Fighting fake medicines: First quality evaluation of cardiac drugs in Africa

Int J Cardiol. 2017 Sep 15;243:523-528. doi: 10.1016/j.ijcard.2017.04.099. Epub 2017 Jun 20.


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: Cardiology; Counterfeit drugs; Developing countries; Drug quality; Drugs; Falsified drugs; Hypertension.

Publication types

  • Evaluation Study

MeSH terms

  • Africa / epidemiology
  • Africa South of the Sahara / epidemiology
  • Cardiovascular Agents / analysis*
  • Cardiovascular Agents / standards*
  • Chromatography, Liquid / methods
  • Chromatography, Reverse-Phase / methods
  • Counterfeit Drugs / analysis*
  • Humans
  • Pharmacies / standards
  • Pilot Projects
  • Prospective Studies
  • Quality Control*
  • Tandem Mass Spectrometry / methods


  • Cardiovascular Agents
  • Counterfeit Drugs