Posted on

Dr Des Corrigan Takes The Temperature ‘down Under’ After Low-Dose Codeine Products Were Rescheduled From Otc To Prescription-Only Status.

The last time we got to visit the Australian branch of the family was in 2018 and our trip coincided with the rescheduling of low-dose codeine products from OTC to prescription-only status by the Australian authorities. Now, four years later, we were finally allowed to travel to Perth, having valiantly dealt with requests for Covid vaccine certs, G2G passes, Safe WA apps, DPDs and negative PCR tests. Amid all the emotion, tears and hugs when we arrived, the pharmaceutical part of my brain was wondering what the impact of that codeine rescheduling had been and if there had been any unintended consequences that might serve as a warning should similar rescheduling ever be mooted in Ireland. 

I did get an opportunity to discuss the matter with the owner of the community pharmacy that my son and his family rely on. I asked that pharmacist about his feelings about the move to prescription status and how it had affected his practice. He told me that, of course, it had a noticeable impact on his bottom line, but that he personally thought the public health benefits in terms of dependence, but above all, the reduction in GIT ulcers linked to codeine-ibuprofen combinations made the changes worthwhile. He also commented that the fact the law had changed removed pressure on pharmacists from patients seeking codeine products — a sentiment likely to be echoed by Irish pharmacists on the receiving end of patient ire when questioned about their reasons for seeking codeine. He told me that there had been an increase in prescribing of tramadol and tapentadol, but that Australian drug laws meant that any inappropriate prescribing could be readily monitored and if necessary, the prescribing authority of individual physicians could be revoked. 

Those anecdotal comments are mirrored to a great extent in the published research on the impact of the rescheduling. A 2019 paper in the International Journal of Clinical Pharmacy reported that of 113 pharmacists surveyed in Victoria (mainly) during the second quarter of 2018, 43 per cent agreed that the change would have a positive impact on their ability to manage pain for patients. 

Perceived advantages of the move included increased engagement with patients and less codeine use, leading to a better overall risk: benefit outcome. Disadvantages included fewer analgesic options and an increased burden on patients, GPs and the health system. 

Data from Australia’s largest poisons information centre in New South Wales was evaluated in a 2019 paper in Addiction. Between 2015 and 2019, there was a 56 per cent drop in monthly reports of codeine-related poisonings. Sales of codeine combination products dropped by 87 per cent, with no increase in sales of higher-strength codeine products. 

Changes in Australian prescription opioid data was the subject of a 2019 paper in the International Journal of Drug Policy arising from a concern that rescheduling would result in a large increase in the prescribing of high-dose codeine or of other opioids such as oxycodone, tramadol and fentanyl, given the high level of OTC codeine use (15.5 million packs in 2013). The study looked at prescription data for two years prior to the change, and 11 months post-rescheduling. R 

Removing OTC availability did not appear to have had an immediate effect on codeine prescribing, as the data showed a decreasing trend for both codeine and other opioids. Sales of OTC and prescription analgesics, cold and flu products and cough suppressants to community pharmacies were investigated using a database of pharmaceutical manufacturer sales in a 2020 study published in the Medical Journal of Australia. The authors concluded that the rescheduling was followed by increased sales of paracetamol, ibuprofen and paracetamol combination products. They commented that while these products carried no risk of dependence, their 

inappropriate use is potentially harmful and recommended monitoring of adverse events linked to those drugs. A small increase in the prescribing of codeine was observed. 

Ireland had the second-highest level of sales after South Africa, at 30 dosage units of codeine per person. This was higher than in the UK, France and Latvia 

A 2021 paper in Drug and Alcohol Dependence investigated the impact of codeine restriction on overdoses, emergency department (ED) visits and deaths, as reflected in calls to the Victorian poisons information centre between January 2013 and December 2019. There was a significant reduction in calls about both high- and low-strength codeine products mirrored by a fall in ED presentations. The rate of codeine-related deaths per million of the population halved between 2017 and 2018. 

A report in Addiction in August 2021 evaluated the impact of the rescheduling on 260 Australian adults who reported regular OTC codeine use, but who were not in treatment for codeine dependence. They were surveyed prior to the February 2018 rescheduling and one, four and 12 months later. Daily codeine ingestion declined from 64mg in November 2017, to 28mg one year later. Approximately half of the participants met criteria for opioid use disorder at the start of the study. After one year, this had dropped to 33 per cent. There was a small but statistically significant increase in visits to a GP for prescription pain medication. A commentary on that paper in the same journal issue noted that evidence from this and other studies consistently showed no increase in the use of other opioids. 

So, the Australian experience seems positive and clear-cut. What then are the implications (if any) for Ireland that has similar ‘pharmacist-only’ sales restrictions on low-dose codeine analgesic combination products to those found to be ineffective at reducing use levels in Australia? For a start, we would need adequate baseline data on many issues. We do have data from a 2022 study in Drug Safety that looked at sales of OTC codeine products in 31 countries between 2013 and 2019. Ireland had the second-highest level of sales after South Africa, at 30 dosage units of codeine per person. This was higher than in the UK, France and Latvia. Irish people spent more on codeine than anywhere else, not least because more than half of EU member states do not permit OTC codeine sales. We do need data on real levels of dependence, on ED visits relating to codeine, and on codeine-linked deaths. Morbidity data on levels of gastrointestinal haemorrhage, renal tubular acidosis and analgesic nephropathy linked to ibuprofen-codeine products and on hepatotoxicity associated with paracetamol-codeine combinations is also a prerequisite to any discussion about changing the status of codeine. 

Should any change be contemplated arising from an evaluation of the evidence base, then significant funding for public information campaigns about the change will be necessary, as will a reasonable transition period for manufacturers, pharmacies and patients. 

A final comment on the Australian situation: Although I was unable to buy low-dose codeine while there, any of the pharmacies I visited in Perth were quite willing to sell me 100 tablet packs of paracetamol. That, I found strange and disconcerting.