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

BMC Clinical Pharmacology

Kazuko Kimura³  Tsuyoshi Tanimoto¹  Hirohito Tsuboi³  Manabu Akazawa⁵  Nam Nivanna⁴  Heng Bun Kiet²  Tey Sovannarith⁴  Eav Dararath²  Hitomi Tabata³  Mohiuddin Hussain Khan³  Naoko Yoshida³ 

[1] Faculty of Pharmaceutical Sciences, Doshisha Women’s University, Kodo, Kyotanabe, Kyoto 610-0395, Japan;Department of Drugs and Food, Ministry of Health, 151-153, Kampuchea Krom St, Khan 7 Makara, Phnom Penh, Cambodia;Drug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa 920-1192, Japan;National Health Product Quality Control Center, Ministry of Health, 151-153, Kampuchea Krom St, Khan 7 Makara, Phnom Penh, Cambodia;Department of Public Health and Epidemiology, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan

关键词: Cambodia;    Essential medicine;    Authenticity;    Spurious/falsely labeled/falsified/counterfeit (SFFC) medicine;    Quality of medicine;   

Others  :  860372
DOI  :  10.1186/2050-6511-15-13

 received in 2013-10-01, accepted in 2014-02-27,  发布年份 2014

【 摘 要 】

Background

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 2006, the Ministry of Health of Cambodia, in collaboration with Kanazawa University, Japan, initiated a project to combat SFFC medicines.

Methods

To 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.

Results

In 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.

Conclusions

The 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.

【 授权许可】

   
2014 Yoshida et al.; licensee BioMed Central Ltd.

【 图 表 】

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