ABSTRACT
Background and Objectives Falsified or substandard antimicrobials present a health hazard to patients, and may promote antimicrobials resistance. We conducted a four-year study to evaluate the quality of selected antimicrobials and to examine the prevalence of falsified or substandard antimicrobials in Cambodia, aiming to promote efforts to improve the quality of medicines in Cambodia.Methods We collected samples of clarithromycin, sulfamethoxazole/trimethoprim, ceftriaxone, cefuroxime, levofloxacin, gentamicin, ciprofloxacin, fluconazole, nalidixic acid, ofloxacin, phenoxymethyl penicillin and roxithromycin products from several different types of drug outlets in five provinces (rural areas) and Phnom Penh (an urban area), during 2011 to 2014. The authenticity of the collected medicines was investigated, and the medicines were analyzed to determine whether they met the appropriate pharmacopoeial standards.Results We collected 647 samples, produced by 179 manufacturers, from 353 outlets. Only 51 (15%) of the outlets were air-conditioned. We found different-coloured packaging of the same brand (different lots) of products from some manufacturers. The insert information of one sample was different from the package information. Twelve (1.9%) samples were not officially registered with Department of Drug and Food (DDF). In authenticity investigation, 43 of 179 manufacturers replied and confirmed the authenticity of 154 samples (out of 647); also, 18 out of 40 Medicine Regulatory Authority (MRA) replied to enquiries about whether products were licensed or not (one was not). Among the samples, 424 (80.4%), 406 (86%) and 533 (90.6%) passed in dissolution, content uniformity and quantity tests, respectively. Samples of cefuroxime and roxithromycin that failed were significantly cheaper than those that passed.Conclusion Poor-quality antimicrobials were found in Cambodian markets, though no falsified medicines were detected. Result of samples were not confirmed in authenticity, so it was possible to include falsified medicines. Manufacturers should be encouraged to improve GMP implementation. Storage conditions in the distribution chain may also need to be improved. Continuous efforts by stakeholders are needed to ensure that medicines are properly licensed.
ABSTRACT
BACKGROUND/AIMS: Functional dyspepsia (FD) is one of the commonest diseases in the field of Internal Medicine. The Japanese Society of Gastroenterology (JSGE) has been enlightening the term and concept of FD. Aim of this survey was to elucidate the understanding status of FD and Rome criteria and attitude toward FD among Japanese internists. METHODS: Data were collected at the time of lifelong education course for certified members of Japanese Society of Internal Medicine. Self-administered questionnaires were delivered to the medical doctors prior to the lectures. RESULTS: Analysis subjects were 1,623 (24-90 years old) internists among 1,660 medical doctors out of 4,264 attendees. The terms related to FD were known in 62.0-68.9% of internists, whereas 95.5% understood chronic gastritis. Internists who had been taking care of FD patients informed them as chronic gastritis (50.0%), FD in Japanese Kanji character (50.8%) and FD in Kanji and Katakana (18.6%). Logistic linear regression analysis revealed that positive factors for the understanding of FD and intensive care for FD patients were practitioner, caring many patients and certified physician by JSGE. Existence of Rome criteria was known in 39.9% of internists, and 31.8% out of them put it to practical use. The certified physician by JSGE was a positive factor for awareness, but not for utilization. CONCLUSIONS: The results suggest the needs of enlightening the medical term FD in Japan and revision of Rome criteria for routine clinical practice. Precise recognition of FD may enhance efficient patient-based clinical practice.