TGA dismisses bid to make contraceptive pill available over the counter in Australia
A push to make the contraceptive pill available over the counter has been dismissed by Australia’s drugs regulator.
In an interim decision, now open for further consultation, the Therapeutic Goods Administration found the risk of making the contraceptive pill available over the counter outweighed the benefits.
The TGA received two private applications to amend the poisons legislation so that the pill would no longer require ongoing prescriptions from a doctor.
Oral contraceptives containing levonorgestrel or norethisterone, in combination with ethinylestradiol, have been in use since the 1960s and are considered the “gold standard” in relation to safety, one of the applicant’s proposed.
The applicant argued these lowdose oral contraceptives could safely be provided by pharmacists without a prescription, as long as patients had the same substance prescribed by an authorised doctor within the previous two years.
In its submission to the inquiry, the Pharmaceutical Society of Australia supported the proposal, saying there would be public health benefits to easier oral contraceptive pill access.
“This option to obtain ongoing supply of selected oral contraceptives can increase opportunity for women to be take responsible actions in self-managing sexual and reproductive health,” the submission said.
“Ongoing supply of a selected oral contraceptive under pharmacist oversight to women who have previously been prescribed the medicine can help promote regular and consistent use. For some women, this will support improved contraceptive continuation by preventing inadvertent breaks in therapy.” But after considering 27 public submissions, the TGA found that the proposed changes would introduce new risks which outweigh the potential benefits.
“The use of oral contraceptive pills can cause significant adverse effects that are not consistent with over the counter medicines,” the interim decision said.
“These effects include weight gain, emotional anxiety, heavy bleeding and thromboembolism, particularly with increasing age.”
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The decision states that even oral contraceptive products with the highest safety profiles lead to a rate of 5-7 cases of thromboembolism per 10,000 women a year, compared to a baseline of 2 in 10,000. Thromboembolism occurs when a blood clot in a vein or artery breaks off and blocks another blood vessel.
The pill may exacerbate the risks of cardiovascular disease including stroke, especially in women who are over 35, obese, smoke, have diabetes, have uncontrolled hypertension or get migraines with aura, the TGA found.
The president of the Australian Medical Association, Dr Omar Khorshid, said the TGA had made the right decision.
President Dr Omar Khorshid said if accepted by the TGA it would mean the compromise of patient safety and quality of care.
“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,” he said.
“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.”
Further submissions close on 1 November, before the TGA will make a final decision.