Medina Edwin, Bel Elvira, Suñé Josep María
Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.
BMJ Open. 2016 Apr 4;6(4):e010387. doi: 10.1136/bmjopen-2015-010387.
To consolidate and assess information on counterfeit medicines subject to pharmaceutical alerts issued by the Peruvian Medicines Regulatory Authority over 18 years (1997-2014) of health monitoring and enforcement.
A retrospective review of drug alerts.
A search of the website of the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Ministry of Health of Peru for drug alerts issued between 1997 and 2014.
Drug alerts related to counterfeit medicines.
A total of 669 DIGEMID alerts were issued during the study period, 354 (52.91%) of which cover 1738 cases of counterfeit medicines (many alerts deal with several cases at a time). 1010 cases (58.11%) involved pharmaceutical establishments and 349 (20.08%) involved non-pharmaceutical commercial outlets. In 126 cases (7.25%), counterfeit medicines were seized in an unauthorised trade (without any marketing authorisation); in 253 cases (14.56%) the type of establishment or business associated with the seized product was not identified.
Counterfeit medicines are a serious public health problem in Peru. A review of the data cannot determine whether counterfeit medicines in Peru increased during the study period, or if monitoring by different government health agencies highlighted the magnitude of the problem by providing more evidence. The problem is clearly structural, since the majority of cases (58.11% of the total) were detected in legitimate supply chains. Most counterfeit medicines involve staple pharmaceutical products and common dosage forms. Considerable work remains to be done to control the serious problem of counterfeit medicines in Peru.
巩固和评估秘鲁药品监管机构在18年（1997 - 2014年）健康监测与执法期间发布的药品警示中有关假药的信息。
对药品警示进行回顾性审查。
检索秘鲁卫生部药品、供应和药品总局（DIGEMID）网站，查找1997年至2014年期间发布的药品警示。
与假药相关的药品警示。
研究期间共发布了669条DIGEMID警示，其中354条（52.91%）涵盖1738例假药案例（许多警示一次涉及多个案例）。1010例（58.11%）涉及药品经营企业，349例（20.08%）涉及非药品商业网点。126例（7.25%）中，假药在未经授权的交易中被查获（无任何上市许可）；253例（14.56%）中，与被查获产品相关的经营企业或业务类型未明确。
假药在秘鲁是一个严重的公共卫生问题。对数据的审查无法确定在研究期间秘鲁的假药是否增加，或者不同政府卫生机构的监测是否通过提供更多证据凸显了该问题的严重程度。该问题显然是结构性的，因为大多数案例（占总数的58.11%）是在合法供应链中被发现的。大多数假药涉及基本药品和常见剂型。在秘鲁，控制假药这一严重问题仍有大量工作要做。
