Falsified medicines

For April Fakes Day 2024, Professor Paul Newton tells us more about falsified medicines.

When we are ill, we trust that the medicines that we take will make us feel and be better. But what if our pills do not contain the ingredients they state on the packaging?

Falsified or fake medicines are those that have been made by criminals, to deceive patients and health workers that they are the real thing, to make money by fraud. They may contain no, too little, too much or wrong medicine.

Falsified medicines are different from substandard medicines: these are medications of poor quality, due to mistakes in manufacture or distribution, for example through becoming too hot or too cold during storage and transport.

The World Health Organization estimated that 1 in 10 medicines are substandard or falsified in low-and middle income countries..

While the UK has a well-functioning medicine regulation mechanism, this is an important but neglected public health problem, threatening people all over the world, especially in lower income countries.

  • Falsified and substandard medications increase the risk that patients will not recover or recover more slowly.
  • For anti-infectives (such as antibiotics), falsified and substandard medications  might contribute to an increase in antimicrobial resistance worldwide.
  • For patients, health care systems, governments and the pharmaceutical industry, they risk economic and reputational harms.

Medicine regulatory authorities

In the United Kingdom, falsified medicines are very rare. One of the reasons is that the country has a well-functioning medicine regulatory authority, responsible for reducing the risk of falsified medicines being used by patients. Sadly, many countries do not have fully functional medicine regulatory authorities.

Do you know the name of the authority in the UK?

It is the Medicines & Healthcare products Regulatory Agency (MHRA). ? 2D bar code

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Amongst other functions the MHRA reviews and regulates all medical devices and medications used in the UK, and when necessary, brings prosecutions against manufactures of falsified or substandard medical products.

What to look out for?

Globally, the quality of the majority of medical products, including medicines and vaccines, is good: these reports should not put you off taking medicines.

However, there are hotspots of problems that vary in time and space.

Things to look out for include medicines being less expensive than expected (though this is not always true of falsified medications), and/or the packaging including spelling mistakes. Falsified/substandard medications may not work as you expect or may have unexpected side effects.

If you have concerns please discuss with your pharmacist for advice.

Research in Oxford

Globally, there are not many research groups working on this public health problem. In Oxfordshire there are groups collaborating on research to innovate to inform policy to reduce the prevalence and impact of poor quality medicines

Fakes, fabrications and falsehoods in global health in Oxford Population Health, University of Oxford

Medicine Quality Research Group in Nuffield Department of Medicine, University of Oxford

Department of Sociology, University of Oxford

Department of Biochemistry, University of Oxford

Department of Chemistry, University of Oxford

STFC Rutherford Appleton Laboratory, Harwell, Oxfordshire

Packets of pills against blue background