Thursday, 3 August 2023

Bills

Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023

Second reading

Debate resumed.

Jacinta ERMACORA (Western Victoria) (14:02): Unsurprisingly, this bill places an emphasis on women and reproductive health. I would like to point out that once again the Victorian Labor government is following through on its record of improving access to reproductive health for women in Victoria. The Andrews Labor government has already made important investments in women’s health, including funding Victoria’s first-ever sexual and reproductive health phone line. The Victorian budget 2023–24 is investing more than $153 million to completely change the way women’s health issues are treated in our state. This includes initiatives such as establishing 20 new comprehensive women’s health clinics to provide free comprehensive care and support for Victorians experiencing conditions like endometriosis, pelvic pain, polycystic ovary syndrome and for those managing the symptoms of perimenopause and menopause.

This bill, at a critical primary care level, very importantly gives women far easier access to birth control, which remains largely the bailiwick of women. This bill will make contraception more affordable for women, it will make appointments more timely and it will make accessibility easier, as contraception will be available in more locations now that pharmacies are involved, particularly in rural and regional areas.

By making antibiotics for some mild UTI conditions available and easily accessible through pharmacies, this bill will help many Victorians. UTIs, which are urinary tract infections, are common and can be very painful and debilitating but can often be easily treated with antibiotics. Outcomes are often better when treatment is accessed early, which this bill will facilitate. As Daniel Andrews has succinctly put it:

When you wake up feeling sick, or you run out of your prescription medication, it doesn’t do you any good if you can’t get in to see your GP for more than a week.

Women in particular across every generation are impacted by UTIs. I know of one elderly gentleman taking care of his wife, who has dementia. They are dealing with her incontinence, which is leading to increased UTI bacterial infections. These infections are obviously a source of discomfort and are compounding her general disorientation. He is currently finding it very hard to make an appointment within weeks at the doctor’s, let alone within days. He recounted his gratitude to his GP, who recently rang him at 7:30 at night to let him know a script would be waiting for him the next day. We can all imagine the stress of waiting for that outcome. To be able to simply go straight to the pharmacy and receive an antibiotic treatment in a timely manner would make their lives much easier and would also help to alleviate pressure on a GP’s already fully committed diary.

Skin conditions, particularly mild ones, are very common and affect all parts of the community. For example, the Australian Institute of Health and Welfare reports that one in three people will develop shingles in their lifetime. It just makes sense that Victorians with an already diagnosed painful condition such as shingles should be able to easily access the treatments they need in a timely manner from their local pharmacy. Under the pilot pharmacists will also be able to administer travel and other public health vaccines, including for hepatitis A, hepatitis B, typhoid and polio, to people from five years of age.

This bill puts strong clinical governance first and foremost. Clinical governance describes the systems, processes, leadership and culture that help us to deliver safe health care. These governance systems address patient safety and quality systems, clinical performance and quality systems and a safe environment for delivery of care. These are things that will be prescribed and described in the pilot. All aspects of clinical governance have been covered by this bill.

The pilot will include the establishment of a wideranging clinical governance committee and an advisory group. The advisory group membership includes representatives from organisations and groups representing the pharmacy and medical professions, consumers and government, as listed below: Victorian Pharmacy Authority; the Pharmaceutical Society of Australia, Victoria branch; the Pharmacy Guild of Australia, Victoria branch; the Royal Australian College of General Practitioners, Victoria branch; Gippsland Primary Health Network; Rural Doctors Association of Australia; Health Issues Centre; Women’s Health Victoria; Victorian Aboriginal Community Controlled Health Organisation – one person; and Safer Care Victoria – co-chair. The Department of Health will be the secretariat. So there are a wide range of highly experienced technical experts involved in capturing the learnings from this pilot but also in ensuring that the pilot is conducted in the way it is supposed to be conducted. A safe environment for the delivery of care is ensured, with all community pharmacies to be required to provide appropriate rooms and facilities for safe delivery of care.

There is a reason why Labor is trusted by the majority of Australians to look after their health at both federal and state levels. It is abysmal how Liberal governments have neglected Medicare for almost a decade. It can take weeks to get an appointment with a doctor, and the price gap is so big that many families have to bring their health issues to the emergency department rather than go to a GP. So is there any wonder emergency departments are overrun with people who have had to wait too long to go to the doctor and something which could have been treated more effectively sooner has now become a bigger problem? This is stressful for patients and for those working in the healthcare system.

I do think it is worthwhile noting that the shadow health minister at the time Mary Wooldridge, making a comment in 2018, a coalition election pledge, pledged to enable women to get repeat prescriptions of oral contraceptives over the counter from pharmacists. On this we certainly agree.

Locally, in my electorate of Western Victoria, empowering community pharmacists to better service our population will greatly alleviate the gridlock currently being experienced whilst trying to see a GP. The Standard newspaper in Warrnambool reported on 2 November 2022 that one in every 10 Warrnambool patients were waiting more than 3 hours to see the doctor. The new data showed this figure had moved even higher to an average wait time of 190 minutes for the longest waiting patients, 60 per cent higher than average. It is to this government’s credit that since then the new priority primary care centre recently established on 7 June has already had a significant impact, particularly in alleviating some stress from the Warrnambool Base Hospital emergency department.

This trial will provide important learning opportunities for pharmacists and important learning opportunities in the space of primary care, and I think this bill is yet another example of the Andrews Labor government doing what matters for Victorians.

David LIMBRICK (South-Eastern Metropolitan) (14:11): I am pleased to speak on the Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023, and I would like to start by saying firstly that what this bill actually does is set up a pilot program to allow pharmacies to distribute certain drugs that at the moment require prescription from a doctor – drugs such as the oral contraceptive pill and antibiotics for urinary tract infections and certain skin conditions. I am a very enthusiastic supporter of this bill. In fact my colleague Mr Quilty back in 2019 asked the health minister at the time, Ms Mikakos, why women were not allowed to buy the pill over the counter and why we were not doing a trial like they were doing in Queensland, and to our surprise she came back in one of those rare moments in question time where you get a good answer, and she surprised us by saying she was in conversation with her staff and colleagues at that very moment talking about a trial. It is unfortunate that it took four years to get here, but we are here nonetheless.

So I think that this is a great idea to allow women and people suffering these ailments to be able to just simply go to the pharmacist without having to go to all the trouble of going to a doctor and getting another prescription, especially for the pill, but I would like to state that I think that the government could go a lot further here. I think that there are a bunch of other drugs that could make a lot of sense ‍–

Sonja Terpstra: HRT – hormone replacement therapy.

David LIMBRICK: Potentially. That was not on my list, but I am open-minded about it. I have got a list of a few drugs here that have been suggested to me by my team and others that might actually be very useful.

Sonja Terpstra: I bet they didn’t have that. Was that on their list?

David LIMBRICK: It is not on the list. Firstly, anti-emetic drugs – many people who are suffering from nausea from chemotherapy or other conditions take anti-nausea drugs to manage their symptoms. This is a very, very time-sensitive thing. You do not want to go to the doctor to get a prescription and then go to the pharmacy to get the drug. In fact many people who suffer from this and have run out of their drug end up going to an emergency department to get treated. Clearly that is a waste of health resources, and I think it makes a lot of sense for that to be available after consultation with a pharmacist. Certain asthma medications – I note that you can already buy Ventolin over the counter, and that was a good development; one of my own children suffers from asthma. But there are also other drugs like asthma prevention medications. I think that if someone has already been prescribed it in the past it makes sense that they should be able to get those drugs after consultation with the pharmacist.

Another drug that I am quite familiar with is EpiPens for children and adults that suffer from anaphylactic allergy conditions. I think it makes a lot of sense for them to be available over the counter. It is actually a real pain going through the whole process of just updating it, because they only last a year and then you have to throw them out. My family also has to purchase these every year. I think it makes a lot of sense for those. And while we are looking at women’s sexual health issues, we might as well look at men’s sexual health issues. For a drug like sildenafil, commonly known as Viagra, why not allow that over the counter as well, and a whole range of drugs that make sense with the skills of a pharmacist and with consultation. They are fairly low risk, most of these drugs, especially things like EpiPens. Children carry them around. They are fairly safe, and they are not going to cause a lot of issues. If someone has already undergone some initial consultation with a doctor in the past and has a consultation with the pharmacist, I think that makes a lot of sense.

I really look forward to this trial going ahead. I hope it is successful. I would urge the government to go a bit further. It sounds like there are some in the government that are keen on that as well, so that is a good thing. I think it will save taxpayers money and it will save consumers time and potentially money as well. It will lower the drain on our hospital system, because people will not be going to emergency wards. I know that some doctors probably are not happy about it because they will not have as many customers, but nevertheless we have to put patient autonomy first and trust the decisions of patients as much as we can. I think that pharmacists have more than enough skills to be able to handle this and consult with patients and dispense these types of drugs without a prescription. I commend the bill to the house.

Sonja TERPSTRA (North-Eastern Metropolitan) (14:16): I also rise to make a contribution on the Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023. In a strange confluence of events, I find myself agreeing with Mr Limbrick. I did not think I would ever say that. I think I might have said it once before in this term.

David Limbrick: You’ve said it a couple of times.

Sonja TERPSTRA: No, I think only once before, but here we are again. I am quite surprised that I am actually agreeing with Mr Limbrick. As you can see, I have listened to a number of the contributions –

Bev McArthur: There’s hope for us all.

Sonja TERPSTRA: There is. I have listened to the contributions in here today, and I think we are all on a unity ticket in regard to this bill. I think the common themes that are coming through are that the amendments that are being made by virtue of this particular bill will mean that more people can get access to the prescription medications they need sooner and have easier access.

I think some things stood out to me, particularly as a woman but also as a mum: when your children are little, you are always at the doctor’s, because there is always something going on. You might need a script for this or that. It starts to mount up, particularly if you cannot find a bulk-billing doctor. I remember living in Canberra for a while when my children were little. There were no bulk-billing doctors in Canberra at all at that time. In fact if you found a GP, if they were bulk-billing, they were not taking on new patients, so you just found whatever doctor you could get. Nevertheless, to get in to the doctor you would still have to wait weeks. I found that very disappointing, and at a time when we were living on one income, I think the payment that I had to make was $70. My kids are in their late teens and twenties now, so that was a long time ago. For me, as a parent, I was weighing up: do I use that $70 to actually make the GP visit and wait 3 hours? They were always running late, and with little kids it was hell on earth going to the GP, I must say. I used to hate it because my son particularly was a very active toddler. He would be climbing the walls and running around and all that, and people would give me the death stares. But this is the reality of being a parent with toddlers when you are going to the doctor. You just hope and pray that they are running on time, and of course they never were. It was incredibly stressful as well. On top of that, then you would have to get your script for whatever it was you needed, and then you would go off to the pharmacy and you would obviously have to pay for that as well. That is just talking about it from having young children. I think that that cost mounts up.

As a young parent and certainly as mum, you find that the expenses you are expected to bear as a woman often far outweigh those of men. That is a generalisation, but I was someone that was healthy. All things being equal, if you are a male or female and you are healthy, you generally do not need to go and see your GP unless you want a check-up or an annual check-up or whatever. But women, generally speaking, have more reason to go and visit their GP for things like if you are taking the contraceptive pill, if you are taking HRT – hormone replacement therapy – or if you need to go for your annual Pap smear. I was really grateful to see the recent announcement that you can now do the Pap smear at home on your own – because, yes, we all love going off to the doctor and getting the Pap smear! We hate it, and I love the fact that you can now do it yourself. So that was a great announcement as well. There are a variety of reasons why women do not like to do that. Particularly if some women have been through sexual assault and have to go through that procedure, it can be quite confronting and triggering. So there are a range of reasons – cultural reasons as well – that women were sort of not wanting to go down that path, but of course it is important to make sure that they are getting these things checked out.

I think women suffer from the inequality factor when they are having to go and find money if they cannot find a bulk-billing doctor and they are having to get these scripts and medications, so being able to go to a pharmacy and just get the pill is fantastic. It means there is no doctor visit, so if you have not got a bulk-billing doctor you are saving that money in your pocket and, rather than waiting for 3 hours because your doctor is running late, you can just go down to the pharmacy and grab what you need and be on your way.

I also note there was some discussion around urinary tract infections and things like that. I did meet with the Pharmacy Guild of Australia earlier in the year, and they were telling me the number of hospital admissions that include UTIs. It is always incredible in this job – I find myself in a very fortunate position – that I always learn things that I thought I would never have the need to know. But once you learn them you go, ‘Oh, wow, that’s really interesting; I did not know that.’ So with the incidence of people being admitted to hospital emergency departments because they had a UTI, clearly, had they been able to get to a doctor before that to get the antibiotics they needed or whatever treatment they needed, they would not have needed to end up in hospital. I was interested in that. I said, ‘I wonder why people are going to the emergency department.’ The recollection was that there were a range of factors, like not being able to get to the GP because they cannot afford it and not being able to afford the medication. So these changes allow people to be able to go to the pharmacy.

I heard some discussion in some of the other debates about the complexity of UTIs: well, yes and no. I think just about every woman in this chamber would have had a UTI at some point in their life, and you know when you have got one and you know what you need. After you have had your first UTI you go to the doctor, and they do a test with a stick in the urine and either it tests positive or it does not. If it tests positive, you know you need antibiotics. It is not hard; it is pretty straightforward. Being able to have that done perhaps at the chemist and them being able to say ‘Here’s the appropriate medication’ means that you are going to get that treatment earlier.

The problem is, if you cannot get into a GP, you have got to wait longer and potentially run the risk of that infection getting much worse and then ending up with a kidney infection. In fact that happened to me one time when I was younger. I had a UTI. I could not see the doctor for a number of days. I was prescribed antibiotics by the doctor. They turned out to be the wrong antibiotics, so it got worse. These things do happen, but that could happen at the GP or it could happen at a pharmacy – it could be either/or. But it is certainly something that is going to mean that women are not being put in a position where they are having to face economic disadvantage and having to find money that they may not have, when, all things being equal, men are not put in the same position. They do not have to find that amount of money, because they are not experiencing the same sorts of conditions that impact women.

I think these changes are good. As Mr Limbrick said, this is a pilot and it is a trial, so they are obviously just testing the waters to see. I am hopeful and look forward to the pilot and the trial and other things being added as we go. I think they should.

I mentioned – I was singing out about it – HRT to Mr Limbrick. I know there are a number of women who experience symptoms in relation to going through menopause, and hormone replacement therapy can absolutely make a huge difference to women when they are going through that change in life. I think it should be more widely available. Some hormone replacement therapy treatments, I think the patches, are on the PBS, for example, but some in the tablet form are not. So I think there is work to do for the federal government around that. I would like to see all forms of hormone replacement therapy on the PBS, because they are currently not. That is annoying. and there are reasons for that. But again I think about women who may not be able to get access to their GP, who may not be able to access the care. You are backwards and forwards to the doctor all the time. You are getting blood tests. They are trying to figure out what is going on. Is there some other underlying condition or is it just the change of life? And then they may prescribe patches for you, and it might work for you, it might not. So there is a bit of a process there. But once you have got that sorted out, you do not really need to go backwards and forwards to the GP all the time, like every month, to get a script. That is the same scenario that you find with the contraceptive pill as well. It makes perfectly good sense.

I note some of the other things that participating pharmacists will be able to do are immunisations for travel and other public health vaccines – hepatitis A, hep B, typhoid and polio – for people from five years of age in a community pharmacy setting. Well, why not. Absolutely, it is great. It will be fantastic.

In Victoria there are 1453 community pharmacies and 8324 pharmacists with general registration, and the participation pilot that we are looking at rolling out will be on an opt-in basis for pharmacists and consumers. That is a good thing. The pilot’s design will be informed by an advisory group representing key stakeholders, including pharmacists, doctors, the community and consumers. There is a process there for ongoing feedback and refinement should it be necessary. The pilot will be evaluated of course with all of the feedback through the clinical reference group and advisory group. They will test how well it is going and whether it is timely and meets patients’ needs and all the like. I think anything that is going to save women money and enhance their ability to access the medications and care that they need when they need them is good.

I have got friends who have children who are diabetics as well, and they have medications. I know in the public hospital system some people are under the care of a diabetes nurse educator as well. There are services there that they may not go and see a GP for, but they will see the nurse in hospital if they have been in hospital and they get discharged. They might have some ongoing contact with the diabetes educator as well, so there is certainly scope for other things to be looked at as part of the trial. There are lots and lots of other things. Again, it is good. It is going to save people lots of money.

I think we can see the benefits that are already happening in other states like New South Wales and Queensland. In 2020 Queensland established a two-year pilot of the structured prescribing of pharmacists for uncomplicated UTIs – and that is hopefully at that point that you get to before it gets worse that you catch them early and you can treat them quite easily and quickly – and the Queensland UTI pilot has demonstrated the effect of the community pharmacists prescribing program in Australia and how this model can improve access to safe primary healthcare delivery.

Something that I have noted too when I have been overseas, certainly in other countries, is that there are different regimes where you can go to a pharmacist and get things that you could never get here. I think I remember even being in France at one point and being able to get antibiotics for something at a chemist, and it was the first time I actually experienced that. I was quite surprised that you could get some things over the counter in different countries without a prescription that you simply could not get here in Australia. So I think in Europe perhaps they have been ahead of the game there for some time where perhaps we have had a more restrictive system for whatever reason. There are certainly examples that I have found where you can get things over the counter in other countries that you just could not get here, so it is good that we are finally catching up.

Also then, turning to New South Wales, they are currently implementing the statewide trial of appropriately trained pharmacists to supply certain treatments for uncomplicated UTIs in women and continuing the prescription for resupply of low-risk oral contraceptive medications as well. In New Zealand the supply of selected oral contraceptives by pharmacists has been available since 2017. Again you can see there are lots of examples in other jurisdictions where trials have been underway and are successful and have been successful and successfully operating, so it is about time we did this. It is good to see us catching up.

As well, I might just say in the 2 minutes that I have got left it was really pleasing to see the announcement by the federal government – and I know this is not related to this bill, but it is sort of tangentially related to pharmacists – just cleaning up the dispensing of RU 486, the medical termination pill, which previously was only available through pharmacists by prescription, but they had to be participating because they had to have the training to be able to do it. What that meant was that for women there was not an equity of access across the state. So if you could not find a pharmacist that was participating to be able to fill that script, it meant you had to travel or go somewhere to find it. It was really pleasing to see that restriction being removed by the federal government for training for pharmacists and to see that that would, I guess, provide greater equity of access. I am really pleased to see a range of work being done on improving access to healthcare requirements for women, whether it be prescription medications or certainly in the area of women’s reproductive health. So that was certainly pleasing to see that as well.

Again, this is tangentially related, but I note in the UK Parliament there is actually a committee dedicated to looking at the impact that menopause is having on the workplace, in regard to women experiencing menopause, and they are doing a power of work looking at the economic impacts of menopause on the workplace. I am heartened to see those sorts of things, particularly in relation to women’s health. I look forward to seeing our federal government perhaps leading some more work in that space as well. I know our government, as a progressive government, would always be open to supporting those sorts of reforms. I commend this bill to the house and also encourage all members in this house to support the bill as well.

Matthew BACH (North-Eastern Metropolitan) incorporated the following:

I echo the sentiments of Ms Crozier and other speakers on this side. Different medical professionals have different views about some of the matters we have been debating. But they do not have different views on the importance of physical exercise and participation. Another reason why the government’s cancellation of the Commonwealth games is such a disaster for our state.

Ingrid STITT (Western Metropolitan – Minister for Early Childhood and Pre-Prep, Minister for Environment) (14:31): I will try not to take too much time in making some comments about the bill. I would like to thank members for their contributions on this bill. It is obviously an important process that we are going through here. By amending the Drugs, Poisons and Controlled Substances Act 1981 to create a mechanism for pharmacists to be legally authorised to supply some prescription-only medicines, the bill is really essential to delivering our 2022 election commitment, backing pharmacists to boost our health system. Our government has committed $20 million in the state budget to deliver the 12-month community pharmacist statewide pilot enabled by this bill. From October this year the pilot will enable community pharmacists to treat, as others have said, mild skin conditions and uncomplicated urinary tract infections (UTIs), reissue supply of oral contraceptives and administer more travel and public health vaccines – so a very practical set of measures for piloting.

For many Victorians it can be quite hard to see a local GP at short notice, and not being able to see a GP can really be frustrating and distressing when people are experiencing these sorts of mild conditions. That is why our government is delivering this pilot – to improve community access to affordable, timely primary health care, particularly for women. The pilot will expand the role of community pharmacists and help ease pressure on the healthcare system more generally, including general practice and hospitals, particularly in regional Victoria. Victorians accessing care under the pilot will pay no more than if they had sought the same treatment from a bulk-billing GP.

The passage of the bill will allow for amendments to, as I have said, the Drugs, Poisons and Controlled Substances Regulations 2017 to authorise pharmacists to supply specified schedule 4 medications directly to consumers in accordance with established prescribing protocols outlined in an approval that will be issued by the Secretary of the Department of Health.

The Department of Health has been working closely with the pilot’s expert clinical reference group and the advisory group, which have been established to provide expert clinical, quality and safety advice to support the successful design and implementation of the pilot. This will be chaired by Safer Care Victoria and include experts in microbiology, general practice, pharmacology, antimicrobial stewardship, women’s health and community pharmacies, among others. The clinical reference group will ensure that the pilot operates with all of the necessary safeguards to ensure safe and quality care for consumers. The pilot advisory group is comprised of stakeholders representing the pharmacy and medical professions as well as consumers. It is providing key strategic and expert input to the operational and technical aspects of the pilot and will continue to be essential to engaging stakeholders through the design, rollout and implementation phases of this reform.

The pilot is modelled on successful trials in other states and is utilising existing materials from those jurisdictions. Pharmacists will be required to undergo specific training before they commence participation in the pilot, which will cover up-to-date clinical best practice. A thorough evaluation framework is a core part of the delivery of this pilot, which has been developed with the input of the expert clinical reference group and advisory group. The evaluation will assess how well and safely the pilot has improved consumer access to primary health care for the selected health conditions, particularly for women, as well as gaining an understanding of how this service can help ease the pressure on the broader health system. It will test how well the pilot is delivering treatment that is safe, timely and equitable, that meets patients’ needs, that provides a positive experience for patients and pharmacists, that is communicated, importantly, with patients’ usual GPs or other healthcare providers and that provides an alternative to hospital or GP visits.

Following the conclusion of the 12-month pilot, the results of this evaluation will be made publicly available. The evaluation we are undertaking for the Victorian community pharmacist statewide pilot is broadly compatible with the New South Wales pharmacy trial, and neither the New South Wales trial nor the Victorian pilot are being conducted as a randomised controlled clinical trial, as would be the case for a new medication or treatment, for example. Uptake of services under the pilot will be monitored closely, including uptake rates in metro, regional and rural areas. It is also worth noting that antimicrobial stewardship – have I got that right, Doctor? – is an important consideration in healthcare delivery, and evidence from New Zealand shows that pharmacist-led prescribing of antibiotics for uncomplicated UTIs in women did not increase overall antibiotic usage. Nonetheless, antibiotic prescribing through the pilot will be carefully monitored. All antibiotic dispensing to women accessing care for an uncomplicated UTI will be recorded as part of the pilot’s detailed evaluation, allowing for an assessment of prescribing patterns and antibiotic usage.

Of course the safety of Victorians in the delivery of health care is absolutely paramount, and that is why this pilot is being designed with safety as the top priority. A key role for the pilot’s expert clinical reference group, which is chaired by Safer Care Victoria, is to identify and advise on clinical risks and opportunities to ensure the pilot’s successful implementation, with a focus on delivering high-quality and safe care. Any safety issues raised during the pilot will be reviewed by the clinical reference group to identify opportunities to reduce risk and ensure the delivery of safe care. The pilot is also designed to ensure that wherever possible and with consent, a patient’s My Health Record is updated with relevant information and information is shared with the patient’s regular GP about their symptoms and treatment under the pilot.

The pilot evaluation framework will also assess the quality of pharmacist record keeping when providing services under the pilot, and the clinical protocols followed by the pharmacist under the pilot will set out clear pathways for referral to other healthcare providers where this is clinically indicated. These referral pathways will form a key part of the compulsory training that pharmacists will undertake before they are able to participate in the trial, as well as any other key guidelines and documents. To be eligible to participate, pharmacies will also need be able to provide suitable facilities to conduct services supplied, including private consultation space. This will enable pharmacists to have detailed conversations with patients on issues like contraceptive counselling, where appropriate. It is also worth noting that prescribing by pharmacists is already an established part of practice in a number of other countries, including New Zealand, Canada and the United Kingdom, and evidence from these jurisdictions, as well as from our friends in Queensland, indicates that it is safe and clinically appropriate.

This bill, by enabling the community pharmacist statewide pilot, will improve Victorians’ access to primary health care, particularly for women and people in rural and regional Victoria. It will save families money as they will pay no more to access care under the pilot than they would if they visited a bulk-billing GP, and it will strengthen our primary healthcare system, helping to ease pressure on GPs and hospitals. And finally, this bill will help more Victorians to access the primary health care they need when they need it most. I am very pleased to commend the bill to the house.

Motion agreed to.

Read second time.

Committed.

Committee

Clause 1 (14:40)

David LIMBRICK: I just have a couple of questions for the minister. I noted in my second-reading speech, and a number of other members, including members of the government, had ideas on other drugs that might be suitable for a trial like this. My question to the minister is: why were these particular drugs chosen for this trial instead of other drugs that might have been suitable for this type of dispensing?

Ingrid STITT: The scope of the trial was carefully considered, and as a number of people have already indicated in the chamber and I have just outlined, it will include the provision of a continued supply of selected oral contraceptives, treatment for some mild skin conditions and antibiotics for uncomplicated urinary tract infections. These were seen as the types of services that pharmacists would be well within their remit to be able to give advice to patients about. I think it is important that the trial is safe for patients, and these were considered to be the most appropriate treatments that should be tested through the 12-month trial period.

David LIMBRICK: I thank the minister for her answer. Noting that the bill itself does not actually specify any of these drugs but rather gives that power to the Secretary of the Department of Health, does that mean that the government has an intention to potentially expand the range of drugs that might be available without prescription under this scheme in the future, assuming of course that this trial is successful?

Ingrid STITT: No, Mr Limbrick. The trial is very specific in scope and nature, and we have given a commitment about the trial being thoroughly reviewed and evaluated, and a lot of that work will be done by the expert clinical advisory panel. So there are no plans to extend the trial. The treatments have been chosen carefully and they will be evaluated, and then that evaluation will be made publicly available and then it will be, I guess, a question of what happens beyond the trial.

David LIMBRICK: I thank the minister for her answer. My last question is: would the minister know how many prescriptions for these drugs per year happen at the moment in Victoria?

Ingrid STITT: I have got some stats, Mr Limbrick, on urinary tract infections that I can share. It is the third most common human infection after respiratory and gastro infections, and women are significantly more likely, obviously, to get UTIs than men, with an estimated 12 to 15 per cent of women being affected annually, which is quite a significant number.

In terms of oral contraceptives, it is the most used method of birth control in Australia among women at risk of pregnancy, with approximately 30 per cent of women who require contraceptives relying on it, and that is an Australia-wide figure, obviously, not Victoria-specific. But the clinical reference group is going to be finalising the oral contraceptives to be included in the pilot and the eligibility criteria for women to have their contraceptive resupplied without a prescription.

Skin conditions I think are a little harder to quantify, but for example, the Australian Institute of Health and Welfare reports that one in three people will develop shingles in their lifetime. But obviously there are a range of other common skin conditions that you would imagine are quite widespread, sometimes in children, such as eczema and the like.

David LIMBRICK: I know I said that was my final question. I do have one further question. I realise it is a federal expenditure, not a state expenditure, but considering the very widespread use of these drugs and potential large numbers of doctor’s visits that will not happen, presumably, do we have any sort of idea of the savings to Medicare of this type of scheme? It seems to me like it would be a fairly significant saving for the federal government; maybe they should give us some more GST or something.

Ingrid STITT: I might just ask for some advice from the box, but I like the way you are thinking.

We do not have figures to hand. We can see, Mr Limbrick, whether we are able to get anything relevant, but I think it is fair to say that that is not the primary driver of this policy or the government’s intent in carrying out this pilot. It is really about trying to provide timely and safe care which avoids the need for people needing to go and find a GP at short notice.

Georgie CROZIER: If I can just go to a couple of points: you spoke about the detailed evaluation and also the reference group. I am wondering if you could just outline to the house who will be on that reference group and how that evaluation will be undertaken. I thank the minister’s office for providing me with the first draft evaluation framework, and off the back of that it does speak about some follow-up surveys of pilot patients. I am wondering if you could please provide how those surveys will be conducted, who will be collating that information, how it will be collated – I am happy for these to go on notice, Minister, if you need to too – and what happens with those follow-ups for those patients during those surveys.

Ingrid STITT: Ms Crozier, maybe if I deal with the composition of the clinical reference group first. Firstly, let us look at the advisory group. The advisory group membership includes representatives from a range of different organisations, including the Victorian Pharmacy Authority, the Pharmaceutical Society of Australia, Victorian branch; the Pharmacy Guild of Australia, Victorian branch; the Royal Australian College of General Practitioners, Victorian branch; Gippsland Primary Health Network; Rural Doctors Association of Australia; Health Issues Centre; Women’s Health Victoria; Victorian Aboriginal Community Controlled Health Organisation; Safer Care Victoria; and the Department of Health. So that is the advisory group.

The clinical reference group will include experienced clinicians, pharmacists, educators and safety experts, including the Pharmaceutical Society of Australia; the Society of Hospital Pharmacists of Australia; Monash University faculty of pharmacy and pharmaceutical sciences and the Pharmacy Board of Australia; Therapeutic Guidelines Ltd; the Royal Australian College of General Practitioners and Monash Uni; Melbourne University and the National Centre for Antimicrobial Stewardship; an infectious disease physician, public health, north-eastern public health unit, Department of Health; a practising community pharmacist; the Alfred and Monash University; Austin Hospital; a dermatologist representative on the clinical reference group; Women’s Health Victoria; two representatives from consumer organisations; a number of representatives from Safer Care Victoria; and a number of representatives from the Department of Health. I note that the AMA has also been invited to participate in that clinical advisory reference group.

In terms of the details of the evaluation process itself, I think I have already indicated that we will make the evaluation findings public. I will just put my hands on the more detailed information. The evaluation will be led by the Centre for Evaluation and Research Evidence. Can you just bear with me for one moment please, Ms Crozier and Deputy President?

Thanks very much for your patience, Ms Crozier. Essentially the evaluation framework for the pilot is still being designed, with the input of that clinical advisory committee obviously. It is expected to use a combination of quantitative and qualitative data collected with consent from pharmacists and consumers, including data relating to services provided, and also via surveys of both pharmacists and consumers around their experiences with the service model. It will enable the pilot to be assessed against its intent to determine how effectively and safely it has improved consumers access to high-volume, low-risk primary care. As I have said, the outcomes will then inform future decisions about the suitability of extending authorisations to pharmacists in other settings. The pilot evaluation recommendations will be provided within an agreed time frame from the conclusion of the 12-month pilot. Does that cover off the key questions?

Georgie CROZIER: Thank you very much, Minister, for that response. That does assist. I am just wondering about the follow-up surveys for the patients. How are they conducted? Does that come from the individual pharmacist who dispenses the products or does that come after? Do they notify the department that they have dispensed these products? I am just wondering how those surveys are conducted and who does that follow-up.

Ingrid STITT: I can seek a bit more advice from the box on this, but I am advised that the evaluation will be led by the Centre for Evaluation and Research Evidence. The information I have is that we will be surveying both pharmacists and consumers, but I will just check for you whether that is being done separately.

Ms Crozier, it will be done separately. There will be obviously a very rigorous process in place for who conducts those surveys, and obviously the privacy of the results will be important before that information is collated and then eventually released.

Georgie CROZIER: Just on that, so it will not be the pharmacist that collates that information, it will be in the evaluation centre?

Ingrid Stitt interjected.

Georgie CROZIER: Thank you. If I could also just go to Ms Terpstra’s contribution. She spoke about going in and having a dipstick of urine in a pharmacy. It is not my understanding from the briefing that that would happen. Is that part of this? Is that part of what the expectation is for pharmacists to undertake? My understanding from speaking to the evaluator in Queensland is that it was more asking the patients that come in about symptoms and history rather than doing any clinical assessment like testing of urine. I am just wondering if the minister could clarify that – otherwise I think it is going to be quite problematic for pharmacists to be able to undertake that – and what they are expected to provide in terms of privacy and an appropriate space for patients to conduct that, if that is what Ms Terpstra has told the Parliament. I am just wondering if we could get some clarification on that.

Ingrid STITT: Ms Crozier, I thought Ms Terpstra was actually just talking about her experience of having had those tests done. I did not read it as part of the trial. But that aside, no, this is going to be for simple, uncomplicated UTI patients that can be supported by a pharmacist. There will be additional training provided to anybody participating in that pilot through a community pharmacy, but it will not involve urine testing, as I understand it. Yes, that is correct.

Georgie CROZIER: That was my understanding as well, but I thought I heard her say that. That is why I am asking you, because I was a little bit alarmed about the potential for that to occur. So thank you for that clarification.

If I could just move to some questions now that the AMA have provided to the minister in relation to some concerns about this pilot: will the government provide a copy of the documented processes equivalent to TGA processes that were used to assess the clinical risk benefit and patient safety of effectively down-scheduling schedule 4 medications?

Ingrid STITT: I will just seek some advice from the box.

Ms Crozier, no, this process is not going to be scheduling medicines. It will be structured prescribing under the protocol.

Georgie CROZIER: Minister, according to the AMA, the Queensland trial has shown that there has been evidence around pharmacists’ overdispensing of antibiotics. I am wondering how the government will implement external independent regulatory compliance oversight to identify, monitor and guard against pharmacists’ overdispensing of antibiotics and the like.

Ingrid STITT: In response to your concerns, or the AMA’s concerns, around ensuring that antibiotics are not overprescribed, I suppose it is relevant that a New Zealand study in 2017 found that the introduction of a community pharmacist program to treat UTIs did not increase the overall antibiotic use. However, antimicrobial stewardship is obviously an issue that will be closely monitored and considered in the pilot design. The risk of antibiotic resistance is being considered also by the pilot’s clinical reference group, which includes multiple experts obviously in this area, and their advice will be underpinned by the established and accepted therapeutic guidelines for prescription of antibiotics. The advice received will obviously be reflected in the pilot’s structured prescribing protocols for use within the trial.

Georgie CROZIER: Minister, in relation to record keeping and how that will be undertaken, for pharmacists or for the government to be able to track what is being dispensed, how will pharmacist documentation of a patient’s history and the service provided be undertaken to ensure that professional practice standards are adhered to? The documentation of referral – how will that be monitored and how will that occur? And the educational counselling provided to the patient – could you outline to the house how that will be undertaken or what the expectation is in relation to having privacy or how a pharmacist is expected to undertake those requirements when taking a patient’s history in essentially a retail setting?

Ingrid STITT: Perhaps if I can go to the safety issues first, Ms Crozier, a safety and escalation framework will support the pilot, and that includes monitoring of safe prescribing. The pilot’s governance structure includes obviously, as we have discussed several times already, the clinical reference group with that expert clinician membership, and a key role for that group will be to identify and advise on clinical risks and opportunities and provide advice to support the pilot’s successful implementation, with a focus on delivering high-quality and safe care. Safety issues raised and feedback provided during the pilot will be reviewed by that clinical reference group and obviously form part of any final evaluation. There will be requirements for pharmacists to provide information back to the patients – or customers, for want of a better term – GP or health provider, so that will be part of the terms of the pilot, if you like, that any participating pharmacist will need to undertake that record keeping. Just let me get some advice on the education aspect of your question.

Ms Crozier, all record keeping will be in accordance with privacy regulations which already cover the records of pharmacists. There will be a requirement for any participating community pharmacist to undertake training before participating in the pilot, and also within that training there will be information provided around the prescription and treating of these particular conditions that form part of the pilot. I think we have already mentioned that another aspect of privacy will be just the need for them to have some private consulting areas in the pharmacy.

Georgie CROZIER: Where pharmacists are required or recommended by pilot protocols to refer the consumer to a medical practitioner, what form will that referral take?

Ingrid STITT: I think, Ms Crozier, that would most definitely be covered off in the design of the pilot protocols, which is being overseen by that expert clinicians advisory group.

Georgie CROZIER: We have only got a few weeks till this pilot starts. When will that be all concluded?

Ingrid STITT: One moment and I will get some advice.

Ms Crozier, the advice I have is that work is already well advanced and is being worked through with the advisory body and also the clinician expert advisory panel, and it will be ready by the time we are commencing the trial in October – the pilot, I should say.

Georgie CROZIER: Minister, thank you for that reassurance. I would hope that would be the case, but I do think that is the concern that has been raised by a number of stakeholders about these time frames and having this pilot ready to go by 1 October, where there is a lot of information and work that needs to be done, particularly around patient information, the record keeping, who will be contributing to this pilot and what pharmacists will be able to meet the criteria. So I am a little concerned about the government’s time frames that they have set in place. I note that the Premier is advertising all over his Facebook that this is going to happen by 1 October, which I think is, you know, really presumptuous, actually, to be doing that before this actual legislation gets through the Parliament. But that is pretty typical of the Premier and his arrogance. Nevertheless I do think there are valid concerns from a number of stakeholders about those time frames, and I myself am a little concerned about it. There seems to be a lot that is still under consideration.

Nevertheless I will move on to another question, if I can. Could you outline what the minimum hours of experience in working in a community pharmacy patient-facing role are that will be required to be considered competent in giving out schedule 4 medications without a prescription – for a UTI, for instance?

Ingrid STITT: Give me one moment, Ms Crozier. I will seek some further advice, but obviously I have already indicated in answers to a couple of your questions that there will be training required for any participating pharmacists. Let me get that.

Ms Crozier, any participating pharmacists would need to be fully qualified and registered with the Pharmacy Board of Australia and undertake the training I have already outlined, as part of the terms of the pilot. In addition to that, the owners of the pharmacy would need to be registered with the Victorian Pharmacy Authority.

Georgie CROZIER: Would pharmacists who are part of this program be required to undertake continuing professional development to keep their skills or be abreast of new issues that are arising? Is there some sort of requirement that there is ongoing professional development for pharmacists?

Ingrid STITT: Ms Crozier, I think the best way to provide that answer is to go back to what the requirements are to be eligible to participate in the pilot. To ensure that pharmacists can provide that safe clinical service, they need to be familiar with the latest evidence or recommendations and comply with the relevant legislation. The training requirements will be determined by and the guidelines will by developed by the pilot’s clinical reference group to capture those requirements and will include educators from accredited pharmacy programs.

Georgie CROZIER: I also was a little concerned about – with all good intent, I think – Ms Terpstra’s contribution. She was talking about broadening the scope of medications to go to HRT and diabetes medication. I mean, these are very complex conditions that actually need close monitoring. I am sure the government will be fully abreast of understanding that the scope, even though it sounds very simple to the layperson, does need to be monitored and a patient’s health status needs to be considered by a medical professional, I would suggest, on a regular basis, rather than just having a carte blanche of medications or widening the scope. But in terms of the evaluation and the broadening of the scope according to the secretary’s abilities, is there a time frame for what the government is looking to do to broaden the scope of what has already been laid out in what this bill provides?

Ingrid STITT: To be fair to Ms Terpstra, Ms Crozier, I think she was sort of projecting about what might be great to include. But the particular treatments have been carefully chosen on the basis that they are the most low risk, if you like, and some of the most common minor ailments that people might present with. It will be important I think in that regard to make sure that the evaluation fully captures whether that has been successful and safe and obviously highlight any circumstances that could be improved.

Georgie CROZIER: There is no real issue with it, but I am concerned that there could be a perception within the community that people will go to the pharmacist and want a whole range of things because it is convenient, rather than going and getting appropriate medical care. I only raise that in relation to that scoping. So what are the time frames, as I said, for the evaluation to consider further medications to be on this list?

Ingrid STITT: There are no further treatments being considered. The idea is to run a 12-month pilot on those three prescribing models for the continued supply, and I think that is an important point, of oral contraceptive pills for women – that is obviously for people who are already on a prescription for that particular medication – treatments for minor skin conditions and antibiotics for uncomplicated urinary tract infections. All of that will be made abundantly clear in the pilot guidelines that are being developed by that clinical advisory group and also will be encompassed in the training that any pharmacist will be required to undertake before participating in the pilot.

Georgie CROZIER: I thought there were. I thought the briefing said – I could have that wrong – that this was a pilot for these particular conditions and for these particular medications and that there was room to further expand that at a later time. And my question is, which I might not have articulated properly: when will that be decided? When will it be decided by the department about that expansion?

Ingrid STITT: Not before the conclusion of the pilot and after the evaluation has been considered, I believe. Just let me double-check that.

Yes, that is right, Ms Crozier. We will run the 12-month pilot, evaluate it and assess the findings of that evaluation, but nothing further will occur until all of that has happened.

Georgie CROZIER: I appreciate that. I suppose the reason I ask is that there are concerns about how far you go with this. So the reason I ask that is the government obviously have some views about expanding this because they have just put these three areas in it and it can be expanded by regulation of course. But it really goes to the issues that the AMA was raising around what, in terms of the process and assessment of public health need, the government has undertaken to get to this point. I realise you are using this trial because it is being done in Queensland –

Ingrid STITT: Other jurisdictions.

Georgie CROZIER: and other jurisdictions, and it has been successful in other international jurisdictions. So that was the reason for my question. And I think the Victorian public would like to understand that, as well as the medical professionals.

But if I could just go to one last question, if I may. It has been raised with me about the cross-border issues, particularly around this area –

The DEPUTY PRESIDENT: Sorry, there are a couple of conversations that are just getting a little bit loud. Can we just keep our conversations down so we can hear the minister and Ms Crozier.

Georgie CROZIER: Minister, in relation to the cross-border issues, in New South Wales they have got a clinical trial going on. We do not. So what is it going to mean for –

Ingrid STITT: Oh, for border communities, you mean?

Georgie CROZIER: Border communities, correct – border communities and perhaps potentially those consumers that will cross the border. There will be different requirements from Victoria as opposed to New South Wales. What has happened between the Victorian and New South Wales governments, and how will you manage that – and South Australia?

Ingrid STITT: Ms Crozier, I will get some advice on that. It is a good question.

Ms Crozier, the advice I have is that Queensland, New South Wales and Victoria are working together insofar as they will be sharing information about how the pilots are going in those different jurisdictions. South Australia are not currently having a pilot of any type; they are having a parliamentary inquiry, which has not reported yet. In terms of what happens with cross-border communities and the like, you do not have to be a resident in Victoria to access this medication, but the pharmacist and the pharmacy do need to be based in Victoria.

Georgie CROZIER: Yes, and that was my point. So if we have got South Australians who are coming across the border to access a pharmacy in Victoria, then it is the responsibility of the pharmacy to keep those records. Do they pass it back to the South Australian health department or to the Victorian health department? Do they come under the – how does that get managed? Sorry, that is it.

Ingrid STITT: I will get some advice on that, Ms Crozier.

Ms Crozier, Victorian pharmacists, with the consent of a hypothetical South Australian customer, could share that information with their GP if they were given consent for that, but bearing in mind that all of the data from the pilot is being collected anyway, I think it would probably capture issues that might come up across borders. I do not think it would be significant. It may be more of an issue between New South Wales and Victoria, given the population centres on that border, but the difference there is that both states are undertaking a pilot of some sort now, or are about to.

Georgie CROZIER: That just sparked another question. My apologies, I said that was my last question. It goes to the point of international visitors: if they have got these complaints, can they just go into a Victorian pharmacy and get free medication –

Ingrid STITT: It is not free.

Georgie CROZIER: Well, not free, but can they get access to these medications and therefore their data is just collected amongst the entire – I mean, it is no different from travelling anywhere, but will their data become part of the pilot?

Ingrid STITT: I think that the data would be captured in terms of what was prescribed. Whether or not there was any request or compulsion to share that with a GP in, I do not know, Japan or Europe or wherever I think is another matter, but these matters will I think be crystallised in the protocols that are being developed prior to the pilot commencing.

Sarah MANSFIELD: Minister, I have got a number of questions. I will try not to repeat too many of the questions you have already been asked, but there might be some variations on themes. The first question is: is the government open to delaying the start of this pilot if it is not ready by 1 October?

Ingrid STITT: The advice that I have is that we are on track for October.

Sarah MANSFIELD: What public health need or data informed the choice of conditions and clinical scenarios that are included in this pilot?

Ingrid STITT: I did indicate, I think in an answer to one of Mr Limbrick’s questions, some of those statistics about those three conditions. They are very common, particularly the first two, for women. I am not sure if you were in the chamber for that answer, but particularly skin conditions – very widespread – uncomplicated UTIs and oral contraceptive pills for women, or the continued supply thereof, were seen as the most appropriate to form part of the pilot. Of course Victorians’ safety is paramount, and these were considered to be appropriate to be in scope for the pilot for this type of treatment.

Sarah MANSFIELD: Which stakeholders or experts were consulted prior to the announcement of the pilot?

Ingrid STITT: To date the main stakeholder consultation has been via those two advisory groups, so the general advisory group with those organisations. I am happy to restate them, but I think you were here for that and you would be aware of the membership of the advisory group. Of course the clinical reference group is made up of experienced clinicians, pharmacists, educators and safety experts. That has been the basis of most of the consultation. That is because obviously the bill is enabling the pilot; it does not establish the details of its operation. So stakeholder consultation will be an important component built into the later stages of the pilot’s development, and that work is underway. As we draw closer to the commencement of the pilot, that further consultation will occur.

Sarah MANSFIELD: I guess I am just trying to understand how the concept of the pilot, when it was announced by the Premier last year – what fed into that? You have listed some data around conditions, and I understand that is part of it, but what other consultation fed into the idea of the pilot that was announced last year?

Ingrid STITT: I think, Dr Mansfield, one of the contributing factors to choosing these particular treatments is to align with what is happening in other jurisdictions, both in Australia and overseas, and the desire on the part of the government to provide easier pathways for people to get treatment without the need to go to a GP in those limited circumstances.

Sarah MANSFIELD: I know Ms Crozier asked some questions about antibiotic resistance earlier, but I am just curious about how the government will actually monitor the impact of this pilot on antibiotic resistance. I am curious about how that will be done.

Ingrid STITT: One moment. I think that I have already referenced the data, Dr Mansfield, from New Zealand from that 2017 study, which found that there was not an increase overall in antibiotic use as a result of a pilot such as this. But this will be a very important aspect of the pilot design. Obviously, the data that is collected during the pilot will be critical in terms of assessing and evaluating how that has gone. We do not want to see a situation where there is overprescription of antibiotics, but in other jurisdictions where similar reforms have been pursued it has not been shown that there has been a significant increase.

Sarah MANSFIELD: It sounds like it will be an important part of the design. We are relying on studies that have been done in other jurisdictions to say that it has not had that impact in their particular trials with the way their systems were set up, but we are not necessarily going to be evaluating that here as part of the trial. Are we actually going to be monitoring for antibiotic resistance as part of this pilot here?

Ingrid STITT: Yes. The risk of antibiotic resistance is being considered by that clinical reference group in the design of the pilot. There are obviously, as I have indicated, multiple experts with relevant experience on that clinical reference group, and their advice will be underpinned by the established and accepted therapeutic guidelines for the prescription of antibiotics. I think that in addition to that I have already indicated that there will be mandatory training requirements for any pharmacists participating in the pilot, which will cover off the issues and the guidelines that are going to be provided in terms of antibiotic resistance by the clinical reference group.

Sarah MANSFIELD: Moving on to the minor skin conditions, do we have a sense yet of what is considered a minor skin condition for the purposes of this pilot?

Ingrid STITT: Yes. One moment. I will seek some advice.

I am going to again defer to the expertise of the clinicians on that advisory panel. They are doing work around which skin conditions will be included in the pilot. That information will be available well before the pilot commences and will obviously be included in the training program that will be rolled out in advance.

Sarah MANSFIELD: I was also curious about which particular classes of schedule 4 medicines pharmacists might be authorised to dispense without a script for a minor skin condition, but I guess it is difficult to know that without knowing what the minor skin conditions are. It is conceivable that they could be antibiotics or could be various forms of corticosteroid creams, but I guess we will not be able to get answers on that at this stage. Will there be scope for pharmacists to provide advice about long-acting reversible contraceptives when dispensing repeat pill scripts?

Ingrid STITT: This is a pilot. The scope of the pilot is very prescriptive and clear. If there needed to be a conversation of that nature, it would need to be a conversation between the patient and their GP.

Sarah MANSFIELD: Just on oral contraceptive pills, you mentioned that select oral contraceptive pills will be covered. Again, the detail of this is probably still being worked out, but quite a number of oral contraceptive pills are not currently on the pharmaceutical benefits scheme. We have been told that the cost of accessing medications will not be more than – correct me if this is wrong – the concessional PBS co-payment for a medication. A number of these oral contraceptive pills cost more than that amount, and I am just wondering: will those particular types of pills be available through this pilot scheme?

Ingrid STITT: On the costs, we have indicated that seeing a pharmacist will cost no more than it would if you went to a GP for the service, but the cost of the medication would be whatever it would have been if you had gone to the doctor. If I can maybe help a little bit regarding giving you the details, the secretary’s approval prior to the pilot commencing will detail all of the requirements for eligibility, for the premises, for the training and also for specific schedule 4 substances that can be supplied or administered. That will all be prescribed by the secretary of the health department subject to the bill passing the house and the pilot commencing.

Sarah MANSFIELD: Just to dig into the cost aspects of it a little bit further, you said then that it is not going to cost someone any more than going to see their doctor for this service.

Ingrid STITT: Yes, a bulk-billing doctor.

Sarah MANSFIELD: If they saw a bulk-billing doctor, they would not pay anything out of pocket to see the doctor, so will the cost just be for the medication part of it?

Ingrid STITT: That is correct, Dr Mansfield.

Sarah MANSFIELD: So the amount that they will pay for a medication will be the same as what they would have paid for it if they had a prescription from a doctor. Does that include things like if you are a concession card holder, you will only pay the concessional price, and if you are a non concession card holder you will pay the general co-payment? You pay the same as the general PBS co-payment, and if it is a private script, you pay the private script amount? Is that correct?

Ingrid STITT: Yes, I am advised that that is correct.

Sarah MANSFIELD: Will these medications therefore count towards a consumer’s PBS safety net?

Ingrid STITT: I am advised that it will not.

Sarah MANSFIELD: Will First Nations participants be eligible for Closing the Gap concessions?

Ingrid STITT: Dr Mansfield, if you are happy for us to take that on notice, we will see if we can get an answer for you, but if we cannot get an answer for you today it will be before the pilot commences that we will be able to clarify that question.

Sarah MANSFIELD: So in terms of the pharmacists’ remuneration for providing this service, is the only payment they receive just the amount they make from dispensing that medication or do they receive a payment for the service provision aspect of this pilot?

Ingrid STITT: Dr Mansfield, the advice I have is that the payment process for pharmacists will be based on periodic service reporting by community pharmacies that will be validated by the Department of Health or a vendor prior to payment. The amount paid will be offset by, but may not totally cover the costs of, the pharmacy participating. Community pharmacists will be paid a reimbursement payment of $20 to cover the admin activities and the additional time required to collect data, including other costs and commitments associated with the pilot. They will also be reimbursed for any pharmaceutical benefits scheme gaps in the medicines dispensed, and this will vary depending on the medication. Post pilot there is no commitment to ongoing reimbursement of fees, consultation or pharmaceutical benefits scheme gap.

Sarah MANSFIELD: And just to clarify, will there be any financial incentive for pharmacists to dispense the medication, say, instead of providing just advice in this pilot?

Ingrid STITT: I am advised that there will not.

Sarah MANSFIELD: Will there be any requirements for pharmacies to have a private room to undertake these consultations, and if not, how will they ensure privacy and confidentiality?

Ingrid STITT: I understand, Dr Mansfield, that will be part of the criteria to participate in the trial. You will need to have appropriate areas for private consultation.

Sarah MANSFIELD: I know you have answered a number of questions around the record-keeping side of this. Not every patient will have My Health Record, so I am just curious about the processes to ensure that there is some sort of record kept of what has happened in the interaction, what medication has been dispensed, how that will be communicated to the person’s usual GP and whether any of that documentation will be given to the patient, particularly if they do not have something like My Health Record.

Ingrid STITT: I am just trying to put my finger on that particular information for you, Dr Mansfield, but as I understand it there will be a requirement for records to be shared with the customer/patient’s GP or medical health provider. Just bear with me one moment.

The following data will need to be collected: the location and contact details of the pharmacy; obviously there will be banking details for reimbursements et cetera; de-identified service details for evaluation purposes around outcome prescription details; other service details including symptoms experienced to inform evaluation and fraud monitoring; consumer contact details; demographic data and other information required for evaluation purposes; consumer consent to receive treatment; and consumer consent to participate in the research elements of the pilot. Just let me double-check something with the advisers box, but I think that I have already indicated previously that sharing of information with the patients’ GPs will be required as part of the pilot as well and of course, importantly, consent from the patient to share that information with their medical practitioner.

Sarah MANSFIELD: What are the indemnity arrangements for pharmacists participating in this pilot?

Ingrid STITT: The pilot is being designed so that pharmacists’ professional indemnity insurance will cover the services in the structured prescribing model.

Sarah MANSFIELD: How will the public know where they can access this service, given that only certain pharmacists will be able to provide certain components of this? Each pharmacist has to do individual modules of training to be able to provide the service. So how will the public know where they can access this? Because it will not be that they can just walk into their local pharmacy and get access from 1 October.

Ingrid STITT: Obviously, it will be community pharmacists that are participating in the pilot, but I will just seek some guidance from the box about whether that will be communicated and in what way.

We will be allowing participating community pharmacists to advertise the fact that they are participating in the pilot and what services they can provide, and it will all be centrally available via the Department of Health website, as you would expect.

Sarah MANSFIELD: I have just got a number of questions about the evaluation side of this. Why did the government decide not to do this as a clinical trial, like in New South Wales?

Ingrid STITT: Dr Mansfield, the evaluation approach for the pilot is broadly comparable with the New South Wales pharmacy trial. Neither the New South Wales trial nor the Victorian pilot are being conducted as a randomised controlled clinical trial. You would know, given your background, that such trials are usually conducted for a new medication or treatment. By contrast, the Victorian pilot will rely on tested and well understood and widely used treatments. Registering and conducting the pilot as a clinical trial would not deliver any additional benefits to patients or pharmacists or the community and would only serve to delay access to health care for the people who need it the most. That is why we have chosen the framework that we have. The evaluation framework developed for the pilot is aligned to the World Health Organization’s domains for quality healthcare services, and it will assess whether the model of care used in the pilot provides safe, effective, people-centred, timely, equitable, integrated and efficient care.

Sarah MANSFIELD: I appreciate the department providing a copy of that draft evaluation framework. I did note that the framing of a lot of the questions that the evaluation will be looking at was really looking for positive outcomes from the trial. It did not take a more neutral stance and look at: well, there could be potentially some negative outcomes. An example is that a measure was, ‘How many potential GP visits did this save?’ There are scenarios where this could create some additional GP visits. I guess it is just a question of: are some of those potential inefficiencies or negative impacts also going to be considered as part of the evaluation?

Ingrid STITT: Obviously the clinical reference group and the advisory group will be finalising the framework. But to your question about ‘Will it get to the bottom of all of the issues?’, I think some of the analysis will evaluate whether the care provided met the needs of the patient. There are going to be opportunities like that to interrogate not just the positive outcomes but where there might be improvements necessary, and all of that will be tested, I guess, during the collation of all the evaluation data and information. The government is committed to being transparent about that and publicly releasing that information.

Sarah MANSFIELD: Will the evaluation look at the rates of referral to other services? That was one of the things that did not appear to be in the evaluation – how often someone coming in for the service is told, ‘Actually, no, you need to be going to see someone else about this.’

Ingrid STITT: As I understood it, Dr Mansfield, that was part of the data that was required to be kept by the pharmacist.

Sarah MANSFIELD: Last one: you mentioned that the evaluation will be made public – the findings from it – and we welcome that. Can you give an indication of the time frame for the release of that evaluation being made public?

Ingrid STITT: My understanding was it would be after the pilot, but let me just get some clarity on that for you just to be sure.

Dr Mansfield, obviously there needs to be some collation of data et cetera, so it will be as soon after the conclusion of the pilot as possible.

Renee HEATH: This is my first time asking questions in committee, so I apologise if I am repeating any of them. My first question is: women who are obese, smoke or suffer from migraines are at a greater risk of stroke when taking the oral contraceptive pill, and these are obviously things that can change at any time, so for how long can the script be filled without reassessment? Is it a number of years, or is it over a lifetime?

Ingrid STITT: That would form part of the secretary’s approval of the terms of the pilot, and that would be guided by the expert clinical advisory panel, so it is not something that we can answer right now. It is something that will be worked through in that advisory process, and all of the eligibility and all of the criteria – including the specific training requirements, importantly, for participating pharmacists so they know what the guidelines are – will be finalised ahead of the trial commencing.

Renee HEATH: Thank you for the answer to that question. In terms of record keeping, will there be restrictions on how often you can access the renewal of your scripts, or will you just have to show identification? And will pharmacists have visibility of other medications so they are aware of the health history when giving these drugs?

Ingrid STITT: Just bear with me, Dr Heath, while I find the specifics of that for you.

Thanks for your patience, Dr Heath. In terms of the data reporting and privacy, the data that need to be collected from pharmacies during the pilot are – I have gone through this once, but I will do it for your benefit because I am not sure if you were in the room at the time – pharmacy location and contact details to inform evaluation and give the ability to seek feedback; pharmacy banking details and de-identified service details, including outcome prescription details for reimbursement; other service details, including symptoms experienced, to inform evaluation – and fraud monitoring will be another requirement; consumer contact details; demographic data, which probably goes to your point around particular demographics; consumer consent to receive treatment, importantly; and consumer consent to participate in the research elements of the pilot.

Renee HEATH: Will you need to book an appointment to have your health issues assessed by a pharmacist?

Ingrid STITT: I do not know if we can be that prescriptive. It will depend on the particular pharmacy that is participating. It might be a very busy pharmacy, and they might have a system they want to set up. I do not know that we are going to be prescriptive about that.

Renee HEATH: The reason I ask is that we were talking about the private rooms before, and it goes in with that. How can you be sure that a UTI is uncomplicated? What protections exist if a patient is treated for a UTI but is misdiagnosed and something like diabetes or a neurological disorder is missed? Will pharmacists be able to have the referral rights to do pathological testing?

Ingrid STITT: Sorry, I could not hear that last bit. Can you repeat that?

Renee HEATH: No worries. That is absolutely okay. In terms of UTIs being uncomplicated, what protections are in place for the pharmacist? Will they have the referral rights to send for testing, such as urinary testing or pathological testing, to confirm their diagnosis or are they only legally allowed to treat, without the confirmation of a diagnosis?

Ingrid STITT: I mean, you are coming up with examples now, but the answer to this question, Dr Heath, is in the pilot model design. The primacy of protecting patients’ safety will be paramount. That is why we will be getting advice from that expert clinical advisory body, and they will be developing the guidance for participating pharmacists about these matters. There will be mandatory training for those pharmacists around how and in what circumstances they should not be issuing medication but in fact referring patients to their GP. I would expect that the issues around what an uncomplicated UTI is will be well covered by that work.

Renee HEATH: I think I am almost there. Skin treatments can currently be treated – and Dr Mansfield probably already covered this one in a sense – and fungal and inflammatory conditions are probably considered minor. Will this committee also have the scope to determine what conditions are allowed to be treated by a pharmacist?

Ingrid STITT: I think the answer to that question is really about the training and expertise that pharmacists already hold and the fact that they are adept at giving advice to customers with a range of different conditions. But again, there will be very strong guidance available for the pilot through that clinical advisory panel. We will also look to both the evidence and the frameworks that have been developed in other jurisdictions to assist us with this for pharmacies.

Renee HEATH: My final question: obviously there are huge concerns about antibiotic resistance, and I spoke earlier today about how Harvard University has been talking about the incredible rising amount of UTIs that do not respond to antibiotics. What protections will be in place for these patients, and how will they be monitored?

Ingrid STITT: As I indicated to I think Dr Mansfield in her line of questioning, the risk of antibiotic resistance is specifically being considered by the clinical reference group, which includes multiple experts with experience in microbiology and antimicrobial stewardship, and their advice will be underpinned by the established and therapeutic guidelines in relation to these matters for the prescription of antibiotics. The advice received will obviously be reflected in the pilot structure’s prescribing protocols to ensure that permitted supply of antibiotics under the pilot adheres to the current established therapeutic guidelines.

Renee HEATH: Will there be higher insurance premiums because of the added responsibility of diagnosis?

Ingrid STITT: I think we have touched on indemnity insurance, but participating in the pilot will not be a mandatory thing. Community pharmacists can apply to participate in the pilot, but this is about actually making pathways to treatment easier, not harder.

Bev McARTHUR: Minister, just help me out here: this is all going to take place in three weeks time, no? The pilot.

Ingrid STITT: October.

Bev McARTHUR: October the first?

Ingrid STITT: October.

Bev McARTHUR: No date in October?

The DEPUTY PRESIDENT: Sorry, Minister. I think they are trying to get a clarification. Is it 1 October or just sometime during October?

Ingrid STITT: I am advised that the pilot will commence in October. I am not aware that it is a specific date in October, but the work is moving at pace to be ready by October.

Bev McARTHUR: I would assume that everybody would be trained by now, wouldn’t they, if they were about to start operation in October?

Ingrid STITT: No, they are not at this point in time, but there will be details provided once all of the protocols and the compulsory training elements are determined. There has already been a power of work commenced. That work is ongoing, and the government is very serious about being ready to go in October.

Bev McARTHUR: You referred to this ‘experienced clinicians group’. I might have not been hearing properly, but are the AMA involved in your advisory group or the expert clinicians group?

Ingrid STITT: I think I have gone through the list of experienced clinicians, pharmacists, educators and safety experts that are on that particular clinical reference group, including the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia, the pharmacy and pharmaceutical sciences division of Monash Uni, the Pharmacy Board of Australia, Therapeutic Guidelines Limited, the Royal Australian College of General Practitioners, Monash University, Melbourne University, the National Centre for Antimicrobial Stewardship, infectious disease physicians, the North Eastern Public Health Unit, the public health unit of the Department of Health, practising community pharmacists, the Alfred and Monash University and the Austin Hospital. There will be a dermatologist represented on the panel, consumer representatives and a number of representatives from Safer Care Victoria and the Department of Health. I note that the AMA has been invited to participate in this clinical reference group.

Bev McARTHUR: So you are confirming that the AMA are not involved in the advisory group or the expert clinicians group?

Ingrid STITT: No, that is not correct, Mrs McArthur. What I am advising you is that they have been invited to attend.

Bev McARTHUR: But they have not accepted your invitation, have they?

Ingrid STITT: I am not advised about the status of that – whether that invitation has been accepted or rejected – Mrs McArthur. I am simply being very transparent about the fact that they have been invited to participate.

Bev McARTHUR: Minister, we have got a very short time to go before this whole show is in operation, and the main group of doctors that exists does not appear to be involved. Does anybody know, in that box over there, whether they have accepted the invitation or rejected it?

Ingrid STITT: I am very happy to go and seek their advice on that point, but I think that we would all agree, would we not, that the membership of this particular reference group is quite impressive in terms of their clinical experience, particularly in the area of pharmacist medicine and the treatment of the particular conditions that are in scope for this pilot. But do bear with me, Mrs McArthur, while I get some advice.

Mrs McArthur, I do not want to get argumentative about such a simple and meritorious bill before the house today, but I do want to just point out that there are many, many GPs represented on both the advisory group and the clinical reference group by virtue of their membership of a number of different organisations that are represented. I can confirm that the AMA was involved in the advisory group, which they have now chosen to withdraw from. Notwithstanding that, they have also been invited to participate in that clinical reference group, so that invitation stands.

Bev McARTHUR: I am glad we got to that conclusion – that they have withdrawn from the operation. Going back to the indemnity insurance, GPs have to pay for quite hefty indemnity insurance. We are asking pharmacists to give out advice for medical conditions. Wouldn’t they need to have the same comprehensive indemnity insurance as the medical profession?

Ingrid STITT: Mrs McArthur, the pilot is being designed so that the pharmacists’ professional indemnity insurance will cover the services in the structured prescribing model.

Bev McARTHUR: Minister, you keep referring to the fact that the pharmacists will be transferring the information they gain from the patient, or when they are distributing medication, to the patient’s GP. What happens if the client, customer, patient actually does not have a GP?

Ingrid STITT: I am not sure if you were in the chamber, Mrs McArthur, when we went through this in some detail, but any sharing of the information, including the diagnosis and what was prescribed and the advice that was given, would need the consent of the customer in order for that information to be provided to their GP. If they did not have a GP, that would be unfortunate, and hopefully the pharmacist would talk to them about the importance of primary health care and maybe suggest that they seek out a GP. But in any event the de-identified data from the consultation and treatment would be collected as part of the pilot and used as part of the evaluation – de-identified.

Bev McARTHUR: It will all end up probably in the Department of Health; would that be correct?

Ingrid STITT: No, it is not. There will be a provider that is responsible for the pilot evaluation and assessment, including the assessment of the data. It will be the Centre for Evaluation and Research Evidence, and of course there will be strict privacy requirements on any of that data that they hold as part of this work.

Bev McARTHUR: Well, that is a relief, because we have not had a great experience with the Department of Health of recent times, so if somebody else is going to manage it, that would be better.

Now, when I get a vaccination, I get a text from my doctor and the clinic to say, ‘How did all that go? Are there any downsides, upsides?’, whatever. Is that the sort of evaluation that might occur in this instance – the pharmacist sending a text to the patient, ‘How did that vaccination go?’ or ‘How did that prescription go? Did you have any side effects or repercussions?’ Is that what might be in mind?

Ingrid STITT: I will seek some advice on that. I am not sure whether that level of detail will be finalised yet, given that the evaluation is after a 12-month pilot, but please let me get some advice from the box.

Mrs McArthur, the pharmacy or the pharmacist will not be directly involved in evaluating the experience of the customer. As part of the service and part of the consent, a question will be, ‘Do you consent to being part of follow-up research?’ If that is the case, then that body that is responsible for the evaluation may contact that person for some feedback about their experience during the pilot, but it will not be the individual pharmacist involved in that activity. It is not a marketing opportunity either.

Bev McARTHUR: Well, that is fabulous. One of the benefits of going to a GP – especially, you know, it might be a woman going about the pill or something else – is that the GP might discover that there are other extenuating circumstances in the person’s health. They might even discover a domestic violence issue with that patient. Are the pharmacists going to – as part of this accelerated training program to be ready by some time in October – be trained in identifying those potential issues and offering particular advice?

Ingrid STITT: I think it would be fair to make the observation, Mrs McArthur, that community pharmacists are already quite adept at supporting the community, but the details of the particular training that they will be required to undertake are in the process of being developed, and the clinical reference group will be key to designing that. In terms of your example that you have given about the contraceptive pill, I think it is important to remember that it is only the continued supply of that medication that would be permitted under this pilot. Patients would already have to have been through that process with their GP in order to be on that medication in the first place, so it is only repeat prescriptions, if you like, that it will be possible to get through this pilot.

Bev McARTHUR: Minister, is there anything to stop a patient, a client, a customer from script-hopping from one participating chemist to another on this activity?

Ingrid STITT: I think that logic would tell you that they are already on a script in order to get a repeat script for the contraceptive pill. I am not sure that there would be any real benefit in prescription-hopping for a UTI or a minor skin condition, but please let me just consult with our advisers in the box about whether there is something I am missing here and need to provide you with.

Mrs McArthur, I think my answer stands. I think we have to keep this in perspective. This is a 12-month pilot and there will be eligibility criteria as to which community pharmacists can participate. Obviously the evaluation will need to pick up any issues around overprescription. I think I have already gone to that point in answering questions from both Dr Heath and Dr Mansfield around overprescription of antibiotics, and that is something that that clinical expert reference group are designing at the moment in terms of the framework.

Bev McARTHUR: Minister, just to clarify, the patients going into this pilot, with their consent – this is a repeat prescription they are getting, and a chemist cannot prescribe a new form of medication?

Ingrid STITT: Not for the contraceptive pill – it is the continued supply of that medication. But they will be able to prescribe treatment for some mild skin conditions, the terms of which will be determined by the expert clinical panel, and antibiotics for uncomplicated urinary tract infections in women – again, as advised by the expert clinical panel.

Nicholas McGOWAN: Just to be clear there, in my understanding at least, for the pill the patient must have a repeat script, evidence of a repeat script or evidence of a script at some point. However, with all the other applications, they do not require a script at all to prove having had that medication previously. Am I correct in saying that?

Ingrid STITT: I think you are missing the point, with respect. Part of the mandatory training that the pharmacists will have to undertake, and the guidelines that will be issued after the expert panel have determined them, will go to: in what circumstances should a diagnosis be made and a script issued? So it is not just that somebody rocks up and just asserts that they need a script. There would be a process and an examination that would be undertaken. Let me rephrase that: there will be an area in the pharmacy that will be required to be available for consultation. This will not be just standing at the glass counter at the chemist and asserting that you have a condition and getting a script handed over that counter. There will be guidelines that will be required to be followed by that community pharmacist, and those guidelines will go to the established therapeutic guidelines that those in the medical community are very familiar with.

Nicholas McGOWAN: Just picking up on that, so in some instances there will be examinations that will be required – is that correct? – undertaken by the pharmacist.

Ingrid STITT: I think I would like to withdraw the term ‘examination’ in hindsight, but I have indicated that one of the requirements for a pharmacist to participate in the pilot is that they would have to have a dedicated area available to consult with a patient about any one of those three medical conditions.

Nicholas McGOWAN: That actually leads nicely on, because I know in response to Dr Mansfield’s question before – Dr Mansfield asked about ‘the room’ – your response used that same language, ‘an area’, and that gives me some concerns. I am sure everyone here has been to a pharmacist before where in all reality we were having frank conversations with the pharmacist with the participation of the crowd of everyone around us, regardless of what it was about. Am I clear in understanding, therefore, that no pharmacist will participate in this trial unless they actually have a separate room – that is, a room with a door where no-one else hears it except the pharmacist and the patient?

Ingrid STITT: It will be one of the criteria to be eligible to participate in the pilot.

Nicholas McGOWAN: Just to clarify, the criteria is therefore a room where the door can be closed and confidentiality assured between both the pharmacist and the patient. Is that correct?

Ingrid STITT: I am just trying to put my hands on the exact wording for you so we can resolve this issue. Just one moment.

Pharmacies will need to be able to provide suitable facilities to conduct services supplied, including private consultation space.

Bev McARTHUR: Minister, apart from having a room, have they got the skills to actually conduct an examination of a patient that a doctor might have before they prescribe a medication?

Ingrid STITT: Asked and answered, Mrs McArthur. We are going over old ground here. One of the criteria for participating in the pilot is that community pharmacists will be required to complete mandatory training before providing any service. I think that we should not be doing a disservice to those community pharmacists, who provide a terrific level of support to the community. You would know that.

Nicholas McGOWAN: In respect to the advertising – that is, making the public aware that this is going to be a new program and in place in October – can you tell me what the budget is in terms of the Department of Health and their expenditure on raising awareness?

Ingrid STITT: Just let me get some advice, but I would not characterise it as advertising, Mr McGowan. I would characterise it as community information.

You should save that one up for the Public Accounts and Estimates Committee, Mr McGowan, but as you are probably aware, there was an announcement made about this important and exciting program, and we will be funding it to the tune of $19 million to deliver the 12-month pilot. Any provision of community information will be within that envelope.

Clause agreed to; clauses 2 to 4 agreed to.

Reported to house without amendment.

Ingrid STITT (Western Metropolitan – Minister for Early Childhood and Pre-Prep, Minister for Environment) (16:37): I move:

That the report be now adopted.

Motion agreed to.

Report adopted.

Third reading

Ingrid STITT (Western Metropolitan – Minister for Early Childhood and Pre-Prep, Minister for Environment) (16:37): I move:

That the bill be now read a third time.

Motion agreed to.

Read third time.

The DEPUTY PRESIDENT: Pursuant to standing order 14.28, the bill will be returned to the Assembly with a message informing them that the Council have agreed to the bill without amendment.