E-DRUG: Fighting fake medicines: First quality evaluation of cardiac drugs in Africa
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International Journal of Cardiology
<http://www.sciencedirect.com/science/journal/01675273>
Volume 243
<http://www.sciencedirect.com/science/journal/01675273/243/supp/C>,
15 September 2017, Pages 523-528
Fighting fake medicines: First quality evaluation of cardiac drugs in Africa
Author Marie Antignaca.
<http://www.sciencedirect.com/science/article/pii/S0167527317322726#!>
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.
Keywords Drugs Counterfeit drugs Falsified drugs Drug quality Developing countries Hypertension Cardiology
e-med@healthnet.org
e-drug@healthnet.org
Carinne Bruneton <carinne.bruneton@gmail.com>