Counterfeit medicines in Peru: a retrospective review (1997–2014)

OBJECTIVE 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. DESIGN A retrospective review of drug alerts. SETTING 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. ELIGIBILITY CRITERIA Drug alerts related to counterfeit medicines. RESULTS 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. CONCLUSIONS 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.