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The Therapeutic Goods Administration (TGA) is currently seeking to expand the list of available over-the-counter drugs, ie through a non-prescription pharmacist.
If these changes materialize, we will soon be able to go directly to the pharmacy for a range of medications, including birth control pills, Viagra®, and some treatments for nausea and migraines.
This approach can reduce the number of doctor visits, save time and reduce costs for both the patient and the health system.
This could also cause pharmacists to seek help and advice for certain conditions when they might not have asked for help from a doctor.
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How are medicines regulated in Australia?
The TGA is responsible for the regulation of medicines and medical devices in Australia.
Drugs and other substances considered as poisons are divided into "annexes" numbered from 2 to 9. The schedules determine the availability of these substances, including where they can be sold, by whom, to whom and to what labeling is necessary.
The drugs are divided into four programs (2, 3, 4 and 8). A higher schedule means that there are more access restrictions.
The items in Appendix 3 are called pharmacist only drugs – so they are available to the public without a prescription. The pharmacist dispenses the drug along with any relevant advice and, if necessary, directs the person to a physician.
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Schedule 3 drugs include, but are not limited to, herpes labialis (famciclovir), badl thrush (fluconazole), and the morning after pill (levonorgestrel, ulipristal). Schedule 3 also covers drugs used in life-threatening situations, such as salbutamol for asthma and epinephrine (epinephrine) for anaphylaxis.
Meanwhile, Appendix 4 indicates prescription only medications – so those that must be prescribed by a doctor. Examples include medications for chronic diseases such as diabetes (metformin), heart disease (perindopril), as well as various antibiotics for infections, among others.
What are the proposed changes?
Different appendices may have schedules that may stipulate other conditions.
A new schedule for drugs in Schedule 3 – Schedule M – opens the door to drugs currently only available with a prescription and accessed through a pharmacist with specific training and expertise in health conditions (and drugs) of interest . This essentially means that some Schedule 4 drugs are transferred to Schedule 3.
These changes are currently the subject of a public comment period. Therefore, no medication is listed in this appendix.
Which drugs could become available over-the-counter?
One of Australia's closest neighbors is a good example of how this annex could work in practice.
New Zealand-trained pharmacists are providing certain medications that require an over-the-counter prescription in Australia for a number of years, while Australia is falling behind.
Examples include trimethoprim, an antibiotic for urinary tract infections, sildenafil (Viagra®) for the treatment of erectile dysfunction, triptans for migraines and the contraceptive pill.
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Pharmacists may be required to document the provision of these drugs and share this information with other health professionals, such as the patient's GP.
Research in New Zealand and Canada shows that pharmacists can successfully manage the appropriate supply of these types of drugs.
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Although common fears of asking for drugs 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 seen when New Zealand pharmacists were allowed to provide trimethoprim without a prescription.
This additional list of over-the-counter medications could benefit consumers and allow pharmacists to expand their role in the health system.
However, for more serious medical reasons, it is always important to consult a doctor.
Expanding the role of pharmacists
Pharmacists are well placed to advise on the safe and appropriate use of drugs.
The role of pharmacists has been expanded in recent years. They now provide an increased number of Schedule 3 drugs and provide health services such as vaccinations.
The Australian public seems to support the expanded role of pharmacists. In a 2018 survey, two-thirds of respondents agreed that pharmacists should be allowed to administer more vaccines. Many said it would be more convenient than consulting a doctor.
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The new Schedule M recognizes the skills and knowledge of pharmacists to enable them to directly provide additional drugs to the public in a timely manner in specific circumstances.
To ensure that the supply of these drugs is appropriate and that service delivery remains consistent, the TGA has offered pharmacists additional training for each drug to be added to Schedule M.
Public submissions on the subject are open until April 1 st. We do not know yet when the first drug will be available in this new schedule.
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