Managing medicine shortages

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Medicine shortages can be caused by a variety of reasons. Unfortunately, managing medicine shortages falls on the shoulders of busy clinicians, potentially taking time away from other patient care. It is a resource-intensive task to find suitable alternatives to maintain a consistent medication supply to patients and to communicate this to all relevant parties. There are safety risks associated with substituting medicines with alternatives as well.

In this interview, I'd like to explore what could be done at both policy and clinician levels to improve how medicine shortages are managed, and I can't wait to ask our experts joining us today, Tom Simpson and Jerry Yik. Tom Simpson is the Executive Director of Statewide Hospital Pharmacy Tasmania and the President of Advanced Pharmacy Australia, formerly known as the Society of Hospital Pharmacists of Australia. And Jerry Yik is the Head of Policy and Advocacy at Advanced Pharmacy Australia. Tom and Jerry have both authored an article for Australian Prescriber called Managing Medicine Shortages. I'm Jo Cheah, a hospital pharmacist in Melbourne and your host for this episode of the Australian Prescriber Podcast. Welcome, Tom and Jerry.

TS: Thanks for having us, Jo. Nice to speak to you.

JY: Thanks for having us.

Jerry, I'll start with you. Could you describe the current situation of medicine shortages in Australia? As stated in your article, there were approximately 400 medicine product shortages according to the Therapeutic Goods Administration or TGA at the time of writing.

JY: Shortages have been occurring for a very long time. But in recent years, it's the frequency and the rate at which they're occurring that is causing a lot more issues. There was a lot of national awareness around the shortages of IV antimicrobials and oral paracetamol liquid and EpiPens, to list a few going back to 7 years ago. And then that's where we started seeing a lot more of these in newspaper articles.

Since then, we've had the COVID-19 pandemic, which has put a lot of strain on supply chains that are across various sectors. If you ask practitioners today ‘Have medicine shortages gotten worse or have they gotten better?’, most people would say they've gotten worse. In recent months, you may have seen articles in the media around opioid medicines, medicines used for menopause, some antibiotics as well. And so certainly these medicines which are used often by a large range of patient cohorts are still in shortage. And if you look at the Medicine Shortage [Reports] Database as at the time [of] recording, there's 395 current reported medicine shortages according to the TGA. There's another 81 that are anticipated and another 273 flagged discontinuations going back from November 2023 going into next year.

TS: It's just important, I think, to get a picture as to what that impact looks like every day because the shortages just seem to affect all therapeutic areas and potentially all patient groups. So right now the [IV] fluid shortage is very much in everyone's mind. In some cases, we're having to rationalise the use of IV fluids in hospitals, but there isn't a therapeutic area that isn't affected by this. In other countries, we've seen shortages of antidepressants, antipsychotics, Ritalin, and other stimulants. So this isn't just around access to hospital-only therapies. A lot of this is the medicines that people depend upon to live their daily lives. And whilst there are other therapeutic alternatives, we really don't want to have to be making these kinds of changes for patients who are on stable treatment. Another impact is a lot of the time when we do have access to alternative treatments, they won't be entirely identical, so there's real impact and it is writ large across the health system.

Tom, in the article, Box 1 lists many potential causes of medicine shortages. Can you briefly summarise the main causes and whether anything is being done locally or internationally to address some of these concerns? One example that pops to my mind is Australia's reliance on imported medicines. Is there any sign that we will be producing more medicines locally?

TS: Yeah, I think something like 90% of all of the medicines that we use in Australia come from overseas, very much part of a modern globalised supply chain. And as we saw particularly during the pandemic, it isn't just the raw active pharmaceutical ingredients that might be in shortage. It's everything from the ink that goes on the label of the vial through the box that it's put in. Any of these things could go into temporary supply outage and then lead downstream to shortage or constraints on supply. We're a vulnerable country to supply-chain disruptions.

One of the good things, I guess, about Australia is it's a very regulated environment. One of the positive responses we've seen from government the last few years has been to increase the regulatory response around shortages and to require sponsors (manufacturers of medicines) to notify and to also carry enlarged stockholdings of medicines in the country. But even that regulation itself can be a barrier then to other organisations wanting to enter the Australian market. So it's very hard to get that balance right.

We also know that because of our size as a market, again one of the government responses has been to introduce floor pricing for a range of essential but inexpensive medicines, which is welcomed by us and by industry, to have that real focus on continuity of supply. But there're lots of things that are very hard to predict and control. Sometimes, all it takes is a particular shipment to be delayed on a dock somewhere on the other side of the world and the company that has been planning on that being in Australia suddenly is left without supply, or a competitor product might be unavailable and shut down, therefore putting all of the demand for a particular product to a company that just doesn't have the entire Australian market's worth of market share sitting in a warehouse somewhere.

JY: Just to add to that as well, I do want to point out that the TGA has also undertaken a consultation on options to look at medicine shortages reform this year. And we've done a written submission and we've participated in some multidisciplinary workshops as well, which are really, really interesting to hear from other stakeholders. Our understanding is that there will be some reform options presented to government to make a decision on, so we are waiting for that to be reported on and fairly hopeful that something meaningful will come out of that.

I think it also would be interesting to note that with the Future Made in Australia policy, which is related to the National Reconstruction Fund, is that one of the priority areas identified by the Australian Government is medicines and medical devices in terms of looking at our sovereign capability to ensure that we do have enough medicines and medical devices in Australia, potentially domestically manufactured, so that we are more resilient to any of those supply-chain disruptions that Tom's talked about.

And Tom, how are clinicians alerted to medicine shortages? Can you describe some proactive ways clinicians can find out about shortages earlier?

TS: It's fair to say that a lot of the time when a clinician, particularly a clinician who is practising in a community setting, the way that they'll typically find out about a shortage is from patients, coming in and saying, ‘My pharmacy wasn't able to supply this medicine,’ or they'll get the phone call from the pharmacist themselves saying, ‘Actually, we can't get this medicine in for this patient.’

There are lots of proactive sources of information. TGA actually has a very good Medicine Shortage Reports Database, so if you are concerned that something you're about to prescribe may be in shortage, you can actually do some fact checking on that. We also know some products that have particular focus, high-risk populations – that kind of thing, that state health departments will often communicate directly with clinicians. And within hospitals as well, the pharmacy departments will communicate with clinicians. Often there, they're able to actually put in place advice around specific substitute products that might be utilised instead.

JY: If I was just to add one thing, from what we do hear from practitioners and what we do feel on the ground, there is still a small percentage of medicines where we are experiencing the shortage, but it's still not reported yet on that [medicine shortage reports] database. So, to some extent, you still rely on your other forms of finding out from word of mouth, from your peers and notices from manufacturers. And so those are still really important. The more sources of information that we have, the better.

What are the main considerations and suggested steps that prescribers and pharmacists can take when dealing with a medicine shortage to minimise risk to patient care?

TS: I think working in collaboration is the first thing I want to talk about. The best decisions around what medicines can be safely provided to a patient are made when you have the doctor, the pharmacist, and the patient all looped up together to have that conversation around what's available, what the good options are, considering the patient's values as well and their ability to comply with the alternatives.

But as we've described in the article, there's a few steps to take. The steps are sorted in order of how much impact they have on continuity to their patient's treatment, but also the actual challenge of implementing. So if you're faced with an issue where the medication that's been prescribed for a patient isn't available, first thing is it might just be one brand of the medication that's in shortage. If that's the case, then it's just about substituting alternative brands. If there are no other brands available of that particular medication in that dose, in that presentation, then it's looking at, well, what are the other formulations we can prescribe?

There are now the Serious Scarcity Substitution Instruments that the TGA has for medicines in shortages that allow pharmacists to do that in consultation with the patient without needing a new script to be written where it's accepted that alternative strengths, dosage forms might be necessary, but still it's always best done in collaboration. So your step 2 is what other ways can we get this same medication into the patient in a way that doesn't compromise the efficacy of the medication?

The next step is to consider, well, if we can't get the medication fullstop, are there other medications which might have the same function and to which the patient can be switched? Obviously there, there's a lot of considerations. If for example, you're dealing with an antidepressant, there are washout periods. If you're dealing with other drugs, you know that there will be dose–dose equivalency and even sometimes pharmacokinetic interactions. So again, that has to be done in consultation with the 3 stakeholders.

And finally there's accessing medicines from other sources. Although products might be in short supply here in Australia, it might be possible to have access to an imported product from one of the overseas markets. And so there's a few pathways there. Sometimes sponsors will work with the TGA on getting what's called a section 19A approval, which allows importation of an equivalent product. Of that 400 or so shortages that are currently listed on the TGA website [Medicine Shortage Reports Database], there are section 19A approvals in place for around 150 or thereabouts of those medicines to ensure that we have continued access.

One challenge with that is that that doesn't automatically mean that a product will be PBS listed, so sometimes there'll be costs to patients if we are to use an equivalent product imported under section 19A that isn't reimbursed by the PBS. There's also the Special Access Scheme, which always exists whether there's a shortage or not, as an importation mechanism for specific medicines, either for an individual patient or for an entire cohort.

There's still some therapeutic challenges. The products that we import from other countries may have different excipients, so they might be therapeutically the same but they might have ethanol or sodium metabisulfite. And a lot of these products will also not have English labelling on them. So that's handing a patient a product that isn't just a different brand, but actually the whole box is labelled in German or French or something like that. Clearly there's communication that needs to take place there.

JY: Yeah. Thanks, Tom. That's a really comprehensive answer, and I think your starting point around collaboration is key. For example, when you talked about changing the actual medicine to another medicine, that introduces a lot of variability to that patient and the practitioner. And so firstly, you need to assess the health literacy of that patient, but then also you need to look at the medicine itself. Is this a medicine they're using for a number of years or is it a short-term medicine? So based on that, is it even worth it that we change them over to another medicine or can we try and find stock from somewhere so that they don't have to change that medicine?

And then even when they do change that medicine, how do you make sure that that is communicated through to all their healthcare providers? If that doctor is making that decision to change to another medicine, does the pharmacist know that that is meant to be for life or for a very long time, or is the view to then change it back to the other medicine when it comes back into stock?

The other issue around this is, as you will see on the Medicine Shortage [Reports] Database, sponsors are meant to nominate a date when they expect that supply of medicine to re-enter the Australian market. And so again, we rely on that information to be accurate so that we can make these treatment decisions based on the best available data. Unfortunately, what we have seen from some shortages is that next available date is pushed back 3 months, pushed back to another 3 months. And so it is another area that is highly variable, which makes decision-making a bit difficult for us on the ground.

TS: Some of the decision-making here, it's not always made about individual patients. Even when you don't have an individual patient in mind and an individual encounter, you're still having to make systems-level changes to medication decisions based on medication availability. One of the challenges that we have now is just how embedded some of those decisions are in protocolised decision-making. A lot of acute hospitals now have smart IV pumps. They're drug pumps that are programmed with a drug library, a dose, a rate, a volume. And you can't then suddenly say, ‘Oh, actually we're not going to have tenecteplase anymore. We need to use alteplase or whatever the other alternatives are we're using.’ And you actually then suddenly need to reprogram a thousand IV pumps and ensure that those are there and ready to use. So the reactions can be both at the individual patient level and at the organisational level.

And also something you mentioned in the article as well, which is at that starting point, even assessing whether the drug is still necessary and potentially de-prescribing if that's clinically appropriate as well.

TS: Absolutely. Look, the unavailability of a medicine should be a trigger to say, ‘Was this the right medicine? Is the medicine necessary? If it is, is it this one?’ The hospital that I work at, our average general medical patient is taking 9 medicines upon admission to hospital, and we'd love to think that every encounter with a patient is an opportunity to ensure that the medicines that they take continue to deliver what matters to them and is making them better rather than sicker. De-prescribing should always be part of that initial consideration.

It's mentioned in the article that the TGA may convene a Medicines Shortage Action Group or MSAG. Can you briefly describe what this is and does the MSAG engage with a wide variety of stakeholders, including one's representative of vulnerable patient groups?

JY: The TGA will convene an MSAG for certain medicines; they’re usually medicines that have much a greater impact on more patient cohorts. And they are meant to be collaborative, short-term working groups that allow the TGA to hear from a variety of stakeholders, including medical, pharmacy, and consumer groups, which include the vulnerable groups that you've mentioned, to discuss how we can potentially clinically manage some of these medicines and their shortage, what type of communications that we put out to stakeholders. They often do involve the sponsor or manufacturers in the room as well to talk about any anticipated supply in the future, what the expected dates are. Of course, these MSAGs aren't going to automatically reveal a magical supply of medicines, but it at least makes sure that we can give the right messages in a consistent way to our stakeholders.

To finish us up today, what are your final suggestions for managing medicine shortages in Australia at both a policy and clinician level?

TS: I can't emphasise the need to communicate enough. Hopefully, every GP in this country has a community pharmacy that they trust to just pick up the phone and have that conversation with. And likewise, in reverse. It's about having those open conversations where the patient's interests are put centrally around what matters to this patient, what can we do for them, what are the options.

At a policy level, there's a lot of levers that are coming into play, and we do need to see how they play out. A lot of those changes to the TGA reporting and mandatory reporting have been in place now for 12 months plus. So looking at how effective they've been and seeing where we need to tweak things.

I'm really interested to see how things are going with the latest TGA's consultation. It's been great to learn more about what happens behind the scenes, especially with MSAG and things like that. So thank you both for joining me on the podcast today.

TS: Absolute pleasure. Thanks, Jo.

JY: Thanks, Jo.

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Tom and Jerry's full article is available on the Australian Prescriber website. The views of the host and the guests on the podcast are their own and may not represent Australian Prescriber or Therapeutic Guidelines. I'm Jo Cheah, and thanks again for joining us on the Australian Prescriber Podcast.

Tom Simpson has received funding from Advanced Pharmacy Australia, formerly the Society of Hospital Pharmacists of Australia, for attendance at meetings and educational events. Jerry Yik has represented Advanced Pharmacy Australia on the Medicines Shortage Action Group convened by the Therapeutic Goods Administration and in advocacy activities and stakeholder consultations in relation to medicine shortages. I am a paying member of Advanced Pharmacy Australia.