The quality of medicines of the private pharmaceutical distributors in Sub-Saharan Africa. A secondary quantitative data analysis from a sample of private distributors

Introduction: Access to quality-assured medicines is crucial for access to health. The quality of medicines manufactured, imported and distributed in a given country should be ensured by the National Regulatory Authority. Unfortunately, in Sub-Saharan Africa they lack sufficient human and financial resources to fulfil this mandate in a stringent manner (World Health Organization 2008). Poor-quality medicines, as well as poor medicines management, is a result of insufficient regulatory supervision, and they may harm patients, communities, and health systems (Caudron et al. 2008; Yadav, Tata & Babaley 2011).It falls within the mandate of the WHO to provide guidance on good pharmaceutical practices. Among other guidance instruments, in 2007 the WHO adopted the Model Quality Assurance System (MQAS) for Procurement Agencies (Annex III of the WHO Expert Committee on Specifications for Pharmaceutical Preparations 2014), that sets quality standards for pharmaceutical procurement agencies, wholesalers and distributors. The MQAS has been adopted as a reference tool for assessing the quality of pharmaceutical distributors by (among others) QUAMED, a North-South network that aims at improving access to quality medicines in low and middle income countries, by raising awareness among the key players involved in the pharmaceutical supply system and by reinforcing the quality assurance systems and supply procedures of partner organizations. Among its activities, QUAMED conducts audits of pharmaceutical distributors according to the standards of the WHO MQAS. A study based on the findings of QUAMED audits recently showed a low compliance with WHO MQAS for a sample of national African procurement agencies and international procurement agencies that supply medicine in LMICs (Nebot Giralt et al. 2016). Low MQAS compliance indicates a risk that poor quality medicines may be supplied.Problem statementIn Sub-Saharan Africa, the supply and distribution of medicines are managed by a variety of public, private and nongovernmental actors (Yadav, Tata & Babaley 2011). This region is characterized by insufficient regulatory supervision (World Health Organization 2008), thus it may be expected that quality standards are poor. To our knowledge, no evaluation has been carried out so far of the compliance with appropriate quality standards in the private sector7in Sub-Saharan Africa. Therefore, in the current study we assessed the MQAS compliance of a sample of local, private pharmaceutical distributors in Sub-Saharan Africa.MethodologyThis descriptive study is a quantitative analysis of secondary data derived from the results of QUAMED audits. First, we developed an ad hoc 'rating system for small distributors', to translate the qualitative source information into quantitative information. The newly developed rating system includes 5 Quality Assurance criteria regrouping 12 MQAS activities: Selection of Sources, Good Distribution Practices, General Quality Requirements, Quality Control and Cold Chain Management. For each criterion, the MQAS compliance was calculated as the average of the scores of its activities. Second, we performed descriptive statistics to describe the MQAS compliance for the different criteria. We looked at the central tendency, the dispersion and the distribution of the data.FindingsThe study includes a convenient sample of 30 local, private distributors from 8 different Sub-Saharan African countries. Overall the level of compliance with WHO MQAS standards was poor: for the criteria Good Distribution Practices, General Quality Requirements, and Cold Chain Management it was low, and for Selection of Sources and Quality Control it was very low. A separate comparison of the MQAS compliance of distributors located in Ethiopia vs DR Congo seems to indicate that the compliance has improved (yet still in the ‘low’ range) for distributors operating in a less weak regulatory environment.ConclusionThe increasing globalization of pharmaceutical production, coupled with the lack of resources of National Regulatory Authorities in Sub-Saharan Africa, makes it difficult to assess quality medicines. Our results are based on a small, convenient sample, and they were obtained using a newly developed ‘rating system’ that should be further refined. Yet, they suggest that local, private distributors in Sub-Saharan Africa may have poor to very poor compliance with WHO quality standards. This indicates a concrete risk that patients are exposed to poor quality medicines, and highlights the need to provide adequate guidance for setting up and assessing the quality systems of pharmaceutical distributors in the private sector. It also confirms the urgent need to invest in strengthening the capacity of National Regulatory Authorities in Sub-Saharan Africa.