The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis.

BACKGROUND: Vortioxetine is the first mixed serotonin agonist and antagonist antidepressant approved in the US. We sought to evaluate all published and unpublished data available to determine the efficacy and harms of vortioxetine in adults with major depressive disorder. METHODS: We used a predefined search strategy of MEDLINE, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Drugs@FDA to identify studies evaluating vortioxetine in the acute treatment of major depressive disorder. Only randomized controlled trials (RCTs) that provided results on relevant clinical efficacy and safety outcomes were included. Study quality was assessed and results were pooled using mixed effect meta-analyses where applicable. RESULTS: We identified 11 RCTs with 6,145 participants meeting inclusion criteria (eight were published and three were unpublished). The trials did not exceed 8 weeks in duration. The response rate with vortioxetine was significantly higher for 1-mg (relative risk (RR) = 1.91; 95% confidence interval (CI) 1.36 to 2.69), 5-mg (RR = 1.33; 95% CI 1.10 to 1.61), 10-mg (RR = 1.42; 95% CI 1.21 to 1.67), and 20-mg doses (RR = 1.58; 95% CI 1.19 to 2.08) compared to placebo. Remission rates were significantly higher for the 10-mg group (RR = 1.45; 95% CI 1.18 to 1.77) and the 20-mg group (RR = 1.68; 95% CI 1.19 to 2.37) compared to placebo. Meta-regression of dose on the log odds ratio of response was not statistically significant (ß = 0.01; P = 0.46). Vortioxetine response rates were lower than active serotonin and norepinephrine reuptake inhibitor (SNRI) comparators for the 5-mg (RR = 0.88; 95% CI 0.80 to 0.98), 15-mg (RR = 0.78; 95% CI 0.68 to 0.90), and 20-mg (RR = 0.82; 95% CI 0.72 to 0.94) doses. The most common adverse events were nausea and vomiting which increased in frequency with higher doses. CONCLUSIONS: Vortioxetine was significantly more effective than placebo for acute treatment of major depressive disorder (MDD). Although treatment effect estimates varied substantially between studies, a dose effect was not observed. Vortioxetine does not appear to be more effective, and is potentially less effective, than an SNRI. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42013006198 .

Use of administrative data to identify off-label use of second-generation antipsychotics in a Medicaid population.

OBJECTIVE The use of second-generation antipsychotics for conditions not approved by the U.S. Food and Drug Administration (FDA) is a prevalent phenomenon with important implications. The objective of this study was to determine the accuracy of administrative claims for identifying off-label use of second-generation antipsychotics in a Medicaid population in 2009. METHODS The authors estimated the sensitivity, specificity, positive predictive values (PPV), and negative predictive values of Medicaid claims data for detecting off-label use of second-generation antipsychotics in the electronic health records of 788 patients. Separate estimates were calculated for patients without schizophrenia and bipolar disorder, the two most long-standing FDA indications for use of second-generation antipsychotics, and for a subset of patients using a second-generation antipsychotic with indications for treatment-resistant depression. RESULTS Medicaid claims determined a lack of schizophrenia and bipolar disorder in the medical record with a sensitivity of 72% and a specificity of 85%. The prevalence of identifying neither diagnosis was 83%, which was associated with a predictive ability (PPV) of 96%. Among those using a second-generation antipsychotic with an indication for treatment-resistant depression, the sensitivity, specificity, and PPV of Medicaid claims for identifying off-label use were 41%, 86%, and 87%, respectively. CONCLUSIONS Medicaid claims data had high predictive ability for identifying users of second-generation antipsychotics who did not have documentation of schizophrenia or bipolar disorder in the medical record. The predictive utility of the claims was diminished when the analyses were limited to patients using a second-generation antipsychotic with an indication for treatment-resistant depression.

One practice's experiment in refusing detail rep visits.

PURPOSE: The physician-pharmaceutical industry relationship has come under increasing scrutiny. Little guidance exists concerning how smaller practices should manage this relationship.In 2006, Madras Medical Group, a small family practice in rural Oregon, implemented a policy prohibiting visits from representatives of the pharmaceutical industry and the acceptance of drug samples. This qualitative study documents the attitudes of clinic personnel in response to this policy. METHODS: Semistructured interviews were conducted using standardized questions related to 4 areas of policy perception: verification of policy decision, impact on clinic operations,influence of pharmaceutical industry, and lessons to share. Common themes were identified. RESULTS: Three physicians and 3 nurses participated in the study. There was consensus on the existence and effectiveness of the clinic policy. Key themes identified from both groups of interviewees included the perception of enhanced clinic operation after eliminating interruptions from pharmaceutical representatives, positive response from the public, and reduced diversion of samples for personal use. Clinicians interviewed agreed that samples were of questionable benefit,that information obtained from industry representatives was incomplete or of questionable veracity or objectivity, and that it was helpful to substitute other drug information sources and clinic-sponsored lunches for past industry offerings. CONCLUSION: In this case study, a policy prohibiting pharmaceutical representatives from a small family practice was well accepted and a source of pride among physicians and nurses. Other clinics wishing to enact a similar policy may wish to supplement their efforts by proactively using other sources of drug information.

Effect of drug sample removal on prescribing in a family practice clinic.

PURPOSE: Little is known about the impact of recent restrictions on pharmaceutical industry detailing and sampling on prescribing behavior, particularly within smaller, independent practices. The objective of this study was to evaluate the effect of a policy prohibiting prescription drug samples and pharmaceutical industry interaction on prescribing patterns in a rural family practice clinic in central Oregon. METHODS: Segmented linear regression models were used to evaluate trends in prescribing using locally obtained pharmacy claims. Oregon Medicaid pharmacy claims were used to control for secular prescribing changes. Total and class-specific monthly trends in branded, promoted, and average prescription drug costs were analyzed 18 months before and after policy implementation. RESULTS: Aggregate trends of brand name drug use did not change significantly after policy implementation. In aggregate, use of promoted agents decreased by 1.43% while nonpromoted branded agents increased by 3.04%. Branded drugs prescribed for respiratory disease declined significantly by 11.34% compared with a control group of prescribers. Relative to the control group, prescriptions of promoted cholesterol-lowering drugs and antidepressants were reduced by approximately 9.98% and 11.34%, respectively. The trend in average cost per prescription for lipid-lowering drugs was significantly reduced by $0.70 per prescription per month. Overall, average prescription drug costs increased by $5.18 immediately after policy implementation. CONCLUSIONS: Restriction of pharmaceutical industry representatives and samples from a rural family practice clinic produced modest reductions in branded drug use that varied by class. Although aggregate average costs increased, prescriptions for branded and promoted lipid-lowering agents and antidepressants were reduced.

Antimicrobial prescribing for upper respiratory infections and its effect on return visits.

BACKGROUND AND OBJECTIVES: Antibiotic resistance is a growing problem that complicates the treatment of various illnesses. This study analyzes Medicaid encounter data to (1) determine antibiotic prescribing rates for common respiratory tract infections in Oregon and (2) assess the effect of receiving an antibiotic at an index visit on whether there was a return visit within 30 days. METHODS: Subjects included in this study were Medicaid patients in Oregon between 2001--2003 who were enrolled in Medicaid for a full year and were diagnosed with an upper respiratory tract infection, including bronchitis, sinusitis, acute otitis media (AOM), pharyngitis, and upper respiratory infections (URIs). Claims data were analyzed to determine receipt of an antibiotic within 3 days of the initial visit and if there was a return visit within 30 days. RESULTS: During 2001--2003, the proportion of patients receiving antibiotics for bronchitis and sinusitis decreased, from 70% to 61%, and from 78% to 74%, respectively, while antibiotic prescribing for AOM, URI, and pharyngitis changed little. After controlling for age, gender, race/ethnicity, Medicaid plan type, and location, we determined that patients who had received antibiotics during the index visit for AOM, URI, and pharyngitis were more likely to return with a respiratory tract infection during the subsequent 30 days than patients who did not receive antibiotics. CONCLUSIONS: Antibiotic prescribing among Medicaid patients in Oregon has decreased. Receiving an antibiotic does not decrease the rate of subsequent return visits.

Impact of a Medicaid copayment policy on prescription drug and health services utilization in a fee-for-service Medicaid population.

BACKGROUND: Copayments (copays) for prescription drugs are a common policy among state Medicaid programs. Research exploring the effects of copays on pharmacy and health care utilization in Medicaid patients is limited, especially among patients with chronic disease. OBJECTIVES: The goal of this research was to quantify the impact of a copay policy for prescription drugs on medication and health services utilization overall and among subjects with several common chronic diseases enrolled in a state Medicaid program. RESEARCH DESIGN: Using aggregated pharmacy claims, segmented linear regression models were used to evaluate changes in overall and disease-specific pharmacy utilization after implementation of a copay policy. Trends in emergency department encounters, office visits, and hospitalizations were used to evaluate the impact of this policy on unintended consequences. Utilization among cohorts of patients with several chronic conditions were analyzed to determine if a differential response existed by drug indication. RESULTS: After copay implementation, utilization of prescription drugs declined significantly by 17.2% (P < 0.0001). This pattern was observed at varying degrees for all drug classes investigated. Rates of emergency department encounters, office visits, or hospitalizations did not increase after the policy was introduced. Subjects with diabetes, respiratory disease, and schizophrenia immediately reduced their use of nonindicated drugs significantly more than drugs indicated for their condition. CONCLUSIONS: Among Medicaid recipients, nominal copays are associated with significant reductions in use of clinically important drug classes. However, patients with chronic disease exhibited a differential response depending on the disease indication of the drug class.

Patterns of atypical antipsychotic subtherapeutic dosing among Oregon Medicaid patients.

OBJECTIVE: To examine a cohort of Medicaid patients with new prescriptions for atypical antipsychotic medication to determine the prevalence of subtherapeutic atypical antipsychotic medication use and to identify patient and prescribing provider characteristics associated with occurrence of subtherapeutic use. METHOD: This observational cohort study examined Medicaid administrative claims data for patients aged 20 to 64 years with a new prescription for an atypical antipsychotic medication (clozapine, olanzapine, quetiapine, risperidone, ziprasidone) between January 1, 2004, and December 31, 2004. Patient diagnostic information was identified using the International Classification of Diseases, Ninth Revision, Clinical Modification codes on submitted medical claims. Patient characteristics, prescribing provider characteristics, length of therapy, and dosing were examined. A logistic regression assessed the probability of subtherapeutic dosing. RESULTS: Among 830 individuals in our sample who began treatment with an atypical antipsychotic, only 15% had a documented diagnosis of schizophrenia, subtherapeutic dosing was common (up to 86% of patients taking quetiapine), and 40% continued less than 30 days with the index prescription. A logistic model indicated that a general practitioner as prescribing provider, length of therapy equal to or less than 30 days, and prescription of quetiapine were significantly associated with a subtherapeutic dose (p < .001, p = .028, and p < .001, respectively). CONCLUSIONS: These results suggest that there is extensive use of expensive atypical antipsychotic medications for off-label purposes such as sedation or for other practice patterns that should be explored further. Approaches that minimize off-label atypical antipsychotic use could be of considerable value to Medicaid programs. In addition, these findings support the need for the introduction or increased use of utilization monitoring and the implementation of medication practice guidelines as appropriate decision support for prescribing providers.

How expensive is antipsychotic polypharmacy? Experience from five US state Medicaid programs.

OBJECTIVE: To characterize healthcare costs associated with antipsychotic polypharmacy and to investigate predictors of high-cost patients. METHODS: A retrospective cohort study using Medicaid claims data from California, Nebraska, Oregon, Utah, and Wyoming evaluated 55 383 fee-for-service patients with antipsychotic prescriptions between 1998 and 2002. Polypharmacy was defined as initiating multiple antipsychotic drugs or concomitant antipsychotic therapy (>or=60 days). Healthcare costs (drug and non-drug) were summed for 365 days following index antipsychotic claim. Adjusted mean costs were compared to antipsychotic monotherapy. Logistic regression was performed to identify predictors of high-cost patients (top quintile) with regard to patient age, gender, race/ethnicity, mental disorders, hospitalization, index antipsychotic, concomitant psychotropic drugs, and polypharmacy. RESULTS: The average annual prevalence of antipsychotic polypharmacy was 6%. 70-80% of total healthcare expenditures for polypharmacy patients were drug-related. Polypharmacy was associated with significantly higher drug expenditures ($1716-2079) in the year following drug initiation than monotherapy even after adjusting for case mix and index antipsychotic (p < 0.05). Differences in non-drug expenditures versus monotherapy were smaller and varied by state ranging from a $77 increase in California (p < 0.001) to a $211 savings in Utah (p = 0.02). In California, polypharmacy alone (OR = 2.69; 95% CI: 2.30-3.16) or in combination with concomitant psychotropics (OR = 6.26; 95% CI: 5.51-7.11) was associated with greater likelihood of being a high-cost patient than monotherapy. CONCLUSIONS: Cost savings from limiting antipsychotic polypharmacy could be significant. Caution must be taken in ensuring reductions in polypharmacy do not lead to unintended consequences or shift care to more costly alternatives. Study limitations, including the known shortcomings of claims data and differences across state Medicaid programs, should be considered when interpreting the results of this or any multi-state study.

Rates of adverse events of long-acting opioids in a state Medicaid program.

BACKGROUND: Despite widespread use and emerging safety concerns, data on the comparative safety and effectiveness of long-acting opioid (LAO) analgesics are weak. OBJECTIVE: To compare rates of adverse events among patients newly prescribed an LAO. METHODS: A retrospective observational cohort study using Medicaid administrative claims data was conducted examining time until first adverse outcome among patients with new prescriptions for methadone, extended-release (ER) oxycodone, ER morphine, or transdermal fentanyl. Adverse outcomes included emergency department (ED) encounters or hospitalizations for opioid-related adverse events, all-cause ED encounters or hospitalizations, death, and diagnoses for opioid-related adverse effects. Cox proportional hazards models were used to adjust for a variety of measured covariates overall and within subgroups of patients with and without cancer. RESULTS: This study included 5684 subjects. Patients prescribed ER oxycodone were 55[corrected]% less likely (adjusted hazard ratio [HR] 0.45; 95% CI 0.26 to 0.77) to experience an ED or hospitalization involving an opioid-related adverse event, 23% lower risk of hospitalization (adjusted HR 0.77; 95% CI 0.66 to 0.91), 41% lower risk of constipation (adjusted HR 0.59; 95% CI 0.35 to 1.00), and a 29% lower risk of death (adjusted HR 0.71; 95% CI 0.54 to 0.94) compared with those prescribed ER morphine. Among subjects with noncancer pain, fentanyl was associated with a higher risk of ED encounters (adjusted HR 1.27; 95% CI 1.02 to 1.59) and methadone was associated with a greater risk of overdose symptoms (adjusted HR 1.57; 95% CI 1.03 to 2.40) compared with ER morphine. CONCLUSIONS: Our results support a modest safety advantage with ER oxycodone compared with ER morphine. Among subjects with noncancer pain, fentanyl and methadone were associated with an increased risk of an adverse event compared with ER morphine. Additional studies are needed to confirm our findings and further clarify risks associated with different LAOs.

Prevalence, utilization patterns, and predictors of antipsychotic polypharmacy: experience in a multistate Medicaid population, 1998-2003.

OBJECTIVES: This study was conducted to estimate the prevalence of antipsychotic polypharmacy among fee-for service state Medicaid beneficiaries initiating antipsychotic drug therapy and to investigate psychiatric and demographic predictors of such polypharmacy. METHODS: This was a retrospective cohort study employing Medicaid claims data from California, Nebraska, Oregon, Utah, and Wyoming for patients who filled >1 antipsychotic prescription between 1998 and 2003 and who were continuously eligible for benefits from 180 days before to 1 year after the index antipsychotic claim. Antipsychotic Polypharmacy was defined as initiation of multiple antipsychotic medications or at least 60 consecutive days of concomitant antipsychotic medication overlapping the index antipsychotic prescription at any time during the 365 days after the index drug claim. Primary and secondary diagnosis codes (International Classification of Diseases, Ninth Revision, Clinical Modification) were used to identify patients with mental disorders and mental health-related hospitalizations. Multivariate logistic regression, with adjustment for sex, age, race/ethnicity, state, mental health diagnoses, hospitalization, year, and type of index antipsychotic, was performed to identify predictors of polypharmacy. A multivariate Cox proportional hazards model was used to compare the cumulative incidence of polypharmacy by index antipsychotic drug. RESULTS: The study cohort consisted of 55,481 individuals with > or =1 prescription claim for an antipsychotic drug. The mean prevalence of long-term antipsychotic polypharmacy in the year after initiating antipsychotic medication was 6.4%. Approximately half of those with polypharmacy were started on multiple antipsychotic drugs and half were started on monotherapy but received > or =2 antipsychotic drugs concomitantly in the year after drug initiation. Among the stronger predictors of polypharmacy were a diagnosis of schizophrenia (odds ratio [OR] = 2.95; 95% Cl, 2.43-3.58), recent mental health hospitalization (OR = 1.17; 95% Cl, 1.02-1.33), and the number of mental health diagnoses (OR = 1.07 per diagnosis; 95% CI, 1.06-1.08). Polypharmacy was more likely among male than female patients (OR = 1.26; 95% Cl, 114-1.39) and among those between the ages of 18 and 24 years. The cumulative incidence of polypharmacy was greater among patients initiating clozapine compared with those initiating other antipsychotics (P < 0.001). CONCLUSIONS: In these fee-for-service Medicaid beneficiaries from 5 states, the prevalence of chronic antipsychotic polypharmacy was low in the year after the initiation of therapy. Polypharmacy was more common in patients with indicators of more severe mental illness.

An evaluation of Oregon's evidence-based Practitioner-Managed Prescription Drug Plan.

This paper describes Oregon's implementation of its publicly developed, evidence-based, Practitioner-Managed Prescription Drug Plan (PMPDP). Oregon's PMPDP was initially self-enforced with a dispense as written (DAW) exception process, followed by an educational prior authorization (soft PA) method, and finally no active enforcement. Market-share trends indicate that the educational prior authorization process was most effective at increasing the use of preferred agents. Pharmacy costs decreased 9.1 percent and 17.7 percent after implementation of the DAW and soft PA policies, respectively. Data from nonenforced PMPDP classes showed no change; this suggests the need for effective methods to encourage PMPDP compliance.

Initial results of the use of prescription order change forms to achieve dose form optimization (consolidation and tablet splitting) of SSRI antidepressants in a state Medicaid program.

BACKGROUND: One method to reduce drug costs is to promote dose form optimization strategies that take advantage of the flat pricing of some drugs, i.e., the same or nearly the same price for a 100 mg tablet and a 50 mg tablet of the same drug. Dose form optimization includes tablet splitting; taking half of a higher-strength tablet; and dose form consolidation, using 1 higher-strength tablet instead of 2 lower-strength tablets. Dose form optimization can reduce the direct cost of therapy by up to 50% while continuing the same daily dose of the same drug molecule. OBJECTIVE: To determine if voluntary prescription change forms for antidepressant drugs could induce dosing changes and reduce the cost of antidepressant therapy in a Medicaid population. METHODS: Specific regimens of 4 selective serotonin reuptake inhibitors (SSRIs)- citalopram, escitalopram, paroxetine, and sertraline- were identified for conversion to half tablets or dose optimization. Change forms, which served as valid prescriptions, were faxed to Oregon prescribers in October 2004. The results from both the returned forms and subsequent drug claims data were evaluated using a segmented linear regression. Citalopram claims were excluded from the cost analysis because the drug became available in generic form in October 2004. RESULTS: A total of 1,582 change forms were sent to 556 unique prescribers; 9.2% of the change forms were for dose consolidation and 90.8% were for tablet splitting. Of the 1,118 change forms (70.7%) that were returned, 956 (60.4% of those sent and 85.5% of those returned) authorized a prescription change to a lower-cost dose regimen. The average drug cost per day declined by 14.2%, from Dollars 2.26 to Dollars 1.94 in the intervention group, versus a 1.6% increase, from Dollars 2.52 to Dollars 2.56, in the group without dose consolidation or tablet splitting of the 3 SSRIs (sertraline, escitalopram, and immediate-release paroxetine). Total drug cost for the 3 SSRIs declined by 35.6%, from Dollars 333,567 to Dollars 214,794, as a result of a 24.8% decline in the total days of SSRI drug therapy and the 14.2% decline in average SSRI drug cost per day. The estimated monthly cost avoidance from this intervention, based on pharmacy claims data, was approximately Dollars 35,285, about 2% of the entire spending on SSRI drugs each month, or about Dollars 0.09 per member per month. Program administration costs, excluding costs incurred by prescribers and pharmacy providers, were about 2% of SSRI drug cost savings. CONCLUSIONS: Voluntary prescription change forms appear to be an effective and well-accepted tool for obtaining dose form optimization through dose form consolidation and tablet splitting, resulting in reduction in the direct costs of SSRI antidepressant drug therapy with minimal additional program administration costs.

Risk of hospitalization for heart failure associated with thiazolidinedione therapy: a medicaid claims-based case-control study.

STUDY OBJECTIVES: To determine, in patients with type 2 diabetes mellitus, whether an association exists between thiazolidinedione therapy or other diabetes therapies and hospital admission for heart failure. DESIGN: Retrospective case-control study. DATA SOURCE: Oregon Medicaid claims database. PATIENTS: A total of 288 case patients and 1652 control patients. MEASUREMENTS AND MAIN RESULTS: Case patients were defined as any patients hospitalized for heart failure, controls as any patients with a hospital claim for a condition other than heart failure. Controls were matched by age and sex in a 6:1 ratio. Exposure to a thiazolidinedione or other antihyperglycemic drug was assessed 60 days before the first hospitalization. This was used to construct an odds ratio of exposure in case patients compared with controls using a multivariate logistic regression model and controlling for potential confounders. Charlson comorbidity index scores and frequency of diabetes-related office visits were significantly higher for case patients than for controls. The unadjusted and adjusted odds ratios for exposure to a thiazolidinedione were 1.71 (95% confidence interval [CI] 1.24-2.36) and 1.37 (95% CI 0.98-1.92), respectively. The unadjusted and adjusted odds ratios for exposure to insulin in patients hospitalized for heart failure were 1.68 (95% CI 1.27-2.22) and 1.25 (95% CI 0.92-1.69), respectively. The unadjusted and adjusted odds ratios for exposure to a combination of insulin and a thiazolidinedione in case patients were 1.81 (95% CI 1.14-2.86) and 1.35 (95% CI 0.84-2.18), respectively. No association with hospitalization for heart failure was found for patients exposed to a sulfonylurea, metformin, or alpha-glucosidase inhibitor. CONCLUSION: This study showed a likely association between thiazolidinedione therapy and hospitalization for heart failure within 60 days of the prescription date. A similar trend occurred with insulin therapy alone and with the combination of thiazolidinedione and insulin, but not with other oral antihyperglycemics. When thiazolidinediones are prescribed, careful consideration should be given to patients with known heart failure. In addition, all patients should be educated regarding heart failure and monitored for signs and symptoms.

Effects of a prior-authorization policy for celecoxib on medical service and prescription drug use in a managed care Medicaid population.

BACKGROUND: Prior authorization (PA) is a poorly studied but commonly employed policy used by health care payers to manage the rising costs of pharmacy benefits. OBJECTIVE: The aim of this study was to evaluate the intended and unintended effects of a PA policy for celecoxib on pharmacy and medical-service utilization in a Medicaid managed-care organization. METHODS: This was a retrospective, interrupted time-series analysis of 22 monthly health-related utilization rates from January 1, 1999, to October 31, 2000. All Medicaid claims for CareOregon (a managed-care organization) and a fee-for-service program were reviewed. A model was constructed to evaluate changes in utilization of therapeutically related drug classes (eg, conventional nonsteroidal anti-inflammatory drugs [NSAIDs], gastrointestinal agents), office and emergency-department encounters, and hospitalizations before and after the PA policy was implemented on November 16, 1999. A secondary analysis evaluated these changes among a sample of prior NSAID users. RESULTS: After the PA policy was implemented, use of celecoxib was immediately reduced from 1.07 to 0.53 days' supply per person-year (58.9%; 95% CI, 50.0%-67.9%). The monthly rate of increase was also reduced (P < 0.001). Utilization changes were not observed in other drug classes. Similar changes were observed in the secondary analysis. An 18% (95% CI, 2.2%-33.9%) nonsignificant increase in emergency-department visits was observed in the entire sample after the PA policy was implemented. However, a similar change was not observed in the secondary analysis of prior NSAID users. No other changes in medical service encounters were noted after the PA policy was activated. CONCLUSIONS: This observational study found that celecoxib use was substantially reduced after the implementation of a PA policy. No important changes in use of other drug classes were detected. The overall increase in emergency-department visits--although not observed among previous NSAID users--should be explored on the individual level.

Gabapentin use in a managed medicaid population.

OBJECTIVE: The use of gabapentin, an antiepileptic agent, in a primary care setting was evaluated to determine (a) the conditions being treated, (b) specialties of the prescribers, (c) dose ranges, and (d) the extent of documentation and follow-up. METHODS: A retrospective review of both claims data and patient charts was performed by a clinical pharmacist. Patients were identified from CareOregon and Oregon Medicaid fee-for-service drug claim databases. All patients were recipients of the Oregon Medicaid program known as the Oregon Health Plan (OHP) and were enrolled members of CareOregon, a contracted OHP managed care organization that primarily serves Medicaid recipients. All patients received care at one of four Oregon Health and Science University primary care clinics. RESULTS: Of the 105 patients studied, 95% received gabapentin for off-label diagnoses. Chronic pain and mental disorders were the diagnoses associated with the majority of prescriptions for gabapentin. Dose and dose intervals varied greatly. Very few patients (12%) had a documented efficacious response to gabapentin therapy. Of the patients started on gabapentin, 40% of patients had no documented follow-up. CONCLUSIONS: Almost all patients in this sample from the Medicaid managed population received gabapentin for off-label indications. Evidence from clinical trials does not support the use of gabapentin for many of the conditions treated with gabapentin in this study. Most patients did not appear to benefit from gabapentin therapy.