Beware counterfeit drugs, particularly online supplies

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A geographical intensification of illegal counterfeit medicines, which may be ineffective or even toxic, is now a global problem, largely because of the internet and is a real danger for patient health. Compounding the problem is the fact that the online offers are no longer just about lifestyle products, such as medicines for erectile dysfunction or weight loss, but now includes prescription medicines for treating chronic and serious diseases such as cardiovascular diseases or cancer.

In the recent 'Sanofi Fights Against Counterfeit Medicines Report', Dr Caroline Atlani, director, anti-counterfeiting coordination says, "The offerings do not contain the expected amount of active ingredient and they don't meet any of the standard requirements for quality, efficiency and safety. Therefore, patients run a number of risks: besides the presence of toxic substances, these drugs can be inactive and cause major adverse effects and complications for patients. The public is not really aware of the existence of counterfeit medicines and the risks they may incur in certain purchasing situations."

Survey indicates ignorance on counterfeiting of drugs

A newly released Sanofi commissioned European consumer opinion survey of 5010 people shows that very few of the Europeans surveyed associate the term 'counterfeiting' with medicines (20%).

• While the majority (66%) have heard of drug counterfeiting, respondents seem to have little information on the issue of counterfeit medicines
  
• 77% say they have not been adequately informed or are ignorant on the subject
  
• 84% of those surveyed say they have never seen or identified a counterfeit drug
  
• 96% believe that counterfeit drugs can be and are probably dangerous

Drug counterfeiting across the globe

In recent years, medicines were the leading counterfeit products seized by European customs, ahead of counterfeit cigarettes (Pharmaceutical Security Institute "2011 situation report"). Other statistics include:

• 1 in 10 drugs sold worldwide is counterfeit; this figure reaches 7 out of 10 in some countries (LEEM 2011)
  
• $75 billion in 2010: the profits yielded by counterfeit medicines; greater than those derived from drug trafficking (Institute of Research Against Counterfeit Medicines (IRACM)
  
• For every $1000 invested, criminals can generate $20 000 in profits from heroin trafficking and $400 000 by trafficking counterfeit medicines
  
• As of 22 May 2014, Interpol reported that nearly 200 enforcement agencies across 111 countries have collaborated on Operation Pangea VII targeting criminal networks behind the sale of fake medicines via illicit online pharmacies. To date this has resulted in the closure of more than 10 600 websites and the seizure of 9.4 million fake and illicit medicines worth a total of $36 million. (Interpol "Operation Pangea VII")

Online 'Pharmacies'

The sale of medicines on the Internet has surged in recent years. While some online pharmacies are legally established, in certain countries as much as 96% of the websites offering medicines are believed to be operating in defiance of the law.

"These sites offer prescription medicines without requiring a prescription and sell unapproved or falsified products," says Sanofi's Dr Rashem Mothilal, medical director for South Africa. "Run by illegal organisations, such structures operate as a network, hiding their true identity or misrepresenting their actual location."

According to WHO, in 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.

In industrialised countries with regulatory systems and effective market control mechanisms, the occurrence level is low. However, in many countries in Africa, Asia, Latin America and in emerging economies, where the pharmaceutical control system is less regulated, the percentage of counterfeit medicines is higher.

Importing into South Africa illegal

Some countries allow and regulate the sale of drugs online (Germany, US, Netherlands, Portugal, UK etc) but in others, legislation does not allow it. Mothilal says that in South Africa, the South African Pharmacy Council only allows it when it is associated with a retail pharmacy under the supervision of a pharmacist. "However, it is illegal for someone to import drugs into South Africa without an import licence, which is effectively what you are doing if you order them online."

"Sanofi discourages the South African public from using illegal (other than pharmacies) source of supply. Consumers need to be aware of the dangers connected with purchasing medicines online with regard to medicine quality and personal risks. Pharmacists operating as part of a secured distribution system are the only ones allowed to provide medicines to patients."

When an online pharmacy does not comply with the conditions set out by the local legislation, neither the drug quality, origin, or storage and transport conditions can be guaranteed.

Public health

Dr Atlani warns that counterfeit medicines can also lead to collective risks, especially due to the emergence of drug-resistance in the case of treatments for infectious diseases with antibiotics or antimalarial drugs.

According to the American Enterprise Institute, 100,000 people worldwide die each year because they take branded and generic counterfeit drugs. In an article in the medical journal The Lancet in mid-2012, it was noted that one third of malaria medicines used in East Asia and sub-Saharan Africa are fraudulent.

Dr Mothilal says that it takes collaboration to fight the counterfeit battle. Sanofi recently signed a partnership with Interpol, together with 29 major pharmaceutical companies, at a cost of 4.5 million euros, which covers the creation of the Interpol Pharmaceutical Crime Program, focusing on fighting counterfeit medicines and combines training with targeted enforcement actions.

Sanofi has created its own laboratory dedicated to analysing counterfeit Sanofi products in Tours, France manned by a dedicated team of experts. All Sanofi medicines suspected of being counterfeited are sent to the Central Anti-Counterfeit Laboratory (LCAC) to be analysed.

It has also created a website to inform and advise against fake medicines www.fakemedicinesrealdanger.com, which offers advice tips for travellers.