Press release

Opioid Expert Working Group meets at MHRA

An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) met yesterday at the Medicines and Healthcare products Regulatory Agency (MHRA) to begin the review of the benefits and risks of opioid medicines, including dependence and addiction.

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The EWG will undertake a comprehensive independent scientific review of all available evidence on the use of opioid medicines in the UK, drawing on best practice internationally, to make sure the information for patients and health professionals helps curb the over-prescription and misuse of these medicines.

In light of growing concerns about overuse and misuse, 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 Leaflet, 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
  • a lay member

The review is anticipated to work promptly in line with the regulatory process.

To support this, we will be engaging with relevant stakeholders from across the health sector, charities and addiction support groups, to advise on how we can improve communications on the use of opioids. We will work together with these stakeholders to raise awareness among both healthcare professionals and the public on the risks of addiction and how these can be managed.

Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines 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.

Professor Jamie Coleman, Chair of the Opioid Expert Working Group, said:

In taking forward this important work we will focus on providing clear information to healthcare professionals, patients and carers - no one should be unaware of the potential risks of opioid medicines.

We have set out a clear programme of work to look at regulatory options. We have already planned some initial steps to work with stakeholders to produce consistent and clear label wording that opioid medicines may lead to addiction. We are also going to examine access to opioid medicines.

If you suspect you have experienced a side effect to a medicine, please report this to us through our Yellow Card Scheme.

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Published 13 February 2019