Quality assurance systems of pharmaceutical distributors in low-income and middle-income countries: weaknesses and ways forward (Peer reviewed)

The study investigated the quality assurance systems of pharmaceutical distributors in low-income and middle-income countries (LMICs). The research retrospectively assessed the compliance of 75 distributors with WHO quality standards, specifically the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP). These distributors were audited by QUAMED in 14 LMICs between 2017 and 2019. The results revealed that most distributors in the sample were private for-profit entities. Only one out of 11 MQAS-audited distributors was found compliant with all MQAS activities, while none of the 64 GDP-assessed distributors were fully compliant with all GDP activities. The GDP-assessed distributors generally had lower compliance with WHO standards compared to MQAS-audited distributors. The areas with the lowest compliance were quality control and physical storage conditions, while warehouse organization and stock control had the highest compliance. The study concluded that the quality systems of pharmaceutical distributors in LMICs are weak. It recommended urgent implementation of stringent regulatory oversight, incorporation of WHO MQAS and GDP standards in national regulations, and public availability of information on the quality systems of distributors.