Revista Panamericana de Salud Pública
On-line version ISSN 1680-5348
Print version ISSN 1020-4989
EXEBIO, Luis E. Moreno; RODRIGUEZ, Javier and SAYRITUPAC, Freddy. Counterfeit pharmaceuticals in Peru. Rev Panam Salud Publica [online]. 2010, vol.27, n.2, pp.138-143. ISSN 1680-5348. http://dx.doi.org/10.1590/S1020-49892010000200008.
OBJECTIVE: To determine the quantity of counterfeit pharmaceutical drugs found by the National Quality Control Center (Centro Nacional de Control de Calidad (CNCC), Instituto Nacional de Salud, Peru) during the period from 2005&2008, and the types and properties of these drugs. METHODS: A form was created to amass the relevant data collected directly from CNCC reports. The reports underwent a review and analysis process, and where counterfeiting was confirmed, it was categorized by type into one of four groups. RESULTS: The percentage of counterfeit drugs relative to the total drugs evaluated was: 3.0% in 2005, 5.0% in 2006, 7.3% in 2007, and 9.2% in 2008. The main groups of counterfeit drugs, classified according to the World Health Organization Anatomical Therapeutic Chemical Classification System, were: alimentary tract and metabolism, 34.5% (29.1%&39.8%); antiinfectives for systemic use, 21.1% (16.5%&25.7%); nervous system, 17.1% (12.8%&21.3%); and musculo-skeletal system, 15.4% (11.3%&19.5%). The most common type of forgery occurred in cases where the drug contained the correct amount of active ingredients, but the manufacturer was one other than the one indicated (62.4% of the total counterfeit drugs); and medications that did not contain any active ingredient (22.4%). Of the counterfeit drugs, 61.0% (56.0%&67.0%) were national brands and 39.0%, (33.0%&44.0%) were imported. The pharmaceutical formulations with the highest rate of forgery were tablets, 66.0% (60.0%&71.0%); injectables, 19.0% (14.0%&23.0%); and capsules 7.0% (4.0%&10.0%). CONCLUSIONS: From 2005&2008, drug counterfeiting had an average annual variation of 45%. Drug counterfeiting was shown to be most prevalent among national brands& as opposed to imported medications&although the types and formulations of the fake drugs attest to a certain level of sophistication employed in the forgery process. The counterfeiting of life-saving drugs, such as antimicrobials, signifies a serious public health threat.
Keywords : Drug quality; health surveillance of products; quality control; pharmaceutical preparations; Peru.