MP calls for greater pharmacovigilance in Australia

Paul Hayes 6/12/2017 12:58:29 PM

Federal MP Julian Hill speaks with newsGP about increased pharmacovigilance in Australia following his daughter’s near-fatal experience with off-label prescribing.

News teaser
Federal MP Julian Hill wants tighter restrictions on off-label prescribing in Australia.

Elanor Hill knew something was seriously wrong with her leg while on holiday in Sri Lanka earlier this year. Not long after the long-haul flight from Australia, she experienced pain and swelling in her calf that continued to worsen.
Her experience of working in a medical clinic meant Elanor was sensitive to the signs of deep vein thrombosis (DVT) and her father, Federal Labor MP Julian Hill, was able to get her to a hospital in time to address the clot in her leg.
Prior to the trip, 20-year-old Elanor had been prescribed Diane-35 for use as a contraceptive. While Diane-35 is regularly prescribed as a contraceptive in Australia, it is also used as an anti-acne medication. Diane-35 has previously been temporarily banned in France due to increased risk of blood clots.
In a speech to Federal Parliament last night, Hill said that his daughter had never been made aware she was being prescribed an off-label medication, nor of the fact it comes with a risk of blood clots. He is now calling for tighter restrictions on off-label prescribing, with patients given more information when prescribed a drug for a purpose other than that for which it is TGA-approved.
‘The point I have tried to make very rigorously, methodically and based on evidence and consultation with every part of the pharmacovigilance chain, is actually that there is a safer way to do things that reduces these risks and will definitely save lives and reduce the incidence of blood clots,’ he told newsGP.
Hill’s quest to improve pharmacovigilance in Australia has seen him engage with a number of healthcare bodies in Australia, including the RACGP, Pharmacy Guild of Australia, Pharmaceutical Society of Australia, National Prescribing Service, and the TGA.
‘There is room to improve Australia’s overall pharmacovigilance regime, or drug safety systems, because everyone has a little piece of that puzzle,’ he said. ‘Australia’s overall regime is a lot weaker than many countries in terms of making pharmacists aware and putting some extra thought or discipline on clinicians when they are doing off-label prescriptions.
‘There is no automatic notification of the pharmacist where that has been done, so the pharmacist can provide some extra education at the counter and say, “This is an off-label prescription, you have probably got some high risks, here’s a few of the things you should look out for”.’
An important factor in the case of Hill’s daughter Elanor was that she has a relatively common genetic mutation Factor V Leiden, an inherited blood-clotting disorder. However, there is no routine testing or screening for this disorder when prescribing Diane-35 in Australia.
‘Things like that Factor V Leiden test could easily be worked in to significantly reduce the risk [of blood clots]. Any doctor I have spoken to has said, “If I knew someone had that genetic disorder I would never prescribe this pill”,’ Hill said.
Hill understands that GPs must be supported if they are to perform a test for Factor V Leiden before prescribing Diane-35.
‘That [Factor V Leiden] test would need to be listed on the Medicare Benefits Schedule … which is it currently not,’ he said.
Hill does not pretend to have all of the answers in this situation. He knows that GPs and other healthcare professionals are extremely time-poor and always working with their patients’ best interest in mind. However, he sees cases like his daughter’s and believes Australia’s policy-makers have a role to play in helping the country’s doctors and pharmacists carry out the safest possible prescribing habits.
‘I strongly argue that it should be scheduled so there’s the requirement of a blood test, and a warning be put on the packet so that consumers are crystal clear that it’s not approved as a contraceptive in Australia,’ he said.
‘I also think that helps to support doctors in their role to explain to patients who may be pushing for this drug, that it is a more risky choice.’




Max Kamien
Did the daughter know she had the Factor V Leiden before or after the DVT?
Did she have a regular GP?
Did The Hon J Hill talk with anyone with a better understanding of the issues than he has? Was this just bad medicine or poor patient education and knowledge? Methinks the Hon. J Hill has a way to go before travelling down the bureaucratic and regulatory pathway.
8/12/2017 8:32:44 PM

Max Kamien
This is just poor medicine. 20 year-old works in a medical clinic. Knows about DVT, also knows she has a genetic mutation that makes her a candidate for a DVT especially before long distance flying and when taking high oestrogen containing contraceptives. So she knows a bit but not enough to keep her safe. The prescribing GP also has the same basic knowledge that would be used to pass an exam but also can't apply what he or she knows. Bet that is because the necessary information is not in the patient's medical record. Or this is a drop-in medical practice lauded by non-comprehending patients as 'terrific' because you don't have to book or wait, 'they give you what you want', and it's free.
And the solution according to medically illiterate father and politician is more legislation. More bureaucratic time wasting eating into the time that GPs should be spending with patients. In short this near tragedy is due to poor medicine, poor medical education of the patient and the remedy is not more bureaucracy. Surely MP Julian Hill has the nouse and resources to get better informed before pretending to have any expertise in this area.
8/12/2017 1:50:47 PM

Antje Sharman
I cant see that this is OFF LABEL use - if you go on TGA web page and search for diane 35 it tells you that is is used for treatment of acne AND can act as a contraceptive - where does the off label use information comes from ??? any decent GP will inform the patient of possible risks before prescribing anyway and then it is up to the patient to make the decision.
8/12/2017 1:35:05 PM

Factor V Leiden and its effects were discovered in 1994. Modern medicial practices needs to ensure that the women who have this condition are not put at unnecessary risk. I support the idea that a screening blood test be introduced to prevent further unnecessary suffering.
8/12/2017 12:07:42 PM

Philip Dawson
all oestrogen containing contraceptive pills carry the risk of deep venous thrombosis, more so in smokers (we were not told her smoking status in the article). The risk is mainly related to oestrogen dose, although some but not all progestogens also carry that risk.While Factor V Leiden may be one of the more common thrombophilias it is not routinely tested as it is relatively rare. However a family history should alert of the need for testing.
8/12/2017 10:22:30 AM

Pharmacist should not have prescribing rights .This is only the tip of the iceberg!!
8/12/2017 10:21:21 AM

Farid Zaer
Mr. hill should focus on workforce issues and his electoral area and its people, off label use has been practised forever, and yes the TGA has its reasons to limit its use, but that does not mean it cannot work in other situations, and by the way Mr. Hill Diane-35 was approved by TGA for its beneficial effects on the skin! I am too old to be a politician, but I would know my limitations if I were to have started younger in the field of politics.
8/12/2017 10:15:06 AM

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