Opioid prescribing – TGA changes, the PBS and the Law
The crisis
In Australia, pharmaceutical opioids are currently responsible for more deaths and poisoning hospitalisations than illegal opioids1. For most patients with chronic non-cancer pain, opioid medicines do not provide clinically relevant recovery from pain or injury compared to placebo treatments. Conversely, they pose significant risk of harm, even when used as prescribed2.
New indications for opioid prescribing
- Opioids should only be used when other analgesics are not suitable or have proven not to be effective.
- Immediate release opioids are for short-term management of severe pain.
- Immediate release opioids should only be used when the pain is opioid responsive, and the patient requires daily, continuous and long-term treatment.
- Modified release opioids are not indicated to treat chronic non-cancer pain (other than exceptional circumstances), or to be used for “as-needed” pain relief.
- Exceptional circumstances are subjected to the clinical judgement of the prescriber
- Prescribers are encouraged to reflect on their opioid prescribing practice when initiating or continuing to prescribe
- Hydromorphone and fentanyl modified release products should not be used in opioid naïve patients.
Other relevant changes
- Smaller pack sizes for immediate-release opioids
- New boxed warnings and class statements added to the Product Information for almost all opioids, including:
- Limitations of use
- Hazardous and harmful use
- Life threatening respiratory depression
- Concomitant use of benzodiazepines and other central nervous system depressants (including alcohol)
- Updates to Consumer Medicines Information to follow changes to the Product Information
Key advice for healthcare practitioners
Short Term Pain Listings First Line: codeine, codeine with paracetamol, oxycodone, tramadol
- Restricted benefits: no authority approval is required before prescribing listed quantities, the product can only be prescribed according to restriction criteria.
- For the treatment of patients with severe pain, post-operative or cancer related pain where non-opioid analgesics are not tolerated, contraindicated or do not provide adequate pain relief.
- Increases only to be considered for severe disabling pain (malignant neoplasm) or chronic severe disabling pain under specific conditions.
Short Term Pain Listings Second Line: hydromorphone, morphine.
- Restricted benefits: no authority approval is required before prescribing listed quantities, the product can only be prescribed according to the restriction criteria.
- For the treatment of patients with severe pain, cancer related pain, pre-operative care, or as an adjunct in general anaesthesia where non-opioid analgesics and First Line opioid analgesics are contraindicated, not tolerated, or have not provided adequate pain relief.
- Increases only to be considered for chronic severe disabling pain associated with malignant neoplasm, or for chronic severe disabling pain under certain conditions.
Long Term Pain Listings First Line: buprenorphine, tapentadol, tramadol, morphine, oxycodone with naloxone.
- Authority required (streamlined): no authority approval is required before prescribing listed quantities when prescribed according to the restriction criteria. Prescribers must include the correct streamlined code on the prescription. Streamlined codes are provided on the PBS website against the relevant PBS item code and restriction.
- Authority required (phone or online): authority approval is required before prescribing listed quantities (high dose morphine only)
- For the treatment of patients with chronic severe pain, requiring daily, continuous long-term therapy where non-opioid or other opioid analgesics are contraindicated, not tolerated, or have not provided adequate pain relief.
- Increases will only be considered for severe disabling pain under certain conditions.
Authority requirements
- Most PBS listings require a secondary review of the patient’s pain management with a second practitioner if opioid treatment will exceed or has exceeded 12 months duration (annual requirement)
- Secondary reviews may be conducted by phone or telehealth consultation.
- It is not mandatory to consult a pain specialist as part of the secondary review requirement.
- Prescribers may request real-time authority approval through the Online PBS Authorities system (OPA) for quantities and/or repeats that provide up to 3 months’ treatment.
- Prescribers can request up to 1 months’ treatment via telephone and up to 3 months’ treatment in writing (via mail or Health Professional Online Services (HPOS) form upload)
References
1Australian Institute of Health and Welfare. Opioid harm in Australia and comparisons between Australia and Canada. Australian Institute of Health and Welfare; 2019.
2 Busse JW, Wang L, Kamaleldin M, Craigie S, Riva JJ, Montoya L, Mulla SM, Lopes LC, Vogel N, Chen E, Kirmayr K. Opioids for chronic noncancer pain: a systematic review and meta-analysis. JAMA. 2018 Dec 18;320(23):2448-60.
Useful resources
Better Pain Management – Pain education for professionals
NPS MedicineWise - Opioids: redefining ‘doing well’ on opioids
Reducing Opioid Harm (ACRRM)
Reducing Opioid Harm (RDAA)
Opioid resources (TGA)
National Pain Services Directory
MIPS relevant resources
Webinar
Practice notes