When the TGA says no, but NSW says yes

Key doctor groups are concerned the NSW pharmacy prescribing trial may fly in the face of TGA directions.

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Last year, the national medicines regulator rejected an application to down-schedule the oral contraceptive pill.

But next year, people in NSW will be able to walk into a pharmacy without an existing prescription and walk out with a box of the pills anyway.

On Sunday, Premier Dominic Perrottet announced a series of wide-ranging reforms to pharmacists’ scope of practice that included a commitment to supporting a state-wide pilot. According to Mr Perrottet, appropriately trained pharmacists would be able to prescribe medications for skin ailments, ear infection and hormonal contraceptives.

While details of that prescribing trial were left vague, the premier also authorised pharmacists to administer a wider range of vaccines and made a more explicit commitment to funding a 12-month urinary tract infection prescribing trial.

These will essentially mirror the controversial Queensland pharmacy trials, and the initiative has been backed by the state Pharmaceutical Society of Australia (PSA) and the powerful Pharmacy Guild.

“As the most accessible healthcare professional, pharmacists should be able to offer patients renewals of their ongoing medications,” PSA NSW president Chelsea Felkai said.

“Allowing pharmacists to renew prescriptions for oral contraceptives is the first step in giving patients greater access to medicines for stable but chronic conditions that have already been diagnosed.”

RACGP president Adjunct Professor Karen Price sees it differently.

“It’s inconvenient to slow down your build by having an engineer review the foundations,” she told TMR.

This push-pull dynamic, with consumer convenience on one side and high-quality medicine on the other, has come to define the scope-of-practice debate.

The oral contraceptive, particularly its potential involvement in the NSW trial, makes a great case study.

Last year, two hormonal contraceptive pill manufacturers made an application to the TGA to down-schedule the medicines to Schedule 3, making them available over the counter.

The TGA rejected the applications, writing in an interim decision – which it ultimately stood by – that “the adverse effects of oral contraceptive substances, and the potential for evolving risks over time, are significant and require management by a medical practitioner”.

It specifically addressed the tension between convenience and good medicine in the context of pharmacist-led prescribing.

“Consumers can identify when they require (oral) contraception, but consultation with a pharmacist is not sufficient to ensure safety, particularly over extended periods of time,” the regulator wrote.

The TGA only administers the Poisons Standard – it does not implement or enforce it – and is powerless to intervene when state and territory governments depart from it.

Professor Price said that allowing pharmacists to be the main prescribers of the oral contraceptive would mean that patients miss out on all the tangential care that can come from an ongoing GP-patient relationship.

“For younger women, it [will be] all of the STI checks and the relationship checks [as well as] all the other proactive checks that we do for women,” she said.

“We know that the long-acting reversible progesterone contraceptives, if you’re following the research coming out of the SPHERE research group at Monash, are usually first line now.”

Another reason the TGA decided against down-scheduling the oral contraceptive was that its use may mask symptoms of conditions like PCOS or endometriosis, which affect a significant proportion of Australian women.

“[The possibility of endometriosis] is a really important discussion to have with any woman regarding painful menses – whether they’re still getting pain in their cycle and what the patterns are, because that can help us identify [it],” Professor Price said.

At the end of the day, the Melbourne GP said, the TGA decision was made in the interests of medicines safety and the NSW government was effectively bypassing that.

AMA NSW president Dr Michael Bonning said that many of the other conditions and treatments set to be included in the trial would also likely fail a TGA down-scheduling application.

“If the TGA was to do reviews of many of the topics that were brought forward by these trials, there would likely be some similar outcomes,” he told TMR.

“Psoriasis can be both difficult to treat and complex, or masquerade as other conditions.

“The same goes for … uncomplicated urinary tract infections.”

The kicker? In reality, Dr Bonning pointed out, the consumer convenience argument shouldn’t necessarily apply to the oral contraceptive.

“It’s one review every 12 months for the re-prescribing and reassessment of the appropriateness and efficacy of an oral contraceptive,” he said.

“It’s a fairly low bar.”