Off-label scripts under the spotlight

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Pharmacists should be notified when and why a drug is being prescribed off-label says MP who has called for an inquiry into the practice

A federal MP, whose daughter suffered severe health issues after being prescribed an off-label medication, has called for an independent inquiry into Australia’s pharmacovigilance regime.

Among his suggestions is a requirement for pharmacists need to be informed when and why a drug is being prescribed off-label.

Julian Hill, MP for the Victorian seat of Bruce, spoke at length on the health problems experienced by his daughter after she was prescribed the “old and dangerous drug Diane-35” for use as a contraceptive pill to regulate irregular periods.

Mr Hill said the drug, banned in Europe for a time was prescribed “off list” and led to his “healthy 20-year old daughter” almost dying and needing two year of treatment. She now has irreversible damage to multiple veins and post-thrombotic syndrome, he said. 

He says Australia’s pharmacovigilance system has fallen behind world-leading standards, and an investigation is required. 

“I’ve come to realise… that the problem is wider than just Diane-35. Australia’s whole
pharmacovigilance regime—a fancy word for drug safety—needs strengthening. So I call tonight for an independent inquiry to officially review Australia’s pharmacovigilance system, as we have now fallen behind many other countries in too many areas,” he said in Parliament this week (19 February).

“More can and must be done to improve drug safety and to minimise harm to Australian patients”.

Among his suggestions are for pharmacists to play a greater role in vigilance of off-label prescribing, and for regulators to have the ability to impose restrictions, where appropriate.

A “key focus… should be to examine the introduction of a mandatory requirement for
prescribers to notify pharmacists on prescriptions when a drug is off-label and what ailment or illness it is being prescribed for,” Mr Hill said.

“Australian pharmacists are not generally involved in overseeing or second-guessing prescriptions. Nevertheless, pharmacists usually check patient understanding of prescription drugs and dosages prior to dispensing them.

With off-label prescriptions, this final check cannot be as effective in Australia, as pharmacists are unlikely to know why a drug is being prescribed or to have sufficient pharmacological information about a drug’s risk profile if it’s used off-label”.

“In other countries, such as the US, some European countries, Thailand and the Philippines, there is this extra check, and pharmacists are notified when a drug is prescribed off-label so that better conversation can occur at the counter at that last check”.

He said that, as the last professional link in the prescription chain, pharmacists could “provide a critical extra check in improving patient awareness of and education about those risks so patients don’t just take off-label drugs unwittingly and so they can encourage patients to return to them or to their doctor if they’re experiencing any adverse drug effect or side effect”.

He also said the inquiry should examine the introduction of a mandatory requirement that doctors advise patients that they are being prescribed an off-label drug with a potentially higher
or different risk profile and that they seek their consent prior to issuing the prescription, “unless this is practically impossible”.

“Some jurisdictions also give drug safety regulators an explicit power to step in and impose special conditions or restrictions in relation to off-label prescribing,” he said.

“I wish this would happen in Australia in relation to Diane-35 to stop it being handed out by lazy doctors as a first-line contraceptive”.

Click here to read more on the story of Mr Hill’s daughter’s health problems, which he says is linked to use of Diane-35 


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