Making Sense of Drug Safety Science

Investigating the science of side effects.
Side effects (known as adverse drug reactions) are both a big public health concern and a major barrier to the development of new medicines.

Published: 13 November 2013
All our guides are date stamped and reflect the scientific findings and knowledge available at the time of publication.

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Show me a drug with no side effects and I’ll show you a drug with no benefits. When you take a medicine you’re entering into a bargain. The prescriber, to the best of their knowledge, gives you a medicine that will do you more good than harm, but you have to accept the risk that it may do you more harm than good. For some medicines, we understand the risks and can mitigate them, but for others the knowledge is just not there yet.

Dr Martyn Lobley

GP and medical journalist

Did you Know?

For every 100,000 chemicals researched, only four are eventually licensed for prescription.

Background

Most medical research aims to discover more about health and to find new ways to treat or prevent diseases. Within this, the science of how to make drugs safer has received relatively little research funding and attention. This is despite the fact that side effects (known as adverse drug reactions) are both a big public health concern and a major barrier to the development of new medicines. In the coming pages we look at some patients’ frustrations about side effects, discussing why they happen and what could be done about them.

Partners

This guide was produced in collaboration with the MRC-funded Centre for Drug Safety Science. The centre is a joint venture between the Universities of Liverpool and Manchester to bring together a critical mass of knowledge and technologies in order to advance our understanding of adverse drug reactions.

What is the problem this guide is addressing?

Drug safety became a focus of public interest in the 1960s when thalidomide – a drug prescribed for morning sickness – was found to cause birth defects. In 2006 drug safety again came to wider attention following a clinical trial that tested an antibody drug from the company TeGenero Immuno Therapeutics. This resulted in six volunteers being hospitalised from near-fatal side effects. It led to calls for greater support for drug safety science.

Side effects are also responsible for many promising drugs being dropped at the development stage or in clinical trials. And once a drug is licensed and being prescribed in the general population, if severe side effects appear and regulators decide that the harms outweigh the benefits, it is withdrawn.

However, researchers could develop more tests to predict who will experience side effects, which would allow a beneficial drug to continue and be used by people who are not at risk. More generally, new funding of drug safety science is opening up our understanding about what gives rise to side effects.

Impact

Making Sense of Drug Safety was launched in Liverpool at an event with patients, nurses and drug safety scientists. NICE sent the guide out with their prescribing alerts and it was shared across social media.

“We know that serious drug side effects are having an impact on which medicines we can use and how. We need to understand more about side effects and who will be at risk to use a wider number of existing drugs safely, develop new drugs more effectively, and allocate healthcare funds more efficiently. I welcome this guide to help demystify why side effects happen for the public, policy makers and clinical professionals.” — Dr Keith Ridge, the Chief Pharmaceutical Officer for the Department of Health