Despite concerns about drug safety, current information on older adults' use of prescription and over-the-counter medications and dietary supplements is limited. To estimate the prevalence and patterns of medication use among older adults (including concurrent use), and potential major drug-drug interactions. Three thousand five community-residing individuals, aged 57 through 85 years, were drawn from a cross-sectional, nationally representative probability sample of the United States. In-home interviews, including medication logs, were administered between June 2005 and March 2006. Medication use was defined as prescription, over-the-counter, and dietary supplements used "on a regular schedule, like every day or every week." Concurrent use was defined as the regular use of at least 2 medications. Population estimates of the prevalence of medication use, concurrent use, and potential major drug-drug interactions, stratified by age group and gender. The unweighted survey response rate was 74.8% (weighted response rate, 75.5%). Eighty-one percent (95% confidence interval [CI], 79.4%-83.5%) used at least 1 prescription medication, 42% (95% CI, 39.7%-44.8%) used at least 1 over-the-counter medication, and 49% (95% CI, 46.2%-52.7%) used a dietary supplement. Twenty-nine percent (95% CI, 26.6%-30.6%) used at least 5 prescription medications concurrently; this was highest among men (37.1%; 95% CI, 31.7%-42.4%) and women (36.0%; 95% CI, 30.2%-41.9%) aged 75 to 85 years. Among prescription medication users, concurrent use of over-the-counter medications was 46% (95% CI, 43.4%-49.1%) and concurrent use of dietary supplements was 52% (95% CI, 48.8%-55.5%). Overall, 4% of individuals were potentially at risk of having a major drug-drug interaction; half of these involved the use of nonprescription medications. These regimens were most prevalent among men in the oldest age group (10%; 95% CI, 6.4%-13.7%) and nearly half involved anticoagulants. No contraindicated concurrent drug use was identified. In this sample of community-dwelling older adults, prescription and nonprescription medications were commonly used together, with nearly 1 in 25 individuals potentially at risk for a major drug-drug interaction.

Despite abundant evidence of racial disparities in the use of surgical procedures, it is uncertain whether these disparities reflect racial differences in clinical appropriateness or overuse or underuse of care. We performed a literature review and used an expert panel to develop criteria for determining the appropriateness of renal transplantation for patients with end-stage renal disease. Using data from five states and the District of Columbia on patients who had started to undergo dialysis in 1996 or 1997, we selected a random sample of 1518 patients (age range, 18 to 54 years), stratified according to race and sex. We classified the appropriateness of patients as candidates for transplantation and analyzed data on rates of referral to a transplantation center for evaluation, placement on a waiting list, and receipt of a transplant according to race. Black patients were less likely than white patients to be rated as appropriate candidates for transplantation according to appropriateness criteria based on expert opinion (71 blacks [9.0 percent] vs. 152 whites [20.9 percent]) and were more likely to have had incomplete evaluations (368 [46.5 percent] vs. 282 [38.8 percent], P<0.001 for the overall chi-square). Among patients considered to be appropriate candidates for transplantation, blacks were less likely than whites to be referred for evaluation, according to the chart review (90.1 percent vs. 98.0 percent, P=0.008), to be placed on a waiting list (71.0 percent vs. 86.7 percent, P=0.007), or to undergo transplantation (16.9 percent vs. 52.0 percent, P<0.001). Among patients classified as inappropriate candidates, whites were more likely than blacks to be referred for evaluation (57.8 percent vs. 38.4 percent), to be placed on a waiting list (30.9 percent vs. 17.4 percent), and to undergo transplantation (10.3 percent vs. 2.2 percent, P<0.001 for all three comparisons). Racial disparities in rates of renal transplantation stem from differences in clinical characteristics that affect appropriateness as well as from underuse of transplantation among blacks and overuse among whites. Reducing racial disparities will require efforts to distinguish their specific causes and the development of interventions tailored to address them.

In 2011, Bristol-Myers Squibb set the price of its newly approved melanoma drug ipilimumab—brand name Yervoy—at $120,000 for a course of therapy. The drug was associated with an incremental increase in life expectancy of four months. Drugs like ipilimumab have fueled the perception that the launch prices of new anticancer drugs and other drugs in the so-called “specialty” pharmaceutical market have been increasing over time and that increases are unrelated to the magnitude of the expected health benefits. In this paper, we discuss the unique features of the market for anticancer drugs and assess trends in the launch prices for 58 anticancer drugs approved between 1995 and 2013 in the United States. We restrict attention to anticancer drugs because the use of median survival time as a primary outcome measure provides a common, objective scale for quantifying the incremental benefit of new products. We find that the average launch price of anticancer drugs, adjusted for inflation and health benefits, increased by 10 percent annually—or an average of $8,500 per year—from 1995 to 2013. We argue that the institutional features of the market for anticancer drugs enable manufacturers to set the prices of new products at or slightly above the prices of existing therapies, giving rise to an upward trend in launch prices. Government-mandated price discounts for certain classes of buyers may have also contributed to launch price increases as firms sought to offset the growth in the discount segment by setting higher prices for the remainder of the market.

The first atypical antipsychotic, clozapine, was introduced in the United States in 1989, followed by risperidone, olanzapine, and most recently, paliperidone (2006). Many agents that were initially approved to treat schizophrenia have been subsequently approved by the Food and Drug Administration (FDA) to treat mania associated with bipolar affective disorder and irritability associated with autism.¹ Although they are less likely to cause extrapyramidal adverse effects (eg, parkinsonism) than conventional or typical antipsychotics,² several safety concerns have arisen regarding atypical agents, including a 2003 Medwatch warning³ about increased risk of stroke with risperidone use and a 2004 warning about an association between atypical drug use and hyperglycemia and diabetes.⁴

Objective: To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. Data Sources: The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Study Selection: Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. Data Extraction: We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Results: Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. Conclusions: Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

Peter B Bach and colleagues call for an end to contradictory regulatory standards in the US that allow drug manufacturers to boost profits by producing single dose vials containing quantities that increase leftover drug