Professor leads national group of experts reviewing the benefits and risks of opioid medicines

A University of Birmingham Professor is leading a national review into the benefits and risks of opioid medicines including issues around dependency and addiction.

Opioids are a class of drugs including morphine and morphine-like drugs that are widely used as prescription pain relievers.

Jamie Coleman, Professor of Clinical Pharmacology and Medical Education at the University of Birmingham’s Institute of Clinical Sciences, has been selected as Chair of the Opioid Expert Working Group of the UK’s Commission on Human Medicines.

The group met yesterday at the Medicines and Healthcare products Regulatory Agency (MHRA) to begin its comprehensive independent scientific review of all available evidence on the use of opioid medicines in the UK.

Professor Coleman said: “In the United States there is a so-called ‘opioid crisis’ due to the increasing misuse of, and addiction to, opioids including prescription pain killers.

“There is no evidence that there is a similar opioid addiction crisis in the UK, however, the use of opioid based medicines has gradually increased in Britain over the last decade or so.

“The ultimate aim of this review is to provide clear information to healthcare professionals, patients and carers - no one should be unaware of the potential risks of opioid medicines.

“I am honoured to be part of this important piece of work and to be leading the Expert Working Group to ensure that information for patients and health professionals promotes best use whilst helping curb the over-prescription and misuse of these medicines in the UK.”

The group has now set out initial steps as to how it will conduct its review, drawing on best practice internationally.

The review will:

• consider the current data on the utilisation of opioid-containing medicines in the UK, both prescribed and over the counter.
• examine whether the risk minimisation measures implemented for over the counter and prescription opioids have been effective or whether further measures are required.
• consider the benefit risk of opioid-containing medicines in particular for non-cancer indications, taking into account alternatives.
• make recommendations for regulatory action to better support appropriate use of prescription opioids, such as relevant changes to the Summary of Product Characteristics and Patient Information Leaflets, product labelling and packaging, and any other risk minimisation measures.

The EWG is made up of experts in relevant scientific disciplines, including pain management, General Practice, nursing, pharmacy, psychiatry and substance abuse, anaesthesia, toxicology and pharmacology, geriatric medicine, paediatric medicine, rheumatology, epidemiology and a lay member.

Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines (VRMM) Division, said: “Our highest priority is making sure the medicines you and your family take are safe and effective.

“In response to the growing concern internationally and in the UK about overuse and increased prescribing of opioid analgesics, we are seeking expert advice on the benefits and risks of opioid medicines, including best practice for risk minimisation.

“We will be listening to patients, stakeholders, and relevant experts, and working across the health sector to make sure the warnings on opioid medicines are consistent, clear, relevant and represent the known risks of tolerance and addiction.

“Anyone who has questions about their pain-relieving medicine should speak to their healthcare provider who is best placed to provide advice.”

For more information or to arrange interviews with Prof Coleman please contact Emma McKinney, Communications Manager (Health Science), University of Birmingham: +44 (0)121 414 6681. Alternatively, contact MHRA news centre on 020 3080 7651 or out of hours 07770 446 189.

• The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
• Jamie Coleman is Professor of Clinical Pharmacology and Medical Education at the University of Birmingham’s Institute of Clinical Sciences.
• MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health and Social Care.