Trends in the prescribing of opioids for non-malignant pain in UK primary care: a descriptive study

Date of ISAC Approval: 
Lay Summary: 
Opioids are a group of medicines used to treat various types of pain from mild to severe. Whilst these medicines have many benefits in terms of pain relief, they are linked with side-effects including dependence and addiction. In recent years there has been an increase in the use of these medicines particularly to treat pain that is not due to cancer or terminal illness. The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a review of these medicines to ensure that the warnings of the risks are adequate and consistent across the different opioid medicines and that the risk of them occurring are minimised as much as possible. This study aims to assess patterns in opioid prescribing over the past ten years across the UK. This includes analysing the data to gain an understanding of the number of patients prescribed an opioid by a General Practitioner (GP), the number of prescriptions issued, and length of time that patients are prescribed an opioid for. This data will provide useful information to support the review being conducted by the MHRA.
Technical Summary: 
Public health concerns have been raised regarding the increasing use of opioids for the treatment of non-malignant pain despite the increased risks of tolerance, dependence and addiction. The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a review of the opioid class of medicines to ensure warnings of the risks are sufficient and consistent across the different opioid substances, focusing in the first instance on six opioids with the greatest use and/or the potential for dependence and addiction. The review will also assess whether the current regulatory risk minimisation measures are adequate in view of the increasing use and highlighted risks associated with opioid use. This descriptive study aims to assess trends in the prescribing of specific opioids in UK primary care over the last ten years, including the number of patients and number of opioid prescriptions issued. The average duration of opioid treatment will also be estimated. All patients with a record of at least one opioid prescription between the period 1st October 2008 & 30th September 2018 will be included. Prescriptions in patients with a preceding record of a malignancy in their clinical record will be excluded. This study will provide useful information to inform the MHRA's review and potential need for regulatory action and changes to regulatory risk minimisation measures.
Health Outcomes to be Measured: 
Number of patients with at least one opioid prescription during the study period; Number of prescriptions issued during the study period; Strength/Dose of prescription; Duration of opioid treatment. All outcomes will be stratified by opioid drug substance, age, gender and country.

Katherine Donegan - Chief Investigator - MHRA
Craig Allen - Collaborator - MHRA
Jenny Wong - Collaborator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
Mrs Preeti Datta-Nemdharry - Collaborator - MHRA
Stephanie Dellicour - Collaborator - MHRA