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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