The move to greater accessibility doesn’t mean the drugs are any less risky, say experts.
Experts warn the availability of over-the-counter triptans for migraine patients could be risky if they aren’t regularly monitored by their GPs.
As of February 1, patients can buy sumatriptan (Imigran) and zolmatriptan (Zomig) from their pharmacist without a prescription – providing they have “a stable, well-established pattern of symptoms”.
The laxer restrictions only apply to two-dose packages of those triptans, although the TGA has signalled interest in evaluating whether other triptans can be downscheduled.
Carol Bennett, CEO of Painaustralia, welcomed the increased accessibility this would provide for migraine patients, noting that migraine affected millions of Australians – often during their more productive years.
But she warned that pain management wasn’t supported well enough in the healthcare system, and urged for patients and their risks to be treated holistically rather just sporadically with OTC medications.
Triptans are available without a prescription in a number of other countries, and are generally thought to be safe and effective when taken before the acute, headache phase of a migraine. However, they shouldn’t be used by some people with heart conditions, those taking Monoamine oxidase inhibitors, people who are pregnant or at risk of becoming pregnant and people with some types of migraines. Using triptans while taking SSRIs or SNRIs can lead to serotonin syndrome, although the risk is low.
“The message needs to be clear to consumers and to GPs about the potential risks of these medications, and ensuring people get active management for the totality of their health condition,” said Ms Bennett.
The move to make triptans OTC was rejected here once before, in part because patients can already access up to three days’ supply of a drug under emergency supply provisions.
But under these new rules, pharmacists can dispense the medication to patients who do not have aura, and whose “history of migraine or acute migraine treatment has ideally been verified e.g. via the patient’s My Health Record, or through previous prescribing/dispensing,” according to the TGA.
Chair of the RACGP Expert Committee for Quality Care, Professor Mark Morgan, noted that the regulator had carefully balanced the risks and benefits in making this decision.
However, he was concerned that making the medication available without a script would jeopardise the monitoring of safety and usage data over time.
Without data on patterns of use, it would be difficult or impossible to know whether patients were using these medications correctly, or whether there was “slippage” of their use into a greater range of circumstances, he said.
“Will it become a headache management service run out of pharmacy without all the knowledge and skills and the ability to do the physical examination that happens in general practice when we see somebody with a headache?”
Within general practice, doctors can be alert to unusual reactions, issues among patients with liver disease, high risk of cardiovascular disease and those who are elderly or pregnant, he said.
“In general practice, if somebody sees me with migraine symptoms, I’m also looking at whether they’re on hormonal contraceptive medications and whether that’s still appropriate for them. So I’m looking beyond those direct interactions into what it means for that person.”
Professor Morgan also noted the risks that patients could become almost habitual users of triptans, triggering rebound symptoms. Taking triptans for more than 10 days in a month can trigger medication overuse headaches.
A spokeswoman from the Pharmaceutical Society of Australia said that the organisation had developed a “comprehensive training to support pharmacists for the downscheduling” and offered support through a pharmacist advice line.
For Ms Bennet, this move highlights a broader problem around the increasingly tricky situation many pain patients face as their access to medications becomes more restricted.
“What we see is people switching to other medications, and there’s potential for there to be interactions and side effects that may not have been anticipated,” she said.
“We’d like to see these medications readily accessible and available, but within the context of an assessment, review and a regular update from a GP who is aware of all of that person’s health conditions and medications that they’re taking.”
