Suspected poor-quality medicines in Kenya
A retrospective descriptive study of medicine quality-related complaints reports in Kenya’s pharmacovigilance database
Bibliographic Data
| ID | 15375698 |
|---|---|
| Authors | Anthony Martin Toroitich (0000-0002-9069-4063, University of Nairobi, corresponding author), Rachel Armitage (0000-0002-9106-4119, University of Leicester), Sangeeta Tanna (0000-0001-5246-3603, De Montfort University) |
| Year | 2024 |
| Volume | 24 |
| Issue | 1 |
| Pages | 2561-2561 |
| Publication date | 2024-09-19 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | BMC Public Health (JOURNAL) |
| Journal identifiers | ISSN: 1471-2458 • E-ISSN: 1471-2458 |
| Publisher | BioMed Central (PUBLISHER • GB) |
| DOI | 10.1186/s12889-024-20036-4 |
| PMID | 39300437 |
| OpenAlex | W4402697947 |
| Language | EN |
| References cited | 34 |
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 non-adherence 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
Adverse effect · Alternative medicine · Biostatistics · Descriptive statistics · Environmental health · Family medicine · Pharmacovigilance · Public health · Quality (philosophy · Traditional medicine · Medicine · Nursing · Pharmaceutical Economics and Policy · Pharmaceutical Quality and Counterfeiting · Pharmacovigilance and Adverse Drug Reactions · Epidemiology · Internal Medicine · Pediatrics · Pharmacology
| Citation velocity | historical |
|---|---|
| Highly cited | No |