Buprenorphine for palliative care

From 1 December 2016 there is a new listing for all strengths of buprenorphine transdermal patches as Authority required on the Palliative Care Schedule.

The new listing is for a maximum of four patches with two repeats per script, providing up to 3 months’ supply. While the restriction is listed as a telephone authority, the prescriber must apply in writing for the repeat scripts.1

Eligibility is for patients with chronic severe disabling pain unresponsive to non-opioid analgesics who are receiving palliative care.1

The new listing is in addition to the Restricted benefit listing on the General Schedule for two patches with no repeats for each script, sufficient for 2 weeks’ therapy, which has been available since 2005. Patient eligibility for the General Schedule listing is for chronic severe disabling pain unresponsive to non-opioid analgesics.1,2

The Pharmaceutical Benefits Advisory Committee recommended the new listing, which aligns buprenorphine with modified-release morphine on the Palliative Care Schedule,1,2 after it found there was a clinical need for an increased quantity and number of repeats for palliative care patients, to improve access and convenience.1

At the same time, however, the increased supply is a timely reminder of the importance of correct disposal of buprenorphine patches in particular, and schedule 8 (S8) medicines in general.

Importance of correct disposal

The PBAC noted that the new listing is unlikely to lead to an increase in the number of patients using buprenorphine.1

However, the increase from two to a maximum of four patches with two repeats per script increases the likelihood of unused patches being left over if a patient changes opioid medication or passes way.

Unused patches need to be correctly disposed.3 The only currently safe and accepted method of disposal of pharmaceutical waste is through high temperature incineration. This type of incineration is specialised and must be carried out by an approved waste management contractor.4

There is also a need for correct disposal of used patches,3 as buprenorphine patches can retain up to 83% of the original dosage at the end of the 7-day application period.5

As with all S8 medicines, the safety risks of incorrect disposal include abuse; accidental exposure, which can lead to toxicity and death in children; and damage to the environment.3,6,7

Evidence of incorrect disposal of S8 medicines includes:

  • Therapeutic Goods Administration reports on accidental exposure in children.8
  • audit data from the National Return and Disposal of Unwanted Medicines (NatRUM) project that found 1.9% of disposed medicines were S8, despite State/Territory laws requiring S8 medicines to be rendered unusable (and for the purposes of the audit, unidentifiable) before inclusion in RUM bins.9

Unused patches

Guidance for pharmacies and healthcare facilities (such as palliative care units, nursing homes, general practices)

Unused patches should be recorded, witnessed, handled and destroyed in accordance with the laws on S8 medicines in each State/Territory. Local authorities can provide specific advice (see box).

General guidelines for correct disposal may include:3,4,10,11,12-15

  • knowing who are the authorised persons and approved witnesses for destruction
  • knowing the record-keeping requirements
  • having protocols for ensuring security before transport for destruction
  • making the S8 medicines unidentifiable and unusable before transport for destruction.

Guidance for consumers

While the laws on correct disposal of unused patches may not extend to patients and their families or carers, the principles should still be applied.4

All healthcare professionals involved in providing palliative care for patients should discuss the importance of correct disposal. In particular, they can advise to return unused patches to a community or hospital pharmacy as soon as possible.3,4,16

Used patches

The recommended disposal of used patches is to fold the used patch over so that the adhesive side of the patch sticks to itself, and dispose of it safely out of reach of children.17,18

Guidance for pharmacies and healthcare facilities (such as palliative care units, nursing homes, general practices)

While recording the disposal of used patches may not be considered a legal requirement, adopting appropriate and safe practices and local policies may be recommended.3

For example, the South Australian Department of Health and Ageing (SA DoHA) advises that the disposal process, including removal of patches from patients’ skin, folding the patches onto themselves with adhesive sides facing each other, and placing the patches in a sharps medical-waste disposal container, be witnessed by an approved person according to that State’s laws.

Recording the disposal process in the drug of dependence register should also be countersigned by the witness.3

Guidance for consumers

Advice in addition to reading the Consumer Medicines Information (CMI) may be provided to consumers. For instance, the SA DoHA recommends wrapping the folded patch in newspaper or something similar, and discarding it in general household refuse or alternatively, taking it directly to a pharmacy.3

Correct storage and application

The increased supply of buprenorphine patches is also a timely reminder for healthcare professionals to discuss with consumers correct storage, such as keeping patches in their pouch and a cool dry place.17 Discussing correct application is also recommended.19

For instructions on how to correctly store and apply buprenorphine patches, advise patients to read the CMI.17 Healthcare professionals should also ensure consumers have understood the instructions correctly by asking them to explain in their own words what to do.20

Practice Points for correct disposal of buprenorphine patches

  • Be informed of the legal requirements and recommended practices for correct disposal of unused and used patches.
  • Remember that the legal requirements and recommended practices for correct disposal of unused and used patches vary according to the situation (in the pharmacy or healthcare facility) and also in each State/Territory. See the box above for contact details of local authorities.
  • Remember that general guidelines for pharmacies and healthcare facilities for correct disposal of unused patches may include knowing:
    • who are the authorised persons and approved witnesses for destruction
    • the record keeping requirements
    • protocols for ensuring security and making patches unusable and unidentifiable before transport for destruction.
  • Advise patients and their families or carers to return unused patches to a pharmacy and follow the instructions on used patches in the CMI. 

References

  1. Pharmaceutical Benefits Advisory Committee. Public Summary Document. Buprenorphine (Norspan) July 2016 PBAC Meeting. Australian Government Department of Health, 2016. (Accessed 30 October 2016.)
  2. Department of Health. Schedule of Pharmaceutical Benefits. Canberra: Government of Australia, 2016. (Accessed 30 October 2016.)
  3. Department for Health and Ageing. Disposal of transdermal opioid patches. Adelaide: Government of South Australia, 2015. (Accessed 30 October 2016.)
  4. Department of Health. Information for health practitioners – disposal of controlled drugs. Government of Western Australia. (Accessed 30 October 2016.)
  5. Pastore MN, Kalia YN, Horstmann M, et al. Transdermal patches: history, development and pharmacology. Br J Pharmacol 2015;172:2179–209.
  6. Bergen PJ HS, George J, Kong DCM, Kirkpatrick CMJ,. Safe disposal of prescribed medicines. Aust Prescr 2015; 38: 90-2.
  7. NPS MedicineWise. Accidental fentanyl exposure in children can be fatal. NPS MedicineWise Health News and Evidence. Sydney: NPS MedicineWise, 2015
  8. Department of Health. Fentanyl patches and accidental exposure in children. Medicines Safety Update. Canberra: Government of Australia, 2014. (Accessed 2 November 2016.)
  9. Bergen P, Kong D, George J, et al. The National Return and Disposal of Unwanted Medicines (NatRUM) Project Audit. Melbourne: Monash University, 2013. (Accessed 30 October 2016.)
  10. Department of Health. Remote health atlas return/disposal of unwanted or expired S8/RS4 medicines. Government of Northern Territory, 2016. (Accessed 30 October 2016.)
  11. Government of NSW. Poisons and Therapeutic Goods Regulation 2008. Government of NSW, 2008. (Accessed 30 October 2016.)
  12. Department of Health and Human Services. Pharmacists managing Schedule 8 medicines. Government of Victoria. (Accessed 2 November 2016.)
  13. Government of Tasmania. Poisons regulations 2008. Hobart: Government of Tasmania, 2008. (Accessed 2 November 2016.)
  14. Government of the Australian Capital Territory. Medicines, Poisons and Therapeutic Goods Regulation 2008. 2016. (Accessed 2 November 2016.)
  15. Government of Queensland. Health (Drugs and Poisons) Regulation 1996. Brisbane: 1996.
  16. Rowett D, Rothmore J. Pharmacy profile: Disposal of unwanted medicines. CareSearch, 2015. (Accessed 30 October 2016.)
  17. Mundipharma Pty Limited. Norspan Consumer Medicine Information. 2016. (Accessed 30 October 2016.)
  18. Mundipharma Pty Limited. Norspan Product Information. 2009. (Accessed 2 November 2016.)
  19. NPS MedicineWise. A planned approach to prescribing opioids. NPS News. 2010. (Accessed 30 October 2016.)
  20. Australian Commission on Safety and Quality in Health Care. Health literacy: Taking action to improve safety and quality. Sydney: 2014. (Accessed 11 November 2016.)