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药物警戒在药品安全监测中的作用。

Role of Pharmacovigilance in Drug Safety Monitoring.

作者信息

Paul Anju E, Sasidharanpillai Sarita

机构信息

Department of Dermatology and Venereology, Government Medical College, Kozhikode, Kerala, India.

出版信息

Indian Dermatol Online J. 2025 Jun 17;16(4):545-550. doi: 10.4103/idoj.idoj_771_24. eCollection 2025 Jul-Aug.

Abstract

With the introduction of more and more drugs, modern medicine has succeeded in saving mankind from many fatal infections and other diseases. As newer drugs are brought into the market, the reported adverse drug events also increase. Drug safety measures include meticulous premarketing trials, post-marketing surveillance, avoidance of errors from drug prescription to administration, and ensuring the availability of quality medicines at healthcare facilities. Early diagnosis and prompt treatment of pharmacological side effects and idiosyncratic drug reactions are of utmost importance. Pharmacovigilance program helps to compile data on preventable and non-preventable adverse drug events through vigilant monitoring, utilizes the data to recommend regulations, and conveys information on potential risks associated with specific medicines to all stakeholders. The advances in technology, including artificial intelligence, offer unlimited scope to expand pharmacovigilance services. In this review, we have attempted to discuss the functioning and prospects of the pharmacovigilance program with a special focus on cutaneous adverse drug reactions.

摘要

随着越来越多药物的问世,现代医学已成功将人类从许多致命感染和其他疾病中拯救出来。随着更新的药物进入市场,报告的药物不良事件也在增加。药物安全措施包括细致的上市前试验、上市后监测、避免从药物处方到给药过程中的错误,以及确保医疗机构有优质药品供应。早期诊断和及时治疗药物副作用和特异质药物反应至关重要。药物警戒计划通过 vigilant 监测有助于汇编可预防和不可预防的药物不良事件数据,利用这些数据推荐法规,并向所有利益相关者传达与特定药物相关的潜在风险信息。包括人工智能在内的技术进步为扩大药物警戒服务提供了无限空间。在本综述中,我们试图讨论药物警戒计划的运作和前景,特别关注皮肤药物不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/96e5/12270453/50b998e4950b/IDOJ-16-545-g001.jpg

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