A cross-sectional investigation of the quality of selected medicines in Cambodia in 2010

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.

An Investigation into the Quality of Medicines in Yangon, Myanmar

“…In the case of OM, at least 33.8% of samples failed the DS in the acid phase and/or buffer phase. This is similar to the high failure ratio in DS of OM samples collected in the Cambodian pharmaceutical market [ 4 , 22 ]. The cause of this high DS failure ratio of OM in Myanmar should be investigated.…”

“…We have been attempting to clarify distribution channels of such poor-quality medicines, and to check the spread of such medicines. Although the World Health Organization (WHO) reported that the proportion of substandard or counterfeit drugs supplied in developed countries was approximately 1% [ 3 ], the risks appear to be increasing according to the development of the Internet and the progress of globalization [ 4 ]. WHO also reported that the proportion of such poor-quality drugs supplied in developing countries was about 10% [ 3 ].…”

Invisible medicine sellers and their use of antibiotics: a qualitative study in Cambodia

“…Another limitation of this study is the potential desirability effect: community members and HCPs may have answered in a way that they believed made their views more favourable to researchers or other participants. It is likely that IMS are found more frequently in rural areas,50 and our results may underestimate the presence of and reliance on IMS. Future studies in rural Cambodia may provide an insightful comparison with our results.…”

Classification and Visualization of Physical and Chemical Properties of Falsified Medicines with Handheld Raman Spectroscopy and X-Ray Computed Tomography

“…In 2015, 128 countries were impacted by pharmaceutical crime, including sale of substandard and falsified medicines (SFs), and the number of incidents in the Asia Pacific Region exceeded 1,000 for the first time. [1][2][3][4][5][6][7][8][9] The World Health Organization and the European Commission have warned about the danger posed to public health by SFs, and pointed out the need for measures to detect and prevent distribution of SFs. [10][11][12] The term of falsified medicines means any medicinal product with a false representation of 1) its identity, including packaging, labeling, name, or composition, as regard any of the ingredients including excipients and the strength of those ingredients; 2) its source, including manufacturer, country of manufacture, country of origin, or marketing authorization holder; or 3) its history, including records and documents relating to the distribution channels used.…”