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

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

Author information

1
Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France. Electronic address: marie.antignac@aphp.fr.
2
Department of Cardiology, University Hospital of Fann, Dakar, Senegal.
3
Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France; Paris Cardiovascular Research Centre, INSERM U970, Paris, France; Paris Descartes University, Paris, France.
4
Department of Laboratories, Agence Générale des Equipements et Produits de Sante, AP HP, Paris, France; Faculty of Pharmacy, Paris-Sud University, UA 401 Matériaux et Santé, Chatenay-Malabry, France.
5
Department of Cardiology, National University Hospital of Brazzaville, Marien NGOUABI University, Brazzaville, Congo.
6
Department of Cardiology, Cardiology Institute of 'Abidjan, Côte d'Ivoire.
7
Department of Cardiology, University Hospital of Conakry, Guinea.
8
Unité de Soins, d'Enseignement et de Recherches en Cardiologie (USERC), National University Hospital of Cotonou, Benin.
9
Cardiology Clinics, Nouakchott, Mauritania.
10
Department of Internal Medicine and Cardiology, University Hospital of Lamorde, Niamey University, Niger.
11
Department of Cardiology, National Sanou Souro de Bobo-Dioulasso Hospital, Ouagadougou, Burkina Faso.
12
Department of Cardiology, Hospital of Lomé, Togo.
13
Department of Internal Medicine, General Hospital of Kinshasa, The Democratic Republic of the Congo.
14
Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France.
15
Paris Cardiovascular Research Centre, INSERM U970, Paris, France.
16
Department of Cardiology, European Georges Pompidou Hospital, AP-HP, Paris, France; Paris Cardiovascular Research Centre, INSERM U970, Paris, France; Paris Descartes University, Paris, France.
17
Paris Cardiovascular Research Centre, INSERM U970, Paris, France; Maxcure Hospitals, Hyderabad, India.

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:

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

PMID:
28641892
DOI:
10.1016/j.ijcard.2017.04.099
[Indexed for MEDLINE]

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