National Medicines Policy 2.0

National Medicines policy is about improving the health of Australians, making sure that Australia's investment in medicines is an investment in the health of the community.

[Music] Welcome to the Australian Prescriber Podcast. An independent, no-nonsense podcast for busy health professionals.

I'm Dhineli Perera, your host for this episode, and it's a pleasure to be speaking to Professor Andrew McLachlan today about Australia's National Medicines Policy. Andrew is no stranger to Australian Prescriber podcasts. I had the pleasure of chatting to him back in 2020. He's the Head of School and Dean of pharmacy at the Sydney Pharmacy School, University of Sydney. Andrew and Parisa Aslani, have reviewed the 2022 National Medicines Policy discussing what has changed and where we take it from here. Andrew, welcome back to the programme.

It’s good to be back and thanks for the invitation.

You’re very welcome. So Andrew, for those listeners who may not know what the National Medicines Policy is, can you please introduce what it entails and what impact it has on our daily interactions with medications?

I certainly can. I actually think this is a really important policy for health professionals, but also the Australian community. And importantly the Australian Medicines Policy, which we’ve had one for over 20 years here in Australia and we were one of the first countries around the world to really embrace a universal National Medicines Policy, that really provides the guarantee for Australians that they can access medicines in a timely way that are high quality, safe and effective at a price that they can afford. This policy also embraces really important elements around our wider health system as it relates to medicines, recognising that medicines are really the most common health intervention.

They have enormous opportunity to provide benefit in treating and preventing disease, but also they carry a risk of unwanted or harmful effects that we need to manage. Also, knowing that we wouldn't have these medicines without a medicines industry and the research that underpins. The pharmaceutical industry, of course guiding a lot of that, the research infrastructure more broadly through the NHMRC [National Health and Medical Research Council] and other funding bodies. So I think the new policy really addresses that. But of course, National Medicines Policy has been with us for some time. It's actually the very fabric of many decisions that are made in the healthcare system when it comes to say budgetary decisions and of course different organisations that have carriage of different elements of that.

Great. So it really sits at the bottom as a foundation for everything else to build on.

I think that's a good way to think about it. People listening to the podcast, they would know about the quality use of medicines, those elements that we embrace when we're choosing a medicine, whether a medicine is appropriate, is it the right medicine for the individual we're caring for. Are we using that medicine safely and effectively? And of course these very elements came out of the first version of the National Medicines Policy, the glue which sticks these different pillars together around quality, safety, affordability.

So coming back to that first policy, the first iteration was back in the year 2000, your 2020 paper called for a revision. Back then, what were your priority areas for change?

It was quite exciting to see that when the refreshed policy came out in 2022, 2 years after our paper, which was looking at the need for a refresh, many of the elements that we'd identified actually were picked up. And I suppose that's not rocket science, because there's a lot of trends that were happening in healthcare more broadly that the original policy really needed updating and refreshing. The most important element of that is that medicines are a lot more complex these days. So this has really expanded over the last two decades and it was really important that the next version of the policy really embraced the complexity that therapeutics, particularly pharmacological therapeutics, would recognise that diversity and complexity. So that's been an important part of what has appeared in the new policy.

The other aspect to this was recognising the medicines and medical research industry changes that were happening and the idea that we need to ensure we have a viable sector here in Australia that brings medicines to the Australian marketplace, which of course brings them to Australian healthcare. It's always done in the right framework of having a viable and responsible pharmaceutical industry. That was embraced in the original iteration of the National Medicines Policy and really enhanced in the version that came out in 2022. Also, the complexity of the health system, which I think is really quite important. There's a lot more focus on vulnerable communities, whether that's First Nations people, whether that's people living with mental health problems.

Of course, the aged care sector, quite rightly has had a strong focus on providing quality care and medicines have a vital role in each of those sectors and how this policy supported and recognised vulnerable members of the community, including people such as refugees who come to Australia and how they can access affordable healthcare including medicines. The last bit has been the massive expansion of technology in the healthcare sector, including digital health, the interoperability of systems, the role that using medicine safely and effectively relies on the appropriate use of digital technologies that have been implemented and evaluated appropriately. So the revised policy has really picked up on one of the key themes and that was that medicines are situated within a complex health system and how the policy elements might support those elements to make sure that we use medicine safely and effectively is really quite important.

It's kind of mind boggling what's changed since the year 2000. It makes me feel really old, to be honest. Coming back to your paper, I really liked Box 1, which italicise as the changes to the 4 central pillars of the policy. Could you just run us through those pillars and their changes?

Yeah. So the original policy essentially had four pillars around safety, efficacy, affordability, and then of course quality use of medicines and the role that the industry plays. Those main elements are pretty much there. There's a bigger focus now on equitable access, to make sure that there's equity in how people can access those medicines. Timely is of course still a commitment. A bigger focus on safety, so medication safety was the World Health Organization's third Global Patient Safety Challenge: Medication Without Harm, and the Australian government really committed to that with its National Health Priority just a couple of years ago. So safety is now front and centre. There's another word which has crept in there when you read the article and have a look at the box, it's actually reliable access to not only medicines but medicines related services and I think this really speaks to the challenge of medication shortages that we're able to observe and really came to the fore, particularly during COVID, but have been building for some time.

The global nature of the pharmaceutical industry means that supply chains are relatively shallow and that even any minor glitch can actually lead to medicines being out of stock and unavailable. These are often essential medicines, so the word reliable is now in there as well. The other part of that too is around medication related services that I just mentioned then, and this speaks to that point I made earlier, that medicines are often provided within the framework of a health system, whether that might from a pharmacy point of view, involve medication review. Of course it's not only about the availability of the medicine but how it might be administered. We could think about vaccines as a good example of that as well, and other services that are relevant here, pharmacogenomic testing to identify suitable treatments for individuals, their risk of unwanted effects, and maybe even guiding the right dose.

So that's nicely picked up here. I mentioned that medication safety theme, which is now a national priority that's also picked up in the box. And the very last dot point when you have a look at it is about collaborative, innovative and sustainable medicines industry and research sector. So they've really broadened this idea that medicines come from a variety of sources, not just the pharmaceutical industry, but also a fundamental investment in medical research. And it certainly recognises the last two decades where major pharma companies have really changed the way they source and identify new chemical entities or medicines to market, often relying heavily on academic innovation early on. So governments around the world, including the Australian government in investing in medical research and having an infrastructure which helps the support and development of medicines, really supports the health of the nation.

So reading further into your article, Andrew, I kind of visualise the factors you've addressed as puzzle pieces. All different in shape, but critical to the entire system coalescing together. Could you elaborate on the focus in the new policy and the importance of shared decision making?

People who have heard about shared decision making may have heard the tagline, ‘no decision about me, without me’. And I think this is a great way to think about the way that medicines are prescribed and dispensed and it respects the autonomy of the individual, helping them understand and have the information they need to be able to decide whether this medicine is suitable for them, a better understanding of what type of help this medicine might provide or even what harms may be resulting. So this is being fully informed. We certainly made a shout-out for the shared decision making in our previous article and it was delightful to see that's been picked up. And of course under that heading of individuals and communities is thinking about all those vulnerable groups and how Australia designs or co-designs interventions and support for those groups to best meet their needs.

With regards to health professionals, how has this focus changed in the updated policy? Would I be right to say that the improved collaboration between professions is central to the change?

Yeah, I think you're right on the money there, there's a big emphasis on collaboration. The complexity and challenges of the health system mean that we do need to work together. In our paper as well, we were commenting, we wanted to see more collaboration rather than competition between healthcare professionals. We are all custodians of this National Medicines Policy. We have a shared responsibility to ensure that it's fully implemented and effectively used. Collaboration and culture feature there as well. And remembering of course that there's no healthcare without a workforce.

In terms of medicines and medicine related services, we are really no longer talking about a single pill for an ill. And you've highlighted that in some of the points earlier. Was there any further points you wanted to expand on?

The important point here is that medicines and medicines related services really do fit together and acknowledging that this policy, which will hopefully be reviewed in an ongoing way, needs to be fit for the future. If you think about some of the complexity of treatments and cures that Australians have access to now, these come with a range of complexity, but also supported by codependent technologies that facilitate it. Right now, of course, the health technology assessment review process that the Australian government's going through is really trying to recognise how Australia can afford and should fund and recognise the value of these complex interventions.

We have discussed the digital health part, but one thing I wanted to ask you, Andrew, do you think the new policy has really adequately prepared us and addressed how critical digital health is to us? Is the policy able to really adapt and pivot as quickly as it needs to?

Policies like this provide a framework for how things might be implemented and if we take those elements of safe and timely and affordable, question is how digital systems might best support that to ensure that the policy can be implemented. But we've got smart systems that really are about linking information from different parts of the health system to make informed and good choices about medicines, making sure these systems solve a problem. If the problem is about addressing the key elements of the policy, what we'd like to see is digital systems do that. But you highlight the massive change that's been happening in this area, particularly over the last two decades and more change will happen. Of course now with things like generative AI and other types of machine learning systems that are adapting and changing all the time. We do need to have a guiding policy approach to say, what are we trying to achieve here? What are the elements that we value and we think are important.

The guiding principles for medication management in the community really scaffolds the bricks of your good prescribing. Could you tell us a little bit more about the principles?

Yeah, so a policy of course is that higher level framework for how medicine should be used and how we'd like to make them available and what Australians can expect. How we translate that into what needs to be done is nicely set out in a set of guiding principle documents, then they're related to each of the key areas that we know to be important. Medication management in the community, in residential aged care, also in hospitals. And of course these resources are also supported by major tools. The Australian Medicines Handbook is one important independent resource that Australian clinicians and I suppose consumers can access. Therapeutic Guidelines of course, are also an absolutely vital tool in supporting the implementation of the policy. So I think the refresh of these guiding principle documents is a real bonus, and that's something that the Australian Commission for Quality and Safety in Health Care has been leading, and I think that's been a really good process.

So coming straight to that point, implementation, I would argue that implementation is key and often harder than getting the guideline or policy together. Can you tell us a bit about what's been done in this space and most importantly, what our individual health professional listeners can do to get involved and be part of the solution?

So you're right, the smart money is on how we implement this policy. Having a great framework is one thing. There is a bit of a risk, I think of fragmentation. When I've talked to consumer groups, that's been their concerns and I think that making sure that we have that centralised approach, there is carriage and leadership in this area. I'm excited to hear about the work that's happening at the moment about developing national indicators. So if we set out what we'd like to achieve and call them indicators, then we measure them. We should measure what matters. They’re the things that observers would say might be a bit underdeveloped in the current version of the policy, but things like the guiding principles help us with implementation for healthcare professionals. Knowing and using those tools is a great way to start implementing National Medicine's Policy. Then of course, watching this space to look at how we're accountable to those indicators going forward. And really this National Medicines Policy is about improving the health of Australians, making sure that Australia's investment in medicines is an investment in the health of the community.

That's unfortunately all the time we've got for this episode. Andrew, thanks so much for joining us today.

Thanks very much and really appreciate the opportunity to have this conversation.

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Andrew and Parisa's full article is available on the Australian Prescriber website. The views of the hosts and guests on the podcasts are their own and may not represent Australian Prescriber or Therapeutic Guidelines. Andrew receives funding from the National Health and Medical Research Council. The Sydney Pharmacy School receives research scholarship from GSK for a PhD student under Andrew's supervision. Andrew served as a consultant on Australian government committees related to medicines regulation, including the TGA Advisory Committee of Medicines. He is Vice President of the Council of Pharmacy Schools Australia and New Zealand. He is also Chair of the Medication Oversight Committee for the Australian Commission on Safety and Quality in Health Care. I'm Dhineli Perera and thanks for joining us on the Australian Prescriber podcast.