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Objective: To examine changes in the prescribing of analgesics after the market entry and subsequent withdrawal of zomepirac sodium, a nonsteroidal anti-inflammatory drug (NSAID), following repeated reports of zomepirac-related deaths.Design: To evaluate this natural quasi experiment, we conducted time-series analyses to compare prescribing in two cohorts of primary care physicians from July 1980 through September 1983.Setting: Study physicians provided outpatient pharmaceutical care to patients enrolled in the New Jersey Medicaid program.Participants: We identified 260 primary care physicians who provided 10 or more prescriptions for zomepirac (zomepirac prescribers) and 308 who provided 10 or more prescriptions for NSAIDs other than zomepirac (other-NSAID prescribers) in Medicaid during the study period.Main Outcome Measures: Monthly rates of prescribing for zomepirac and several categories of substitute analgesics among Medicaid patients seen by study physicians.Main Results: Zomepirac accounted for a stable 11.0% of analgesic prescribing among the zomepirac-prescriber cohort; label changes and manufacturer product-risk warnings 11 months before the product's withdrawal from the market had no impact on use. After market entry, zomepirac prescribers reduced use of other NSAIDs and propoxyphene (hydrochloride or napsylate) in comparison with other-NSAID prescribers (-8.1% and -2.8% of total analgesic prescribing, respectively; P < .001). After the product's withdrawal from the market, zomepirac prescribers showed significant increases in relative prescribing of other NSAIDs (+6.8%; P < .001), propoxyphene (+2.1%; P < .05), and analgesics containing barbiturates (+2.7%; P < .001).Conclusions: The sudden withdrawal of zomepirac from the market resulted in substitutions not only of other NSAIDs, but also of alternative analgesics that carry risks of habituation and adverse effects. Apparent gains in patient safety resulting from market withdrawal of medications must be evaluated in comparison with risks of medications likely to be substituted. [ABSTRACT FROM AUTHOR]

Objective: This study examined the association between a Medicaid prior-authorization policy for second-generation antipsychotic and anticonvulsant agents and medication discontinuation and health service use by patients with bipolar disorder.Methods: A pre-post design with a historical comparison group was used to analyze Maine Medicaid and Medicare claims data. A total of 946 newly treated patients were identified during the eight-month policy (July 2003-February 2004), and a comparison group of 1,014 was identified from the prepolicy period (July 2002-February 2003). Patients were stratified by number of visits to community mental health centers (CMHCs) before medication initiation (proxy for illness severity): CMHC attenders, at least two visits; nonattenders, fewer than two. Changes in rates of medication discontinuation and outpatient, emergency room, and hospital visits were estimated.Results: Compared with nonattenders, at baseline CMHC attenders had substantially higher rates of comorbid mental disorders and use of medications and health services. The policy was associated with increased medication discontinuation among attenders and nonattenders, reductions in mental health visits after discontinuation among attenders (-.64 per patient per month; p<.05), and increases in emergency room visits after discontinuation among nonattenders (.16 per patient per month; p<.05). During the eight-month policy period, the policy had no detectable impact on hospitalization risk.Conclusions: The prior-authorization policy was associated with increased medication discontinuation and subsequent changes in health service use. Although small, these unintended effects raise concerns about quality of care for a group of vulnerable patients. Long-term consequences of prior-authorization policies on patient outcomes warrant further investigation. [ABSTRACT FROM AUTHOR]

Objective: Medicaid expenditures for antipsychotic medications have risen rapidly, from under $1.0 billion in 1995 to over $5.5 billion in 2005. In response, at least ten states have implemented prior-authorization programs that restrict access to particular second-generation antipsychotic agents (aripiprazole and olanzapine). Twenty-two states restrict particular dosing forms (injections). This study examined the impact of such restrictions.Methods: The authors used interrupted time-series analysis of quarterly state-level drug utilization data to examine the impact of prior authorization for particular agents in West Virginia and Texas. Changes in market share of nonpreferred medications and total pharmacy costs were compared with changes in states without similar prior-authorization requirements.Results: The West Virginia policy led to an immediate 3.5% reduction in market share level (p<.01) and a 1.3% decrease in trend per quarter in market share (p<.001) for nonpreferred antipsychotics, leading to a 13.9% reduction after two years. In Texas, prior authorization reduced the market share level of nonpreferred agents by 2.6% (p=.055). However, prior authorization did not lead to a significant decrease in pharmacy reimbursements in either state.Conclusions: Current prior-authorization policies for second-generation antipsychotics do not appear to reduce pharmacy reimbursement, probably because alternative medications are costly. These findings suggest that any cost savings from prior-authorization policies would accrue largely through supplemental rebate agreements with manufacturers, which are likely reduced by the transfer of dually eligible Medicaid enrollees to Medicare Part D plans. Further evaluation of the clinical consequences resulting from such policies is urgently needed to determine whether the minimal cost savings outweigh the potential clinical risks. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although studies have documented hospital and surgical service geographic variability, prescription use geographic variability is largely unknown. Opiate pain medications are widely used, particularly because the promulgation of clinical guidelines promoting aggressive pain treatment. This study describes temporal and interstate variability in aggregate prescription opiate medication use within U.S. Medicaid programs. METHODS: A dataset of 49 states' fee-for-service (FFS) Medicaid prescription drug dispensing records from 1996 to 2002 was compiled and used to quantify medication dispensing examining all opiates, controlled release oxycodone, and methadone. The defined daily dose (DDD) per 1000 FFS Medicaid adult enrollees per day was calculated for all opiate medication categories. A market basket of nonpain prescription medications was constructed for comparison. Rates, trends, and the coefficient of variation were determined overall, by year and for each state. RESULTS: From 1996 to 2002, overall use of opiate pain medications increased 309%. The market basket use increased 170%. Total opiate dispensing varied widely from state to state, with a range of 6.9 to 44.1 DDD/1000/d in 1996, and 7.1 to 165.0 DDD/1000/d (a 23-fold difference) in 2002. The coefficient of variation was 49.6 in 2002. Controlled release oxycodone and methadone had a greater rate of increase compared with all opiates. CONCLUSIONS: The dispensing of opiate medications in Medicaid programs increased at almost twice the rate of nonpain-related medications during the 7-year study period. Large, unexplained geographic variation in aggregate use exists. The impact of Medicaid cost-containment strategies on utilization and outcomes should be investigated. [ABSTRACT FROM AUTHOR]