The TGA’s scheduling delegate said in a written decision the use of oral contraceptive pills “can cause significant adverse effects”, such as weight gain, emotional anxiety, heavy bleeding and thromboembolism, “particularly with increasing age”.
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The pill could worsen cardiovascular risks in women aged over 35, along with those who were obese, smoked cigarettes, had uncontrolled hypertension, migraines or diabetes, making it inappropriate to be sold over-the-counter, the decision said.
“I am of the view 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.”
The TGA rejected the argument that making the pill available over-the-counter was needed to improve access to contraception in regional and remote areas, saying that telehealth and emergency supply arrangements were in place to address this.
Pharmacists can already dispense an emergency four-month supply of the contraceptive pill once a year.
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“The complexity of the risk factors, adverse effects and interactions necessitates regular medical reviews with a GP, even after the initial establishment of treatment,” the TGA delegate said.
“The proposed changes would introduce new risks which outweigh the potential benefits.”
GP visits allowed women “to review the most appropriate form of contraception for them from a full range of options,” the decision said.
“By moving conversations about contraception to pharmacies, I am concerned that the proposals would impede women from accessing the most appropriate form of contraception for their circumstances and individual risk factors.”
‘Insulting’: TGA rejects proposal to sell contraceptive pill over-the-counter
Source: Philippines Alive
