• 03 Feb 2020
  • 18 min
  • 03 Feb 2020
  • 18 min

Dhineli Perera interviews Andrew McLachlan about critical issues that need to be addressed when updating the National Medicines Policy, and why. Read the full article in Australian Prescriber.


Welcome to the Australian Prescriber podcast. Australian Prescriber, independent, peer-reviewed and free.

I'm Dhineli Perera, your host for this episode, and it's a pleasure to be speaking to Professor Andrew McLachlan. Andrew is the Head of School and Dean of Pharmacy at University of Sydney. Andrew and his team write about the upcoming review to the National Medicines Policy. Andrew, welcome to the program.

It's good to be here.

Great. Andrew, would it be fair to say that many health professionals may not be aware that a National Medicines Policy even exists in Australia?

It's so true. A lot of health professionals, I'm sure a lot of the readers of the Australian Prescriber would certainly be aware there might be a policy, but what it means for them and how it's implemented every day, it's probably not something they've actually thought about. So I'm sure when they see the title of our paper, they'll probably think, "Wow, what a waste of time." But actually the National Medicines Policy is this incredible framework and whether people know it or not, it has provided a foundation for health care that I know that every healthcare professional would actually have come across.

So if I remind people, it's about four things. It's about timely and affordable access to medicines that people need. It's about having high-quality medicines that are safe and effective. It's about the quality use of medicines. I'm sure all the readers of the AP would know about what QUM is, but it also has a fourth arm, which is about a viable and responsible medicines industry. Those four elements are things that healthcare professionals and readers of the AP would come across and know about. But also it's led to a range of very important policies, procedures, and legislation that supports different structures about medicine.

So the National Medicines Policy really is about keeping Australians healthy and providing their medicines needs. It includes organisations like, of course, the Therapeutic Goods Administration, about safety and quality of medicines, about affordable access, which is the PBS, lauded around the world, which really comes out of the National Medicines Policy and how it operates. Of course, the great organisation that everyone knows about, NPS MedicineWise, really came into being through the structures of the National Medicines Policy and the different consequences of that over 20 years.

Lastly, Australia's commitment to have a viable yet ethical and responsible pharmaceutical industry, the policies, procedures, incentives that are around that, all come out of our National Medicines Policy. We joined that policy with others around the world. We're a part of a bigger network, of course, of the global health community, and National Medicines Policies are seen as an absolute fabric of robust healthcare systems, and Australia's had one for 20 years.

Yeah, it really has. It's been 20 years since it was not only put together but implemented as well. I guess the question would be, why do we need to review it now? Clearly lots of things have changed in the world of medicine since then.

Yeah. I think that's really the two words you mentioned there, about change and implementation. This, as a policy, and those tenets that I described, the four things that make up this policy, really have stood the test of time and they remain very, very relevant. It's how we implement them in the healthcare system, which I think has been part of the need for change of how we look at the policy, to make sure that it remains relevant to our increasingly complex health system. Also that it's meeting its purpose.

Part of that purpose, as I said, is to make sure that Australians get the medicines they need, the quality that they expect, and of course lead to the health benefits that are essential, and avoiding things like harms. The word you mentioned there was ‘implementation’. The readers and listeners would know about some of our challenges currently around medication safety. If I'd just take one example around preventable harm from medicines in vulnerable people, and even the class of medicines such as opioid analgesics. We have a real crisis on our hands in dealing with some of these things. You'd have to say, has that been a failure of the policy as it currently stands? That is really part of the wakeup call.

On the other part of this, we have the global challenge of antimicrobial resistance, which at the very heart of it is about a quality use of medicines issue. It's about using those medicines judiciously and appropriately. So there are certainly signs that our National Medicines Policy needs a refresh to make sure ... a reboot, that it is still relevant to what we're doing. The other, I suppose alarm bell, too is that we still have a number of vulnerable people in our country that the National Medicines Policy perhaps isn't serving as well as it could. You would probably spring to mind indigenous Australians and their health needs.

While there's been much done within the National Medicines Policy framework and QUM to best support indigenous Australians, there's still much more we could do. A recent Royal Commission has highlighted some of the medicines issues tied up again with the policy for vulnerable older people, particularly those living in aged care. We know that people living with mental illness are a group of people that still need better care, improved outcomes. Part of that is wrapped up in our National Medicines Policy structures and particularly how we implement them, and also emerging global challenges that range from everything from conflict to climate change, leading to refugees and the refugee health.

I guess your article does really discuss these changes in turn, but it's not an easy thing to signpost and say that there are 10 different changes that have happened, or we need to address them. They're kind of so interwoven, when I was reading your article, it was hard to separate them. So I guess if we start with the consumer, what changes have we seen in the consumer itself?

I think you've highlighted a great point about the really integrated and interconnected parts of our health system. Any change in a policy which is overarching really needs to make sure that we maintain that connectivity. I'm glad you started with consumers because by its very elements, the National Medicines Policy puts consumers right at the centre of what it's about. So if you take the patients, people in the communities, look at the 20 years of a National Medicines Policy when things were laid down, we now know that consumers ... of course we're all consumers ... are more informed, more empowered, value their health literacy in decision-making, want to be involved in shared decision-making.

Other studies show that our consumers take more medicines. The prevalence of polypharmacy remains both an opportunity and a challenge, and then we also see changes in things like the rise of complementary and alternative medicines being used. Consumers have also been the most vulnerable when it's come to preventable harms from medicines. The other part of it too is that consumers have been asked to navigate an increasingly complex health system, and that disconnect we have between different parts of our health system don't make it easy for consumers at times.

How have the medicines themselves changed, and what is the ripple effect of their increasing cost and complexity? Most of us would know that since we've been at university, the medicines that we learned about are almost completely outdated, so that surely those changes will have a big effect.

Look, I think obviously we still have some of the medicines that you learned about at university, so don't panic. But I'd agree with you, this is a really interesting area because look at the rise and rise of biological medicines, therapeutic proteins and monoclonal antibodies as an example. Then add the complexity around things like biosimilars. There's different routes of administration. There's particular requirements about how these medicines are tested, are used in the clinic, the paradigms of make a diagnosis, measure something, administer, write a prescription, have it dispensed, and the person keeps taking it. These are changing enormously.

While the classic small molecule, take regularly type of medicine will continue to be part of health care for a long time yet, we're seeing this incredible shift towards therapeutic agents which are complex, which are expensive to make available. What is the evidence needed to provide these? What is the nature of the health system that gets the best out of these potentially disease-modifying therapies? That complexity isn't necessarily built into our structures, particularly of the National Medicines Policy that might look at safe and effective medicines through the TGA. And even the affordable access through the PBS.

The TGA and the PBS over the last two decades have really continued to develop how we test and evaluate these new medicines and what it means for consumers. Look, my own observations is I think they've done a good job, but the change continues and the complexity increases, including that idea that therapeutic agents now, no longer just the drug molecule. There could be other tests or devices. This complexity has implications for testing, but also for funding and affordable access.

Subsequent to that, the healthcare environment as a whole is noticeably more complex, which we have touched on. It can no longer really be pigeonholed into sort of GP and hospital care providers. What are the big changes in this area and what consequences do you see from such changes?

Yeah, I think you've really highlighted there some of the things we captured in our article about how the nature of where health care is being provided is really starting to change. That's driven not only by the funders who pay for it, but also by consumers and healthcare professionals to some extent. Most consumers want to receive health care in their home, in a place that suits them, rather than an appointment at a hospital or in a clinic where they've got to wait.

This idea of best meeting the needs of Australians needs to come into sharper focus. Are we ready for that? I'm not necessarily sure. We know, for example, that as people move between different parts of our health system, between home and the hospital, or hospital and the aged care facility, this creates gaps and slips. That has led to major challenges around the continuity of health care. That actually remains a challenge. While there's been many steps to improve it, it's still an unmet need in many ways that we've got to resolve.

The environment is now more fluid than ever. It's changing, with many drivers and factors about funding, about of course the digital age, but of course the expectation of consumers themselves. So I think a policy, when we re-think about that, we have to look beyond the traditional walls and boundaries of the places where health care is provided. And to appreciate that we now have a much more diverse system that needs to incentivise people to get the health care they need, to prevent things, perhaps in a healthcare environment that best suits them.

Okay. There was a second point or another point in your article that I thought was quite important to highlight, and that was the inequitable access to off-label medicines between jurisdictions.

Yeah. This is, I suppose, one example that we highlighted in our article about part of the challenge our current system has in helping people access the medicines that they need. My experience has been to work obviously at universities, but also in different public hospitals. I'm sure many listeners and some of the readers of the journal will also have this experience, where decisions are made about the access to medicines where an individual can't afford that medicine.

The best example would be a person who might have a rare health condition or has failed first- and second-line treatment for their cancer. There's some evidence that an expensive medicine, often a biologic medicine, may be of benefit to that individual and it's worth a trial. The question is how do they get access to that medicine? We did use the words ‘inequitable access’ because it's fairly clear that in some centres you would be able to, through essentially the charity of that organisation, to be able to access that medicine. But if you're in say a rural area or a remote area, your chances of getting the same access would be significantly less. That is an inequity. Now, there are a range of things tied up in this and we've had a range of national committees and organisations really try and put some guidelines around this, but there's much more we could do.

It's recognising that to get to the evidence standard needed to demonstrate cost-effectiveness, that might mean listing on the PBS, that's a different level when more and more medicines are designed to treat smaller niche groups of patients with particular characteristics. So tied up into this very issue is not just about people getting health care, it's also about a policy framework that recognises that some people will have a specific and different need that won't necessarily fit with a large-scale paradigm of one medicine for all people with the same health condition.

Okay, Andrew, so now the big one, digital health. This would definitely have to be the most significant change we've seen in the last 20 years. Can you summarise the changes in this area that you think should be considered in this policy reboot?

Yeah, thank you. I do think this is really one of the landmark changes that certainly happened as both a challenge but most importantly, one of the biggest opportunities. I think in a National Medicines Policy and the framework that was set around it, would really make sure that Australians leverage the benefit from this investment. So if you take, for example, people would know about My Health Record, think about a fully implemented My Health Record. I know some people expressed concern. To be honest, I think we've really got to get on board with the My Health Record.

Imagine one record for all, that everyone can access. If we buy into it, we use it safely and appropriately like many countries around the world have, this can make a real difference. We've seen the benefit of electronic medication management systems in hospitals to reduce errors, to improve efficiencies, to certainly resolve a whole lot of those medication safety issues. I think even issues around real-time prescription monitoring, these are all just small examples of digital health initiatives that can really start to make a massive change. So a really clear lens about digital health, the benefits it provides and what the opportunities are, need to be embedded into a National Medicines Policy of the future.

It would definitely comprise a big part of this policy because as you said, it's only going to get bigger. It's not going anywhere.

Totally. Take for example, the technology we use in our day to day lives. That's reflected of course in health care. Everyone has -

A smartphone.

A very powerful computer -


That's right. A powerful computer in their pocket, which tells them what their heart rate and number of steps they're doing at any one time. That's just even a tiny example of what the future might hold when it comes to point of care testing or near-person monitoring, to help us improve the safety and quality of health care and particularly how we might be using medicines. I think it's really exciting and we need to make sure that those elements, particularly around even how we might look at the safety and quality of different technologies which support medicines use. That's a bit of a frontier at the moment. That's still emerging, as how we control and regulate those things.

Your article mentions partnerships between different stakeholders for policy implementation. Who are these stakeholders and what type of collaborations would you like to see between them?

The 20 years of the National Medicines Policy really have highlighted the importance of how partnerships are essential in implementing a policy like this. It can't just be the responsibility of government. I mentioned already that healthcare professionals, I believe, and arguably other partners are really the custodians of things like quality use of medicines. Ultimately this is about ensuring that everyone has a voice. The loudest voice of course should be the people who are at the centre, and that's consumers. The decisions and framework that we make, whether it's about this policy or how we implement it, should be within the lens of consumers. Particularly the people that stand to gain the most from this and that could be the most vulnerable.

Just on the pharmaceutical industry, I know that there are many who might have concerns about having pharmaceutical industry at the table. But let's remember that we wouldn't have the ability to provide healthcare benefits from those medicines, or even a PBS, without a viable and responsible medicines industry here in Australia. In the global sense of pharmaceutical companies, we do have to remember that Australia is a relatively small market if you just want to look at the commercial aspect of that. So we have to be very careful about making sure that industry are welcomed as partners.

Finally, Andrew, how would this updated policy impact the health professional in their day to day practice? What do you see those changes being with this reboot?

What I'd like to see, and I'm glad that other people online support me in that regard, is that this policy would put healthcare professionals in, I suppose, the best position to use medicines that can provide the best outcomes for Australians. That's really the whole aim of this policy. But it would start to make sure that we have a more connected system, that the tools and the framework that we have for healthcare professionals to provide medicines to people, whether that's in the prescribing or in the dispensing, can really make a difference. And it's not leading to unintended consequences, which we do see to some extent at this stage.

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

Thanks for the chance to have a chat.


The views of the hosts and guests on the podcast are their own and may not represent Australian Prescriber or NPS MedicineWise. I'm Dhineli Perera and thanks for joining us on Australian Prescriber Podcast.