Review of product information for selected antiretroviral medicines circulating in five African countries (Review)

The document is a comprehensive survey conducted by the World Health Organization (WHO). The primary aim of this survey was to assess if the product information (PI) provided by manufacturers with their antiretroviral medicines in five African nations adhered to WHO norms, standards, and conditions for WHO prequalification. The secondary objectives included gauging the awareness and utilization of WHO Public Assessment Reports (WHOPAR) by healthcare providers and evaluating the quality, presentation, and format of PI in resource-limited settings. The findings revealed that 82% of the antiretroviral product samples were not in alignment with published WHOPAR information. Only a quarter of the collected samples were accompanied by a Patient Information Leaflet (PIL), and 91% of these did not comply with WHOPAR PILs. The survey also highlighted a significant lack of awareness of both WHOPARs and the WHO Prequalification website among healthcare providers. Furthermore, none of the evaluated PILs met the Baker Able Leaflet Design (BALD) criteria for good design characteristics, indicating poor readability and quality of the PI. The document underscores the critical importance of accurate and standardized product information for ensuring patient safety and effective treatment outcomes.