Pharmaceutical News 2.0

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. 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 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.

Read more here.

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Thirty thousand packs of counterfeit life-saving drugs may have been consumed by National Health Service (NHS) patients, including drugs used to treat prostate cancer, strokes, heart conditions and schizophrenia.

When: June 2007

Where: The United Kingdom

How: According to reports by the BBC, reputable UK wholesalers were “duped by sophisticated counterfeits.”

Who: MHRA; National Health Service; Orient Pacific International; Pfizer

Additional details

In June 2007, the Medicines Health products Regulatory Agency (MHRA) issued four Class One emergency recalls on the following life saving medicines:

• Casodex – used to treat prostate cancer
• Plavix – used to treat strokes and heart conditions
• Zyprexa – used to treat schizophrenia

A UK wholesaler spotted discrepancies in the packaging of drugs bought in Europe. A former investigator told the BBC that drugs from other parts of Europe can be purchased at lower prices, and that the UK can import the drugs from the EU under an arrangement known as a parallel trade—after which point the drugs are repackaged with English language packaging. The investigator said that the three drugs “would have pretended to be medicines that were destined for other European markets, in the case of Plavix, they would be in a French language pack.”

The counterfeit packaging wasn’t found until the imports were already in the supply chain, distributed to chemists, doctors and hospitals, and dispensed to patients, according to the BBC.

The head of enforcement at the MHRA said they had seized 40,000 of the estimated 70,000 packs of counterfeit drugs, but issued the recall because 30,000 packs were unaccounted for. The 30,000 missing packs are assumed to have been consumed by patients. It is unknown which patients consumed the counterfeit drugs, and thus it is unknown how many patients were made ill or died as a result of ingesting the counterfeits.

While there is no way to determine which patients received which drugs, the same batch numbers from the drugs were traced to the man at the center of an international fake drugs ring, Kevin Xu, a citizen of the People’s Republic of China and owner of Orient Pacific International.

In August 2007, Xu was indicted for distributing counterfeit and misbranded pharmaceuticals in the United States via the internet, at which time he also faced allegations for introducing counterfeit drugs into the UK supply chain. Xu was convicted and sentenced to six and a half years in prison in January 2009.

Read more about how thousands of fake pills for very serious conditions made it into the UK supply.

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One in 10 UK men interviewed recently admitted to purchasing prescription-only medicines from unregulated sources, without a prescription. What they probably don’t know is that it’s estimated that between 50 and 90 per cent of medicines sold in this way have proven to be counterfeit which means they are taking a real gamble with their health.

The World Health Organisation (WHO) estimates that 10% of all medicines available around the world are counterfeit.

And counterfeiters do not only target medicines for weight loss, smoking cessation and erectile dysfunction (ED) but also pain, heart and mental health conditions.

The cinema commercial on this site portrays a man pulling a dead rat from his mouth after taking a counterfeit pill. This site allows you to view the commercial, learn more about the dangers of counterfeit drugs and share this information with friends and colleagues.

Watch a video about the danger of counterfeit medicines.

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