Abstract
BackgroundAccess to good-quality medicines in many countries is largely hindered by the rampant circulation of spurious/falsely labeled/falsified/counterfeit (SFFC) and substandard medicines. In 2006, the Ministry of Health of Cambodia, in collaboration with Kanazawa University, Japan, initiated a project to combat SFFC medicines.MethodsTo assess the quality of medicines and prevalence of SFFC medicines among selected products, a cross-sectional survey was carried out in Cambodia. Cefixime, omeprazole, co-trimoxazole, clarithromycin, and sildenafil were selected as candidate medicines. These medicines were purchased from private community drug outlets in the capital, Phnom Penh, and Svay Rieng and Kandal provinces through a stratified random sampling scheme in July 2010.ResultsIn total, 325 medicine samples were collected from 111 drug outlets. Non-licensed outlets were more commonly encountered in rural than in urban areas (p < 0.01). Of all the samples, 93.5% were registered and 80% were foreign products. Samples without registration numbers were found more frequently among foreign-manufactured products than in domestic ones (p < 0.01). According to pharmacopeial analytical results, 14.5%, 4.6%, and 24.6% of the samples were unacceptable in quantity, content uniformity, and dissolution test, respectively. All the ultimately unacceptable samples in the content uniformity tests were of foreign origin. Following authenticity investigations conducted with the respective manufacturers and medicine regulatory authorities, an unregistered product of cefixime collected from a pharmacy was confirmed as an SFFC medicine. However, the sample was acceptable in quantity, content uniformity, and dissolution test.ConclusionsThe results of this survey indicate that medicine counterfeiting is not limited to essential medicines in Cambodia: newer-generation medicines are also targeted. Concerted efforts by both domestic and foreign manufacturers, wholesalers, retailers, and regulatory authorities should help improve the quality of medicines.
Highlights
Access to good-quality medicines in many countries is largely hindered by the rampant circulation of spurious/falsely labeled/falsified/counterfeit (SFFC) and substandard medicines
In 1999, two people died through taking fake anti-diabetic medicines containing illegal quantities of glibenclamide in China; in 2008, four people died in Singapore after taking an Spurious/falsely labeled/falsified/counterfeit (SFFC) phosphodiesterase type 5 inhibitor containing glibenclamide [8,9]
In our previous study in Cambodia in 2006–09, we identified 19 SFFC products among life-saving essential medicines [15,16]
Summary
Access to good-quality medicines in many countries is largely hindered by the rampant circulation of spurious/falsely labeled/falsified/counterfeit (SFFC) and substandard medicines. Spurious/falsely labeled/falsified/counterfeit (SFFC) medicines are deliberately and fraudulently mislabeled with respect to identity or source [1,2]. Precise, detailed data on SFFC medicines are difficult to obtain, estimates range from less than 1% of sales in developed countries to over 10% in developing. In addition to SFFC products, substandard and degraded medicines are classified as poor-quality medicines [10]. Degraded products may result from exposure of good-quality medicines to light, heat, and humidity; it can be difficult to distinguish degraded medicines from those that left the factory as substandard [12].
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