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

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.

Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid - an analysis of Cambodian samples.

BACKGROUND: The use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillin-clavulanic acid preparations under tropical conditions in a developing country. METHODS: Amoxicillin-clavulanic acid tablets were obtained from outlets in Cambodia. Packaging condition, printed information, and other sources of information were examined. The samples were tested for quantity, content uniformity, and dissolution. Authenticity was verified with manufacturers and regulatory authorities. RESULTS: A total of 59 samples were collected from 48 medicine outlets. Most (93.2%) of the samples were of foreign origin. Using predetermined acceptance criteria, 12 samples (20.3%) were non-compliant. Eight (13.6%), 10 (16.9%), and 20 (33.9%) samples failed quantity, content uniformity, and dissolution tests, respectively. Samples that violated our observational acceptance criteria were significantly more likely to fail the quality tests (Fisher's exact test, p < 0.05). CONCLUSIONS: Improper packaging and storage conditions may reduce the quality of amoxicillin-clavulanic acid preparations at community pharmacies. Strict quality control measures are urgently needed to maintain the quality of amoxicillin-clavulanic acid in tropical countries.

Investigation Into the Antinfluenza Agent Oseltamivir Distributed via the Internet in Japan.

This study evaluated the quality and authenticity of the anti-influenza agent oseltamivir acquired via the Internet in Japan. The brand name drugs Tamiflu and Antiflu were obtained via the Internet using a search engine. The authenticity and legitimacy of the medicines were verified with the samples' manufacturers and the regulatory authorities of the country of origin, respectively. In addition, quantitative and dissolution tests were carried out using high-performance liquid chromatography. No counterfeits were detected among the samples. Additionally, all samples passed qualitative and quantitative tests according to the US Pharmacopeia monograph. However, different sorts of mismanagement were observed in the distribution channels. Through the Internet, oseltamivir can be purchased in quantities larger than the permissible amount in Japan. Furthermore, maintenance of medicine quality cannot be guaranteed. In addition, insufficient information and lack of quality control in some samples may cause unwanted health problems in patients.

Public health concerns for anti-obesity medicines imported for personal use through the internet: a cross-sectional study.

OBJECTIVE: To explore the circulation of anti-obesity medicines via the internet and their quality. DESIGN: Cross-sectional study. SETTING: Internet pharmacies and pharmaceutical suppliers accessible from Japan. PARTICIPANTS: Anti-obesity medicines were purchased using relevant keywords on Japanese Google search engine. Blogs and advertisement-only sites were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: The authenticity of the samples was investigated in collaboration with the manufacturers of the samples and medicine regulatory authorities. Quality of the samples was assessed by pharmacopoeial analyses using high-performance liquid chromatography. RESULTS: 82 samples were purchased from 36 internet sites. Approximately half of the sites did not mention a physical address, and 45% of the samples did not contain a package insert. A variety of custom declarations were made for the shipments of the samples: personal health items, supplement, medicines, general merchandise, tea and others. Among 82 samples, 52 samples were analysed to check their pharmacopoeial quality. Authenticity responses were received from only five of 20 manufacturing companies. According to the pharmacopoeial analyses and authenticity investigation, three of the samples were identified as counterfeits and did not contain any active ingredients. Two of these samples were confirmed as counterfeits by the manufacturer of the authentic products. The manufacturer of the other sample did not respond to our request for an authenticity check even after several communication attempts. These counterfeit cases have been reported at the rapid alert system of Western Pacific Region of the WHO. CONCLUSIONS: Many counterfeit and unapproved anti-obesity medicines may be easily bypassing regulatory checks during shipping and are widely circulated through the internet. Regulatory authorities should take measures to prevent these medicines from entering countries to safeguard their citizens.

Prevalence of counterfeit anthelminthic medicines: a cross-sectional survey in Cambodia.

OBJECTIVES: To assess the prevalence of counterfeit anthelminthic medicines in Cambodia, and to determine influential factors. METHODS: Commonly used anthelminthic medicines were collected from private drug outlets. Medicines were carefully observed including their registration labelling, and their authenticity was investigated with the manufacturers and the Medicines Regulatory Authorities. Samples were analysed by High-Performance Liquid Chromatography at the National Health Product Quality Control Centre, Cambodia. RESULTS: Two hundred and three samples of anthelminthics were collected from 137 drug stores. Domestic products constituted 36.9%. Of 196 samples which were verified for registration, 15.8% were not registered. Of 165 samples successfully investigated for their authenticity, 7 (4.2%) were identified as counterfeit. All of these medicines were purchased in open packs or containers, and most of them were foreign manufactured and/or without registration. CONCLUSION: The results of our survey urge strict implementation of drug registration and vigilance on the availability of unregistered medicines to combat counterfeit medicines in Cambodia.