Codeine - patient safety before profit

Addiction specialist and President of the Royal Australasian College of Physicians’ Chapter of Addiction Medicine, Associate Professor Adrian Reynolds says the potential for codeine addiction and related harms requires doctor oversight before these products are supplied.

Most Australians don’t realise how much harm codeine can cause. In fact, medicines containing codeine are so harmful that in most parts of the world a prescription is required.

This will change in Australia in February next year, when the independent medicine regulator, the Therapeutic Goods Administration (TGA), reschedules codeine products from Schedule 3 (available over-the-counter) to Schedule 4 (sold only with prescription).

Codeine - the ‘fast food’ of big pharma

Addiction specialists and general practitioners overwhelmingly support the rescheduling of these medicines, mostly because we see first-hand the consequences of these products being so freely available in pharmacies.

Codeine is closely related to morphine and, like morphine, is derived from opium poppies. It often results in opioid tolerance, addiction, poisoning and, in high doses, can contribute to both accidental and intentional death.

When combined with paracetamol or ibuprofen, the addictiveness of codeine drives some people to increase the number of tablets taken as their body’s tolerance to the codeine builds. As a result of large doses of paracetamol or ibuprofen, serious damage can occur to the liver, kidneys and stomach and even cause death.

We know that codeine in many cases confers little benefit to patients and yet it is being consumed in larger quantities than ever before. More than one million Australians are sold codeine based medications every year and a recent AIHW report revealed that 4.8 per cent of Australians have misused pharmaceuticals in the last 12 months.

There is a broad body of evidence that documents the misuse, addiction, and secondary harm due to high dose exposure to the non-opioid analgesic medicines with which codeine is combined (for example gastric ulcer with complications of haemorrhage or perforation, hypokalaemia, or renal tubular acidosis).
The morbidity and mortality associated with codeine-containing combination analgesics is the main reason why doctors support tighter regulation when it comes to selling these medicines.

The regulator has done its homework

There is no hidden agenda in pursuing greater medical oversight for codeine. Unpredictable pharmacokinetics, risks of codeine harm, addiction and the limited evidence of benefit when compared with much safer alternatives are among the reasons for restricting access to these medicines.
The TGA led a comprehensive review of the evidence and worked closely with all stakeholders and the wider community. The review process showed these products to be low value, high risk medicines when considered alongside what is known about the social, financial and health costs associated with these medicines.

The TGA is not alone in arriving at this decision. A number of relevant medical organisations strongly support these measures including the Royal Australasian College of Physicians, the Royal Australian College of General Practitioners, the Royal Australian and New Zealand College of Psychiatrists, the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists, and the Australian Medical Association.

As is the way with most regulatory reforms, not everyone is going to agree.

Resistance to reform

Codeine is a big deal for the pharmaceuticals industry with media estimating these products generate revenue of more than $200 million each year. Business groups like the Pharmacy Guild have made strong representations to state and territory governments on the need to ‘adjust’ the TGA’s rescheduling decision.

Among the changes proposed by the Guild are ‘exceptions’ for pharmacists to “receive additional codeine related training … (to) supply up to an agreed quantity of these medicines to patients for the temporary relief of acute pain, with a requirement to adhere to a strict protocol and use a mandatory national real time monitoring system like MedsASSIST.”

The Guild maintains they are not trying to “undermine” the scheduling changes but are seeking “practical” and “common sense” adjustments. My first response to this commentary is that ‘practicality’ is irrelevant if a medicine is not effective or safe.

What lacks common sense is the proposition that these medicines be offered without medical oversight while at the same time requiring pharmacists to monitor their use. Pharmacists need to know what to do with this information.

Most pharmacists are not trained in assessing and dealing with drug dependence and drug seeking behaviours and few community pharmacies are equipped with the private space required to have sensitive discussions with patients about these matters.

A nationally coordinated and implemented real-time reporting and monitoring system in the form of the Electronic Recording and Reporting of Controlled Drugs is a good idea. In addition to codeine, the system should include other prescribed medication of concern in addition to Schedule 8 medicines.
A monitoring system on its own, however, is not a solution to the problem.

We know from the evidence that codeine regulatory changes introduced in 2010 reducing pack sizes did little to reduce the harms of these medicines, even though pharmacy counselling was then touted as one of the strategies to address these problems.

Furthermore, in accordance with Australia’s Standard for the Uniform Scheduling of Medicines and Poisons, any medicine dispensed by a pharmacist without a prescription must be assessed as substantially safe and without the risk of misuse or abuse.

These products can no longer be considered substantially safe and without the risk of misuse.
A doctor shortage in remote parts of Australia is another “concern” raised by the Guild, claiming that chronic pain sufferers will be without pain relief.

In some cases, people seeking over the counter remedies without a script may consider the combination of paracetamol and ibuprofen as a more suitable and effective option than codeine. If a pharmacist assesses the pain to be moderate to severe or these single or combination paracetamol-ibuprofen medicines are not effective, the patient should be assessed by their doctor.

Codeine abuse and doctor shortages are two separate issues. An appropriate response to the latter is for state and territory governments, together with the medical and pharmacy community, to link rural health care clinicians and specialist services. These specialist outreach programs would bridge the gap between general practitioners and specialist services.

It would also allow community pharmacists to act within their scope of practice and provides a framework for better communication between all members of a patient’s treating team.

The months ahead

The scheduling change is an adjustment for patients, pharmacists and doctors. The clinical landscape for opioid therapy is evolving dramatically; scientific evidence is expanding and our health professional practice must evolve with it. The doctors and pharmacists I have talked with want nothing less.

Rather than dragging the chain, doctors and pharmacists and the groups who represent them, should work together to ensure these changes are implemented by February 2018 and ensure that treatment optimisation and patient safety are prioritised ahead of commercial interests.

Associate Professor Adrian Reynolds
President of the Chapter of Addiction Medicine
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