Off-label drugs a risky business

SAW Pink Pill - April 15, Medicine pills in hand, selective focus - StockMedicine pills in hand , selective focus

Three years ago a 64cm blood clot caused by a drug used to treat acne, Diane-35, almost killed my healthy 20-year-old daughter. It had been prescribed “off-label” to regulate another issue.

Off-label prescribing occurs when a doctor recommends a medication to treat a condition outside its Therapeutics Goods Administration-approved purpose.

Doctors can do this because once a drug is approved they are free to prescribe it drug for other uses.

Thousands of Australian patients­ are prescribed drugs off-label every day. Many benefit, however, adverse­ reactions are more common when drugs are prescribed off-label than on-label.

Patients prescribed off-label drugs are, in effect, being subjected to an unregulated experiment conducted by their doctor.

Presently, doctors are not compelled to inform patients that the drug has never been approved for that purpose.

This must change. Doctors should be required to obtain consen­t from patients or their parents in the case of children, preferably in writing, that a medicatio­n is not being prescribed for the purpose for which it was approved.

When doctors prescribe off-label, it is a win-win for drug companies. They sell more product but are not liable for any adverse outcomes unless they have promoted­ the drug for off-label purposes.

Tightening up on this may encourage­ pharmaceutical companies to have their drugs approve­d for a broader range of purposes and thereby help ensure that medication use is based on robust evidence.

Among the most common and worrying examples of off-label prescribing is the use of anti­depressants to treat depression in children.

No antidepressant is approved for the treatment of depression in people younger than 18, yet antidepressants were dispensed for more than 101,000 children in 2017-18.

In 2004, the US Food and Drug Administration warned that antidepressant use roughly doubled the risk of suicidal thoughts and behaviours in people­ younger than 25 years old.

Alarmingly, over the past ­decade an increased suicide rate among young Australians has correlated with a significant increase­ in the prescription of anti­depressants.

Correlation, of course, is not causation, and the causes of suicide­ are complex. So we canno­t draw firm conclusions based on this data alone. But a decade of data revealing an epidemi­c of prescriptions and suicides­ are red flags that warrant serious attention. Another example, exposed by the Royal Commission into Aged Care Quality and Safety, is the extensive­ use of antipsychotics, antidepressants and sedatives in aged-care facilities. These are mostly prescribed off-label and far too often for the wrong ­reasons — to cut costs, a source of national shame.

There are many other worrying examples of off-label prescribing, including anti-psychot­ics used to treat insomnia, and Motil­ium for problems with breast milk supply.

These concerns are not new. In 2014, the Senate select committee on health heard evidence from the West Australian Health Consumers’ Council that there should be an inquiry into off-label prescriptions. A 2016 study of 45,000 patients found significantly higher rates of harm with off-label drug use. Yet the government has failed to confront the issue.

In Australia, the TGA recommends that off-label use only be considered when other options are unavailable, exhausted, not tolerated or unsuitable. In these circumstances, patients should be fully informed by doctors so they can decide whether they wish to take a drug, knowing the risks, and being particularly watchful for adverse effects.

The Australian Advisory Com­mittee on Medicines has recog­nised that informed consent is critical in all prescription decis­ions. Australian clinical practice encourages doctors to discuss medication risks with patients, but there is no legal obligation for them to inform patients when the drugs are prescribed off-label.

France, Spain, The Netherlands and Italy all require doctors to advise patients when they’re prescribing such drugs and to obtain­ a patient’s informed consent before they commence any drug regimen.

We need a similar model, with appropriate exemptions where consent is practically impossible. Full clinical discretion can be preserved­, as off-label prescribing is often appropriate, but our doctor­s should be required to give patients the choice of accepting the risk. This would lead to better quality conversations between doctors and patients and more empowered patients.

Change could be achieved by mandating a positive duty in the national law that controls the Australian Health Practitioner Regulation Agency and the medical boards. Doctors’ lobby groups may protest, but private conversations suggest many practitioners would be receptive.

Health Minister Greg Hunt announced last November that medicine safety was now the 10th national health priority area. A public inquiry into off-label prescriptio­ns would help fulfil this promise, whether by experts, a reference to AHPRA, or a parliamentar­y committee.

Related opportunities to strengthen this regime could also be considered. Why not require prescribers to notify pharmacists that a drug prescription is off-label, as happens in some other countries?

Pharmacists have a significant role in drug safety and patient education as the last professional link in the prescription chain, and could provide a critical additional check in improving patient awareness of the risks and what to be vigilant for.

We deserve the strong­est possible drug safety regime, yet we have fallen behind so many others. We can and must do ­better.

Julian Hill is the federal member for Bruce.