ABSTRACT
The import of medicines for personal use by physicians for aesthetic-related medical treatments in Japan is limited to cases such as a medical emergency and when substitutes are unavailable in the country. However, the real reasons why doctors import these products and their safety have not been investigated. Therefore, to contribute to future countermeasures, we investigated the circumstances for personal import of these medicines. We found that 60 of 177 (33.9%) physicians in the cosmetic surgery, plastic surgery, and dermatology departments had experience of importing medicines. Although only medically urgent medicines can be imported, 11.7% of physicians who imported medicines cited price differences between Japan and other countries as the reason for importing. Botulinum toxin injections (25.0%) were the most commonly imported medicines. Furthermore, 11 physicians (18.3%) responded that there was some defect in the products. This proportion was significantly higher among physicians who experienced a product efficacy or safety issue (68.8%) than among those who had never experienced it (0.0%) (P<0.001). This survey revealed that the import of aesthetic-related medicines that are not suitable for personal import is rampant. In addition, there could be an association between the defects of these products and their efficacy/safety. Therefore, to prevent health damage caused by these medicines, it is important to strengthen the regulatory system for collecting and providing information to ensure thorough confirmation (regarding specifications and package insert) at the time of delivery and use in patients and to tighten administrative checks about reasons for import.
ABSTRACT
Health service provision is one of the components in Universal Health Coverage (UHC). Medicines are vital for health services, and they should be affordable and accessible for safe and appropriate usage for everyone. This article is a report on the symposium “Medicines for UHC,” held in the academic meeting of the Japanese Association of International Health in December 2017. In Lao PDR, a study was conducted in urban and rural hospitals examining lists of available medicines, as well as their usage, distribution, and prices. The study showed that neurological medicines including anesthetics made up 29% of all medicines used in the urban central hospital, as it was one of the few hospitals that provided complex surgeries in Laos, resulting in a high concentration of patients. Anti-tuberculosis, ARV, and anti-Malaria medicines, as well as vaccines, were provided by Global Fund, GAVI, and other organizations, so that their costs were not included in the hospital’s procurement lists. While anti-microbial medicines only accounted for 13% of the medicines used at the urban central hospital, they accounted for 43% of those in rural hospitals, where most patients presented with upper respiratory and digestive infections. While the Ministry of Health sets the standards for evaluating and regulating the quality and cost of medicine, individuals can purchase medicines from private pharmacies without prescriptions, making it difficult to evaluate appropriate usage. Regarding the quality of medicines, distribution companies, health workers, and patients cannot distinguish between authentic and falsified or substandard medicines. As an example, after a study in Cambodia revealed the existence of inappropriate medicines, the Cambodian government required companies to provide results of dissolution tests. As the limitations on pharmaceutical regulatory authorities and their staff in developing countries impact their capabilities, we recommend supporting them in establishing effective pharmaceutical regulations internationally.
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.