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TGA rules out over-the-counter sales of oral contraceptives


Matt Woodley


21/12/2021 3:54:08 PM

The RACGP has consistently opposed any efforts to down-schedule the pill, citing patient safety.

Woman taking oral contraceptive.
There are risks associated with the contraceptive pill that require regular review by a doctor.

The Therapeutic Goods Administration (TGA) has confirmed its interim ruling to not allow the sale of oral contraceptives over the counter in Australian pharmacies.
 
The national health regulator had been considering two separate proposals that would have down-scheduled some ingredients found in oral contraceptive pills, paving the way for them to be sold without the need for a fresh prescription, in some circumstances.
 
However, having made a final call for further submissions in October, the TGA ultimately decided to keep oral contraceptives as a prescription-only medicine.
 
‘I consider that while the proposed changes would address some barriers affecting access to ongoing supply of oral contraceptives, I do not feel the benefits of supply from a pharmacist outweigh the risks to women’s health when supplied without consultation from a medical practitioner,’ the author of the decision, who was not named, said.
 
‘I remain of the firm view that medical practitioner involvement is required and the current scheduling of oral contraceptive substances under Schedule 4 remains appropriate.’
 
It is not known who had requested the down-scheduling, as the applications were submitted ‘privately’. Had they both passed, it would have meant that a woman would only need to have shown that she had been prescribed the same pill within the past two years to access the contraceptive.
 
Additionally, the applications would also have allowed the pharmacist to consult with the patient regarding whether the pill was still the right contraceptive choice, and only refer back to the prescribing doctor if they deemed it necessary.
 
The Pharmacy Guild said the decision is ‘deeply regrettable’ and ‘reinforces gender bias’, while National Councillor Natalie Willis had initially described the interim determination as ‘patronising’ to women and pharmacists.
 
However, Dr Amy Moten, Chair of RACGP Specific Interests Sexual Health, previously told newsGP there are risks associated with the contraceptive pill that require regular review by a doctor, especially as these risks can change over time with age and the development of comorbidities.
 
‘For example, [someone] who’s had the pill for years might suddenly develop high blood pressure, which will then increase their risk of having a blood clot, and that risk also increases with age,’ she said.
 
‘Also people might have started taking a new medication, which actually makes the pill less effective, and they might not necessarily think to mention that to the pharmacist, for example.
 
‘They may also have turned a certain age, at which point, again, it might be recommended [that they have] a different dose of the combined pill or a different contraception altogether.’
 
Dr Moten had also held concerns that the proposed down-scheduling would have reduced the opportunity for sexual health screening, such as for chlamydia, which the RACGP recommends annually for people under 30.
 
These points were noted in the TGA’s final determination, alongside the potential for a reduction overall in important routine health screening like Pap smears had the pill gone over the counter.
 
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oral contraceptive pharmacy preventive healthcare sexual health TGA Therapeutic Goods Administration women’s health


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