印度国家药物警戒规划协调中心发布的药物安全警报:当前做法和未来建议

IF 0.2 Q4 PHARMACOLOGY & PHARMACY
D. Rajesh, M. Thejaswini
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摘要

背景:药物治疗引起的药物不良反应(adr)是不可避免的,事先了解其病原体可以避免给患者和卫生保健系统带来不必要的经济负担。目标:提高卫生保健专业人员对印度国家药物警戒规划协调中心(NCC-PvPI)发布的药物安全警报(dsa)的认识,直至2022年12月,并重申自发报告不良事件对改善患者护理的重要性。方法:回顾性分析2016年3月至2022年12月发布的141份dsa。根据反应类型、系统器官类别和药物类别对不良反应进行分析。使用Microsoft Office 2007编制数据,并使用数字和百分比以描述性的方式呈现。结果:在分析的141个dsa中,101个单独药物、2个药物类别和7个药物组合发生了144个adr。这些不良反应被压缩成86种不同的类型,因为类似的不良反应是由一种以上的药物引起的。药物反应伴嗜酸性粒细胞增多和全身性症状是最常见的ADR,其次是皮肤表现,如中毒性表皮坏死松解、急性全身性脓疱病、皮肤色素沉着、固定性药疹、对称性药物相关性三节间和弯曲性药疹、光敏反应。最常见的引起不良反应的药物是抗菌药物,头孢菌素是最常见的药物类别。结论:大多数由NCC-PvPI通过dsa密切监测的不良反应通过早期和适当的管理是可以治愈的。由于分析中观察到大量皮肤表现,皮肤科医生在对皮肤病变进行鉴别诊断时,详细的用药史至关重要。激励和提高卫生保健专业人员和患者自发报告不良事件的意识只能加强印度的药物警戒系统。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug Safety Alerts Issued by the National Coordination Centre for Pharmacovigilance Programme of India: Current Practices and Future Recommendations
Background: Adverse drug reactions (ADRs) due to drug therapy are inevitable and prior knowledge of their causative agents can avoid unnecessary economic burden on patients as well as on the health-care system. Objectives: To create awareness among health-care professionals about the drug safety alerts (DSAs) issued by the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) till December 2022 and to reiterate the importance of spontaneous reporting of adverse events for better patient care. Methodology: A retrospective analysis of 141 DSAs issued from March 2016 to December 2022 was done. The ADRs were analyzed for the type of reactions, system organ class, and according to drug class. Microsoft Office 2007 was used to formulate the data and presented it in a descriptive manner using numbers and percentages. Results: Out of 141 DSAs under analysis, 101 individual drugs, 2 drug classes, and 7 drug combinations have developed 144 ADRs. These ADRs were compressed into 86 different types as similar ADRs were caused by more than one drug. Drug Reaction with Eosinophilia and Systemic Symptoms is the most common ADR noticed, followed by skin manifestations such as toxic epidermal necrolysis, acute generalized exanthematous pustulosis, skin hyperpigmentation, fixed drug eruption, symmetrical drug-related intertriginous and flexural exanthema, and photosensitivity reaction. The most common causative drugs for ADRs were antimicrobial agents, cephalosporins being the most commonly implicated medication class. Conclusions: Most of the ADRs advised to closely monitor by the NCC-PvPI through DSAs were treatable by early and appropriate management. Due to the high number of skin manifestations observed in the analysis, the role of dermatologists in taking detailed drug history is critical when making a differential diagnosis of skin lesions. Motivation and creating awareness among health-care professionals and patients to spontaneously report adverse events can only strengthen the pharmacovigilance system in India.
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