The TGA Has Denied a Request to Allow Birth Control Pills to Be Sold Over the Counter Without a Prescription

The Pharmacy Guild of Australia has slammed the decision.

On Monday, the Therapeutic Goods Administration (TGA) announced the denial of two proposals to allow for the contraceptive pill to be sold over the counter without a prescription by a pharmacist.

The news of the rejection has caused major debate among health and medicine organisations as the decision was slammed by the Pharmacy Guild of Australia but supported by the Australian Medical Association (AMA).

The two proposals asked the TGA to allow people to be sold the pill over the counter and without prescription if they can prove that they had been prescribed the same pill within the last two years.

The request also stated that only after consultation from a pharmacist would the medication be issued or the patient referred back to their GP.

As of right now, Australians who want to access an oral contraceptive pill need to obtain a prescription from their GP. These medications can only be prescribed for a maximum of three repeats at a time, which means that patients need to revisit their GP for another prescription at least once a year.

So, why is there a push to change the access to the contraceptive pill?

Essentially, to make access to contraception easier.

The hassle of having to book GP appointments, take time off work or uni, sit in a waiting room, chat with a doctor for two minutes, and then wait for a pharmacist to fill a script can create frustrating barriers to healthy and safe contraceptive options for people who prefer the pill.

Many people are unable to find time outside of class or work, don’t feel comfortable with other forms of contraception, require the pill for different medical reasons other than pregnancy prevention or are just frustrated with the inconvenience of trying to access it.

Easy access to contraception and sexual health products is imperative to preventing unwanted pregnancy and in some cases (depending on the contraceptive), the spread of sexually transmitted diseases.

The Pharmacy Guild of Australia has stated that the change to make the pill over the counter is a “common sense” move and the decision not to allow it is “an insult to women across Australia.”

“Allowing pharmacies to sell the pill in certain situations would take the pressure off GPs and increase its accessibility for women,” Pharmacy Guild of Australia National Councillor Natalie Willis said in a statement.

"It's merely improving convenience for women to the same level as men, who can pop down to the shops and take care of their contraceptive needs very easily, whereas women have to jump through all these hoops.

“Rather than making a sensible and progressive decision in the interests of women, this interim decision is a retreat into the safety of the status quo. This has simply shelved an issue of great importance for women’s health.”

Ms Willis also argued that shifting the consultation for the pill from GPs to pharmacists would take pressure off GPs and the aging health system.

“There is a two to three week wait to see a GP in most areas. The rescheduling of oral contraceptives would provide recognition of women’s right to access contraception in a safe and convenient manner, is backed by global evidence on safety and quality service delivery and would free up GP time to focus on patients with more complex health needs,” she said.

“Failure to recognise the expertise of pharmacists as the custodians of safe medicine delivery by not allowing them to provide medications such as oral contraception without a prescription is holding back the entire health system in this country, creating unnecessary costs to the taxpayer, placing an undue burden on GPs who are already struggling to cope with demand and inconveniencing patients by denying them easier access to quality healthcare.”

The Pharmacy Guild of Australia also stated that unplanned pregnancy is a public health concern and that pharmacists are highly trained professionals able to undertake this type of consultation.

What are other health bodies saying?

On the other side of the coin, health bodies like the AMA have backed the TGA’s decision, arguing that pharmacists do not have appropriate settings for this type of consultation and that the contraceptive pill has too many risks.

“Retail pharmacies are not appropriate private clinical settings for anyone to monitor and manage their contraceptive health, or to discuss details of sexual health and medical history,” AMA President Dr Omar Khorshid said in a statement.

“Pharmacists, while experts in medicines are not qualified to make clinical assessments.

“Taking the oral contraceptive pill is not without risks, and people need to talk to their GP about which contraceptive option is right for them. It can take a long time to determine which contraceptive pill is appropriate, and this is best done under the advice of a doctor.

When it comes to the contraceptive pill, the main risks of concern include thrombosis (blood clotting), high cholesterol, high blood pressure, some cancers, migraine headaches and cardiovascular disease.

The pill also often shows a myriad of other less severe side effects, including things like weight gain or acne, but these side effects and risks vary from person to person many people experience little to no side effects or find that many settle with time.

If you are on a contraceptive medication and are experiencing any of the above side effects or are considering getting started on a contraceptive pill, speak to your GP for more information and accurate medical care.

The AMA has argued that consultation with a GP will allow doctors to be able to pick up health issues and prevent any adverse effects.

“Research shows contraceptive pill consultations are often about much more than getting a script. GPs often pick up health issues and conduct preventative health checks. Annual visits to the GP are also important to review contraception options,” Dr Khorshid said.

“Medical and personal circumstances of the patient, including mental health are discussed. Other medical conditions, such as endometriosis might go unresolved without these important consultations.

“The federal government must ensure it invests in evidence-based GP-led primary health care instead of ill-considered substitution strategies which give people poorer quality care.”

What is the TGA’s stance?

Although there are already a large number of pharmacist-only medications available over the counter and can be sold following a consultation with a pharmacist, the TGA believes that birth control pills should not be added to the list.

In September, the TGA cited that the risk vs benefits of over the counter contraceptives as the reason why they have chosen to deny both proposals.

“The use of oral contraceptive pills can cause significant adverse effects that are not consistent with over the counter medicines,” the TGA stated.

Despite this cautionary stance, the TGA did loosen the rules on over the counter contraceptives during the peak of the COVID-19 pandemic to allow for an interim amendment so that people who use the pill could gain easier access without having to visit their GP or a doctor’s surgery.

For now, people wanting to access a birth control pill will need to continue visiting their doctor for a script but submissions on the TGA’s interim decision can be made up until 1 November 2021.

For more information on medications or contraceptive advice, contact your local GP.

Header Image: Reproductive Health Supplies Coalition via Unsplash