Skip directly to content

Counterfeit medicines

Counterfeit medicines are medicines that are described as ‘fake’ or 'falsified'. They are deliberately and fraudulently mislabelled with respect to identity and / or source.

 

Counterfeiting can apply to over the counter medicines and products and both generic and branded prescription medicines. Counterfeits may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging.1

 

Scale of the problem

It is estimated that 1% of medicines sold in industrialised nations like the UK are counterfeit, compared to 10%-30% in developing countires.2

Between 2004 and June 2016, counterfeit versions of 26 Pfizer medicines were detected in the legitimate supply chain of at least 60 countries, including the US, Canada and the UK.3

However, to put this into perspective, in the UK, over 750 million prescriptions are written each year but only a small number of counterfeit medicines have reached the supply chain since August 2004.1

 

What is the risk?

Counterfeit medicines pose a serious threat to public health and safety and may cause harm to patients or fail to treat the disease they were intended for. They have been found to commonly contain corn starch, potato starch or chalk or other toxic ingredients or toxic levels of the wrong active ingredient. Additionally they may contain impurities and / or bacteria.4

Unregulated websites are a potential source of counterfeit medicines. Consumers should therefore be cautious about ordering medicines online and be aware that some online pharmacies are unregistered.5

Look for the internet pharmacy logo when ordering online.

It can be difficult to distinguish between registered online pharmacies and other commercial websites. The General Pharmaceutical Council (GPhC) operates an internet pharmacy logo scheme to identify legitimate online pharmacies so that you can be sure you are purchasing safe and genuine medicines online.1

Each logo contains the pharmacy’s unique seven digit registration number, and when clicked takes the user to the RPSGB website to help vertify the pharmacy.1

In the UK, an online pharmacy must receive a legally valid prescription before dispensing prescription-only medicines.1

 

What’s being done?

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) puts systems in place to prevent or detect counterfeit or fake healthcare products entering the supply chain, in order to protect the public and has statutory powers to enter property to seize products.6

Pfizer has a strong working relationship with the MHRA, providing expert analysis of suspected counterfeit Pfizer medicines from our UK counterfeit medicines laboratory located in Sandwich, Kent. This facility supports not only the UK, but Europe, the Middle East and Africa. Our forensic scientists work with our global security team and with external Regulatory and Health authorities and Law enforcement agencies delivering reports that can aid prosecution.7

In February 2016, the European Parliment announced new measures to tackle counterfeit medicine, which will take effect in 2019.9 This requires new safety features on packging for medicines that are at risk of falsification. These safety features include:

  • A unique identifier to be placed on medicial products that can be scanned at fixed points along the supply chain
  • Tamper evident features on the pack

The above rules are in alignment with the MHRA and the Royal Pharmaceutical Society of Great Britain (RPSGB) who are working on measures to correctly identify medicines electronically, through serial numbers and electronic tagging of packaging and through using diagnostic machinery while medicines are still in their packaging.1

 

Who to contact if you suspect a counterfeit medicine8

 

Patients, carers and members of the public can report suspected counterfeit medicines via the Yellow Card scheme:

 

 

References

  1. https://www.fip.org/files/fip/counterfeit/national/UKCounterfeitadvice209.pdf Last accessed Sept 2017.
  2. https://www.fip.org/menu_counterfeitmedicines_policy Last accessed Sept 2017.
  3. Pfizer Global Security. Data on file 2017.
  4. http://www.who.int/mediacentre/factsheets/fs275/en/ Last accessed Sept 2017.
  5. http://www.nhs.uk/NHSEngland/AboutNHSservices/pharmacists/Pages/internet-drugs.aspx Last accessed Sept 2017.
  6. https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/ Last accessed Sept 2017.
  7. Pfizer data on file 2017
  8. ttps://www.gov.uk/drug-safety-update/yellow-card-extended-to-include-devices-counterfeits-and-defective-medicines Last accessed Sept 2017.
  9. https://www.gov.uk/government/news/new-rules-to-help-fight-falsified-medicines Last accessed Sept 2017
PP-PFE-GBR-0591 / Sept 2017