‘Unsafe and unnecessary’: RACGP opposes down-scheduling of the pill

Updated 5 August 2021*

Pharmacists will be able to dispense the oral contraceptive pill without a GP prescription, should two proposed changes to down-schedule substances go ahead.
 
The Therapeutic Goods Administration (TGA) this week released public consultation on the proposals, which would see certain substances reduced from Schedule 4 to Schedule 3 when used in oral contraceptive pills.
 
The RACGP does not support either proposal. It highlighted in a 27 May submission to the TGA that GPs are ‘already very accessible’, and that recent advances such as Medicare-subsidised telehealth and ePrescribing have helped pave the way to better access to general practice.
 
‘The proposals are both unsafe and unnecessary. Women’s health is more than just a prescription service,’ RACGP President Dr Karen Price wrote in the college submission.
 
‘The increased risk to patients does not outweigh the doubtful benefits, for which there is no substantiation. Safe clinical governance frameworks must not be compromised unnecessarily for benefits of a dubious nature.’
 
Gold Coast GP Dr Evan Ackermann, who has long been wary of pharmacy overreach, told newsGP the proposals are being used as a ‘mechanism for lowering health standards’ through marketing purposes to get people into pharmacy business models.
 
‘The “additional standards” proposed for these dispensed medications do not translate to maintained safety standards,’ Dr Ackermann said.
 
‘While the proposal of pharmacists prescribing the pill may have superficial appeal, the reality of implementation in community pharmacy shopfronts, raises significant concerns.
 
‘Clinical corners get cut and standards quickly drop. You only have to look at mystery shopper studies of Australian population and emergency contraception to show this – the lack of privacy, poor assessment by the pharmacist, lack of ongoing advice, role transfers are recurrent findings.’
 
Citing oral contraceptives containing levonorgestrel or norethisterone in combination with ethinylestradiol as the ‘gold standard’, the proposals are to make the substances – when used in low-dose oral contraceptives – available through ‘suitably trained pharmacists working within a framework of professional practice standards and guidance issued by the Pharmaceutical Society of Australia’.
 
Guidelines for pharmacists would specify all patients must have had the same substance prescribed by an authorised health professional within the previous two years, with the pharmacist determining whether it is appropriate and safe to maintain ongoing supply of the medicine ­– or refer the patient to an authorised prescriber for further assessment.
 
The proposal claims that the requirement for healthy patients to visit their GP for the sole purpose of obtaining a prescription for an oral contraceptive ‘they have taken safely for at least 12 months’ creates ‘unnecessary barriers’ to care and access to medicines.
 
‘Enabling these substances when used in oral contraceptive pills to be supplied as Schedule 3 medicines would increase patient access, to reduce avoidable treatment interruptions and unplanned pregnancies – which are a significant public health issue,’ the TGA consultation paper states.


Dr Evan Ackermann said the proposals are a ‘mechanism for lowering health standards’.

The RACGP argues that the separation of dispensing and prescribing of medicines is critical to maintaining patient safety and quality of care.
 
‘Risk around contraceptive needs evolve over time. When a patient visits their GP for a repeat prescription, the GP takes the opportunity to review the patient’s condition and the appropriate treatment,’ Dr Price wrote.
 
‘A patient obtaining additional supply of their medication directly from a pharmacy will bypass this necessary medical review. This poses unnecessary risk and could have negative consequences for their health and wellbeing.’
 
Dr Price also notes that women taking the pill are at greater risk of clots than they are from receiving the AstraZeneca COVID-19 vaccine, but with the current awareness of the risk of thrombosis, it is ‘not prudent’ to reduce clinical oversight of prescribing the pill.
 
According to the RACGP, there is no evidence of the need to increase access to the pill, given that patient access to GPs is not seen as a challenge in Australia, with GPs remaining the most commonly seen healthcare professional.
 
The latest Medicare statistics show that nine in 10 Australians see a GP at least once each year, and almost three in four who need urgent medical care report they can see their GP within 24 hours, while less than 1% report they are unable to do so.
 
‘General practices are highly accessible to the community,’ Dr Price wrote. ‘If it is thought that separation of prescribing and dispensing is not needed for the [pill], then GPs safely prescribe and can dispense medicines with appropriate clinical oversight.’
 
Dr Ackermann agrees.
 
‘You do not maintain standards by reducing clinical oversight to a retail environment,’ he said.
 
While the TGA says the benefits of the proposed scheduling include increased ease of access, continuity of supply and engagement with the healthcare system and a strengthening of primary healthcare, the RACGP warns that ‘the suggestion that advice provided by a health professional that has no access to patient history or interface with the patient’s primary care provider would strengthen primary healthcare, is both naïve and dangerous’.
 
The RACGP has long been strongly opposed to pharmacist prescribing, with late RACGP President Dr Harry Nespolon previously warning that allowing Queensland pharmacists to prescribe the pill and certain antibiotics was a ‘misguided solution’.
 
‘It’s quite simple. Pharmacists don’t have the medical training required to safely deliver these crucial healthcare services,’ he told newsGP. ‘Only GPs can provide this comprehensive and holistic care.’

A better solution to pharmacist prescribing and a safer way to increase access to medicines, the college has previously advised, would be to increase to the number of drugs included in the Pharmaceutical Benefits Scheme (PBS) Prescriber’s Bag.
 
‘GPs know their patients and communities. They are widely distributed and more accessible than ever with Medicare-funded telehealth,’ REC­–QC Chair Professor Mark Morgan previously told newsGP.
 
As one alternative to the proposed TGA amendment, Dr Price outlined in the submission that the college supports including a greater range of oral medications in the Prescriber’s Bag – allowing general practices to ‘appropriately supply medicines to manage urgent care’, particular relevant to after-hours services.
 
‘General practices are also perfectly placed to begin dispensing medicines under non-emergency situations to increase patient convenience and access to medicines,’ she wrote.
 
The full submission to the TGA is available on the RACGP website.

*This article originally stated that women on the pill are at greater risk of thrombosis after receiving the AstraZeneca vaccine, and has since been corrected to state there is no combined risk.

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