MHRA Drops Post-Op Pain Use for Prolonged-Release Opioids

The Medicines and Healthcare products Regulatory Agency ( MHRA) has removed postoperative pain relief from the licensed indications of prolonged-release morphine sulphate and prolonged-release oxycodone. The decision follows concerns over persistent postoperative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).

The announcement comes after a safety review by the MHRA, which analysed data from clinical guidelines, literature, and regulatory sources.

Risks of Prolonged Opioid Use 

PPOU is defined as continued opioid use beyond 90 days after surgery. Evidence from the European Union and the UK shows it affects 2%-44% of patients treated with prolonged-release opioids, and up to 60% of those who take prolonged-release opioids preoperatively.

OIVI is characterised by respiratory depression, sedation, and reduced upper airway muscle tone. International estimates suggest that its incidence ranges from 0.4% to 41% of patients. 

A separate review by theCommission on Human Medicines (CHM) concluded that the risks of using prolonged-release opioids for short-term postoperative pain exceeded the benefits. The CHM recommended the removal of their indication for postoperative pain. 

The commission also recommended adding warnings about PPOU and OIVI to the product information for all modified-release opioids and increasing availability of smaller pack sizes for all opioids to allow prescribing of limited quantities without breaking packs.

Prolonged-release opioids continue to be indicated for moderate or severe pain and cancer-related pain. However, NICE guidance advises against opioid use for chronic primary pain unexplained by an underlying condition. 

Advice to Healthcare Professionals 

In its Drug Safety Update, the MHRA advised health professionals to discuss the risks of PPOU and OIVI with patients before surgery, particularly those with underlying respiratory conditions. 

Healthcare professionals should also discuss pain management strategies with patients that involve use of immediate-release opioids and multimodal analgesia. They should also plan for opioid discontinuation and coordinate with primary care teams after discharge.

The MHRA highlighted that between 11% and 77% of prescribed opioids go unused globally. To minimise risk, clinicians should prescribe only the necessary amount of immediate-release opioids for postoperative pain, reducing excess supply and potential misuse.

The MHRA advised reviewing preoperative opioid treatment in line with Consensus Best Practice Guidelines. Any suspected opioid dependence or respiratory depression should be reported through the Yellow Card Scheme.

Annie Lennon is a medical journalist. Her writing appears on Medscape Medical News, Medical News Today, and Psych Central, among other outlets.