Your questions to the PBAC

Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals.

This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS, see are determined.

Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.

Analgesics for the elderly

Our practice looks after patients in a local nursing home. We occasionally see patients who have conditions that do not fit the restrictions for prescribing a drug on the Pharmaceutical Benefits Scheme (PBS). As a result of this, there are two specific problems. Firstly, we are unable to prescribe what we believe to be the best drug and so we opt for a sub-optimal treatment. Secondly, we are unable to order repeat prescriptions and so we have to see the patient more frequently just to write prescriptions. This results in additional visits and higher Medicare and prescribing costs.

An example of this difficulty is in prescribing adequate, appropriate analgesia in a form that patients can take. We feel very strongly that we are sometimes not able to provide the best possible care to our patients and this frustrates us.

Three cases illustrate this difficulty:

1. An 85-year-old demented patient with severe osteoarthritis who is not compliant with oral medication.

Fentanyl patches would be a reasonable option to control her severe pain. However, as she does not have terminal malignancy, this is not an option on the PBS.

2. An elderly bedridden patient who has multiple spinal fractures due to osteoporosis, severe osteoarthritis and requires opiates for pain control.

This patient should not have to be sent to a pain management clinic or be admitted to hospital for pain relief. However, this is what is required to satisfy the PBS as the patient does not have a terminal malignancy. The patient cannot get more than 10 days supply of controlled release morphine at a time.

3. An elderly dying demented patient who is in pain and is in need of palliative care.

Fentanyl patches might be appropriate, but again this is not allowed by the PBS as the patient does not have a terminal malignancy.

We believe the PBS restrictions should be changed so that patients in aged care facilities have easier access to opioids in order to improve their care.

Chris Boyle
Damian Welbourne
Tim Cocks
Rachel Hughes
Prabaka Subbaraju
Elizabeth Kaiko

General practitioners
Raymond Terrace Family Practice
Raymond Terrace, NSW

PBAC response:

While the Pharmaceutical Benefits Advisory Committee (PBAC) and the Government endeavour to provide affordable access to pharmaceuticals to the Australian community, the PBAC also has a responsibility that PBS-listed medicines are used in medically appropriate ways and will therefore recommend that certain restrictions apply to the prescribing of some listed pharmaceuticals, such as the opioid analgesics.

Most narcotic analgesics for non-cancer pain can be prescribed in small quantities on the PBS. Increased quantities and/or repeats can be obtained for patients with proven malignant neoplasia or chronic severe disabling pain where treatment is initiated in a hospital. The requirement for a hospital assessment before approving increased maximum quantities and/or repeats arose out of the belief that the management of severe chronic pain of non-malignant origin represents a complex problem, which is best addressed through expert evaluation of individual patients by interdisciplinary teams in hospitals.

The PBAC regularly reviews listings and has in recent years considered a number of requests to relax the restricted availability of opioid analgesics. It is therefore aware that restricting the quantities of drugs available for patients with chronic severe disabling pain not associated with proven malignant neoplasia is frustrating to prescribers. The PBAC agrees that some changes to the restrictions may be desirable, however, it is reluctant to recommend any changes without wider consultation.

The PBAC has recommended that a working group be established to examine this issue. It is planned to convene this group shortly, with the intent of reporting back to the PBAC as soon as possible.

Update (added April 2005)

As of April 2005, the PBAC has now relaxed the requirements for authority prescriptions for increased maximum quantities and repeats of some narcotic analgesics.

With respect to the PBS availability of fentanyl patches in the treatment of non-malignant pain, there is added complexity. Before the patches can be recommended for listing for this purpose, the PBAC must be presented with an application that shows fentanyl is cost-effective for this indication.

Australian Prescriber readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee. The segment 'Your questions to the PBAC' will publish selected questions from readers, and answers from the Committee itself. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and Authority prescriptions.