A simplified checklist for the visual inspection of finished pharmaceutical products: a way to empower frontline health workers in the fight against poor-quality medicines

Abstract

Background

Substandard and falsified medicines, mainly prevalent in low and middle-income countries (LMICs), cause avoidable morbidity and mortality, and put at stake the performance of health systems. They may be prevented by an adequate implementation of pharmaceutical Quality Assurance (QA) guidelines, but unfortunately, most guidelines address upstream stakeholders and specialized staff in the supply chain. A multi-layered approach is needed, in order to empower the health workers at the point-of-care to proactively contribute to the fight against poor-quality medicines.

Visual inspection is a simple technique, suitable for field screening. The findings of a survey conducted in the Democratic Republic of the Congo (DRC) suggested that it might be a fairly good (yet partial) predictor of poor-quality, when compared to full laboratory tests.

Methods and results

Starting from the 68-questions checklist originally used in the survey in the DRC, we developed a simplified checklist, specifically designed to guide health workers at the point of care to rapidly identify suspect poor-quality medicines. We selected those medicines’ attributes the assessment of which does not require technical expertise, or access to regulatory information. Attributes were categorized according to a 3-level risk scale, to guide decision-making on suspect poor-quality medicines, based on an informed risk assessment.

The simplified checklist contains 26 binary questions (YES/NO), grouped into four themes: packaging, identification, traceability, and physical appearance. Each non-conformity corresponds to a level of risk for patients. The user is guided towards three possible actions: A) reasonably safe for dispensing; B) dispense with explanation; C) quarantine and make a risk-benefit evaluation before dispensing.

Conclusion

The simplified checklist should now be implemented in real-life setting in LMICs. If proven useful in guiding health workers at the point-of-care to take rapid, transparent, patient-centred actions when facing a suspect poor-quality medicine, it could be further extended to address specific formulations. Digitalization for linkage with pharmacovigilance programs could also be considered.

Keywords:

• Medicines
• Quality assurance
• Developing countries
• Visual inspection
• Pharmacovigilance
• Primary health care
• Substandard
• Falsified
• Post-marketing surveillance
• Point of care
• Health workers

Supplementary information

Supplementary information accompanies this paper at https://doi.org/10.1186/s40545-020-00211-9.

Acknowledgements

Epco Hasker was a co-author of the quality survey conducted in the Democratic Republic of Congo. His input on the drafting of the present manuscript was invaluable and we are grateful for his support. Dina Van Geluwe of Artsen Zonder Vakantie, Mechelen, Belgium, supervised the pre-test in DRC.

Authors’ contributions

All the Authors were co-authors of the quality survey previously conducted in the Democratic Republic of Congo, and they all equally contributed to the discussion that led to the writing of this manuscript. BS wrote the draft text of the paper, with significant inputs from BDS, EW, RR and VM. RR has revised the text. All authors had re-read and approved the final manuscript.

Funding

This work was funded by the Belgian Development Cooperation (DGD) and is based on a previous work funded by the Belgian Development Cooperation (DGD), through the project CTB/CDR2 executed by the Belgian Technical Cooperation. Such support does not constitute endorsement by the funding body of the views expressed in this publication.

Availability of data and materials

The initial 68-questions checklist is provided as additional documentation.

The manuscript results from the follow-up work to a medicines quality survey conducted in the DRC: Schiavetti B, Wynendaele E, De Spiegeleer B, Mbinze GJ, Kalenda N, Marini R, et al. The Quality of Medicines Used in Children and Supplied by Private Pharmaceutical Wholesalers in Kinshasa, Democratic Republic of Congo: A Prospective Survey. Am J Trop Med Hyg. 2018;98 (3):894–903. https://doi.org/10.4269/ajtmh.17-0732

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

We declare no competing interests.

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