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

I want to make some remarks—this is a non-controversial bill; I'll say that at the outset, as you can tell by the fact that I don't think anyone else is speaking on it—but I want to firstly make some remarks about schedule 5, which piqued my interest. It gives medical practitioners greater flexibility to prescribe unapproved therapeutic goods. In response to that, I asked some questions. The minister's office—and I thank them for this—set up a discussion with Professor Skerritt, the head of the TGA, which was very informative.

What I discovered—which is not apparent from the bill, because it's incredibly arcane, technical, pharmaceutical regulatory architecture—is that in essence this is a very sensible schedule but it introduces a form of off-label prescribing. That is when a drug has not been approved by the TGA for a purpose for which it's prescribed by a medical practitioner, with very clear requirements for informed consent. I want to spend a little bit of time talking about this. In essence, just to explain the schedule, there's a group of medications, I think they're called special access C medications. They're often either: old drugs that have been taken off by the sponsor because they don't want to pay the annual fee, because there's only a few of them prescribed each year and it's not commercial; or they're drugs which, for whatever reason—usually because they have very small markets and are very rarely used—might have been approved in larger markets such as the United States or the EU, but have never actually been approved for use in Australia. But they have, importantly, been approved somewhere else in the world in a comparable country with similar oversight to the TGA.

What this bill does is, effectively, tidy up the arrangements whereby medical practitioners can get access to these drugs. Currently, a doctor can just prescribe them, but the authorised prescriber scheme doesn't allow for it. What the bill does is allow an authorised prescriber for a certain patient group. They still have to go through ethics committee approvals in their respective specialist colleges and apply to the college. They can go to the TGA and then get an authority, effectively, to prescribe these rarely-used drugs for a particular patient group. But, importantly, the requirement then is that the patient—or, in the case of children, their parents—has to provide written informed consent, which stays on the file of the medical practitioner. I think it lasts for about three years, or something of that order. That all seems quite sensible. It cuts red tape, effectively, for the prescriber, who currently has to fill in a special access form for each individual patient. So that all makes sense.

However, what it raises for me is a really important example of the government actually acting on the requirement for informed consent for off-label prescribing. So I use this opportunity to renew my call to the House for an inquiry into off-label prescribing. Off-label prescribing is, in essence, when you go to the doctor and the doctor gives you a script for a drug for a condition. You might have something wrong with you, whatever it may be, and they're recommending a drug for you for a purpose other than that which the TGA has approved it for. It happens every day, and it's enormously beneficial to many patients. There's no fundamental concern about clinical discretion. But it's also clear that there is a higher risk—I confirmed this with the head of the TGA and I've seen scientific studies—in aggregate where there's no rigorous scientific proof that's been undertaken for the drug to treat a particular condition. The medical negligence lawyers know this and they've been warning medical practitioners for years that they run a high risk of medical negligence in the case of off-label prescribing. There was a study of adverse drug reactions on off-label uses without strong scientific evidence of benefit with over 45,000 patients which found high rates of harm with off-label use compared to on-label use. In one sense it's a small difference—around 20 people per 10,000 versus 13 per 10,000—but when you scale up that to a population level it's very material. Indeed, the TGA's own warnings in Australia say very clearly that they recognise off-label prescribing may be appropriate in some circumstances but recommends that such use only be considered where 'other options are unavailable, exhausted, not tolerated or unsuitable'. The TGA has written to me a number of times confirming that off-label prescribing is not endorsed by the TGA, yet anyone and everyone knows that it's widespread.

My point is not to restrict clinical discretion, despite what some of the response to this in the media has been. I'm not hunting the doctors. My dad was a doctor. I think it's great we don't have lawyers sitting in doctors' surgeries like we do in America and that we've got a pretty high bar. Doctors don't set out to harm people. I get that. But I do believe we should look at a requirement for informed consent in Australia. In essence, with an off-label prescription, a patient in Australia is being subjected to an experiment by their doctor. There have never been any scientific rigorous tests. Drug companies have not run the gauntlet of the TGA to get a drug approved for a particular purpose. The doctor is conducting an experiment on them. It may be an experiment they've conducted many times or that doctors across the country have conducted many times, but it is still not approved, and I believe that Australian patients have a right to be told when that experiment is being conducted on them. That's all. There should be a positive duty on a clinician to tell a patient, 'The script I'm giving you now is for a purpose other than which the drug's been approved in Australia.' I've spent a lot of time with medical practitioners, with the Pharmaceutical Guild, with the PSA, with Medicines Australia and with others, and I think in many quarters there's quiet support for this proposition to at least be tested through a proper inquiry into off-label prescribing. That would promote better quality conversations between medical practitioners and patients. It would allow the patient to decide whether they want to accept that risk and, particularly, to look at the side effects.

I got into this issue in a personal way. My daughter almost died three years ago from a near-fatal blood clot from her ankle to her hip from an off-label drug. I've spoken previously about this and I won't repeat it at length. It was a drug called Diane-35. She'd been prescribed it—and she's asked me to talk publicly about this; I'm not disclosing her medical history—to regulate irregular periods. It's a very common issue for young women. She was prescribed this drug which is only approved for excessive acne and to treat excessive body hair in the case of androgyny, but its side effect is as a contraceptive. It would never be approved as a contraceptive in Australia because it's got a higher risk of blood clots than other more modern contraceptives, but it's widely prescribed by doctors. Anyway, I've spoken elsewhere about that.

More recently, there's the case of antidepressants and youth suicide. There was a study released Monday last week, which I spoke on in the Federation Chamber and which was reported on in the media last week. In essence, it points out that not one antidepressant is approved in Australia to treat depression in children—kids under 18 in effect—yet nearly two per cent of Australian kids are now taking an antidepressant. Correlation is not causation, but in the case of that massive epidemic of off-label prescribing we see over 100,000 Australian kids taking antidepressants, none of which have been approved, and over the last 10 years we've seen the suicide rate per capita in young Australians rise by 49 per cent correlated with a rise in antidepressant prescribing of 66 per cent. The US FDA in 2004 and 2007 looked at the risk of suicidality and suicide ideation and behaviours in antidepressants, and they issued their highest form of warning, black box warnings, in 2004 and 2007 for antidepressants prescribed for young people. In Australia, the TGA decided to not take that action, and they took much softer action in 2005. I think this is a problem. I think after 10 years of data heading in the wrong direction, it's time that we actually had a proper inquiry into this.

For the first time, actually, in the decade or so, this issue has been raised by some—and it's quite controversial; it's disputed within the mental health community of Australia. The paper was co-authored by the professor of psychiatry from the University of South Australia. These are not fringe dwellers or nutters. They have a fundamentally different view of this issue to the doyens, the mental health establishment professors McGorry and Hickey, and Beyond Blue, headspace and Suicide Prevention Australia—all the people who've been recommending this epidemic of prescribing. And that's fine; the scientists should contest it. I'm not an expert. But the point is that, with 10 years of data heading in the wrong direction, the suicide rate going up and the prescribing rate going up, to the point where Australia now has the second-highest rate of antidepressant use across the whole population of any country in the world—second only to Iceland—it's time that we had a proper look at this.

In that regard, I'm really pleased with the health minister's response to the speech that I made last week and to the paper. The health minister indicated to The Sydney Morning Herald that he'd asked his department to review the results of the study and have an inquiry into this matter, though the extent of that inquiry is as yet unclear. The study raised issues not just in regard to the dispute about prescribing; it also raised significant issues in regard to the quality of prior research that had influenced the TGA's response to the issues raised in the FDA warnings and challenged the veracity of the advice of the prominent Australian suicide prevention experts and mental health organisations.

So I welcome the health minister's inquiry, but I would also welcome his advice, whether to the House or shortly, as to what the terms of reference for this review are, what the time frame of the review is, what age demographic is to be analysed, and whether antidepressant use and suicide data is to be analysed. Since I made the speech and since the media reporting last week, I've been contacted by many people across Australia from all age groups reporting concerns around this issue. Will the review consider the quality of research that informed the prior TGA responses to the FDA warnings? Will the review consider the veracity of the advice of prominent Australian suicide prevention experts and prominent mental health organisations? Who will be conducting the review? Will there be an opportunity for public submissions to the review? How, if at all, will the authors of the study be consulted in the review? They stand ready to assist, contribute their views and explain their paper. I note that it was a peer reviewed paper in a proper psychiatric journal. What's the reporting deadline for the review, and will the review report be made publicly available? I'd welcome the minister's advice on that.

I've previously outlined other examples of off-label prescribing which are of concern. Shamefully for this nation, one example of off-label prescribing is the use of sedatives in aged-care settings. I understand the difficulties around informed consent with dementia patients and emergency settings and all that kind of stuff, and of course you can provide for sensible exemptions, but there have been calls for some time for this kind of examination of off-label prescribing and of whether we can do a better job of regulating it. Given that the minister announced in, I think, November last year that medicines would be the ninth or 10th national health priority, this broader issue of off-label prescribing is an important issue that could easily be looked at through an expert inquiry.

In closing, I make the point that I welcome the minister's commitment to review the issues raised about suicide in young people and the link, or possible link, with antidepressants. But I do think there's a broader issue around the regulation and oversight of off-label prescribing in Australia. Ultimately, I don't think the TGA is responsible for this. It goes to an issue of clinical practice, and current clinical practice. Before I spoke about this in the previous parliament, I actually consulted with former member Dr Kerryn Phelps, who was in cautious agreement with some of the propositions I was putting forward but did agree that they should be tested through an inquiry and that there was enough of an issue to merit a proper examination.

Current clinical practice in Australia encourages doctors to discuss medication risks, but, as I said, there is no duty to tell patients when they're being given an off-label prescription. I think this is wrong. I think Australians should have the right to be told. That's what I would want to be told if I went in to see a doctor. What I think most people would like to be told is that the drug they're being offered or asked to take is not approved by the TGA for the purpose for which it's being prescribed. In that regard, one approach would be to have AHPRA, the Australian Health Practitioner Regulation Agency, look at the basic medical law and strengthen the requirement on clinicians to provide that informed consent. Other countries do this. It's important to note that several European countries, including France, Spain, the Netherlands and Sweden, require doctors to advise patients when they're being given off-label drugs so that they get that informed consent and, I would hope, have those better-quality conversations. I don't see any reason why we couldn't adopt a similar model here in Australia. As I said, you've got to carve out sensible things for emergencies, although there are particular issues with paediatrics because of the difficulties in getting ethical approval to conduct clinical trials on children. But, for example, in the case of the antidepressants, you've got 10 years of real-world data. If you're collecting the right data, after some years you can do a retrospective analysis which goes close to approximating a clinical trial. I spoke to Medicines Australia about that, and they agreed that, if the right data was there, that real-world data can be looked at.

My colleague the member for Dobell is a pharmacist, and pharmacists have a critical role also in that chain of events before a person actually takes a medication. They're often the last check in that chain, and so, as part of a proper look at off-label prescribing, I would suggest that we consider a requirement to notify pharmacists when a prescription is off-label, at least for the first time, so that at the pharmacist's counter they can have that extra minute or so talking about the side effects. I know that if my daughter had had the opportunity to be warned about the higher risks—she's like Saffy from AbFab: she's very sensible; far more sensible, they say, than her parents—I think she would have made a different decision about whether to put that drug in her body before getting on a long-haul flight, and she'd be in a very different situation now.

See this speech in context