The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic.

INTRODUCTION: On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, "drugs") for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration's (FDA's) need to initiate heightened surveillance across these drugs. OBJECTIVE: We aimed to describe the FDA's approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health. METHODS: The FDA conducted surveillance of adverse event and medication error data using the FDA Adverse Event Reporting System, biomedical literature, FDA-American College of Medical Toxicology COVID-19 Toxicology Investigators Consortium Pharmacovigilance Project Sub-registry, and the American Association of Poison Control Centers National Poison Data System. RESULTS: From 4 February, 2020, through 31 January, 2022, we identified 22,944 unique adverse event cases worldwide and 1052 unique medication error cases domestically with drugs to treat or prevent COVID-19. These were from the FDA Adverse Event Reporting System (22,219), biomedical literature (1107), FDA-American College of Medical Toxicology COVID-19 Toxicology Investigator's Consortium Sub-registry (638), and the National Poison Data System (32), resulting in the detection of several important safety issues. CONCLUSIONS: Safety surveillance using near real-time data was critical during the COVID-19 pandemic because the FDA monitored an unprecedented number of drugs to treat or prevent COVID-19. Additionally, the pandemic prompted the FDA to accelerate innovation, forging new collaborations and leveraging data sources to conduct safety surveillance to respond to the pandemic.

Interprofessional Collaboration to Improve Discharge from Skilled Nursing Facility to Home: Preliminary Data on Postdischarge Hospitalizations and Emergency Department Visits.

An interprofessional collaborative practice model was established at Hennepin County Medical Center to improve discharge management from the transitional care unit of the skilled nursing facility (SNF) to home. The practice model involves a geriatrician, nurse practitioner, and pharmacist who care for individuals at a community-based SNF. Before SNF discharge, the pharmacist conducts a chart and in-person medication review and collaborates with the nurse practitioner to determine the discharge medication regimen. The pharmacist's review focuses on assessing the indication, safety, effectiveness, and convenience of medications. The pharmacist provides follow-up in-home or over the telephone 1 week after SNF discharge, focusing on reviewing medications and assessing adherence. Hospitalizations and emergency department (ED) visits 30 days after SNF discharge of individuals who received care from this model was compared with those of individuals who received usual care from a nurse practitioner and geriatrician. From October 2012 through December 2013, the intervention was delivered to 87 individuals, with 189 individuals serving as the control group. After adjusting for age, sex, race, and payor, those receiving the intervention had a lower risk of ED visits (odds ratio (OR) = 0.46, 95% confidence interval (CI) = 0.22-0.97), although there was no significant difference in hospitalizations (OR = 0.47, 95% CI = 0.21-1.08). The study suggests that an interprofessional approach involving a pharmacist may be beneficial in reducing ED visits 30 days after SNF discharge.

Integrating home-based medication therapy management (MTM) services in a health system.

OBJECTIVES: To describe the integration of home-based Medication Therapy Management (MTM) into the ambulatory care infrastructure of a large urban health system and to discuss the outcomes of this service. SETTING: Minnesota from September 2012 to December 2013. The health system has more than 50 primary care and specialty clinics. Eighteen credentialed MTM pharmacists are located in 16 different primary care and specialty settings, with the greatest number of pharmacists providing services in the internal medicine clinic. PRACTICE INNOVATION: Home-based MTM was promoted throughout the clinics within the health system. Physicians, advanced practice providers, nurses, and pharmacists could refer patients to receive MTM in their homes. A home visit had the components of a clinic-based visit and was documented in the electronic health record (EHR); however, providing the service in the home allowed for a more direct assessment of environmental factors affecting medication use. EVALUATION: Number of home MTM referrals, reason for referral and type of referring provider, number and type of medication-related problems (MRPs). RESULTS: In the first 15 months, 74 home visits were provided to 53 patients. Sixty-six percent of the patients were referred from the Internal Medicine Clinic. Referrals were also received from the senior care, coordinated care, and psychiatry clinics. Approximately 50% of referrals were made by physicians. More referrals (23%) were made by pharmacists compared with advanced practice providers, who made 21% of referrals. The top 3 reasons for referral were: nonadherence, transportation barriers, and the need for medication reconciliation with a home care nurse. Patients had a median of 3 MRPs with the most common (40%) MRP related to compliance. CONCLUSION: Home-based MTM is feasibly delivered within the ambulatory care infrastructure of a health system with sufficient provider engagement as demonstrated by referrals to the service.