State health ministers call for review of OTC codeine rules


By Tessa Hoffman

9 Oct 2017

The pharmacy owners’ industry body has clocked a win in its bid to water down impending new rules for OTC codeine, after state and territory health ministers called on the federal government to review the TGA’s decision citing concerns it could leave people living in the bush without access to ‘appropriate pain relief’.

The move to make OTC codeine products prescription-only (s4) from February 2018 was announced in December, after the TGA found little evidence low-dose codeine is more effective than alternative analgesics for most people.

The Pharmacy Guild has been railing against it ever since, lobbying state and territory governments to amend their own laws to create an exemption that would allow people in “certain circumstances” – such as those in acute pain who can’t access medical services – to continue to buy it from a pharmacy without a script.

The AMA has branded the lobbying an “unprincipled” and “sneaky” attempt to undermine an independent regulator.

But it appears to have paid off.

On Thursday, a letter co-signed by state and territory health ministers was sent to federal health minister Greg Hunt outlining their concerns about the TGA’s decision and asking him to review the situation.

The letter was signed by all except SA’s health minister Peter Malinauskas, a spokeswoman for NSW Health Minister Brad Hazzard told the limbic.

“The ministers’ letter highlights the difficulties presented by the decision in relation to rural/regional residents who may not have ready access to a GP and who may have urgent need for appropriate pain relief,” the spokeswoman said.

“All the ministers are supportive of measures to limit the inappropriate usage of codeine but are looking for the Federal Minister to review the regulatory regime to ensure equitable access across the country”.

On its website, the TGA addresses the issue of rural access explaining that from February 2018, nurse practitioners will be able to prescribe codeine medicines in most jurisdictions and in remote areas.

The letter came days after NSW Nationals leader and deputy premier John Barilaro came out in support of the guild’s proposed model, in which pharmacies could dispense without a script where a customer has severe toothache and no access to a dentist, or when GP clinics are closed or in rural areas where medical services are unavailable – as long as it records the sale in the guild’s MedsASSIST real time recording software.

The AMA has repeatedly condemned the model, with AMA president Michael Gannon telling the ABC on Friday the Guild is “wrong” on the issue.

“They (the TGA) looked at the science, looked at the increasing understanding of the risks of codeine use, made a determination, gave that advice to Federal Minister Greg Hunt who agreed and, with the full support of the AMA – and, we thought, the Pharmacy Guild, the Pharmaceutical Society, and certainly other medical bodies like the College of GPs, the College of Physicians – that we would join the situation in roughly 25 other countries that you need a script to get codeine.

“Now, what we’ve seen is the Guild going out, doing what they’re good at, lobbying politicians hard, they’re very well resourced, but they’re wrong on this. And we will continue to make the case that this was a good decision, it’s long overdue. Codeine is a harmful drug. And do you know what? It’s not even that good a painkiller, there are better alternatives.

The guild meanwhile accuses doctors of “missing the point” on the codeine issue, pointing to ABS figures released in September which show almost 70 per cent of drug-related deaths in Australia in 2016 were a result of prescription drug abuse.

“There is no dispute that overuse and dependence on these codeine containing medicines can cause harm or fatalities. The question is how best to address it – and shifting medicines to prescription only is demonstrably a flawed solution,” Mr Tambassis said.

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