Ref: Toroitich et al. Suspected poor‑quality medicines in Kenya: a retrospective descriptive study of medicine quality‑related complaints reports in Kenya’s pharmacovigilance database. BMC Public Health (2024) 24:2561
Dear Friends,
This interesting paper from Kenya provides a nice model on how the routine data available by national regulatory authorities – in this specific case, the Pharmacovigilance database- can be used to map and analyze the presence on substandard and falsified (SF) medical products on the market. Perhaps, this is also an useful reminder that while research data are very useful to describe the problem of SF medical products and its cause, and to propose corrective measures, data from research are by definition limited (and to some extent, their scope maty depend on funders’ priorities). Therefore, joining forces between academia and regulators, like here, remains a very important way to get a comprehensive understanding of this significant threat to public health.
Have a nice reading (for those who lack time, the abstract is copy-pasted below),
Raffaella
Poor-quality, substandard and falsified, medicines pose a significant public health threat, particularly in low-middle-income countries. A retrospective study was performed on Kenya*’s Pharmacovigilance Electronic Reporting System (2014–*2021) to characterize medicine quality-related complaints and identify associations using disproportionality analysis.
A total of 2767 individual case safety reports were identified, categorized into medicines with quality defects (52.1%), suspected therapeutic failure (41.6%), and suspected adverse drug reactions (6.3%). Predominantly reported were antineoplastic agents (28.6%), antivirals (11.7%), and antibacterial agents (10.8%) potentially linked to nonadherence to good manufacturing practices, inappropriate usage and supply chain degradation. Notably, analgesics (8.2%), and medical devices (3.5%) notified had quality defects, predominantly from government health facilities (60.0%). Antineoplastic agents (20.2%) and antivirals (3.7%) were frequently reported from suspected therapeutic failures and suspected adverse drug reactions, respectively, across both private for-profit facilities (26.5%) and not-for-profit facilities (5.4%). Underreporting occurred in unlicensed health facilities (8.1%), due to unawareness and reporting challenges.
Pharmacists (46.1%), and pharmaceutical technicians (11.7%) predominantly reported quality defects, while medical doctors (28.0%) reported suspected therapeutic failures. Orally administered generic medicines (76.9%) were commonly reported, with tablets (5.8%) identified as potential sources of suspected adverse drug reactions, while quality defects were notified from oral solutions, suspensions, and syrups (7.0%) and medical devices (3.9%). The COVID-19 pandemic correlated with reduced reporting possibly due to prioritization of health surveillance.
This study provides valuable evidence to supporting the use of medicine quality-related complaints for proactive, targeted regulatory control of high-risk medicines on the market. This approach can be strengthened by employing standardized terminology to prioritize monitoring of commonly reported suspected poor-quality medicines for risk-based sampling and testing within the supply chain.
(attachments)
2024 BMC PH Suspected poor-quality medicines in Kenya from PV database.pdf (1.86 MB)