Julian Hill (Bruce, Australian Labor Party) Share this | Hansard source

Lydia, some years ago, had already paid back $3½ thousand to the Commonwealth for a debt she did not owe. This was because she got a notice claiming the debt. She knew that she'd reported her income correctly to Centrelink every fortnight, but when she tried to get the documents to prove that—the debt was more than five years old—her tax agent said, 'We don't have them, because you don't have to keep documents for more than five years.' She went to the business, but it had gone bankrupt, so she couldn't get the payslips. As she had no way of proving that she did not owe that debt, she was compelled by the brutality, the bullying of the state to repay $3½ thousand she did not owe. Lydia has worked for over 10 years as an English as a second language teacher. She works on an intermittent casual basis, so her income fluctuates throughout the year. Therefore, because of this casual work, she relies at times on income support payments to make ends meet. The government's cruel robodebt has a real human impact and is incredibly distressing. Lydia summed it up to me in one word, which was 'unjust'.

The government, of course, have now hit the brakes on this scheme after immense pressure from Labor and after the threat of a class action. They panicked after hearing from the lawyers but didn't listen to the community, which has been crying out for years about the unjustness of this robodebt extortion scheme. They're still pretending there's nothing wrong. The minister said in question time that backtracking on the scheme doesn't prove that anything is flawed, but it's a very late admission that there's something rotten at the core of robodebt. Questions still need to be answered. What happens to the victims of robodebt over the last few years who have repaid money?

What happens to the money which has been improperly and unjustly obtained by the Commonwealth? This is a harsh misuse of government power.

The government, in effect, has been acting like an internet scammer, scaring vulnerable and innocent people with the Commonwealth crest saying, 'Pay up or we'll get you.' It's had a particularly negative impact—I know from my electorate—on migrants to this country, who struggle to challenge this unclaimed debt and get extra terrified when they see the government's coming after them. Robodebt has had extraordinary impacts on my community after struggling with six years of cuts to essential services.

I want to turn my remarks to another topic, which is the need for Australia to get real on medicine safety. Too many Australians are being seriously injured, sometimes with lifelong impacts or dying, because of the weakness in our pharmacovigilance system. In a recent study the Pharmaceutical Society of Australia estimated the extent of the problem at 250,000 annual hospital admissions as a result of medication related problems and 400,000 additional presentations to emergency departments, likely because of medicine related problems. There's an annual cost of $1.4 billion, and yet 50 per cent of this harm is estimated to be preventable.

I have spoken before about my concerns in this area, and so have many other advocates, but the government is still not taking these issues seriously. Every day of inaction means Australians are at risk of death or serious harm from medicines when it could be avoided. I have spoken a number of times in the parliament about how, almost three years ago, my daughter almost died because she was prescribed an old and dangerous drug, Diane-35, for a purpose for which it was not approved. No-one told her this before she took it. Her doctor did not tell her and her pharmacist, therefore, could not. There was no possibility of informed consent. There was a clear failure to warn of potentially serious side effects, so she took the drug, developed a 64 centimetre blood clot in her leg and almost died after a long-haul flight from Sri Lanka.

I believe this lack of informed consent is wrong in Australia. It is a fact that there is a higher likelihood of side effects when a drug is prescribed for a purpose other than which it is approved by the TGA. Of course many off-label prescriptions are safe. The TGA recognises that off-label prescriptions may be clinically appropriate in some circumstances, but it also recommends that such use only be considered where other options are unavailable, exhausted, not tolerated or unsuitable, in essence, because it is riskier. Failure to inform and warn patients means they cannot decide for themselves, and the quality of the conversations between doctors and patients is therefore diminished.

What was meant to be a family holiday for us quickly turned into a nightmare. If Elanor had been told about the heightened risk of blood clots, she would not have taken that drug, especially before long-haul travel. There were so many opportunities for her to be told of the risks, yet but no-one was required to tell her. These types of iatrogenic illnesses are far too common in Australia. However, due to flaws in our medicine safety system, the real size of this problem is unknown. The health minister declared in July this year that medicine safety is a national health priority. He said:

I am delighted to announce and confirm today that the Australian Government will now move through the Council of Australian Government's process to make the quality and safe use of medicines a National Health Priority. He said:

That work is underway and we will not stop until it is done.

But it's almost six months on and there's no evidence that the government has a plan or any specific commitments beyond the rhetoric. It looks as if the minister needed an announcement to go to the conference so they dreamt this up.

I want to propose again a few areas of concern that should be looked at seriously if the minister is serious about this and willing to look at difficult issues. The areas of concern are: firstly, this broader issue of off label prescribing—again, the practice of prescribing TGA approved drugs for a purpose for which they were approved; secondly, Australia's adverse reporting regime, which is underreporting, as compared to other jurisdictions; thirdly, the transparency of the TGA's operations. I'll flag this as a topic for another day, given the lack of time available.

Off-label prescribing is not a new concern. The general risks have been talked about for years. The medical negligence lawyers are warning doctors. There is endless public reporting that doctors bear increased legal risk for off-label prescribing. Good old Dr Google provides oodles of information about the risks and the clinical and legal issues involved.

I'll demonstrate the problem, quickly using my daughter as an example. The doctor prescribed her an off-label drug. Elanor presented with an indication and the doctor says, 'You should try this drug,' and yet that drug was not actually approved for that indication. Diane-35 was approved for severe acne, when other options had failed, or excessive body hair, in the case of androgyny. They're pretty narrow indications, because the drug makers knew they could never get it approved as a contraceptive pill. They could not; it would not be approved. There are safer, more modern alternatives. The issue here is consent. There's no obligation in Australia for a clinician to tell a patient that the prescription they've been handed is for a drug for a purpose that it was not approved for. The critical feature there of consent is, I believe, that a person should consent to treatment. But how can this be so if they don't know all the facts? I believe we need to look at a positive duty on clinicians. It's there. It says that good clinical practice is that you should foster informed consent and tell patients about this, but it's not mandatory. I'm told by many clinicians who agree with my position that this is controversial because of the doctor's lobby. I'll talk about that in a moment. But my belief is that people in this parliament and the health minister should first and foremost stick up for consumers.

The next thing that happens, of course, when you get that script is you go and get the drug from the pharmacist. In Australia, the pharmacist does not know if a prescription is off label, so the pharmacist has no ability to warn or provide information about possible side effects and the heightened risks that we know will come. I believe we should look at a system whereby pharmacists can simply be notified by a tick box from the doctor if a prescription is being given for a drug for a purpose for which it was not approved. Other countries have this.

Thirdly there is the issue of adverse events. You have to have post-approval monitoring to see what side effects are happening. Again, this goes back to the idea that the clinician should have an obligation to notify of adverse events. In Australia again there is no obligation on doctors to notify of adverse events. I'll talk further in a moment about that.

Through this example of my daughter and what happened to my family, I came to investigate and learn far more about these issues of off-label prescribing. They're systemic; they're not isolated concerns. My view, I know, is shared by various doctors, academics, regulators and colleagues, both in the Labor Party and indeed across the aisle, about the general concerns, and I'll state them, about off-label uses. Firstly, in many cases rigorous scientific evidence of benefit does not exist. Patients taking the drug are not protected by the manufacturer having been required to at least show how this drug has the claimed effect in premarket studies. This is like the situation with all drugs pre-thalidomide and pre-modern drug regulation introduced in the 1960s in all industrialised countries, including Australia.

Secondly, a study of adverse drug reactions in off-label uses without strong scientific evidence of benefit that included over 45,000 patients found high rates of harm with off-label use compared to approved use. Around 20 people per 10,000 experienced harm with each month of off-label use, versus around 13 per 10,000 with approved use. That's not a big difference but when you scale it up it is material. This is not a new concern. The government has known about this for years. For instance, in 2014, the Senate Select Committee on Health heard evidence that the licensing subsidising and monitoring of pharmaceuticals in Australia was far from transparent and effective. The Health Consumers' Council submission suggested seven reforms to improve transparency and safety. One of those seven reforms called for a proper look at the incidence of off-label prescribing:

7. The Commonwealth Government should commission or conduct research into the incidence and impact of 'off label' prescribing. The research should concentrate on the health impacts of off label prescribing and the extent of PBS subsidisation for the off label use of medications. Based on the outcome of this research the Commonwealth Government may consider if over time it is worth encouraging 'off label' prescribing to become 'on label'. This could be achieved by gradually enforcing PBS subsidisation of medications to those prescribed within the approved guidelines. This may encourage pharmaceutical companies to apply to the TGA to expand the range of authorised uses of their products and would help ensure that prescribing practices are supported by robust evidence.

The PBS comment is an interesting point, worthy of exploration in a proper inquiry to help ensure taxpayers' dollars are not subsidising ineffective or dangerous off-label prescribing, because currently the PBS specifies indications for which subsidisation is available, but those indications don't match the approved on-label uses and there is no penalty for, or policing of, prescribers who lie. In essence, in plain English, if you prescribe a drug for an approved purpose when it has been prescribed for another purpose and lie about it, nothing will happen. The truth is no-one really knows the extent or the PBS cost of off-label prescribing.

As I said, to be clear—I just want to put this on the record—off-label prescribing is not always a problem. The submission goes on to say:

Off label prescribing does not necessarily result in adverse outcomes, often patients benefit. But it is unregulated and outside safety parameters established through licencing process. The extent to which medications that are listed on the PBS and prescribed 'off label' receive full subsidy is unknown but the cost is likely to be substantial. The net health benefit (or loss) of off label prescribing is also unknown and warrants investigation.

In essence, we have no real idea of how common this is in Australia or its impact. Furthermore, the HCC cautioned:

However once a drug has been approved doctors are free to prescribe it as they see fit, even in contravention to the manufacturer's recommendations ('off label' use). 'Off label' prescribing occurs so regularly that it has, in many cases, become the norm.

Again I say that I'm not proposing to remove that clinical discretion, but I do think that we should have informed consent. I think we need a proper look at the extent to which this is happening.

There are many examples, not just Diane-35. Firstly, there is the off-label prescription of antidepressants and youth suicide. There is not one antidepressant approved by the TGA for use in Australia among people under 18—not one. Yet, in 2017-18, nearly two per cent of Australian children were prescribed an antidepressant. This practice is completely unregulated and outside the safety parameters established through the licensing process. Worryingly, there is now a statistical correlation in Australia between the rate of prescription of antidepressant drugs for young people and youth suicide. Between 2008-09 and 2017-18, antidepressant prescribing for people between the ages of nought and 27 increased by approximately 66 per cent. In that same period, suicide rates in that cohort rose by 49 per cent. Before this, the rate of prescribing was decreasing, as were suicide rates.

Between 2006 and 2016 there was a 98 per cent increase in intentional poisonings among five- to 19-year-olds in New South Wales and Victoria, with substantial overlap between the most commonly dispensed psychotropics and the drugs most commonly used in self-poisonings. To be clear: correlation, of course, is not causation. The causes of suicide are complex and we cannot draw conclusions based on this data alone. But these statistics now—we have 10 years of them—are red flags that need investigation because there is no adequate mechanism in Australia whereby our regulatory body is required to investigate what is going on and there is no requirement for doctors who prescribe these antidepressants off label to report instances of suicide if they're aware of them.

Particularly worrying is the US FDA's warning that antidepressants are associated with increased risk—approximately double—of suicidal thoughts and behaviours in people under 25 years. I understand that this is a contentious and controversial area. There are many mental health advocates—indeed, some of the most prominent in Australia—who are strongly in favour of such prescribing, while others urge caution. But the 10 years of data now and the epidemic of prescribing should be enough to warrant a serious look at the issue.

Another example is the sedative drugs used in aged-care facilities. The recent royal commission into aged care revealed that antipsychotics, antidepressants and sedatives were being used at an exceptionally alarming rate in Australia's aged-care facilities to control residents. These drugs were mostly prescribed off list for behavioural symptoms of serious diseases, such as dementia, rather than for the purpose which the TGA had approved the drug. They were used on patients far too often for the wrong reasons—to cut costs for the aged-care facilities. The fact that this practice happened is a source of national shame for our country. The epidemic, out-of-control practice of off-label prescribing should be seriously looked at.

They are just two examples. There are other worrying examples. Antipsychotics, such as Seroquel, are used at low doses to treat insomnia in patients without mental illness. Clinical trials have failed to show benefit, yet this practice is widespread. Motilium is used for inadequate breast milk supply. There is no clinical evidence of its efficacy. I note that the EU restricted its use in 2014 to no more than 30 milligrams a day for no more than one week—that's the on-label use—and recommended against off-label use, including for breastfeeding. Ketamine is being prescribed for depression. The list is long.

As I said, the UK and several European countries require doctors to inform patients—it's a legal positive duty—when they're prescribing off-label drugs, so informed consent is required. I'm not proposing that we remove clinical discretion from doctors, but I do think we need to look at strengthening that duty to inform patients.

Also important is adverse reporting. A robust postapproval monitoring system is a critical part of drug safety. A key part of this is to ensure that adverse incidents from taking a drug are reported to increase the body of clinical knowledge about off-label use for the benefit of all consumers. In comparison with similar jurisdictions, Australia now has relatively low rates of adverse incident reporting. The raw data over the last five years is concerning. The majority of reports come from pharmaceutical companies, which are under a legal obligation to report. This has risen over five years from about 9,000 reports in 2014-15 to about 14,000 reports in 2018-19. That's good. Yet over the same period we've seen a fall in the number of reports from doctors—from 4,831 to 4,415. In Australia, astoundingly, there is no obligation on the part of doctors who prescribe drugs to report adverse impacts to the TGA, even when prescribed off label, and only a fraction are reported.

After her near-fatal blood clot, my daughter rang her doctor's surgery and said, 'Have you reported this to the TGA?' I think they freaked out. A week later they rang back and said, 'We've had a practice meeting and decided that that's not appropriate and we don't need to, because blood clots are a known side effect of the pill.' What a nonsensical answer. The point is that we need to collect statistics on how often this is occurring to determine if drugs are safe or not. So why are doctors not obliged to report suspected adverse medication incidents? I get the paperwork argument, but we can automate this stuff now. When a doctor changes someone from one medication to another, why can't they press a button and have that automatically go to the TGA so that we get better data?

Australia needs to think critically about reform because the current system is not effective. If the health minister were serious about making medicine misuse and danger a national health priority, as he said he is, he would look at these more difficult issues.

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