Australia’s national medicines regulator has made a final decision not to allow the contraceptive pill to be sold over the counter at pharmacies, after two proposals to consider it were made.
The Therapeutic Goods Administration (TGA) has upheld an interim decision made in June to block the contraceptive pill from being sold over the counter by a pharmacist, meaning a prescription from a doctor will still be necessary to access the pill in Australia.
The TGA, which is the medicine and therapeutic regulatory agency of the government, considered two proposals that pushed for the pill to be sold at pharmacies in certain circumstances where a person could prove they had been prescribed the same pill within the last two years. The TGA previously made an interim decision to reject the proposed changes, and after considering further submissions, has now made its final decision.
According to the TGA’s final decision, the risks of allowing the pill to be sold over the counter in certain circumstances outweighed the potential benefits.
“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 TGA’s decision said.
“The National Health Continued Dispensing Determination 2012 allows for supply of oral contraceptives at a subsidised cost via the Pharmaceutical Benefits Scheme (PBS) and state and territory legislation allows for emergency ongoing supply of oral contraceptives by a pharmacist.”
The author of the TGA’s decision said they acknowledged the “clinical capabilities of pharmacists” but there are many benefits associated with seeing a doctor regularly, including using the opportunity for preventative health screenings and to monitor other contraceptive options.
“Regular reassessment by a medical practitioner allows routine preventive health screening (such as cervical smears, pelvic exams, clinical breast exams and screening for sexually transmitted infections) as well as regular review of the suitability of continued oral contraception compared to other forms of long-acting reversible contraception, which are not available without a prescription,” the TGA spokesperson said.
“I have weighed the severity and frequency of adverse effects, alongside the seriousness of potential drug-drug and drug-condition interactions without medical practitioner intervention and follow-up against the benefits of increased access. In doing so, 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.”
The TGA’s final decision also noted that “several factors outweigh the benefits of access to oral contraceptives without the requirement for a prescription at this time”.