Opioids: New and amended PBS listings

• On 1 June 2020, changes were made to the listings of many opioids and multiple formulations listed on the PBS General Schedule
  Changes included new listings for half pack sizes, increased restrictions, and new and amended clinical criteria, prescriber instructions and administrative advice.
• Short-term therapy with opioids for acute severe pain has new Restricted Benefit listings
  The new listings are for half pack sizes (10 tablets/capsules) with no repeats or increases in maximum quantity or number of units.
• Full pack sizes of opioids for acute severe pain have been amended, and some that were previously Unrestricted Benefit are now Restricted Benefit
  PBAC acknowledged that larger quantities of opioids might be required for some patients with acute severe pain.
• Opioid listings for chronic severe pain are now Authority Required (Streamlined)
  They are for the treatment of cancer and non-cancer pain that requires daily, continuous, long-term therapy.
• The new and amended PBS listings complement ongoing TGA regulatory measures to support the safe and appropriate use of opioids
  Changes aim to reduce the number of patients prescribed more opioids than required for acute pain, and the amount of opioids circulating in the community.

On 1 June 2020, changes were made to many opioids and multiple formulations listed on the PBS General Schedule (Section 85). The changes included new listings for half pack sizes, increased restrictions for full pack sizes, and new and amended clinical criteria, prescriber instructions and administrative advice.^1,2

The opioids affected by changes include buprenorphine, codeine, codeine with paracetamol, fentanyl, hydromorphone, methadone, morphine, oxycodone, oxycodone with naloxone, tapentadol and tramadol.^1,2

The changes apply to these opioids when prescribed for patients with acute severe pain and chronic severe pain (non-cancer and cancer).^1,2

Check full details when prescribing

When prescribing opioids under the PBS, prescribers and pharmacists should check that their prescribing and dispensing software program is up to date with the full details of the many new and amended listings.

Full details are also available at the PBS website, including item codes, restriction levels, clinical criteria, prescriber instructions, administrative advice and ‘streamlined authority code’.³

New listings have been made that provide a simple way to prescribe smaller quantities of immediate-release (IR) formulations of opioids for short-term therapy for acute severe pain that are consistent with guidelines and recent TGA regulatory changes that support the safe and appropriate use of opioids.²

The listings are summarised in Table 1. For more details about the TGA regulatory changes see below ‘Why were changes made?’.

These medicines include codeine, codeine with paracetamol, hydromorphone, morphine, oxycodone and tramadol.²

The listings are Restricted Benefit for:¹

• half pack sizes (10 tablets/capsules)
• no repeats
• no increases in the maximum quantity or number of units.

Codeine, codeine with paracetamol, oxycodone, and tramadol IR formulation capsules must be prescribed under the following clinical criteria for these listings:¹

• patient must have previously experienced inadequate management of pain relief following maximum tolerated doses of other non-opioid analgesics, or
• condition must be such that maximum tolerated doses of non-opioid analgesics would provide inadequate management of pain relief, or
• patient must be unable to use other non-opioid analgesics due to contraindications, adverse effects or intolerance.

Hydromorphone and morphine IR formulation tablets must be prescribed under the same clinical criteria as listed above, with the addition that each criterion is for ‘non-opioid analgesics and other opioid analgesics’.¹

Table 1. Acute severe pain – half pack sizes¹

New PBS listings for opioids are for the prescription of half pack sizes = 10 tablets/capsules (full pack size = 20 tablets/capsules). No repeats or increases in maximum quantity sizes are allowed. They are Restricted Benefit listings.

a. Can be prescribed by dental practitioners. b. Can be prescribed by nurse practitioners.

While half pack sizes may be sufficient for acute severe pain relief, larger quantities might still be required for some patients with acute severe pain and can be prescribed as full pack sizes under the PBS.²

Amended listings with increased restriction levels

Opioids that were full pack sizes with Unrestricted Benefit listings for acute severe pain have been amended to now be Restricted Benefit.^1,4

These listings have been summarised in Table 2a, and include codeine, and codeine with paracetamol tablets (20-pack sizes), and hydromorphone and morphine ampoules for injection.¹

For treatment of acute severe pain with codeine, codeine with paracetamol and hydromorphone, the clinical criteria are the same as the corresponding new listings for half pack sizes (see above; ‘Acute severe pain – half pack sizes’).¹

For treatment of acute severe pain with morphine, the treatment may also be part of pre-operative care or used as an analgesic adjunct in general anaesthesia.¹

Most of these opioids also have ‘authorities for increased maximum quantities and/or repeats'. They must only be considered for severe disabling pain associated with proven malignant neoplasia or chronic severe disabling pain. Additional requirements are found in the prescriber instructions.¹ (See the current PBS Schedule at the PBS website for full details)

Table 2a. Acute severe pain – full pack sizes¹

Amended listings with increased restriction levels for full pack sizes (20 tablets or injection ampoules). They are Restricted Benefit listings. Previously they were Unrestricted Benefit. Amendments include clinical criteria.

a. Can be prescribed by dental practitioners. b. Can be prescribed by nurse practitioners. c. Can be prescribed by midwives. d. Codeine item 1214X (Aspen Pharma Pty Ltd) was also added to the PBS for cough suppression.

Amended listings with restriction levels that have not changed

Some listings for full pack sizes for acute severe pain have changed even though the medicines’ restriction levels have remained the same (see Table 2b). Amended listings for opioids that have unchanged restriction levels include hydromorphone tablets and oral solution, morphine tablets and oral solution, oxycodone tablets, capsules, oral solution and suppository, and tramadol capsule, injection and oral drops.^1,4

The amended clinical criteria for these listings are the same as for the corresponding opioids listed for new half pack sizes. (See above; ‘Acute severe pain – half pack sizes’.)¹ For oxycodone suppository, the treatment must also be for cancer pain and/or post-operative pain following a major operative procedure.¹

In the listings of these opioids that also have ‘authorities for increased maximum quantities and/or repeats’, the requirements are the same as the listings for the opioids in the section above; ‘Amended listings with increased restriction levels’.¹ (See the current PBS Schedule at the PBS website for full details).

Table 2b. Acute severe pain – full pack sizes¹

Amended listings (eg to clinical criteria) with restriction levels that have not changed for full pack sizes (20 tablets/capsules, oral drops/solutions, suppository)

a. Can be prescribed by dental practitioners. b. Can be prescribed by nurse practitioners. c. Can be prescribed by midwives. d. Codeine item 1214X (Aspen Pharma Pty Ltd) was also added to the PBS for cough suppression.

Opioids for chronic severe pain (cancer and non-cancer) are now Authority required (Streamlined) listings on the PBS (see Table 3). Previously they were Restricted Benefit listings. The same amendment applies to opioids listed specifically for chronic severe disabling pain.^1,4

These opioids include:¹

• modified-release (MR) formulations
• buprenorphine transdermal patches
• morphine capsules, tablets and granules
• oxycodone and oxycodone with naloxone tablets
• tapentadol tablets and
• tramadol tablets.

One new listing for each of morphine MR granules and morphine MR tablets have also been added to the PBS.¹

All these opioids must be prescribed under the following clinical criteria:¹

• condition must require daily, continuous, long-term therapy with this treatment, and
• patient must have pain directly attributable to cancer, or
• patient must have previously experienced inadequate management of pain relief following maximum tolerated doses of non-opioid or other opioid analgesics, or
• condition must be such that maximum tolerated doses of non-opioid or other opioid analgesics would provide inadequate management of pain relief, or
• patient must be unable to use non-opioid or other opioid analgesics due to contraindications, adverse effects or intolerance.

MR opioid formulations including hydromorphone tablets, methadone tablets and injection, and fentanyl transdermal patches have the same clinical criteria, but in addition patients must also not be opioid-naïve.¹

Table 3. Chronic severe (disabling) pain¹

Authority Required (Streamlined) listings for opioids for this condition that were previously Restricted Benefit listings. These medicines can be prescribed by nurse practitioners.

What’s changed?

On I July 2020, a new listing for codeine 30 mg tablets for cough suppression (item code 12081W) was added to the PBS General Schedule (Section 85). The listing is a Restricted Benefit for full pack sizes (20 tablets). There are no additional clinical criteria, prescriber’s instructions or administrative advice.^a

Codeine for cough suppression was previously listed as a clinical indication together with acute severe pain under a single listing (item code 1214X), which was also a Restricted Benefit for full pack sizes. In effect codeine for cough suppression has simply been removed from item code 1214X, which remains just for acute severe pain, to create a separate listing.^a,b

Why were the changes made?

The new listing reduces the risk of prescribers being confused about prescribing codeine for cough suppression under the PBS due to not being aware that the indication was listed together with acute severe pain. The separate listings also allow the Department of Health to track prescriptions of this codeine formulation for the two different clinical indications.

What else should health professionals know?

The new listing doesn’t change how health professionals, including nurse practitioners, prescribe codeine for cough suppression under the PBS because it is effectively the same as the previous listing.^a,b

When prescribing, health professionals and pharmacists just need to check that their prescribing and dispensing software program is up to date with the full details of the new listing, particularly the new item code. Full details are also available at the PBS website.

References

a. Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (July 2020). Canberra: Australian Government Department of Health, 2020 (accessed 23 June 2020).

b. Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (June 2020). Canberra: Australian Government Department of Health, 2020 (accessed 1 June 2020).

Deleted listings

Two opioids listings have been deleted:

• item code 8785J for codeine (30 mg) with paracetamol (500 mg) tablets
• item code 8611F tramadol 50 mg capsule.¹

Nurse practitioners

Authorised nurse practitioners may prescribe these opioids on the PBS General Schedule. See the PBS website for more information on nurse practitioner PBS prescribing.¹

Midwives

Authorised midwives may prescribe a small number of these opioids on the PBS General Schedule. See the PBS website for more information on midwives PBS prescribing.¹

Dentists

Dentists have a Dental Schedule on the PBS from which they can prescribe some of these opioids for their patients.¹

Every day in Australia, an average of 3 people die, 150 people are hospitalised and 14 people present to emergency departments because of harm from opioids.⁵

The Therapeutic Goods Administration (TGA), part of the Department of Health, has been undertaking regulatory measures to reduce harms associated with prescription opioid dependence and inappropriate use (including overdose fatalities).²

The regulatory measures, which are based on findings from the TGA’s 2018 prescription opioid review and advice from the Opioid Regulatory Advisory Group (ORAG), are summarised in Table 4.²

Table 4. TGA opioid regulatory measures²

In July 2019, the PBAC acknowledged the potential quality use of medicine (QUM) benefit of reduced maximum quantities for opioids used for acute pain (such as after surgery).²

At the December 2019 PBAC Intracycle Meeting, the PBAC considered proposed changes to the restrictions for opioids listed on the PBS.²

PBAC’s contribution to TGA’s regulatory measures²

The TGA worked with ORAG, and with government and other stakeholders, to identify activities to support the appropriate use of opioids, including:

• education and awareness campaigns by the TGA, professional medical indemnity insurers and peak prescriber and pharmacist associations
• changes to clinical guidelines
• ensuring that sponsors comply with the requirements of the Therapeutic Goods Act 1989, by only promoting the new narrower indications when advertising to prescribers
• integration of the changes into policies and regulatory schemes administered by state and territory health departments
• use of real time prescription monitoring programs and continuing to monitor prescriber compliance with the Department’s health payment requirements.

The PBAC shared the TGA’s concerns about the high number of deaths and hospitalisations caused by prescription opioids in Australia and considered that changes to opioid PBS listings would complement the TGA’s efforts.

The PBAC acknowledged the need to support the safe and clinically appropriate use of opioids, while also recognising their role as a component of pain management for many people and their potential to cause harm.

PBAC rationale for the changes²

Acute severe pain – half pack and full pack sizes

The PBAC considered that the half pack sizes would provide a simple way for prescribers to prescribe smaller quantities of IR opioids for acute severe pain, prior to the smaller pack sizes being available.

These half pack sizes would be sufficient for acute pain relief at the lowest effective dose, but the PBAC acknowledged that larger quantities might be required for some patients with acute severe pain.

The PBAC noted that the TGA would be requiring sponsors to register new smaller pack sizes for some IR opioids within 24 months from January 2020, and considered that new PBS listings with smaller maximum quantities could assist with reducing the number of patients prescribed more opioids than required for the management of acute severe pain.

As a result, the PBAC recommended smaller maximum quantities rather than limiting treatment duration to a set number of days, such as 2 to 3 days.

The PBAC noted that new listings for smaller quantities of IR opioid liquid formulations will not be possible until these bottle sizes are available on the market.

Acute and chronic severe pain

The PBAC noted that the TGA had revised the indications of several opioid analgesics, to broadly categorise them as opioids for acute severe pain or chronic severe pain. They recommended that PBS restrictions for IR and MR opioids should be changed to align with the TGA’s changes.

The PBS restrictions for fentanyl patches were also revised in line with the TGA’s amended indications for fentanyl patches.

In addition, the authority level of opioids for chronic severe pain was increased to Authority Required (Streamlined), in line with the TGA’s opioid reforms.

The PBAC noted that this would help the Department of Health undertake utilisation analyses and compliance activities to identify inappropriate prescribing.

Deletion of listings

The PBAC noted that codeine (30 mg) with paracetamol (500 mg) tablets had two listings, one of which allowed a 6-month supply on a single prescription. This was inconsistent with other opioid listings, which only allow a 3-month supply.

It was recommended that one listing be deleted (item code 8785J) and the remaining one be aligned with criteria for other opioid listings.

Tramadol 50 mg capsules also had two listings, one for acute pain (with no repeats) and another for dose-titration in chronic pain (with two repeats). The PBAC considered that a specific dose-titration listing was not needed and recommended the deletion of item code 8611F.

The changes to the opioids PBS listings were made to support appropriate prescribing and use of opioids, and to prompt ongoing assessment of harms and benefits by prescribers and other healthcare professionals working with people requiring severe pain management.²

The half pack sizes will provide a simplified way for prescribers to prescribe smaller quantities of IR opioids for acute severe pain.²

These changes will lead to fewer patients being prescribed more opioids than required for acute severe pain, resulting in fewer remaining unused tablets and prescription opioids circulating in the community.²

The revised restriction for fentanyl should reduce the number of new patients using fentanyl patches. Fentanyl is one of the strongest opioids available in Australia and one that has increased potential for harmful and hazardous use. The changes are not intended to require patients who are currently reliant on fentanyl patches to switch to alternative pain medicines.^2,6

The ‘other conditions in opioid-tolerant patients’ section in the revised fentanyl restriction (see Table 4) applies to patients for whom other prescription opioids are inappropriate, such as patients with end-stage renal failure or who cannot swallow.²

As before 1 June 2020, requests to extend opioid treatment will need to be made using the Online PBS Authorities System or Health Professional Online Services (HPOS), or by telephone for up to 1 month or in writing for 1–3 months.²

Prepare for the listing updates

To prescribe under the new and amended PBS listings, prescribers and pharmacists should check their prescribing and dispensing software is up to date.

Prescribers should ensure that patients meet the relevant restriction criteria when prescribing opioids under Restricted Benefit and Authority Required (Streamlined) PBS listings.

Full details of the changed opioids listings on the current PBS Schedule are also available at the PBS website, including item codes, restriction levels, clinical criteria, prescriber instructions, administrative advice and ‘streamlined authority code’.³

For PBS subsidy for Authority Required (Streamlined) listings, prescribers need to complete an authority prescription form and endorse the prescription with the valid streamlined code.³

Prescribers can also request approval for Authority Required (Telephone/Electronic) items from Services Australia, either through the Online PBS Authorities System or by calling 1800 888 333.¹

Written authority applications can be uploaded online through Health Professional Online Services (HPOS) or mailed to the PBS.¹

Opioids have an important role in the treatment of acute severe pain.^7-9

RACGP guidelines recommend that when opioids are used for acute pain, the lowest effective dose of IR opioids and no greater quantity should be prescribed than is needed for the expected duration of pain severe enough to require opioids. Less than 3 days will often be sufficient for acute pain and more than 7 days will rarely be needed.⁷

However long-term opioid use often begins with the treatment of acute pain.¹⁰ Current clinical guidelines do not recommend the use of opioids for long-term chronic non-cancer pain management.^7,8,11

Available evidence examining long-term (> 1 year) opioid efficacy and risk remains insufficient to determine the effectiveness of opioids for improving chronic pain and function.¹² A meta-analysis including over 26,000 patients with chronic non-cancer pain showed that opioids did not provide clinically important improvements in pain or function, compared with placebo.¹³

Prescribers should discuss with their patients the limited role of opioids for managing chronic non-cancer pain and the potential for opioids to cause serious harm when used long term.⁷

Prescribers should make appropriate decisions on opioids based on the guidelines. Medicinewise News: If not opioids, then what? provides further information about the role of opioids in chronic non-cancer pain.

As part of the opioid regulatory reforms, the TGA is working with medicine sponsors to update their Product Information (PI) and Consumer Medicines Information (CMI) documents before October 2021.² (See Table 4 for details)

Updates include the need to prominently display warnings on the PIs and CMIs for all prescription opioids registered in Australia. The PBAC proposed that ‘the risk of drug dependence is high’ should be applied consistently across all listings.²

Information for GPs and specialists²

For listings of opioids that have ‘authorities for increased maximum quantities and/or repeats’, these authorities must only be considered in certain circumstances. These include when opioid use by a patient to help manage severe pain (cancer or chronic non-cancer) exceeds or is expected to exceed 12 months. In these cases the patient must also be referred to another medical practitioner (no specialists are specified) for clinical review.^1,4

The full name of the medical practitioner consulted and date of the consultation must be provided for every authority application.¹

Information for dentists

In making recommendations for the 1 June 2020 PBS new and amended listings for opioids, the PBAC noted that the Australian Therapeutic Guidelines recommend that dentists should not prescribe codeine for pain relief.²

The PBAC has asked the Department of Health to consult with the Australian Dental Association before making a final recommendation on whether to align the PBS listings with the guidelines.²

Prescribing of drugs of addiction by dentists is not permitted in some states or territories.¹ Prescribers can seek advice on the interpretation of the Poisons Standard and check legal requirements from their relevant medicines and poisons regulation units.

Information for pharmacists²

Medicine sponsors are required to register smaller opioid pack sizes with the TGA within 24 months from January 2020. However, although the TGA has powers to compel the registration of smaller pack sizes, it cannot compel the supply of the smaller pack sizes.

Before smaller pack sizes are available, the government will remunerate pharmacists if they need to dispense a quantity less than the manufacturer’s pack size listed on the PBS. This is to support the use of new PBS listings for half pack sizes.

The payment is composed of a wastage fee based on the proportion of the pack supplied, in addition to the applicable dispensing fee, dangerous drug fee (if applicable) and appropriate container fee.

Deleted listings

To assist with a smooth transition for prescriptions written for the deleted listings prior to 1 June and claimed on or after 1 June, pharmacists will need to claim and acknowledge the mismatch code:^14,15

• under item code 1215Y, mismatch code (W 162/W 163) for item code 8785J for codeine (30 mg) with paracetamol (500 mg) tablets
• under item code 8455B, mismatch code (W 150/151) for item code 8611F for tramadol 50 mg capsule

Pharmacists will need to keep sufficient information for each claimed prescription. Pharmacists are also encouraged to advise patients of the changes that have been made to relevant opioid PBS listings and encourage them to seek further information from their prescriber at their next visit.^14,15 For more details see the PBS website.

Patients may have questions about the changes or be concerned that the changes will prevent them from receiving their regular treatment.

Advise patients of these key points.⁶

• Multiple prescription opioids are being affected (including fentanyl, codeine, hydromorphone, oxycodone, morphine, tramadol, tapentadol, buprenorphine and methadone).
• The same opioids are available, but health professionals now need to prescribe smaller pack sizes for short-term pain and check updated patient requirements before prescribing.
• Changes are being made because some countries (such as the United States) have experienced an 'opioid crisis'. Harmful use in Australia has also been rising, and on average, 3 people die from opioids every day.
• Smaller pack sizes reduce the risk of harm from unused opioids and updated patient criteria will help reduce the inappropriate use of powerful opioids (such as fentanyl) by people for whom harms outweigh benefits.
• People who require long-term pain relief from opioids, such as people with cancer and those receiving palliative care, are likely to receive the same opioid medicine and pack size as they did before.
• Stopping opioids suddenly can lead to withdrawal symptoms. People should continue to take their pain medicine but speak with their doctor about alternative options or reducing their dose, in case it is no longer appropriate.
• Any unused opioids should be returned to a local pharmacy.

Further information for consumers (including the information above) can be found at the TGA’s codeine information hub.

NPS MedicineWise has published information and resources for consumers, including:

• Opioids information video
• Pain: what is going on?
• Opioid medicines and chronic non-cancer pain.

If preferred, patients can also get information over the phone by calling NPS MedicineWise’s Medicines Line at 1300 MEDICINE (1300 633 424).

• TGA information for sponsors on the opioid reforms.
• TGA details about reforms to opioid boxed warnings and class statements.

NPS MedicineWise has information and resources on opioids, including:

• an opioid tapering algorithm,
• a podcast series about SafeScript and 
• a RADAR article on Naloxone nasal spray (Nyxoid) for opioid overdose.

NPS MedicineWise offers CPD options for GPs and pharmacists:

• Educational visit: Opioids and the bigger picture when treating chronic pain.
• Clinical e-Audit: Opioids: redefining ‘doing well’ on opioids.
• Pharmacy Practice Review: Opioids: reducing harms from long-term use.

Australian Prescriber has developed useful articles and podcasts, including Prescribing wellness: comprehensive pain management outside specialist services