Antidepressant Reformulations: Who Uses Them, And What Are The Benefits?

The Hatch-Waxman Act provides pharmaceutical manufacturers an incentive to introduce reformulations of existing products about to lose patent protection in order to extend marketing exclusivity and maintain high prices. Antidepressant reformulations are particularly common. To determine whether antidepressant reformulation use confers benefits, we examine who uses reformulations, and compare medication continuation and the likelihood of receiving guideline-consistent pharmacotherapy duration among reformulation and original formulation users. We find some evidence of benefit for subgroups of antidepressant users, although benefits vary across reformulations

Trends in co-prescribing of antidepressants and tamoxifen among women with breast cancer, 2004–2010

Nearly a decade ago, researchers identified a potential interaction between tamoxifen and strong CYP2D6 inhibitors, including several frequently used antidepressants. Based on evidence available at that time, a United States Food and Drug Administration advisory committee recommended tamoxifen’s label be changed in October 2006, noting that postmenopausal women with estrogen receptor-positive breast cancer who are poor CYP2D6 metabolizers by genotype or drug interactions may be at increased risk of cancer recurrence. The impact of accumulating drug risk information on antidepressant use is unknown

The Impact of Emerging Safety and Effectiveness Evidence on the Use of Physician-administered Drugs: The Case of Bevacizumab for Breast Cancer

Spending on physician-administered drugs is high and uses not approved by the U.S. Food and Drug Administration (FDA) are frequent. While these drugs may be targets of future policy efforts to rationalize use, little is known regarding how physicians respond to emerging safety and effectiveness evidence

High-Risk Medication Use by Nursing Home Residents Before and After Hospitalization

Two prominent challenges in nursing home care are ensuring appropriate medication use and achieving high quality care as residents transition from the hospital to the nursing home and back. Research about prescribing practices at this important clinical juncture is limited

Effect of Part D Coverage Restrictions for Antidepressants, Antipsychotics, and Cholinesterase Inhibitors on Related Nursing Home Resident Outcomes

In 2006, Medicare Part D transitioned prescription drug coverage for dual-eligible nursing home residents from Medicaid to Medicare and randomly assigned them to Part D prescription drug plans (PDPs). Because PDPs may differ in coverage, residents’ assigned plans may be relatively more or less restrictive for drugs they take. Taking advantage of the fact that randomization mitigates potential selection bias common in observational studies, this study seeks to assess the impact of PDP coverageon resident outcomes for three medication classes – antidepressants, antipsychotics, and cholinesterase inhibitors

Medicare Part D Plan Generosity and Medication Use Among Dual-eligible Nursing Home Residents

In 2006, dual-eligible nursing home residents were randomly assigned to a Medicare Part D prescription drug plan (PDP). Subsequently, residents not enrolled in qualified plans at the start of the next year were re-randomized. PDPs vary in generosity through differences in medication coverage and utilization management. Therefore, residents’ assigned plans may be relatively more or less generous for their particular drugs. The impact of generosity on residents’ medication use and health outcomes is unknown

Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008

This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices

How Do Payers Respond to Regulatory Actions? The Case of Bevacizumab

In February 2008, the US Food and Drug Administration (FDA) granted accelerated approval for bevacizumab for metastatic breast cancer. After public hearings in July 2010, and June 2011, the FDA revoked this approved indication in November 2011, on the basis of additional evidence regarding its risk/benefit profile. The Centers for Medicare and Medicaid Services, local Medicare contractors, and commercial payers varied in their stated intentions to cover bevacizumab after FDA's regulatory actions. We examined payer-specific trends in bevacizumab use after the FDA's regulatory actions

Systematic review on quality control for drug management programs: Is quality reported in the literature?

<p>Abstract</p> <p>Background</p> <p>Maintaining quality of care while managing limited healthcare resources is an ongoing challenge in healthcare. The objective of this study was to evaluate how the impact of drug management programs is reported in the literature and to identify potentially existing quality standards.</p> <p>Methods</p> <p>This analysis relates to the published research on the impact of drug management on economic, clinical, or humanistic outcomes in managed care, indemnity insurance, VA, or Medicaid in the USA published between 1996 and 2007. Included articles were systematically analyzed for study objective, study endpoints, and drug management type. They were further categorized by drug management tool, primary objective, and study endpoints.</p> <p>Results</p> <p>None of the 76 included publications assessed the overall quality of drug management tools. The impact of 9 different drug management tools used alone or in combination was studied in pharmacy claims, medical claims, electronic medical records or survey data from either patient, plan or provider perspective using an average of 2.1 of 11 possible endpoints. A total of 68% of the studies reported the impact on plan focused endpoints, while the clinical, the patient or the provider perspective were studied to a much lower degree (45%, 42% and 12% of the studies). Health outcomes were only accounted for in 9.2% of the studies.</p> <p>Conclusion</p> <p>Comprehensive assessment of quality considering plan, patient and clinical outcomes is not yet applied. There is no defined quality standard. Benchmarks including health outcomes should be determined and used to improve the overall clinical and economic effectiveness of drug management programs.</p