Survey on Web Contents Available for Education about Falsified Medicines / 医薬品情報学

Objective: Crimes related to falsified medicines for medical use are of international concern and becoming increasingly sophisticated. Therefore, in this study, we investigated information on education and training/enlightenment activities on falsified medicines worldwide that are open to the public on the Internet to contribute to medical/pharmaceutical professionals’ and consumers’ education regarding falsified medicines in Japan.Methods: In April 2023, we searched the information written in English and Japanese on education and training/enlightenment activities on falsified medicines using the Internet.Results: We surveyed several countries and obtained important findings. In particular, the World Medical Association (WMA), the International Pharmaceutical Federation (FIP), and the World Health Professions Alliance (WHPA) released programs for healthcare professionals. The US news programs, the US Department of Justice, and the Council of Europe released consumer warning videos. Japan issued the “Guidelines for Good Distribution Practice (GDP)” to the pharmaceutical distribution industry in 2018. Additionally, US and UK medicine regulators and the International Criminal Police Organization (ICPO) offered programs for professionals such as police and customs officers, and public prosecutors.Conclusion: These programs contain useful information not only for medical/pharmaceutical professionals in Japan but also for consumers. However, many are provided by foreign governments or international organizations, while few are from Japan. Therefore, to prevent the distribution of falsified medicine in Japan, educational institutions must further strengthen education and training/enlightenment activities and develop and publish educational tools for falsified medicines.

Poor-quality medicines: a global threat to health / Lao Medical Journal

@#Poor quality medicines have been described as a global pandemic that threatens the lives of millions of people. The problem is much more severe in poor-resource countries where pharmaceutical legislation and regulation are limited. Poor quality medicines are divided into three categories: substandard, degraded and falsified and the countermeasures vary according to each category. The use of poor quality medicine leads from minimal to severe complications (including death) for the individuals but also harms the community. Furthermore, they lead to a loss of confidence of the patients in essential medicines, in manufacturers and in health system and they increase the work burden for health workers, customs and police. To detect them, different techniques have been developed, each with advantages and limits. This article describes these aspects of poor quality medicines and also presents the factors that contribute to the existence and spread of poor quality medicines. A section of the article is devoted to the issue of poor quality medicine in Laos.

Four-year survey of the quality of antimicrobial medicines in Cambodia / 国際保健医療

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.