Raffaella’s Literature Update
Ref. Review of product information for selected antiretroviral medicines circulating in five African countries. Geneva: World Health Organization; 2022. Licence: Licence: CC BY-NC-SA 3.0 IGO.
Dear Friends,
This is a heavy document, but it conveys some findings and messages that are important for those who work around pharmaceutical systems at different levels, from procurement and supply to regulation, to policymaking and advocacy. You may read only the Executive Summary or if you really lack time, only my informal summary herein.
Just a bit of background information: “WHO Public Assessment Reports” (WHOPARs) are publicly available reports from the WHO Medicines Prequalification Team, and they include the “product information” that should accompany any pharmaceutical products, i.e. the (technical) Summary of Product Characteristics, and the Patient Information Leaflets (the one we all find in the medicines we buy for personal use).
This survey, organized by the WHO Regulation and Safety and Prequalification Units, and carried out in 2015 in Burkina Faso, Democratic Republic of the Congo, Nigeria, Rwanda and Zambia, looked at whether the product information supplied by manufacturers to the countries met WHO norms and standards, and the conditions for WHO prequalification. The researchers also evaluated the awareness and usage of WHOPARs by healthcare providers, and if selected paediatric dispersible tablets were considered to be palatable. Product information was collected and analyzed for 107 WHO-prequalified and WHO-non-prequalified antiretroviral products.
In total, 82% of ARV product samples included in this survey were not in line with published WHOPAR information; only a quarter of ARV samples was supplied with a Patient Information Leaflet; and of these, 91% did not comply with published WHOPAR Patient Information Leaflet. Only four products were supplied with information fully compliant with published WHOPAR information. Most healthcare providers at ART centres were unfamiliar with WHOPARs and the Prequalification website. On a more positive note, acceptance levels of dispersible ARV products for paediatric patients were reported to be high, with complaints reported by only 30% of survey participants.
These findings indicate that the product information approved by the WHO Prequalification is often not used by ARV manufacturers. This may pose a direct patient health risk, e.g., if indications or dosing recommendations included with the market product differ from approved information. It is also of major concern that none of the five national regulatory authorities (NRAs) was able to provide copies of the approved product information during the survey period; and that none of the patient’s information leaflets met the criteria for good design characteristics and readability. The quality of information that accompanies a product is as critical as the product’s other attributes for ensuring the continued quality, effectiveness or safety of the product.
Manufacturers and NRAs should be made aware that compliance with WHOPAR information is directly linked to both patient safety and prequalification status, and they should improve respectively their practices and oversight. I would add that users and purchasers should not hesitate to issue a complaint to the suppliers, if they are unhappy with the quality of the product information and, particularly, of the patient information leaflet.
Warm regards,
Raffaella