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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]

Citing evidence from studies conducted by Frank Lichtenberg, some health policy advocates have argued that, on average, use of new prescription drugs reduces total health care costs. While recognizing that the cross-sectional research design cannot guard against many biases that could overstate the results, we replicated the original study results and examined the findings' sensitivity to different analytical approaches. Using the same data, we were able to replicate the original results; however, the original findings are not maintained under plausible alternative assumptions. More rigorous research on specific drugs and conditions is necessary before one can claim that newer drugs lower total health care costs. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To examine the effect of replacing drug-specific computerized prescribing alerts with age-specific alerts on rates of dispensing potentially inappropriate medications in older people and to determine whether group academic detailing enhances the effectiveness of these alerts. DESIGN: Cluster-randomized trial of group academic detailing and interrupted time-series analysis. SETTING: Fifteen clinics of a staff-model health maintenance organization. PARTICIPANTS: Seven practices (113 clinicians, 24,119 patients) were randomly assigned to receive age-specific prescribing alerts plus the academic detailing intervention; eight practices (126 clinicians, 26,805 patients) received alerts alone. Prior implementation of drug-specific alerts established a downward trend in use of target medications that served as the baseline trend for the present study. INTERVENTION: The computerized age-specific alerts occurred at the time of prescribing a targeted potentially inappropriate medication (e.g., tertiary tricyclic amine antidepressants, long-acting benzodiazepines, propoxyphene) and suggested an alternative medication. Clinicians at seven sites were randomized to group academic detailing, an interactive educational program delivering evidence-based information. MEASUREMENTS: Number of target medications dispensed per 10,000 patients per quarter, 2 years before and 1.5 years after the replacement of drug-specific with age-specific alerts. RESULTS: Age-specific alerts resulted in a continuation of the effects of the drug-specific alerts without measurable additional effect (P=.75 for level change), but the age-specific alerts led to fewer false-positive alerts for clinicians. Group academic detailing did not enhance the effect of the alerts. CONCLUSION: Age-specific alerts sustained the effectiveness of drug-specific alerts to reduce potentially inappropriate prescribing in older people and resulted in a considerably decreased burden of the alerts. [ABSTRACT FROM AUTHOR]

BACKGROUND: Insurance coverage of patient self-management devices like self-monitoring blood glucose (SMBG) equipment may help to reduce race-related barriers to effective care. OBJECTIVES: We examined whether providing free home glucose monitors had greater impacts on self-monitoring among black versus white patients with diabetes. RESEARCH DESIGN: Using electronic medical record data (1992-1996), we used longitudinal survival analysis to examine racial differences in rates of initiation of SMBG after coverage and rates of discontinuation of SMBG 18 months after initiation. We used piecewise Cox models to compare relative rates of SMBG initiation between black and white patients before and after the policy. SUBJECTS: The study cohort included 2275 continuously enrolled adult patients with diabetes in a large, staff model HMO. Multivariate models were restricted to patients using oral therapy. RESULTS: Controlling for time-dependent and fixed effects, black patients were as likely to initiate SMBG as white patients before the policy (hazard ratio 1.14; 95% confidence interval 0.86-1.50) but more likely after the policy (hazard ratio 1.33; 95% confidence interval 1.01-1.76). Among postpolicy SMBG initiators, black patients were consistently at higher risk of SMBG discontinuation than white patients over time (P < 0.05). By the end of follow-up, discontinuation rates were 78% among black patients and 64% among white patients. CONCLUSIONS: The policy is effective in triggering additional diabetes patients to self-manage, particularly black patients. However, persistence after initiation of monitoring is short-lived. Although our results show the potential of such policies to narrow racial gaps in self-management among racial minority groups, further interventions may be needed to promote long-term adherence. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine rates of potentially inappropriate medication use in elderly persons in managed care plans in the United States in 2000-2001. DESIGN: Cross-sectional study using automated medication-dispensing data. SETTING: Ten geographically distributed health maintenance organizations (HMOs). PARTICIPANTS: One hundred fifty-seven thousand five hundred seventeen members aged 65 years and older enrolled in one of the HMOs. MEASUREMENTS: Prevalence of use of 33 potentially inappropriate medications from January 1, 2000 through June 30, 2001. RESULTS: In 2000-2001, 28.8% (95% confidence interval=28.6-29.1) of elderly individuals received at least one of 33 potentially inappropriate medications. This rate ranged from 23.0% to 36.5% across the 10 HMOs. Approximately 5% of elderly patients received at least one of the 11 medications classified by an expert panel as 'always avoid,' 13% received at least one of the eight medications that would rarely be considered appropriate, and 17% received at least one of the 14 medications that have some indications but are often misused. Overall, rates of use of these medications were greater in women (32.4%) than in men (24.2%). At least 1% of elderly members received belladonna alkaloids (2.3%), dicyclomine (1.1%), or hyoscyamine (1.2%), each of which multiple expert panels have classified as always inappropriate in patients aged 65 years and older. Seven percent of elderly members received propoxyphene, an analgesic medication considered rarely appropriate in the elderly and a drug that has a long history of limited efficacy and potential for toxicity. CONCLUSION: Recent rates of potentially inappropriate medication use by elderly HMO members were at least as great as in a 1996 national sample. This study highlights the need to understand more fully the rationale behind the continued use of these medications. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine the relationship between adherence to antidepressant medications and HbA1c levels among patients with diabetes in a managed care setting. METHOD: The analysis included measures of HbA1c levels before, during, and after initial antidepressant use among 568 patients with diabetes enrolled in the Harvard Pilgrim Health Care insurance plan from 1991-1995. Adherence was defined as four refills in a six-month period after the first antidepressant prescription. General linear models using SAS PROC MIXED were used to estimate the effects of covariates including antidepressant adherence on HbA1c levels over time, comparing patients who were adherent to antidepressant medications to those patients who were non-adherent to antidepressant medications. RESULTS: Adherence to antidepressant treatment was not significantly associated with HbA1c levels among diabetic patients who are antidepressant users. Younger age, use of insulin and oral medications, and female gender were all significantly associated with HbA1c levels over time. CONCLUSIONS: Although we did not observe any association between level of adherence to antidepressant therapy among diabetic patients and levels of glucose control, our results confirm previously established associations between patient characteristics and glycemic control. Further research is needed to disentangle the complex relationship among antidepressant treatment adherence and diabetes outcomes. [ABSTRACT FROM AUTHOR]

Background: Increasing copayments for higher-priced prescription medications has been suggested as a means to help finance drug coverage for elderly patients, but evaluations of the impact of such policies are rare. The objective of this study was to analyze the effect of reference-based pricing of angiotensin-converting enzyme (ACE) inhibitors on drug utilization, cost savings and potential substitution with other medication classes.Methods: We analyzed 36 months of claims data from British Columbia for 2 years before and 1 year after implementation of reference-based pricing (in January 1997). The 119,074 patients were community-living Pharmacare beneficiaries 65 years of age or older who used ACE inhibitors during the study period. The main outcomes were changes over time in use of ACE inhibitors, use of antihypertensive drugs and expenditures for antihypertensive drugs, as well as predictors of medication switching related to reference-based pricing.Results: We observed a sharp decline (29%) in the use of higher-priced cost-shared ACE inhibitors immediately after implementation of the policy (p < 0.001). After a transition period, the post-implementation utilization rate for all ACE inhibitors was 11% lower than projected from pre-implementation data. However, overall utilization of antihypertensives was unchanged (p = 0.40). The policy saved $6.7 million in pharmaceutical expenditures during its first 12 months. Patients with heart failure or diabetes mellitus who were taking a cost-shared ACE inhibitor were more likely to remain on the same medication after implementation of reference-based pricing (OR 1.12 [95% confidence interval, CI, 1.06-1.19] and 1.28 [95% CI 1.20-1.36] respectively). Patients with low-income status were more likely than those with high-income status to stop all antihypertensive therapy (OR 1.65 [95% CI 1.43-1.89]), which reflects a general trend toward discontinuation of therapy among these patients even before implementation of reference-based pricing.Interpretation: Reference-based pricing in British Columbia achieved a sustained reduction in drug expenditures, and no changes in overall use of antihypertensive therapy were observed. Further research is needed on the overall health and economic effects of such policies. [ABSTRACT FROM AUTHOR]

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]

Objectives: To study determinants and adverse outcomes (mortality and rehospitalization) of beta-blocker underuse in elderly patients with myocardial infarction; and whether the relative risks (RRs) of survival associated with beta-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 beta-blockers.Main Outcome Measures: beta-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 beta-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 beta-blocker after their AMIs. Advanced age and calcium channel blocker use predicted underuse of beta-blockers. Controlling for other predictors of survival, the mortality rate among beta-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 > or = 85 years) and consistent with the results for elderly subgroups of 2 large RCTs. beta-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 beta-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 beta-blockers.Conclusions: beta-Blockers are underused in elderly AMI survivors, leading to measurable adverse outcomes. These data suggest that the survival benefits of beta-blockade after an AMI may extend to eligible patients older than 75 years, a group that has been excluded from RCTs. [ABSTRACT FROM AUTHOR]

Objective: The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing.Research Design and Methods: We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes.Results: In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes.Conclusions: Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes. [ABSTRACT FROM AUTHOR]

More than one-third of Medicaid programs and Medicare Part D plans use prior authorization (PA) policies to control the use of atypical antipsychotics (AAs). We used Medicaid and Medicare claims data to investigate how Maine's PA policy affected AA use, treatment discontinuities, and spending among schizophrenia patients initiating AA therapy. Patients initiating AAs during Maine's policy experienced a 29 percent greater risk of treatment discontinuity than patients initiating AAs before the policy took effect; no change occurred in a comparison state. AA spending was slightly lower in both states. Observed increases in treatment discontinuities without cost savings suggest that AAs should be exempt from PA for patients with severe mental illnesses. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 $616,572.43 in Michigan and $868,265.97 in Indiana in the first postpolicy year. CONCLUSIONS: Prior authorization was associated with lower use of nonpreferred antihypertensive drugs that was largely offset by increases in the use of preferred drugs. The possible clinical consequences of policy-induced drug switching for individual patients remain unknown because the present study did not include access to medical record data. Further research is needed to establish whether large-scale switches in medicines following the inception of prior-authorization policies have any long-term health effects. [ABSTRACT FROM AUTHOR]

BACKGROUND: Benzodiazepines are treatment mainstays for several disorders, but there is often concern about dependency and addiction. In January 1989, New York implemented regulations requiring physicians to order benzodiazepines using state-monitored triplicate prescription forms. OBJECTIVE: The purpose of this study was to assess the effects of the triplicate prescription program (TPP) on changes in use of benzodiazepines and other psychoactive drugs in clinically vulnerable Medicaid populations. METHODS: Using an interrupted time series with comparison series design, psychoactive medication use was examined in the New York (intervention) and New Jersey (control) Medicaid programs before and after implementation of the New York benzodiazepine TPP among community-dwelling Medicaid beneficiaries aged >/=19 years continuously enrolled from January 1988 through December 1990 in New York or New Jersey with diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizoid personality disorder, or schizotypal personality disorder; bipolar disorder; epilepsy; and/or panic disorder, agoraphobia without history of panic disorder, social phobia, or specific phobia. RESULTS: A total of 125,837 New York and 139,405 New Jersey Medicaid beneficiaries were continuously enrolled and met the study inclusion criteria. Of these, there were 6054 Medicaid enrollees in New York and 6875 enrollees in New Jersey who were clinically vulnerable patients with >/=1 of the specified diagnoses. New York Medicaid patients with any of these diagnoses experienced a -48.1% relative change (95% CI, -50.0% to -46.2%) in benzodiazepine use at 6 months after TPP implementation, with no decline in use in New Jersey patients. The largest reduction in benzodiazepine use was seen among patients with seizure disorder (-59.9% at 6 months; 95% CI, -63.9% to -55.9%). Although use of substitute drugs increased slightly in New York after the TPP, it did not offset reductions in benzodiazepine use. The effects of TPP were sustained for 7 years of follow-up and had the greatest impact on nonproblematic benzodiazepine use. CONCLUSIONS: During the time period studied in this analysis, the New York TPP reduced benzodiazepine use among chronically ill patients for whom these agents represent effective treatment. Our findings suggest that many patients previously receiving benzodiazepines did not receive any pharmacologic intervention. [ABSTRACT FROM AUTHOR]

Since 2003, the Food and Drug Administration (FDA) has warned that antidepressants may be associated with suicidal thoughts and behaviors among youth. An FDA advisory in 2003 and a black-box warning in 2005 focused on children and adolescents younger than age eighteen. The FDA expanded the black-box warning in 2007 to include young adults. Both warnings were intended to increase physician monitoring of suicidal thoughts and behaviors. Our systematic review identified thirty-four studies of depression and suicide-related outcomes after these warnings; eleven of these studies met research design criteria established to reduce biases. The eleven studies examined monitoring for suicidal thoughts and behaviors, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use, and psychotropic drug poisonings (a proxy for suicide attempts) and suicide deaths. We assessed possible spillover to adults not targeted by the warnings. The one study that measured intended physician monitoring of suicidal thoughts and behaviors did not find evidence of an increase. Multiple studies found significant unintended reductions in mental health care after the warnings. After these reductions, there were marked increases in psychotropic drug poisonings and suicide deaths. These findings support reevaluation of risks and benefits of the FDA's black-box antidepressant warnings.