The document “ Access to Quality Medicines in Low- and Middle-Income Countries. An informal selection of scientific literature“ is produced by Raffaella Ravinetto of the Institute of Tropical Medicine in Antwerp. Even if it is a non-exhaustive, non-systematic review, it is quite user-friendly, and it can be used to inform and raise awareness about the extent and risks of substandard and falsified medicines in health systems. It includes definitions, notions, regulatory and policy documents, and thematic sections with articles on specific pharmaceutical products including vaccines”.
Having appropriate quality systems throughout pharmaceutical supply chains is very important to protect individuals and communities from substandard and falsified medical products. Thus, pharmaceutical distributors are regularly assessed by qualified experts. But because of the COVID-19 pandemic, remote assessments via video conferencing replaced on-site audits. Through this document, you will find out about our evaluation on the feasibility of remote assessments of pharmaceutical distributors, within LMICs that are hard to reach during the COVID-19 pandemic.
To read more click here.
After the research studies done by QUAMED groups in 2017 and 2018, they both indicated that the quality systems of pharmaceutical distributors in low-income and middle-income are generally weak, and insufficient to prevent and detect the supply of poor-quality medicines. Different measures can be taken to prevent and detect the supply of poor-quality medicines including adopting stringent regulatory oversight on pharmaceutical distributors at a country level across all sectors, carrying out regular monitoring exercises, and investigating the relationships between potential oligopolies along the pharmaceutical supply chain and the commitment to quality assurance. Read more about the study here.
Less and less attention is given to the ‘Quality Assurance (QA) of medicines’ as compared to the ‘availability of medicines’ especially in Low and Middle-Income Countries (LMICs) while a significant part of public funding used by the implementers of programs of the European national cooperations, the Ministries of Foreign Affairs and the European Commission(EC) are allocated to the purchase of medicines for humanitarian and development medical programs in/for LMICs. The findings in the survey done could highlight opportunities for further harmonization, joint positioning and leadership in this field at the European level. Read more.
Christophe Perrin, Sandrine Cloëz
22 April 2020
This survey aims to obtain the perspectives of some small and medium-sized organizations on the World Health Organization (WHO) prequalification programme for medicines and ascertain organizations’ unmet needs. The qualitative study was conducted on 17 representatives of 15 small and medium-sized Belgian and non-Belgian organizations who purchase medicines for humanitarian, development, or public programmes in low- and middle-income countries. The gathered findings include concerns about the irregular availability of WHO-prequalified medicines in the marketplace and high prices, and more.
Ariadna Nebot Giralt, Maya Ronse & Raffaella Ravinetto
Published online: 07 April 2020.
Different audits by QUAMED group were conducted at 60 local private pharmaceutical distributors in 13 LMICs. The supply system of low-income and middle-income countries (LMICs) are exposed to the risk of poor-quality medicines due to the rapid globalization of pharmaceutical production and distribution that don’t harmonize with regulatory systems worldwide. The new findings suggest that the quality systems of private pharmaceutical distributors in LMICs appear to be poorly compliant with adequate quality standards, as defined by WHO. Read more here on how to prevent the distribution of poor-quality medicines.
A research study was done by QUAMED to evaluate the compliance of sample pharmaceutical distributors active in sub-Saharan Africa as compared to the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies. It has been seen that poor quality medicines are more prevalent in low-income and middle-income countries where national regulatory authorities lack sufficient resources for effective regulatory supervision. The analysis has suggested that international distributors based in Europe perform better, on average than sub-Saharan distributors due to different factors. Read more here.
Counterfeit drugs and sub-standards: a death threat, exceptional in industrialized countries, common in developing countries”, written by Jacques PINEL.
Adherence of pharmaceutical distributors to WHO quality assurance standards – Analysis of a sample of public sector distributors and development aid in sub-Saharan Africa and Europe. Thesis Ariadna Nebot Giralt
Report of the meeting of the working group on the new harmonized MQAS tool (co-organized by WHO and the Global Fund) – August 2011
Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations – June 2014 – Technical Report Series 986
Clarification with Respect to a Stringent Regulatory Organization as Applicable to the Stringent Regulatory Authority (SRA) Guideline