Opioid-Related Trends in Active Duty Service Members During the Coronavirus Disease 2019 Pandemic.

INTRODUCTION: The USA is experiencing an opioid epidemic. Active duty service members (ADSMs) are at risk for opioid use disorder (OUD). The Coronavirus disease 2019 (COVID-19) pandemic has disrupted health care and introduced additional stressors. METHODS: The Military Healthcare System Data Repository was used to evaluate changes in diagnosis of OUD, medications for OUD (MOUD), opioid overdose (OD), and opioid rescue medication. ADSMs ages 18-45 years enrolled in the Military Healthcare System between February 2019 and April 2022 were included. Joinpoint Trend Analysis Software calculated the average monthly percent change over the study period, whereas Poisson regression compared outcomes over three COVID-19 periods: Pre-lockdown (pre-COVID-19 period 0) (February 2019-February 2020), early pandemic until ADSM vaccination initiation (COVID-19 period 1 [CP1]) (March 2020-November 2020), and late pandemic post-vaccination initiation (COVID-19 period 2 [CP2]) (December 2020-April 2022). RESULTS: A total of 1.86 million eligible ADSMs received care over the study period. Diagnoses of OUD decreased 1.4% monthly, MOUD decreased 0.6% monthly, diagnoses of opioid OD did not change, and opioid rescue medication increased 8.5% monthly.Diagnoses of OUD decreased in both COVID-19 time periods: CP1 and CP2: Rate ratio (RR) = 0.74 (95% CI, 0.68-0.79) and RR = 0.72 (95% CI, 0.67-0.76), respectively. MOUD decreased in both CP1 and CP2: RR = 0.77 (95% CI, 0.68-0.88) and RR = 0.86 (95% CI, 0.78-0.96), respectively. Adjusted rates for diagnoses of opioid OD did not vary in either COVID-19 time period. Opioid rescue medication prescriptions increased in CP1 and CP2: RR = 1.09 (95% CI, 1.02-1.15) and RR = 6.02 (95% CI, 5.77-6.28), respectively. CONCLUSIONS: Rates of OUD and MOUD decreased, whereas rates of opioid rescue medication increased during the study period. Opioid OD rates did not significantly change in this study. Changes in the DoD policy may be affecting rates with greater effect than COVID-19 pandemic effects.

The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.

OBJECTIVE: To summarize the US Food and Drug Administration's (FDA's) review of the safety and effectiveness for pimavanserin, an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. We describe the regulatory and clinical issues important to the FDA's approval of this New Drug Application, with special focus on the risk-benefit balance. We also describe a new labeling feature that presents additional efficacy data to clinicians. DATA SOURCES: Data sets for all relevant clinical trials of pimavanserin and the Applicant's and FDA's analyses of these data were considered in this review. Data were available from 616 patients with Parkinson's disease with hallucinations and delusions who received at least 1 dose of pimavanserin, with a total exposure of 825 patient-years in the Parkinson's disease psychosis population. RESULTS: Pimavanserin 34 mg/d was effective in treating hallucinations and delusions associated with Parkinson's disease. In the Applicant's single pivotal trial, 80.5% of pimavanserin patients experienced at least some improvement in symptoms compared to 58.1% of patients taking placebo. Pimavanserin did not worsen motor function, an adverse effect commonly observed with other antipsychotics, probably because of a lack of consequential dopamine binding. CONCLUSIONS: Pimavanserin is the only FDA-approved treatment for the hallucinations and delusions seen in patients with psychosis of Parkinson's disease. Although pimavanserin appears to have a pharmacologic mechanism that is different from other atypical antipsychotics, concern remained that the increased risk of death seen with antipsychotic use in elderly demented patients, and described in all approved antipsychotic labels, would also occur with pimavanserin. Pimavanserin bears the same boxed warning about the risk of death associated with antipsychotic use in elderly patients with dementia.

Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government.

OBJECTIVE: To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field. METHOD: Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research in the 1990s. Despite the increase in research, concerns exist about methods and incentives for making new medications available for use in pediatric psychiatric disorders. In recognition of these concerns, the Duke Clinical Research Institute held a roundtable in September 2004. Participants from the National Institutes of Health, regulatory agencies, academia, and the pharmaceutical industry spoke about the effects of government regulations such as the U.S. Food and Drug Administration Modernization Act and the Pediatric Research Equity Act on pediatric research from academic, clinical, and industry perspectives, and bioethical considerations of such research. CONCLUSIONS: To ensure development of new drugs for treating psychiatric disorders in children and adolescents, we must address the challenges posed by the regulatory environment governing pediatric psychopharmacology research. Strategies were identified for improving the evidence base for psychopharmacologic interventions in youth before widespread use and for more effectively defining a research agenda for the future.