A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs
| Autor: | Laurelle A Cascio, Shannon N Glueck, Sophia Y Park, Susan C Rimmel, Garrette F Martin-Yeboah, Ashlee N Janusziewicz, Dien N Nguyen, Gina Y Doh |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Drug
medicine.medical_specialty Drug Compounding media_common.quotation_subject Pharmacist Pharmacists 030226 pharmacology & pharmacy Food and drug administration 03 medical and health sciences 0302 clinical medicine medicine Humans 030212 general & internal medicine Adverse effect adverse drug event media_common Pharmacology MedWatch United States Food and Drug Administration business.industry Descriptive Report Health Policy Public health adverse drug reaction reporting systems medicine.disease United States Pharmaceutical Preparations Compounding AcademicSubjects/MED00410 Medical emergency business Clinical skills |
| Zdroj: | American Journal of Health-System Pharmacy: AJHP |
| ISSN: | 1535-2900 1079-2082 |
| DOI: | 10.1093/ajhp/zxab176 |
| Popis: | Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. 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. |
| Databáze: | OpenAIRE |
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