Publications

Published: June 2005

Counterfeit Medicines - Don't Fake Concern

Prescriber Update 26(1): 15–16
June 2005

Medsafe Pharmacovigilance Team

Counterfeit medicines are a growing problem in many countries and are increasingly being supplied over the internet.  As well as being deliberately fraudulent, there is the potential for harm with counterfeit medicines especially if treatment failure occurs.  Health professionals and consumers should be vigilant for any unexpected effects or changes in medicines and report these to the appropriate authority.

A problem in both developed and undeveloped countries

Counterfeit medicines are becoming increasingly available worldwide.  The number of investigations conducted by the Food and Drug Administration (FDA) in the USA has risen to more than 20 per year since 2000.1  In 2004, there were 58 new cases investigated by the FDA.2  Counterfeit prescription medicines found in the USA include Lipitor® (atorvastatin) and a brand of epoetin alpha (Procrit®),1 as well as Viagra® (sildenafil) and Zyprexa® (olanzapine).3  In the UK, a counterfeit version of Cialis® (tadalafil) was discovered in 2004, following a consumer complaint of crumbling of the tablets.4  Counterfeit Reductil® (sibutramine) was also found in the UK last year, resulting in a patient-level recall of the counterfeit batch.5

A counterfeit medicine is one that is deliberately and fraudulently mislabelled with respect to identity and/or source.  Counterfeiting can occur with both branded and generic medicines.  Counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.6  It is estimated that 5-7% of the global pharmaceutical market is counterfeit.  In some Asian and African countries, this figure is closer to 40-50%.4

Awareness and vigilance are needed

While there have been no reported cases of counterfeit medicines entering the legitimate distribution chain in New Zealand, there are anecdotal reports of counterfeits appearing amongst medicines being imported for personal use by consumers.  This, along with the discovery of counterfeit prescription medicines in the UK and USA, illustrates that there is the potential for these products to come into this country.

It is worth noting there have been a number of herbal products and traditional Chinese medicines imported into New Zealand that have subsequently been found to contain undeclared prescription medicines such as corticosteroids and NSAIDs.7  Prescribers should be alert to this possibility when patients present with unusual or unexpected adverse (or even therapeutic) effects.

The presence of authenticity indicators, such as holograms and tamper-evident seals, on products is not always a reliable gauge as counterfeiters can replicate these.  Detection often relies on awareness and vigilance by encouraging consumers to report any unusual features of their medicine.  The following should be brought to the attention of the dispensing pharmacist or the pharmaceutical company who distributes/sponsors the medicine in New Zealand:3

If health professionals notice any of the above, please notify the pharmaceutical company in the first instance and Medsafe secondly.

Patients should also be advised to inform prescribers of any unusual reactions, side effects or change in efficacy of the medicine.  Similarly, prescribers should consider the possibility of a counterfeit medicine if the patient responds differently or unexpectedly, or if treatment failure occurs.3

Pharmacists requiring assurance about the authenticity of stock supplied to them should ask their wholesalers to confirm that they purchase directly from genuine manufacturers.8  Limiting the number of times a product changes hands between the pharmaceutical manufacturer and the end user helps to reduce the opportunities for counterfeit products to enter the supply chain.3

Beware of purchasing medicines on the internet

In some overseas cases, counterfeit medicines have been supplied over the internet.3  Use of the internet as a medium for selling counterfeit medicines is growing; it offers a global gateway (7 days a week, 24 hours a day) and it is easy to establish a convincing web site.  If closed down, another site can be quickly created.  Additionally, it can be difficult to identify and apprehend the people behind the web site.9

In New Zealand, it is illegal for consumers to be in possession of a prescription medicine unless it has been prescribed for them by a New Zealand-registered prescriber.  Prescribers should take into account the medico-legal and ethical implications of providing consumers with a prescription for medicines ordered on the internet.  Prescribers need to consider whether they are prepared to facilitate patient access to a medicine that has been delivered via an uncontrolled route of distribution (i.e. the internet) and whether they are able to reassure themselves that the product is of an appropriate safety, quality and efficacy, or that it actually contains the active ingredients required to treat the patient.  It would additionally be prudent for prescribers to satisfy themselves that the medicine is appropriate for the patient's medical condition; also that the quantity of supply and dose are reasonable.  Prescribers should also consider their legal liabilities and duty of care to patients if there are harmful or other consequences arising from the use of a medicine obtained over the internet for which the prescriber provided a prescription.  Prescribers who have queries about this should contact their medical indemnity organisation for advice.  There are also guidelines provided by the New Zealand Medical Council (see www.mcnz.org.nz/portals/1/Guidance/Internet%20guidelines-revised2001.pdf).

As the risk of being supplied with a counterfeit is greater when medicines are obtained through the internet than from a New Zealand pharmacy, it would be reasonable to warn consumers against purchasing their medicines from internet sites based offshore.  The Pharmaceutical Society of New Zealand (Inc) operates an accreditation programme to officially recognise New Zealand pharmacy sites that meet the prescribed professional standards for operating on the internet (see http://psnz.www0-w2k3.net24.net.nz/public/home/internet_accreditation/Intro.aspx).

References
  1. Food and Drug Administration, United States of America. Protecting consumers from counterfeit drugs. FDA Consumer 2004 (May-June);38(3):12.
  2. Food and Drug Administration. Combating counterfeit drugs: A report of the Food and Drug Administration annual update (18 May 2005). www.fda.gov/oc/initiatives/counterfeit/update2005.html
  3. Rudolf PM, Bernstein IB. Counterfeit drugs. N Engl J Med 2004;350(14):1384-1386.
  4. Gibson L. Drug regulators study global treaty to tackle counterfeit drugs. BMJ 2004;328(7438):486.
  5. Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Drug Alert - Patient level recall for counterfeit Reductil capsules (2 September 2004). http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/defmedsrepcen/reductil%5F2904.pdf
  6. World Health Organisation. Substandard and counterfeit medicines - fact sheet no. 275 November 2003. www.who.int/mediacentre/factsheets/fs275/en/
  7. Medsafe. Warnings about various herbal products and traditional Chinese medicines. www.medsafe.govt.nz/safety/archive.asp
  8. Food and Drug Administration. Consumer education: Counterfeit medicine (10 September 2004). www.fda.gov/cder/consumerinfo/counterfeit_text.htm
  9. Lowe P. Combating counterfeit medicines - an International Chamber of Commerce Counterfeiting Intelligence Bureau Perspective (United Kingdom). Presentation at the pre-ICDRA Satellite Workshop on Counterfeit Medicines 13-14 February 2004 held in Madrid, Spain.