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.


Your question to the PBAC

Sir, - I wish to draw attention to the difficulty in prescribing dalteparin sodium (Fragmin) 5000 units for patients with deep vein thrombosis. A young patient with a recurrent unexplained history of thromboembolic disease was discharged from a teaching hospital on subcutaneous Fragmin 5000 units twice daily for 10 days. He was given a 4-day supply and told to see his general practitioner for a further prescription. The authority prescription service was willing to allow prescription of the 10 000 unit injection, but not the 5000 unit syringe, according to the regulations in the Schedule of Pharmaceutical Benefits. They suggested that I should apply for a repeat and that the patient could be instructed to take only half of the 1 mL ampoule.

Since the dispensed price of the 5000 unit syringe is $81.34 against $230.24 for the 10 000 unit ampoule, this is hardly a cost-effective solution. Furthermore, there is the potential for confusion when patients are asked to manipulate unfamiliar doses and syringes.

There is bureaucratic irony in a well qualified doctor, during a busy Monday morning surgery, needing to spend 17 minutes on the phone arguing with an unqualified clerk and then a pharmacist, neither of whom is empowered to use their common sense. Any regulation, no matter how well thought out, is likely to produce anomalies.

A sensible system would recognise this and have a mechanism in place where common sense can prevail for the well being of the patient, if not for the prescribing doctor trying to prescribe for them.

M. Kamien
Professor and Head
Department of General Practice
University of Western Australia
Perth, W.A.


PBAC response

The problem to which Professor Kamien refers results from the particular way the product information for Fragmin was structured by the sponsor at the time of registration approval from the Therapeutic Goods Administration.

The product information for Fragmin has since been amended and the `indications' section no longer restricts the use of ampoules and single-dose syringes to particular indications.

To allow for greater flexibility of dosage, the Pharmaceutical Benefits Scheme listing has been changed by the addition of a 7500 unit strength for use in the treatment of deep vein thrombosis. In accordance with requests from the sponsor, the items now listed on the Pharmaceutical Benefits Scheme are graduated single-use syringes.

M. Kamien

Professor and Head, Department of General Practice, University of Western Australia, Perth, W.A.