Christine Y. Lu

Interventions designed to improve the quality and efficiency of medication use in managed care: A critical review of the literature - 2001–2007

BackgroundManaged 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.MethodsWe 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.ResultsWe 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.ConclusionThere 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.

Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

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.

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

Objective To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Results Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Conclusions Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

Observational studies: a review of study designs, challenges and strategies to reduce confounding

There are several methods in which one can assess the relationship between an intervention and an outcome. Randomized controlled trials (RCTs) are considered as the gold standard for evaluating interventions. However, for many questions of clinical importance, RCTs would be impractical or unethical. Clinicians must rely on observational studies for the best available evidence when RCTs are unavailable. This article provides an overview of observational research designs to facilitate the understanding and appraising of their validity and applicability in clinical practice. Major methodological issues of observational studies including selection bias and confounding are also discussed. In addition, strategies to minimize these problems in the design and analytical phases of a study are highlighted. Knowledge of the strengths, weaknesses and recent methodological advances in observational studies can assist clinicians to make informed decisions about whether a particular observational study would provide useful information to enhance patient care.

Unintended impacts of a Medicaid prior authorization policy on access to medications for bipolar illness.

Objectives:Prior authorization policies (PA) are widely used to control psychotropic medication costs by state Medicaid programs and Medicare Part D plans. The objective of this study was to examine the impact of a Maine Medicaid PA policy on initiation and switching of anticonvulsant and atypical antipsychotic treatments among patients with bipolar disorder. Methods:We obtained Maine and New Hampshire (comparison state) Medicaid and Medicare claims data for 2001 to 2004; the Maine PA policy was implemented in July 2003. Among continuously enrolled patients with bipolar disorder (Maine: n = 5336; New Hampshire: n = 1376), we used an interrupted times series with comparison group design to estimate changes in rates of initiating new episodes of bipolar treatment and generalized estimating equations models to examine rates of switching therapies among patients under treatment. Results:The Maine PA policy was associated with a marked decrease in rates of initiation of bipolar treatments; a relative reduction of 32.3% (95% CI: 24.8, 39.9) compared with expected rates at 4 months after policy implementation. This decrease was driven primarily by reductions in the initiation of nonpreferred agents. The policy had no discernable impact on rates of switching therapy among patients currently on treatment (RR: 1.03; 95% CI: 0.76, 1.39). Conclusions:The findings of this study provide evidence that PA implementation can be a barrier to initiation of nonpreferred agents without offsetting increases in initiation of preferred agents, which is a major concern. There is a critical need to evaluate the possible unintended effects of PA policies to achieve optimal health outcomes among low-income patients with chronic mental illness. In addition, more research is needed to understand how these barriers arise and whether specific seriously mentally ill populations or drug classes should be exempted from PA policies.

Prior Authorization for Antidepressants in Medicaid : Effects Among Disabled Dual Enrollees

BACKGROUND Prior authorization is a popular, but understudied, strategy for reducing medication costs. We evaluated the impact of a controversial prior authorization policy in Michigan Medicaid on antidepressant use and health outcomes among dual Medicaid and Medicare enrollees with a Social Security Disability Insurance designation of permanent disability. METHODS We linked Medicaid and Medicare (2000-2003) claims for dual enrollees in Michigan and a comparison state, Indiana. Using interrupted time-series and longitudinal data analysis, we estimated the impact of the policy on antidepressant medication use, treatment initiation, disruptions in therapy, and adverse health events among continuously enrolled (Michigan, n = 28 798; Indiana, n = 21 769) and newly treated (Michigan, n = 3671; Indiana, n = 2400) patients. RESULTS In Michigan, the proportion of patients starting nonpreferred agents declined from 53% prepolicy to 20% postpolicy. The prior authorization policy was associated with a small sustained decrease in therapy initiation overall (9 per 10,000 population; P = .007). We also observed a short-term increase in switching among established users of nonpreferred agents overall (risk ratio, 2.88; 95% confidence interval, 1.87-4.42) and among those with depression (2.04; 1.22-3.42). However, we found no evidence of increased disruptions in treatment or adverse events (ie, hospitalization, emergency department use) among newly treated patients. CONCLUSIONS Prior authorization was associated with increased use of preferred agents with no evidence of disruptions in therapy or adverse health events among new users. However, unintended effects on treatment initiation and switching among patients already taking the drug were also observed, lending support to the states previous decision to discontinue prior approval for antidepressants in 2003.

Use of antipsychotic medications in pediatric populations: what do the data say?

Recent reports of antipsychotic medication use in pediatric populations describe large increases in rates of use. Much interest in the increasing use has focused on potentially inappropriate prescribing for non-Food and Drug Administration-approved uses and use amongst youth with no mental health diagnosis. Different studies of antipsychotic use have used different time periods, geographic and insurance populations of youth, and aggregations of diagnoses. We review recent estimates of use and comment on the similarities and dissimilarities in rates of use. We also report new data obtained on 11 health maintenance organizations that are members of the Mental Health Research Network in order to update and extend the knowledge base on use by diagnostic indication. Results indicate that most use in pediatric populations is for disruptive behaviors and not psychotic disorders. Differences in estimates are likely a function of differences in methodology; however, there is remarkable consistency in estimates of use by diagnosis.

Determinants of patient-reported medication errors: a comparison among seven countries.

Objective:  Medication errors are a frequent cause of adverse drug events and a major concern for patient safety. This study compared the predictors of error among seven countries (Australia, Canada, New Zealand, the United Kingdom, the United States, Germany and the Netherlands).

Impact of Two Medicaid Prior-Authorization Policies on Antihypertensive Use and Costs Among Michigan and Indiana Residents Dually Enrolled in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study

BACKGROUND In response to rising pharmaceutical costs, many state Medicaid programs have implemented policies requiring prior authorization for high-cost medications, even for established users. However, little is known about the impact of these policies on the use of antihypertensive medicines in the United States. OBJECTIVE The aim of this longitudinal, population-based study was to assess comprehensive prior-authorization programs for antihypertensives on drug use and costs in a vulnerable Medicaid population in Michigan and Indiana. METHODS A prior-authorization policy for antihypertensives was implemented in Michigan in March 2002 and in Indiana in September 2002; Indiana also implemented an antihypertensive stepwise-therapy requirement in July 2003. Our study cohort included individuals aged >or=18 years in Michigan and Indiana who were continuously enrolled in both Medicaid and Medicare from July 2000 through September 2003. Claims data were obtained from the Centers for Medicare and Medicaid Services. We included all antihypertensive medications, including diuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, beta-blockers, alpha-blockers, and angiotcnsin II receptor blockers. We used interrupted time-series analysis to study policy-related changes in the total number and cost of antihypertensive prescriptions. RESULTS Overall, 38,684 enrollees in Michigan and 29,463 in Indiana met our inclusion criteria. Slightly more than half of our cohort in both states was female (53.29%in Michigan and 56.32%in Indiana). In Michigan, 20.23% of patients were aged >or=65 years; 77.44% were white, 20.11% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. In Indiana, 20.07% were aged >or=65 years; 84.93% were white, 13.64% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. The implementation of both policies was associated with large and immediate reductions in the use of nonpreferred medications: 83.33% reduction in the use of such drugs in Michigan (-84.30 prescriptions per 1000 enrollees per month; P < 0.001) and 35.76% in Indiana (-64.45 prescriptions per 1000 enrollees per month; P < 0.001). As expected, use of preferred medications also increased substantially in both states (P < 0.001). Overall, antihypertensive therapy immediately dropped 0.16% in Michigan (P = 0.04) and 1.82% in Indiana (P = 0.02). Implementation of the policies was also associated with reductions in pharmacy reimbursement of

New users of antidepressant medications: first episode duration and predictors of discontinuation

616,572.43 in Michigan and