Antiviral influenza treatments and hemorrhage-related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

STUDY OBJECTIVE: To determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. DESIGN: Disproportionality analysis. DATA SOURCE: The FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022. MEASUREMENTS: Antiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications. MAIN RESULTS: A total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage. CONCLUSION: In this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.

Contextual factors affecting the implementation of drug checking for harm reduction: a scoping literature review from a North American perspective.

BACKGROUND: The opioid epidemic continues to be a significant cause of morbidity and mortality in the US. In 2020, 83% of opioid-related overdose deaths were due to synthetic opioids, such as fentanyl. Drug checking services have been widely implemented as a harm reduction intervention to facilitate the identification of substances in a drug sample. There is a need to inform decision-making on drug checking technologies and service implementation. This research aims to outline contextual considerations for the implementation of a drug checking service. METHODS: A scoping review was conducted using a structured search strategy in PubMed and EMBASE. Articles were independently screened by two reviewers, and included if they were primary literature and reported on an actionable consideration(s) for drug checking services. Data elements were extracted using a standardized form, and included study design, study population, drug checking technology utilized or discussed, and main findings. RESULTS: Twenty-nine articles were selected for inclusion, and four primary areas of consideration were identified: drug checking technologies, venue of a drug checking service, legality, and privacy. Technological considerations include the need for highly accurate, quantitative results which appeal to both populations of people with drug use disorder and recreational users. Accessibility of services was identified as an important factor that may be impacted by the location, integration with other services, how the service is provided (mobile vs. fixed), and the hours of operation. Maintaining plausible deniability and building trust were seen as important facilitators to service use and engagement. Issues surrounding legality were the most frequently cited barrier by patrons, including fear of criminalization, policing, and surveillance. Patrons and stakeholders identified a need for supportive policies that offer protections. Maintaining anonymity for patrons is crucial to addressing privacy-related barriers. CONCLUSION: This review highlights the need to understand the local population and climate for drug checking to implement a drug checking service successfully. Common themes identified in the literature included considerations related to the choice of technology, the type of venue, and the impact of legality and privacy. We intend to utilize these considerations in future research to help guide discussions with US-based stakeholders.

Pharmacists and Naloxone: Barriers to Dispensing and Effectiveness of an Educational Outreach Program.

BACKGROUND: The Illinois Naloxone Standing Order allows community pharmacists to dispense naloxone; however, this policy initiative may be underutilized. OBJECTIVE: Our study aims to characterize naloxone dispensing barriers, overall and by pharmacy type, make recommendations that can inform future policies to improve naloxone access, and evaluate outreach initiative effectiveness from academic detailers' perspectives. METHODS: We conducted a retrospective analysis of semistructured data collected as part of an educational outreach program targeting Illinois community pharmacists in 2021. Academic detailers conducted educational outreach visits across community pharmacy settings (i.e., primary pharmacy, grocery pharmacy, or independent pharmacy) to promote standing order use and discuss barriers pharmacists face when dispensing naloxone. Following each visit, detailers recorded visit characteristics, pharmacist-identified obstacles impacting naloxone dispensing, and visit effectiveness. RESULTS: Detailers performed in-person visits at 270 (78%) of 348 targeted sites. A lower proportion of independent pharmacies (61%) routinely stock naloxone than primary (95%, P < 0.001) or grocery (98%, P < 0.001) pharmacies. Among pharmacists at independent pharmacies, 43% indicated they were highly or extremely comfortable dispensing naloxone, a significantly lower proportion than pharmacists at grocery (79%, P < 0.001) or primary (68%, P < 0.001) pharmacies. The prevalence of salient barriers to naloxone dispensing was: cost/insurance issues (primary pharmacy = 38% vs. grocery pharmacy = 36% vs. independent pharmacy = 28%, P = 0.46), stigma (36% vs. 49% vs. 16%, P < 0.05), and lack of standing order enrollment (0% vs. 0% vs. 49%, P < 0.05). On average, detailers perceived visits as less useful to pharmacists working at independent pharmacies than those at primary or grocery pharmacies. CONCLUSIONS: Over 80% of pharmacists reported facing greater than one naloxone dispensing barrier. While cost/insurance issues appear ubiquitous, patient stigma-related factors were prevalent in primary and grocery pharmacies. Although many pharmacists are comfortable dispensing naloxone under the standing order, pharmacists at independent pharmacies are less comfortable, potentially secondary to lower standing order enrollment.