MHRA Drug Safety Update: Use of prolonged-release opioids in post-operative pain

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the use of prolonged-release opioids in post-operative pain.

The indication for the treatment of post-operative pain has been removed from the licences of all prolonged release opioids including prolonged-release morphine and prolonged-release oxycodone, due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). It is not recommended to use transdermal patches for the treatment of post-operative pain.

Advice for Healthcare Professionals:

• prolonged-release opioids provide relief from chronic severe pain, however, they should not be used for the treatment of acute pain following surgery
• prolonged-release opioids are associated with an increased risk of PPOU characterised as continued opioid use beyond 90 days following the operation, and an increased risk of OIVI causing serious respiratory depression, sedation, and depression of upper airway muscle tone
• before surgery, discuss with the patient the following:
  • explain the risks of PPOU, dependence and potential risk of addiction and withdrawal reactions
  • explain the risk of OIVI especially for patients with underlying respiratory conditions
  • immediate-release opioids are used for short-term treatment of pain
  • discuss with the patient pain management strategies involving the use of immediate-release opioids and multimodal analgesia and plan for end of treatment
• patients whose pain is managed with opioids pre-operatively should have their treatment reviewed before and after surgery in line with Consensus Best Practice Guidelines
• at discharge from hospital:
  • only prescribe and supply a sufficient amount of immediate-release opioids to treat acute post-operative pain to minimise the risk of PPOU, dependence, stock piling of unused opioids and potential for diversion
  • communicate the pain management plan with the primary care practice taking over care in the community and document in patient clinical notes
• it is important to report suspected dependence or respiratory depression to any medicine, including an opioid, via the Yellow Card Scheme

Advice for Healthcare Professionals to Provide to Patients:

• opioids provide relief from moderate to severe pain. Pain following an operation is usually short-lived and therefore should only require short-term treatment
• immediate release opioids are used for the treatment of short-term post-operative pain
• if you are taking prolonged release opioids before going into hospital for an operation, talk to your doctor to discuss your pain management and ongoing needs
• there is a greater risk of respiratory depression (problems breathing) and persistent post-operative opioid use with prolonged release opioids
• if you notice new or increased trouble with your breathing, dial 999 as this could be a sign of respiratory depression
• if you feel like you cannot stop taking opioids as you had originally planned, contact your doctor as this could be a sign of persistent post-operative opioid use (PPOU)
• if you are concerned for someone who has been using more opioids than prescribed, you can also seek advice from the NHS website or if you are in Northern Ireland from the Health and Social Care website

For further details, please view the full Drug Safety Update here.