Codeine – let’s hear all the facts

Facts myths scale

Misinformation is muddying the waters around the Guild’s proposals for continued pharmacist provision of codeine-containing medicines, says Anthony Tassone

Concern over the impact on patients of the upcoming rescheduling of medicines containing codeine has led to the Pharmacy Guild of Australia proposing a system under which these medicines could still be provided by pharmacists without a prescription, under very strict circumstances.

But this proposal has seen a flurry of misinformation or at least unbalanced reporting of all the facts, from interests associated with the push to prevent genuine access to low-dose codeine.

The Pharmacy Guild is in no way trying to circumvent or reverse the TGA decision to upschedule codeine. What the Guild is seeking to do is ensure that acute pain patients have access under specific criteria to these medicines. The medicines would be provided by appropriately trained pharmacists authorised to supply them under a structured supply arrangement, with mandatory real time recording in place.

This would see codeine analgesics supplied:

  1. by a pharmacist who has completed specified training on managing analgesics containing codeine, including opioid addiction and pain management
  2. for the treatment of acute pain conditions, determined by a clinical protocol
  3. to a maximum of 3 days’ therapy
  4. with recording in the MedsASSIST real-time monitoring system developed by the Guild and already used in most pharmacies   

Despite the robustness of the proposal, there has been a concerted campaign to try to discredit it, pointing to the dangers of codeine and its supposed ineffectiveness in low doses.

At all times in consideration, development and advocacy of its proposal – the Guild has been mindful and acknowledged the risks associated with use of codeine.

But the opposition arguments mostly rely on the dangers of prescription codeine medicines and not the low-dose medicines subject to the Guild proposal. In fact, one of the Guild’s concerns are that removing complete access to these low-dose medicines will see more codeine prescriptions being written, and thus potentially adding to the already significant prescription codeine problems.

What the data shows is Australia has experienced an increase of 87 per cent in prescription opioid deaths, and rural/ regional Australia has experienced an increase of 148 per cent in prescription opioid related deaths. Overall more Australians die from prescription medication overdose than illicit drug and/or car crashes.

But the statistics that are often used are not up-to-date, quote the wrong years, and routinely fail to differentiate between over-the-counter and prescription strength codeine-containing medicines.

Those opposed to the Guild proposal also assert that low-dose codeine is ineffective. In fact, a codeine efficacy and safety review in the over-the-counter setting that concluded combination medicines containing codeine provide clinically significant pain relief for the immediate term (defined as three hours following a single dose) although the effects appeared to decline in the short term (4–6 hours after a single dose).

A separate evaluation (in the same report) showed continued improvement over time in pain relief generally above the minimum threshold considered to be clinically important. The authors report that this suggests “a continued course of these medicines is effective in relieving pain”.

The Guild’s proposal makes good sense, especially considering the requirement that the high-effective MedsASSIST system (or at least a suitable mandatory real-time monitoring system) be an integral part of the proposal. The mandatory use of a real-time monitoring system such as MedsASSIST is fundamental to the Guild proposal and is underpinned by the system’s proven efficiency.

To date, 4,035 pharmacies (72 per cent of all PBS-approved pharmacies) are voluntarily using MedsASSIST and over 8.6 million transactions have been recorded. Of these, around 2 per cent of transactions have been for a ‘deny/non-supply’ and 1 per cent recorded as a safety sale. These 204,000 safety sale instances were where pharmacists identified potential dependence issues and counselled consumers about appropriate treatment options.

However, under the present planning for the upscheduling it has not been confirmed beyond the currently operational Tasmanian system and the upcoming Victorian system which States or Territories will provide real time prescription monitoring.  There is currently consultation by the Tasmanian department of health for potential inclusion of codeine in its monitoring system, and Victoria has already determined that codeine will be monitored with its system.

In addition, Victoria is the only jurisdiction to commit funding for drug addiction counselling or treatment which is likely to be required upon commencement of real-time prescription monitoring and increased identification of patients misusing or potentially abusing opioid medicines.

The upscheduling of codeine will also bring changes in consumer behavior.  A Guild survey found 72 per cent of consumers indicated they would most likely go to the doctor for a prescription to obtain these medicines after February 2018. In addition, 61 per cent believe they will visit the doctor more often once codeine is upscheduled, and an overwhelming 92 per cent indicated they would support the Guild supply proposal.

This change in consumer behaviour will no doubt lead to an increase in the workload of GPs and increased waiting times for patients, especially as many medical practices have limited capacity to accept new patients.  Patients who reside in regional, rural and remote areas would be most impacted, given the time and cost to visit a GP is substantially greater compared to metropolitan areas.[1]

For patients who do not have ready or affordable access to a medical practitioner, their pain management may go untreated or have delays in commencing treatment leading to an increase in presentations to hospitals

The negative impact on consumers was highlighted in December last year with the Consumers Health Forum and Painaustralia, saying in a joint statement: “Both CHF and Painaustralia have opposed making codeine products prescription-only previously because it would penalise the majority of users who do not abuse it by requiring them to visit a doctor and potentially incur additional costs.”

It is time to stop the misinformation and start putting the patients’ interests at the forefront of the debate.


*Anthony Tassone is president of the Pharmacy Guild of Australia (Victoria)


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  1. Kingsley Coulthard

    I would agree that we should be aware of the facts behind the current debate over the risk:benefit of adding low doses of codeine to a second analgesic. Ignoring the well shown and significant risks of codeine , the essence of the efficacy debate is “does adding low dose codeine to paracetamol or a NSAID provide additional analgesia to the paracetamol or NSAID alone?”
    I would recommend that we read the efficacy and safety review in the above link – a TGA commissioned report and conducted by Australian researchers.With regard to efficacy, this review included studies on combination codeine OTC products vs placebo an a second literature review of OTC codeine products vs OTC analgesics without codeine.The comment re the ” clinically important pain relief in the immediate term ( 3 hours post ingestion) although the effect appeared to decline in the short term ( 4-6 hours after a single dose)” actually related to the first efficacy review….ie OTC codeine combination products were better than placebo.
    With regard to second and most relevant question in the current debate ( does adding codeine provide benefit?) the review concluded that “It was difficult to evaluate the incremental effectiveness of codeine as some of the studies comparing combination codeine medicines with single ingredient medicines did not use same-drug comparisons e.g. NSAID + codeine vs paracetamol, making it difficult to attribute
    the findings to codeine alone. Three trials compared combination codeine medicines with
    appropriate single ingredient comparisons, two of which report no statistically significant
    difference in analgesia and one reported a marked difference in analgesia attributable to
    codeine”. This one study ( McQuay 1989) that supported the addition of 20mg codeine to 400mg ibuprofen vs ibuprofen alone was conducted in only 22 patients undergoing molar removal.
    Given that we now have combination paracetamol/ibuprofen products that have demonstrated efficacy and low numbers needed to treat in dental pain plus the lack of high quality data as shown in the above review to support the benefit of adding low dose codeine, then I believe the facts do not demonstrate a favourable risk:benefit ratio that supports the use of low dose OTC codeine containing analgesics. The use of low dose codeine products, whether OTC or prescribed, are not in the patient’s best interest.

    • Jarrod McMaugh

      The current proposal that is being discussed is the introduction of an accredited role for pharmacists to provide certain schedule-4 medications in situations of acute need, where the involvement of a GP may not be necessary (due to clear differential diagnosis & lack of confounding circumstances).

      For the majority of people in pain, simple analgesics are effective enough for acute pain.

      For a small proportion, combination products will be required, and the newer NSAID+P products will be effective.

      For a yet smaller proportion, NSAIDs or paracetamol will be inappropriate.

      This last group of people should be able to access effective treatment (both types of low-dose codeine combination products have demonstrated efficacy) without the significant time delays that occur when accessing GP services, and without the potential cost burden of seeing a GP to ratify what the pharmacist has already identified. These people should also be able to access effective pain relief without being exposed to higher-than-necessary doses of analgesics that can occur through prescribed pain relief. Prescribing patterns for codeine-containing analgesics via the RPBS (where low-dose codeine is subsidised) clearly shows that prescribers will utilise higher doses of codeine in preference to low-dose codeine.

    • jason northwood

      so why are these products still registered on the ARTG if they are not efficacious?

  2. Tony Pal

    The upscheduling of low-dose Codeine is 100% to doctors satisfaction & is the equivalent of foxes being put in charge of the hen house. It is not low-dose Codeine that is the start of the addiction journey, it is instead part of the end of the addiction journey, where the most likely opportunity for exposure occurs. The start in my opinion is more likely to high level of opioid exposure that has been prescribed than to the odd OTC low-dose. I am not saying all doctors are irresponsible but they never mention that they may have a part in the addiction process other than to point out that it is all the pharmacist fault for having access to low-dose Codeine. The vast majority of both sides, doctors and pharmacists, do the right thing, but it is the addicts task to find the weak links whether OTC or weak prescriber. The decision to upschedule lays all the blame on the pharmacist, with very few, if any, GP voices defending pharmacists. I have only ever had one Panadeine Forte tablet in my life, and hope never to experience it again. For me low-dose Codeine defies EBM and is effective for me when I need something more than Paracetamol, which is rare, Thanks to age I will be requesting regular good stuff as soon as I reach retirement age and no longer have to be responsible for my own hen house of goodies. Until then I put up with the pain, which is better than a single Panadeine Forte anytime.

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