Hydromorphone prolonged-release tablets (Jurnista) for chronic severe disabling pain

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The risk of toxicity is high | Provide patients and carers with clear instructions on how to take hydromorphone prolonged-release tablets | Avoid concomitant use with other CNS depressants, including alcohol | Intentional misuse may cause serious toxicity | References

Hydromorphone prolonged-release (Jurnista), a once-daily long-acting opioid, was listed on the Pharmaceutical Benefits Scheme (PBS) on 1 May 2009. It is available as a restricted benefit for chronic severe disabling cancer or non-cancer pain not responding to non-opioid analgesics. Other oral formulations of hydromorphone available on the PBS are immediate-release tablets and oral liquid (both with the brand name Dilaudid).

A maximum quantity of 10 hydromorphone prolonged-release tablets can be supplied under the PBS, with an authority required for supply of increased maximum quantities and/or repeats.

The Pharmaceutical Benefits Advisory Committee recommended listing on the basis of cost minimisation compared with oxycodone controlled-release tablets (that is, no less effective and at a similar price).1

Hydromorphone prolonged-release tablets are an option for chronic severe pain not responding to non-opioid analgesics. In the absence of adequate, published head-to-head trials there is no evidence that hydromorphone is more effective than equivalent doses of other modified-release opioids with established clinical experience.

The risk of toxicity is high

Hydromorphone is a strong opioid that is approximately 5 times more potent than morphine.2 The once-daily tablets are available in 8 mg, 16 mg, 32 mg and 64 mg strengths. The 32 mg and 64 mg tablets equate to about 160 mg and 320 mg oral morphine respectively and so would be suitable only for patients who are highly opioid tolerant. Prescribers are reminded of the risks of toxicity with inappropriate use or accidental overdose.

Opioid-naïve patients should start treatment with an immediate-release preparation, titrating upwards until an adequate level of analgesia is achieved, before converting to the appropriate total daily dose of hydromorphone prolonged-release tablets.3

If switching to hydromorphone from another opioid, switch to between one-third and one-half of the equianalgesic total daily dose of hydromorphone prolonged-release tablets to allow for incomplete cross-tolerance.3,4

Provide patients and carers with clear instructions on how to take hydromorphone prolonged-release tablets

Advise patients and carers that hydromorphone prolonged-release tablets2:
  • should only be taken once daily, at or around the same time each day
  • must be swallowed whole; do not crush or chew hydromorphone prolonged-release tablets, as this can cause absorption of a large dose over a short time
  • may cause adverse effects, including constipation, nausea, vomiting, sedation, somnolence, dizziness, headache, sweating, mood swings, dry mouth and pruritus
  • can increase the risk of adverse effects, including sedation and potentially fatal respiratory depression if taken incorrectly or more often than prescribed
  • have a non-dissolvable outer coating that may be visible in the patient's stool.

Avoid concomitant use with other CNS depressants, including alcohol

As with any slow-release opioid, concomitant use of hydromorphone prolonged-release tablets with other central nervous system depressants (e.g. other opioids, sedatives or alcohol) can increase the risk of adverse effects, including sedation, hypotension, respiratory depression and coma.2,3

Intentional misuse may cause serious toxicity

Hydromorphone is a potential drug of abuse. The excipients in hydromorphone prolonged-release tablets may cause fatal complications when crushed and injected. In animals intravenous administration caused anaemia, damage to myocardial and renal tubular cells and death.2

Ensure a genuine medical need for hydromorphone. If in doubt, consider seeking management advice from a drug and alcohol specialist advisory service.5 Referring the patient to a drug and alcohol service is usually appropriate.

Be aware of common drug-seeking behaviours related to hydromorphone prolonged-release tablets, such as requests for injectable opioids or opioids in more than one form (injectable and oral), or being asked for hydromorphone by name.5

If you suspect that a patient is obtaining multiple PBS prescriptions for hydromorphone ('doctor-shopping') consider contacting Medicare Australia's Prescription Shopping Information Service for more information.3,6

References

  1. Australian Government Department of Health and Ageing. Positive Recommendations made by the PBAC – November 2008. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-nov08-positive (accessed 6 April 2009).
  2. JANSSEN-CILAG Pty Ltd. Jurnista prolonged-release tablets product information. 23 July 2008.
  3. Analgesic Expert Group. Therapeutic Guidelines: Analgesic. Version 4. Melbourne: Therapeutic Guidelines Ltd, 2007.
  4. Rossi S, ed. Australian Medicines Handbook 2009. Adelaide: Australian Medicines Handbook Pty Ltd, 2009.
  5. NSW Therapeutic Assessment Group Inc. Prescribing guidelines for primary care clinicians: Rational use of opioids in chronic or recurrent non-malignant pain. 2002. http://www.ciap.health.nsw.gov.au/nswtag/guidelines.html (accessed 6 April 2009).
  6. Australian Government Medicare Australia. Prescription Shopping Program. http://www.medicareaustralia.gov.au/provider/pbs/prescription-shopping/index.jsp (accessed 6 April 2009).