Data from: Substandard and falsified medicines in the UK: A retrospective review of drug alerts (2001–2011)

Objective: To determine the extent of substandard and falsified medicines in the UK. Design: A retrospective review of drug alerts and company-led recalls. Setting: The Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011. Eligibility criteria: Drug alerts related to quality defect in medicinal products. Main outcome measure: Relevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert. Results: There were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11 year period. The number of defective medicines reported by the MHRA increased tenfold from five in 2001 to 50 in 2011. Conclusions: Substandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicines.研究目标：明确英国境内不合规药品与假冒药品的波及范围。研究设计：对药品预警公告及企业主动召回事件开展回顾性分析。研究场景：检索2001至2011年间发布于英国药品和医疗产品监管署（Medicines and Healthcare Products Regulatory Agency, MHRA）官网的药品预警公告。纳入标准：涉及药品质量缺陷的药品预警公告。主要结局指标：药品预警与企业主动召回中报告的缺陷药品相关数据，包括缺陷描述、制剂类型、预警发布年份及预警类别。研究结果：本次共纳入280种不合规药品，其中222种已被召回。最常见的两类问题为污染事件（74起）与包装相关问题（98起）。胃肠外给药制剂（117起事件）为受影响最频繁的制剂类型。在11年的研究周期内，共报告11起符合英国药品和医疗产品监管署定义的假冒药品事件。英国药品和医疗产品监管署报告的缺陷药品数量增长10倍，从2001年的5起增至2011年的50起。研究结论：不合规药品在英国是一项重大问题。目前尚无法确定报告数量的增长是源于检测能力提升，还是不合规药品实际数量的增加。