Quality assurance systems of pharmaceutical distributors in low-income and middle-income countries: weaknesses and ways forward.

INTRODUCTION: 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. METHODS: 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 low-income and middle-income countries (LMICs) between 2017 and 2019. We calculated the compliance per quality assurance activity, and we defined the percentage of compliant distributors, that is, the percentage (%) of distributors with MQAS or GDP levels of >2 for each activity. RESULTS: The distributors in our sample were mainly private for-profit (66/75). Only one MQAS-audited distributor out of 11 was found compliant with all MQAS-activities, while none out of 64 GDP-assessed distributors were found compliant with all GDP activities. The GDP-assessed distributors were generally less compliant with WHO standards than MQAS-audited distributors. Common weaknesses and strengths were observed. The activities with lowest compliance were quality control, and physical storage conditions, while those with highest compliance were warehouse organisation and stock control. CONCLUSIONS: 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.

Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries.

INTRODUCTION: The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. METHODS: This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors' compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines 'Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). RESULTS: Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. CONCLUSION: The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.

Fighting poor-quality medicines in low- and middle-income countries: the importance of advocacy and pedagogy.

The globalization of pharmaceutical production has not been accompanied by a strengthening and harmonization of the regulatory systems worldwide. Thus, the global market is characterized today by a situation of multiple standards, and patients in low- and middle-income countries are exposed to the risk of receiving poor-quality medicines. Among those who first raised the alarm on this problem, there were pioneering humanitarian groups, who were in a privileged position to witness the gap in quality of medicines between high-income countries and low- and middle-income countries. Despite an increasing awareness of the problem and the launch of some positive initiatives, the divide in pharmaceutical quality between the North and the South remains important, and insufficiently addressed. More advocacy is needed for universal access to quality-assured medicines. It should target all those who are strongly "involved" with medicines: regulators, international organizations, journalists, purchasers, prescribers, program managers, policy makers, public health actors and the patients. Advocacy should be based on evidence from research and monitoring programs, and technical concepts should be translated in lay language through communication tools that address all the stakeholders. The fight to ensure universal access to quality medicines needs the participation of all, and can only be successful if grounded in common understanding.