An unscheduled dilemma

In the first of our series of reviews of the biggest issues facing pharmacy in 2017, Megan Haggan looks at the fraught issue of the codeine upschedule

There’s no doubt that the looming upschedule of codeine has been one of the year’s most controversial issues.

Just before Christmas 2016, the TGA announced that it would change the schedule of over-the-counter preparations containing codeine, including analgesics and cough medicines, to prescription-only.

The TGA said it made the decision “after significant consideration and consultation on the effects of medicines containing codeine on people’s health and wellbeing”.

There was significant surprise around the decision, and dismay among stakeholder groups such as ASMI and PSA, as well as grassroots pharmacists.

AJP readers were not happy, with 62% of respondents to an poll saying that alternatives such as MedsASSIST should have been made mandatory; and 62% also saying the decision would put more strain on the health system.

At the time, the Pharmacy Guild told the AJP that “the demand for codeine products will remain, and there is no evidence that making codeine products prescription-only will reduce demand or abuse;” and national president George Tambassis told Today’s Lisa Wilkinson that the upschedule was a “silly” decision.

The Guild was soon highlighting two areas of concern that it would speak out about all year: the lack of a real-time monitoring system post-upschedule, which it says is likely to push the misuse issue into the doctor shopping, not pharmacy shopping, arena; and access to pain relief.

By mid-year, it had put together its “Prescription – except when” model, which would see pharmacies still able to dispense low-dose codeine-containing analgesics under certain limited circumstances.

The example most commonly given was for relief of acute toothache, when a dentist’s surgery could not be accessed, after hours or in rural areas without GP services.

This led to a year-long and often bitter stoush with doctors over whether or not pharmacists had been appropriately selling OTC codeine, and what exactly doctor groups planned to do about doctor shopping.


The fate of MedsASSIST

In March, stakeholders began to wind up offers which would no longer be viable following the upschedule. First, GSK announced that it was planning to discontinue its entire OTC codeine offer, including Panadeine, by the time 1 February 2018 rolls around.

On March 29, the Pharmacy Guild announced that MedsASSIST was to be shut down across the nation – the next day, on March 30.

Prior to the December 2016 upscheduling decision, the decision-making tool had been hoped to help inform a TGA decision to retain low-dose codeine’s S3 status.

The Guild said that the upschedule would “regrettably” make MedsASSIST obsolete.

Pharmacists reacted with shock and concern to the decision: researcher and pharmacist Penelope Wood, a pharmacotherapy clinical adviser at Western Victoria Primary Health Network in Geelong, told the AJP that the “beauty” of MedsASSIST was that it allowed pharmacists to “see a pattern, and have more clout to your discussion”.

Health Minister Greg Hunt.

But Health Minister Greg Hunt swooped in to save the day. On March 30, the Guild had another announcement to make: that Mr Hunt was going to work with it to keep MedsASSIST up and running up to 1 February.

Several of our readers had suggested that now that the upschedule was to go ahead, pharmacies would stop using MedsASSIST: but user numbers barely slipped, if at all. By August, the Guild’s figures showed that around 70% of pharmacies were still voluntarily using the tool.

It clocked up 8.5 million transactions between its national rollout in March 2016, and in August, when the Guild released a snapshot of its use: around 2% of these transactions were for a deny/non-supply, and another 1% were recorded as a safety sale.


The Nationals spark a storm

MedsASSIST will, of course, become obsolete from 1 February – and without real-time monitoring yet implemented, pharmacy stakeholders remain concerned that there will now be no way to track excess prescribing of codeine.

In July, Greg Hunt told the PSA17 conference that the Federal Government is to work with the states to develop a real time monitoring system for dangerous prescription drugs – which is hoped to be implemented by the end of 2018. In making the announcement, Mr Hunt singled out “drugs such as morphine, Oxycontin and so many others”.

But as the Pharmacy Guild has repeatedly pointed out, in the meantime – and with Victoria’s real time monitoring system, announced in October, also not yet off the ground – there will be no way to track the prescribing and dispensing of formerly-S3 codeine-containing preparations.

Access is also an issue, the Guild argues. By October, it was still encouraging politicians to think about the “Prescription – except when” model: and it found an ally in NSW Deputy Premier and state Nationals leader John Barilaro.

David Heffernan and John Barilaro
David Heffernan and John Barilaro.

Mr Barilaro spoke out on the subject while at the Harden Pharmacy in rural NSW – a pharmacy which is in a designated district of workforce shortage for GPs. Harden has recently been without a GP for up to five days at a time.

Instead of just calling on state and territory health ministers to back the Guild’s “prescription – except when” model, he went one step further.

“We’ve made an announcement where the Nationals are calling on the Federal Government to reverse their decision in relation to the way customers can access codeine products over the counter,” he said.

“A reverse would be great, or a compromise position, which I know the Pharmacy Guild have been looking to.”

New NSW Guild president David Heffernan was on hand to explain the “Prescription – except when” model.

The response from doctors was swift and angry. The AMA issued a statement in which it called the Guild “irresponsible and unprincipled” for lobbying politicians to “sneakily” use State legislation to avoid the upschedule, while social media accounts erupted.

On Twitter, RACGP president Dr Bastian Seidel accused the Guild of “policy by chequebook at its worst,” while Chair of the RACGP Expert Committee – Quality Care Evan Ackermann declared on Twitter that “a corpse lies deeply buried in the backyard of the pharmacy Guild (sic) – its name is ‘pharmacy credibility’.”

The Pharmacy Guild responded: “It is time for the AMA to get real on codeine. Accept that doctor shopping is rife; and acknowledge that patients using codeine medicines safely and appropriately should continue to be able to do so with safeguards and real time recording in place.

“What are patients with migraine, toothache or period pain meant to do in Harden when there is no doctor within a hundred kilometres for a week at a time? The AMA has no answer.”

Soon, Dr Gannon in particular was taking to mainstream media to explain that low-dose codeine is not an effective painkiller and probably would not be approved today; he says better pain relief can be obtained by ibuprofen-paracetamol combinations.


Where are we now?

As it stands, the upschedule is a done deal.

In late October, Dr John Skerritt, Deputy Secretary of the department’s Health Products Regulation Group told a Senate Community Affairs Committee Estimates hearing that there is no indication that the measure will be rejected by state and territory governments.

This followed weeks of speculation following the Barilaro announcement, in which state and territory health ministers (bar South Australia’s new Minister, Peter Malinauskas) wrote to Greg Hunt to clarify some issues around the upschedule, including how GPs would handle an influx of pain patients, particularly in rural areas.

NSW’s Brad Hazzard in particular showed public support for “Prescription – except when”.

Liberal MPS reportedly also flagged concerns with Mr Hunt during a party room meeting in late October.

But Dr Skerrit said that not only was there no indication that state governments would reject the upschedule, no formal submissions to delay the measure have been received.

Now, it’s up to the health sector to manage the transition. And with Guild figures showing that 72% of consumers would most likely visit a GP for a script for low-dose codeine, it may be a difficult transition to manage.



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