Monitoring the Quality of Medicines: Results from Africa, Asia, and South America

Abstract

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, antimalarial, 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.

The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa

“…213 Furthermore, substandard and counterfeit medicines continue to pose severe threats to human health in Africa. 214,215 More than 100 000 deaths in children under five in SSA were estimated to be associated with poor quality antimalarials in 2013 alone. 190 While the scope of the problem is enormous, it remains difficult to quantify with precision.…”

Perceptions and utilization of generic medicines in Guatemala: a mixed-methods study with physicians and pharmacy staff

“…In addition, the limited data available suggest that there are quality issues in the Guatemalan drug market. For example, in the international Medicines Quality Database, whose results have been published in aggregate form [30], eight of the 37 medicine samples submitted from Guatemala failed to pass a quality test [31]. A series of dissolution studies carried out by students and faculty at San Carlos University in Guatemala showed that, in multiple cases, generic versions of drugs were not bioequivalent to originator products [29].…”

Post Marketing Surveillance of Anti-malarial Medicines in Tanzania

“…Presence of substandard and/or falsified anti-malarial medicines is a major concern in countries with high prevalence of malaria as it may lead to inadequate treatment and ultimately to development of drug resistance, which pose an urgent threat to vulnerable populations [10,11]. They also jeopardize progress and investment in combating malaria.…”

“…In recent years, various studies conducted in several African and Asian countries reported the widespread circulation of substandard and falsified medicines and anti-malarial medicines identified as the most frequently falsified at a rate of 92.7% [11][12][13][14][15][16]. A survey conducted in Afghanistan in the year 2015 reported substandard quinine and Sulfadoxine/Pyrimethamine (SP) at rates of 32% (12/32) [17].…”