Making more drugs available 'over the counter' would be a win for the public and the health care system

The Therapeutic Goods Administration (TGA) is currently looking to expand the list of medicines available “over the counter” – that is, via a pharmacist without a prescription.

If these changes get off the ground, we could soon be able to head straight to the pharmacy for a range of medications including the contraceptive pill, Viagra®, and selected treatments for nausea and migraines.

This approach may reduce the need for trips to the doctor, saving time and lowering costs both for the patient and the health care system.

It could also result in people seeking help and advice for some conditions from their pharmacist, when they may not have otherwise sought medical help.

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How are medicines regulated in Australia?

The TGA is responsible for the regulation of medicines and medical devices in Australia.

Medicines and other substances considered to be poisons are divided into “schedules” numbered from 2 to 9. The schedules determine the availability of these substances, including where they can be sold, by whom, to whom, and what labelling is required.

Medicines fall into four schedules (2, 3, 4, and 8). A higher schedule means there are more restrictions on access.

Schedule 3 items are known as pharmacist only medicines – so they’re available to the public without a prescription. The pharmacist dispenses the medicine together with any relevant advice, and when necessary, will refer the person to a doctor.

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Examples of Schedule 3 medications include treatments for cold sores (famciclovir), vaginal thrush (fluconazole), and the morning after pill (levonorgestrel, ulipristal). Schedule 3 also covers medicines used for potentially life-threatening situations, such as salbutamol for asthma and adrenaline (epinephrine) for anaphylaxis.

Meanwhile, Schedule 4 denotes prescription only medicines – so those that need to be prescribed by a doctor. Examples include medicines for chronic conditions such as diabetes (metformin), heart disease (perindopril), as well as a variety of antibiotics for infections, among others.

What are the proposed changes?

Different schedules can have appendices which may stipulate other conditions.

A new appendix for Schedule 3 medicines – Appendix M – opens the door for medicines currently only available with a prescription to be made accessible via a pharmacist who has specific training and expertise in the health conditions (and medicines) of interest. Essentially, this means shifting some medicines from Schedule 4 to Schedule 3.

These changes are currently under a period of public consultation, so no medicines are listed in this appendix yet.

What medicines could become available over the counter?

One of Australia’s closest neighbours offers a good example of how this appendix might work in practice.

Trained pharmacists in New Zealand have been supplying certain medicines that require a prescription in Australia over the counter for a number of years, while Australia is falling behind.

Examples include trimethoprim, an antibiotic for urinary tract infections, sildenafil (Viagra®) for erectile dysfunction, triptans for migraines, and the contraceptive pill.

Pharmacists may be required to document the supply of these medicines, and share this information with other health care professionals, such as the patient’s GP.

Research from New Zealand and Canada shows pharmacists can successfully manage the appropriate supply of these sorts of medicines.

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Despite common fears switching medicines to be available without a prescription may result in a rapid increase in use, this is not necessarily the case. For example, no increase in use was found when New Zealand pharmacists were allowed to supply trimethoprim without a prescription.

This additional list of medicines available without prescription may benefit consumers, and would allow pharmacists to broaden their role within the health care system.

For a variety of more serious medical concerns, though, it’s still important to see a doctor.

Expanding the role of pharmacists

Pharmacists are well-positioned to provide advice on the safe and appropriate use of medicines.

The role of pharmacists has been extended in recent years. They now provide an increased number of Schedule 3 medicines, and deliver health services such as vaccinations.

The Australian public appears to support the expanded role of pharmacists. In a 2018 survey, two thirds of respondents agreed pharmacists should be allowed to administer more vaccinations. Many said this would be more convenient than seeing a doctor.

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The new Appendix M recognises the skills and knowledge of pharmacists to be able to directly provide additional medicines to the public in a timely manner under specified circumstances.

To ensure the supply of these medicines is appropriate, and that service delivery remains consistent, the TGA has proposed pharmacists will undergo additional training for each medication to be added to Appendix M.

Public submissions on the topic are open until April 1. It’s not yet known when we can expect the first medicine to become available in this new appendix.