Prescribing restrictions for anti-epileptic drugs expose flaws in the review process of the Pharmaceutical Benefits Scheme (PBS), a University of Queensland researcher proposes.
UQ neurologist Professor Christian Gericke said the PBS needed to implement an effective review process of its own restrictions that would allow Australian doctors to prescribe in accordance with American and European clinical guidelines that facilitated safe and up-to-date clinical practice.
"The PBS urgently needs to update anti-epileptic drug restrictions that put patients and prescribers at risk," Professor Gericke said.
"When a new medication is first listed on the PBS, prescribing restrictions are put in place to protect the taxpayer from unreasonably high costs.
"The current system for listing drugs is well organised and provides a good balance between taxpayer and patient interests.
"But there is currently no adequate and effective mechanism to review PBS restrictions once they are in place.
"In the long term, this fosters outdated prescribing practice and suboptimal care."
Professor Gericke said the problem was not limited to anti-epileptic drugs but they were a glaring example of it.
In 2018, the Therapeutic Goods Administration Advisory Committee on Medicines advised doctors to avoid prescribing the common anti-epileptic drug valproate to pregnant women, due to the risk of birth defects and reduced intelligence in children exposed to valproate during pregnancy.
"However the TGA recommendations cannot be implemented in daily prescribing practice in Australia unless the PBS lifts its restrictions on other anti-epileptic drugs," Professor Gericke said.
"In practice, most epileptologists and many physicians and general practitioners ignore the PBS restrictions and follow the international prescribing guidelines in order to provide safe care for their patients.
"These medical practitioners are at risk of legal and financial sanctions.
"It's not fair on doctors, and it's not fair on our patients.
"Doctors should not be forced to choose between safe patient care and complying with outdated government regulation."
Professor Gericke called on the PBS to urgently update its restrictions on the use of anti-epileptic drugs and to create a regular review mechanism of its own prescribing restrictions for all medications on the PBS.
"This will allow Australian doctors to prescribe in line with international best practice without imposing a financial burden on patients or contravening PBS regulations," he said.
An opinion paper co-authored by Professor Gericke and Epilepsy Society of Australia president Professor Terence O'Brien from Monash University is published today in the Medical Journal of Australia.