Person:

Soumerai, Stephen

Background: Adherence to oral antidiabetic medications is often suboptimal. Adherence differences may contribute to health disparities for black diabetes patients, including higher microvascular event rates, greater complication-related disability, and earlier mortality. Methods: In this longitudinal retrospective cohort study, we used 10 years of patient-level claims and electronic medical record data (1/1/1992–12/31/2001) to assess differences in short- and long-term adherence to oral antidiabetic medication among 1906 newly diagnosed adults with diabetes (26% black, 74% white) in a managed care setting in which all members have prescription drug coverage. Four main outcome measures included: (1) time from diabetes diagnosis until first prescription of oral antidiabetic medication; (2) primary adherence (time from first prescription to prescription fill); (3) time until discontinuation of oral antidiabetic medication from first prescription; and (4) long-term adherence (amount dispensed versus amount prescribed) over a 24-month follow-up from first oral antidiabetic medication prescription. Results: Black patients were as likely as whites to initiate oral therapy and fill their first prescription, but experienced higher rates of medication discontinuation (HR: 1.8, 95% CI: 1.2, 2.7) and were less adherent over time. These black-white differences increased over the first six months of therapy but stabilized thereafter for patients who initiated on sulfonylureas. Significant black-white differences in adherence levels were constant throughout follow-up for patients initiated on metformin therapy. Conclusion: Racial differences in adherence to oral antidiabetic drug therapy persist even with equal access to medication. Early and continued emphasis on adherence from initiation of therapy may reduce persistent racial differences in medication use and clinical outcomes.

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

Introduction: Many low and middle-income countries rely on out-of-pocket payments to help finance health care. These payments can pose financial hardships for households; valid measurement of this type of economic burden is therefore critical. This study examines the validity of five survey measures of economic burden caused by health care payments. Methods: We analyzed 2002/03 World Health Survey household-level data from four Asia Pacific countries to assess the construct validity of five measures of economic burden due to health care payments: any health expenditure, health expenditure amount, catastrophic health expenditure, indebtedness, and impoverishment. We used generalized linear models to assess the correlations between these measures and other constructs with which they have expected associations, such as health care need, wealth, and risk protection. Results: Measures of impoverishment and indebtedness most often correlated with health care need, wealth, and risk protection as expected. Having any health expenditure, a large health expenditure, or even a catastrophic health expenditure did not consistently predict degree of economic burden. Conclusions: Studies that examine economic burden attributable to health care payments should include measures of impoverishment and indebtedness.

Objective: To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. Design: Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. Setting: Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. Participants: Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). Main outcome measures Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. Results: Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were −31.0% (95% confidence interval −33.0% to −29.0%) among adolescents, −24.3% (−25.4% to −23.2%) among young adults, and −14.5% (−16.0% to −12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100 000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, −6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100 000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. Conclusions: Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.

Context Treatment for depression can be expensive and depression can affect the use of other medical services, yet there is little information on how depression affects the prevalence of cost-related medication nonadherence (CRN) in elderly patients and patients with disabilities.

Objective To quantify the presence of CRN in depressed and nondepressed elderly Medicare beneficiaries and nonelderly Medicare beneficiaries with disabilities prior to the implementation of the Medicare Drug Benefit.

Design and Setting 2004 Medicare Current Beneficiary Survey.

Participants Depressed and nondepressed elderly Medicare beneficiaries and beneficiaries with disabilities.

Main Outcome Measures Cost-related medication nonadherence included taking smaller doses or skipping doses of a prescription to make it last longer, or failing to fill a prescription because of cost, controlling for health insurance status, comorbid conditions, age, race, sex, and functional status.

Results In a nationally representative sample of 13 835 noninstitutionalized elderly Medicare enrollees and Medicare enrollees with disabilities, 44% of beneficiaries with disabilities and 13% of elderly beneficiaries reported being depressed during the previous year. Among enrollees with disabilities reporting depressive symptoms, 38% experienced CRN compared with 22% of enrollees with disabilities who did not report depressive symptoms. Among elderly enrollees who reported depressive symptoms, 19% experienced CRN, compared with 12% of elderly enrollees who did not report such symptoms. In adjusted analyses, depressive symptoms remained a significant predictor of CRN in both groups (persons with disabilities: odds ratio, 1.7; 95% confidence interval, 1.3-2.3; elderly persons: odds ratio, 1.4; 95% confidence interval, 1.1-1.7).

Conclusions Depressive symptoms were associated with CRN in elderly Medicare enrollees and Medicare enrollees with disabilities. Providers should elicit information on economic barriers that might interfere with treatment of Medicare beneficiaries with depression.

To the Editor: High drug costs cause some elderly or disabled patients to take less medication than prescribed or forgo basic needs to pay for medicines. The 2006 Medicare Part D drug benefit was intended to increase economic access to medicines. Data from 2006 indicated modest nationwide decreases in cost-related medication nonadherence (CRN) and forgoing basic needs following Part D implementation, but no decline in high rates of CRN among the sickest beneficiaries. We analyzed more recent data to determine whether the reductions remained stable in 2007.

In an attempt to contain costs, 27 Medicaid programs have implemented patient-level payment limits for medications, but the effects of these restrictions on quality of care, costs, and health status remain largely unknown. We measured the effect of one state's limit of three paid prescriptions per month and its replacement a year later by a $1 copayment. Using data on 48 months of claims in the study state (New Hampshire) and a comparison state (New Jersey), we employed time-series analysis to evaluate patient-level changes in the number of prescriptions filled for 16 drugs that varied in their clinical importance and cost. Among 10,734 continuously enrolled patients, the limit of three paid prescriptions per month caused a sudden, sustained drop of 30 percent in the number of prescriptions filled (from 1.10 to 0.77 prescriptions per patient per month); no change was observed in the comparison state. The 860 recipients of multiple drugs, who were predominantly female and elderly or disabled, were most severely affected; the number of prescriptions per month dropped from 5.2 to 2.8 (46 percent). The decrease was greatest for "ineffective drugs" (58 percent), but large drops were also observed for "essential" medications, such as insulin (28 percent), thiazides (28 percent), and furosemide (30 percent). Reductions in Medicaid prescriptions were minimally offset by increases in the size of the prescription or in out-of-pocket payments. When a $1 copayment replaced the three-prescription cap, prescriptions for most medications increased to just below precap levels. Medicaid's savings on drug costs resulting from both policies were comparable ($0.4 to $0.8 million annually), but the copayment policy had less effect on patients receiving multiple drugs. Because the clinical consequences of such policies cannot be assessed from prescription data alone, further study is needed to determine the effects of cost-containment strategies on health status and the use of other services among poor populations. (N Engl J Med 1987; 317:550–6.)

Background: The impact of clinical trials on medical practice remains controversial, in part because of weak study designs and nonrepresentative study samples.

Objective: To assess changes in trends in medication use in the setting of acute myocardial infarction (AMI) before and after publication of two large clinical trials: the Second International Study of Infarct Survival (ISIS-2) trial that supported the use of aspirin after AMI and the Multicenter Diltiazem Postinfarction Trial that reported no overall benefit from the use of calcium antagonists after AMI.

Methods: Study patients consisted of 2114 patients hospitalized with AMI in 16 hospitals in metropolitan Worcester, Mass, during 1986, 1988, and 1990. Data were obtained from medical records. We used multivariable logistic regression models to examine the rate of change in the use of selected medications before and after trial publication, controlling for medical history, characteristics and complications of AMI, medications taken, and procedures performed during hospitalization. The dependent variable was receipt of the specific medication under investigation.

Results: Before publication of ISIS-2, 26% of patients with AMI received aspirin while hospitalized compared with 66% after its publication. However, in-hospital aspirin use began to rise before ISIS-2 with an immediate increase in the level of use occurring after trial publication but with no significant change in the rate of increase. Before publication of the Multicenter Diltiazem Postinfarction Trial, 57% of patients with AMI were new recipients of calcium antagonists compared with 51% after trial publication. The decrease in calcium antagonist use began after trial publication (odds ratio, 0.79 per 6-month period; 95% confidence interval, 0.71 to 0.88).

Conclusions: The published results of large trials of cardiovascular therapies have had variable impact on medication use. Efforts to assess the effects of publication of new scientific information on medical care need to consider prior trends in treatment patterns and the varying contexts of medical care. They should consider both direct and indirect routes of influence.(Arch Intern Med. 1996;156:54-60)

Objectives. —To study determinants and adverse outcomes (mortality and rehospitalization) of β-blocker underuse in elderly patients with myocardial infarction; and whether the relative risks (RRs) of survival associated with β-blocker use were comparable to those reported in the large randomized controlled trials (RCTs).

Setting. —New Jersey Medicare population.

Design. —Retrospective cohort design using linked Medicare and drug claims data from 1987 to 1992.

Patients. —Statewide cohort of 5332 elderly 30-day acute myocardial infarction (AMI) survivors with prescription drug coverage, of whom 3737 were eligible for β-blockers.

Main Outcome Measures. —β-Blocker and calcium channel blocker use in the first 90 days after discharge and mortality rates and cardiac hospital readmissions over the 2-year period after discharge, controlling for sociodemographic and baseline risk variables.

Results. —Only 21% of eligible patients received β-blocker therapy; this rate remained unchanged from 1987 to 1991. Patients were almost 3 times more likely to receive a new prescription for a calcium channel blocker than for a new β-blocker after their AMIs. Advanced age and calcium channel blocker use predicted underuse of β-blockers. Controlling for other predictors of survival, the mortality rate among β-blocker recipients was 43% less than that for nonrecipients (RR=0.57; 95% confidence interval [CI], 0.47-0.69). Effects on mortality were substantial in all age strata (65-74 years, 75-84 years, and ≥85 years) and consistent with the results for elderly subgroups of 2 large RCTs. β-Blocker recipients were rehospitalized 22% less often than nonrecipients (RR=0.78; 95% CI, 0.67-0.90). Use of a calcium channel blocker instead of a β-blocker was associated with a doubled risk of death (RR=1.98; 95% CI, 1.44-2.72), not because calcium channel blockers had a demonstrable adverse effect, but because they were substitutes for β-blockers.

Conclusions. —β-Blockers are underused in elderly AMI survivors, leading to measurable adverse outcomes. These data suggest that the survival benefits of β-blockade after an AMI may extend to eligible patients older than 75 years, a group that has been excluded from RCTs.