Pharmacovigilance in Hospice/Palliative Care: De-Prescribing Combination Controlled Release Oxycodone-Naloxone

Katherine Clark, Paul G. Byrne, Jane Hunt, Linda Brown, Debra Rowett, Gareth Watts, Melanie Lovell, David C. Currow

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


Background: Pharmacovigilance studies in hospice/palliative care provide extra information to improve medication safety. Combination controlled release oxycodone-naloxone offers an alternative opioid with less risk of opioid-induced constipation. Objective: To examine why palliative care clinicians chose to cease oxycodone-naloxone and to explore immediate and short-term benefits and harms of this medication change. Design: A consecutive cohort study. Setting: 112 adults from 13 palliative care centers. Measurements: Reasons for ceasing medication and the harms and benefits that followed this 24 and 72 hours later. Symptom burdens were summarised by the National Cancer Institute Common Terminology Criteria for Adverse Events Toxicity Gradings. Results: Combination medication was most commonly ceased because of poor pain control or impaired hepatic function. The last median oral morphine equivalent oxycodone dose before the switch was 45 mg (range 7.5-240 mg) with 76 switched to an alternative long-acting opioid (initial median oral morphine equivalent dose being 45 mg [range 5-210 mg]). Subgroup analysis of those switched because of clinicians' concerns about hepatic dysfunction demonstrated this group were receiving significantly lower opioid doses pre-cessation compared to those switched because of other reasons( p = 0.007). Regardless of why the medication was changed, improvements in pain and constipation scores were seen, the latter associated with an attendant increase in laxatives. Conclusions: This preliminary work suggests that despite theoretical concerns regarding the effect of the naloxone on opioid doses, most people were switched safely to very similar opioid doses with attendant improvements in pain control.

Original languageEnglish
Pages (from-to)656-661
Number of pages6
JournalJournal of Palliative Medicine
Issue number5
Publication statusPublished - 4 May 2020
Externally publishedYes


  • opioid-induced constipation
  • opioids
  • pharmacovigilance


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