Abstract

Introduction

In October 2015, the Food and Drug Administration (FDA) instituted an update to the mandatory Risk Evaluation and Mitigation Strategy (REMS) program for clozapine to improve safety monitoring of hematologic events. However, the impact of the clozapine REMS program on reporting of hematologic adverse events has not been quantified.

Methods

We assessed adverse event reports for agranulocytosis, granulocytopenia, leukopenia, and neutropenia from the FDA Adverse Event Reporting System (FAERS) for a 1-year time period before (October 2014 to September 2015, pre-REMS) and after (October 2015 to September 2016, post-REMS) the implementation of the clozapine REMS program. The AERSMine platform was used to capture historical effect estimates (October 2004 to September 2014). Reporting odds ratios (ROR), proportional reporting ratios (PRR), and corresponding Taylor series 95% confidence intervals (CIs) were calculated for hematologic events with clozapine compared with all other medications using OpenEpi.

Results

Reporting rates for agranulocytosis, granulocytopenia, leukopenia, and neutropenia with clozapine all increased from the pre-REMS to post-REMS time frames, ranging from a 2-fold increase with leukopenia to a 40-fold increase with neutropenia; the composite measure of all hematologic reports had a 12-fold increase. During the post-REMS time frame, the ROR increased by 1691% (111.4, 95% CI 100.6-123.4) compared with the pre-REMS time frame (7.1, 95% CI 5.2-9.6), and the PRR increased by 1280% (83.1, 95% CI 76.8-90.0 vs 6.9, 95% CI 5.1-9.4) for the composite outcome.

Discussion

We observed significant increases in reports of hematologic adverse events with clozapine after the introduction of the clozapine REMS program. Future research should explore the impact of the less stringent exclusionary and discontinuation criteria on utilization (eg, expanded access) and clinical outcomes (eg, treatment effectiveness and adverse events).

Abstract

Introduction

Mental health services are an area of high need in many health care systems in the United States. With a limited number of psychiatric providers and a projected increase in the deficit of psychiatrists, a call for increased mental health services is apparent. The inclusion of mental health clinical pharmacy specialists (MH-CPS) as part of interdisciplinary care teams has enabled the William S. Middleton Memorial Veterans Hospital & Clinics as well as numerous other Veterans Affairs sites to improve access to mental health providers when pharmacists serve as an integral part of the mental health team. Our objectives were to (1) evaluate impressions of nonpharmacist mental health providers of MH-CPS and (2) assess for areas of improvement in MH-CPS services.

Methods

A survey was formulated, using 5-point Likert scale criteria, to evaluate impressions of MH-CPS from other mental health providers. Questions were designed to address impressions of clinical skills, knowledge, team contribution, and comfort with MH-CPS providers. These were distributed and completed in December 2018 by members of mental health treatment teams at the William S. Middleton Memorial Veterans Hospital & Clinics.

Results

Overall, mental health team members rated satisfaction with MH-CPS highly across all evaluated criteria.

Discussion

Per review of these results, MH-CPS are a valued and respected part of the mental health team.

Abstract

Introduction

Opioid use disorder (OUD) can cause significant morbidity and mortality with more than 115 people dying from an opioid overdose daily in the United States. Treatment with buprenorphine/naloxone (BUP/NAL) can be effective; however, there is conflicting evidence on the utility of higher doses in preventing relapse. This study was designed to assess BUP/NAL maintenance doses and the rate of relapse in veterans with OUD.

Methods

Patients diagnosed with OUD who received a prescription for BUP/NAL through the substance use disorder recovery program were retrospectively evaluated. Patients were categorized into 2 treatment groups: those prescribed ≤16 mg of BUP/NAL daily and those prescribed >16 mg of BUP/NAL daily. The primary outcome was to determine rates of relapse between maintenance doses of BUP/NAL. Secondary outcomes included evaluating the difference in rates of relapse between daily versus take-home dosing, tablets versus films, time to relapse, and use of illicit substances during treatment.

Results

Patients prescribed >16 mg of BUP/NAL daily had statistically significantly lower rates of relapse compared to patients prescribed ≤16 mg of BUP/NAL daily (P = .0018). Regarding secondary outcomes, there was a statistically significant difference in time to relapse (P = .036) and dosage form (P = .0124). Difference in administration of dose and illicit substance use during treatment were not statistically significant.

Discussion

This study identified that rate of relapse can be lowered and time to relapse can be lengthened when doses >16 mg of BUP/NAL are prescribed in the veteran population for OUD.

Charles Dorflinger,

PharmD, BCPS