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

Just over two years ago a 64 centimetre blood clot almost killed my healthy 20-year-old daughter Elanor after she was prescribed the old and dangerous drug Diane-35. This drug has never been approved for use in the US and was banned in Europe in 2013 for a time after too many women died of blood clots. It was prescribed to Elly off-list as a contraceptive pill simply to regulate irregular periods, despite only being approved for use in Australia to treat acne and excessive hirsutism in cases of androgyny. Yet Diane-35 is still prescribed by Australian doctors off-label as a contraceptive without proper warnings, education or discussion about the risks. All contraceptive pills have the risk of blood clots, but the risk with Diane-35 is higher than the more modern, safer alternatives. Quite simply, while for a small number of women it may be on balance okay, it should not be prescribed as a first-choice contraceptive, yet it still is. Just to explain, 'off label' or 'off list' are terms used when a drug is prescribed to treat a condition other than what it was actually approved for.

In relation to my daughter, after two years of treatment and seeing every type of doctor imaginable, Elly is now left with serious lifelong impacts, such as irreversible damage to multiple veins and intermittent swelling and pain—post thrombotic syndrome. She had another blood clot late last year as the veins are so damaged. She'll probably be on blood thinners forever. She can't have surgery without coming off them. She is waiting for the doctor to say she can risk a break to have her wisdom teeth out. She has very sexy and expensive leg stockings. She is unable to ever take the contraceptive pill again. She has constant check-ups, doctors appointments and tests, risks in pregnancy, expensive travel insurance and longer term risks of serious deterioration, ulcers and worse.

Since we first spoke publicly a year ago, Elly and I have worked together to raise awareness and speak up on behalf of women across Australia. I've been contacted by hundreds of women with similar harrowing stories. Some women did not live to tell their tale and I spoke with their families. I promised that I would not give up pushing for changes to reduce the harm from this drug, and I have not. I have spoken to pharmaceutical companies, regulators, the minister, colleagues in the Labor Party, across the aisle and on the cross bench, including Dr Phelps.

These efforts last year produced some positive changes, including stronger, harmonised product warnings and the Pharmacy Guild's new professional development modules. The Royal Australian College of GPs, under the presidency of Dr Bastian Seidel, was wonderful and pushed out awareness campaigns to GPs. The TGA considered the many requests I made and provided reasonable responses. But it's still not enough.

Despite my efforts, I don't think enough has changed. I have no hesitation in saying that there are still women in Australia today who needlessly die or are at risk of harm due to this drug. I'll give you one small illustration. Only late last year my daughter told me in frustration that a close friend of hers went to the GP and asked for a contraceptive pill. The GP prescribed her Diane-35 as the first choice, without asking any family history and warning that this drug was not approved as a contraceptive or that it was risky. Fortunately, she remembered that that was the drug Elly was on and walked out of that GP to find a better doctor. Not all women would be so lucky.

I've come to realise, however, 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. More can and must be done to improve drug safety and to minimise harm to Australian patients. A key focus for the inquiry should be to 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.

In Australia currently, while the TGA recognises that off-label prescription may be clinically appropriate in some circumstances, it recommends that such use only be considered where other options are unavailable, exhausted, not tolerated or unsuitable. There are inherent risks in prescribing off-label drugs. Drug companies of course make a commercial decision when they choose to get a drug approved for certain indications. They pick the easiest thing and then may pursue other indications, or word may just spread that it's also good for X or Y, through case studies or clinical practice and so on. But in off-label cases there is insufficient clinical data about the efficacy in the novel situation that they're being prescribed for, and they could have unknown, serious or possibly irremediable side effects.

Scientific literature indicates that an adverse reaction is more likely to occur soon after a patient commences a new drug, and risks are heightened where a drug is prescribed for a purpose other than one for which it is approved. Particular risks—which I don't have time to outline tonight—apply for patients aged over 65 years and children. Australian clinical practice currently encourages doctors to discuss medication risks with patients, but there is no legal obligation in this country upon doctors to inform patients when the drug they are prescribed is off-label.

In effect, in being prescribed off-label drugs, the patient is being subjected to an experiment which may or may not work but could have unexpected medical outcomes or complications. It's critical that patients be fully informed about this by doctors so patients can decide whether they wish to take a drug, knowing of the risks and being extra watchful then for adverse side effects.

The UK and several European countries, including France, Spain, the Netherlands and Sweden, require doctors to advise patients when they're prescribing off-label drugs so their informed consent is obtained before they commence any drug regimen. There is no reason not to adopt a similar model in Australia. The Australian Advisory Committee on Medicines has recognised that informed consent is critical in all prescribing decisions. Requiring Australian doctors to give patients the choice of whether to accept the risks or not, by informing them that the drug is being used contrary to label and may have unknown consequences or complications, will lead to better quality conversations between doctors and patients, increase patient awareness of risks and potentially adverse drug reactions and empower patients.

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. 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.

Another key focus for the inquiry 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. Pharmacists, of course, have a significant role in drug safety and patient education. 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. As the last professional link in the prescription chain, pharmacists in Australia 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.

Reporting of adverse reactions, of course, is so important, as it increases the body of clinical knowledge about the off-label use for the benefit of all consumers, so an independent inquiry should also be tasked to examine improvements to Australia's adverse event reporting system. There were about 17,000 reports to the TGA in 2016 of suspected adverse events due to medicines, yet Australia now has relatively low rates of adverse incident reporting in comparison with similar jurisdictions. This is something that in all our systems we should be aiming to be world leading in, right at the top.

There's no clear responsibility for reporting. It can sit with anyone, including consumers, practitioners and drug companies. Adverse event reporting by sponsors such as pharmaceutical companies and medical device suppliers is mandatory, and around 54 per cent—so the majority—of the total reports in 2016 were received from that source. Yet there's no mandatory obligation on doctors or clinicians to make reports to the TGA of suspected adverse reactions. This seems astonishing to me on the face of it, when our rates of reporting are lower than they should be. There's also room for improvement in consumer reporting. Australia was an early adopter of consumer reporting in 1964, yet only six per cent of reports received in 2016 came from consumers.

So an independent inquiry should consider a requirement for the mandatory reporting of adverse events by medical professionals and the circumstances in which that is a reasonable thing. It should consider training of all medical practitioners in adverse event reporting and support for this. In informal conversations it seems the practices are very varied in different practices and it is just not part of the culture. The use now of IT systems can automate this process. When a doctor is changing a patient from one drug to the other, it can become a fairly simple automatic check so you're not tying people up in red tape and paperwork. And there should be a public awareness campaign of the TGA's ADR reporting mechanism in order to improve the rates of consumer reporting.

In closing, I want to do my best, having committed to follow this issue through, to make sure that what happened to my daughter does not happen with other Australians—not just with the drug Diane-35 and the many names that it is marketed under but, as I have come to discover, with the much broader issue about off label prescribing Australia. These are sensible practical recommendations that can improve the situation.