Opioids in the United Kingdom: safety and surveillance during COVID-19.

PURPOSE OF REVIEW: Opioid use is prevalent in the United Kingdom and prior to the COVID-19 pandemic it had been recognized that the safety of opioids was an important issue to be monitored by the UK medicines regulatory agency. With the emergence of COVID-19, this requirement has been even greater. This review was undertaken to determine the impact of the pandemic on safety and surveillance of opioids in the United Kingdom. RECENT FINDINGS: During the COVID-19 pandemic, the surveillance of opioids in the United Kingdom continued, although primary research was often conducted with data prior to the pandemic. Of those studies that were conducted while the pandemic was ongoing, access to opioids (or opioid substitution therapy) and the subsequent effect on patient safety was the main theme. SUMMARY: In the United Kingdom, changes in accessibility to the healthcare system and how healthcare providers operated during the COVID-19 pandemic may have had unintended consequences on use and safety of opioids, due to the shift in focus to preventing COVID-19 from overwhelming the healthcare system. The findings from this review support the need to continue surveillance in the United Kingdom, including the impact of the COVID-19 pandemic on opioid utilization and safety.

Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment.

INTRODUCTION: There is a need to identify effective, safe treatments for COVID-19 (coronavirus disease) rapidly, given the current, ongoing pandemic. A systematic benefit-risk assessment was designed and conducted to examine the benefit-risk profile of remdesivir in COVID-19 patients compared with standard of care, placebo or other treatments. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation, which starts with inevitably limited information (to meet the urgent unmet public health need worldwide), then update the benefit-risk evaluation as more data become available. METHODS: The Benefit-Risk Action Team (BRAT) framework was used to assess the overall benefit-risk of the use of remdesivir as a treatment for COVID-19 compared with standard of care, placebo or other treatments. We searched PubMed, Google Scholar and government agency websites to identify literature reporting clinical outcomes in patients taking remdesivir for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. RESULTS: Using the BRAT method, several key benefits and risks for use of remdesivir in COVID-19 compared with placebo have been identified. In one trial, the benefit of time to clinical improvement was not statistically significant (21 vs 23 days, HR 1.23, 95% CI 0.87-1.75), although the study was underpowered. In another trial, a shorter time to recovery in patients treated with remdesivir was observed (11 vs 15 days), with non-significant reduced mortality risk (8% vs 12%). Risk data were only available from one trial. This trial reported fewer serious adverse events in patients taking remdesivir (18%) compared with the placebo group (26%); however, more patients in the remdesivir group discontinued treatment as a result of an adverse event compared with those patients receiving placebo (12% vs 5%). CONCLUSIONS: Preliminary clinical trial results suggest that there may be a favourable benefit-risk profile for remdesivir compared with placebo in severe COVID-19 infection and further data on benefits would strengthen this evaluation. There is limited safety data for remdesivir, which should be obtained in further studies. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit-risk assessment.

A Longitudinal Analysis of the Substance Abuse, Violence, and HIV/AIDS (SAVA) Syndemic among Women in the Criminal Justice System.

Using data from a randomized controlled trial of 319 women mainly recruited from a Municipal Drug Court System in St. Louis, MO, this study evaluates substance use, victimization, and HIV/AIDS risk behaviors over time. The results indicated that, for all participants, the likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk decreased by 46% by the eight-month follow-up; however, results did not differ significantly by intervention group. Women who were sexually abused as a child, had 4+ arrests, or believed they had sexual and drug-using behaviors that need changing at baseline were more likely to experience these issues over time.

Non-medical opioid use in youth: Gender differences in risk factors and prevalence.

BACKGROUND: Non-medical use (NMU) of prescription opioids in youth is of concern since they may continue this pattern into adulthood and become addicted or divert medications to others. Research into risk factors for NMU can help target interventions to prevent non-medical use of opioids in youth. METHOD: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) was conducted from 2008 to 2011. Participants 10-18years of age were recruited from entertainment venues in urban, rural and suburban areas of 10 US cities. Participants completed a survey including questions on their use of prescription opioids. NMU was defined as a non-labeled route of administration or using someone else's prescription. Information on age, gender, alcohol, marijuana and tobacco use was also collected. Summary descriptive, chi-square statistics and logistic regression were conducted using SAS 9.4. RESULTS: Of the 10,965 youth who provided information about past 30day prescription opioid use, prevalence of reported opioid use was 4.8% with 3.2% reported as NMU (n=345) and 1.6% as medical use (MU) only (n=180). More males than females (55.7% vs. 44.4%) reported opioid NMU (p<0.0001). Logistic regression revealed that among males (comparing NMU to MU only), current smokers were 4.4 times more likely to report opioid NMU than non-smokers (95% CI: 1.8, 10.7). Among females (comparing NMU to MU only), current smokers and alcohol users were more likely to report opioid NMU than those who had never smoked or used alcohol (OR=3.2, 95% CI: 1.4, 7.0 and OR=4.1, 95% CI: 1.7, 10.4, respectively). CONCLUSIONS: These results suggest that further research on gender differences in opioid NMU is needed; interventions for opioid NMU may need to be gender specific to obtain the best results.