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Rescheduling alprazolam -

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Norman Swan: Now, there's an antianxiety drug around called Xanax, many of you may have heard about it, it's actually quite toxic, and the government realised that it was fairly toxic, lots of calls to the Poison Centre, and they rescheduled it. And there has been a study done at the University of New South Wales, with colleagues at the University of Sydney, looking at what the effect of rescheduling those drugs are, because how do you actually change the way drugs are prescribed and influenced, and can regulation actually have an influence? And the person doing that study, along with her colleagues, is Andrea Schaffer, who is in the unit of Big Data Research in Health at the University of New South Wales. Welcome to the Health Report.

Andrea Schaffer: Thank you very much Norman.

Norman Swan: Big Data Research in Health. Just tell us about your unit before we get onto the subject of Xanax.

Andrea Schaffer: Well, we primarily do a research that uses data that has been collected for reasons other than research purposes, so administrative data. For example, in the study that we did we used Pharmaceutical Benefits Scheme data on pharmacy claims that has been dispensed at chemists, and hospitalisation data collected at the state level as well as emergency department data, Medicare benefits scheme data as well.

Norman Swan: You've been sitting listening to the program while it's been going to air and you heard Stephen Duckett at the beginning complaining that he wasn't getting open data from the Commonwealth. Did you? Because the Commonwealth is boasting about the fact they are making all their data available, but are they?

Andrea Schaffer: Yes, I think there's something coming up in the pipeline, but at the moment you have to go through a few hoops to get access to data.

Norman Swan: And sometimes when you talk about big data in health people are using your other data that are not in health at all, like supermarket data, people's shopping habits and things like that. Do you use that in your research too?

Andrea Schaffer: I'm not aware of anyone in our group who uses that sort of data, no, at this stage, it's mostly health data.

Norman Swan: So let's talk about Xanax. What's the problem with the Xanax? The actual proper name for it is alprazolam.

Andrea Schaffer: It is, yes. Well, alprazolam, when it's compared to other benzodiazepines…

Norman Swan: It's used for anxiety and panic disorder.

Andrea Schaffer: Anxiety, and insomnia as well, although in Australia it's only PBS listed for the treatment of panic disorder. Compared to other benzodiazepines, alprazolam is more toxic and as well it's more commonly abused. And its use had been increasing in Australia, and so that was concerning and that is why the TGA decided to reschedule it.

Norman Swan: And what was the toxicity?

Andrea Schaffer: Well, individuals might overdose on a benzodiazepine, if they are taking alprazolam they are more likely to die or have worse outcomes than if they overdose on, say, diazepam or oxazepam.

Norman Swan: And was it being abused as well?

Andrea Schaffer: Yes, it's commonly abused, particularly by people who use opioids, for example heroin, and patients who overdose on illicit drugs, they are also often abusing alprazolam.

Norman Swan: So if you are on alprazolam and you are on, say, heroin, that could increase your risk of dying of an overdose simply because of the two drugs working together.

Andrea Schaffer: Yes, in comparison to other benzodiazepines.

Norman Swan: So when they reschedule, what do they actually do?

Andrea Schaffer: In Australia all medicines are classified into a schedule and the majority of medicines that are prescribed, such as statins or blood pressure medicines, they are classified as schedule 4.

Norman Swan: Which means the GP can just write an ordinary script for them.

Andrea Schaffer: Exactly. Medicines that have a high potential for abuse or addiction, they are classified as schedule 8, and those are called controlled drugs.

Norman Swan: So morphine-like drugs would be on schedule 8.

Andrea Schaffer: Exactly, yes, and so what that means is that those medicines, they can still be prescribed but they are just subject to additional restrictions and controls.

Norman Swan: Such as?

Andrea Schaffer: The restrictions vary by state, but it includes things like getting a permit from a state authority to prescribe, requiring that the GP hand-write the prescription, and having the prescriptions expire after six months rather than a year.

Norman Swan: So it just becomes much more difficult.

Andrea Schaffer: It does, yes.

Norman Swan: And what did you do in this study.

Andrea Schaffer: Well, we had access to…

Norman Swan: I mean, is there any doubt that rescheduling changes prescribing habits? I mean, it would make sense that it does.

Andrea Schaffer: Yes, that's what you would expect, but the issue is not only does it reduce prescribing alprazolam but we also want to look at whether there is any unintended consequences, either positive or negative. For example, if alprazolam is more difficult to get, are people switching to other less appropriate drugs or are they switching to more appropriate alternatives.

Norman Swan: Given that the evidence base for these drugs treating anxiety disorder is pretty poor in the first place.

Andrea Schaffer: Yes.

Norman Swan: What did you find?

Andrea Schaffer: Well, we found that almost immediately after the rescheduling the prescribing of alprazolam dropped by 22%.

Norman Swan: And there were a lot of prescriptions, like 18,000 or something like that.

Andrea Schaffer: Yes, we had over our study period, which was six years…

Norman Swan: So it was over six years rather than a year.

Andrea Schaffer: Yes, there was 18,000 people in our sample, so this is a 10% sample of all prescribed alprazolam in Australia, and that was 18,000 people.

Norman Swan: So it's still quite a large number if it's a 10% sample.

Andrea Schaffer: Yes. So the prescribing dropped by 22%. We also found that there was increases in the use of other less toxic benzodiazepines, particularly oxazepam and diazepam.

Norman Swan: Diazepam, the common trade name is Valium.

Andrea Schaffer: Yes.

Norman Swan: So there was a trade-off. Was it a one-to-one trade-off or did the overall rate of prescribing of benzodiazepines, which is actually what you'd want, you'd want that to go down, did it overall go down or was it a one-to-one trade-off?

Andrea Schaffer: It's a bit difficult to compare. One of the issues is alprazolam…all medicines can be prescribed and dispensed privately as well through the PBS, and we only had access to PBS prescriptions.

Norman Swan: So the GPs might have reverted to private prescriptions? But it was still schedule 8, so you've still got rules about the private prescription.

Andrea Schaffer: Exactly, yes. So we suspect that the private market would have acted similarly to the PBS market, but you may have people switching from the private alprazolam market into the PBS diazepam market, for example.

Norman Swan: And calls to the Poisons Centre halved?

Andrea Schaffer: Yes, they did. So over 12 months after the rescheduling they dropped by 50%, and probably most importantly we didn't see any increases in calls for poisoning associated with other benzodiazepines or sedatives.

Norman Swan: So although you could go into a moral contortion about them trading off for other benzodiazepines, overall it was actually safer, even though it might not be more effective for anxiety disorder.

Andrea Schaffer: Yes, so we didn't identify any increases in adverse outcomes. Given the data that we had and the outcomes that we could measure, we didn't see any negative consequences.

Norman Swan: So in this case rescheduling worked.

Andrea Schaffer: It appears so, yes.

Norman Swan: Andrea Schaffer, thank you.

Andrea Schaffer is a biostatistician at the Centre for Big Data Research in Health at the University of New South Wales.

You've been listening to the Health Report, I'm Norman Swan, and I'll see you next week.


Guests
Andrea SchafferBiostatistician
PhD candidate, Centre for Big Data Research in Health (UNSW)

Further Information
Interrupted Time Series Analysis of the Effect of Rescheduling Alprazolam in Australia Taking Control of Prescription Drug Use [$]

Credits
PresenterDr Norman Swan ProducerJoel Werner

Comments (1)

Add your comment

Janet Shaw :

26 Jul 2016 9:14:12am

Fascinating discussion about the effects of rescheduling alprazolam. It is encouraging to hear that there have been no measurable negative consequences from the big data perspective. But what would small data tell us? It might tell us that there are many individuals who have been taking as prescribed for many years - in other words, inappropriately prescribed through no fault of their own - who found themselves suddenly (and dangerously) cut off when their doctor refused to continue prescribing. Many such individuals then faced a difficult withdrawal.