Fighting fake medicines: First quality evaluation of cardiac drugs in Africa.
Int J Cardiol
; 243: 523-528, 2017 Sep 15.
Article
em En
| MEDLINE
| ID: mdl-28641892
ABSTRACT
BACKGROUND:
The growing menace of poor quality and falsified drugs constitutes a major hazard, compromising healthcare and patient outcomes. Efforts to assess drug standards worldwide have almost exclusively focused on anti-microbial drugs; with no study to date on cardiovascular drugs. Our study aims to assess quality of seven routinely used cardiovascular medications (anticoagulants, antihypertensives and statins) in ten Sub-Saharan African countries.METHODS:
Drugs were prospectively collected using standardized methods between 2012 and 2014 from licensed (random pharmacies) and unlicensed (street-markets) places of sale in Africa. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Three quality categories were defined based on the ratio of the measured to the expected dosage of the active ingredient A (good quality) 95% to 105%, B (low quality) 85 to 94.99% or 105.01 to 115%, C (very low quality) <85% or >115%.RESULTS:
All expected medicines (n=3468 samples) were collected in Benin, Burkina-Faso, Congo-Brazzaville, the Democratic Republic of Congo, Guinea, Côte d'Ivoire, Mauritania, Niger, Togo and Senegal. Out of the 1530 samples randomly tested, poor quality (types B and C) was identified in 249 (16.3%) samples. The prevalence of poor quality was significantly increased in certain specific drugs (amlodipine 29% and captopril 26%), in generic versions (23%) and in drugs produced in Asia (35%). The proportion of poor quality reached 50% when drugs produced in Asia were sold in street-markets.CONCLUSION:
In this first study assessing the quality of cardiovascular drugs in Africa, we found a significant proportion of poor quality drugs. This requires continued monitoring strategies.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
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Fármacos Cardiovasculares
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Medicamentos Falsificados
Tipo de estudo:
Evaluation_studies
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Observational_studies
/
Prognostic_studies
Limite:
Humans
País como assunto:
Africa
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article