A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs.

Autor: Janusziewicz AN; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Glueck SN; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Park SY; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Nguyen DN; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Rimmel SC; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Cascio LA; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Doh GY; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA., Martin-Yeboah GF; Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA.
Jazyk: angličtina
Zdroj: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2021 Jul 22; Vol. 78 (15), pp. 1438-1443.
DOI: 10.1093/ajhp/zxab176
Abstrakt: Purpose: To provide an overview of compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and to describe the pharmacist's role within the US Food and Drug Administration's (FDA's) Compounding Incidents Program, whose efforts are aimed at protecting the public against poor-quality compounded drugs through surveillance, review and response to adverse events and complaints.
Summary: Compounded drugs may serve an important medical need for patients who cannot be treated with medications approved by FDA; however, compounded drugs are not approved by FDA and are not subject to premarket review for safety, efficacy, or manufacturing quality; thus, they may pose safety risks to patients. Prompt reporting of adverse events or complaints related to compounding is important in identifying these risks and implementing safeguards to protect the public. FDA's Compounding Incidents Program consists of a team of pharmacists dedicated to the surveillance and review of adverse events and complaints and follow-up actions related to safety risks associated with compounded drugs. Pharmacists are a vital component of FDA's Compounding Incidents Program, utilizing their clinical skill set and regulatory knowledge to review and act on safety issues that affect public health.
Conclusion: As FDA continues to expand the Compounding Incidents Program and its efforts to protect the public against poor-quality compounded drugs, we encourage the continued submission of adverse event reports by healthcare professionals and consumers to FDA's MedWatch reporting system in addition to adverse event reporting compliance by outsourcing facilities.
(Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2021.)
Databáze: MEDLINE
Externí odkaz: