The indication for post-operative pain management has been removed

The indication for the management of post-operative pain has been removed from the licenses of all prolonged release opioids, Because of the elevated risk of opioid-induced ventilatory impairment (OIVI) and persistent post-operative opioid use (PPOU).

Prolonged-release (modified release) opioids are appropriate for moderate to severe pain and cancer pain, although NICE guidance [NG193] advises against using opioids for chronic primary pain when there is no underlying cause. A small number of prolonged release opioids comprising morphine or oxycodone were also approved for the treatment of post-operative pain, although there were concerns about the potential for injury and an increased risk of PPOU and OIVI.

PPOU is defined as continued opioid use beyond 90 days from the day of operation. Dependence is a well-known side effect of opioids and we continue to communicate to raise awareness on this issue (see Drug Safety Update on opioids: risk of dependence and addiction). Evidence from across the EU including the UK has shown that the incidence of PPOU ranges from 2% - 44% in patients treated with prolonged-release opioids. Also PPOU is more prevalent (incidence up to 60%) in patients taking prolonged-release opioids pre-operatively.

Respiratory depression is also a well-known side effect of opioids, especially if taken in excess or in combination with other sedating medicines (for example benzodiazepines, pregabalin or gabapentin) which can lead to coma and potentially death. OIVI is a serious form of respiratory depression associated with:

• depression of respiratory rate and/or depth of breathing – ‘central respiratory depression’
• depression of consciousness – ‘sedation’
• depression of supraglottic airway muscle tone – ‘upper airway obstruction’

The reported incidence of OIVI is difficult to determine, although the international multidisciplinary consensus statement quotes an incidence of OIVI ranging from 0.4% to 41% depending on the identification measures used.

Following the completion of a safety review by the MHRA and recommendations from the Commission on Human Medicines (CHM), the indication for the management of post-operative pain will be removed from prolonged release morphine and prolonged release oxycodone licences. The remaining opioids with longer release are not suggested for acute post-operative pain treatment, and they may already be inefficient or contraindicated for acute pain relief. A Public Assessment Report  presents the material reviewed by the CHM as well as the guidance offered.

Pain after surgery is usually short-lived, lasting 5 - 7 days, and so only requires short-term pain management, which is best addressed with immediate release opioids. However, many patients are discharged from hospitals with excessive opioid doses to meet their acute post-operative pain management requirements. This excess supply of opioids raises the risk of developing PPOU, dependence, addiction, opioid diversion, and OIVI with uncontrolled use. As a result, patients should only be given a prescription for enough instant release opioids to manage their acute post-operative pain upon discharge from the hospital.

Learn more: Prolonged-release opioids: Removal of indication for relief of post-operative pain - GOV.UK