Transparency Committee].

PubMed

Le Jeunne, C

2008-01-01

When a drug has been granted a marketing authorization, if the pharmaceutical company wants it to be covered by the National Health Insurance, the company has to submit a file with all the studies concerning the drug, especially drug-drug comparative studies, to be assessed by the Transparency Committee. Drugs are assessed on two criteria: actual or expected benefit (AB) and improvement in actual benefit (IAB). Actual benefit mainly takes into account the severity of the disease concerned, the level of efficacy relative to known side effects (risk-benefit ratio), and the place the drug is intended to take in the therapeutic strategy. At the end of the assessment, AB is considered as important, moderate, poor or insufficient (to justify inclusion of the drug on the list of products to be reimbursed). After actual benefit is determined, improvement of actual benefit is assessed, comparing the estimated benefit of this drug with one of drugs with the same indication that is already reimbursed, to assess whether this drug will improve the patient's disease. This can be assessed by direct comparison (two drugs compared in the same clinical trial) or by indirect comparison (separate studies with the same design). There are four levels of added value, from I (major improvement) to IV (minor improvement). Level V represents no improvement. This second assessment is always relative to another drug. It never provides an absolute score. However, IAB is very important for pharmaceutical companies, because it is a fundamental criterion to determine the price of the drug, which is discussed with the Economic Committee of Health Products in a final phase. Actual benefit and improvement in actual benefit are allocated for each indication of a drug.

The Efficacy of Dog Assisted Therapy in Detained Drug Users: A Pilot Study in an Italian Attenuated Custody Institute

PubMed Central

Toson, Marica; Montanaro, Maria; Farina, Luca; Costa, Aldo; Nava, Felice Alfonso

2017-01-01

Drug addiction is a major care and safety challenge in prison context. Nowadays, rehabilitation and specific therapeutic programs are suggested to improve health and well-being of inmates during their detention time and to reduce substance abuse relapse after release from prison. Among these programs, several studies reported the benefits for inmates coming from animal assisted interventions. In this pilot controlled study, we investigated the efficacy of a dog assisted therapy program addressed to 22 drug addicted male inmates housed in an attenuated custody institute in Italy. The study lasted six months, the treated group (12 inmates) was involved once a week for one hour in 20 dog assisted therapy sessions, whereas the control group (10 inmates) followed the standard rehabilitation program. One week before the beginning and one week after the end of the sessions, all inmates involved were submitted to symptom checklist-90-revised and Kennedy axis V. Inmates involved in the dog assisted therapy sessions significantly improved their social skills, reducing craving, anxiety and depression symptoms compared to the control group. Despite the limitation due to the small number of inmates enrolled and to the absence of follow up, we found these results encouraging to the use of dog assisted therapy as co-therapy in drug addicted inmates rehabilitation programs, and we claim the need of more extensive study on this subject. PMID:28672787

The Efficacy of Dog Assisted Therapy in Detained Drug Users: A Pilot Study in an Italian Attenuated Custody Institute.

PubMed

Contalbrigo, Laura; De Santis, Marta; Toson, Marica; Montanaro, Maria; Farina, Luca; Costa, Aldo; Nava, Felice Alfonso

2017-06-24

Drug addiction is a major care and safety challenge in prison context. Nowadays, rehabilitation and specific therapeutic programs are suggested to improve health and well-being of inmates during their detention time and to reduce substance abuse relapse after release from prison. Among these programs, several studies reported the benefits for inmates coming from animal assisted interventions. In this pilot controlled study, we investigated the efficacy of a dog assisted therapy program addressed to 22 drug addicted male inmates housed in an attenuated custody institute in Italy. The study lasted six months, the treated group (12 inmates) was involved once a week for one hour in 20 dog assisted therapy sessions, whereas the control group (10 inmates) followed the standard rehabilitation program. One week before the beginning and one week after the end of the sessions, all inmates involved were submitted to symptom checklist-90-revised and Kennedy axis V. Inmates involved in the dog assisted therapy sessions significantly improved their social skills, reducing craving, anxiety and depression symptoms compared to the control group. Despite the limitation due to the small number of inmates enrolled and to the absence of follow up, we found these results encouraging to the use of dog assisted therapy as co-therapy in drug addicted inmates rehabilitation programs, and we claim the need of more extensive study on this subject.

76 FR 77543 - Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

...] Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review AGENCY: Food and Drug... availability of a draft report entitled ``Quantitative Summary of the Benefits and Risks of Prescription Drugs... ``Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review.'' A literature...

Drug Craving Terminology among Opiate Dependents; A Mixed Method Study

PubMed Central

Maarefvand, Masoomeh; Ghiasvand, Hamid Reza

2013-01-01

Objective Drug craving is defined as an urge to continue substance abuse. Drug dependents use different terms to express their subjective feeling of craving. This study was an attempt to generate an understanding of craving terminology among different groups of Persian speaking Iranian opiate dependents. Method Terms used for the meaning of drug craving were listed by 36 ex-opiate dependents in focus group discussion meetings in the first phase of the study. These terms were composed from Craving Terms Questionnaire. In the second phase, 120 subjects in 3 groups of opiate dependents and a group of Current Opiate Abusers rated usage frequency of each term in the questionnaire under a Twelve-Step Program, Methadone Maintenance, and Other Abstinence-based Programs. Results Eighty nine terms were categorized in stimulation and triggering, attention bias and obsession, decision making difficulty, information processing impairment, withdrawal induction, drug euphoric experience, mental urge, motor control problem, negative valancing and stigmatizing. Terms for the three categories of mental urge, attention bias and obsession and motor control problem were used more than others. Patients in Methadone Maintenance Treatment (MMT) group used different categories of craving terms in comparison to other groups. Abstinent cases reported higher total score for craving terms in comparison to other groups in Twelve-Step Program and other abstinence-based programs. Conclusion Each craving-related term is associated with some aspects of the multidimensional concept of craving. A drug-craving thesaurus could provide a better understanding of craving nature from a drug dependent point of view. There are differences among abstinence vs. maintenance based treated opiate dependents in using craving terms. Addiction therapists will benefit from accessing drug dependents’ lexicon to assess and create therapeutic alliance with their clients. PMID:24130609

Assessing causality in drug policy analyses: How useful are the Bradford Hill criteria in analysing take-home naloxone programs?

PubMed

Olsen, Anna; McDonald, David; Lenton, Simon; Dietze, Paul M

2018-05-01

The Bradford Hill criteria for assessing causality are useful in assembling evidence, including within complex policy analyses. In this paper, we argue that the implementation of take-home naloxone (THN) programs in Australia and elsewhere reflects sensible, evidence-based public health policy, despite the absence of randomised controlled trials. However, we also acknowledge that the debate around expanding access to THN would benefit from a careful consideration of causal inference and health policy impact of THN program implementation. Given the continued debate around expanding access to THN, and the relatively recent access to new data from implementation studies, two research groups independently conducted Bradford Hill analyses in order to carefully consider causal inference and health policy impact. Hill's criteria offer a useful analytical tool for interpreting current evidence on THN programs and making decisions about the (un)certainty of THN program safety and effectiveness. © 2017 Australasian Professional Society on Alcohol and other Drugs.

A rationale and model for addressing tobacco dependence in substance abuse treatment.

PubMed

Richter, Kimber P; Arnsten, Julia H

2006-08-14

Most persons in drug treatment smoke cigarettes. Until drug treatment facilities systematically treat their patients' tobacco use, millions will flow through the drug treatment system, overcome their primary drug of abuse, but die prematurely from tobacco-related illnesses. This paper reviews the literature on the health benefits of quitting smoking for drug treatment patients, whether smoking causes relapse to other drug or alcohol abuse, the treatment of tobacco dependence, and good and bad times for quitting smoking among drug treatment patients. It also presents a conceptual model and recommendations for treating tobacco in substance abuse treatment, and provides references to internet and paper-copy tools and information for treating tobacco dependence. At present, research on tobacco treatment in drug treatment is in its infancy. Although few drug treatment programs currently offer formal services, many more will likely begin to treat nicotine dependence as external forces and patient demand for these services increases. In the absence of clear guidelines and attention to quality of care, drug treatment programs may adopt smoking cessation services based on cost, convenience, or selection criteria other than efficacy. Because research in this field is relatively new, substance abuse treatment professionals should adhere to the standards of care for the general population, but be prepared to update their practices with emerging interventions that have proven to be effective for patients in drug treatment.

Does the theory-driven program affect the risky behavior of drug injecting users in a healthy city? A quasi-experimental study.

PubMed

Karimy, Mahmood; Abedi, Ahmad Reza; Abredari, Hamid; Taher, Mohammad; Zarei, Fatemeh; Rezaie Shahsavarloo, Zahra

2016-01-01

The horror of HIV/AIDS as a non-curable, grueling disease is a destructive issue for every country. Drug use, shared needles and unsafe sex are closely linked to the transmission of HIV/AIDS. Modification or changing unhealthy behavior through educational programs can lead to HIV prevention. The aim of this study was to evaluate the efficiency of theory-based education intervention on HIV prevention transmission in drug addicts. In this quasi-experimental study, 69 male drug injecting users were entered in to the theory- based educational intervention. Data were collected using a questionnaire, before and 3 months after four sessions (group discussions, lecture, film displaying and role play) of educational intervention. The findings signified that the mean scores of constructs (self-efficacy, susceptibility, severity and benefit) significantly increased after the educational intervention, and the perceived barriers decreased (p< 0.001). Also, the history of HIV testing was reported to be 9% before the intervention, while the rate increased to 88% after the intervention. The present research offers a primary founding for planning and implementing a theory based educational program to prevent HIV/AIDS transmission in drug injecting addicts. This research revealed that health educational intervention improved preventive behaviors and the knowledge of HIV/AIDS participants.

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.

Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

PubMed

Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P

2012-01-01

  In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing supply on July 1, 2006, was the index claim. Members with a Kmart pharmacy index claim were excluded, since the Kmart membership drug discount program began prior to July 1, 2006. Levothyroxine claims capture nonpersistency, defined as the occurrence of a claim supply end date prior to a 180-day gap, was the primary outcome variable and was assessed from July 1, 2006, through June 30, 2010 (follow-up period). The odds of levothyroxine claims capture nonpersistency by pharmacy group were assessed using a logistic regression analysis adjusted for the following covariates: age, gender, median income in the ZIP code of residence (binomial for ≤ $50,000 vs. greater than $50,000), switch to a brand levothyroxine product during the follow-up period, index levothyroxine claim supply of 90 days or more, and index levothyroxine claim member cost share per 30-day supply in tertiles (≤ $5.00, $5.01-$7.99, ≥ $8.00). Of 2,632,855 eligible members aged 18 years or older, 13,427 met all study eligibility criteria. The baseline pharmacy groups were membership with 3,595 (26.8%), nonmembership with 1,919 (14.3%), and all other pharmacies with 7,913 (58.9%) members. The rates of levothyroxine claims capture persistency throughout the 4-year follow-up period were 85.4% for nonmembership (P = 0.593 vs. all other pharmacies), 77.7% for the membership group (P  less than  0.001 vs. all other pharmacies), and 85.9% for all other pharmacies. The Kaplan-Meier comparison of claims capture persistency found nearly identical claims capture loss for the nonmembership compared with all other pharmacies group, and when compared in a multivariate logistic regression model, there was no difference in the odds of levothyroxine claims capture over 4 years follow-up (OR = 1.01, 95% CI = 0.88-1.16, P = 0.900). The membership generic drug discount programs (Walgreens, CVS, Alberstons, and Savon pharmacies) had a statistically significant 61% higher odds (OR = 1.61, 95% CI = 1.45-1.79, P  less than  0.001) of levothyroxine claims capture nonpersistency. The onset of the difference between the membership group and the all other pharmacies group was temporally associated with the launch of the membership programs. In comparison to index levothyroxine member cost of ≤ $5.00 per 30-day supply, higher cost shares were associated with higher levothyroxine claims capture nonpersistency ($5.01 to $7.99 OR 1.34, 95% CI 1.19-1.52 and ≥ $8.00 OR 1.60, 95% CI 1.40-1.82). Among levothyroxine utilizers in 2006 (prior to the advent of drug discount programs), those with claims from a pharmacy that subsequently implemented a nonmembership generic drug discount program did not appear to have a different rate of levothyroxine claims capture than members from the reference group when followed through June 2010. Utilizers with claims from a pharmacy that subsequently implemented a membership program had a significantly lower levothyroxine claims capture rate. Increasing index levothyroxine member cost was associated with higher levothyroxine claims capture loss. Because the analysis could not directly measure claims capture loss associated with members who switched to a new pharmacy group without presenting their insurance information (e.g., membership discount programs), further research is needed to confirm these findings.

The Potential Return on Public Investment in Detecting Adverse Drug Effects.

PubMed

Huybrechts, Krista F; Desai, Rishi J; Park, Moa; Gagne, Joshua J; Najafzadeh, Mehdi; Avorn, Jerry

2017-06-01

Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the health care system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs. We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773-$884 million for rofecoxib, $3-$10 million for cerivastatin, and $38-$63 million for troglitazone in the United States through the prevention of adverse events. By contrast, the yearly public investment in Food and Drug Administration initiated population-based pharmacovigilance activities in the United States is about $42.5 million at present. These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.

Case outsourcing medical device reprocessing.

PubMed

Haley, Deborah

2004-04-01

IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

45 CFR 156.122 - Prescription drug benefits.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and class...

45 CFR 156.122 - Prescription drug benefits.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and class...

77 FR 22071 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... care facility conditions of participation pertaining to pharmacy services. DATES: Effective dates... of Health Care Prepayment Plans (Sec. 417.801) 2. Plan Performance Ratings as a Measure of... Information AHRQ Agency for Health Care Research and Quality ALJ Administrative Law Judge ANOC Annual Notice...

78 FR 63208 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... Regulations CMS-10260 Medicare Advantage and Prescription Drug Program: Final Marketing Provisions CMS-L564... the Social Security Act as well as the entitlement of the applicant or a spouse regarding a benefit or annuity paid by the Social Security Administration or the Office of Personnel Management for premium...

42 CFR 423.2272 - Licensing of marketing representatives and confirmation of marketing resources.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Licensing of marketing representatives and confirmation of marketing resources. 423.2272 Section 423.2272 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing...

42 CFR 423.440 - Prohibition of State imposition of premium taxes; relation to State laws.

Code of Federal Regulations, 2010 CFR

2010-10-01

...; relation to State laws. 423.440 Section 423.440 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Organization Compliance with State Law and Preemption by Federal Law § 423.440 Prohibition of...

The value of benefit data in direct-to-consumer drug ads.

PubMed

Woloshin, Steven; Schwartz, Lisa M; Welch, H Gilbert

2004-01-01

Direct-to-consumer (DTC) pharmaceutical ads typically describe drug benefits in qualitative terms; they rarely provide data on how well the drug works. We describe an evaluation of a "prescription drug benefit box"-data from the main randomized trials on the chances of various outcomes with and without the drug. Most participants rated the information as "very important" or "important"; almost all found the data easy to understand. Perceptions of drug effectiveness were much lower for ads that incorporated the benefit box than for ads that did not. Most people we interviewed want benefit data in drug ads, can understand these data, and are influenced by them.

Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.

PubMed

Roberts, Andrew W; Farley, Joel F; Holmes, G Mark; Oramasionwu, Christine U; Ringwalt, Chris; Sleath, Betsy; Skinner, Asheley C

2016-10-01

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse. Project HOPE—The People-to-People Health Foundation, Inc.

Drug education in victorian schools (DEVS): the study protocol for a harm reduction focused school drug education trial

PubMed Central

2012-01-01

Background This study seeks to extend earlier Australian school drug education research by developing and measuring the effectiveness of a comprehensive, evidence-based, harm reduction focused school drug education program for junior secondary students aged 13 to 15 years. The intervention draws on the recent literature as to the common elements in effective school curriculum. It seeks to incorporate the social influence of parents through home activities. It also emphasises the use of appropriate pedagogy in the delivery of classroom lessons. Methods/Design A cluster randomised school drug education trial will be conducted with 1746 junior high school students in 21 Victorian secondary schools over a period of three years. Both the schools and students have actively consented to participate in the study. The education program comprises ten lessons in year eight (13-14 year olds) and eight in year nine (14-15 year olds) that address issues around the use of alcohol, tobacco, cannabis and other illicit drugs. Control students will receive the drug education normally provided in their schools. Students will be tested at baseline, at the end of each intervention year and also at the end of year ten. A self completion questionnaire will be used to collect information on knowledge, patterns and context of use, attitudes and harms experienced in relation to alcohol, tobacco, cannabis and other illicit drug use. Multi-level modelling will be the method of analysis because it can best accommodate hierarchically structured data. All analyses will be conducted on an Intent-to-Treat basis. In addition, focus groups will be conducted with teachers and students in five of the 14 intervention schools, subsequent to delivery of the year eight and nine programs. This will provide qualitative data about the effectiveness of the lessons and the relevance of the materials. Discussion The benefits of this drug education study derive both from the knowledge gained by trialling an optimum combination of innovative, harm reduction approaches with a large, student sample, and the resultant product. The research will provide better understanding of what benefits can be achieved by harm reduction education. It will also produce an intervention, dealing with both licit and illicit drug use that has been thoroughly evaluated in terms of its efficacy, and informed by teacher and student feedback. This makes available to schools a comprehensive drug education package with prevention characteristics and useability that are well understood. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000079842 PMID:22321131

Drug education in Victorian schools (DEVS): the study protocol for a harm reduction focused school drug education trial.

PubMed

Midford, Richard; Cahill, Helen; Foxcroft, David; Lester, Leanne; Venning, Lynne; Ramsden, Robyn; Pose, Michelle

2012-02-10

This study seeks to extend earlier Australian school drug education research by developing and measuring the effectiveness of a comprehensive, evidence-based, harm reduction focused school drug education program for junior secondary students aged 13 to 15 years. The intervention draws on the recent literature as to the common elements in effective school curriculum. It seeks to incorporate the social influence of parents through home activities. It also emphasises the use of appropriate pedagogy in the delivery of classroom lessons. A cluster randomised school drug education trial will be conducted with 1746 junior high school students in 21 Victorian secondary schools over a period of three years. Both the schools and students have actively consented to participate in the study. The education program comprises ten lessons in year eight (13-14 year olds) and eight in year nine (14-15 year olds) that address issues around the use of alcohol, tobacco, cannabis and other illicit drugs. Control students will receive the drug education normally provided in their schools. Students will be tested at baseline, at the end of each intervention year and also at the end of year ten. A self completion questionnaire will be used to collect information on knowledge, patterns and context of use, attitudes and harms experienced in relation to alcohol, tobacco, cannabis and other illicit drug use. Multi-level modelling will be the method of analysis because it can best accommodate hierarchically structured data. All analyses will be conducted on an Intent-to-Treat basis. In addition, focus groups will be conducted with teachers and students in five of the 14 intervention schools, subsequent to delivery of the year eight and nine programs. This will provide qualitative data about the effectiveness of the lessons and the relevance of the materials. The benefits of this drug education study derive both from the knowledge gained by trialling an optimum combination of innovative, harm reduction approaches with a large, student sample, and the resultant product. The research will provide better understanding of what benefits can be achieved by harm reduction education. It will also produce an intervention, dealing with both licit and illicit drug use that has been thoroughly evaluated in terms of its efficacy, and informed by teacher and student feedback. This makes available to schools a comprehensive drug education package with prevention characteristics and useability that are well understood. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000079842.

The Queensland experience of participation in a national drug use evaluation project, Community-acquired pneumonia – towards improving outcomes nationally (CAPTION)

PubMed Central

Pulver, Lisa K; Tett, Susan E; Coombes, Judith

2009-01-01

Background Multicentre drug use evaluations are described in the literature infrequently and usually publish only the results. The purpose of this paper is to describe the experience of Queensland hospitals participating in the Community-Acquired Pneumonia Towards Improving Outcomes Nationally (CAPTION) project, specifically evaluating the implementation of this project, detailing benefits and drawbacks of involvement in a national drug use evaluation program. Methods Emergency departments from nine hospitals in Queensland, Australia, participated in CAPTION, a national quality improvement project, conducted in 37 Australian hospitals. CAPTION was aimed at optimising prescribing in the management of Community-Acquired Pneumonia according to the recommendations of the Australian Therapeutic Guidelines: Antibiotic 12th edition. The project involved data collection, and evaluation, feedback of results and a suite of targeted educational interventions including audit and feedback, group presentations and academic detailing. A baseline audit and two drug use evaluation cycles were conducted during the 2-year project. The implementation of the project was evaluated using feedback forms after each phase of the project (audit or intervention). At completion a group meeting with the hospital coordinators identified positive and negative elements of the project. Results Evaluation by hospitals of their participation in CAPTION demonstrated both benefits and drawbacks. The benefits were grouped into the impact on the hospital dynamic such as; improved interdisciplinary working relationships (e.g. between pharmacist and doctor), recognition of the educational/academic role of the pharmacist, creation of ED Pharmacist positions and enhanced involvement with the National Prescribing Service, and personal benefits. Personal benefits included academic detailing training for participants, improved communication skills and opportunities to present at conferences. The principal drawback of participation was the extra burden on already busy staff members. Conclusion A national multicentre drug use evaluation project such as CAPTION allows hospitals which would otherwise not undertake such projects the opportunity to participate. The Queensland arm of CAPTION demonstrated benefits to both the individual participants and their hospitals, highlighting the additional value of participating in a multicentre project of this type. PMID:19646287

Insurance Coverage of Prescription Drugs and the Rural Elderly

ERIC Educational Resources Information Center

Mueller, Curt; Schur, Claudia

2004-01-01

Rural impacts of a Medicare drug benefit will ultimately depend on the number of elderly who are currently without drug coverage, new demand by those currently without coverage, the nature of the new benefit relative to current benefits, and benefit design. Purpose: To enhance understanding of drug coverage among rural elderly Medicare…

Substance abuse treatment as HIV prevention: more questions than answers.

PubMed

Brown, Lawrence S; Kritz, Steven; Bini, Edmund J; Louie, Ben; Robinson, Jim; Alderson, Donald; Rotrosen, John

2010-12-01

This report examines associations between the availability of human immunodeficiency virus (HIV)-related health services in substance abuse treatment programs and characteristics of the programs and the patients they serve. In a cross-sectional, descriptive design and via a validated survey, program administrators within the National Drug Abuse Treatment Clinical Trials Network provided information on program characteristics, patient characteristics (rates of risky sexual and drug behaviors and HIV infection), and the availability of 31 different HIV-related health services. Of 319 programs, 84% submitted surveys. Service availability rates ranged from: 10% (pneumococcal vaccination) to 86% (drug testing) for the 6 HIV-related services offered to all patients, 13% (Pap smear for women) to 54% (tuberculin skin testing) for the 6 services offered to new patients, 2% (sterile injection equipment) to 64% (male condoms) for the 4 risk-reduction services, 37% (Pap smear for women) to 61% (tuberculin skin testing) for the 11 biological assessments offered to HIV-positive patients, and 33% (medical treatments) to 52% (counseling) for the 4 other services offered to HIV-positive patients. The availability of these HIV-related services was associated with clinical settings, the types of addiction treatment services, the rates of risky drug and sexual behaviors, and HIV infection rates among patients. Availability of such services was below published guidelines. While the results provide another basis for the infection-related prevention benefits of substance abuse treatment, the variability in the availability of HIV-related health care deserves further study and has health policy implications in determining how to utilize substance abuse treatment in reducing drug-related HIV transmission.

The NARCONON drug education curriculum for high school students: a non-randomized, controlled prevention trial.

PubMed

Lennox, Richard D; Cecchini, Marie A

2008-03-19

An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program also produced changes in knowledge, attitudes and perception of risk. The eight-module Narconon curriculum has thorough grounding in substance abuse etiology and prevention theory. Incorporating several historically successful prevention strategies this curriculum reduced drug use among youths.

Using 340B drug discounts to provide a financially sustainable medication discharge service.

PubMed

Wu, Timothy; Williams, Carla; Vranek, Kathryn; Mattingly, T Joseph

2018-03-27

The 340B Drug Pricing Program was intended to stretch federal resources by providing significant discounts to covered entities providing care to underserved populations. Program implementation and evidence of expanding services to higher income patients has brought more scrutiny and calls for elimination of the program. While additional review and reform may be warranted, profitability from 340B discounts enables covered entities to provide additional services that may not be feasible in absence of the program. This case report demonstrates one institution's use of 340B discounts to financially justify providing bedside medication delivery services for patients at the time of discharge from an inpatient admission. A simple financial model was developed using hospital data and inputs from available literature to estimate gross profit and earnings before interest, taxes, depreciation, and amortization (EBITDA) with and without 340B discounts. Without the 340B drug price discounts, the service would operate at a financial loss, and further investigation must be done to determine whether other clinical or economic benefits would warrant discharge medication delivery at the institution. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL... Benefits § 404.480 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled beneficiaries who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL... Benefits § 404.480 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled beneficiaries who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL... Benefits § 404.480 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled beneficiaries who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL... Benefits § 404.480 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled beneficiaries who receive benefit payments through a representative payee because drug addiction or alcoholism...

[Analysis of Late AMNOG Benefit Assessments].

PubMed

Rieder, Veronika; Hammerschmidt, Thomas

2018-04-26

Since 2011, new drugs are assessed at the time of launch in Germany (AMNOG). Based on this early benefit assessment (EBA), drug prices are negotiated. At this time, the evidence base might be weak. A later benefit assessment (LBA) is not done on a regular basis except for selected drugs. Our objective was to analyze the impact of LBAs of drugs for the same indication. Analysis of all completed LBAs between 2011 and 2016. 228 benefit assessments have been performed since 2011. 26 drugs were assessed twice for the same indication. Oncology and diabetes were the most common therapeutic areas in LBA and more pronounced than in EBA. 15 LBAs were due to the EBAs having a time limitation because of insufficient evidence base partially based on conditional approval. Time between EBA and LBA was 2.6 years. All 15 drugs had added benefit in the EBA, 4 got a better, 5 a worse assessment in the LBA. Seven drugs without added benefit in the EBA were assessed at the request of the manufacturer because of new data after 1.7 years. Three drugs could show added benefit in the LBA. Finally, 4 orphan drugs were reassessed according to the AMNOG regulation after achieving annual sales of 50 million euros. One got a better, 2 got a worse benefit assessment. Average improvement of benefit was +1.5 on a scale between - 3 (worst negative benefit) and +9 (highest positive benefit). Average deterioration of added benefit was - 1.4. Negotiated prices were significantly correlated with the change in the benefit assessment. LBA on a broader evidence base did not result in a significantly changed outcome. A general LBA for all drugs does not appear to be necessary because of the limited effect on the benefit assessment and the price when considering cost and administrative burden of the AMNOG benefit assessment. The selective approach of LBA for specific drugs is sufficient in cases in which the evidence base was limited at launch. © Georg Thieme Verlag KG Stuttgart · New York.

Compendia and anticancer therapy under Medicare.

PubMed

Tillman, Katherine; Burton, Brijet; Jacques, Louis B; Phurrough, Steve E

2009-03-03

In 1993, Congress directed the Medicare program to refer to 3 existing published compendia, American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia Drug Information for the Health Professional (USP-DI), and American Hospital Formulary Service Drug Information (AHFS-DI), to identify unlabeled but medically accepted uses of drugs and biologicals in anticancer chemotherapy regimens. Public discussion during the preceding years had centered on whether to designate unlabeled uses of anticancer treatments as experimental and thus outside the scope of Medicare benefits. American Medical Association Drug Evaluations and USP-DI subsequently ceased publication, and the Medicare program faced increasing calls to revise the list of acceptable compendia, as authorized in the statute. In 2007, the Centers for Medicare & Medicaid Services used its regulatory authority to establish a publicly transparent process to revise the list. The Centers for Medicare & Medicaid Services considered 5 requests in 2008 and added National Comprehensive Cancer Network Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology to the list of compendia. DrugPoints was not added, and AMA-DE was removed. Because of the potential for conflicts of interest to lead to biased judgments, the 2008 Medicare Improvements for Patients and Providers Act has a provision that explicitly prohibits inclusion of compendia that do not have a publicly transparent process for evaluating therapies and identifying potential conflicts of interest.

A patent extension proposal to end the underrepresentation of women in clinical trials and secure meaningful drug guidance for women.

PubMed

Hathaway, Cynthia

2012-01-01

Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard to how drugs work in the human body, testing of drugs in men alone can both deny women the full benefit of a drug and cause them to suffer from increased adverse side effects. Attempts to reform drug development law and agency practices to resolve this problem have met with only partial success. Proposed herein is a patent term extension and for studies in women, modeled upon the pediatric patent term extension, but with several key differences intended to reduce the cost to the public and fund auxiliary programs to address off-patent medicines as well. Such an extension would incentivize this research and provide meaningful guidance to women and their physicians.

Section 504 and the Legal Rights of Drug and Alcohol Affected Students.

ERIC Educational Resources Information Center

Hicks, Graham M.

Enacted as a part of the Rehabilitation Act of 1973, Section 504 states, "No otherwise qualified individual with handicaps...shall, solely by reason of her or his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance."…

Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.

PubMed

Vivot, A; Jacot, J; Zeitoun, J-D; Ravaud, P; Crequit, P; Porcher, R

2017-05-01

Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The ESMO-Magnitude of Clinical Benefit Scale for novel oncology drugs: correspondence with three years of reimbursement decisions in Israel.

PubMed

Hammerman, Ariel; Greenberg-Dotan, Sari; Feldhamer, Ilan; Birnbaum, Yair; Cherny, Nathan I

2018-02-01

The European Society for Medical Oncology published in 2015 its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for cancer medicines. Our objective was to evaluate the association between Israel's national reimbursement decisions regarding novel cancer drugs, prior to the availability of ESMO-MCBS, and the later published ESMO-MCBS scores. ESMO-MCBS scores were obtained retrospectively for the cancer drugs that were candidates for reimbursement in Israel in 2013-2015 and were categorized to 'highest benefit' (ESMO-MCBS 4-5 or A) 'medium benefit' (3 or B) and 'lowest benefit' (0-2 or C). The reimbursement decisions were accessed and compared with the categorized ESMO scores. ESMO-MCBS score was available for 19/22 drugs approved for reimbursement and 15/16 non-approved drugs. 58% of the approved drugs gained a 'highest benefit' score and 37% were 'medium benefit'. 87% of the non-approved drugs had 'lowest benefit' scores. Median score for approved drugs was 4 vs. 1 for the non-approved (p < 0.05). The Israeli decisions regarding reimbursement of novel cancer drugs, demonstrated concordance with ESMO-MCBS scores. Incorporation of ESMO-MCBS data in reimbursement deliberations could assist in framing the appropriate use of the limited resources to deliver effective and affordable cancer care.

Experiences of burnout among drug counselors in a large opioid treatment program: A qualitative investigation.

PubMed

Beitel, Mark; Oberleitner, Lindsay; Muthulingam, Dharushana; Oberleitner, David; Madden, Lynn M; Marcus, Ruthanne; Eller, Anthony; Bono, Madeline H; Barry, Declan T

2018-03-09

Little is known about possible experiences of burnout among drug counselors in opioid treatment programs that are scaling up capacity to address the current opioid treatment gap. Participants in this quality improvement study were 31 drug counselors employed by large opioid treatment programs whose treatment capacities were expanding. Experiences of burnout and approaches for managing and/or preventing burnout were examined using individual semi-structured interviews, which were audiotaped, transcribed, and systematically coded by a multidisciplinary team using grounded theory. Rates of reported burnout (in response to an open-ended question) were lower than expected, with approximately 26% of participants reporting burnout. Counselor descriptions of burnout included cognitive, affective, behavioral, and physiological symptoms; and job-related demands were identified as a frequent cause. Participants described both self-initiated (e.g., engaging in pleasurable activities, exercising, taking breaks during workday) and system-supported strategies for managing or preventing burnout (e.g., availing of supervision and paid time off). Counselors provided recommendations for system-level changes to attenuate counselor risk of burnout (e.g., increased staff-wide encounters, improved communication, accessible paid time off, and increased clinical supervision). Findings suggest that drug counselor burnout is not inevitable, even in opioid treatment program settings whose treatment capacities are expanding. Organizations might benefit from routinely assessing counselor feedback about burnout and implementing feasible recommendations to attenuate burnout and promote work engagement.

Nurse-midwives in federally funded health centers: understanding federal program requirements and benefits.

PubMed

Carter, Martha

2012-01-01

Midwives are working in federally funded health centers in increasing numbers. Health centers provide primary and preventive health care to almost 20 million people and are located in every US state and territory. While health centers serve the entire community, they also serve as a safety net for low-income and uninsured individuals. In 2010, 93% of health center patients had incomes below 200% of the Federal Poverty Guidelines, and 38% were uninsured. Health centers, including community health centers, migrant health centers, health care for the homeless programs, and public housing primary care programs, receive grant funding and enjoy other benefits due to status as federal grantees and designation as federally qualified health centers. Clinicians working in health centers are also eligible for financial and professional benefits because of their willingness to serve vulnerable populations and work in underserved areas. Midwives, midwifery students, and faculty working in, or interacting with, health centers need to be aware of the regulations that health centers must comply with in order to qualify for and maintain federal funding. This article provides an overview of health center regulations and policies affecting midwives, including health center program requirements, scope of project policy, provider credentialing and privileging, Federal Tort Claims Act malpractice coverage, the 340B Drug Pricing Program, and National Health Service Corps scholarship and loan repayment programs. © 2012 by the American College of Nurse-Midwives.

A Review of Factors That Influence Individual Compliance with Mass Drug Administration for Elimination of Lymphatic Filariasis

PubMed Central

Krentel, Alison; Fischer, Peter U.; Weil, Gary J.

2013-01-01

Background The success of programs to eliminate lymphatic filariasis (LF) depends in large part on their ability to achieve and sustain high levels of compliance with mass drug administration (MDA). This paper reports results from a comprehensive review of factors that affect compliance with MDA. Methodology/Principal Findings Papers published between 2000 and 2012 were considered, and 79 publications were included in the final dataset for analysis after two rounds of selection. While results varied in different settings, some common features were associated with successful programs and with compliance by individuals. Training and motivation of drug distributors is critically important, because these people directly interact with target populations, and their actions can affect MDA compliance decisions by families and individuals. Other important programmatic issues include thorough preparation of personnel, supplies, and logistics for implementation and preparation of the population for MDA. Demographic factors (age, sex, income level, and area of residence) are often associated with compliance by individuals, but compliance decisions are also affected by perceptions of the potential benefits of participation versus the risk of adverse events. Trust and information can sometimes offset fear of the unknown. While no single formula can ensure success MDA in all settings, five key ingredients were identified: engender trust, tailor programs to local conditions, take actions to minimize the impact of adverse events, promote the broader benefits of the MDA program, and directly address the issue of systematic non-compliance, which harms communities by prolonging their exposure to LF. Conclusions/Significance This review has identified factors that promote coverage and compliance with MDA for LF elimination across countries. This information may be helpful for explaining results that do not meet expectations and for developing remedies for ailing MDA programs. Our review has also identified gaps in understanding and suggested priority areas for further research. PMID:24278486

Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis

PubMed Central

Sullivan, Helen W; Dolina, Suzanne; Lynch, Molly; Squiers, Linda B

2017-01-01

Background US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug’s risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. Objective The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. Methods We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. Results Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks. Conclusions These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations. PMID:28676469

The potential exploitation of research participants in high income countries who lack access to health care

PubMed Central

Rid, Annette; Emanuel, Ezekiel; Wendler, David

2016-01-01

There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low‐ and middle‐income countries are not exploited are unlikely to protect participants in high‐income countries. The present manuscript argues that one way to address concerns about exploitation in high‐income countries would be to require sponsors to provide targeted benefits such as medical treatment during the trial, or the study drug after the trial. The latter could be achieved through extension studies, expanded access programs, or named‐patient programs. Sponsors also might provide non‐medical benefits, such as education or social support. Ethical and regulatory guidance should be revised to ensure that research participants in high‐income countries who lack access to healthcare services receive sufficient benefits. PMID:26743927

Using the costs of drug therapy to screen patients for a community pharmacy-based medication review program.

PubMed

Krähenbühl, Jean-Marc; Decollogny, Anne; Bugnon, Olivier

2008-12-01

To measure the positive predictive value (PPV) of the cost of drug therapy (threshold = 2000 Swiss francs [CHF], US$1440, 1360) as a screening criterion for identifying patients who may benefit from medication review (MR). To describe identified drug-related problems (DRPs) and expense problems (EPs), and to estimate potential savings if all recommendations were accepted. Five voluntary Swiss community pharmacies. Of 12,680 patients, 592 (4.7%) had drug therapy costs exceeding 2000 CHF over a six-month period from July 1 to December 31, 2002. This threshold limit was set to identify high-risk patients for DRPs and EPs. Three pharmacists consecutively conducted a medication review based on the pharmaceutical charts of 125 sampled patients who met the inclusion criterion. The PPV of a threshold of 2000 CHF for identifying patients who might benefit from a MR: true positives were patients with at least one DRP, while false positives were patients with no DRP. The selection based on this criterion had a PPV of 86% for detecting patients with at least one DRP and 95% if EPs were also considered. There was a mean of 2.64 (SD = 2.20) DRPs per patient and a mean of 2.14 (SD = 1.39) EPs per patient. Of these patients, 90% were over 65 years old or were treated with at least five chronic medications, two common criteria for identifying patients at risk of DRPs. The main types of DRPs were drug-drug interactions, compliance problems and duplicate drugs. Mean daily drug cost per patient was CHF 14.87 (US$10.70, 10.10). A potential savings of CHF 1.67 (US$1.20, 1.14) per day (11%) was estimated if all recommendations to solve DRPs and EPs suggested herein were implemented. Further studies should investigate whether the potential benefit of medication reviews in preventing DRPs and containing costs in this patient group can be confirmed in a real practice environment.

The Potential Return on Public Investment in Detecting Adverse Drug Effects

PubMed Central

Huybrechts, Krista F.; Desai, Rishi J.; Park, Moa; Gagne, Joshua J.; Najafzadeh, Mehdi; Avorn, Jerry

2017-01-01

Background Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. Objective Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. Research Design We assessed three examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the healthcare system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs. Results We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773 to $884 million for rofecoxib, $3 to $10 million for cerivastatin, and $38 to $63 million for troglitazone in the US through the prevention of adverse events. By contrast, the yearly public investment in FDA initiated population-based pharmacovigilance activities in the US is about $42.5 million at present. Conclusion These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public. PMID:28505041

Does the theory-driven program affect the risky behavior of drug injecting users in a healthy city? A quasi-experimental study

PubMed Central

Karimy, Mahmood; Abedi, Ahmad Reza; Abredari, Hamid; Taher, Mohammad; Zarei, Fatemeh; Rezaie Shahsavarloo, Zahra

2016-01-01

Background: The horror of HIV/AIDS as a non-curable, grueling disease is a destructive issue for every country. Drug use, shared needles and unsafe sex are closely linked to the transmission of HIV/AIDS. Modification or changing unhealthy behavior through educational programs can lead to HIV prevention. The aim of this study was to evaluate the efficiency of theory-based education intervention on HIV prevention transmission in drug addicts. Methods: In this quasi-experimental study, 69 male drug injecting users were entered in to the theory- based educational intervention. Data were collected using a questionnaire, before and 3 months after four sessions (group discussions, lecture, film displaying and role play) of educational intervention. Results: The findings signified that the mean scores of constructs (self-efficacy, susceptibility, severity and benefit) significantly increased after the educational intervention, and the perceived barriers decreased (p< 0.001). Also, the history of HIV testing was reported to be 9% before the intervention, while the rate increased to 88% after the intervention. Conclusion: The present research offers a primary founding for planning and implementing a theory based educational program to prevent HIV/AIDS transmission in drug injecting addicts. This research revealed that health educational intervention improved preventive behaviors and the knowledge of HIV/AIDS participants. PMID:27390684

The Impact of Foster Care and Temporary Assistance for Needy Families (TANF) on Women's Drug Treatment Outcomes

PubMed Central

Lewandowski, Cathleen A.; Hill, Twyla J.

2008-01-01

This study assesses the impact of having a child in foster care and receiving cash benefits through Temporary Assistance for Needy Families (TANF) on women's completion of a residential drug treatment program. The study's hypothesis was that drug treatment completion rates for women who had children in foster care and/or who were receiving TANF would differ from women who did not receive these services. The sample included 117 women age 19 to 54, in a Midwestern state. Findings suggest that women with a child or children in foster care were less likely to complete treatment. Women receiving cash benefits were also somewhat less likely to complete treatment than women not receiving these services. Women with children in foster care had similar levels of psychological, employment, and drug and alcohol concerns as other women, as measured by the Addiction Severity Index. Future research should focus on identifying strategies that enhance retention rates of these vulnerable women. Implications for improving treatment retention are discussed in light of the Adoption and Safe Families Act of 1997 and the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. PMID:19122866

20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... Underpayments § 416.544 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled recipients who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... Underpayments § 416.544 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled recipients who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... Underpayments § 416.544 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled recipients who receive benefit payments through a representative payee because drug addiction or alcoholism...

20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... Underpayments § 416.544 Paying benefits in installments: Drug addiction or alcoholism. (a) General. For disabled recipients who receive benefit payments through a representative payee because drug addiction or alcoholism...

Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis.

PubMed

Aikin, Kathryn J; Sullivan, Helen W; Dolina, Suzanne; Lynch, Molly; Squiers, Linda B

2017-07-04

US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks. These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations. ©Kathryn J Aikin, Helen W Sullivan, Suzanne Dolina, Molly Lynch, Linda B Squiers. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.07.2017.

Nature's Medicines: Traditional Knowledge and Intellectual Property Management. Case Studies from the National Institutes of Health (NIH), USA

PubMed Central

Gupta, Ranjan; Gabrielsen, Bjarne; Ferguson, Steven M.

2009-01-01

With the emergence and re-emergence of infectious diseases and development of multi-drug resistance, there is a dire need to find newer cures and to produce more drugs and vaccines in the pipeline. To meet these increasing demands biomedical researchers and pharmaceutical companies are combining advanced methods of drug discovery, such as combinatorial chemistry, high-throughput screening and genomics, with conventional approaches using natural products and traditional knowledge. However, such approaches require much international cooperation and understanding of international laws and conventions as well as local customs and traditions. This article reviews the forty years of cumulative experience at the National Institutes of Health (initiated by the National Cancer Institute) in natural products drug discovery. It presents (1) three major cooperative programs (2) the legal mechanisms for cooperation and (3) illustrative case studies from these programs. We hope that these discussions and our lessons learned would be helpful to others seeking to develop their own models of cooperation for the benefit of global health. PMID:16475917

Client perspectives on design and implementation of a couples-based intervention to reduce sexual and drug risk behaviors among female sex workers and their noncommercial partners in Tijuana and Ciudad Juárez, México

PubMed Central

Palinkas, Lawrence A.; Robertson, Angela M.; Syvertsen, Jennifer L.; Hernandez, Daniel O.; Ulibarri, Monica D.; Rangel, M. Gudelia; Martinex, Gustavo; Strathdee, Steffanie A.

2014-01-01

This mixed-methods study examined the acceptability of a hypothetical couples-based HIV prevention program for female sex workers and their intimate (non-commercial) male partners in Mexico. Among 320 participants, 67% preferred couples-based over individual programs, particularly among men. Reasons cited for preferring couples-based programs included convenience and health benefits for both partners. Participants reported that they would benefit from general health information and services, HIV counseling and testing, job training (particularly for men) and other services. However, qualitative interviews revealed that barriers relating to the environment (i.e., poor access to services), providers (i.e., lack of a therapeutic alliance), and intimate relationships (i.e., mistrust or instability) would need to be addressed before such a program could be successfully implemented. Despite women’s concerns about privacy and men’s preferences for gender-specific services, couples-based HIV prevention programs were largely acceptable to female sex workers and their intimate male partners. PMID:24510364

The landscape of services for drug users in Yogyakarta, Indonesia.

PubMed

Morrison, Chris; Kurniasih, Yacinta; Barton, Greg

2012-01-01

Drug use has increased rapidly in Indonesia since the late 1990s. The formal drug treatment sector has grown within the bounds of available government funding; however, there is also a substantial informal sector which provides a range of services for current and former users. While information regarding the former is available from the provincial and national governments, there are few sources that detail the latter. The aim of the current study, therefore, is to document the drug treatment services in one Indonesian city, Yogyakarta. This qualitative study utilised nine key informant interviews with drug treatment workers from nine government and non-government treatment services. Transcripts were analysed thematically. There exists a patchwork of enthusiastic yet under-resourced non-government services that complement the government rehabilitation and withdrawal programs in Yogyakarta. The focus of most such services is on abstinence (including several faith-based residential rehabilitation programs); however, some harm reduction programs have emerged in recent years. Under-utilisation is a feature of many non-government services, and all respondents acknowledged a significant gap in service coordination. Yogyakarta has a drug treatment sector in which most major treatment types are represented, and there appears to be potential for growth within many organisations. Nevertheless, the number and reach of the services are limited by a lack of resources and collaboration, and there are substantial cultural barriers to improving inter-organisational coordination. This study suggests that Yogyakarta and greater Indonesia may benefit from greater service coordination facilitated by local government. © 2011 Australasian Professional Society on Alcohol and other Drugs.

Risk evaluation mitigation strategies: the evolution of risk management policy.

PubMed

Hollingsworth, Kristen; Toscani, Michael

2013-04-01

The United States Food and Drug Administration (FDA) has the primary regulatory responsibility to ensure that medications are safe and effective both prior to drug approval and while the medication is being actively marketed by manufacturers. The responsibility for safe medications prior to marketing was signed into law in 1938 under the Federal Food, Drug, and Cosmetic Act; however, a significant risk management evolution has taken place since 1938. Additional federal rules, entitled the Food and Drug Administration Amendments Act, were established in 2007 and extended the government's oversight through the addition of a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. REMS is a mandated strategy to manage a known or potentially serious risk associated with a medication or biological product. Reasons for this extension of oversight were driven primarily by the FDA's movement to ensure that patients and providers are better informed of drug therapies and their specific benefits and risks prior to initiation. This article provides an historical perspective of the evolution of medication risk management policy and includes a review of REMS programs, an assessment of the positive and negative aspects of REMS, and provides suggestions for planning and measuring outcomes. In particular, this publication presents an overview of the evolution of the REMS program and its implications.

Prescription Drug Benefits: Cost Management Issues for Medicare

PubMed Central

Fox, Peter D.

2003-01-01

Little attention has been devoted in policy circles as to how Medicare would manage an outpatient prescription drug benefit. This article, first, discusses the role of the pharmacy benefits manager (PBM), the entity that processes claims and otherwise helps administer the benefit. It then discusses the major decisions that will be necessary regarding such matters as: which drugs should be covered; how broad should the pharmacy network be; whether there should be incentives to obtain generic rather than brand-name drugs when available; for drugs with no generic equivalent, should there be incentives to obtain less expensive, medically appropriate brand-name drugs; and how should prescription drug utilization be managed. PMID:15124374

77 FR 32407 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive... the finding and the reasons therefore in the notice. Section 553(b) of the APA ordinarily requires a... constitute a rulemaking that would be subject to the APA notice and comment or delayed effective date...

The Long-term Outcomes of Sibutramine Effectiveness on Weight (LOSE Weight) study: evaluating the role of drug therapy within a weight management program in a group-model health maintenance organization.

PubMed

Porter, Julie A; Raebel, Marsha A; Conner, Douglas A; Lanty, Frances A; Vogel, Erin A; Gay, Elizabeth C; Merenich, John A

2004-06-01

To assess the benefit of sibutramine hydrochloride monohydrate within a weight management program. Prospective randomized controlled trial in a health maintenance organization. Obese patients (n = 588) starting a weight management program were enrolled. Patients were randomly assigned to participate in the program alone or to participate in the program and receive sibutramine for 12 months. Outcome measures were change in weight, body mass index (BMI), percentage body fat, serum lipids, serum glucose, and blood pressure. At baseline, there was a younger age and higher weight, BMI, and waist circumference in the drug group. There was more degenerative joint disease in the nondrug group. The mean weight loss at 6 months was 6.8 kg (95% confidence interval [CI], -7.4 to -6.1 kg) in the drug group vs 3.1 kg (95% CI, -3.8 to -2.4 kg) (P < .001) in the nondrug group. Weight loss was maintained at 12 months. Significant reductions in BMI, body fat, and waist circumference occurred in the drug group. There were no significant changes in laboratory values or blood pressure. Patients taking sibutramine experienced a significant increase in heart rate (1.7 beats/min [95% CI, 0.5-2.9 beats/min] vs -0.4 beats/min [95% CI, -1.5 to 0.8 beats/min]; P <.004). In this managed care setting, the effectiveness and safety of sibutramine were similar to those observed in randomized, double-blind clinical efficacy trials.

20 CFR 416.1725 - Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... treatment requirements for your drug addiction or alcoholism. 416.1725 Section 416.1725 Employees' Benefits... Or Drug Addiction § 416.1725 Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism. (a) Suspension of benefits. Your eligibility for benefits will be...

20 CFR 416.1725 - Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... treatment requirements for your drug addiction or alcoholism. 416.1725 Section 416.1725 Employees' Benefits... Or Drug Addiction § 416.1725 Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism. (a) Suspension of benefits. Your eligibility for benefits will be...

20 CFR 416.1725 - Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... treatment requirements for your drug addiction or alcoholism. 416.1725 Section 416.1725 Employees' Benefits... Or Drug Addiction § 416.1725 Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism. (a) Suspension of benefits. Your eligibility for benefits will be...

20 CFR 416.1725 - Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... treatment requirements for your drug addiction or alcoholism. 416.1725 Section 416.1725 Employees' Benefits... Or Drug Addiction § 416.1725 Effect of your failure to comply with treatment requirements for your drug addiction or alcoholism. (a) Suspension of benefits. Your eligibility for benefits will be...

Which Benefits Are Mentioned Most Often in Drug Development Publications?

PubMed

Strüver, Vanessa

2017-01-01

The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general. Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results. Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words benefit and clinical research . The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results. The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically expected individual patient benefit was the chance to receive up-to-date care (38.1%). A general increase in knowledge about health care, treatments, or drugs (70.6%) was the most commonly mentioned theoretically expected benefit for society. In contrast, all 13 publications reporting actual benefits of clinical drug development trials focused on personal benefits and only 1 of these publications also mentioned a societal benefit. The most commonly mentioned individual benefit was an increased quality of life (53.9%), whereas the only mentioned collective benefit to society was a general gain of knowledge (100.0%). Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.

The Pharmaceutical Benefits Scheme 2003–2004

PubMed Central

Harvey, Ken J

2005-01-01

The Pharmaceutical Benefits Scheme (PBS) grew by 8% in 2003–04; a slower rate than the 12.0% pa average growth over the last decade. Nevertheless, the sustainability of the Scheme remained an ongoing concern given an aging population and the continued introduction of useful (but increasingly expensive) new medicines. There was also concern that the Australia-United States Free Trade Agreement could place further pressure on the Scheme. In 2003, as in 2002, the government proposed a 27% increase in PBS patient co-payments and safety-net thresholds in order to transfer more of the cost of the PBS from the government to consumers. While this measure was initially blocked by the Senate, the forthcoming election resulted in the Labor Party eventually supporting this policy. Recommendations of the Pharmaceutical Benefits Advisory Committee to list, not list or defer a decision to list a medicine on the PBS were made publicly available for the first time and the full cost of PBS medicines appeared on medicine labels if the price was greater than the co-payment. Pharmaceutical reform in Victorian public hospitals designed to minimise PBS cost-shifting was evaluated and extended to other States and Territories. Programs promoting the quality use of medicines were further developed coordinated by the National Prescribing Service, Australian Divisions of General Practice and the Pharmacy Guild of Australia. The extensive uptake of computerised prescribing software by GPs produced benefits but also problems. The latter included pharmaceutical promotion occurring at the time of prescribing, failure to incorporate key sources of objective therapeutic information in the software and gross variation in the ability of various programs to detect important drug-drug interactions. These issues remain to be tackled. PMID:15679896

42 CFR 423.308 - Definitions and terminology.

Code of Federal Regulations, 2010 CFR

2010-10-01

... exclude any costs attributable to benefits beyond basic prescription drug coverage, but also to exclude... benefits beyond basic prescription drug coverage, but also to exclude any prescription drug coverage costs... assistance outside the Part D benefit, provided that documentation of such nominal cost-sharing has been...

20 CFR 439.625 - Criminal drug statute.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Criminal drug statute. 439.625 Section 439.625 Employees' Benefits SOCIAL SECURITY ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 439.625 Criminal drug statute. Criminal drug statute means a...

Therapeutic drug monitoring in pregnancy.

PubMed

Matsui, Doreen M

2012-10-01

Therapeutic drug monitoring (TDM) is commonly recommended to optimize drug dosing regimens of various medications. It has been proposed to guide therapy in pregnant women, in whom physiological changes may lead to altered pharmacokinetics resulting in difficulty in predicting the appropriate drug dosage. Ideally, TDM may play a role in enhancing the effectiveness of treatment while minimizing toxicity of both the mother and fetus. Monitoring of drug levels may also be helpful in assessing adherence to prescribed therapy in selected cases. Limitations exist as therapeutic ranges have only been defined for a limited number of drugs and are based on data obtained in nonpregnant patients. TDM has been suggested for anticonvulsants, antidepressants, and antiretroviral drugs, based on pharmacokinetic studies that have shown reduced drug concentrations. However, there is only relatively limited (and sometimes inconsistent) information regarding the clinical impact of these pharmacokinetic changes during pregnancy and the effect of subsequent dose adjustments. Further studies are required to determine whether implementation of TDM during pregnancy improves outcome and is associated with any benefit beyond that achieved by clinical judgment alone. The cost effectiveness of TDM programs during pregnancy also remains to be examined.

Are Non-Pharmacological Interventions Effective in Reducing Drug Use and Criminality? A Systematic and Meta-Analytical Review with an Economic Appraisal of These Interventions

PubMed Central

Perry, Amanda E.; Woodhouse, Rebecca; Neilson, Matthew; Martyn St James, Marrissa; Glanville, Julie; Hewitt, Catherine; Trépel, Dominic

2016-01-01

Background: The numbers of incarcerated people suffering from drug dependence has steadily risen since the 1980s and only a small proportion of these receive appropriate treatment. A systematic review to evaluate the effectiveness and economic evidence of non-pharmacological interventions for drug using offenders was conducted. Methods: Cochrane Collaboration criteria were used to identify trials across 14 databases between 2004 and 2014. A series of meta-analyses and an economic appraisal were conducted. Results: 43 trials were identified showing to have limited effect in reducing re-arrests RR 0.97 (95% CI 0.89–1.07) and drug use RR 0.90 (95% CI 0.80–1.00) but were found to significantly reduce re-incarceration RR 0.70 (95% CI 0.57–0.85). Therapeutic community programs were found to significantly reduce the number of re-arrests RR 0.70 (95% CI 0.56–0.87). 10 papers contained economic information. One paper presented a cost-benefit analysis and two reported on the cost and cost effectiveness of the intervention. Conclusions: We suggest that therapeutic community interventions have some benefit in reducing subsequent re-arrest. We recommend that economic evaluations should form part of standard trial protocols. PMID:27690077

20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Paying benefits in installments: Drug addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Deductions; Reductions; and Nonpayments of Benefits § 404.480 Paying benefits in installments:...

20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Paying benefits in installments: Drug addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Payment of Benefits, Overpayments, and Underpayments § 416.544 Paying benefits in installment...

Current FDA directives for promoting public health

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

Hayes, A.H. Jr.

1982-03-01

The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and leastmore » harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.« less

The economic benefits resulting from the first 8 years of the Global Programme to Eliminate Lymphatic Filariasis (2000-2007).

PubMed

Chu, Brian K; Hooper, Pamela J; Bradley, Mark H; McFarland, Deborah A; Ottesen, Eric A

2010-06-01

Between 2000-2007, the Global Programme to Eliminate Lymphatic Filariasis (GPELF) delivered more than 1.9 billion treatments to nearly 600 million individuals via annual mass drug administration (MDA) of anti-filarial drugs (albendazole, ivermectin, diethylcarbamazine) to all at-risk for 4-6 years. Quantifying the resulting economic benefits of this significant achievement is important not only to justify the resources invested in the GPELF but also to more fully understand the Programme's overall impact on some of the poorest endemic populations. To calculate the economic benefits, the number of clinical manifestations averted was first quantified and the savings associated with this disease prevention then analyzed in the context of direct treatment costs, indirect costs of lost-labor, and costs to the health system to care for affected individuals. Multiple data sources were reviewed, including published literature and databases from the World Health Organization, International Monetary Fund, and International Labour Organization An estimated US$21.8 billion of direct economic benefits will be gained over the lifetime of 31.4 million individuals treated during the first 8 years of the GPELF. Of this total, over US$2.3 billion is realized by the protection of nearly 3 million newborns and other individuals from acquiring lymphatic filariasis as a result of their being born into areas freed of LF transmission. Similarly, more than 28 million individuals already infected with LF benefit from GPELF's halting the progression of their disease, which results in an associated lifetime economic benefit of approximately US$19.5 billion. In addition to these economic benefits to at-risk individuals, decreased patient services associated with reduced LF morbidity saves the health systems of endemic countries approximately US$2.2 billion. MDA for LF offers significant economic benefits. Moreover, with favorable program implementation costs (largely a result of the sustained commitments of donated drugs from the pharmaceutical industry) it is clear that the economic rate of return of the GPELF is extremely high and that this Programme continues to prove itself an excellent investment in global health.

20 CFR 439.635 - Drug-free workplace.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Drug-free workplace. 439.635 Section 439.635 Employees' Benefits SOCIAL SECURITY ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 439.635 Drug-free workplace. Drug-free workplace means a site for the...

Differences in health behaviors and parenting knowledge between pregnant adolescents and parenting adolescents.

PubMed

Sangalang, Bernadette B; Rounds, Kathleen

2005-01-01

To better understand the differences between pregnant adolescents and parenting adolescents, we examined substance use, contraceptive behavior, and parenting knowledge among 91 first-time pregnant and parenting adolescents enrolled in an adolescent parenting case management program. After one year of program participation, pre- and post-test comparisons indicated improvements in contraception use and parenting knowledge, and increases in reported use of cigarettes, alcohol and other drugs among both groups. Adolescents who entered the program while pregnant experienced greater benefit than adolescents who entered the program already parenting. We discuss several implications for practitioners at both the programmatic and direct practice level who work with young women during pregnancy and as they transition to early parenthood.

Value for money in drug treatment: economic evaluation of prison methadone.

PubMed

Warren, Emma; Viney, Rosalie; Shearer, James; Shanahan, Marian; Wodak, Alex; Dolan, Kate

2006-09-15

Although methadone maintenance treatment in community settings is known to reduce heroin use, HIV infection and mortality among injecting drug users (IDU), little is known about prison methadone programs. One reason for this is the complexity of undertaking evaluations in the prison setting. This paper estimates the cost-effectiveness of the New South Wales (NSW) prison methadone program. Information from the NSW prison methadone program was used to construct a model of the costs of the program. The information was combined with data from a randomised controlled trial of provision of prison methadone in NSW. The total program cost was estimated from the perspective of the treatment provider/funder. The cost per heroin free day, compared with no prison methadone, was estimated. Assumptions regarding resource use were tested through sensitivity analysis. The annual cost of providing prison methadone in NSW was estimated to be 2.9 million Australian dollars (or 3,234 Australian dollars per inmate per year). The incremental cost effectiveness ratio is 38 Australian dollars per additional heroin free day. From a treatment perspective, prison methadone is no more costly than community methadone, and provides benefits in terms of reduced heroin use in prisons, with associated reduction in morbidity and mortality.

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.

78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and...

Consumer perspectives of the Australian Home Medicines Review Program: benefits and barriers.

PubMed

White, Lesley; Klinner, Christiane; Carter, Stephen

2012-01-01

The Australian Home Medicines Review (HMR) is a free consumer service to assist individuals living at home to maximize the benefits of their medicine regimen and prevent medication-related problems. It consists of a pharmacist reviewing a person's medicines and collaborating with the general practitioner to optimize the individual's medicine management. The uptake of this service has remained below the projected use, although the program has shown to successfully identify medication-related problems and improve drug knowledge and adherence of the patient. This study investigates the perceived benefits and barriers of the patients regarding the HMR service who have used the service and who are eligible for it but have never used it. Consumer perceptions were drawn from 14 semistructured focus groups, with patients and carers belonging to the general HMR target population and consumer segments that have been postulated to be underrepresented with regard to this service. The major benefits reported were acquisition of medicine information, reassurance, feeling valued and cared for, and willingness to advocate medication changes to the general practitioner. Perceived barriers were concerns regarding upsetting the general practitioner, pride and independence, confidence issues with an unknown pharmacist, privacy and safety concerns regarding the home visit, and lack of information about the program. Participants agreed that the potential benefits of the service outweighed its potential barriers. It is expected that direct-to-consumer promotion of HMRs would increase the uptake of this valuable service. It would be necessary to ensure that the process and benefits of the service are communicated clearly and sensitively to eligible patients and their carers to obviate common consumer misconceptions and/or barriers regarding the HMR service. Furthermore, any direct-to-consumer promotion of the service must enable patient/carer self-identification of eligibility. Copyright © 2012 Elsevier Inc. All rights reserved.

Issues in formulary management: therapeutic interchange. The value, cost, and quality of therapeutic interchange.

PubMed

Mahoney, C D

1992-10-01

Therapeutic interchange is a process of substituting a prescribed medication with one that offers therapeutic and cost benefits. The practice not only provides short-term savings but also is associated with decreases in lengths of stay in hospitals and total hospital drug expenses. There may be medicolegal implications when FDA-approved indications differ for interchanged drugs. The potential for liability is decreased when a standard of care is met, but since standards can change, guidelines should be reviewed regularly. High-tech, high-cost drugs are sometimes appropriate for therapeutic interchange. Pharmacy and therapeutics committees should assure best value by considering indirect expenses, quality, and therapeutic outcome, as well as product cost. Therapeutic interchange programs enable pharmacy managers to neutralize or at least slow the rate of drug cost increases, ensuring appropriate utilization of resources and more favorable patient outcomes.

The definition and role of quality of life in Germany's early assessment of drug benefit: a qualitative approach.

PubMed

Lohrberg, David; Augustin, Matthias; Blome, Christine

2016-02-01

In 2011, Germany introduced a new form of drug benefit assessment, linking reimbursement prices to drug benefit and making quality of life (QoL) one of the main benefit criteria. Thus, QoL outcomes co-determine drug prices in Germany. QoL has, however, not been defined in the regulations. This study analyzed the definition and role of QoL in Germany's drug benefit assessment. It serves as a case study on the complexity of QoL as a parameter of health technology and drug assessments, which have become mandatory in almost all industrialized countries. In a qualitative analysis, the publicly available dossiers (summaries), dossier evaluations, protocols of the oral hearings, the final resolutions of the Federal Joint Committee (G-BA) and its rationale of all benefit assessments completed by 2013 (n = 66) were processed. Additionally, quantitative data on the decision outcomes were collected. Only two decisions drew on QoL outcomes as "main justifications" for additional benefit. It was due to a lack of valid and statistically significant QoL results, a deficient presentation of QoL data, or differing understandings of QoL, that QoL benefit was not demonstrated in more than two cases. While manufacturers applied wider definitions of QoL, the assessment institutions questioned evidence if it was not reported with the help of validated QoL questionnaires or deviated from their definition of QoL. The German experience with QoL as a drug benefit criterion highlights the importance of a clear QoL definition and according methodological regulations.

Generic drugs: international trends and policy developments in Australia.

PubMed

Lofgren, Hans

2004-01-01

Public and private third-party payers in many countries encourage or mandate the use of generic drugs. This article examines the development of generics policy in Australia, against the background of a description of international trends in this area, and related experiences of reference pricing programs. The Australian generics market remains underdeveloped due to a historical legacy of small Pharmaceutical Benefits Scheme price differentials between originator brands and generics. It is argued that policy measures open to the Australian government can be conceived as clustering around two different approaches: incremental changes within the existing regulatory framework, or a shift towards a high volume/low price role of generics which would speed up the delivery of substantial cost savings, and could provide enhanced scope for the financing of new, patented drugs.

The Orphan Drug Act: Restoring the Mission to Rare Diseases.

PubMed

Daniel, Michael G; Pawlik, Timothy M; Fader, Amanda N; Esnaola, Nestor F; Makary, Martin A

2016-04-01

The Orphan Drug Act has fostered drug development for patients with rare cancers and other diseases; however, current data suggest that companies are gaming the system to use the law for mainstream drugs. We identify a pattern of pharmaceutical companies submitting drugs to the Food and Drug Administration (FDA) as orphan drugs but once approved, the drugs are used broadly off-label with the lucrative orphan drug protections and exclusivity benefits. Since the law was passed, the proportion of new FDA-approved drugs that were submitted as orphan drugs has increased with a peak last year of 41% of all FDA-approved drugs approved as orphan drugs. On the basis of the current data, we suggest that patients with rare cancers and other diseases may suffer due to dilution of the incentives and benefits. We propose reform to increase submission scrutiny, decrease benefits based on off-label use, and increase price transparency.

Drug Use in Soldiers: Family and Peer Contextual Associations.

PubMed

Habibi, Mojtaba; Darharaj, Mohammad; Kelly, Adrian B; Shahmiri, Hasan; Malekianjabali, Mona; Kheirolomoom, Seyedeh Leili

2017-08-24

Given the stressful nature of military life, people in the armed forces are vulnerable to substance use. The aim of this study was to explore the relationship between family and peers with drug use among military forces in Iran. Convenience sampling was used to recruit a total of 422 draftees doing military service in army units in Tehran, Iran. Measures of family and peers' risk and protective factors, alcohol use, and other drug use were administered. Findings indicated significant relationships between family (i.e., family models for risk behavior, parent sanctions, and family controls) and peers (i.e., peer modeling for risk behavior, peer controls, support from friends) with drug use. A multiple regression analysis revealed that peer modeling for risk behavior, family models for risk behavior, and parent sanctions were significant predictors of drug use in soldiers. These results were consistent with the influence of family and peer on drug use amongst soldiers. Programs designed to reduce alcohol and other drug use may benefit from tailoring to fit risk and protective files amongst peer and family networks.

Drugs in the news: an analysis of Canadian newspaper coverage of new prescription drugs

PubMed Central

Cassels, Alan; Hughes, Merrilee A.; Cole, Carol; Mintzes, Barbara; Lexchin, Joel; McCormack, James P.

2003-01-01

Background Patients routinely cite the media, after physicians and pharmacists, as a key source of information on new drugs, but there has been little research on the quality of drug information presented. We assessed newspaper descriptions of drug benefits and harms, the nature of the effects described and the presence or absence of other important information that can add context and balance to a report about a new drug. Methods We looked at newspaper coverage in the year 2000 of 5 prescription drugs launched in Canada between 1996 and 2001 that received a high degree of media attention: atorvastatin, celecoxib, donepezil, oseltamivir and raloxifene. We searched 24 of Canada's largest daily newspapers for articles reporting at least one benefit or harm of any of these 5 drugs. We recorded the benefits and harms reported and analyzed how such information was presented; we also determined whether clinical or surrogate outcomes were mentioned; if and how drug effects were quantified; whether contraindications, other treatment options and costs were mentioned; and whether any information on affiliations of quoted interviewees and potential conflicts of interest was presented. Results Our search yielded 193 articles reporting at least one benefit or harm for 1 of the 5 drugs. All of the articles mentioned at least one benefit, but 68% (132/193) made no mention of possible side effects or harms. Only 24% (120/510) of mentions of drug benefits and harms presented quantitative information. In 26% (31/120) of cases in which drug benefits and harms were quantified, the magnitude was presented only in relative terms, which can be misleading. Overall, 62% (119/193) of the articles gave no quantification of the benefits or harms. Thirty-seven (19%) of the 193 articles reported only surrogate benefits. Other information needed for informed drug-related decisions was often lacking: only 7 (4%) of the articles mentioned contraindications, 61 (32%) mentioned drug costs, 89 (46%) mentioned drug alternatives, and 30 (16%) mentioned nondrug treatment options (such as exercise or diet). Sixty-two percent (120/193) of the articles quoted at least one interviewee. After exclusion of industry and government spokespeople, for only 3% (5/164) of interviewees was there any mention of potential financial conflicts of interest. Twenty-six percent (15/57) of the articles discussing a study included information on study funding. Interpretation Our results raise concerns about the completeness and quality of media reporting about new medications. PMID:12719316

Drugs in the news: an analysis of Canadian newspaper coverage of new prescription drugs.

PubMed

Cassels, Alan; Hughes, Merrilee A; Cole, Carol; Mintzes, Barbara; Lexchin, Joel; McCormack, James P

2003-04-29

Patients routinely cite the media, after physicians and pharmacists, as a key source of information on new drugs, but there has been little research on the quality of drug information presented. We assessed newspaper descriptions of drug benefits and harms, the nature of the effects described and the presence or absence of other important information that can add context and balance to a report about a new drug. We looked at newspaper coverage in the year 2000 of 5 prescription drugs launched in Canada between 1996 and 2001 that received a high degree of media attention: atorvastatin, celecoxib, donepezil, oseltamivir and raloxifene. We searched 24 of Canada's largest daily newspapers for articles reporting at least one benefit or harm of any of these 5 drugs. We recorded the benefits and harms reported and analyzed how such information was presented; we also determined whether clinical or surrogate outcomes were mentioned; if and how drug effects were quantified; whether contraindications, other treatment options and costs were mentioned; and whether any information on affiliations of quoted interviewees and potential conflicts of interest was presented. Our search yielded 193 articles reporting at least one benefit or harm for 1 of the 5 drugs. All of the articles mentioned at least one benefit, but 68% (132/193) made no mention of possible side effects or harms. Only 24% (120/510) of mentions of drug benefits and harms presented quantitative information. In 26% (31/120) of cases in which drug benefits and harms were quantified, the magnitude was presented only in relative terms, which can be misleading. Overall, 62% (119/193) of the articles gave no quantification of the benefits or harms. Thirty-seven (19%) of the 193 articles reported only surrogate benefits. Other information needed for informed drug-related decisions was often lacking: only 7 (4%) of the articles mentioned contraindications, 61 (32%) mentioned drug costs, 89 (46%) mentioned drug alternatives, and 30 (16%) mentioned nondrug treatment options (such as exercise or diet). Sixty-two percent (120/193) of the articles quoted at least one interviewee. After exclusion of industry and government spokespeople, for only 3% (5/164) of interviewees was there any mention of potential financial conflicts of interest. Twenty-six percent (15/57) of the articles discussing a study included information on study funding. Our results raise concerns about the completeness and quality of media reporting about new medications.

Ovarian Cancer Prevention Program

DTIC Science & Technology

1999-10-01

replacement therapy within the last 6 months? Has the participant used non - steroidal anti - inflammatory drugs (NSAED’s) greater than 3 times per month in...contacting of family members, use of specimens for future cancer studies, registry rights, benefits, risks and costs of participation, confidentiality, and...to conduct interviews. Results of the interviews will be used to create a symptom checklist to pilot among 50 women participating in a high risk

Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

PubMed

Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

2013-10-01

The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting will add more benefits to the existing programmes in Malaysia, although the barrier that we are facing now is the doubt that they hold over patients' ability to write valid reports which are similar to reports which are made by healthcare professionals (HCPs). Therefore, the consumers need to be educated more about their medications, on how to validate any complaints that they had about the drug consumption and on how to file a proper report and channel it to the 'right' person or bodies. Equally importantly, the media and the non-governmental organizations (NGOs) should play an important role in determining the success of consumer reporting.

Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

PubMed Central

Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

2013-01-01

Aim: The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). Methodology: A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Results: Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. Conclusion: The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting will add more benefits to the existing programmes in Malaysia, although the barrier that we are facing now is the doubt that they hold over patients’ ability to write valid reports which are similar to reports which are made by healthcare professionals (HCPs). Therefore, the consumers need to be educated more about their medications, on how to validate any complaints that they had about the drug consumption and on how to file a proper report and channel it to the ‘right’ person or bodies. Equally importantly, the media and the non-governmental organizations (NGOs) should play an important role in determining the success of consumer reporting. PMID:24298470

Pharmaceutical policy reform in Canada: lessons from history.

PubMed

Boothe, Katherine

2018-07-01

Canada is the only country with a broad public health system that does not include universal, nationwide coverage for pharmaceuticals. This omission causes real hardship to those Canadians who are not well-served by the existing patchwork of limited provincial plans and private insurance. It also represents significant forgone benefits in terms of governments' ability to negotiate drug prices, make expensive new drugs available to patients on an equitable basis, and provide integrated health services regardless of therapy type or location. This paper examines Canada's historical failure to adopt universal pharmaceutical insurance on a national basis, with particular emphasis on the role of public and elite ideas about its supposed lack of affordability. This legacy provides novel lessons about the barriers to reform and potential methods for overcoming them. The paper argues that reform is most likely to be successful if it explicitly addresses entrenched ideas about pharmacare's affordability and its place in the health system. Reform is also more likely to achieve universal coverage if it is radical, addressing various components of an effective pharmaceutical program simultaneously. In this case, an incremental approach is likely to fail because it will not allow governments to contain costs and realize the social benefits that come along with a universal program, and because it means forgoing the current promising conditions for achieving real change.

Perspectives on benefit-risk decision-making in vaccinology: Conference report.

PubMed

Greenberg, M; Simondon, F; Saadatian-Elahi, M

2016-01-01

Benefit/risk (B/R) assessment methods are increasingly being used by regulators and companies as an important decision-making tool and their outputs as the basis of communication. B/R appraisal of vaccines, as compared with drugs, is different due to their attributes and their use. For example, vaccines are typically given to healthy people, and, for some vaccines, benefits exist both at the population and individual level. For vaccines in particular, factors such as the benefit afforded through herd effects as a function of vaccine coverage and consequently impact the B/R ratio, should also be taken into consideration and parameterized in B/R assessment models. Currently, there is no single agreed methodology for vaccine B/R assessment that can fully capture all these aspects. The conference "Perspectives on Benefit-Risk Decision-making in Vaccinology," held in Annecy (France), addressed these issues and provided recommendations on how to advance the science and practice of B/R assessment of vaccines and vaccination programs.

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

PubMed

Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet

2018-01-01

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Curbing the costly trend: exploring the need for a progressive approach to the management of specialty pharmaceuticals under the medical benefit.

PubMed

Jacobs, Michael S; Johnson, Kjel A

2012-07-01

Specialty injectables and protein-based biologic therapies represent the fastest growing segment of the drug trend for many plan sponsors. Coupled with the decline in spending on traditional pharmaceuticals and so-called blockbuster drugs coming off patent, the upward trend of specialty drug spending continues at an unprecedented rate, precipitating a shift in the focus of payers who manage prescription drugs. To characterize the current and future specialty drug spending and describe contemporary trends among payers for managing cost and quality in this segment, as well as to elucidate the shortcomings of the current efforts and to explore a comprehensive approach for addressing the cost and quality concerns directly associated with specialty injectables and protein-based biologics through interrelated management interventions. Although a notable decrease in spending on traditional pharmaceuticals was realized in 2010, disproportionate increases in specialty drug utilization and cost per unit fueled the continuing growth of the injectable and biologic markets. Each course of these therapies can cost in the tens of thousands of dollars, and this upward trend of specialty spending represents an escalation of an already significant spending for payers, employers, and members. Beyond the high cost and growing utilization of specialty pharmaceuticals, current management efforts have been met with variable degrees of success and have often proved challenging and, in some cases, even counterproductive. Common interventions used by payers nationwide for addressing specialty drug spending trend include specialty drug formularies, provider reimbursement strategies, distribution channel management, benefit design modifications, utilization management, and operational and administrative improvements such as postclaim edits. Although often overlooked, appropriate implementation of these tactics, and the extent to which they are integrated with overall drug benefit management, are key to the success of the pharmaceutical management program. Conventional specialty pharmaceutical management initiatives offer promise in various areas, but incentives for the best protocols may be misaligned when they are applied individually. Conversely, a comprehensive approach that integrates effective components of the specialty pharmaceutical management interventions can improve the quality of care and control costs associated with these agents, with significant specialty drug management expertise and access to benchmarking data serving as the foundation for appropriate decision-making.

Emerging growth factor receptor antagonists for the treatment of renal cell carcinoma.

PubMed

Zahoor, Haris; Rini, Brian I

2016-12-01

The landscape of systemic treatment for metastatic renal cell carcinoma (RCC) has dramatically changed with the introduction of targeted agents including vascular endothelial growth factor (VEGF) inhibitors. Recently, multiple new agents including growth factor receptor antagonists and a checkpoint inhibitor were approved for the treatment of refractory metastatic RCC based on encouraging benefit shown in clinical trials. Areas covered: The background and biological rationale of existing treatment options including a brief discussion of clinical trials which led to their approval, is presented. This is followed by reviewing the limitations of these therapeutic options, medical need to develop new treatments and major goals of ongoing research. We then discuss two recently approved growth factor receptor antagonists i.e. cabozantinib and lenvatinib, and a recently approved checkpoint inhibitor, nivolumab, and issues pertaining to drug development, and future directions in treatment of metastatic RCC. Expert opinion: Recently approved growth factor receptor antagonists have shown encouraging survival benefit but associated drug toxicity is a major issue. Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, has similarly shown survival benefit and is well tolerated. With multiple options now available in this patient population, the right sequence of these agents remains to be determined.

Interdisciplinary research training in substance abuse and addictions.

PubMed

Thompson, Elaine Adams

2013-01-01

Considerable evidence shows that the management of complex problems of and related to substance abuse and addictions require comprehensive approaches based on solid research. Nonetheless, timely and widespread dissemination of research findings remains uncommon, hindering nursing practice, impeding the health of individuals and families, and imposing untoward costs for society. Shifts in science paradigms underscore the need for efficient and effective interdisciplinary research teams to carry out innovative research within a translational science framework. This means that early career investigators will need the knowledge and skills to conduct research as part of an interdisciplinary team and to contribute systematically to translational research in the area of substance abuse and addictions. This brief report describes a nursing research training program sponsored by the National Institute on Drug Abuse that evolved into an interdisciplinary program administrated within a school of nursing. Factors conducive to program development are described, along with the structure and elements of the program and examples of the scholars' projects and accomplishments. The common benefits of interdisciplinary research training for both predoctoral and postdoctoral research scholars include consistent exposure to new and alternative scientific models and methodological approaches as well as endurance of cross-discipline network connections. Benefits and challenges of this program carry implications for the design of future nursing research training programs in the field of substance abuse and addictions.

Harms and benefits associated with psychoactive drugs: findings of an international survey of active drug users

PubMed Central

Morgan, Celia JA; Noronha, Louise A; Muetzelfeldt, Mark; Fielding, Amanda

2013-01-01

There have been several recent efforts in the UK and the Netherlands to describe the harms of psychoactive substances based on ratings of either experts or drug users. This study aimed to assess the perceived benefits as well as harms of widely used recreational drugs, both licit and illicit, in an international sample of drug users. The survey was hosted at https://www.internationaldrugsurvey.org/ and was available in three languages. Residents reported their experience of 15 commonly used drugs or drug classes; regular users then rated their harms and benefits. In all, 5791 individuals from over 40 countries completed the survey, although the majority were from English speaking countries. Rankings of drugs differed across 10 categories of perceived benefits. Skunk and herbal cannabis were ranked consistently beneficial, whilst alcohol and tobacco fell below many classified drugs. There was no correlation at all between users’ harm ranking of drugs and their classification in schedules of the USA or ABC system in the UK. Prescription analgesics, alcohol and tobacco were ranked within the top 10 most harmful drugs. These findings suggest that neither the UK nor US classification systems act to inform users of the harms of psychoactive substances. It is hoped the results might inform health professionals and educators of what are considered to be both the harms and benefits of psychoactive substances to young people. PMID:23438502

42 CFR 423.908. - Phased-down State contribution to drug benefit costs assumed by Medicare.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Phased-down State contribution to drug benefit costs assumed by Medicare. 423.908. Section 423.908. Public Health CENTERS FOR MEDICARE & MEDICAID... Provisions § 423.908. Phased-down State contribution to drug benefit costs assumed by Medicare. This subpart...

Novel drugs in clinical development for hepatocellular carcinoma.

PubMed

Waidmann, Oliver; Trojan, Jörg

2015-01-01

Sorafenib is the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). Within recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development either due to toxicity or lack of benefit. This review covers recent clinical data on systemic agents and ongoing trials in patients with advanced HCC. In unselected patients with advanced HCC, disappointing results have been reported from several large trials. However, in two subgroups encouraging results have been achieved. Treatment with the MET inhibitor tivantinib resulted in a substantial survival benefit in the subgroup of MET overexpressing tumors in a randomized Phase II trial. Furthermore, the vascular endothelial growth factor receptor 2 antibody ramucirumab resulted in improved overall survival in patients with baseline α-fetoprotein (AFP) ≥ 400 ng/ml in a Phase III trial. These two agents, and several others, will be further developed in HCC. Moreover, immunotherapeutics such as checkpoint inhibitors, programmed death receptor-1 blocking antibodies and oncolytic viruses are under investigation in advanced HCC.

Risks versus benefits of medication use during pregnancy: what do women perceive?

PubMed

Mulder, Bianca; Bijlsma, Maarten J; Schuiling-Veninga, Catharina Cm; Morssink, Leonard P; van Puijenbroek, Eugene; Aarnoudse, Jan G; Hak, Eelko; de Vries, Tjalling W

2018-01-01

Understanding perception of risks and benefits is essential for informed patient choices regarding medical care. The primary aim of this study was to evaluate the perception of risks and benefits of 9 drug classes during pregnancy and associations with women's characteristics. Questionnaires were distributed to pregnant women who attended a Dutch Obstetric Care facility (first- and second-line care). Mean perceived risk and benefit scores were computed for 9 different drug classes (paracetamol, antacids, antibiotics, antifungal medication, drugs against nausea and vomiting, histamine-2 receptor antagonists/proton pump inhibitors, antidepressants, nonsteroidal anti-inflammatory drugs, and sedatives/anxiolytics). For each participant, we computed weighted risk and benefit sum scores with principal component analysis. In addition, major concerns regarding medication use were evaluated. The questionnaire was completed by 136 women (response rate 77%). Pregnant women were most concerned about having a child with a birth defect (35%), a miscarriage (35%), or their child developing an allergic disease (23%), respectively, as a result of drug use. The majority of studied drug classes were perceived relatively low in risk and high in benefit. Higher risk scores were reported if women were in their first trimesters of pregnancy ( p =0.007). Lower benefit scores were reported if women were single ( p =0.014), smoking ( p =0.028), nulliparous ( p =0.006), or did not have a family history of birth defects ( p =0.005). Pregnant women's concerns regarding potential drug adverse effects were not only focused on congenital birth defects but also included a wider range of adverse outcomes. This study showed that most of the studied drug classes were perceived relatively low in risk and high in benefit.

Improving Coverage and Compliance in Mass Drug Administration for the Elimination of LF in Two ‘Endgame’ Districts in Indonesia Using Micronarrative Surveys

PubMed Central

Krentel, Alison; Damayanti, Rita; Titaley, Christiana Rialine; Suharno, Nugroho; Bradley, Mark; Lynam, Timothy

2016-01-01

Background As the Global Programme to Eliminate Lymphatic Filariasis (LF) approaches its 2020 goal, an increasing number of districts will enter the endgame phase where drug coverage rates from mass drug administration (MDA) are used to assess whether MDA can be stopped. As reported, the gap between reported and actual drug coverage in some contexts has overestimated the true rates, thus causing premature administration of transmission assessment surveys (TAS) that detect ongoing LF transmission. In these cases, districts must continue with additional rounds of MDA. Two districts in Indonesia (Agam District, Depok City) fit this criteria—one had not met the pre-TAS criteria and the other, had not passed the TAS criteria. In both cases, the district health teams needed insight into their drug delivery programs in order to improve drug coverage in the subsequent MDA rounds. Methodology/Principal Findings To inform the subsequent MDA round, a micronarrative survey tool was developed to capture community members’ experience with MDA and the social realm where drug delivery and compliance occur. A baseline survey was implemented after the 2013 MDA in endemic communities in both districts using the EPI sampling criteria (n = 806). Compliance in the last MDA was associated with perceived importance of the LF drugs for health (p<0.001); perceived safety of the LF drugs (p<0.001) and knowing someone in the household has complied (p<0.001). Results indicated that specialized messages were needed to reach women and younger men. Both districts used these recommendations to implement changes to their MDA without additional financial support. An endline survey was performed after the 2014 MDA using the same sampling criteria (n = 811). Reported compliance in the last MDA improved in both districts from 57% to 77% (p<0.05). Those who reported having ever taken the LF drug rose from 79% to 90% (p<0.001) in both sites. Conclusions/Significance Micronarrative surveys were shown to be a valid and effective tool to detect operational issues within MDA programs. District health staff felt ownership of the results, implementing feasible changes to their programs that resulted in significant improvements to coverage and compliance in the subsequent MDA. This kind of implementation research using a micronarrative survey tool could benefit underperforming MDA programs as well as other disease control programs where a deeper understanding is needed to improve healthcare delivery. PMID:27812107

What Happens After Treatment? Long-Term Effects of Continued Substance Use, Psychiatric Problems and Help-Seeking on Social Status of Alcohol-Dependent Individuals.

PubMed

Karriker-Jaffe, Katherine J; Witbrodt, Jane; Subbaraman, Meenakshi S; Kaskutas, Lee Ann

2018-03-30

We examined whether alcohol-dependent individuals with sustained substance use or psychiatric problems after completing treatment were more likely to experience low social status and whether continued help-seeking would improve outcomes. Ongoing alcohol, drug and psychiatric problems after completing treatment were associated with increased odds of low social status (unemployment, unstable housing and/or living in high-poverty neighborhood) over 7 years. The impact of drug problems declined over time, and there were small, delayed benefits of AA attendance on social status. Alcohol-dependent individuals sampled from public and private treatment programs (N = 491; 62% male) in Northern California were interviewed at treatment entry and 1, 3, 5 and 7 years later. Random effects models tested relationships between problem severity (alcohol, drug and psychiatric problems) and help-seeking (attending specialty alcohol/drug treatment and Alcoholics Anonymous, AA) with low social status (unemployment, unstable housing and/or living in a high-poverty neighborhood) over time. The proportion of participants experiencing none of the indicators of low social status increased between baseline and the 1-year follow-up and remained stable thereafter. Higher alcohol problem scores and having any drug and/or psychiatric problems in the years after treatment were associated with increased odds of low social status over time. An interaction of drug problems with time indicated the impact of drug problems on social status declined over the 7-year period. Both treatment-seeking and AA attendance were associated with increased odds of low social status, although lagged models suggested there were small, delayed benefits of AA attendance on improved social status over time. Specialty addiction treatment alone was not sufficient to have positive long-term impacts on social status and social integration of most alcohol-dependent people.

Fair Balance? An Analysis of the Functional Equivalence of Risk and Benefit Information in Prescription Drug Direct-to-Consumer Television Advertising

ERIC Educational Resources Information Center

Baird-Harris, Kay

2009-01-01

Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…

How excluding some benefits from value assessment of new drugs impacts innovation.

PubMed

Cook, Joseph P; Golec, Joseph

2017-12-01

Payers often assess the benefits of new drugs relative to costs for reimbursement purposes, but they frequently exclude some drugs' option-related benefits, reducing their reimbursement chances, and making them less attractive R&D investments. We develop and test a real options model of R&D investment that shows that excluding option-related benefits heightens drug developers' incentives to avoid high-risk (volatile) R&D investments and instead encourages them to focus on "safer" (positively skewed) investments. Our model and empirical results could partly explain the decline in the number of risky new molecular entities. Copyright © 2017 John Wiley & Sons, Ltd.

Drug Treatment Service Utilization and Outcomes for Hispanic and White Methamphetamine Abusers

PubMed Central

Niv, Noosha; Hser, Yih-Ing

2006-01-01

Objective To examine differences in drug treatment service needs, utilization, satisfaction, and outcomes between Hispanic and white methamphetamine (meth) abusers. Data Sources Intake assessments and follow-up interviews of 128 Hispanic and 371 non-Hispanic white meth abusers admitted during 2000–2001 to 43 drug treatment programs in 13 counties across California. Study Design A prospective longitudinal study comparing ethnic differences in problem severity during pre- and posttreatment periods, as well as in services received during treatment. Data Collection/Extraction Methods The Addiction Severity Index (ASI) was administered at both intake and the 9-month follow-up to assess clients' problem severity in a number of domains. Service utilization and satisfaction were assessed 3 months following treatment admission. Principal Findings Hispanics were less educated and reported more employment difficulties than whites. Whites were more likely to be treated in residential programs than Hispanics despite similar severity in drug and alcohol use, legal, medical and family/social problems, and psychiatric status. Significantly more whites than Hispanics received psychiatric services, likely because more of them were treated in residential programs. Whites also reported receiving greater numbers of total services and services addressing alcohol and psychiatric problems. While no ethnic differences were found in treatment satisfaction and several other outcomes, Hispanics demonstrated better family and social outcomes than whites. Conclusions Both Hispanic and white meth abusers improved after treatment, although benefits from treatment can be further enhanced if services underscore different facets of their psychosocial problems. PMID:16899005

Parenting While Incarcerated: Tailoring the Strengthening Families Program for Use with Jailed Mothers.

PubMed

Miller, Alison L; Weston, Lauren E; Perryman, Jamie; Horwitz, Talia; Franzen, Susan; Cochran, Shirley

2014-09-01

Most incarcerated women are mothers. Parenting programs may benefit women, children and families, yet effectively intervening in correctional settings is a challenge. An evidence-based parenting intervention (the Strengthening Families Program) was tailored and implemented with women in a jail setting. Goals were to assess mothers' needs and interests regarding parenting while they were incarcerated, adapt the program to address those needs, and establish intervention delivery and evaluation methods in collaboration with a community-based agency. Women reported wanting to know more about effective communication; how children manage stress; finances; drug and alcohol use; self-care; and stress reduction. They reported high program satisfaction and reported reduced endorsement of corporal punishment after the intervention. Barriers to implementation included unpredictable attendance from session to session due to changing release dates, transfer to other facilities, and jail policies (e.g., lock-down; commissary hours). Implications for sustainable implementation of parenting programs in jail settings are discussed.

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.

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer.

PubMed

Raju, G K; Gurumurthi, K; Domike, R; Kazandjian, D; Blumenthal, G; Pazdur, R; Woodcock, J

2016-12-01

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analyses. There is much interest in quantifying regulatory approaches to benefit and risk. In this work the use of a quantitative benefit-risk analysis was applied to regulatory decision-making about new drugs to treat advanced non-small cell lung cancer (NSCLC). Benefits and risks associated with 20 US Food and Drug Administration (FDA) decisions associated with a set of candidate treatments submitted between 2003 and 2015 were analyzed. For benefit analysis, the median overall survival (OS) was used where available. When not available, OS was estimated based on overall response rate (ORR) or progression-free survival (PFS). Risks were analyzed based on magnitude (or severity) of harm and likelihood of occurrence. Additionally, a sensitivity analysis was explored to demonstrate analysis of systematic uncertainty. FDA approval decision outcomes considered were found to be consistent with the benefit-risk logic. © 2016 American Society for Clinical Pharmacology and Therapeutics.

Right-to-try laws and individual patient "compassionate use" of experimental oncology medications: A call for improved provider-patient communication.

PubMed

Hoerger, Michael

2016-01-01

The U.S. Food and Drug Administration's Expanded Access program allows patients with life-threatening diagnoses, such as advanced cancer, to use experimental medications without participating in clinical research (colloquially, "Compassionate Use"). Sixteen U.S. states recently passed "right-to-try" legislation aimed at promoting Expanded Access. Acknowledging popular support, Expanded Access could undermine clinical trials that benefit public health. Moreover, existing norms in oncologic care, for example, often lead patients to pursue intense treatments near the end of life, at the expense of palliation, and improved communication about the risks and benefits of Expanded Access would more often discourage its use.

The Drug Facts Box: Improving the communication of prescription drug information.

PubMed

Schwartz, Lisa M; Woloshin, Steven

2013-08-20

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

The Drug Facts Box: Improving the communication of prescription drug information

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven

2013-01-01

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130

Nonimaging detectors in drug development and approval.

PubMed

Wagner, H N

2001-07-01

Regulatory applications for imaging biomarkers will expand in proportion to the validation of specific parameters as they apply to individual questions in the management of disease. This validation is likely to be applicable only to a particular class of drug or a single mechanism of action. Awareness among the world's regulatory authorities of the potential for these emerging technologies is high, but so is the cost to the sponsor (including the logistics of including images in a dossier), and therefore the pharmaceutical industry must evaluate carefully the potential benefit of each technology for its drug development programs, just as the authorities must consider carefully the extent to which the method is valid for the use to which the applicant has put it. For well-characterized tracer systems, it may be possible to design inexpensive cameras that make rapid assessments.

Population Size Estimates for Men who Have Sex with Men and Persons who Inject Drugs.

PubMed

Oster, Alexandra M; Sternberg, Maya; Lansky, Amy; Broz, Dita; Wejnert, Cyprian; Paz-Bailey, Gabriela

2015-08-01

Understanding geographic variation in the numbers of men who have sex with men (MSM) and persons who inject drugs (PWID) is critical to targeting and scaling up HIV prevention programs, but population size estimates are not available at generalizable sub-national levels. We analyzed 1999-2010 National Health and Nutrition Examination Survey data on persons aged 18-59 years. We estimated weighted prevalence of recent (past 12 month) male-male sex and injection drug use by urbanicity (the degree to which a geographic area is urban) and US census region and calculated population sizes. Large metro areas (population ≥1,000,000) had higher prevalence of male-male sex (central areas, 4.4% of men; fringe areas, 2.5%) compared with medium/small metro areas (1.4%) and nonmetro areas (1.1%). Injection drug use did not vary by urbanicity and neither varied by census region. Three-quarters of MSM, but only half of PWID, resided in large metro areas. Two-thirds of MSM and two-thirds of PWID resided in the South and West. Efforts to reach MSM would benefit from being focused in large metro areas, while efforts to reach PWID should be delivered more broadly. These data allow for more effective allocation of funds for prevention programs.

Using the RxNorm web services API for quality assurance purposes.

PubMed

Peters, Lee; Bodenreider, Olivier

2008-11-06

Auditing large, rapidly evolving terminological systems is still a challenge. In the case of RxNorm, a standardized nomenclature for clinical drugs, we argue that quality assurance processes can benefit from the recently released application programming interface (API) provided by RxNav. We demonstrate the usefulness of the API by performing a systematic comparison of alternative paths in the RxNorm graph, over several thousands of drug entities. This study revealed potential errors in RxNorm, currently under review. The results also prompted us to modify the implementation of RxNav to navigate the RxNorm graph more accurately. The RxNav web services API used in this experiment is robust and fast.

Using the RxNorm Web Services API for Quality Assurance Purposes

PubMed Central

Peters, Lee; Bodenreider, Olivier

2008-01-01

Auditing large, rapidly evolving terminological systems is still a challenge. In the case of RxNorm, a standardized nomenclature for clinical drugs, we argue that quality assurance processes can benefit from the recently released application programming interface (API) provided by RxNav. We demonstrate the usefulness of the API by performing a systematic comparison of alternative paths in the RxNorm graph, over several thousands of drug entities. This study revealed potential errors in RxNorm, currently under review. The results also prompted us to modify the implementation of RxNav to navigate the RxNorm graph more accurately. The RxNorm web services API used in this experiment is robust and fast. PMID:18999038

Benefit-risk analysis : a brief review and proposed quantitative approaches.

PubMed

Holden, William L

2003-01-01

Given the current status of benefit-risk analysis as a largely qualitative method, two techniques for a quantitative synthesis of a drug's benefit and risk are proposed to allow a more objective approach. The recommended methods, relative-value adjusted number-needed-to-treat (RV-NNT) and its extension, minimum clinical efficacy (MCE) analysis, rely upon efficacy or effectiveness data, adverse event data and utility data from patients, describing their preferences for an outcome given potential risks. These methods, using hypothetical data for rheumatoid arthritis drugs, demonstrate that quantitative distinctions can be made between drugs which would better inform clinicians, drug regulators and patients about a drug's benefit-risk profile. If the number of patients needed to treat is less than the relative-value adjusted number-needed-to-harm in an RV-NNT analysis, patients are willing to undergo treatment with the experimental drug to derive a certain benefit knowing that they may be at risk for any of a series of potential adverse events. Similarly, the results of an MCE analysis allow for determining the worth of a new treatment relative to an older one, given not only the potential risks of adverse events and benefits that may be gained, but also by taking into account the risk of disease without any treatment. Quantitative methods of benefit-risk analysis have a place in the evaluative armamentarium of pharmacovigilance, especially those that incorporate patients' perspectives.

Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis.

PubMed

Adams, Crystal

2016-02-18

The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.

Early benefit assessment of new drugs in Germany - results from 2011 to 2012.

PubMed

Hörn, Helmut; Nink, Katrin; McGauran, Natalie; Wieseler, Beate

2014-06-01

Rising drug costs in Germany led to the Act on the Reform of the Market for Medicinal Products (AMNOG) in January 2011. For new drugs, pharmaceutical companies have to submit dossiers containing all available evidence to demonstrate an added benefit versus an appropriate comparator therapy. The Federal Joint Committee (G-BA), the main decision-making body of the statutory healthcare system, is responsible for the overall procedure of "early benefit assessment". The Institute for Quality and Efficiency in Health Care (IQWiG) largely conducts the dossier assessments, which inform decisions by the G-BA on added benefit and support price negotiations. Of the 25 dossiers (excluding orphan drugs) assessed until 31 December 2012, 14 contained sufficient data from randomized active-controlled trials investigating patient-relevant outcomes or at least acceptable surrogates; 11 contained insufficient data. The most common indications were oncology (6) and viral infections (4). For the 14 drugs assessed, the extent of added benefit was rated as minor, considerable, and non-quantifiable in 3, 8, and 2 cases; the remaining drug showed no added benefit. Despite some shortcomings, for the first time it has been possible in Germany to implement a systematic procedure for assessing new drugs at market entry, thus providing support for price negotiations and informed decision-making for patients, clinicians and policy makers. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The inverse benefit law: how drug marketing undermines patient safety and public health.

PubMed

Brody, Howard; Light, Donald W

2011-03-01

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.

Consumer perceptions of prescription and over-the-counter drug advertisements with promotional offers.

PubMed

Aikin, Kathryn J; Sullivan, Helen W; O'Donoghue, Amie C; Betts, Kevin R

2016-01-01

Information on the effects of promotional offers in direct-to-consumer prescription drug ads is limited. In two studies, we examined the effect of promotional offers (e.g., money-back guarantee) and ad type (creating prescription and over-the-counter drug ads by varying the presence of benefit and risk information). We found little effect of promotional offers. Adding benefit (risk) information to the ad increased consumers' knowledge of the benefit (risk) information and their efficacy (risk) perceptions. In most cases, adding risk information to an ad with benefit information increased risk knowledge and perceptions without decreasing benefit knowledge or perceptions.

Post-marketing surveillance of methadone and buprenorphine in the United States.

PubMed

Dasgupta, Nabarun; Bailey, Elise J; Cicero, Theodore; Inciardi, James; Parrino, Mark; Rosenblum, Andrew; Dart, Richard C

2010-07-01

There have been recent increases in the use of methadone and buprenorphine in the United States. Methadone is increasingly being used for pain management, and buprenorphine use has expanded to include treatment for opioid addiction, leading to exposures of these drugs in new populations. There is a debate about the relative safety of these two drugs in routine outpatient medical use. Data from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Programs were used to analyze rates of abuse, misuse, and diversion using the Drug Diversion, Key Informant, Poison Center and Opioid Treatment Programs, 2003-2007. National rate and rate ratios were calculated using population and person-time exposed denominators. Detailed data are presented on severity of medical outcome and drug formulations. Between 2003 and 2007, there were steady increases in the rates of abuse, misuse, and diversion of both methadone and buprenorphine. Rate ratios (per 100,000 population per quarter) of abuse, misuse, and diversion were consistently higher for methadone than buprenorphine. RADARS System poison centers received 7,476 calls for methadone and 1,117 calls for buprenorphine. After accounting for availability, there were higher rates of calls for methadone misuse, abuse, and diversion than buprenorphine in three of the four programs. The numbers of exposures requiring medical attention correspond to 46.8% and 25.8% of all calls, for methadone and buprenorphine, respectively. The most commonly diverted form of methadone was solid oral tablets (which are typically dispensed at pharmacies, not at opioid treatment programs), comprising 73% of cases. Buprenorphine appears to have a better safety profile than methadone during routine outpatient medical use. However, both medications have roles in the treatment of pain and opioid addiction, and further research into their respective benefits and risks should be conducted.

Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

PubMed

Kopp, S W; Bang, H K

2000-01-01

As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

Intergenerational effects of parental substance-related convictions and adult drug treatment court participation on children's school performance.

PubMed

Gifford, Elizabeth J; Sloan, Frank A; Eldred, Lindsey M; Evans, Kelly E

2015-09-01

This study examined the intergenerational effects of parental conviction of a substance-related charge on children's academic performance and, conditional on a conviction, whether completion of an adult drug treatment court (DTC) program was associated with improved school performance. State administrative data from North Carolina courts, birth records, and school records were linked for 2005-2012. Math and reading end-of-grade test scores and absenteeism were examined for 5 groups of children, those with parents who: were not convicted on any criminal charge, were convicted on a substance-related charge and not referred by a court to a DTC, were referred to a DTC but did not enroll, enrolled in a DTC but did not complete, and completed a DTC program. Accounting for demographic and socioeconomic factors, the school performance of children whose parents were convicted of a substance-related offense was worse than that of children whose parents were not convicted on any charge. These differences were statistically significant but substantially reduced after controlling for socioeconomic characteristics; for example, mother's educational attainment. We found no evidence that parent participation in an adult DTC program led to improved school performance of their children. While the children of convicted parents fared worse on average, much--but not all--of this difference was attributed to socioeconomic factors, with the result that parental conviction remained a risk factor for poorer school performance. Even though adult DTCs have been shown to have other benefits, we could detect no intergenerational benefit in improved school performance of their children. (c) 2015 APA, all rights reserved).

20 CFR 404.470 - Nonpayment of disability benefits due to noncompliance with rules regarding treatment for drug...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Nonpayment of disability benefits due to noncompliance with rules regarding treatment for drug addiction or alcoholism. 404.470 Section 404.470 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Deductions; Reductions; and Nonpayment...

Outcomes and Pharmacoeconomic Analysis of a Home Intravenous Antibiotic Infusion Program in Veterans.

PubMed

Ruh, Christine A; Parameswaran, Ganapathi I; Wojciechowski, Amy L; Mergenhagen, Kari A

2015-11-01

The use of outpatient parenteral antibiotic therapy (OPAT) programs has become more frequent because of benefits in costs with equivalent clinical outcomes compared with inpatient care. The purpose of this study was to evaluate the outcomes of our program. A modified pharmacoeconomic analysis was performed to compare costs of our program with hospital or rehabilitation facility care. This was a retrospective chart review of 96 courses of OPAT between April 1, 2011, and July 31, 2013. Clinical failures were defined as readmission or death due to worsening infection or readmission secondary to adverse drug event (ADE) to antibiotic therapy. This does not include those patients readmitted for reasons not associated with OPAT therapy, including comorbidities or elective procedures. Baseline characteristics and program-specific data were analyzed. Statistically significant variables were built into a multivariate logistic regression model to determine predictors of failure. A pharmacoeconomic analysis was performed with the use of billing records. Of the total episodes evaluated, 17 (17.71%) clinically failed therapy, and 79 (82.29%) were considered a success. In the multivariate analysis, number of laboratory draws (P = 0.02) and occurrence of drug reaction were significant in the final model, P = 0.02 and P = 0.001, respectively. The presence an adverse drug reaction increases the odds of failure (OR = 10.10; 95% CI, 2.69-44.90). Compared with inpatient or rehabilitation care, the cost savings was $6,932,552.03 or $2,649,870.68, respectively. In our study, patients tolerated OPAT well, with a low number of failures due to ADE. The clinical outcomes and cost savings of our program indicate that OPAT can be a viable alternative to long-term inpatient antimicrobial therapy. Published by Elsevier Inc.

Rooting out institutional corruption to manage inappropriate off-label drug use.

PubMed

Rodwin, Marc A

2013-01-01

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

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

Estimating preferences for modes of drug administration: The case of US healthcare professionals.

PubMed

Tetteh, Ebenezer K; Morris, Steve; Titchener-Hooker, Nigel

2018-01-01

There are hidden drug administration costs that arise from a mismatch between end-user preferences and how manufacturers choose to formulate their drug products for delivery to patients. The corollary of this is: there are "intangible benefits" from considering end-user preferences in manufacturing patient-friendly medicines. It is important then to have some idea of what pharmaceutical manufacturers should consider in making patient-friendly medicines and of the magnitude of the indirect benefits from doing so. This study aimed to evaluate preferences of healthcare professionals in the US for the non-monetary attributes of different modes of drug administration. It uses these preference orderings to compute a monetary valuation of the indirect benefits from making patient-friendly medicines. A survey collected choice preferences of a sample of 210 healthcare professionals in the US for two unlabelled drug options. These drugs were identical except in the levels of attributes of drug administration. Using the choice data collected, statistical models were estimated to compute gross welfare benefits, measured by the expected compensating variation, from making drugs in a more patient-friendly manner. The monetary value of end-user benefits from developing patient-friendly drug delivery systems is: (1) as large as the annual acquisition costs per full treatment episode for some biologic drugs; and (2) likely to fall in the "high end" of the distribution of the direct monetary costs of drug administration. An examination of end-user preferences should help manufacturers make more effective and efficient use of limited resources for innovations in drug delivery system, or manufacturing research in general. Copyright © 2017 Elsevier Inc. All rights reserved.

Army Science Board: Report of the Ad Hoc Subgroup on the Army Community and Their Families

DTIC Science & Technology

1989-05-01

is viewed as a desirable option for young men and women who seek skilled employment, career advancement, job stability, and need employee benefits...Relationship Effectiveness Training (RET) and the Community Counseling Center (CCC). These services deal with a wide range of emotional , drug, alcohol, spouse...they increase family self-sufficiency. One program that needs to be strengthened is that of training families in the techniques of effective arenting

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

PubMed Central

Hernandez, J. Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M.; Molinski, Steven V.

2017-01-01

The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike. PMID:29184849

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

PubMed

Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

2017-01-01

The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

Hispanic Parenting Women in Women-Only versus Mixed-Gender Drug Treatment: A 10-Year Prospective Study

PubMed Central

Hser, Yih-Ing; Hunt, Samantha A.; Evans, Elizabeth; Chang, Yen-Jung; Messina, Nena P.

2012-01-01

The present study examined Hispanic substance-using parenting women treated in women-only (WO; n=126) versus mixed-gender (MG; n=853) programs and associated outcomes assessed 10 years after admission. Relative to other races/ethnicities of women admitted to the set of 40 California treatment programs in 2000–2002, Hispanic women were underrepresented in WO programs. Compared to those in MG programs, Hispanic women in WO programs demonstrated more severe treatment needs, indicated by their greater severity in drug and alcohol use, health and mental health problems, and criminal justice involvement at admission. They also had fewer economic resources (15% WO vs. 23% MG were employed, p<.05; 48% vs. 37% on public assistance, p<.05). Data based on administrative records covering 3 years pre-admission and 8 years post-admission showed that Hispanic women treated in WO programs had higher mental health service utilization over 8 years post-treatment admission, though no differences were found in trajectories of arrests and incarceration. In sum, long-term outcomes (in terms of criminal justice involvement) among Hispanic women in WO treatment were comparable to those in the MG treatment, despite greater service needs at admission. WO programs were able to engage more Hispanic women in use of mental health services. Future research should focus on factors limiting Hispanic women’s participation in WO programs, which could suggest ways for improvement so as to benefit all Hispanic women in need of these special services. PMID:22398357

Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration.

PubMed

Sullivan, Helen W; Campbell, Miriam

2015-01-01

Direct-to-consumer prescription drug advertising (DTCA) is a major source of consumer information about prescription drugs. The present study updates 2002 U.S. Food and Drug Administration phone survey questions that found that 44% and 61% of consumers thought that DTCA did not include enough information about benefits and risks, respectively. The present study was administered by mail using a nationally representative sample, and provides a more in-depth understanding of how these beliefs relate to demographic and health characteristics. Data collected from 3,959 respondents to the National Cancer Institute's 2011 Health Information National Trends Survey find results similar to the 2002 survey: 46% and 52% of respondents thought that DCTA did not include enough information about benefits and risks, respectively. Respondents fell into four groups: 23% agreed that DTCA tells enough about drug benefits and risks, 41% disagreed, 18% expressed no opinion, and 18% had discordant beliefs. DTCA attitudes were negatively associated with education, income, and whether respondents purchase prescription drugs; attitudes were positively associated with whether respondents understand prescription drug information. This study confirms that a plurality of Americans believe that DTCA does not include enough information about benefits and risks, suggesting that the educational effect of DTCA could be improved.

Renal denervation therapy for hypertension: pathways for moving development forward.

PubMed

White, William B; Galis, Zorina S; Henegar, Jeffrey; Kandzari, David E; Victor, Ronald; Sica, Domenic; Townsend, Raymond R; Turner, J Rick; Virmani, Renu; Mauri, Laura

2015-05-01

This scientific statement provides a summary of presentations and discussions at a cardiovascular Think Tank co-sponsored by the American Society of Hypertension (ASH), the United States Food and Drug Administration (FDA), and the National Heart, Lung, and Blood Institute (NHLBI) held in North Bethesda, Maryland, on June 26, 2014. Studies of device therapies for the treatment of hypertension are requested by regulators to evaluate their safety and efficacy during their development programs. Think Tank participants thought that important considerations in undertaking such studies were: (1) Preclinical assessment: how likely it is that both efficacy and safety data indicating benefit in humans will be obtained, and/or whether a plausible mechanism of action for efficacy can be identified; (2) Early human trial(s): the ability to determine that the device has an acceptable benefit-to-risk balance for its use in the intended patient population and without the influence of drug therapy during a short-term follow-up period; and (3) Pivotal Phase III trial(s): the ability to prove the effectiveness of the device in a broad population in which the trial can be made as non-confounded as possible while still allowing for the determination for benefits when added to antihypertensive therapies. Copyright © 2015 American Society of Hypertension. All rights reserved.

The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health

PubMed Central

Light, Donald W.

2011-01-01

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing. PMID:21233426

Outsourcing drug discovery to India and China: from surviving to thriving.

PubMed

Subramaniam, Swaminathan; Dugar, Sundeep

2012-10-01

Global pharmaceutical companies face an increasingly harsh environment for their primary business of selling medicines. They have to contend with a spiraling decline in the productivity of their R&D programs that is guaranteed to severely diminish their growth prospects. Outsourcing of drug discovery activities to low-cost locations is a growing response to this crisis. However, the upsides to outsourcing are capped by the failure of global pharmaceutical companies to take advantage of the full range of possibilities that this model provides. Companies that radically rethink and transform the way they conduct R&D, such as seeking the benefits of low-cost locations in India and China will be the ones that thrive in this environment. In this article we present our views on how the outsourcing model in drug discovery should go beyond increasing the efficiency of existing drug discovery processes to a fundamental rethink and re-engineering of these processes. Copyright © 2012. Published by Elsevier Ltd.

Summary of findings from the evaluation of a pilot medically supervised safer injecting facility

PubMed Central

Wood, Evan; Tyndall, Mark W.; Montaner, Julio S.; Kerr, Thomas

2006-01-01

In many cities, infectious disease and overdose epidemics are occurring among illicit injection drug users (IDUs). To reduce these concerns, Vancouver opened a supervised safer injecting facility in September 2003. Within the facility, people inject pre-obtained illicit drugs under the supervision of medical staff. The program was granted a legal exemption by the Canadian government on the condition that a 3-year scientific evaluation of its impacts be conducted. In this review, we summarize the findings from evaluations in those 3 years, including characteristics of IDUs at the facility, public injection drug use and publicly discarded syringes, HIV risk behaviour, use of addiction treatment services and other community resources, and drug-related crime rates. Vancouver's safer injecting facility has been associated with an array of community and public health benefits without evidence of adverse impacts. These findings should be useful to other cities considering supervised injecting facilities and to governments considering regulating their use. PMID:17116909

A new perspective on nonprescription statins: an opportunity for patient education and involvement.

PubMed

Fuster, Valentin

2007-09-01

Education of the public and encouragement of patients' involvement in their own health care have been repeatedly proved effective means of increasing health awareness, promoting lifestyle modifications, and improving early disease detection in a variety of clinical scenarios. Despite substantial efforts from different public and private organizations to educate the population on cardiovascular risk, coronary heart disease remains the leading cause of death in the United States, and its prevalence continues to grow. Therefore, alternative approaches with the potential to elicit a meaningful impact in the community deserve consideration. A nonprescription statin program could provide consumers with a tool of proved benefit in cardiovascular risk prevention. The magnitude of the target population (millions of subjects with intermediate to high risk), as well as the safety and efficacy profile of lovastatin 20 mg, support the consideration of this drug for "over-the-counter" availability. Moreover, a nonprescription statin program could represent a unique opportunity not only to enhance patients' involvement in primary prevention but also to reinforce the education of the public and to encourage interaction with health care providers. The success of such a program will undoubtedly require precise labeling of the risks and benefits of the therapy, as well as active support and participation from major medical organizations. In conclusion, nonprescription statin availability, through enhanced unique patients' involvement, offers the potential for enormous public health benefit.

Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. II. Drug disposal, waste reduction, and future directions.

PubMed Central

Daughton, Christian G

2003-01-01

Since the 1980s, the occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants, originating primarily from consumer use and actions rather than manufacturer effluents, continues to become more firmly established. The growing, worldwide importance of freshwater resources underscores the need for ensuring that any aggregate or cumulative impacts on (or from) water supplies are minimized. Despite a paucity of effects data from long-term, simultaneous exposure at low doses to multiple xenobiotics (particularly non-target-organism exposure to PPCPs), a wide range of proactive actions could be implemented for reducing or minimizing the introduction of PPCPs to the environment. Most of these actions fall under what could be envisioned as a holistic stewardship program--overseen by the health care industry and consumers alike. Significantly, such a stewardship program would benefit not just the environment--additional, collateral benefits could automatically accrue, including the lessening of medication expense for the consumer and improving patient health and consumer safety. In this article (the second of two parts describing the "green pharmacy") I focus on those actions and activities tied more closely to the end user (e.g., the patient) and issues associated with drug disposal/recycling that could prove useful in minimizing the environmental disposition of PPCPs. I also outline some recommendations and suggestions for further research and pose some considerations regarding the future. In this mini-monograph I attempt to capture cohesively for the first time the wide spectrum of actions available for minimizing the release of PPCPs to the environment. A major objective is to generate an active dialog or debate across the many disciplines that must become actively involved to design and implement a successful approach to life-cycle stewardship of PPCPs. PMID:12727607

Pharmacy benefit management contracting: an assessment from a recent public sector procurement experience.

PubMed

Bae, Jay P; Justice, Paul G

2002-01-01

In order to contain the cost of pharmaceuticals while preserving access to medically necessary drugs, Georgia state government competitively selected a single vendor in May of 2000 to manage combined pharmacy benefits under all of the state's health programs. By initiating this procedure, it intended to maximize the state's purchasing power and improve efficiency while streamlining the administrative structure. Synthesizing information from the request for proposal (RFP) and technical proposals submitted by 11 pharmacy benefit managers (PBMs) in response, we describe a model of public sector PBM contracting approach and present an assessment of the industry's service capability and performance statistics. Payers who have been using PBM services may find it interesting to compare their experience with the recent Georgia experience. Those who are considering contracting with a PBM will find the assessment of the PBM industry timely and informative.

Understanding Rates of Marijuana Use and Consequences Among Adolescents in a Changing Legal Landscape.

PubMed

D'Amico, Elizabeth J; Tucker, Joan S; Pedersen, Eric R; Shih, Regina A

2017-01-01

There is not one answer to address whether marijuana use has increased, decreased, or stayed the same given changes in state legalization of medical and non-medical marijuana in the USA. Evidence suggests some health benefits for medical marijuana; however, initiation of marijuana use is a risk factor for developing problem cannabis use. Though use rates have remained stable over recent years, about one in three 10th graders report marijuana use, most adolescents do not view the drug as harmful, and over 650,000 youth aged 12 to 17 struggle with cannabis use disorder. Although the health benefits of medical marijuana are becoming better understood, more research is needed. Intervention and prevention programs must better address effects of marijuana, acknowledging that while there may be some benefits medically, marijuana use can affect functioning during adolescence when the brain is still developing.

Medical marijuana programs - Why might they matter for public health and why should we better understand their impacts?

PubMed

Fischer, Benedikt; Murphy, Yoko; Kurdyak, Paul; Goldner, Elliot; Rehm, Jürgen

2015-01-01

Although cannabis is an illegal drug, 'medical marijuana programs' (MMPs) have proliferated (e.g., in Canada and several US states), allowing for legal cannabis use for therapeutic purposes. While both health risks and potential therapeutic benefits for cannabis use have been documented, potential public health impacts of MMPs - also vis-à-vis other psychoactive substance use - remain under-explored. We briefly reviewed the emerging evidence on MMP participants' health status, and specifically other psychoactive substance use behaviors and outcomes. While data are limited in amount and quality, MMP participants report improvements in overall health status, and specifically reductions in levels of risky alcohol, prescription drug and - to some extent - tobacco or other illicit drug use; at the same time, increases in cannabis use and risk/problem patterns may occur. MMP participation may positively impact - for example, by way of possible 'substitution effects' from cannabis use - other psychoactive substance use and risk patterns at a scale relevant for public health, also influenced by the increasing population coverage of MMPs. Yet, net overall MMP-related population health effects need to be more rigorously and comprehensively assessed, including potential increases in cannabis use related risks and harms.

Diabetes benefit management: evolving strategies for payers.

PubMed

Tzeel, Albert L

2011-11-01

Over the next quarter century, the burden of type 2 diabetes mellitus (T2DM) is expected to at least double. Currently, 1 in every 10 healthcare dollars is spent on diabetes management; by 2050, it has been projected that the annual costs of managing T2DM will rise to $336 billion. Without substantial, systemic changes, T2DM management costs will lead to a potentially untenable strain on the healthcare system. However, the appropriate management of diabetes can reduce associated mortality and delay comorbidities. In addition, adequate glycemic control can improve patient outcomes and significantly reduce diabetes-related complications. This article provides an overview of key concepts associated with a value-based insurance design (VBID) approach to T2DM coverage. By promoting the use of services or treatments that provide high benefits relative to cost, and by alternatively discouraging patients from utilizing services whose benefits do not justify their cost, VBID improves the quality of healthcare while simultaneously reining in spending. VBID initiatives tend to focus on chronic disease management and generally target prescription drug use. However, some programs have expanded their scope by incorporating services traditionally offered by wellness and disease management programs. The concept of VBID is growing, and it is increasingly being implemented by a diverse and growing number of public and private entities, including pharmacy benefit managers, health plans, and employers. This article provides key background on VBID strategies, with a focus on T2DM management. It also provides a road map for health plans seeking to implement VBID as part of their programs.

Explaining long-term outcomes among drug dependent mothers treated in women-only versus mixed-gender programs

PubMed Central

Evans, Elizabeth; Li, Libo; Pierce, Jennifer; Hser, Yih-Ing

2013-01-01

Specialized substance abuse treatment for parenting women is thought to improve outcomes, but long-term impacts and how they occur are poorly understood. Utilizing a sample of 789 California mothers followed for 10 years after admission to women-only (WO) or mixed-gender (MG) drug treatment, we examine the relationship between WO treatment and outcomes and whether it is mediated by post-treatment exposures to criminal justice and health services systems. At follow-up, 48% of mothers had a successful outcome (i.e., no use of illicit drugs, not involved with the criminal justice system, alive). Controlling for patient characteristics, WO (vs. MG) treatment increased the odds of successful outcome by 44%. In the structural equation model WO treatment was associated with fewer post-treatment arrests, which was associated with better outcomes. Women-only substance abuse treatment has long-term benefits for drug-dependent mothers, a relationship that may be partially explained by post-treatment exposure to the criminal justice system. Findings underscore additional leverage points for relapse prevention and recovery-supportive efforts for drug-dependent mothers. PMID:23702103

Explaining long-term outcomes among drug dependent mothers treated in women-only versus mixed-gender programs.

PubMed

Evans, Elizabeth; Li, Libo; Pierce, Jennifer; Hser, Yih-Ing

2013-09-01

Specialized substance abuse treatment for parenting women is thought to improve outcomes, but long-term impacts and how they occur are poorly understood. Utilizing a sample of 789 California mothers followed for 10 years after admission to women-only (WO) or mixed-gender (MG) drug treatment, we examine the relationship between WO treatment and outcomes and whether it is mediated by post-treatment exposures to criminal justice and health services systems. At follow-up, 48% of mothers had a successful outcome (i.e., no use of illicit drugs, not involved with the criminal justice system, alive). Controlling for patient characteristics, WO (vs. MG) treatment increased the odds of successful outcome by 44%. In the structural equation model WO treatment was associated with fewer post-treatment arrests, which was associated with better outcomes. Women-only substance abuse treatment has long-term benefits for drug-dependent mothers, a relationship that may be partially explained by post-treatment exposure to the criminal justice system. Findings underscore additional leverage points for relapse prevention and recovery-supportive efforts for drug-dependent mothers. Published by Elsevier Inc.

Comparing Pharmacy Benefit Managers: Moving Well Beyond the Simple Spreadsheet Analysis

PubMed Central

Calabrese, David

2008-01-01

Unabated increases in prescription drug demands, advancing technology, and rising drug inflation rates combined with a sagging economy, continue to intensify budget pressures for payors responsible for delivering pharmacy benefits to plan members. At the same time, high levels of complexity and resource requirements in drug benefit administration have led to a state in which plan sponsors remain heavily dependent on pharmacy benefit managers to assist in these efforts. With pharmacy representing such a critical component of healthcare delivery from clinical and economic perspectives, it is essential that sponsors exercise high levels of due diligence in pharmacy benefit manager review and appraisal to ensure proper balance of quality clinical care, sufficient access, and optimal cost-efficiency in the delivery of such benefits. This review is designed to provide a comprehensive understanding of current pharmacy benefit management business practices and help equip plan sponsors with the knowledge, strategies, and safeguards to drive a well-informed pharmacy benefit selection process and, inevitably, a better-aligned pharmacy benefit management–payor relationship. PMID:25126235

Will growth in cryptomarket drug buying increase the harms of illicit drugs?

PubMed Central

Stevens, Alex; Barratt, Monica J.

2017-01-01

Abstract Background and aim Cryptomarkets—on‐line, anonymous market‐places for illicit goods and services that specialize mainly in drugs—account for a small but rapidly growing share of the illicit drug market in many countries. Policy responses so far are based generally on the assumption that their rise will only increase drug harms. In this contribution for debate, we question this assumption. Methods We provide a narrative review of the emerging literature connected to drug cryptomarkets. We use MacCoun & Reuter's formula to understand the effect of population‐level increases in use on total harm as depending on the level of harm associated with each unit of use. We then consider the potential for cryptomarkets to increase or decrease the harms and benefits related to each unit of drug use, with specific attention to the quality of drugs sold and the non‐drug‐related harms and benefits for customers. Results It is likely that cryptomarkets will increase both the amount and the range of substances that are sold. However, we argue that the effects on harms will depend upon whether cryptomarkets also increase the quality and safety of products that are sold, provide harm‐reducing information to consumers and reduce transactional conflict involved in drug purchasing. Conclusions There is an emerging and rapidly growing evidence base connected to the macro and micro harms and benefits of cryptomarkets for drug users. Future researchers should use appropriately matched comparative designs to establish more firmly the differential harms and benefits of sourcing drugs both on‐ and off‐line. While it is unlikely that the on‐line drug trade can be eradicated completely, cryptomarkets will respond to regulation and enforcement in ways that have complex, and sometimes unanticipated, effects on both harms and benefits. PMID:28766792

Benefits and risks of antimicrobial use in food-producing animals

PubMed Central

Hao, Haihong; Cheng, Guyue; Iqbal, Zahid; Ai, Xiaohui; Hussain, Hafiz I.; Huang, Lingli; Dai, Menghong; Wang, Yulian; Liu, Zhenli; Yuan, Zonghui

2014-01-01

Benefits and risks of antimicrobial drugs, used in food-producing animals, continue to be complex and controversial issues. This review comprehensively presents the benefits of antimicrobials drugs regarding control of animal diseases, protection of public health, enhancement of animal production, improvement of environment, and effects of the drugs on biogas production and public health associated with antimicrobial resistance. The positive and negative impacts, due to ban issue of antimicrobial agents used in food-producing animals, are also included in the discussion. As a double-edged sword, use of these drugs in food-animals persists as a great challenge. PMID:24971079

Antibiotic Policies and Utilization in Oregon Hospice Programs.

PubMed

Novak, Rachel L; Noble, Brie N; Fromme, Erik K; Tice, Michael O; McGregor, Jessina C; Furuno, Jon P

2016-09-01

Antibiotics are frequently used in hospice care, despite limited data on safety and effectiveness in this patient population. We surveyed Oregon hospice programs on antibiotic policies and prescribing practices. Among 39 responding hospice programs, the median reported proportion of current census using antibiotics was 10% (interquartile range = 3.5%-20.0%). Approximately 31% of responding hospice programs had policies for antibiotic initiation, 17% of hospice programs had policies for antibiotic discontinuation, and 95% of hospice programs had policies for managing drug interactions. Diarrhea, nausea/vomiting, and yeast infections were the most frequently reported antibiotic-associated adverse events, occurring "sometimes" or "often" among 62%, 47%, and 62% of respondents, respectively. In conclusion, less than a third of participating hospice programs reported having a policy for antibiotic initiation and even less frequently a policy for discontinuation. More data are needed on the risks and benefits of antibiotic use in hospice care to inform these policies and optimize outcomes in this vulnerable patient population. © The Author(s) 2015.

FDA pregnancy risk categories and the CPS

PubMed Central

Law, Ruth; Bozzo, Pina; Koren, Gideon; Einarson, Adrienne

2010-01-01

ABSTRACT QUESTION My patient is taking a medication for a chronic condition and has just found out that she is 6 weeks pregnant. The US Food and Drug Administration (FDA) has assigned this medication to pregnancy risk category D, and the Compendium of Pharmaceuticals and Specialties provides no additional data. How should I interpret this information, and how does the Motherisk Program evaluate the safety or risks of drug use in pregnancy? ANSWER Pregnancy safety data provided by the FDA pregnancy risk categories and the Compendium of Pharmaceuticals and Specialties are insufficient to guide clinical decisions on how to proceed with a pregnancy following exposure to a category D medication. The Motherisk Program creates peer-reviewed statements derived from the primary literature, and we examine fetal outcomes as well as the risk-benefit profile of maternal treatment when evaluating the safety of medication use in pregnancy. The FDA announced in May 2008 that it is dropping its pregnancy risk categories and adopting a method similar to the one we use at Motherisk. PMID:20228306

Right-to-Try Laws and Individual Patient “Compassionate Use” of Experimental Oncology Medications: A Call for Improved Provider-Patient Communication

PubMed Central

Hoerger, Michael

2016-01-01

The U.S. Food and Drug Administration’s Expanded Access program allows patients with life-threatening diagnoses, such as advanced cancer, to use experimental medications without participating in clinical research (colloquially, “Compassionate Use”). Sixteen U.S. states recently passed “right-to-try” legislation aimed at promoting Expanded Access. Acknowledging popular support, Expanded Access could undermine clinical trials that benefit public health. Moreover, existing norms in oncologic care, for example, often lead patients to pursue intense treatments near the end of life, at the expense of palliation, and improved communication about the risks and benefits of Expanded Access would more often discourage its use. PMID:26313583

The Relationship Between the Accumulated Number of Role Transitions and Hard Drug Use Among Hispanic Emerging Adults

PubMed Central

Allem, Jon-Patrick; Soto, Daniel; Baezconde-Garbanati, Lourdes; Unger, Jennifer

2014-01-01

Emerging adults (ages 18 to 25) who experience multiple role transitions in a short period of time may engage in hard drug use as a maladaptive coping strategy to avoid negative emotions from stress. Given the collectivistic values Hispanics encounter growing up, they may experience additional role transitions due to their group oriented cultural paradigm. This study examined whether those who experience many role transitions are at greater risk for hard drug use compared to those who experience few transitions among Hispanic emerging adults. Participants completed surveys indicating their hard drug use in emerging adulthood, role transitions in the past year of emerging adulthood, age, gender, and hard drug use in high school. Simulation analyses indicated that an increase in the number of role transitions, from 0 to 13, was associated with a 14% (95% CI, 4 to 29) higher probability of hard drug use. Specific role transitions were found to be associated with hard drug use, such as starting to date or experiencing a breakup. Intervention/prevention programs may benefit from acknowledging individual reactions to transitions in emerging adulthood, as these processes may be catalysts for personal growth where identities are consolidated, and decisions regarding hard drug use are formed. PMID:25715073

Return to drug use and overdose after release from prison: a qualitative study of risk and protective factors.

PubMed

Binswanger, Ingrid A; Nowels, Carolyn; Corsi, Karen F; Glanz, Jason; Long, Jeremy; Booth, Robert E; Steiner, John F

2012-01-01

Former inmates are at high risk for death from drug overdose, especially in the immediate post-release period. The purpose of the study is to understand the drug use experiences, perceptions of overdose risk, and experiences with overdose among former prisoners. This qualitative study included former prison inmates (N=29) who were recruited within two months after their release. Interviewers conducted in-person, semi-structured interviews which explored participants' experiences and perceptions. Transcripts were analyzed utilizing a team-based method of inductive analysis. The following themes emerged: 1) Relapse to drugs and alcohol occurred in a context of poor social support, medical co-morbidity and inadequate economic resources; 2) former inmates experienced ubiquitous exposure to drugs in their living environments; 3) intentional overdose was considered "a way out" given situational stressors, and accidental overdose was perceived as related to decreased tolerance; and 4) protective factors included structured drug treatment programs, spirituality/religion, community-based resources (including self-help groups), and family. Former inmates return to environments that strongly trigger relapse to drug use and put them at risk for overdose. Interventions to prevent overdose after release from prison may benefit from including structured treatment with gradual transition to the community, enhanced protective factors, and reductions of environmental triggers to use drugs.

The Relationship Between the Accumulated Number of Role Transitions and Hard Drug Use among Hispanic Emerging Adults.

PubMed

Allem, Jon-Patrick; Soto, Daniel; Baezconde-Garbanati, Lourdes; Unger, Jennifer

2015-01-01

Emerging adults (ages 18 to 25) who experience multiple role transitions in a short period of time may engage in hard drug use as a maladaptive coping strategy to avoid negative emotions from stress. Given the collectivistic values Hispanics encounter growing up, they may experience additional role transitions due to their group-oriented cultural paradigm. This study examined whether those who experience many role transitions are at greater risk for hard drug use compared to those who experience few transitions among Hispanic emerging adults. Participants completed surveys indicating their hard drug use in emerging adulthood, role transitions in the past year of emerging adulthood, age, gender, and hard drug use in high school. Simulation analyses indicated that an increase in the number of role transitions, from 0 to 13, was associated with a 14% (95% CI, 4 to 29) higher probability of hard drug use. Specific role transitions were found to be associated with hard drug use, such as starting to date or experiencing a breakup. Intervention/prevention programs may benefit from acknowledging individual reactions to transitions in emerging adulthood, as these processes may be catalysts for personal growth where identities are consolidated and decisions regarding hard drug use are formed.

Rational Risk-Benefit Decision-Making in the Setting of Military Mefloquine Policy.

PubMed

Nevin, Remington L

2015-01-01

Mefloquine is an antimalarial drug that has been commonly used in military settings since its development by the US military in the late 1980s. Owing to the drug's neuropsychiatric contraindications and its high rate of inducing neuropsychiatric symptoms, which are contraindications to the drug's continued use, the routine prescribing of mefloquine in military settings may be problematic. Due to these considerations and to recent concerns of chronic and potentially permanent psychiatric and neurological sequelae arising from drug toxicity, military prescribing of mefloquine has recently decreased. In settings where mefloquine remains available, policies governing prescribing should reflect risk-benefit decision-making informed by the drug's perceived benefits and by consideration both of the risks identified in the drug's labeling and of specific military risks associated with its use. In this review, these risks are identified and recommendations are made for the rational prescribing of the drug in light of current evidence.

Family-focused preventive interventions: evaluating parental risk moderation of substance use trajectories.

PubMed

Guyll, Max; Spoth, Richard L; Chao, Wei; Wickrama, K A S; Russell, Daniel

2004-06-01

Four years of longitudinal data from 373 families participating in a randomized intervention-control clinical trial were used to examine whether intervention effects on adolescent alcohol and tobacco use trajectories were moderated by family risk, as defined by parental social emotional maladjustment. Consistent with earlier outcome evaluations based on analyses of covariance, analyses confirmed that both the Preparing for the Drug Free Years program and the Iowa Strengthening Families Program favorably influenced alcohol use index trajectories across the time frame of the study; only the latter program, however, evidenced positive effects on a tobacco use index. Concerning the primary research question, analyses provided no support for family risk moderation of any intervention effect. Findings indicate the feasibility of developing universal preventive interventions that offer comparable benefits to all families.

Will growth in cryptomarket drug buying increase the harms of illicit drugs?

PubMed

Aldridge, Judith; Stevens, Alex; Barratt, Monica J

2018-05-01

Cryptomarkets-on-line, anonymous market-places for illicit goods and services that specialize mainly in drugs-account for a small but rapidly growing share of the illicit drug market in many countries. Policy responses so far are based generally on the assumption that their rise will only increase drug harms. In this contribution for debate, we question this assumption. We provide a narrative review of the emerging literature connected to drug cryptomarkets. We use MacCoun & Reuter's formula to understand the effect of population-level increases in use on total harm as depending on the level of harm associated with each unit of use. We then consider the potential for cryptomarkets to increase or decrease the harms and benefits related to each unit of drug use, with specific attention to the quality of drugs sold and the non-drug-related harms and benefits for customers. It is likely that cryptomarkets will increase both the amount and the range of substances that are sold. However, we argue that the effects on harms will depend upon whether cryptomarkets also increase the quality and safety of products that are sold, provide harm-reducing information to consumers and reduce transactional conflict involved in drug purchasing. There is an emerging and rapidly growing evidence base connected to the macro and micro harms and benefits of cryptomarkets for drug users. Future researchers should use appropriately matched comparative designs to establish more firmly the differential harms and benefits of sourcing drugs both on- and off-line. While it is unlikely that the on-line drug trade can be eradicated completely, cryptomarkets will respond to regulation and enforcement in ways that have complex, and sometimes unanticipated, effects on both harms and benefits. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Drug discovery and development for rare genetic disorders.

PubMed

Sun, Wei; Zheng, Wei; Simeonov, Anton

2017-09-01

Approximately 7,000 rare diseases affect millions of individuals in the United States. Although rare diseases taken together have an enormous impact, there is a significant gap between basic research and clinical interventions. Opportunities now exist to accelerate drug development for the treatment of rare diseases. Disease foundations and research centers worldwide focus on better understanding rare disorders. Here, the state-of-the-art drug discovery strategies for small molecules and biological approaches for orphan diseases are reviewed. Rare diseases are usually genetic diseases; hence, employing pharmacogenetics to develop treatments and using whole genome sequencing to identify the etiologies for such diseases are appropriate strategies to exploit. Beginning with high throughput screening of small molecules, the benefits and challenges of target-based and phenotypic screens are discussed. Explanations and examples of drug repurposing are given; drug repurposing as an approach to quickly move programs to clinical trials is evaluated. Consideration is given to the category of biologics which include gene therapy, recombinant proteins, and autologous transplants. Disease models, including animal models and induced pluripotent stem cells (iPSCs) derived from patients, are surveyed. Finally, the role of biomarkers in drug discovery and development, as well as clinical trials, is elucidated. © 2017 Wiley Periodicals, Inc.

Cost-Effectiveness of Providing Full Drug Coverage to Increase Medication Adherence in Post–Myocardial Infarction Medicare Beneficiaries

PubMed Central

Choudhry, Niteesh K.; Patrick, Amanda R.; Antman, Elliott M.; Avorn, Jerry; Shrank, William H.

2009-01-01

Background Effective therapies for the secondary prevention of coronary heart disease–related events are significantly underused, and attempts to improve adherence have often yielded disappointing results. Elimination of patient out-of-pocket costs may be an effective strategy to enhance medication use. We sought to estimate the incremental cost-effectiveness of providing full coverage for aspirin, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins (combination pharmacotherapy) to individuals enrolled in the Medicare drug benefit program after acute myocardial infarction. Methods and Results We created a Markov cost-effectiveness model to estimate the incremental cost-effectiveness of providing Medicare beneficiaries with full coverage for combination pharmacotherapy compared with current coverage under the Medicare Part D program. Our analysis was conducted from the societal perspective and considered a lifetime time horizon. In a sensitivity analysis, we repeated our analysis from the perspective of Medicare. In the model, post–myocardial infarction Medicare beneficiaries who received usual prescription drug coverage under the Part D program lived an average of 8.21 quality-adjusted life-years after their initial event, incurring coronary heart disease–related medical costs of $114 000. Those who received prescription drug coverage without deductibles or copayments lived an average of 8.56 quality-adjusted life-years and incurred $111 600 in coronary heart disease–related costs. Compared with current prescription drug coverage, full coverage for post–myocardial infarction secondary prevention therapies would result in greater functional life expectancy (0.35 quality-adjusted life-year) and less resource use ($2500). From the perspective of Medicare, full drug coverage was highly cost-effective ($7182/quality-adjusted life-year) but not cost saving. Conclusions Our analysis suggests that providing full coverage for combination therapy to post–myocardial infarction Medicare beneficiaries would save both lives and money from the societal perspective. PMID:18285564

20 CFR 404.316 - When entitlement to disability benefits begins and ends.

Code of Federal Regulations, 2014 CFR

2014-04-01

... benefits for any months in which you do substantial gainful activity. (e) If drug addiction or alcoholism... addiction or alcoholism is not available, months before March 1995, and months for which your benefit.... (f) If drug addiction or alcoholism is a contributing factor material to the determination of...

20 CFR 404.316 - When entitlement to disability benefits begins and ends.

Code of Federal Regulations, 2011 CFR

2011-04-01

... benefits for any months in which you do substantial gainful activity. (e) If drug addiction or alcoholism... addiction or alcoholism is not available, months before March 1995, and months for which your benefit.... (f) If drug addiction or alcoholism is a contributing factor material to the determination of...

20 CFR 404.316 - When entitlement to disability benefits begins and ends.

Code of Federal Regulations, 2012 CFR

2012-04-01

... benefits for any months in which you do substantial gainful activity. (e) If drug addiction or alcoholism... addiction or alcoholism is not available, months before March 1995, and months for which your benefit.... (f) If drug addiction or alcoholism is a contributing factor material to the determination of...

20 CFR 404.316 - When entitlement to disability benefits begins and ends.

Code of Federal Regulations, 2013 CFR

2013-04-01

... benefits for any months in which you do substantial gainful activity. (e) If drug addiction or alcoholism... addiction or alcoholism is not available, months before March 1995, and months for which your benefit.... (f) If drug addiction or alcoholism is a contributing factor material to the determination of...

Improving the decision-making process for nonprescription drugs: a framework for benefit-risk assessment.

PubMed

Brass, E P; Lofstedt, R; Renn, O

2011-12-01

Nonprescription drugs pose unique challenges to regulators. The fact that the barriers to access are lower for nonprescription drugs as compared with prescription drugs may permit additional consumers to obtain effective drugs. However, the use of these drugs by consumers in the absence of supervision by a health-care professional may result in unacceptable rates of misuse and suboptimal clinical outcomes. A value-tree method is proposed that defines important benefit and risk domains relevant to nonprescription drugs. This value tree can be used to comprehensively identify product-specific attributes in each domain and can also support formal benefit-risk assessment using a variety of tools. This is illustrated here, using a modification of the International Risk Governance Council (IRGC) framework, a flexible tool previously applied in a number of fields, which systematizes an approach to issue review, early alignment of stakeholders, evaluation, and risk mitigation/management. The proposed approach has the potential to provide structured, transparent tools for regulatory decision making for nonprescription drugs.

Discrete-choice modelling of patient preferences for modes of drug administration.

PubMed

Tetteh, Ebenezer Kwabena; Morris, Steve; Titcheneker-Hooker, Nigel

2017-12-01

The administration of (biologically-derived) drugs for various disease conditions involves consumption of resources that constitutes a direct monetary cost to healthcare payers and providers. An often ignored cost relates to a mismatch between patients' preferences and the mode of drug administration. The "intangible" benefits of giving patients what they want in terms of the mode of drug delivery is seldom considered. This study aims to evaluate, in monetary terms, end-user preferences for the non-monetary attributes of different modes of drug administration using a discrete-choice experiment. It provides empirical support to the notion that there are significant benefits from developing patient-friendly approaches to drug delivery. The gross benefits per patient per unit administration is in the same order of magnitude as the savings in resource costs of administering drugs. The study argues that, as long as the underlying manufacturing science is capable, a patient-centred approach to producing drug delivery systems should be encouraged and pursued.

Potential Synergies of β-Hydroxybutyrate and Butyrate on the Modulation of Metabolism, Inflammation, Cognition, and General Health

PubMed Central

2018-01-01

The low-carbohydrate high-fat diet (LCHFD), also known as the ketogenic diet, has cycled in and out of popularity for decades as a therapeutic program to treat metabolic syndrome, weight mismanagement, and drug-resistant disorders as complex as epilepsy, cancer, dementia, and depression. Despite the benefits of this diet, health care professionals still question its safety due to the elevated serum ketones it induces and the limited dietary fiber. To compound the controversy, patient compliance with the program is poor due to the restrictive nature of the diet and symptoms related to energy deficit and gastrointestinal adversity during the introductory and energy substrate transition phase of the diet. The studies presented here demonstrate safety and efficacy of the diet including the scientific support and rationale for the administration of exogenous ketone bodies and ketone sources as a complement to the restrictive dietary protocol or as an alternative to the diet. This review also highlights the synergy provided by exogenous ketone, β-hydroxybutyrate (BHB), accompanied by the short chain fatty acid, butyrate (BA) in the context of cellular and physiological outcomes. More work is needed to unveil the molecular mechanisms by which this program provides health benefits.

20 CFR 416.1331 - Termination of your disability or blindness payments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... due to 12 consecutive suspension months for failure to comply with treatment for drug addiction or alcoholism. If you are disabled and drug addiction or alcoholism is a contributing factor material to the... benefits terminate due to payment of 36 months of benefits based on disability when drug addiction or...

20 CFR 416.1331 - Termination of your disability or blindness payments.

Code of Federal Regulations, 2012 CFR

2012-04-01

... due to 12 consecutive suspension months for failure to comply with treatment for drug addiction or alcoholism. If you are disabled and drug addiction or alcoholism is a contributing factor material to the... benefits terminate due to payment of 36 months of benefits based on disability when drug addiction or...

20 CFR 416.1331 - Termination of your disability or blindness payments.

Code of Federal Regulations, 2013 CFR

2013-04-01

... due to 12 consecutive suspension months for failure to comply with treatment for drug addiction or alcoholism. If you are disabled and drug addiction or alcoholism is a contributing factor material to the... benefits terminate due to payment of 36 months of benefits based on disability when drug addiction or...

20 CFR 416.1331 - Termination of your disability or blindness payments.

Code of Federal Regulations, 2014 CFR

2014-04-01

... due to 12 consecutive suspension months for failure to comply with treatment for drug addiction or alcoholism. If you are disabled and drug addiction or alcoholism is a contributing factor material to the... benefits terminate due to payment of 36 months of benefits based on disability when drug addiction or...

[Interplay between marketing authorization and early benefit assessment of drugs].

PubMed

Beinlich, Peggy; Müller-Berghaus, J; Sudhop, T; Vieths, S; Broich, K

2015-03-01

The early benefit assessment of newly approved drugs with new active substances or new applications that came into force on 1 January 2011 still presents a challenge to the parties involved. This article highlights the interplay between drug marketing approval and early benefit assessment. The constellation of a European, and even an international, largely harmonized, drug authorization process, with a mostly nationally regulated drug reimbursement situation causes inevitably friction, which could be reduced through joint advice discussions during the planning phase for pivotal studies. In 2013, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) provided 439 scientific advice procedures, compared with 98 advice meetings held at the Federal Joint Committee (G-BA), for 12 of which the BfArM or PEI provided written advice. The numbers of advice meetings held at the G-BA are increasing; however, the national competent authorities are involved in only a fraction of these. From the perspective of the national competent authorities, prompt and consistent involvement in the advice procedures regarding early benefit assessment would be useful and desirable.

Parenting While Incarcerated: Tailoring the Strengthening Families Program for Use with Jailed Mothers

PubMed Central

Miller, Alison L.; Weston, Lauren E.; Perryman, Jamie; Horwitz, Talia; Franzen, Susan; Cochran, Shirley

2015-01-01

Most incarcerated women are mothers. Parenting programs may benefit women, children and families, yet effectively intervening in correctional settings is a challenge. An evidence-based parenting intervention (the Strengthening Families Program) was tailored and implemented with women in a jail setting. Goals were to assess mothers' needs and interests regarding parenting while they were incarcerated, adapt the program to address those needs, and establish intervention delivery and evaluation methods in collaboration with a community-based agency. Women reported wanting to know more about effective communication; how children manage stress; finances; drug and alcohol use; self-care; and stress reduction. They reported high program satisfaction and reported reduced endorsement of corporal punishment after the intervention. Barriers to implementation included unpredictable attendance from session to session due to changing release dates, transfer to other facilities, and jail policies (e.g., lock-down; commissary hours). Implications for sustainable implementation of parenting programs in jail settings are discussed. PMID:26612963

20 CFR 404.315 - Who is entitled to disability benefits?

Code of Federal Regulations, 2013 CFR

2013-04-01

... against reentitlement to disability benefits if drug addiction or alcoholism is a contributing factor... drug addiction or alcoholism is a contributing factor material to the determination of disability and...

20 CFR 404.315 - Who is entitled to disability benefits?

Code of Federal Regulations, 2014 CFR

2014-04-01

... against reentitlement to disability benefits if drug addiction or alcoholism is a contributing factor... drug addiction or alcoholism is a contributing factor material to the determination of disability and...

20 CFR 404.315 - Who is entitled to disability benefits?

Code of Federal Regulations, 2012 CFR

2012-04-01

... against reentitlement to disability benefits if drug addiction or alcoholism is a contributing factor... drug addiction or alcoholism is a contributing factor material to the determination of disability and...

20 CFR 404.315 - Who is entitled to disability benefits?

Code of Federal Regulations, 2011 CFR

2011-04-01

... against reentitlement to disability benefits if drug addiction or alcoholism is a contributing factor... drug addiction or alcoholism is a contributing factor material to the determination of disability and...

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

PubMed

Patriarca, Peter A; Van Auken, R Michael; Kebschull, Scott A

2018-01-01

Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained as a means of quantitatively assessing the potential benefits and risks of a new chemical entity, we focused our attention on the unique scenario in which a drug was initially approved based on one set of data, but later withdrawn from the market based on a second set of data. In this analysis, a dimensionless risk to benefit ratio was calculated in each instance, based on the risk and benefit quantified in similar units. The results indicated that FDA decisions to approve the drug corresponded to risk to benefit ratios less than or equal to 0.136, and that decisions to withdraw the drug from the US market corresponded to risk to benefit ratios greater than or equal to 0.092. The probability of FDA approval was then estimated using logistic regression analysis. The results of this analysis indicated that there was a 50% probability of FDA approval if the risk to benefit ratio was 0.121, and that the probability approaches 100% for values much less than 0.121, and the probability approaches 0% for values much greater than 0.121. The large uncertainty in these estimates due to the small sample size and overlapping data may be addressed in the future by applying the methodology to other drugs.

Antimicrobial stewardship programs: interventions and associated outcomes.

PubMed

Patel, Dimple; Lawson, Wendy; Guglielmo, B Joseph

2008-04-01

Guidelines regarding antimicrobial stewardship programs recommend an infectious diseases-trained physician and an infectious diseases-trained pharmacist as core members. Inclusion of clinical microbiologists, infection-control practitioners, information systems experts and hospital epidemiologists is considered optimal. Recommended stewardship interventions include prospective audit and intervention, formulary restriction, education, guideline development, clinical pathway development, antimicrobial order forms and the de-escalation of therapy. The primary outcome associated with these interventions has been the associated cost savings; however, few published investigations have taken into account the overall cost of the intervention. Over the past 5 years, there has been an increased focus upon interventions intended to decrease bacterial resistance or reduce superinfection, including infections associated with Clostridium difficile colitis. Few programs have been associated with a reduction in antimicrobial drug adverse events. Antimicrobial stewardship programs are becoming increasingly associated with clear benefits and will be integral in the in-patient healthcare setting.

Intergenerational effects of parental substance-related convictions and adult drug treatment court participation on children’s school performance

PubMed Central

Gifford, Elizabeth J.; Sloan, Frank A.; Evans, Kelly E.

2015-01-01

Objective This study examined the intergenerational effects of parental conviction of a substance-related charge on children’s academic performance and, conditional on a conviction, whether completion of an adult drug treatment court (DTC) program was associated with improved school performance. Method State administrative data from North Carolina courts, birth records, and school records were linked for 2005–12. Math and reading end-of-grade test scores and absenteeism were examined for 5 groups of children, those with parents who: were not convicted on any criminal charge, were convicted on a substance-related charge and not referred by a court to a DTC, were referred to a DTC but did not enroll, enrolled in a DTC but did not complete, and completed a DTC program. Results Accounting for demographic and socioeconomic factors, the school performance of children whose parents were convicted of a substance-related offense was worse than that of children whose parents were not convicted on any charge. These differences were statistically significant but substantially reduced after controlling for socioeconomic characteristics, e.g., mother’s educational attainment. We found no evidence that parent participation in an adult DTC program led to improved school performance of their children. Conclusion While the children of convicted parents fared worse on average, much—but not all—of this difference was attributed to socioeconomic factors, with the result that parental conviction remained a risk factor for poorer school performance. Even though adult DTCs have been shown to have other benefits, we could detect no intergenerational benefit in improved school performance of their children. PMID:26460705

Conditional rights, benefit reform, and drug users: reducing dependency?

PubMed

Harris, Neville

2010-01-01

United Kingdom government policy to increase social security claimants' entry to the labour market through conditions attached to unemployed, sickness and incapacity benefits now includes additional measures to activate particular groups such as lone parents and drug users. The latter are a prime target because of their high level of dependency on benefits and because social security rules are seen as having the potential to modify the behaviour of individuals with a lifestyle regarded as being at odds with the moral obligations of citizenship and incompatible with the government's realization of its wider economic and social goals. There are strict procedures for the identification of drug-user claimants, enabling additional conditions to be attached to their benefit rights. This article discusses the general trend in benefit reform towards increased conditionality and evaluates the reforms affecting drug users, considering human rights and other implications. It concludes by reflecting on the status of conditional rights to social security as social rights.

Cost-benefit of a clinical services integrated with a decentralized unit dose system.

PubMed

Warrian, K; Irvine-Meek, J

1988-06-01

Clinical pharmacy services are believed to be beneficial to patient care and to have the potential to reduce drug costs. This study was designed to apply cost-benefit analysis techniques to selected clinical pharmacy services provided by staff pharmacists assigned to a mobile decentralized unit-dose drug distribution system. Pharmacists' interventions were identified and recorded by the pharmacists and the investigator over an eight-week period. Interventions, to which a monetary value could be assigned, included non-formulary drug use, drug regimen adjustments, and the duration of drug therapy. A total of 543 interventions were recorded or observed. Of these, 174 (32 percent) fit the criteria for inclusion in the study. Those interventions accepted by physicians (87 percent) were assigned a dollar value and tabulated. Costs to provide the service were the pharmacists' salaries. Benefit to cost ratios of 1.08 and 1.59 demonstrated that the benefits accrued from selected clinical pharmacy services exceeded the costs to the hospital.

Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses.

PubMed

Fisher, Laurel M; Martinez, Amy S; Richmond, Frances J; Krieger, Mark D; Wilkinson, Eric P; Eisenberg, Laurie S

2017-01-01

Children with congenital cochleovestibular abnormalities associated with profound hearing loss have few treatment options if cochlear implantation does not yield benefit. An alternative is the auditory brainstem implant (ABI). Regulatory authority device approvals currently include a structured benefit-risk assessment. Such an assessment, for regulatory purposes or to guide clinical decision making, has not been published, to our knowledge, for the ABI and may lead to the design of a research program that incorporates regulatory authority, family, and professional input. Much structured benefit-risk research has been conducted in the context of drug trials; here we apply this approach to device studies. A qualitative framework organized benefit (speech recognition, parent self-report measures) and risk (surgery- and device-related) information to guide the selection of candidates thought to have potential benefit from ABI. Children with cochleovestibular anatomical abnormalities are challenging for appropriate assessment of candidacy for a cochlear implant or an ABI. While the research is still preliminary, children with an ABI appear to slowly obtain benefit over time. A team of professionals, including audiological, occupational, and educational therapy, affords maximum opportunity for benefit. Pediatric patients who have abnormal anatomy and are candidates for an implantable auditory prosthetic require an individualized, multisystems review. The qualitative benefit-risk assessment used here to characterize the condition, the medical need, potential benefits, risks, and risk management strategies has revealed the complex factors involved. After implantation, continued team support for the family during extensive postimplant therapy is needed to develop maximum auditory skill benefit.

Spillover effects of HIV testing policies: changes in HIV testing guidelines and HCV testing practices in drug treatment programs in the United States.

PubMed

Frimpong, Jemima A; D'Aunno, Thomas; Helleringer, Stéphane; Metsch, Lisa R

2016-07-29

To examine the extent to which state adoption of the Centers for Disease Control and Prevention (CDC) 2006 revisions to adult and adolescent HIV testing guidelines is associated with availability of other important prevention and medical services. We hypothesized that in states where the pretest counseling requirement for HIV testing was dropped from state legislation, substance use disorder treatment programs would have higher availability of HCV testing services than in states that had maintained this requirement. We analyzed a nationally representative sample of 383 opioid treatment programs from the 2005 and 2011 National Drug Abuse Treatment System Survey (NDATSS). Data were collected from program directors and clinical supervisors through telephone surveys. Multivariate logistic regression models were used to measure associations between state adoption of CDC recommended guidelines for HIV pretest counseling and availability of HCV testing services. The effects of HIV testing legislative changes on HCV testing practices varied by type of opioid treatment program. In states that had removed the requirement for HIV pretest counseling, buprenorphine-only programs were more likely to offer HCV testing to their patients. The positive spillover effect of HIV pretest counseling policies, however, did not extend to methadone programs and did not translate into increased availability of on-site HCV testing in either program type. Our findings highlight potential positive spillover effects of HIV testing policies on HCV testing practices. They also suggest that maximizing the benefits of HIV policies may require other initiatives, including resources and programmatic efforts that support systematic integration with other services and effective implementation.

A Time-Trend Economic Analysis of Cancer Drug Trials

PubMed Central

Browman, George P.; Hoch, Jeffrey S.; Kovacic, Laurel; Peacock, Stuart J.

2015-01-01

Background. Scientific advances have led to the discovery of novel treatments with high prices. The cost to publicly fund high-cost drugs may threaten the sustainability of drug budgets in different health care systems. In oncology, there are concerns that health-benefit gains are diminishing over time and that the economic evidence to support funding decisions is too limited. Methods. To assess the additional costs and benefits gained from oncology drugs over time, we used treatment protocols and efficacy results from U.S. Food and Drug Administration records to calculate cost-effectiveness ratios for drugs approved to treat first- and second-line metastatic or advanced breast, colorectal, and non-small cell lung cancer during the years 1994–2013. We assessed reimbursement recommendations reached by health technology assessment agencies in the U.K., Australia, and Canada. Results. Cost-effectiveness ratios were calculated for 50 drugs approved by the U.S. regulator. The more recent approvals were often based on surrogate efficacy outcomes and had extremely high costs, often triple the costs of drugs approved in previous years. Over time, the effectiveness gains have increased for some cancer indications; however, for other indications (non-small cell lung and second-line colorectal cancer), the magnitude of gains in effectiveness decreased. Reimbursement recommendations for drugs with the highest cost-effectiveness ratios were the most inconsistent. Conclusion. Evaluation of the clinical benefits that oncology drugs offer as a function of their cost has become highly complex, and for some clinical indications, health benefits are diminishing over time. There is an urgent need for better economic evidence from oncology drug trials and systematic processes to inform funding decisions. Implications for Practice: High-cost oncology drugs may threaten the ability of health care systems to provide access to promising new drugs for patients. In order to make better drug-funding decisions and enable equitable access to breakthrough treatments, discussions in the oncology community should include economic evidence. This study summarizes the extra benefits and costs of newly approved drugs from pivotal trials during the postgenomic era of drug discovery. The reader will gain an appreciation of the need for economic evidence to make better drug-reimbursement decisions and the dynamics at play in today’s oncology drug market. PMID:26032135

A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising.

PubMed

Frosch, Dominick L; Grande, David; Tarn, Derjung M; Kravitz, Richard L

2010-01-01

Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA. This advertising has some benefits, but significant risks are evident as well, magnified by the prominence of DTCA in population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, the quality and quantity of information should be improved to enable consumers to better self-identify whether treatment is indicated, more realistically appraise the benefits, and better attend to the risks associated with prescription drugs. We propose guidelines for improving the utility of prescription drug advertising.

A new prize system for drug innovation.

PubMed

Gandjour, Afschin; Chernyak, Nadja

2011-10-01

We propose a new prize (reward) system for drug innovation which pays a price based on the value of health benefits accrued over time. Willingness to pay for a unit of health benefit is determined based on the cost-effectiveness ratio of palliative/nursing care. We solve the problem of limited information on the value of health benefits by mathematically relating reward size to the uncertainty of information including information on potential drug overuse. The proposed prize system offers optimal incentives to invest in research and development because it rewards the innovator for the social value of drug innovation. The proposal is envisaged as a non-voluntary alternative to the current patent system and reduces excessive marketing of innovators and generic drug producers. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

A Decade of Controversy: Balancing Policy With Evidence in the Regulation of Prescription Drug Advertising

PubMed Central

Grande, David; Tarn, Derjung M.; Kravitz, Richard L.

2010-01-01

Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA. This advertising has some benefits, but significant risks are evident as well, magnified by the prominence of DTCA in population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, the quality and quantity of information should be improved to enable consumers to better self-identify whether treatment is indicated, more realistically appraise the benefits, and better attend to the risks associated with prescription drugs. We propose guidelines for improving the utility of prescription drug advertising. PMID:19910354

[Right-to-health litigation in three Latin American countries: a systematic literature review].

PubMed

Reveiz, Ludovic; Chapman, Evelina; Torres, Rubén; Fitzgerald, James F; Mendoza, Adriana; Bolis, Mónica; Salgado, Osvaldo

2013-03-01

Identify and evaluate studies that analyzed characteristics of right-to-health litigation in Brazil, Colombia, and Costa Rica. Studies were evaluated that analyzed characteristics of right-to-health litigation identified through a search of PubMed, LILACS, Cochrane Library, and Scirus (April 2012). Two reviewers evaluated the studies. Variables collected were, among others, grounds for litigation, proportion of lawsuits for benefits covered by the health system, and lawsuits on high-cost technologies. Thirty studies were identified (Brazil 19, Colombia 10, and Costa Rica 1). Judgments were frequently in favor of plaintiffs: Colombia (75%-87%), Costa Rica (89.7%), and Brazil (70%-100%). In Colombia, lawsuits were filed for benefits included in the Compulsory Health Plan (range: 41%-69.9%). In Brazil there was considerable variation in the amount of lawsuits between the Exceptional Circumstance Drug Dispensing Program (13%-31%) and basic medicines in the Unified Health System (approximately 50%). Lawsuits on drugs varied as a percentage of all lawsuits (Colombia 11.9%-35.6%, Costa Rica 30.2%, and Brazil 49.6%). A study in Brazil found a statistically significant difference when comparing lawsuits on exceptional drugs versus all other drugs, by social class; and in another study, according to lawsuits from municipalities with better socioeconomic indicators. A concentration of lawsuits on drug prescribing by a limited group of physicians was reported. Prescribing was not always supported by scientific evidence. Another study found that in half of the cases, the cost of legal proceedings was higher than the cost of the services being claimed. There are similarities in the grounds, nature, and impact of litigation in the context of the countries studied. The studies included show weaknesses of health systems to ensure access to different services as well as in the introduction of new health technologies.

20 CFR 416.202 - Who may get SSI benefits.

Code of Federal Regulations, 2014 CFR

2014-04-01

... have more resources than are permitted (subpart L). (e) You are disabled, drug addiction or alcoholism... treatment was available or 36 months of SSI benefits on the basis of disability where drug addiction or...

20 CFR 416.202 - Who may get SSI benefits.

Code of Federal Regulations, 2013 CFR

2013-04-01

... have more resources than are permitted (subpart L). (e) You are disabled, drug addiction or alcoholism... treatment was available or 36 months of SSI benefits on the basis of disability where drug addiction or...

20 CFR 416.1123 - How we count unearned income.

Code of Federal Regulations, 2014 CFR

2014-04-01

... period for which you did not receive SSI. (2) Social security disability benefits where drug addiction or... benefits to disabled recipients whose drug addiction or alcoholism is a contributing factor material to the...

20 CFR 416.1123 - How we count unearned income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... period for which you did not receive SSI. (2) Social security disability benefits where drug addiction or... benefits to disabled recipients whose drug addiction or alcoholism is a contributing factor material to the...

20 CFR 416.202 - Who may get SSI benefits.

Code of Federal Regulations, 2012 CFR

2012-04-01

... have more resources than are permitted (subpart L). (e) You are disabled, drug addiction or alcoholism... treatment was available or 36 months of SSI benefits on the basis of disability where drug addiction or...

20 CFR 416.1123 - How we count unearned income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... period for which you did not receive SSI. (2) Social security disability benefits where drug addiction or... benefits to disabled recipients whose drug addiction or alcoholism is a contributing factor material to the...

20 CFR 416.202 - Who may get SSI benefits.

Code of Federal Regulations, 2011 CFR

2011-04-01

... have more resources than are permitted (subpart L). (e) You are disabled, drug addiction or alcoholism... treatment was available or 36 months of SSI benefits on the basis of disability where drug addiction or...

20 CFR 416.1123 - How we count unearned income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... period for which you did not receive SSI. (2) Social security disability benefits where drug addiction or... benefits to disabled recipients whose drug addiction or alcoholism is a contributing factor material to the...

20 CFR 404.352 - When does my entitlement to child's benefits begin and end?

Code of Federal Regulations, 2014 CFR

2014-04-01

... entitled to disability benefits based on a finding that drug addiction or alcoholism was a contributing... disability is based on a finding that drug addiction or alcoholism was a contributing factor material to the... otherwise disabled without regard to drug addiction or alcoholism (see § 404.470(c)). (2) If you have...

20 CFR 404.352 - When does my entitlement to child's benefits begin and end?

Code of Federal Regulations, 2013 CFR

2013-04-01

... entitled to disability benefits based on a finding that drug addiction or alcoholism was a contributing... disability is based on a finding that drug addiction or alcoholism was a contributing factor material to the... otherwise disabled without regard to drug addiction or alcoholism (see § 404.470(c)). (2) If you have...

20 CFR 404.352 - When does my entitlement to child's benefits begin and end?

Code of Federal Regulations, 2011 CFR

2011-04-01

... entitled to disability benefits based on a finding that drug addiction or alcoholism was a contributing... disability is based on a finding that drug addiction or alcoholism was a contributing factor material to the... otherwise disabled without regard to drug addiction or alcoholism (see § 404.470(c)). (2) If you have...

20 CFR 404.352 - When does my entitlement to child's benefits begin and end?

Code of Federal Regulations, 2012 CFR

2012-04-01

... entitled to disability benefits based on a finding that drug addiction or alcoholism was a contributing... disability is based on a finding that drug addiction or alcoholism was a contributing factor material to the... otherwise disabled without regard to drug addiction or alcoholism (see § 404.470(c)). (2) If you have...

21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

Code of Federal Regulations, 2013 CFR

2013-04-01

... applications for drugs to treat life-threatening and severely-debilitating illnesses. 312.84 Section 312.84... Severely-debilitating Illnesses § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. (a) FDA's application of the...

21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

Code of Federal Regulations, 2014 CFR

2014-04-01

... applications for drugs to treat life-threatening and severely-debilitating illnesses. 312.84 Section 312.84... Severely-debilitating Illnesses § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. (a) FDA's application of the...

21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

Code of Federal Regulations, 2011 CFR

2011-04-01

... applications for drugs to treat life-threatening and severely-debilitating illnesses. 312.84 Section 312.84... Severely-debilitating Illnesses § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. (a) FDA's application of the...

21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... applications for drugs to treat life-threatening and severely-debilitating illnesses. 312.84 Section 312.84... Severely-debilitating Illnesses § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. (a) FDA's application of the...

Food-Drug Interactions

PubMed Central

Bushra, Rabia; Aslam, Nousheen; Khan, Arshad Yar

2011-01-01

The effect of drug on a person may be different than expected because that drug interacts with another drug the person is taking (drug-drug interaction), food, beverages, dietary supplements the person is consuming (drug-nutrient/food interaction) or another disease the person has (drug-disease interaction). A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substances. Regarding food-drug interactions physicians and pharmacists recognize that some foods and drugs, when taken simultaneously, can alter the body's ability to utilize a particular food or drug, or cause serious side effects. Clinically significant drug interactions, which pose potential harm to the patient, may result from changes in pharmaceutical, pharmacokinetic, or pharmacodynamic properties. Some may be taken advantage of, to the benefit of patients, but more commonly drug interactions result in adverse drug events. Therefore it is advisable for patients to follow the physician and doctors instructions to obtain maximum benefits with least food-drug interactions. The literature survey was conducted by extracting data from different review and original articles on general or specific drug interactions with food. This review gives information about various interactions between different foods and drugs and will help physicians and pharmacists prescribe drugs cautiously with only suitable food supplement to get maximum benefit for the patient. PMID:22043389

Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

PubMed

Bender, Ralf; Beckmann, Lars; Lange, Stefan

2016-07-01

The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.

Critical analysis of common canister programs: a review of cross-functional considerations and health system economics.

PubMed

Larson, Trent; Gudavalli, Ravindra; Prater, Dean; Sutton, Scott

2015-04-01

Respiratory inhalers constitute a large percentage of hospital pharmacy expenditures. Metered-dose inhaler (MDI) canisters usually contain enough medication to last 2 to 4 weeks, while the average hospital stay for acute hospitalizations of respiratory illnesses is only 4-5 days. Hospital pharmacies are often unable to operationalize relabeling of inhalers at discharge to meet regulatory requirements. This dilemma produces drug wastage. The common canister (CC) approach is a method some hospitals implemented in an effort to minimize the costs associated with this issue. The CC program uses a shared inhaler, an individual one-way valve holding chamber, and a cleaning protocol. This approach has been the subject of considerable controversy. Proponents of the CC approach reported considerable cost savings to their institutions. Opponents of the CC approach are not convinced the benefits outweigh even a minimal risk of cross-contamination since adherence to protocols for hand washing and disinfection of the MDI device cannot be guaranteed to be 100% (pathogens from contaminated devices can enter the respiratory tract through inhalation). Other cost containment strategies, such as unit dose nebulizers, may be useful to realize similar reductions in pharmacy drug costs while minimizing the risks of nosocomial infections and their associated medical costs. The CC strategy may be appropriate for some hospital pharmacies that face budget constraints, but a full evaluation of the risks, benefits, and potential costs should guide those who make hospital policy decisions.

Risk evaluation and mitigation strategies: a focus on belatacept.

PubMed

Sam, Teena; Gabardi, Steven; Tichy, Eric M

2013-03-01

To review the elements and components of the risk evaluation and mitigation strategies (REMS) for the costimulation blocker belatacept and associated implications for health care providers working with transplant recipients. The MEDLINE and EMBASE databases (January 1990 to March 2012) were searched by using risk evaluation and mitigation strategies, REMS, belatacept, and organ transplant as search terms (individual organs were also searched). Retrieved articles were supplemented with analysis of information obtained from the Federal Register, the Food and Drug Administration, and the manufacturer of belatacept. REMS are risk-management strategies implemented to ensure that a product's benefits outweigh its known safety risks. Although belatacept offers a novel strategy in maintenance immunosuppression and was associated with superior renal function compared with cyclosporine in phase 2 and 3 trials, belatacept is also associated with increased risk of posttransplant lymphoproliferative disorder and central nervous system infections. The Food and Drug Administration required development of a REMS program as part of belatacept's approval process to ensure safe and appropriate use of the medication and optimization of its risk-benefit profile. Elements of the belatacept REMS include a medication guide that must be dispensed with each infusion and a communication plan. In the management of a complex population of patients, it is essential that those who care for transplant recipients, and patients, recognize the implications of potential and known risks of belatacept. The REMS program aims to facilitate careful selection and education of patients and vigilant monitoring.

Psychosocial Correlates of Clinicians' Prescription Drug Monitoring Program Utilization.

PubMed

Pugliese, John A; Wintemute, Garen J; Henry, Stephen G

2018-05-01

The purpose of this study is to extend prior research on barriers to use of a prescription drug monitoring program by examining psychosocial correlates of intended use among physicians and pharmacists. Overall, 1,904 California physicians and pharmacists responded to a statewide survey (24.1% response rate) from August 2016 to January 2017. Participants completed an online survey examining attitudes toward prescription drug misuse and abuse, prescribing practices, prescription drug monitoring program design and ease of use, professional obligations, and normative beliefs regarding prescription drug monitoring program use. Data were analyzed in 2017. Perceived prescription drug monitoring program usefulness and normative beliefs fully mediated the relationship between concern about prescription drug abuse and intentions to use the prescription drug monitoring program. Clinicians' sense of professional and moral obligation to use the prescription drug monitoring program was unrelated to intention to use the prescription drug monitoring program despite a positive relationship with concern about misuse and abuse. Compared with physicians, pharmacists reported greater concern about prescription drug misuse, greater professional and moral obligation to use prescription drug monitoring program, and greater rating of prescription drug monitoring program usefulness. Interventions that target normative beliefs surrounding prescription drug monitoring program use and how to use prescription drug monitoring programs effectively are likely to be more effective than those that target professional obligations or moralize to the medical community. Published by Elsevier Inc.

Effect of generic drug competition on the price of prescription drugs in Ontario.

PubMed Central

Lexchin, J

1993-01-01

OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22. PMID:8439888

Extended Cost-Effectiveness Analysis for Health Policy Assessment: A Tutorial.

PubMed

Verguet, Stéphane; Kim, Jane J; Jamison, Dean T

2016-09-01

Health policy instruments such as the public financing of health technologies (e.g., new drugs, vaccines) entail consequences in multiple domains. Fundamentally, public health policies aim at increasing the uptake of effective and efficient interventions and at subsequently leading to better health benefits (e.g., premature mortality and morbidity averted). In addition, public health policies can provide non-health benefits in addition to the sole well-being of populations and beyond the health sector. For instance, public policies such as social and health insurance programs can prevent illness-related impoverishment and procure financial risk protection. Furthermore, public policies can improve the distribution of health in the population and promote the equalization of health among individuals. Extended cost-effectiveness analysis was developed to address health policy assessment, specifically to evaluate the health and financial consequences of public policies in four domains: (1) the health gains; (2) the financial risk protection benefits; (3) the total costs to the policy makers; and (4) the distributional benefits. Here, we present a tutorial that describes both the intent of extended cost-effectiveness analysis and its keys to allow easy implementation for health policy assessment.

Asymptomatic bacteriuria: when to screen and when to treat.

PubMed

Nicolle, Lindsay E

2003-06-01

Asymptomatic bacteriuria is common. Populations with structural or functional abnormalities of the genitourinary tract may have an exceedingly high prevalence of bacteriuria, but even healthy individuals frequently have positive urine cultures. Asymptomatic bacteriuria is seldom associated with adverse outcomes. Pregnant women and individuals who are to undergo traumatic genitourinary interventions are at risk for complications of bacteriuria and benefit from screening and treatment programs. Although screening is recommended for renal transplant recipients, the benefits for these patients are less clear. For other populations, including most bacteriuric individuals, negative outcomes attributable to asymptomatic bacteriuria have not been described. Treatment of asymptomatic bacteriuria in these patients is not beneficial and, in fact, may be associated with harmful outcomes, such as increased short-term frequency of symptomatic infection, adverse drug effects, and reinfection with organisms of increased antimicrobial resistance. Screening for asymptomatic bacteriuria and treatment is recommended for only selected groups where benefit has been shown. Many research questions still need to be addressed. Different populations have unique risk factors, and the benefits and risks of different management approaches for asymptomatic bacteriuria must continue to be addressed systematically in appropriate clinical trials.

An analysis of benefits and risk information on pharmaceutical web sites for the treatment of menopause.

PubMed

Charbonneau, Deborah H

2013-09-01

As the Internet is a source of information for many health consumers, there is a need to evaluate the information about prescription drugs provided on pharmaceutical manufacturers' web sites. Using a sample of pharmaceutical manufacturers' web sites for the treatment of menopause, the main objective of this study was to evaluate consumer-oriented information about benefits and risks of prescription drugs for the treatment of menopause provided on pharmaceutical web sites. Pharmaceutical manufacturers' web sites for analysis were identified using a list of U.S. FDA-approved hormone therapies for the treatment of menopause. This study revealed substantial gaps in how benefits and risk information were presented on the web sites. Specifically, information about the benefits was prominent while risk information was incomplete and challenging to find. Further, references to the scientific literature to support claims advertised about prescription drug benefits were not provided. Given the lack of scientific evidence to support claims of benefits and limited disclosure about risks, more information is needed for consumers to be able to weigh the benefits and risks of these treatments for menopause. Overall, these findings provide guidance for evaluating drug information provided on pharmaceutical web sites. © 2013 The author. Health Information and Libraries Journal © 2013 Health Libraries Group.

An inevitable wave of prescription drug monitoring programs in the context of prescription opioids: pros, cons and tensions.

PubMed

Islam, M Mofizul; McRae, Ian S

2014-08-16

In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriate therapeutic uses of these drugs with the risk of developing dependence. This article discusses pros and cons of PDMP in reducing diversion of prescription opioids, without hampering access to those medications for those with genuine needs, and highlights tensions around PDMP implementation. PDMPs may help alleviate diversion, over-prescription and fraudulent prescribing/dispensing; prompt drug treatment referrals; avoid awkward drug urine test; and inform spatial changes in prescribing practices and help designing tailored interventions. Fear of legal retribution, privacy and data security, potential confusion about addiction and pseudo-addiction, and potential undue pressure of detecting misuse/diversion - are the major problems. There are tensions about unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP. In this era of information technology PDMP is likely to flourish and remain with us for a long time. A clear standard of practice against which physicians' care will be judged may expedite the utilisation of PDMP. In addition, adequate training on addiction and pain management along with public awareness, point-of-supply data entry from pharmacy, point-of-care real-time access to data, increasing access to addiction treatment and appropriate regulatory enforcement preferably through healthcare administration, together, may help remove barriers to PDMP use.

An inevitable wave of prescription drug monitoring programs in the context of prescription opioids: pros, cons and tensions

PubMed Central

2014-01-01

Background In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriate therapeutic uses of these drugs with the risk of developing dependence. This article discusses pros and cons of PDMP in reducing diversion of prescription opioids, without hampering access to those medications for those with genuine needs, and highlights tensions around PDMP implementation. Discussion PDMPs may help alleviate diversion, over-prescription and fraudulent prescribing/dispensing; prompt drug treatment referrals; avoid awkward drug urine test; and inform spatial changes in prescribing practices and help designing tailored interventions. Fear of legal retribution, privacy and data security, potential confusion about addiction and pseudo-addiction, and potential undue pressure of detecting misuse/diversion - are the major problems. There are tensions about unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP. Summary In this era of information technology PDMP is likely to flourish and remain with us for a long time. A clear standard of practice against which physicians’ care will be judged may expedite the utilisation of PDMP. In addition, adequate training on addiction and pain management along with public awareness, point-of-supply data entry from pharmacy, point-of-care real-time access to data, increasing access to addiction treatment and appropriate regulatory enforcement preferably through healthcare administration, together, may help remove barriers to PDMP use. PMID:25127880

Gender-Specific Barriers to Self-Sufficiency among Former Supplemental Security Income Drug Addiction and Alcoholism Beneficiaries: Implications for Welfare-To-Work Programs and Services

PubMed Central

Hogan, Sean R; Unick, George J.; Speiglman, Richard; Norris, Jean C.

2011-01-01

This study examines barriers to economic self-sufficiency among a panel of 219 former Supplemental Security Income (SSI) drug addiction and alcoholism (DA&A) recipients following elimination of DA&A as an eligibility category for SSI disability benefits. Study participants were comprehensively surveyed at six measurement points following the policy change. Generalized estimating equations were used to examine full-sample and gender-specific barriers to economic self-sufficiency. Results indicate that access to transportation, age, and time are the strongest predictors of achieving self-sufficiency for both men and women leaving the welfare system. Gender-specific barriers are also identified. Future research needs to assess the generalizability of these results to other public assistance recipients. PMID:21625301

Alternative strategies for Medicare payment of outpatient prescription drugs--Part B and beyond.

PubMed

Danzon, Patricia M; Wilensky, Gail R; Means, Kathleen E

2005-03-01

Reimbursement options for pharmaceuticals reimbursed under Medicare Part B (physician-dispensed drugs) are changing and the new comprehensive Part D Medicare outpatient drug benefit brings further changes. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) replaces traditional policy, of reimbursing Part B drugs at 95% of average wholesale price (AWP, a list price), with a percentage markup over the manufacturer's average selling price; in 2005 an indirect competitive procurement option will be introduced. In our view, although AWP-based reimbursement has been fraught with problems in the past, these could be fixed by constraining growth in AWP and periodically adjusting the discount off AWP. With these revisions, an AWP-based rule would preserve incentives for competitive discounting and deliver savings to Medicare. By contrast, basing Medicare reimbursement on a manufacturer's average selling price undermines incentives for discounting and, like any cost-based reimbursement rule, may result in higher prices to both public and private purchasers. Indirect competitive procurement for drugs alone, using specialty pharmacies, pharmacy benefit managers, or prescription drug plans, is unlikely to constrain costs to acceptable levels unless contractors retain flexibility to use standard benefit management tools. Folding Part B and Part D into comprehensive contracting with health plans for full health services is likely to offer the most efficient approach to managing the drug benefit.

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

Benefit and harms of new anti-cancer drugs.

PubMed

Vera-Badillo, Francisco E; Al-Mubarak, Mustafa; Templeton, Arnoud J; Amir, Eitan

2013-06-01

Phase III randomized controlled trials (RCTs) assess clinically important differences in endpoints that reflect benefit to and harm of patients. Defining benefit of cancer drugs can be difficult. Overall survival and quality of life are the most relevant primary endpoints, but difficulty in measuring these mean that other endpoints are often used, although their surrogacy or clinical relevance has not always been established. In general, advances in drug development have led to numerous new drugs to enter the market. Pivotal RCT of several new drugs have shown that benefit appeared greater for targeted anticancer agents than for chemotherapeutic agents. This effect seems particularly evident with targeted agents evaluated in biomarker-driven studies. Unfortunately, new therapies have also shown an increase in toxicity. Such toxicity is not always evident in the initial reports of RCTs. This may be a result of a statistical inability to detect differences between arms of RCTs, or occasionally due to biased reporting. There are several examples where reports of new toxicities could only be found in drug labels. In some cases, the small improvement in survival has come at a cost of substantial excess toxicity, leading some to consider such therapy as having equipoise.

Videotape educational program for people with asthma.

PubMed Central

Moldofsky, H.; Broder, I.; Davies, G.; Leznoff, A.

1979-01-01

A videotape educational program was produced for use in adults with asthma. The program provided an overview of lung function, the physiologic abnormalities and treatment of asthma, and the approach to common problems encountered by the patients. Its benefits were examined in a randomized controlled study. The efficacy of the program in 62 patients whose mean duration of illness was 17 years was assessed by comparing the level of knowledge of the experimental group immediately after viewing the tape with that of the controls, who had not seen it; the experimental group scored significantly higher than the control group. Retention of knowledge attributed to the program was assessed after a mean interval of 16 months. The knowledge test score of the experimental group was found to have decreased to the level of the control group. The main areas in which the experimental group lost knowledge were self-care and drug therapy for asthma. The medical status of the two groups did not change appreciably over the period of the study. PMID:436049

Collaborative evaluation of a high school prevention curriculum: How methods of collaborative evaluation enhanced a randomized control trial to inform program improvement.

PubMed

Orsini, Muhsin Michael; Wyrick, David L; Milroy, Jeffrey J

2012-11-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome variables that can be used for program improvement. Throughout this project there were many examples of client learning from evaluator and evaluator learning from client. This article presents convincing evidence that collaborative evaluation can improve the design, implementation, and findings of the randomized control trial. Throughout this paper, we discuss many examples of good science, good evaluation, and other practical benefits of practicing collaborative evaluation. Ultimately, the authors created the term pre-formative evaluation to describe the period prior to data collection and before program implementation, when collaborative evaluation can inform program improvement. Copyright © 2012 Elsevier Ltd. All rights reserved.

Falling Short of the Rights to Health and Scientific Progress

PubMed Central

Henry, Ian; Lessem, Erica

2016-01-01

Abstract The incorporation of human rights-based approaches into TB programs is gaining traction, but little work has explored the application of human rights norms and principles to TB research (a domain traditionally left to bioethics). TB research is gravely underfunded, and the scarcity of resources for TB drug development has contributed to the stubborn persistence of the TB epidemic and helped to create the conditions under which drug-resistant TB has developed and spread. This article shows how human rights—particularly human rights standards, norms, and principles related to the rights to health and benefits of scientific progress—can provide insight into understanding how underfunding TB drug research undermines efforts to secure access to safe, effective, and optimized treatment for all people with TB. By analyzing TB research in relation to the rights to health and scientific progress, we aim to clarify the legal obligations of governments to improve the TB drug research system, fund TB research, and make medical advances that result from research available to all people with TB. PMID:27780996

Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs

PubMed Central

Wieseler, Beate; Kaiser, Thomas; Thomas, Stefanie; Bender, Ralf; Windeler, Jürgen; Lange, Stefan

2016-01-01

At the beginning of 2011, the early benefit assessment of new drugs was introduced in Germany with the Act on the Reform of the Market for Medicinal Products (AMNOG). The Federal Joint Committee (G‐BA) generally commissions the Institute for Quality and Efficiency in Health Care (IQWiG) with this type of assessment, which examines whether a new drug shows an added benefit (a positive patient‐relevant treatment effect) over the current standard therapy. IQWiG is required to assess the extent of added benefit on the basis of a dossier submitted by the pharmaceutical company responsible. In this context, IQWiG was faced with the task of developing a transparent and plausible approach for operationalizing how to determine the extent of added benefit. In the case of an added benefit, the law specifies three main extent categories (minor, considerable, major). To restrict value judgements to a minimum in the first stage of the assessment process, an explicit and abstract operationalization was needed. The present paper is limited to the situation of binary data (analysis of 2 × 2 tables), using the relative risk as an effect measure. For the treatment effect to be classified as a minor, considerable, or major added benefit, the methodological approach stipulates that the (two‐sided) 95% confidence interval of the effect must exceed a specified distance to the zero effect. In summary, we assume that our approach provides a robust, transparent, and thus predictable foundation to determine minor, considerable, and major treatment effects on binary outcomes in the early benefit assessment of new drugs in Germany. After a decision on the added benefit of a new drug by G‐BA, the classification of added benefit is used to inform pricing negotiations between the umbrella organization of statutory health insurance and the pharmaceutical companies. PMID:26134089

Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs.

PubMed

Skipka, Guido; Wieseler, Beate; Kaiser, Thomas; Thomas, Stefanie; Bender, Ralf; Windeler, Jürgen; Lange, Stefan

2016-01-01

At the beginning of 2011, the early benefit assessment of new drugs was introduced in Germany with the Act on the Reform of the Market for Medicinal Products (AMNOG). The Federal Joint Committee (G-BA) generally commissions the Institute for Quality and Efficiency in Health Care (IQWiG) with this type of assessment, which examines whether a new drug shows an added benefit (a positive patient-relevant treatment effect) over the current standard therapy. IQWiG is required to assess the extent of added benefit on the basis of a dossier submitted by the pharmaceutical company responsible. In this context, IQWiG was faced with the task of developing a transparent and plausible approach for operationalizing how to determine the extent of added benefit. In the case of an added benefit, the law specifies three main extent categories (minor, considerable, major). To restrict value judgements to a minimum in the first stage of the assessment process, an explicit and abstract operationalization was needed. The present paper is limited to the situation of binary data (analysis of 2 × 2 tables), using the relative risk as an effect measure. For the treatment effect to be classified as a minor, considerable, or major added benefit, the methodological approach stipulates that the (two-sided) 95% confidence interval of the effect must exceed a specified distance to the zero effect. In summary, we assume that our approach provides a robust, transparent, and thus predictable foundation to determine minor, considerable, and major treatment effects on binary outcomes in the early benefit assessment of new drugs in Germany. After a decision on the added benefit of a new drug by G-BA, the classification of added benefit is used to inform pricing negotiations between the umbrella organization of statutory health insurance and the pharmaceutical companies. © 2015 The Authors. Biometrical Journal Published by Wiley-VCH Verlag GmbH & Co. KGaA.

20 CFR 404.335 - How do I become entitled to widow's or widower's benefits?

Code of Federal Regulations, 2012 CFR

2012-04-01

... received 36 months of payments based on disability when drug addiction or alcoholism was a contributing... benefits is not based on a disability where drug addiction or alcoholism is a contributing factor material...

20 CFR 404.335 - How do I become entitled to widow's or widower's benefits?

Code of Federal Regulations, 2013 CFR

2013-04-01

... received 36 months of payments based on disability when drug addiction or alcoholism was a contributing... benefits is not based on a disability where drug addiction or alcoholism is a contributing factor material...

20 CFR 404.335 - How do I become entitled to widow's or widower's benefits?

Code of Federal Regulations, 2014 CFR

2014-04-01

... received 36 months of payments based on disability when drug addiction or alcoholism was a contributing... benefits is not based on a disability where drug addiction or alcoholism is a contributing factor material...

20 CFR 404.335 - How do I become entitled to widow's or widower's benefits?

Code of Federal Regulations, 2011 CFR

2011-04-01

... received 36 months of payments based on disability when drug addiction or alcoholism was a contributing... benefits is not based on a disability where drug addiction or alcoholism is a contributing factor material...

NHI-PharmaCloud in Taiwan--A preliminary evaluation using the RE-AIM framework and lessons learned.

PubMed

Huang, San-Kuei; Wang, Pen-Jen; Tseng, Wen-Fuh; Syu, Fei-Kai; Lee, Miaw-Chwen; Shih, Ru-Liang; Sheen, Mao-Ting; Chen, Michael S

2015-10-01

The aim of this article is to present the preliminary impact of a medication monitoring program, PharmaCloud, in Taiwan and analyze the embedded factors that have contributed to the performance thereof. This article also compared PharmaCloud with similar international programs in order to draw lessons learned. The five domains of the RE-AIM framework - reach, effectiveness, adoption, implementation, and maintenance - were examined using qualitative and quantitative data. A difference-in-differences model was applied to analyze the quantitative impact of PharmaCloud on drug utilization and drug expenses. The qualitative impact was evaluated by document analysis based on field reports from the participating medical institutions. Reach and adoption: although all of the major hospitals adopted PharmaCloud and some of the hospitals had high inquiry rates, more time and incentives are needed to raise the overall inquiry rate. Effectiveness: during the study period of 3 months, the number of medications per prescription declined in the intervention group was 0.15 more than that of the general population, and the drug expense per person declined in the intervention group was NT $567 (US $18.9) more than that of the general population. The potential savings could be between 2% and 5% of the total pharmaceutical expenditure. Medication duplication was found to have decreased more in the intervention group. a variety of innovations in care delivery are being developed in which the pharmacists play a more significant role. Maintenance: the embedded National Health Insurance would lend strong support for PharmaCloud to grow and thrive. PharmaCloud owes its effectiveness to the embedded National Health Insurance (NHI) program, which is universal and provides a comprehensive benefit package including more than 16,000 prescription drugs. An effective medication program is one that operates under the principle of universality and comprehensiveness, facilitates innovations, and has a substantial level of interoperability with the intra-hospital health information systems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

PubMed

Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

2015-12-01

The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

Position stand on androgen and human growth hormone use.

PubMed

Hoffman, Jay R; Kraemer, William J; Bhasin, Shalender; Storer, Thomas; Ratamess, Nicholas A; Haff, G Gregory; Willoughby, Darryn S; Rogol, Alan D

2009-08-01

Hoffman, JR, Kraemer, WJ, Bhasin, S, Storer, T, Ratamess, NA, Haff, GG, Willoughby, DS, and Rogol, AD. Position stand on Androgen and human growth hormone use. J Strength Cond Res 23(5): S1-S59, 2009-Perceived yet often misunderstood demands of a sport, overt benefits of anabolic drugs, and the inability to be offered any effective alternatives has fueled anabolic drug abuse despite any consequences. Motivational interactions with many situational demands including the desire for improved body image, sport performance, physical function, and body size influence and fuel such negative decisions. Positive countermeasures to deter the abuse of anabolic drugs are complex and yet unclear. Furthermore, anabolic drugs work and the optimized training and nutritional programs needed to cut into the magnitude of improvement mediated by drug abuse require more work, dedication, and preparation on the part of both athletes and coaches alike. Few shortcuts are available to the athlete who desires to train naturally. Historically, the NSCA has placed an emphasis on education to help athletes, coaches, and strength and conditioning professionals become more knowledgeable, highly skilled, and technically trained in their approach to exercise program design and implementation. Optimizing nutritional strategies are a vital interface to help cope with exercise and sport demands (). In addition, research-based supplements will also have to be acknowledged as a strategic set of tools (e.g., protein supplements before and after resistance exercise workout) that can be used in conjunction with optimized nutrition to allow more effective adaptation and recovery from exercise. Resistance exercise is the most effective anabolic form of exercise, and over the past 20 years, the research base for resistance exercise has just started to develop to a significant volume of work to help in the decision-making process in program design (). The interface with nutritional strategies has been less studied, yet may yield even greater benefits to the individual athlete in their attempt to train naturally. Nevertheless, these are the 2 domains that require the most attention when trying to optimize the physical adaptations to exercise training without drug use.Recent surveys indicate that the prevalence of androgen use among adolescents has decreased over the past 10-15 years (). The decrease in androgen use among these students may be attributed to several factors related to education and viable alternatives (i.e., sport supplements) to substitute for illegal drug use. Although success has been achieved in using peer pressure to educate high school athletes on behaviors designed to reduce the intent to use androgens (), it has not had the far-reaching effect desired. It would appear that using the people who have the greatest influence on adolescents (coaches and teachers) be the primary focus of the educational program. It becomes imperative that coaches provide realistic training goals for their athletes and understand the difference between normal physiological adaptation to training or that is pharmaceutically enhanced. Only through a stringent coaching certification program will academic institutions be ensured that coaches that they hire will have the minimal knowledge to provide support to their athletes in helping them make the correct choices regarding sport supplements and performance-enhancing drugs.The NSCA rejects the use of androgens and hGH or any performance-enhancing drugs on the basis of ethics, the ideals of fair play in competition, and concerns for the athlete's health. The NSCA has based this position stand on a critical analysis of the scientific literature evaluating the effects of androgens and human growth hormone on human physiology and performance. The use of anabolic drugs to enhance athletic performance has become a major concern for professional sport organizations, sport governing bodies, and the federal government. It is the belief of the NSCA that through education and research we can mitigate the abuse of androgens and hGH by athletes. Due to the diversity of testosterone-related drugs and molecules, the term androgens is believed to be a more appropriate term for anabolic steroids.

Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review.

PubMed

Kanji, Salmaan; Seely, Dugald; Yazdi, Fatemeh; Tetzlaff, Jennifer; Singh, Kavita; Tsertsvadze, Alexander; Tricco, Andrea C; Sears, Margaret E; Ooi, Teik C; Turek, Michele A; Skidmore, Becky; Ansari, Mohammed T

2012-05-31

The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed.Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s) with the drug(s) alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets) and garlic (plus nitrates or warfarin) on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

[Evaluation of the medical value of a drug. A necessity for the Transparency Commission].

PubMed

Avouac, B

1992-01-01

The marketing approval (AMM) is based on criteria of pharmaceutical quality, efficacy and safety of use. Before marketing, the data are collected by means of double-blind, randomized, prospective clinical trials that compare the study product to a reference product. A post-AMM assessment is needed to define the increase of the medical benefit (ASMR) and the therapeutic value of the new drugs. The quantification of the ASMR is essential for registration on the list of drugs reimbursable for those who benefit from Social Security. The evaluation of the therapeutic value and the nature of the affection treated are the criteria upon which the reimbursement ratio is chosen. After marketing, the reevaluation of the medical benefit and the drugs' usefulness may be compared to the treatment's net medical cost (direct + indirect cost--avoided cost) in cost/utility or cost/benefit studies. The Transparency Commission has worked out a scale of assessment of the ASMR which will orient recommendation, or non-recommendation, of registration on the list of reimbursable drugs as well as price fixing proposals. In the future, the Transparency Commission is to strengthen its position regarding the good use of the drug through a better prescriber information system. Thanks to the pharmaco-epidemiology and the pharmaco-vigilance data, the Transparency Commission will be able to guarantee the post-marketing follow-up of the drugs. The examination of the products' conditions of use, the reevaluation of the treatment's advantages based on the utility studies and the epidemiological surveys, and the cost-benefit studies will contribute to a medical control of health spending linked to drug consumption.

Prescription of drugs during pregnancy in France.

PubMed

Lacroix, I; Damase-Michel, C; Lapeyre-Mestre, M; Montastruc, J L

2000-11-18

A survey of the records of the French Health Insurance Service of drug prescriptions during pregnancy in 1000 women living in Haute-Garonne, southwest France, showed that 99% of the women received a prescription for at least one drug during pregnancy with a mean of 13.6 medications per woman. 1.6% of women received one or more prescriptions of drugs from the US Food and Drug Administration X category (fetal risk outweighs benefits). 59% of women had a prescription of drugs from the D category (fetal risk but benefits may be acceptable) and 79% of women were exposed to drugs for which information about safety in pregnancy was not available from animal or human studies.

Health plan utilization and costs of specialty drugs within 4 chronic conditions.

PubMed

Gleason, Patrick P; Alexander, G Caleb; Starner, Catherine I; Ritter, Stephen T; Van Houten, Holly K; Gunderson, Brent W; Shah, Nilay D

2013-09-01

Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD (13.7%) and highest for MS (71.8%). The lowest total annual cost of care was for psoriasis ($14,815), and the highest total annual cost was for MS ($36,901). The most commonly used specialty drugs for each of the conditions were as follows: glatiramer (MS), etanercept (RA and psoriasis), and infliximab (IBD). The total annual costs were more than double for the specialty drug users for psoriasis compared with all the psoriasis members ($29,565 vs. $14,815). The total costs were only somewhat higher among MS members using specialty drugs ($41,760 vs. $36,901). Among specialty drug users for each of the cohorts, the annual costs of specialty drugs accounted for 50% or more of the total annual costs. The annual spending growth rate for specialty drugs ranged from 4.4% to 18.0%. Although specialty drug utilization varied widely across the 4 chronic conditions analyzed, when specialty drugs were used they accounted for the majority of the annual total direct cost of care. Because specialty drugs are accounting for a growing portion of chronic disease total cost of care, health insurers will need to become more vigilant regarding specialty drug use and focus on 4 cost saving management opportunities: drug distribution channel, utilization management, contracting activities, and care coordination.

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing.... (4) A part 145 certificate holder who has your own drug testing program Obtain an Antidrug and...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... Specification, Letter of Authorization, or Drug and Alcohol Testing Program Registration from the FAA: If you...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

Educational program for physicians to reduce use of non-steroidal anti-inflammatory drugs among community-dwelling elderly persons: a randomized controlled trial.

PubMed

Ray, W A; Stein, C M; Byrd, V; Shorr, R; Pichert, J W; Gideon, P; Arnold, K; Brandt, K D; Pincus, T; Griffin, M R

2001-05-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently prescribed drugs for patients 65 years of age or older, primarily for musculoskeletal symptoms of osteoarthritis. Because NSAIDs frequently cause serious gastrointestinal (GI) and other complications among elderly patients, expert guidelines for osteoarthritis recommend acetaminophen-based regimens, which are safer and often as effective as NSAIDs. Evaluate a physician education program that communicated guidelines for management of osteoarthritis in elderly patients that emphasized avoidance of NSAIDs when possible. The program reviewed NSAID risks and benefits and recommended: re-evaluating continuous NSAID users, considering substitution of up to 4 g/d of acetaminophen for the NSAID, and trying topical agents and nonpharmacologic measures. Randomized controlled trial among community-dwelling Tennessee Medicaid enrollees. Study physicians had 5 or more patients who: were community-dwelling Medicaid enrollees 65 years of age or older; had used NSAIDs regularly for at least 180 days; had had no medical care encounters during this period suggesting an indication other than osteoarthritis; and had 1 year of baseline and follow-up data. The study thus included 209 physicians (103 intervention/106 control) with 1,566 qualifying regular NSAID users (768/798). Face-to-face visit to study physicians by another physician, and reminder placements in the charts of patients eligible to have NSAID use reevaluated. Change between baseline and follow-up years in: days of prescribed NSAIDs, acetaminophen, other drugs for musculoskeletal disorders, and GI drugs; outpatient visits and inpatient days of stay; SF36 measures of general health, physical function, and bodily pain (from 40% random patient sample); and over-the-counter NSAIDs (from the sample). Intervention-attributable reduction of 7% (95% CI, 3% to 11%) in days of prescribed NSAIDs use with concomitant increase in acetaminophen use. No significant changes in other study endpoints. The intervention effect was greater among 75 physicians with a completed study visit, whose 564 patients had a 10% (95% CI, 6% to 14%) attributable reduction in NSAID use. The educational program modestly reduced NSAID exposure in community-dwelling elderly patients without undesirable substitution of other medications or detectable worsening of musculoskeletal symptoms.

Utilization of smoking cessation medication benefits among medicaid fee-for-service enrollees 1999-2008.

PubMed

Kahende, Jennifer; Malarcher, Ann; England, Lucinda; Zhang, Lei; Mowery, Paul; Xu, Xin; Sevilimedu, Varadan; Rolle, Italia

2017-01-01

To assess state coverage and utilization of Medicaid smoking cessation medication benefits among fee-for-service enrollees who smoked cigarettes. We used the linked National Health Interview Survey (survey years 1995, 1997-2005) and the Medicaid Analytic eXtract files (1999-2008) to assess utilization of smoking cessation medication benefits among 5,982 cigarette smokers aged 18-64 years enrolled in Medicaid fee-for-service whose state Medicaid insurance covered at least one cessation medication. We excluded visits during pregnancy, and those covered by managed care or under dual enrollment (Medicaid and Medicare). Multivariate logistic regression was used to determine correlates of cessation medication benefit utilization among Medicaid fee-for-service enrollees, including measures of drug coverage (comprehensive cessation medication coverage, number of medications in state benefit, varenicline coverage), individual-level demographics at NHIS interview, age at Medicaid enrollment, and state-level cigarette excise taxes, statewide smoke-free laws, and per-capita tobacco control funding. In 1999, the percent of smokers with ≥1 medication claims was 5.7% in the 30 states that covered at least one Food and Drug Administration (FDA)-approved cessation medication; this increased to 9.9% in 2008 in the 44 states that covered at least one FDA-approved medication (p<0.01). Cessation medication utilization was greater among older individuals (≥ 25 years), females, non-Hispanic whites, and those with higher educational attainment. Comprehensive coverage, the number of smoking cessation medications covered and varenicline coverage were all positively associated with utilization; cigarette excise tax and per-capita tobacco control funding were also positively associated with utilization. Utilization of medication benefits among fee-for-service Medicaid enrollees increased from 1999-2008 and varied by individual and state-level characteristics. Given that the Affordable Care Act bars state Medicaid programs from excluding any FDA-approved cessation medications from coverage as of January 2014, monitoring Medicaid cessation medication claims may be beneficial for informing efforts to increase utilization and maximize smoking cessation.

Effects of emotional tone and visual complexity on processing health information in prescription drug advertising.

PubMed

Norris, Rebecca L; Bailey, Rachel L; Bolls, Paul D; Wise, Kevin R

2012-01-01

This experiment explored how the emotional tone and visual complexity of direct-to-consumer (DTC) drug advertisements affect the encoding and storage of specific risk and benefit statements about each of the drugs in question. Results are interpreted under the limited capacity model of motivated mediated message processing framework. Findings suggest that DTC drug ads should be pleasantly toned and high in visual complexity in order to maximize encoding and storage of risk and benefit information.

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

47 CFR 1.2002 - Applicants required to submit information.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Grants by Random Selection Implementation of the Anti-Drug Abuse Act of 1988 § 1.2002 Applicants required... benefits that includes FCC benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988. 21 U.S.C...

47 CFR 1.2002 - Applicants required to submit information.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Grants by Random Selection Implementation of the Anti-Drug Abuse Act of 1988 § 1.2002 Applicants required... benefits that includes FCC benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988. 21 U.S.C...

47 CFR 1.2002 - Applicants required to submit information.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Grants by Random Selection Implementation of the Anti-Drug Abuse Act of 1988 § 1.2002 Applicants required... benefits that includes FCC benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988. 21 U.S.C...

Adverse event management in mass drug administration for neglected tropical diseases.

PubMed

Caplan, Arthur; Zink, Amanda

2014-03-01

The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of and rote response to AEs and SAEs. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Riding the rollercoaster: the ups and downs in out-of-pocket spending under the standard Medicare drug benefit.

PubMed

Stuart, Bruce; Briesacher, Becky A; Shea, Dennis G; Cooper, Barbara; Baysac, Fatima S; Limcangco, M Rhona

2005-01-01

This study projects how much Medicare beneficiaries who sign up for the standard Part D drug benefit in 2006 will pay in quarterly out-of-pocket payments through 2008. In the first year we estimate that about 38 percent of enrollees will hit the benefit's no-coverage zone, known as the "doughnut hole," and that 14 percent will exceed the catastrophic threshold. Because drug spending is highly persistent over time, beneficiaries who experience the biggest gaps in coverage are likely to do so year after year, with potentially serious financial consequences.

Toward Value-Based Pricing to Boost Cancer Research and Innovation.

PubMed

Ocana, Alberto; Amir, Eitan; Tannock, Ian F

2016-06-01

The high market price of new anticancer agents has stimulated debate about the long-term sustainability of healthcare systems and whether these new agents can continue to be supported by public healthcare or by private insurers. In addition, some drugs have been approved with limited clinical benefit, raising concerns about setting a minimum requirement for medical benefit. Options to resolve these problems include raising the bar for approval of new drugs and/or pricing of new agents based on the medical benefit that they offer to patients. In this commentary, we suggest that new agents should be marketed in a two-step process that would include first the approval of the new drug by the regulatory agencies and second the introduction of a market price based on the medical benefit that the new intervention offers to patients. Introduction of value-based pricing would maintain the sustainability of health care systems and would improve drug development, as it would pressure pharmaceutical companies to become more innovative and avoid the development of compounds with limited benefit. Value-based pricing could also stimulate the funding of research directed to development of new anticancer drugs with novel mechanisms of action. Cancer Res; 76(11); 3127-9. ©2016 AACR. ©2016 American Association for Cancer Research.

Traumatic Brain Injury: A Guide for Caregivers of Service Members and Veterans: Navigating Services and Benefits Module 4

DTIC Science & Technology

2010-04-01

help outside their chain of command. 41 Your family member may also: • feel depressed • begin to abuse alcohol or drugs • have problems with...P.O. Box 5715 Helena, MT 59604 P.O. Box 95083 301 Centennial Mall South, 6th Floor Lincoln, NE 68509 5460 Reno Corporation Dr. Reno, NV 89511 275...main.htm or call the toll-free line at 1-800-444-5445. DoD Mental Health Self Assessment Program Anonymous self-assessments are available for depression

Challenges in the clinical development of new antiepileptic drugs.

PubMed

Franco, Valentina; French, Jacqueline A; Perucca, Emilio

2016-01-01

Despite the current availability in the market of over two dozen antiepileptic drugs (AEDs), about one third of people with epilepsy fail to achieve complete freedom from seizures with existing medications. Moreover, currently available AEDs have significant limitations in terms of safety, tolerability and propensity to cause or be a target for clinically important adverse drug interactions. A review of the evidence shows that there are many misperceptions about the viability of investing into new therapies for epilepsy. In fact, there are clear incentives to develop newer and more efficacious medications. Developing truly innovative drugs requires a shift in the paradigms for drug discovery, which is already taking place by building on greatly expanded knowledge about the mechanisms involved in epileptogenesis, seizure generation, seizure spread and development of co-morbidities. AED development can also benefit by a review of the methodology currently applied in clinical AED development, in order to address a number of ethical and scientific concerns. As discussed in this article, many processes of clinical drug development, from proof-of-concept-studies to ambitious programs aimed at demonstrating antiepileptogenesis and disease-modification, can be facilitated by a greater integration of preclinical and clinical science, and by application of knowledge acquired during decades of controlled epilepsy trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

Crime Control Act of 1990 [29 November 1990]. [Summary].

PubMed

1990-01-01

In the US, the Crime Control Act of 1990 was approved on November 29, 1990. This various titles of this Act include provisions relating to the following: 1) international money laundering; 2) child abuse; 3) child pornography; 4) kidnapping, abducting, or unlawfully restraining a child; 5) the protection of crime victims; 6) funding for local law enforcement agencies; 7) funding for federal law enforcement; 8) rural drug enforcement assistance; 9) mandatory detention for certain criminals; 10) juvenile justice; 11) penalties for use of certain firearms; 12) improvements in miscellaneous criminal law; 13) disability benefits for public safety officers; 14) money laundering; 15) drug-free school zones; 16) miscellaneous amendments to the federal judicial and criminal codes; 17) general provisions; 18) grants for correctional options; 19) control of anabolic steroids; 20) asset forfeiture; 21) student loan cancellation for law enforcement officers; 22) firearms provisions; 23) chemical diversion and trafficking; 24) drug paraphernalia; 25) banking law enforcement; 26) licit opium imports; 27) sentencing for methamphetamine offenses; 28) drug enforcement grants; 29) prisons; 30) shock incarceration (prison boot camps); 31) bankruptcy and restitution; 32) appropriations for law and drug enforcement agencies; 33) anti-drug programs; 34) support of law enforcement; 35) technical and minor substantive amendments to the federal criminal code; 36) federal debt collection; and 37) national child search assistance (for missing children).

42 CFR 423.124 - Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies. 423.124 Section 423.124 Public Health CENTERS FOR MEDICARE... PRESCRIPTION DRUG BENEFIT Benefits and Beneficiary Protections § 423.124 Special rules for out-of-network...

42 CFR 423.124 - Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies. 423.124 Section 423.124 Public Health CENTERS FOR MEDICARE... PRESCRIPTION DRUG BENEFIT Benefits and Beneficiary Protections § 423.124 Special rules for out-of-network...

Use and Spending for Biologic Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis Among US Medicare Beneficiaries.

PubMed

Yazdany, Jinoos; Tonner, Chris; Schmajuk, Gabriela

2015-09-01

Biologic therapies have assumed an important role in treating rheumatoid arthritis (RA). We sought to investigate use, spending, and patient cost-sharing for Medicare beneficiaries using biologic drugs for RA, comparing patients exposed to minimal cost-sharing because of a Part D low-income subsidy (LIS) to those facing substantial out-of-pocket costs (OOP). We performed a retrospective, nationwide study using 2009 Medicare claims for a 5% random sample of beneficiaries with RA who had at least 1 RA drug dispensed. We analyzed biologic drug utilization and costs across the Part B (medical benefit) and Part D (pharmacy benefit) programs by LIS status using multinomial regression. We also projected OOP costs as the Affordable Care Act (ACA) mandates closure of the Part D coverage gap by 2020. Among 6,932 beneficiaries, 1,812 (26.1%) received a biologic drug. LIS beneficiaries were significantly more likely to obtain Part D home-administered biologics (relative risk ratio [RRR] 2.98, 95% confidence interval [95% CI] 2.50-3.56), while non-LIS beneficiaries were less likely to receive Part D biologic agents (RRR 0.58, 95% CI 0.48-0.69). OOP costs in Part D were lower, as expected, for LIS beneficiaries ($72 versus $3,751 per year for non-LIS). Non-LIS beneficiaries had lower costs for Part B facility-administered biologic agents (range $0-$2,584) than for Part D home-administered biologic agents. ACA reforms will narrow OOP differences between Part D and B for non-LIS beneficiaries. In contrast to LIS beneficiaries who receive mostly Part D home-administered biologic DMARDs, nonsubsidized beneficiaries have significant cost-based incentives to obtain facility-administered biologic DMARDs through Part B. The ACA will result in only slightly lower costs for Part D biologic drugs for these beneficiaries. © 2015, American College of Rheumatology.

Postmarketing surveillance in developing countries.

PubMed

Meirik, O

1988-01-01

Authorities in developing countries need to monitor the possible adverse consequences of the increasing use of drugs in their countries. Definite differences exist in the risk-benefit ratios for developed and developing countries, particularly with fertility-regulating drugs. Some physicians believe that the increased risk of thrombosis associated with oral contraceptives (OCs) should not be considered as important in developing countries due to the fact that the background level of venous thrombosis is so low in developing countries that even a 50- or 100-fold increase in relative risk would neither be detectable nor important compared to the risk of unwanted pregnancy. In addition, evidence exists of geographically linked factors in the etiology of some adverse drug reactions (ADRs). Authorities in Brazil, India, Indonesia, Pakistan, the Philippines, Thailand, and Venezuela have established voluntary ADR reporting systems. Several developing countries also actively follow the World Health Organization's International Drug Monitoring Program and have access to its data base. A number of other methodological approaches to postmarketing surveillance are in use in addition to voluntary ADR reporting systems. These include cross-sectional surveys, studies of temporal and geographic correlations of diseases and drug use, and case-control and cohort studies. Each of these approaches offers specific advantages. Postmarketing surveillance should begin at the time new drugs, including contraceptive methods are introduced. Surveillance needs to be an integral part of plans for the introduction of new contraceptive methods in settings where the infrastructure to carry out such surveillance is in place. 3 major public sector agencies, Family Health International, the Population Council, and the World Health Organization, developed a plan to obtain funding for the postmarketing surveillance of a contraceptive implant, Norplant-R. A controlled cohort study will be conducted in 6-10 developing countries. The pilot phase of the surveillance began in 1987. The project objective is to detect possible adverse effects of Norplant-R as well as any health benefits of the method. It also will assess the feasibility of the cohort methodology for postmarketing surveillance in developing countries.

Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation?

PubMed

Arnold, Denis G; Troyer, Jennifer L

2016-04-01

The pharmaceutical industry has been criticized for developing and aggressively marketing drugs that do not provide significant health benefits relative to existing drugs but retain the benefits of patent protection. Critics argue that drug marketing increases health care expenditures and provides a disincentive for pioneering drug innovation. However, evidence that marketing expenditures have any relationship to new drug approvals has been anecdotal. We hypothesized that, at publicly traded pharmaceutical firms, increased marketing expenditures will result in a reduced volume of pioneering new drugs in comparison to less innovative new drugs. We also hypothesized that additional research and development spending will result in an increased volume of pioneering new drugs in comparison to less innovative drugs. Results confirm our hypotheses. Specific policy recommendations for altering firms' incentives for the development of pioneering drugs are provided. Copyright © 2016 by Duke University Press.

Header: Do adult DTC programs prevent child maltreatment? Parental criminal justice involvement and children’s involvement with child protective services: Do adult drug treatment courts prevent child maltreatment?

PubMed Central

Eldred, Lindsey M.; Sloan, Frank A.; Evans, Kelly E.

2016-01-01

Background In light of evidence showing reduced criminal recidivism and cost savings, adult drug treatment courts have grown in popularity. However, the potential spillover benefits to family members are understudied. Objectives To examine: 1) the overlap between parents who were convicted of a substance-related offense and their children’s involvement with child protective services (CPS); and 2) whether parental participation in an adult drug treatment court program reduces children’s risk for CPS involvement. Methods Administrative data from North Carolina courts, birth records, and social services were linked at the child level. First, children of parents convicted of a substance-related offense were matched to (a) children of parents convicted of a non-substance-related offense and (b) those not convicted of any offense. Second, we compared children of parents who completed a DTC program with children of parents who were referred but did not enroll, who enrolled for <90 days but did not complete, and who enrolled for 90+ days but did not complete. Multivariate logistic regression was used to model group differences in the odds of being reported to CPS in the one to three years following parental criminal conviction or, alternatively, being referred to a DTC program. Results Children of parents convicted of a substance-related offense were at greater risk of CPS involvement than children whose parents were not convicted of any charge, but DTC participation did not mitigate this risk. Conclusion/Importance The role of specialty courts as a strategy for reducing children’s risk of maltreatment should be further explored. PMID:26789656

[Prescription of drugs with ASMR V in patients over 65 years in a primary care ambulatory setting. Drug prescription analysis in the Midi-Pyrénées region (France)].

PubMed

Bismuth, Serge; Chalvignac, Caroline; Bagheri, Haleh; Oustric, Stéphane

2010-12-20

In French patients over 65 years, drug intake is characterized by polytherapy, causing iatrogenic events. The general practitioner is the main actor in the follow-up and reassessment of drug prescriptions. To assess the proportion of ASMR V (Amélioration du service medical rendu - additional therapeutic benefit versus current standards) drugs [drugs producing no medical improvement] prescribed to patients over 65 years in the management of a chronic disease. In May 2009, 849 drug prescriptions were collected from 34 general practitioners in the Midi-Pyrénées region. Specialties with ASMR V were classified according to the anatomical therapeutic chemical (ATC) classification system. 58.8% of the prescriptions concerned female patients; 67.4% of the prescriptions contained at least one ASMR-V drug. Approximately 20% of the prescriptions in subjects over 65 years contained ASMR-V drugs. This study shows that older subjects are being prescribed a significant number of ASMR-V drugs. However, this classification combines several situations, including a product line extension, a fixed combination of preexisting drugs, an insufficient therapeutic benefit, the absence of additional therapeutic benefit versus a comparative drug, the absence of comparative study in some indications, or a less favorable benefit-risk ratio comparing to that of the reference drug.This classification includes as well the generic drugs prescribed using the international non proprietary names. This study did not analyze the influence of certain factors, such as treatment history, history of drug allergy or dose titration, which could influence the physician's decision. Following this study, it appears useful to extend this type of survey to other general practitioners in other French regions, and to analyze the reasons for prescribing ASMR-V drugs. These data would help increasing general practitioners' awareness of "proper drug use" to reduce the proportion of "inadequate" drugs prescribed to older subjects. One could also consider conducting a survey amongst older patients under polytherapy, to question them on the treatments taken.

Personal Benefits of a Health Evaluation and Enhancement Program

NASA Technical Reports Server (NTRS)

Heinzelmann, F.; Durbeck, D. C.

1970-01-01

A study was made of the benefits reported by participants in a health evaluation and enhancement program dealing with physical activity. Program benefits were identified and defined in regard to three major areas: program effects on work; program effects on health; and program effects on habits and behavior. A strong positive and consistent relationship was found between reported benefits in each of these areas and measures of improvement in cardiovascular functioning based on treadmill performance. Significant differences in these measures of improvement were also found between participants who reported program benefits and those persons who did not. These findings provide a meaningful profile of the pattern of benefits generated by this kind of health program.

20 CFR 404.336 - How do I become entitled to widow's or widower's benefits as a surviving divorced spouse?

Code of Federal Regulations, 2011 CFR

2011-04-01

... not previously received 36 months of payments based on disability when drug addiction or alcoholism... widower's benefits is not based on a disability where drug addiction or alcoholism is a contributing...

20 CFR 404.337 - When does my entitlement to widow's and widower's benefits start and end?

Code of Federal Regulations, 2011 CFR

2011-04-01

... termination month and you meet the other requirements for widow's or widower's benefits. (3) If drug addiction... entitlement periods you may have had, unless you are otherwise disabled without regard to drug addiction or...

20 CFR 404.336 - How do I become entitled to widow's or widower's benefits as a surviving divorced spouse?

Code of Federal Regulations, 2012 CFR

2012-04-01

... not previously received 36 months of payments based on disability when drug addiction or alcoholism... widower's benefits is not based on a disability where drug addiction or alcoholism is a contributing...

20 CFR 404.337 - When does my entitlement to widow's and widower's benefits start and end?

Code of Federal Regulations, 2013 CFR

2013-04-01

... termination month and you meet the other requirements for widow's or widower's benefits. (3) If drug addiction... entitlement periods you may have had, unless you are otherwise disabled without regard to drug addiction or...

20 CFR 404.336 - How do I become entitled to widow's or widower's benefits as a surviving divorced spouse?

Code of Federal Regulations, 2013 CFR

2013-04-01

... not previously received 36 months of payments based on disability when drug addiction or alcoholism... widower's benefits is not based on a disability where drug addiction or alcoholism is a contributing...