The Therapeutic Goods Administration (TGA) recently made an interim decision to block the oral contraceptive pill from being sold over the counter in pharmacies, after two applications to consider it were made . The TGA, which is the medicine and therapeutic regulatory agency of the government, said the risks of allowing the pill to be sold over the counter in certain circumstances outweighed the potential benefits.
“The use of oral contraceptive pills can cause significant adverse effects that are not consistent with over-the-counter medicines,” it said.
Questioned at Senate Estimates by Greens Senator Larissa Waters on Wednesday, Professor John Skerritt, head of the TGA, said public submissions on the issue were still open, and a final decision on the matter could be expected from the TGA by Christmas time.
“One of the reasons behind the interim decision was that for a product like the oral contraceptive pill and we’ve talked so much about clotting after the AstraZeneca vaccine, the rates of clotting with the oral contraceptive pill are orders of magnitude higher, several orders of magnitude higher,” he said.
“This is not a harmless set of products, as are few medicines.”
Professor Skerritt said it is “not inappropriate” to ask someone, especially a woman who is ageing and at higher risk of clotting, to see a doctor once a year. He also noted that extending how long prescriptions for the pill are valid for is a complex decision, as there is a maximum 12-month period for any script in Australia under state and territory laws.
“However, as you mentioned, there are other alternatives of whether there should be changes to the frequency. There is another requirement under prescriptions in Australian state and territory law that they are generally valid for a 12-month period maximum, so writing two-year prescriptions would open up a separate legal can of worms.
“We will review every single application received, and the decision maker will make their decision with advice, based on those submissions.”
Asked by Senator Waters what the TGA is doing to support greater awareness of the use of alternatives to the oral contraceptive pill, Professor Skerritt noted that there has been a “very significant” increase in the use of long acting, reversible contraceptives, like the 3-month injection.
“In terms of convenience but potentially in terms of adverse events, LARC or these long term, 3 monthly injections are preferred,” he said. “It isn’t an option that the pharmacist can offer.”
“There are other alternatives such as IUDs which again, so if a woman, for example, has a previous history of clots, they may suggest an IUD as opposed to an oestrogen-based substance or a progesterone only pill, though the efficacy of those is lower.”
“Australia was one of the world leaders in enabling women, who for whatever reason, need emergency contraception, to get it without fear or favour from their pharmacist.”
“Any person wanting to find out about one of the long acting contraceptives, or different types of the pill, there’s plain English consumer medicines information in a central place on our website.”
Public submissions on the TGA’s interim decision about the oral contraceptive pill can be made until November 1.