Sumatriptan and zolmitriptan are to be down-scheduled to over-the counter (OTC) medicines to allow pharmacists to diagnose migraine and dispense the medications for people in the early stages of an attack.
In an interim decision the TGA’s Advisory Committee on Medicines Scheduling has approved a proposal for retail pharmacies to provide two tablets of sumatriptan or zolmitriptan for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms.
The rescheduling from S4 (prescription only medicine) to S3 (pharmacist only medicine) will take effect from February 2021 and will also allow the advertising of the triptan direct to consumers.
In its decision summary, the committee said it accepted the rationale that timely access to a triptan via a pharmacy would be beneficial, since they need to be taken within an hour of the onset of migraine headache – and this is sometimes not possible if patients can not see a GP promptly to obtain a prescription for the drug.
“Delay in treatment increases the risk of more severe and prolonged headache pain, increases risk of inappropriate simple analgesic use and risk of medication overuse headache [and] increases risk of progression to chronic migraine,” the application for down-scheduling stated.
It noted that retail pharmacies regularly have migraineurs who find themselves without a supply of sumatriptan, but can only sell them OTC products such as metoclopramide + paracetamol or prochlorperazine.
“Further, the already available products under Schedule 3 for symptomatic treatment of migraine headaches largely aim to relieve nausea or vomiting associated with the headache, with paracetamol possibly only offering some relief against the headache itself.
“Having 50 mg x 2 tablets sumatriptan available as a Schedule 3 medicine would improve accessibility to this substance especially in after-hours situations or rural and remote areas where access to a GP is not possible.”
The application asserted that retail pharmacists have the clinical skill and knowledge to appropriately assess the migraine symptoms and history of patients and to provide a triptan to an appropriate selection of people. It also noted that sumatriptan has been available over the counter for some years without any adverse consequences in countries such as New Zealand, the UK and Germany.
The re-scheduling proposal was supported by the AMA, although it warned that there should be safeguards to ensure that access to this medication does not delay more urgent care.
“For example, symptoms similar to those of a migraine may actually be the result of a brain tumour. There needs to be increased pharmacist education around how to accurately and confidently diagnose a migraine. Further, the new Schedule entries should specify a certain number of times a patient can purchase this medication until it is recommended to consult a medical practitioner.”
In its decision the TGA committee said the 2021 rescheduling date for triptans would allow time for a pharmacist education program on migraine diagnosis to be implemented.
The interim decision has to be confirmed by the TGA as a final decision, subject to further public submissions with a deadline of 20 March 2020.