Updated 22nd October, 2015
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The ACMS has recommended codeine be moved to schedule 4 and made available only on prescription after June 2016. The argument that codeine is dangerous to a subset of (liver enzyme) super metabolisers is insubstantial. The fact that codeine is of low therapeutic value necessarily implies the substance is of minimal toxicity. Codeine is fundamental to the useful role played by Australias approximately 6000 pharmacies in managing pain within the community without causing burden to the medicare system. If there is any substance that requires rescheduling it is alcohol and not codeine.
The following is my submission to the TGA which refutes the ACMS’s reasons for change plus some additional reasons for supporting the maintenance of codeine within Schedule 3 (Pharmacist Only). Please consider the points I raise here – and take action to have this decision overturned.
Codeine is used in tablets for the relief of mild to moderate pain, often with a non-opioid analgesic such as aspirin, ibuprofen, or paracetamol. It is also used to stop coughing and to treat diahhroea.
The reasons for the recommendations of the ACMS are given here followed by the reasons I believe these points are invalid.
- Risks of medication misadventure through polymorphic metabolism, deliberate misuse/abuse combined with the relative lack of efficacy compared to safer products.
The idea that codeine is dangerous to super metabolizers is an unnecessary overreaction. This subset of CYP450 metabolizers represent a very small percentage of the population 1-2%- and the assertion that high doses of codeine in this subset can cause severe reactions and even death – while true – is unnecessary sensationalism aimed at gaining an emotionally negative reaction.
- OTC intended for management of acute self-limiting pain, however, there is inappropriate use for chronic pain.
How can the ACMS know what is and what isn’t appropriate use for chronic pain?
- Purpose is questioned since benefit is low.
This could also be interpreted as a reason to not upschedule codeine. If the benefit is low is it really necessary to make the substance more difficult to obtain? If codeine doesn’t work as a painkiller where is the perceived danger?
- OTC sales data are incomplete.
Will sales data be more complete when codeine is available on prescription only?
- Codeine shares the properties of other opioid analgesics and is potentially capable of producing dependence and, in overdose, respiratory depression and reduced level of consciousness.
This is true of ALL opioids – not just codeine. Pholcodine and dihydrocodeine – useful for the treatment of dry cough as well as loperamide – useful in the treatment of diarrhoea – are capable – in large doses – of producing respiratory depression and reduced levels of consciousness. Codeine is a mild analgesic and not the dangerous drug the ACMS makes it out to be.
- Changing the labelling and decreasing the pack size will not adequately address the problem of misuse and dependence.
In the event codeine does become schedule 4 patients will seek out larger and larger pack sizes and quantities – given the rigmarole required to obtain a prescription. This then opens the way for unprecedented cases of misuse and severe dependence.
- Increasing amount of evidence for harm from abuse
Without a clinical reference it is difficult to accept this point.
- Misuse of OTC codeine products including deaths resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression.
All substances within the poisons schedule are capable of producing death. Paracetamol is well known for the morbidity it causes – and yet it is available through supermarkets.
- Genetic influence on codeine’s action complicates risk and benefit decisions, and leads to questions regarding the role of codeine in clinical practice.
Genetic influence complicates risk and benefit decisions for all medicines and not just codeine.
- To adequately determine the clinical needs an appropriately qualified practitioner to assess risk.
Is the ACMS suggesting every patient have their liver function tested in the event they have minor pain, like a headache? This is both onerous and impractical. Do doctors have the time – or the need – to assess every patients liver function?
A relevant point about metabolism. Phenylketonurics are at risk of severe reaction and even death from an overdose of Diet Coke and yet this product remains readily available in supermarkets.The can merely features a warning that the product contains phenylanaine (poisonous to sufferers of PKU) in super small script hidden on the side of the can alongside the ingredient and manufacturers details. Concerns about metabolism mean Diet Coke should be on script?
Codeine is a marginal pain killer, not particularly efficacious. If the molecule is put on prescription the choice to prescribe the molecule will be given to doctors. The medical profession relies on the AMH and MIMs for quick and readily digested information on the suitability of medicines – in this case in the suitability of a painkiller. Given the lack of effectiveness of codeine doctors will understandably choose more effective painkillers – stronger opiates such as oxycodone would become an increasingly popular choice – as has been the case in the UNITED STATES. Increased prescribing of oxycodone will lead to unforeseen bad results – including deaths – effects not predicted by the sudden change of re-scheduling codeine.
Monitoring the sale of codeine based products is akin to trying to “herd cats.” It is pointless and impossible.
Changing codeine to schedule 4 makes it difficult to obtain for patients with minor ailments – especially given that repeat prescriptions for opioids are increasingly difficult to obtain. This will be a particular problem in rural areas.
Finally I note a perceived double standard with supermarkets Woolworths and Coles promoting the sale and use of alcohol “cheaper by the half dozen” This is inappropriate behaviour given alcohol is a poison far more dangerous than codeine. How is the sale of alcohol allowed to continue unabated when it is responsible for far more deaths from misuse in a given population http://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm than those attributed to the comparatively safe codeine? (impossible to quantify as codeine is metabolised to morphine in the body and detected as such in the blood of the decedent.)
Codeine is not as dangerous as the ACMS’s recommendation implies – and the sudden need to change the molecule to prescription only is merely overreaction. A simple campaign run by pharmacists to stamp out potential abuse is all that’s needed to ensure the continued safe and timely supply of this medicine.
Please consider my petition. Posted at change.org