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Abstract
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.
- public health
- descriptive study
- health services research
- health systems
- health policy
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Handling editor Seye Abimbola
Twitter Follow Raffaella Ravinetto @RRavinetto, Follow Bruno Meessen @bmeessen
Contributors Conceived and designed the survey: KVA, RR, ANG, JMC, BS and CP. Performed some of the audits: JMC and CP. Performed the survey and analysed the data: KVA. Wrote the paper: KVA and RR. Reviewed the paper: ANG, JMC, BS, CP, AT and BM.
Funding The audits described in this paper were funded by the ECHO program of the European Commission, the Belgian Development Cooperation and membership fees by QUAMED members. A part of the research work of KVA was funded by the Belgian Development Cooperation.
Competing interests None declared.
Ethics approval The study protocol was approved by the Institutional Review Board of the Institute of Tropical Medicine, Antwerp, Belgium (IRB/AB/ac/100_ref:1102/16; IRB/AB/ac/057_ref:1167/17).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Coded data are available in the article. Motivated request to access data by country should be addressed to the corresponding author.