What happened following the codeine upschedule?


PBS data shows no evidence of increased opioid prescribing in the year after the codeine reschedule, with overall opioid use trending down, according to ongoing research

It’s been over one year since low-dose codeine preparations became prescription only on 1 February 2018.

Some warned that scripts for stronger opioids would surge and addiction services could be overwhelmed in the fallout.

Research presented at the International Medicine in Addiction Conference in Melbourne this month looked at PBS data for all opioids in Australia over a three-year period—two years before the upschedule of codeine, and the year following.

“We used an interrupted time-series analyses and we found no evidence of increased codeine prescribing or increased prescribing of S4 or S8 opioids,” explains Associate Professor Suzanne Nielsen, Deputy Director of the Monash Addiction Research Centre at Monash University.

“And in fact, the trends are that those are going down – opioid use in Australia in general is trending down now, it has been increasing for a number of years but it seemed to have turned a corner.”

A/Prof Nielsen says that as codeine supply accounted for around 6% of total oral morphine equivalents in Australia, the codeine upschedule doesn’t explain all of the reduction.

“But I think that there was a lot of awareness that was raised by the rescheduling and a lot of work going on in parallel to the rescheduling, to bring people’s knowledge up to date in terms of efficacy and the role of opioids in varied conditions,” she tells AJP.

“So I think that there’s a lot of work going on and you couldn’t say it was any one thing, but all of these pieces of work are related and they’re all aiming to address what has been trends of significantly increasing harms, particularly with pharmaceutical opioids.”

There are many high-potency opioids that take up a much bigger proportion than codeine when looked at as oral morphine equivalents, says A/Prof Nielsen, who is a trained pharmacist.

“Of course when you look at it as pack sizes codeine takes up quite a lot of [this], but what we do in our analyses in convert everything to oral morphine equivalent, so we’re looking at things on the same scale … because not all pack sizes are equal.”

She said the PBS data revealed some slow increases in tapentadol and oxycodone-naloxone.

“Overall the trends are going down, those ones seem to be increasing slightly, but the increase was not related in any way to the timing of the rescheduling [of codeine].

“They were increasing slowly prior to the rescheduling, and that basically continued on in exactly the same trend and I think that might just reflect a bit of a move from, for example, oxycodone to oxycodone-naloxone.

“But overall, when you look at all of the opioids combined, the total amount … seems to be going down.”

A/Prof Nielsen says these findings aren’t necessarily a positive outcome, highlighting the importance of looking at what’s happening at the patient level.

“We need to understand the reason that opioid supply is going down. If opioid supply is going down because people are being given effective non-opioid medications and their overall pain management is improving, that’s a good outcome,” she says.

“If opioid supply is going down only because they’re cutting people off opioids, that might not necessarily represent a good outcome. Just reducing supply, if you don’t reduce harm or if you don’t provide alternatives, you can understand that might not represent a good outcome at the patient level.

“So we need to do a bit more detailed analyses of patient-level outcomes, so that we can really understand [whether] these reductions represent good patient outcomes.”

A/Prof Nielsen points out that the prescribing data is one small data point in the bigger picture.

Her team at Monash University is currently conducting an ongoing cohort study looking at outcomes at the patient level, to see how patients who were using codeine regularly prior to the rescheduling were affected by the decision.

They hope to receive more detailed data from that study.

“I think we need to be able to put that together with the prescription data to get a bit more of a nuanced understanding about how the rescheduling has impacted not only opioid supply but patient outcome,” she says.

“PBS data or prescription data in general has a lot of fluctuations in it – it does tend to go up and down over month to month, year to year. So because there’s these variations in the data, we’re quite cautious when we draw conclusions.”

But Anthony Tassone, president of the Pharmacy Guild’s Victorian branch, says that PBS dispensing data from the Department of Health actually shows that since the upscheduling of codeine there has been an increase in the number of prescriptions dispensed for 30mg strength codeine products each month year on year.

“The magnitude of the increase can vary from month to month but is around 13% from Feb-Nov 2018 compared to the same month the previous year,” Mr Tassone told the AJP.

“This trend has also been experienced in my pharmacy and anecdotally from pharmacist colleagues.”

He says that regarding opioid prescribing more generally, the PBS dispensing data from the Department of Health for molecules such as oxycodone with or without naloxone suggests a steady rate of prescribing without any significant increase. 

“At the pharmacy level, more and more Schedule 8 products seem to be prescribed and pharmacies may need to consider expanding their lockable safe facilities to store Schedule 8 medicines,” Mr Tassone says.

He says that he has received feedback over the last year from patients who felt inconvenienced by the upschedule, who said they used it appropriately for the management of acute pain.

“There have been inconveniences not only in the time taken to see a doctor but the additional cost of purchasing the product due to increases in the ex-manufacturer price for some low dose codeine products and if there is out of pocket costs in seeing the doctor.

“There have been some patients who may have used low dose codeine containing analgesics for chronic or longer lasting pain where codeine is not indicated but they may have felt it helped them manage their pain day to day. 

“The upscheduling has prompted patients with chronic pain to reconsider their pain management options and possibly seek advice from other health professionals. Through the Chronic Pain MedsCheck trial there is an opportunity for community pharmacy to demonstrate their important role in increasing health literacy with patients, helping set and manage expectations on chronic pain management and work collaboratively as part of the broader healthcare professional team.”

The Guild’s position on low-dose codeine has not changed since the upschedule, he says.

“We felt it was a blunt instrument that would inhibit access of treatment for acute pain for the vast majority of patients who used it safely and appropriately,” Mr Tassone says.

“The jury is still out whether upscheduling codeine to prescription only has reduced codeine related overdose deaths and there is an urgent need for the implementation of real-time prescription monitoring in every state and territory across Australia as Victoria and Tasmania are the only states currently to have such a system.”

In late 2018, UNSW’s National Drug & Alcohol Research Centre (NDARC) released statistics regarding actions taken by illicit drug users who also used codeine low-dose codeine, following the upschedule.

Both users of stimulants and those who injected drugs reported high rates of codeine use, but following the codeine scheduling change, the majority of both groups reported taking ‘no action’.

Meanwhile about a tenth said they ‘stopped using low-dose codeine’ in response to the change, while a further 3-5% said they ‘stockpiled low-dose codeine’.

Six per cent of stimulant users and 3% of those who inject drugs said they adapted to the change by obtaining codeine not prescribed to them.

Only a small proportion took action by gaining a prescription, with more gaining a prescription for high-dose codeine than for low-dose codeine.

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