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.

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

Diane-35 Julian-Hill off-label-prescribing Pharmacovigilance

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Farid Zaer   8/12/2017 10:15:06 AM

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.

Mythily   8/12/2017 10:21:21 AM

Pharmacist should not have prescribing rights .This is only the tip of the iceberg!!

Philip Dawson   8/12/2017 10:22:30 AM

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.

Clare   8/12/2017 12:07:42 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.

Antje Sharman   8/12/2017 1:35:05 PM

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.

Max Kamien   8/12/2017 1:50:47 PM

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.

Max Kamien   8/12/2017 8:32:44 PM

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.

Anonimous   3/05/2018 4:46:06 PM

I apologize for unpleasant details, but I would like to ask not to ban Diane 35, to share what its Iike without it and some facts from my medical history. I hope it will help many people. I am in my late 30s and have been taking Diane35 for over 3 years non-stop without sugar-pill intervals. I am taking it because it helps me to remain functional in my daily life and protects me from cancers, specifically: helps against debilitating back pain, helps against debilitating headache, helps me against absence of night sleep, helps against different kinds of "out of place" feelings including feeling of doom that just falls down on you, also because I want to have children and my FSH decreased after I started it, very annoying to me high sexual drive also decreased after I have been taking it for a while, also I had endometrial polyp removed and I know that Diane 35 have been used to reverse abnormal endometrial growths, I also know that Diane 35 if taken for at least 4 years, as well as 4 pregnancies will significantly decrease my chance of developing ovarian cancer. Like the MP's daughter I was diagnosed with polycystic ovaries at the age of 19 or 20. They diagnosed it through ultrasound scan on particular days of the cycle and blood test for testosterone which showed polycystic ovaries, a cyst of the yellow body and very high testosterone levels, my pathology results were fabulous. In relation to high testosterone in me I remember the gyno-doctor asked me if I had a very active life, I think didn't but stress levels were inhuman being a uni student . I did have very little if any acne at that time. I was prescribed Diane35 for 3 months. I asked if it could decrease my long-term ability to have children, the gyno-doctor said that Diane 35 would increase it. I stopped after 3 months, 3 months was sort of a minimal limit standard I don't remember if any follow up was made. In a couple of years I experienced a horrid acne and sexual drive out brake I didn't go to a gynaecologist this time because I wasn't impressed with consultation quality and the way they prescribe birth control to improve my looks!? As my face was moon surface with craters and volcanos on it this time I treated it in a public Skin and Venerial Deseases Hospital - they took a puss swab from a pimple on my face and analysed it for reaction to different antibiotics, they identified the one they injected me for a few days together with blood cleansing injections and autohemotherapy from vein into backside muscle. My face turned from moon surface into flawless porcelain within weeks and remained pretty much ever since. The doctor who already cured my face with antibiotic recommended for me go on Diane 35. I didn't - I found it suspicious and insulting that they suggest birth control to help my looks, that's how they presented it and didn't explain the science behind. Years passed male free, gynaecological consultations free, child free, inhuman stress levels and very regular cycles. At age 32 my ovaries showed less ovaries they normally see at my age, I suffer from back pain, insomnia, headaches which are considerably reduced since I started Diane35 again. Only Diane 35 helps, the gynaecological consultation is worse then 15 years ago. Oh yes, like MP's daughter and some other white Caucasians I have blood clotting disorder, so I take aspirin daily, also I don't fly to Sri-Lanka while on a pill drink plenty of water and maintain physically active through the day - I am childcare educator. I still horrified with the fact that medical community needs to declare that a woman has moustache and pimples to be allowed to help her. Please don't ban Diane 35, I need it to have children and be able to make it to my work place.