Monitoring the Quality of Medicines: Results from Africa, Asia, and South America
| Autor: | Mustapha Hajjou, Elaine Yuan, Patrick H. Lukulay, Regina Okafor, Christi Lane-Barlow, Tuan-Anh Vuong, Victor S. Pribluda, Lawrence Evans, Latifa El-Hadri, Kennedy M. Chibwe, Lang Siv, Kwasi Poku Boateng, Laura Krech, Lukas Roth, Souly Phanouvong, Christopher Raymond |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Asia
Time Factors Databases Factual media_common.quotation_subject Antitubercular Agents Antimalarials Field screening Virology Environmental health Screening method Quality monitoring Medicine Quality (business) media_common Traditional medicine business.industry Field Studies and Innovations South America Anti-Bacterial Agents Counterfeit Infectious Diseases Pharmaceutical Preparations Counterfeit Drugs Minilab Africa Parasitology business Quality assurance |
| Zdroj: | The American Journal of Tropical Medicine and Hygiene |
| ISSN: | 1476-1645 0002-9637 2003-2013 |
| DOI: | 10.4269/ajtmh.14-0535 |
| Popis: | Monitoring the quality of medicines plays a crucial role in an integrated medicines quality assurance system. In a publicly available medicines quality database (MQDB), the U.S. Pharmacopeial Convention (USP) reports results of data collected from medicines quality monitoring (MQM) activities spanning the period of 2003-2013 in 17 countries of Africa, Asia, and South America. The MQDB contains information on 15,063 samples collected and tested using Minilab ® screening methods and/or pharmacopeial methods. Approximately 71% of the samples reported came from Asia, 23% from Africa, and 6% from South America. The samples collected and tested include mainly antibiotic, anti- malarial, and antituberculosis medicines. A total of 848 samples, representing 5.6% of total samples, failed the quality test. The failure proportion per region was 11.5%, 10.4%, and 2.9% for South America, Africa, and Asia, respectively. Eighty-one counterfeit medicines were reported, 86.4% of which were found in Asia and 13.6% in Africa. Additional analysis of the data shows the distribution of poor-quality medicines per region and by therapeutic indication as well as possible trends of counterfeit medicines. testing, and reporting. The testing involves field screening tests, verification tests to confirm results obtained in the field by repeating a screening test on failed and doubtful samples, and a pharmacopeial or validated method to confirm the results of the verification test. This methodology is referred to as the three-level approach for monitoring the quality of medicines available in the market. 12 In this paper, data currently available in MQDB, plus new data not yet publicly available, were analyzed with a focus on global and regional data, and the distribution of therapeu- tic classes, their failure proportions, the presence of counter- feit medicines, and possible trends were explored. Three out of the 17 total countries examined for this paper do not pub- licly release their results in the database; however, their data were included in the global and regional analyses. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|