Counterfeit Medicines

ICN Position:

The International Council of Nurses (ICN) is very concerned with the growing problem of counterfeit medicines and the negative consequences on the prevention and treatment of disease, which can include poor treatment outcomes, or failure of treatment, loss of confidence in health care, resistance to antibiotics and poisoning due to harmful ingredients.

ICN supports international initiatives to combat counterfeiting and urges nurses and NNAs to collaborate with pharmacy associations, pharmacists, physicians and others to disseminate accurate information on detection and elimination of counterfeit medicines. More specifically ICN supports actions that aim to:

• Strengthen quality assurance and medicines regulatory authorities.

• Detect and expose sources of counterfeit medicines.

• Improve supply of medicines to health facilities.

• Educate nurses in detection and prevention of counterfeit medicines.

• Monitor for any failure of treatment that could be a sign of counterfeit medicine.

• Educate and create awareness among the public of counterfeit medicines.

Background

According to the United States Food and Drug Administration (FDA), counterfeit medicines make up more than 10% of the global medicines available in the market and are available in both developed and developing countries. Though there is no accurate data, the World Health Organization has announced that up to 25% of medicines consumed in developing nations, often to treat life-threatening conditions, are believed to be counterfeit or substandard.^[1] All medicines and even vaccines can be counterfeited with serious consequences to patients and the health care system.  

Patients and consumers are the primary victims of counterfeit medicines. In order to protect them from the harmful effects of counterfeit medicines it is necessary to provide them with appropriate information and education on the consequences of counterfeit medicines. As frontline health care providers, nurses are key players in increased vigilance for counterfeit medicines and increased reporting of possible counterfeit drugs.

Counterfeit medicines, as deliberate and fraudulent products with questionable efficacy, represent a serious challenge to the treatment or prevention of disease. According to the World Health Organization’s definition^[2] a counterfeit medicine is one, which is deliberately and fraudulently mislabeled with respect to identity and/or source.

Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

Counterfeit products may contain too much, too little or no active ingredient, the wrong ingredients or high levels of impurities, contaminants and even toxic substances. They could be reject or out-of-date formulations withdrawn from the market which are obtained by counterfeiters, relabeled as bona fide product and introduced back into circulation. Counterfeit medicines have killed and injured thousands of people around the world.

Adopted in 2004