title: A cross-sectional investigation of the quality of selected medicines in Cambodia in 2010.
abstract: 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.
authors.affiliation: Drug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa 920-1192, Japan. naoko@p.kanazawa-u.ac.jp.
authors.forename: Naoko
authors.initials: N
authors.lastname: Yoshida
authors.forename: Mohiuddin Hussain
authors.initials: MH
authors.lastname: Khan
authors.forename: Hitomi
authors.initials: H
authors.lastname: Tabata
authors.forename: Eav
authors.initials: E
authors.lastname: Dararath
authors.forename: Tey
authors.initials: T
authors.lastname: Sovannarith
authors.forename: Heng Bun
authors.initials: HB
authors.lastname: Kiet
authors.forename: Nam
authors.initials: N
authors.lastname: Nivanna
authors.forename: Manabu
authors.initials: M
authors.lastname: Akazawa
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tsuboi
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Tanimoto
authors.forename: Kazuko
authors.initials: K
authors.lastname: Kimura
mesh_terms: D002160:Cambodia; D020682:Cefixime / Q000032:analysis*; D017291:Clarithromycin / Q000032:analysis*; D058110:Counterfeit Drugs; D004348:Drug Labeling; D018954:Drugs, Essential / Q000032:analysis; D005607:Fraud; D009853:Omeprazole / Q000032:analysis*; D010879:Piperazines / Q000032:analysis*; D062486:Public Health Surveillance; D011687:Purines / Q000032:analysis; D011786:Quality Control; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000032:analysis*; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000032:analysis*
chemical_list: D058110:Counterfeit Drugs; D018954:Drugs, Essential; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D020682:Cefixime; D000068677:Sildenafil Citrate; D017291:Clarithromycin; D009853:Omeprazole