Xu Yimin, Patel Dhavalkumar N, Ng Suet-Leng P, Tan Siew-Har, Toh Dorothy, Poh Jalene, Lim Adena Theen, Chan Cheng-Leng, Low Min-Yong, Koh Hwee-Ling
Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore, Singapore.
Applied Sciences Group, Pharmaceutical Division, Health Sciences Authority, Singapore, Singapore.
Front Med (Lausanne). 2018 Jun 12;5:167. doi: 10.3389/fmed.2018.00167. eCollection 2018.
The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010-2016 to identify various trends and signals for pharmacovigilance purposes. A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and CHP were received by HSA between 2010 and 2016. Of these, 143,191 (97.3%) were associated with chemical drugs, 1,807 (1.2%) with vaccines, 1,324 (0.9%) with biological drugs (biologics), and 893 (0.6%) with CHP. The number of adverse event reports associated with Chinese Proprietary Medicine, other complementary medicine and health supplements are presented. Eight hundred and ninety three adverse event reports associated with CHP in the 7-year period have been successfully collated and analyzed. In agreement with other studies, adverse events related to the "skin and appendages disorders" were the most commonly reported. Most of the cases involved dermal allergies (e.g., rashes) associated with the use of glucosamine products and most of the adulterated products were associated with the illegal addition of undeclared drugs for pain relief. Dexamethasone, chlorpheniramine, and piroxicam were the most common adulterants detected. Reporting suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The findings from this study help to create greater awareness on the health risks, albeit low, when consuming CHP and dispelling the common misconception that "natural" means "safe." In particular, healthcare professionals and the general public should be aware of potential adulteration of CHP. The analysis of spontaneously reported adverse events is an important surveillance system in monitoring the safety of CHP and helps in the understanding of the risk associated with the use of such products. Greater collaboration and communication between healthcare professionals, regulators, patients, manufacturers, researchers, and the general public are important to ensure the quality and safety of CHP.
本研究的目的是整理和分析2010年至2016年期间提交给新加坡卫生科学局（HSA）的与使用补充健康产品（CHP）相关的不良事件报告，以识别各种趋势和信号，用于药物警戒目的。2010年至2016年期间，HSA共收到147,215份疑似与药品和CHP相关的不良事件报告。其中，143,191份（97.3%）与化学药物相关，1,807份（1.2%）与疫苗相关，1,324份（0.9%）与生物药物（生物制品）相关，893份（0.6%）与CHP相关。列出了与中成药、其他补充药物和健康补充剂相关的不良事件报告数量。7年期间与CHP相关的893份不良事件报告已成功整理和分析。与其他研究一致，“皮肤和附属器疾病”相关的不良事件报告最为常见。大多数病例涉及与使用氨基葡萄糖产品相关的皮肤过敏（如皮疹），大多数掺假产品与非法添加未申报的止痛药物有关。地塞米松、氯苯那敏和吡罗昔康是检测到的最常见掺假成分。即使因果关系未得到证实，也强烈鼓励报告疑似不良事件，因为任何聚集迹象都将使监管机构能够迅速采取行动。本研究结果有助于提高人们对食用CHP时健康风险的认识，尽管风险较低，并消除“天然”就意味着“安全”的普遍误解。特别是，医疗保健专业人员和公众应意识到CHP可能存在的掺假情况。对自发报告的不良事件进行分析是监测CHP安全性的重要监测系统，有助于了解使用此类产品相关的风险。医疗保健专业人员、监管机构、患者、制造商、研究人员和公众之间加强合作与沟通对于确保CHP的质量和安全至关重要。
