Counterfeit medicine, also known as falsified medicine, is substandard, fake medicine that deliberately appears to be a genuine, authorised product. However falsified medicines have not been properly evaluated to confirm their safety, efficacy and quality, as required by European law, and may therefore be harmful. Their use could potentially poison you, or may mean your treatment does not work. In extreme cases they can cause death. They are always illegal.
Counterfeit medicine may be contaminated, may contain incorrect ingredients, or the ingredients may be correct but in the wrong dose. Some medicines look so similar to the genuine product that even healthcare professionals may be deceived. The only definitive way to tell the difference is for the packaging and ingredients to be analysed by the original manufacturer who holds the medical licence.
Counterfeit medicines are found all over the world and are recognised by the WHO and EU institutions as a growing and serious threat as counterfeiters use ever more sophisticated means. Some people think that falsified medicines are limited to lifestyle drugs but this is not the case. Counterfeits include common prescription medicines such as Parkinson’s medications, antibiotics, and dementia drugs for example.
The role of The European Alliance for Access to Safe Medicines (EAASM)
The European Alliance for Access to Safe Medicines (EAASM) is a not for profit patient safety organisation established in 2007 that works to ensure people are aware of unsafe medical practices and counterfeit (falsified), sub-standard medicines and that national governments have put in place mechanisms to protect the population. The Alliance members include patient groups, pharmaceutical companies and other medical stakeholders involved in healthcare.
Find out more about EAASM.
Why are counterfeit medicines so widespread?
A counterfeiter may make 2,000 times more profit from selling fake medicines than he or she would by selling Class A narcotics, with far less risk of capture or prosecution. The reality is, with 50,000 dollars’ worth of raw materials, tablet pressing, blister-packing and printing equipment - all easily available online - the counterfeiter is in business. Marketing is equally straightforward, with an attractive website easily drawing in vulnerable purchasers from across the world.
As to why counterfeit medicines are so widely purchased, it seems that the main reasons people go online to buy their medications include convenience, to save time and to save money, not realising that in so doing they risk their health whilst also supporting criminal activity.
It is impossible to accurately quantify the extent of counterfeit medicines. But it has been estimated that one percent of medicines in the developed world, including the USA and Europe, may be counterfeit, whilst in developing nations it has been suggested that between 10 percent and 50 percent of medications may be counterfeit.
Why is it dangerous to buy medicines on the internet?
When buying through an online pharmacy or medicines website, it is difficult to establish the authenticity of the website or its products. The internet knows no borders or boundaries. A counterfeiter in China can register a domain name in Chile, host it in Columbia, and bank in Grand Cayman, using a Canadian address and phone number (likely to be fictitious), designed to access the lucrative American market.
The sophistication, functionality and look of these websites can often be better than genuine medication sites. In fact, although the illicit purchase of medicines via the internet EU-wide is estimated at 1 to 3 billion Euros per annum (as at 2015), only four countries allow the operation of legal online pharmacies (Estonia, Holland, Germany, Italy and the UK). These pharmacies will not sell you a prescription medicine unless you can prove that you have a prescription which will be verified by a qualified pharmacist.
A fake online pharmacy will not usually provide a live contact number or a pharmacist. Of the 30 online pharmacies that the EAASM bought products from to demonstrate the extent of the problem, not one asked for a prescription. This is a very important point. If an online pharmacy does not require a prescription for prescription drugs then they are by default operating illegally and you will potentially be endangering your health by buying from them. And remember, if the website is selling fake medicines, how might they treat your highly confidential credit card details?
Case study: “Annie” and her attempt at suicide
In early 2007 “Annie” was looking forward to ‘normal’ life. With her schizophrenia well controlled she was allowed to study at university. But then Annie began to notice subtle changes in her behaviour and that her new medication seemed not be giving the same control as before. Annie had always kept a diary to help manage her condition. Her entries gradually became more and more disturbing until finally she drove to a secluded spot and attempted to take her life. Annie was subsequently sectioned under the Mental Health Act and spent the next six months institutionalised. She is now back to managing her condition well.
In May 2007, counterfeit versions of three major medicines – for prostate cancer, heart attack and stroke, and schizophrenia – entered the UK distribution system. The fake medicine for schizophrenia was tested by the pharmaceutical company that manufactures the genuine product and was found to have only 60% of the active ingredient. It is impossible to establish if this was the cause of Annie’s attempt to take her life but much of this sub-standard medicine remain unaccounted for and could well have been taken by patients who needed their condition to be controlled at all times - and who could reasonably have trusted that the supply chain could not be breached by such criminality.
Top tips for staying safe
Simple steps may help you avoid buying counterfeit medicines.
Check the packaging
- Familiarise yourself with every aspect of the packaging, the blister-pack (if there is one) and the medicine itself.
- Each time you renew your prescription, compare the packaging against your previous pack. You are looking for even the tiniest difference in clarity of print, colour, seals, etc.
- Check that the medicine is in date and that the dosage is correct. Check that it has a patient information leaflet in the correct language.
- If you notice any differences in appearance, report them to your pharmacist and your national regulator immediately.
Check the medicine
- Check carefully that it is consistent in colour and texture with your previous prescription. Does it crumble now, or did it before? Does the colour differ from your normal medicine?
- Be aware of the medicine smelling or tasting differently.
- Consider keeping a diary of effects or side effects. If your medicine does not seem to be working as normal or if you notice new (or absent) side effects, you must report these to your doctor as soon as possible.
The chance of you receiving a counterfeit medicine is relatively small, BUT counterfeiting incidents are increasing at a rapid rate. The internet is a very risky way of buying your medicines unless you can be sure that the online pharmacy is genuine. By checking your medicines on a regular basis, you can reduce the risk of taking a counterfeit medicine.
We acknowledge the help of Mike Isles, Executive Director, EAASM in compiling this information