ReviewJournal of pharmaceutical policy and practice2024
Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review.
Review in Journal of pharmaceutical policy and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed.
- Governing AI for Pharmacovigilance in Low-Income Countries: Systems Perspective.Journal of medical Internet research · 2026Article
- Landscape Analysis of Existing Policies, Laws and Regulations on Antimicrobial Stewardship in 10 Low- and Middle-Income Countries.Antibiotics (Basel, Switzerland) · 2026Article
- In vitro comparative quality evaluation of different brands of metformin hydrochloride tablets available in Mekelle City, Tigray Regional State, Ethiopia.BMC pharmacology & toxicology · 2026Article
- Chemotherapy Medications in Sub-Saharan Africa: Availability, Pricing, Affordability, and Predictors of Quality.JCO global oncology · 2026Article
- Visual assessment of antimicrobial medicine packaging and labeling quality in pharmacies of Ho Municipality, Ghana.PloS one · 2026Article
- Pharmaceutical quality and cost-effectiveness of branded versus generic medicines across 22 drug types and 8 therapeutic categories: a citizen-funded comparative study from regulated retail outlets in Kerala, India.Frontiers in pharmacology · 2026Article
- Quality of different brands of clarithromycin tablets marketed in Ethiopia; implications for the future.JAC-antimicrobial resistance · 2025Article
- Healthcare workers´ perspectives on antibiotic utilization in children under five years of age in the Eastern Democratic Republic of the Congo.Antimicrobial resistance and infection control · 2025Article
- Assessing the quality of antimalarial drugs in Equatorial Guinea: a follow-up study.BMJ global health · 2025Article
- Substandard and falsified medicines in Africa: healthcare systems challenges, supply chain issues, regulatory challenges and strategies to increase access to quality medicines.Frontiers in pharmacology · 2025Review
- Substandard antibiotics and their clinical outcomes among hospitalized patients in southern Malawi: a pilot study.Frontiers in pharmacology · 2025Article
- Is price associated with the quality of medicines? Evidence from active pharmaceutical ingredient testing in Nigeria.PloS one · 2025Article
- Perceptions and practices on substandard and falsified medicines in humans and animals in Wakiso district, Uganda: A qualitative study.PloS one · 2025Article
- A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines.Frontiers in medicine · 2024Review
- Drivers and strategies to combat substandard and falsified medicines in low- and middle-income countries: A systematic review of qualitative evidence.The journal of medicine accessReview
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Substandard, falsified, unlicensed, and unregistered medicines pose significant risks to public health in developed and developing countries. This systematic review provides an overview of the prevalence of substandard, falsified, unlicensed, and unregistered medicine and its associated factors in Africa. Methods: Articles published from April 2014 to March 2024 were searched in Google Scholar, Science Direct, PubMed, MEDLINE, and Embase. The search strategy focused on open-access articles published in peer-reviewed scientific journals and studies exclusively conducted in African countries. The quality of the studies was assessed according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Results: Of the 27 studies, 26 had good methodological quality after a quality assessment. Of the 7508 medicine samples, 1639 failed at least one quality test and were confirmed to be substandard/falsified medicines. The overall estimated prevalence of substandard/falsified medicines in Africa was 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312). Antibiotics, antimalarial, and antihypertensive medicines accounted for 44.6% (712/1596), 15.6% (530/3530), 16.3% (249/1530), and 16.3% (249/1530), respectively. Approximately 60.7% (91/150) were antihelmintic and antiprotozoal medicines. Poor market regulatory permission, Free trade zones, poor registration, high demand, and poor importation standards contribute to the prevalence of these problems. Conclusion/Recommendations: Substandard, falsified, and unregistered medicines are highly prevalent in Africa, and attention has not been paid to the problem. Antibiotics, antimalarial, anthelmintic, and antiprotozoal are the most commonly reported substandard, falsified, and unregistered medicines. A consistent supply of high-quality products, enhancement of registration, market regulatory permission, and importation standards are essential to counter the problems in Africa. Preventing these problems is the primary duty of every responsible nation to save lives.
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Registered trials
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