In February 2018, access to codeine in Australia changed from “Schedule 3” (access without a prescription, requiring interaction with a pharmacist) to “Schedule 4” (prescription only).
This followed a long lead-in period where consumers and health professionals were aware of impending changes, and an even longer period of changes prior to this where pack sizes were reduced and warnings were applied to these medicines (ie not to be used for longer than 3 days).
During this period of change, the debate was fierce about the appropriateness of codeine:
- Whether it is effective at all.
- Whether access changes would make a difference in rates of harm.
- Whether consumers would be disadvantaged due to reduced access; whether consumers would be subject to escalating opioid doses if they were to see a doctor for their pain.
- Whether there would be an explosion of people requiring opioid substitution therapy after developing a substance use disorder driven by access to codeine without prescription.
- Whether people who had a substance use disorder would seek unregulated opioids.
- Whether pharmacy businesses would be financially impacted by changes in sales.
The tone of these discussions were combative.
Groups that cautioned against restricting access to codeine, including pharmacist groups and consumer groups, were roundly criticised as having conflicts of interest rather than having a genuine concern about cessation of access to a product that many found useful or a lack of infrastructure needed to identify and address escalating opioid use such as ‘Real-Time Prescription Monitoring’.
The debate also focused on evidence that wasn’t as strong as it could have been. Deaths from opioid use were rightly part of the discussion, yet all deaths where codeine was detected were discussed as if codeine was the cause of death, ignoring all other opioids, benzodiazepines, or alcohol as causative agents.
Importantly, there is no evidence that these impacts have changed. Of more relevance, harms from accidental poisonings have reduced since codeine access was altered.
So what was the outcome?
Therapeutic Goods Administration (TGA) figures showed a halving in gross tonnage of codeine being used in Australia. This was clearly influenced by commercial factors as demand waned in the lead up to February 2018.
In addition, calls to Poisons Centres regarding poisonings with codeine-associated products has dropped, and analysis of Pharmaceutical Benefits Scheme (publicly funded prescriptions) data found very little impact on the usage of other, stronger opioids.
There was also no increase in the utilisation of opioid substitution therapy. It is possible that these figures and other relevant information is lagging or incomplete (for instance, PBS data does not show private prescription volumes), but it cannot be denied that if any of these measures are going to increase, the proportions will be small.
What the changes seem to have demonstrated is that the vast proportion of “Over The Counter” use was driven by the perception that “strongest is best”, so when codeine combinations became unavailable without prescription, the majority of consumers changed to other analgesics such as paracetamol/NSAID combination products of the “strongest” NSAID (based on public perception). This means that the financial impact on pharmacies has also been minimized.
Pharmacists have reported localised spikes in stronger opioid use, but it has not been a tidal wave of inappropriate prescribing or sudden cessation of treatment.
Has it been smooth sailing?
Primarily, yes. A small portion of consumers were experiencing disproportionate harm through access to OTC codeine – it is hard to say whether they have been further harmed or actually benefited by having OTC codeine removed, but it is clear that OTC codeine is no longer a factor in the harms they experience. The vast majority of consumers have transitioned to other analgesics or supportive treatments, such as allied health, instead.
There is no doubt that codeine is problematic, yet access shouldn’t disappear. Access to codeine needs to occur in an environment where a clinician has access to a consumer’s total exposure to opioids – Real-Time monitoring may be a method of achieving this, but in the short term, restricting access to a prescribing model is the most effective way to achieve this.
Jarrod McMaugh MPS is a primary care pharmacist currently practising in Australia. He is currently the President of Chronic Pain Australia. You can connect with Jarrod by clicking here.
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