Four reasons codeine should be S4 – but Guild disagrees


A pain specialist and researcher says there’s no evidence of benefit from current codeine-containing OTC products – and that “we can’t have a drug of abuse available over the counter”.

Professor Stephan Schug, Director of Pain Medicine at Royal Perth Hospital and Chair of Anaesthesiology at the University of Western Australia, says there’s only evidence of harm, such as addiction and overuse, from the medicines’ OTC status.

But the Pharmacy Guild says that while dependence on opioid painkillers is a problem, the new real-time reporting support tool, MedsASSIST – developed by the Guild for the recording and monitoring of over-the-counter medicines containing codeine – is already proving to be an effective alternative to requiring patients to have to visit a doctor to get a prescription for them.

Much of the data on OTC codeine misuse not only predates MedsASSIST, but also the 2010 scheduling and pack size changes, it points out.

The TGA is currently considering whether or not to move over the counter codeine-containing products onto prescription-only, following an influx of submissions when it first decided to re-evaluate these medicines’ scheduling status.

Of 127 public submissions on the interim decision to upschedule codeine-containing analgesics and cold/flu medicines to prescription-only, 113 did not support the proposal.

Prof Schug says there are four significant problems with the OTC status of some codeine-containing products.

“Firstly, codeine is a poor painkiller; it’s unpredictable and there are risks associated even with its appropriate use,” he says.

“There are many people in the population who carry a gene which makes codeine quite dangerous.

“And it’s not a good pain reliever on its own. Even at the very high dose of 60mg, only one in 12 people achieve a 50% reduction in pain – in this case after an operation.”

Secondly, there’s “almost no evidence” of effectiveness of low dose codeine in combination with either paracetamol or ibuprofen, he says.

“And here’s where the risk escalates because it’s well documented that people who have a problem with codeine use increase the dose and can actually kill or harm themselves from the paracetamol or ibuprofen toxicity.”

He says a patient recently reported taking 80 tablets a day; they were visiting four pharmacies a day to obtain these amounts.

“With regard to ibuprofen, life threatening low potassium levels, acute kidney failure as well as non-healing gastric ulcers with significant risks of perforation and bleeding occur with overdoses.

“Again we see patients using up to 60-100 tablets/day; a patient with a life-threatening ulcer perforation from 60 tablets ibuprofen plus/day was on my round last week.”

Thirdly, dependence on opioid analgesics is a significant concern in Australia, says Prof Schug. 

“And OTC codeine contributes to this by providing unmonitored access to a drug, which in the body is metabolised to morphine.

“The number of overdose deaths in Australia related to codeine has increased from 3.5 per million in 2000 to 8.7 per million in 2009. It is in particular concerning that the ratio of strong opioids to codeine is now in a range of 2:1 for such overdose deaths.

“Fourthly, the rescheduling of codeine containing preparations to prescription-only will not reduce people’s access to effective pain relief.

“There is nearly no improvement of the effect of paracetamol and ibuprofen by adding low doses (<12 mg is permitted) of codeine, while combining paracetamol and ibuprofen is much better with significantly better pain relief and safety.”

Prof Schug says the “easy and widespread” availability of the medicines is not limited or monitored well at all.

“Surveys of pharmacists and codeine dependent people seeking OTC codeine illustrate a number of difficulties managing the safe supply of OTC codeine analgesics,” he says.

“It is unreasonable to expect a pharmacist will be able to detect codeine dependence based solely on a customer’s appearance.”

The MedsASSIST tool was piloted in Newcastle, NSW and North Queensland only in February 2016, and rolled out nationally from March.

A recent AJP poll demonstrated good takeup of the tool already. Earlier this month 68% of AJP readers said they were already using MedsASSIST and thought it was a great initiative; another 8% were using it despite some reservations. Another 5% said their pharmacy was planning to implement it.

A spokesperson for the Pharmacy Guild today said the Guild acknowledges dependence on opioid analgesics is a concern in Australia. This was why the Guild developed MedsASSIST, which focuses on patient care and patient pain management support pathways designed to help pharmacists identify patients who are at risk of codeine dependence.

It facilitates access to suitable referral pathways to support patients to better manage their pain and enhance health outcomes, the spokesperson says.

“In addition to mandating the recording of OTC codeine, the Guild also supports mandatory warning labels advising consumers of the potential for dependence from prolonged use of these products,” the spokesperson says.

“We also support other measures including reducing pack sizes for these products to a maximum of three days’ supply, ongoing education for pharmacists, and a consumer awareness campaign.”

The spokesperson says such measures will help to ensure patients who need these medicines are able to access them.

“Such access is important and an independent review commissioned by the Therapeutic Goods Administration investigating the safety and efficacy of low-dose codeine found there was high-quality evidence that combination-codeine medicines provide clinically important pain relief in the immediate term,” the spokesperson told the AJP.

“We also need to take into context the fact that many studies that investigate abuse/misuse of codeine look at periods before 2010, when OTC codeine was rescheduled from Schedule 2 to Schedule 3 and the maximum available pack size was greatly reduced. 

“Therefore, any conclusions made on OTC codeine based on data pre-2010 are not factoring in critical changes to the scheduling of these medicines.”

The spokesperson says the Guild has consistently argued that making all codeine medicines prescription only is a blunt instrument that would not only be ineffective at addressing concerns of abuse, but could also have potential unintended consequences such as increased use of higher strength pain medicines in larger packs, or more potent opioids.

“It could also lead to substantial increased costs to consumers and the health system in the form of additional doctor visits and PBS costs.”

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