E-DRUG: QA systems of pharmaceutical distributors in LMICs: weaknesses & ways forward
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Dear E-Druggers,
Access to quality-assured medicines is an essential prerequisite for universal health coverage, and pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain. Two studies published by our group in 2017 and 2018, indicated that the quality systems of pharmaceutical distributors in low-income and middle-income countries (LMICs) are generally weak, and insufficient to prevent and detect the supply of poor-quality medicines.
In a new study, we retrospectively assessed the compliance with WHO quality standards, that is, the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP), of a convenience sample of 75 public, private-for-profit and non-for-profit distributors, audited by QUAMED in 14 LMICs between 2017 and 2019.
Unfortunately, findings from our convenience sample of distributors, mainly belonging to the private for-profit sector, indicate that only 1 out of 75 was fully compliant with the adequate standards as set by WHO. The greatest failures were observed in areas purely related to quality assurance, while slightly better results were observed for activities that are also important for commercial reasons, such as warehouse management and stock control.
Our results confirm that the quality systems of pharmaceutical distributors in LMICs remain weak. For preventing harm caused by poor-quality medicines, a comprehensive and stringent regulatory oversight should be urgently implemented; the WHO MQAS-standards and GDP-standards should be incorporated in national regulations; and reliable information on the quality systems of distributors (and manufacturers from which they buy) should be publicly available.
The manuscript is open access and it can be downloaded at https://gh.bmj.com/content/5/10/e003147
With best wishes,
Raffaella Ravinetto
Department of Public Health
Institute of Tropical Medicine, Antwerp
Raffaella Ravinetto <rravinetto@itg.be>