SynthesisThe American journal of tropical medicine and hygiene2022
Characterizing Medicine Quality by Active Pharmaceutical Ingredient Levels: A Systematic Review and Meta-Analysis across Low- and Middle-Income Countries.
Synthesis in The American journal of tropical medicine and hygiene, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Artemisinin-Based Combination Therapies in East Africa: A Systematic Review of Quality, Clinical Efficacy, and Regulatory Progress Towards Sustainable Malaria Control.Tropical medicine & international health : TM & IH · 2026Pooled it
- Assessing disability-adjusted life years (DALY) from multiple medication use and multiple illnesses of older adults in rural Thailand.Aging clinical and experimental research · 2026Article
- Chemotherapy Medications in Sub-Saharan Africa: Availability, Pricing, Affordability, and Predictors of Quality.JCO global oncology · 2026Article
- Nearly one in five essential medicines fail quality standards in Africa: A systematic review and meta-analysis of MNCH medicines and antimalarials.PLOS global public health · 2026Article
- Medicine quality assessment in Nepal using semi randomised sampling and evaluation of a small scale dissolution test and portable Raman spectrometers.Scientific reports · 2025Article
- Article
- Modeling the economic and health impact of substandard uterotonics in Senegal.BMC pregnancy and childbirth · 2025Article
- Substandard antibiotics and their clinical outcomes among hospitalized patients in southern Malawi: a pilot study.Frontiers in pharmacology · 2025Article
- Relationship between Prices and Quality of Essential Medicines from Different Manufacturers Collected in Cameroon, the Democratic Republic of the Congo, and Nigeria.The American journal of tropical medicine and hygiene · 2024Article
- Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria.The American journal of tropical medicine and hygiene · 2024Article
- Modeling the economic burden of postpartum hemorrhage due to substandard uterotonics in Ghana.PLOS global public health · 2024Article
- 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
- Quality evaluation of selected expired fluoroquinolones medicines obtained from the public hospitals in Jimma zone, Oromia regional state, Ethiopia.Frontiers in medicine · 2024Article
- Pharmacopeial quality of artemether-lumefantrine anti-malarial agents in Uganda.Malaria journal · 2023Article
- Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study.PloS one · 2023Article
- Modeling the Health and Economic Impact of Substandard and Falsified Medicines: A Review of Existing Models and Approaches.The American journal of tropical medicine and hygiene · 2022Review
- Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.PloS one · 2022Article
- Motivating factors and strategies to prevent substandard and falsified medicines in low- and middle-income countries.The journal of medicine accessArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Substandard and falsified medicines are often reported jointly, making it difficult to recognize variations in medicine quality. This study characterized medicine quality based on active pharmaceutical ingredient (API) amounts reported among substandard and falsified essential medicines in low- and middle-income countries (LMICs). A systematic review and meta-analysis was conducted using PubMed, supplemented by results from a previous systematic review, and the Medicine Quality Scientific Literature Surveyor. Study quality was assessed using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). Random-effects models were used to estimate the prevalence of medicines with < 50% API. Among 95,520 medicine samples from 130 studies, 12.4% (95% confidence interval [CI]: 10.2-14.6%) of essential medicines tested in LMICs were considered substandard or falsified, having failed at least one type of quality analysis. We identified 99 studies that reported API content, where 1.8% (95% CI: 0.8-2.8%) of samples reported containing < 50% of stated API. Among all failed samples (N = 9,724), 25.9% (95% CI: 19.3-32.6%) reported having < 80% API. Nearly one in seven (13.8%, 95% CI: 9.0-18.6%) failed samples were likely to be falsified based on reported API amounts of < 50%, whereas the remaining six of seven samples were likely to be substandard. Furthermore, 12.5% (95% CI: 7.7-17.3%) of failed samples reported finding 0% API. Many studies did not present a breakdown of actual API amount of each tested sample. We offer suggested improved guidelines for reporting poor-quality medicines. Consistent data on substandard and falsified medicines and medicine-specific tailored interventions are needed to ensure medicine quality throughout the supply chain.
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