Monash professor urges action on epilepsy drugs

The Australian Government’s PBS urgently needs to update prescribing rules governing the use of anti-epileptic drugs that are putting unborn children and doctors at risk, the head of Monash University’s Department of Neuroscience has warned.

Professor Terence O’Brien said in a recent opinion piece in the Australian Medical Journal, co-authored with Professor Christian Gericke from the University of Queensland, that PBS rules for prescribing anti-epileptic drugs (AED) were 30 years old, and conflicted with those of regulatory agencies in the US and Europe.

Current PBS rules mandate that patients should be prescribed the older anti-epileptic drugs first, and only in patients in whom these fail can the newer generation drugs be prescribed. For patients with generalised epilepsies (when seizures start in both hemispheres of the brain) this means they need to be prescribed valproate first. Valproate is the most effective drug for patients with this group of epilepsies, but is associated with a high risk of birth defects, including spina bifida, and neurological development problems such as autism in babies, Professor O’Brien said.
“In fact, if a doctor followed the PBS rules, prescribing valproate first to a woman with a generalised epilepsy after which they became pregnant and had a baby with a problem, you could potentially be successfully sued. On the other hand, if they don’t follow the PBS rules, and prescribe what was best for the women, then they are potentially open to prosecution,” he said. “Doctors are placed between a rock and a hard place.”

The PBS (Pharmaceutical Benefits Scheme) subsidises pharmaceuticals for public patients, with restrictions.

Professor O’Brien said that while valproate worked very well for epilepsy it shouldn’t be given to women of child-bearing age unless there was no other drug that could control their seizures. “Women of child-bearing age don’t always know when they’re going to get pregnant so for that reason you should not be prescribing this drug to them. A fifteen-year-old girl or a 45-year-old woman, can still become pregnant on occasions,” he said.

The review article was prompted by the continued frustration clinicians felt about the PBS prescribing rules, he said. “People have been complaining about these for a long time, but it’s actually the PBS, with the sponsorship of the pharmaceutical companies, that needs to go through the processes of changing them.

“We’d like the rules changed so prescribers have more freedom about which drugs we can prescribe first. There are alternatives that are safer for women to the older AEDs.”

Professors O’Brien and Gericke have called on the PBS to review the restrictions on levetiracetem and lamotrigine which are now available as general medications, and also those on other well-tolerated and effective medications.

Professor O'Brien said his call had attracted considerable reaction and that the Pharmaceutical Benefits Advisory Committee had indicated it would conduct a review of the guidelines.

Gericke CA, O'Brien TJ. Pharmaceutical Benefits Scheme restrictions on anti-epileptic drug prescribing promote unsafe and outdated practice. Med J Aust. 2019 Jul;211(2):55-57.e1. doi: 10.5694/mja2.50246. Epub 2019 Jun 30.