Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?

Abstract

Objective: In today's context of globalisation of pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan Africa with the standards of the WHO guideline 'Model Quality Assurance System (WHO MQAS) for procurement agencies', and we investigated factors favouring or hindering the adequate implementation of the guideline.

Methods: We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design.

Findings: Our analysis suggests that international distributors based in Europe perform, on average, better than sub-Saharan African distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality.

Conclusions: Our findings suggest that pharmaceutical distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards.

Figure 1

Supply chain of medicines for LMICs. LMICs, low-income and middle-income countries.

Figure 2

The procurement cycle in the six modules of the WHO-Model Quality Assurance System (WHO) and in the five components of the QUAMED rating system (QUAMED). QUAMED, Quality Medicines for all.

Figure 3

Sampling design. IHD, International Humanitarian Distributor; MQAS, Model Quality Assurance System.

Figure 4

Average level of compliance with the WHO-MQAS standards by type of supplier. MQAS, Model Quality Assurance System.

Figure 5

Average level of compliance with the WHO-MQAS standards by region. MQAS, Model Quality Assurance System.