GENERAL MEDICINE
Migraine drug to go 'over-the-counter'
July 23, 2014
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The medicines watchdog, the Health Products Regulatory Authority (HPRA), has recommended that the migraine drug sumatriptan be made available over the counter, rather than on prescription-only as at present.
The drug, which is better known under the brand name Imigran, is one of 12 active medicine substances which the HPRA, formerly the Irish Medicines Board, has now recommended can be switched from prescription only to over the counter (OTC).
Sumatriptan is available over the counter in other EU countries, including Spain and the UK.
The HPRA has published published a list of 12 active substances contained in medicines currently classified as prescription-only medicines (POM) which it says could be safely reclassified and switched to over the counter (OTC) sale.
According to the HPRA, this could result in a total of 34 medicines being sold through pharmacies without prescription. The list includes medicines for the treatment of migraine, acid-reflux symptoms, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections and other skin conditions.
The substances recommended for the switch from prescription-only to OTC include diclofenac salts, which is contained in pain medications such as Difene, and rabeprazole, which is better known under the brand name Pariet, for the treatment of heartburn and acid regurgitation.
Other substances recommended for the switch to OTC include azelastine , contained in the branded product Rhinolast, for the treatment of hay fever.
The HPRA says it is now requesting expressions of interest from pharmaceutical companies who are the marketing authorisation holders for these medicines to apply to reclassify their medicines as OTC.
According to Lorraine Nolan, Director of Human Product Authorisation with the HPRA, the medicines on the list are currently only available under prescription. However, in line with certain conditions, these could be reclassified to be made available for sale through pharmacies without a prescription.
"This represents the outcome of measures which have been undertaken by the HPRA to explore unmet needs in the availability of non-prescription medicines in Ireland and follows recommendations made by an independent consultative panel established by the Authority to specifically assist its review of this area."According to Ms Nolan, the HPRA's move will see an increase in the range of medicines that can be made available to Irish patients through pharmacies without prescription.
"Dependent on the nature, quality of applications and the relevant engagement process with Marketing Authorisation Holders, further lists of appropriate substances may be considered in the future".
"The Authority is pleased to bring this reclassification initiative forward with this initial list of products. This will see an increase in the range of medicines that can be made available to Irish patients through pharmacies without prescription."Dependent on the nature, quality of applications and the relevant engagement process with marketing authorisation holders, further lists of appropriate substances may be considered in the future," Ms Nolan said.
According to the HPRA, decisions on whether a medicine should change from prescription-only to over-the-counter are based on a range of factors including the overall safety profile of the product, the proposed condition for treatment, the expected duration of use, the suitability of a condition for self-diagnosis and self-treatment, the interaction potential as well as the possibility of misuse.
The HPRA says it considers that medicines containing substances on the list either meet these criteria currently or could meet these criteria following amendment of their marketing authorisation.
The full list of substances recommended for the switch to OTC is available here