Overview
ABSTRACT
Counterfeit medicines are a threat to public health, and the assessment of their quality is paramount. Besides the issues of intellectual property theft and economic loss, counterfeit products are potentially dangerous for patients' health. In order to carry through police or juridical investigations, the analysis of suspected products is a major issue. This article first gives an overview of the analysis context of these products. Currently used analytical techniques are then presented, illustrated with different examples. Finally, a global approach is proposed for the efficient analysis of counterfeit products.
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Read the articleAUTHORS
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Pauline GUINOT: Doctor of Pharmaceutical and Biological Sciences - Laboratory Scientist, Agence nationale de sécurité du médicament et des produits de santé, ANSM, France
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Hervé REBIÈRE: Laboratory Scientist, Agence nationale de sécurité du médicament et des produits de santé, ANSM, France
INTRODUCTION
Drug falsification is a crime, because it can endanger patients' lives. Beyond the problems of intellectual property misappropriation and economic losses, the fight against drug falsification is a major public health issue. With the globalization of trade and the development of online commerce, this phenomenon is on the increase. The products affected by falsification are comfort drugs (erectile dysfunction, weight loss, etc.), as well as life-saving drugs (anti-cancer drugs, vaccines, antibiotics, anti-malarial drugs, etc.).
The fight against the falsification of medicines involves both police investigations and legal proceedings, based in particular on chemical analysis of the incriminated sample. Faced with the increasing number and sophistication of falsified products, analytical laboratories need a strategy that draws on a wide range of analytical techniques. The methods available to laboratories range from simple observation of the sample and its packaging, through spectrometric and chromatographic techniques, to more sophisticated imaging techniques. The choice and combination of these methods must provide answers to the following questions: is the product adulterated, and is it dangerous to the patient's health?
After presenting the problem, this article describes the main techniques available to laboratories for the analysis of chemical drugs. A methodology is proposed, taking into account the speed of analysis, the cost of the equipment, the destruction of the sample and the possibility of carrying out analyses outside the laboratory.
A table of acronyms is given at the end of the article.
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KEYWORDS
falsification | counterfeit | analytical techniques | medicines
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Drugs and pharmaceuticals
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Analytical techniques to combat drug falsification
Bibliography
- (1) - - http://www.who.int/mediacentre/factsheets/ fs275/en/ (page consultée le 7 septembre 2016).
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Websites
Agence nationale de sécurité du médicament et des produits de santé (ANSM) http://ansm.sante.fr/Activites/Falsifications-de-produits-de-sante/ La-lutte-contre-la-contrefacon/(offset)/7 (page consulted on September 7, 2016)
Council...
Standards and norms
- Impurities : Guideline for Residual Solvents - ICH Q3C(R5) - 2011
Regulations
Law no. 83-634 of July 13, 1983 on the rights and obligations of civil servants. Law known as the Le Pors Law (consolidated version of March 3, 2002).
Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards the prevention of the entry into the legal supply chain of...
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