Palliative care: New, amended and deleted PBS items

• On 1 June 2021, changes were made to a number of medicines prescribed for palliative care on the Palliative Care Schedule (PCS) and General Schedule.
  These changes were based on recommendations made by PBAC at its September 2020 meeting following its consideration of a Department of Health commissioned review of the PCS.

• New and amended listings were included for opioids for acute severe pain and chronic severe pain on the PCS
  They included hydromorphone and morphine IR, fentanyl, methadone, buprenorphine, and hydromorphone, morphine, oxycodone and oxycodone with naloxone MR formulations.

• The changes to opioid listings were made to align the PCS with changes to opioid listings on the General Schedule that occurred on 1 June 2020
  The changes aim to support the quality of use of opioids, while ensuring timely supply of opioids for pain for palliative care patients on the PBS.

• Listings were also added, amended and deleted for non-opioids, a constipation medicine and some other miscellaneous medicines on the PCS and General Schedule
  These included diclofenac, indometacin, bisacodyl, clonazepam, haloperidol and metoclopramide formulations.

• The non-opioid, constipation and miscellaneous listing changes were made to improve the quality use of these medicines for palliative care on the PBS
  The changes included adding new formulations of medicines, broadening the indication for use and increasing repeats.

• For the deleted PCS listings, there are corresponding listings on the General Schedule
  The corresponding General Schedule listings have the same or similar restriction/clinical criteria and maximum quantities/repeats as the deleted PCS listings.

On 1 June 2021, changes were made to the Pharmaceutical Benefits Scheme (PBS) Palliative Care Schedule (PCS) and General Schedule (Section 85) for a number of medicines and multiple formulations used for palliative care.¹ 

Pain

Opioids

Changes were made to the PCS for opioids. New Authority Required (Streamlined) listings for acute severe pain were added for:^2-4

• hydromorphone immediate-release (IR) tablets, oral liquid and injections
• morphine IR oral liquid and injections.

New Authority Required items were listed for chronic severe pain for:^2-4

• fentanyl patches
• methadone tablets and injections
• hydromorphone modified-release (MR) tablets
• morphine MR tablets, capsules and granules
• oxycodone MR tablets
• oxycodone with naloxone MR tablets.

Amendments were made to existing listings for chronic severe pain for:^2-4

• buprenorphine patches
• morphine MR tablets.

For further description and more details, read Opioids in Listings: Palliative care PBS changes

Non-opioids

Changes were made to PCS and General Schedule listings for non-opioid medicines for pain (and malignancy-related fever) used in palliative care, including:¹

• diclofenac suppositories: deleted item
• diclofenac tablets: deleted and amended items
• indometacin suppositories: deleted item

For the deleted PCS listings there are corresponding items on the General Schedule that enable the appropriate use of these medicines for palliative care to continue on the PBS.^2,5

For further description and more details, read Non-opioids in Listings: Palliative care PBS changes

Constipation

Items for bisacodyl enemas, suppositories and tablets for palliative care were deleted from the PCS.¹

For the deleted PCS listings there are corresponding items on the General Schedule that enable the appropriate use of these medicines for palliative care to continue on the PBS.^2,5

For further description and more details read Constipation medicine in Listings: Palliative care PBS changes

Miscellaneous

Changes were made to the PCS for three medicines used for various indications for palliative care, including:¹

• clonazepam injections: new Restricted Benefit item
• clonazepam tablet and oral liquid: amended items
• haloperidol injections: new Restricted Benefit item
• metoclopramide tablets: new Restricted Benefit item
• metoclopramide injections: amended item.

For further description and more details, read Miscellaneous medicines in Listings: Palliative care PBS changes

In 2004, the Palliative Care Schedule (PCS) was established to complement the General Schedule. While both schedules contain medicines suitable for use in palliative care, the benefit of the PCS is that medicines are often listed with larger quantities and numbers of repeats, which can reduce patient co-payment costs and the number of doctors’ visits required to obtain prescriptions for continuing therapy.⁴

However, a range of concerns have been raised about the PCS since its establishment, including:⁴

• whether specific listings were still evidence-based or relevant to current clinical practice
• whether requests for increased maximum quantity and repeats for specific medicines in the Prescriber Bag along with low utilisation of PCS items may be related to incorrect use of the Prescriber Bag for palliative care patients
• whether access needs for palliative care for vulnerable patients were being met
• whether there was still a need for a PCS in general.

Many specific concerns have been addressed over the years with various PBS listing changes and education about the use of the Prescriber Bag.⁴

In February 2020 the Australian Government Department of Health commissioned a broad review of the PCS, led by Emeritus Professor Lloyd Sansom, that included stakeholder consultation with the Royal College of General Practitioners (RACGP) and Palliative Care Australia (PCA).⁴

At the September 2020 PBAC meeting, after considering proposals made in the PCS review, the PBAC concluded there was an ongoing need for a PCS in addition to the General Schedule in order to provide palliative care patients with flexible access to medicines.⁴

The PBAC also made specific recommendations for a number of medicines and multiple formulations for palliative care on the PCS and General Schedule, including:⁴

• opioids
• non-opioids
• constipation medicine
• a miscellaneous group of medicines.

PBAC considered that the PCS should be reviewed again in the future to ensure that listings remain appropriate in the palliative care setting.⁴

Opioids

On 1 June 2020, changes were made to a number of opioid items on the General Schedule.^4,6

The changes included new items for half pack sizes, increased restrictions for full pack sizes, and new and amended clinical criteria, prescriber instructions and administrative advice.⁶

The changes were recommended by the PBAC at its December 2019 meeting and were intended to align the opioid listings with regulatory changes made by the TGA to reduce harms associated with prescription opioid dependence and inappropriate use, including overdose.⁴

In making its recommendations for the 1 June 2021 PCS changes, the PBAC considered that PCS opioid listings should be aligned with the 1 June 2020 General Schedule changes to support the appropriate prescribing and quality use of opioids.⁴

The recommended changes were also intended to reduce barriers to the prescribing and timely supply of opioids for pain for palliative care patients.³ For example, new and amended items on the PCS do not include a requirement for annual review for authorities for increased maximum quantities and/or repeats, unlike the equivalent opioid items for chronic severe pain on the General Schedule.^2,3,5

Read more about changes made to the PBS General Schedule on 1 June 2020 to support the appropriate prescribing and use of opioids.

Non-opioid and constipation medicines

The PBAC recommended deleting the PCS listings for bisacodyl, diclofenac and indometacin because there were corresponding General Schedule items for these medicines with the same or similar restriction/clinical criteria and maximum quantities/repeats, which would enable the appropriate and effective use of these medicines for palliative care to continue on the PBS.⁴

Miscellaneous medicines

The PBAC acknowledged there was a broader use of clonazepam tablets and oral liquid in palliative care than just myoclonus and recommended changing the indication for clonazepam PCS listings to ‘for use in patients receiving palliative care’.⁴ It also recommended adding a new item for an injection formulation, which is consistent with palliative care guidelines.⁷

PBAC also recommended a PCS listing for metoclopramide 10 mg tablets with a maximum quantity of 100 units and 5 repeats, noting that the current Unrestricted Benefit listing on the General Schedule only provides a maximum quantity of 25 units with no repeats. The need for access to increased quantities was also the reason for the PBAC recommendation to increase the repeats for the PCS listing of metoclopramide 10 mg injection from none to two.⁴

Until June 1 2021, haloperidol 5 mg/ml injection, 10 x 1 ml ampoules was listed on the General Schedule with one maximum quantity and no repeats. The new PCS listing included two repeats, which may be required for the treatment of people receiving palliative care.^2,5

The changes to the PCS and General Schedule will further support appropriate, evidence-based and current clinical practice use of medicines for palliative care on the PBS.⁴

It is also expected to further reduce barriers to the prescribing and timely supply, and improve access of medicines for palliative care for vulnerable patients, including reduced patient co-payment costs and the number of doctors’ visits required to obtain prescriptions for continuing therapy.^3,4

Palliative care best practice

Palliative care recognises that death is inevitable, and focuses on the care (rather than cure) of people with multiple chronic conditions, frailty and/or life-threatening or life-limiting illness.⁸

Palliative care aims to improve or optimise a person’s level of comfort and function, and offer appropriate treatment for any distressing symptoms.⁸

According to the RACGP:⁸

• palliative care aims to improve the quality of life of patients and their families facing problems associated with life-limiting illness
• early identification, assessment and treatment of pain and other problems, including physical, psychosocial and spiritual, leads to prevention and relief of suffering
• the role of GPs and general practices is central and critical to an effective and comprehensive palliative care approach in which everyone has a role to play
• a palliative care approach is a broad approach that includes end-of-life and specialist palliative care
• palliative care is a core activity for those looking after and supporting older people, including their families and carers, and should be evidence-based and person-centred.

Australian Therapeutic Guidelines advise that any GP or specialist can adopt a palliative approach to patient care. Principles of palliative care can be applied regardless of a person’s age, health condition, stage of illness or place of care.⁷

The decision to start palliative care reflects the recognition that goals of care are shifting from managing disease and prolonging life towards optimising quality of remaining life.⁷

It is often appropriate to introduce palliative care from the time a patient is recognised as having progressive, life-limiting illness. Health professionals should regularly review their patients with life-limiting illness, and consider whether a shift to a palliative approach is needed.⁷

Health problems at the end of life can be complex and require multidisciplinary care. One health professional (often a senior doctor) should take responsibility to ensure that decisions are made, care is coordinated, and health care providers are aware of their responsibilities.⁷

Not all patients who are dying will require specialist palliative care services, but patients may be referred to specialist palliative care service if they require management of complex problems beyond the skills of their usual health care providers.⁷

PBS and medicines for palliative care

PBS-listed medicines for palliative care can be prescribed from either the PCS or General Schedule. The decision to prescribe from the PCS listing or General Schedule for a particular medicine will depend on the conditions of the particular listing and the patient’s clinical needs and access to medicines.

Most PCS listings are Authority Required (Streamlined) or Restricted Benefits, providing up to 4 months of therapy as an original prescription with repeats. Continuing therapy can be prescribed on consecutive occasions if required.⁹

The guidance from the PBS when prescribing medicines listed in the PCS is that the patient has an active, progressive, far-advanced disease for which the prognosis is limited and the focus of care is the quality of life. In practice, this includes any person with a life-limiting condition, regardless of the condition or the reason for palliative care.⁹

Medical practitioners may prescribe any palliative care item and other PBS prescribers (eg, nurse practitioners) may prescribe items as indicated in the Schedule.⁹

The PBS website has a full list of item codes.

The deleted PCS items have been changed to Supply Only, which makes them unavailable for prescribing, but available for dispensing, usually for a period of up to 12 months from the deletion date. After the Supply Only period, the item will be removed completely from the PBS.¹⁰ For the deleted PCS listings there are corresponding items on the General Schedule that enable the appropriate use of these medicines for palliative care to continue on the PBS.^2,5

Naproxen

On 1 June 2021, naproxen 500 mg, 50 tablets for severe pain for palliative care was deleted from the PCS and naproxen 500 mg, 50 tablets for bone pain due to malignant disease was deleted from the General Schedule. It is listed as Supply Only.¹

However naproxen sodium 550 mg (approximately equivalent to naproxen 500 mg) 50 tablets continues to be listed unchanged on the PCS as a Restricted Benefit for severe pain for palliative care, as well as other dosages and formulations of naproxen.^1,5 This change was made by PBAC separately to the recommendations it made at its September 2020 meeting following its consideration of a Department of Health commissioned review of the PCS.⁴

Check full details when prescribing

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

Palliative care services in general practice

Data on GP palliative care services are not routinely collected, but a Bettering the Evaluation and Care of Health (BEACH) survey found that in 2015–16:¹¹

• ~1 in 1,000 GP encounters were related to palliative care
• ~ 9 out of 10 GP palliative care-related encounters were with people aged ≥ 65 years and ~1 in 20 encounters were with people aged < 55 years
• there were more GP palliative care-related encounters with females (53%) than males (47%).

The majority (94.3%) of the ~1.1 million palliative care-related prescriptions under the PBS or Repatriation PBS in 2017–18 were prescribed by GPs. Palliative medicine specialists prescribed 0.5% and other specialists/nurse practitioners 5.2%. Anti-inflammatory and antirheumatic medicines were the most commonly prescribed (54.0%), followed by analgesics (35.4%) and medicines for constipation (6.8%).¹¹

Palliative care resources

Recommendations for palliative care in Australia can be found in the Australian Therapeutic Guidelines on palliative care and RACGP aged care clinical guide (Silver Book).

caring@home has developed useful resources for health professionals, including:

• Guidelines for the handling of palliative care medicines in community services
• Information on medicine handling legislation
• caring@home app to assist health professionals support families, carers and patients
• palliMEDS app to familiarise primary care prescribers with medicines endorsed by the Australian & New Zealand Society of Palliative Medicine (ANZSPM)

Palliative Care Australia has useful information for health professionals, patients and their carers, including the National Palliative Care Service Directory.

Patients and their carers may be concerned about how the deleted items could affect current management of conditions.

Prescribers and dispensers should let their patients know that for the deleted items, there are corresponding items on the General Schedule that can be prescribed for patients for their palliative care needs. These unchanged items have the same or similar restrictions and clinical criteria and maximum quantities and repeats as the deleted items, which enables the appropriate and effective use of these medicines for palliative care to continue on the PBS.^1,2,5

Patients receiving opioids for palliative care and their carers may also have questions about the changes or be concerned that the changes will prevent them from receiving their regular treatment.

Prescribers and dispensers should advise patients and carers of these key points about opioids for palliative care on the PBS:

• Health professionals can now prescribe additional opioids containing fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxycodone with naloxone for people receiving palliative care who are experiencing acute severe pain and chronic severe pain.^3,4
• However, these medicines can only be prescribed for patients who have had inadequate pain relief with non-opioid and/or other opioid-containing medicines, or patients unable to use these medicines for safety reasons.^2,3
• The 1 June 2021 changes to PCS listings have been made to minimise harms and deaths caused by prescription opioid medicines, while ensuring continued access for patients proven to need them, including people receiving palliative care.^3,4
• 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.⁶
• Any unused opioids should be returned to a local pharmacy.⁶

Patients and their carers can view further information, tools and resources on opioids and pain management on the Palliative Care Australia website.

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