Janusziewicz Ashlee N, Glueck Shannon N, Park Sophia Y, Nguyen Dien N, Rimmel Susan C, Cascio Laurelle A, Doh Gina Y, Martin-Yeboah Garrette F
Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD,USA.
Am J Health Syst Pharm. 2021 Jul 22;78(15):1438-1443. doi: 10.1093/ajhp/zxab176.
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.
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.
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.
概述《联邦食品、药品和化妆品法案》第503A和503B节规定下的配制情况，并描述药剂师在美国食品药品监督管理局（FDA）配制事件计划中的作用，该计划旨在通过监测、审查以及对不良事件和投诉做出回应，保护公众免受劣质配制药品的危害。
配制药品对于那些无法使用FDA批准药物进行治疗的患者而言，可能满足了一项重要的医疗需求；然而，配制药品未经FDA批准，且未经过上市前的安全性、有效性或生产质量审查；因此，它们可能给患者带来安全风险。及时报告与配制相关的不良事件或投诉，对于识别这些风险并实施保障措施以保护公众至关重要。FDA的配制事件计划由一组药剂师组成，他们致力于监测和审查不良事件及投诉，以及针对与配制药品相关安全风险采取后续行动。药剂师是FDA配制事件计划的重要组成部分，利用他们的临床技能和监管知识，对影响公众健康的安全问题进行审查并采取行动。
随着FDA继续扩大配制事件计划及其保护公众免受劣质配制药品危害的工作，我们鼓励医疗保健专业人员和消费者除了通过外包机构进行不良事件报告合规操作外，继续向FDA的MedWatch报告系统提交不良事件报告。
