The Federal Council has before it a decision regarding the amendment of the prescription drug regulations for the migraine medications sumatriptan and zolmitriptan. A decision on this matter is scheduled to be made at the Federal Council meeting on November 8, 2013. The Federal Council's lead Health Committee has currently spoken out against amending the prescription drug regulations – in contrast to the relevant ministries.

The lead health committee argues that the expert committee on prescription drug licenses has very narrowly defined its recommendations for lifting prescription requirements. These are merely recommendations, which the legislature is not obligated to follow. It can deviate from the expert committee's recommendations, particularly if the recommendations are not feasible.

The Health Committee further explains that the conditions for the exemption from prescription requirements include, among other things, the use of a triptan under medical supervision and the extensive information on contraindications and warnings provided for in the consumer and product information leaflets in the regulation. These conditions for the exemption from prescription requirements demonstrate that the substances could endanger human health even when used as intended if they were used without medical, dental, or veterinary supervision.

Furthermore, these conditions are not feasible, as the regulation currently lists seven triptans. Three triptans (rizatriptan, frovatriptan, and eletriptan) are prescription-only without exception. The two triptans naratriptan and almotriptan are prescription-only with a partial exemption, without changes to the package insert or prescribing information. According to the proposals of the relevant ministries, sumatriptan and zolmitriptan should become prescription-only with a partial exemption and extensive changes to the package insert and prescribing information.

The expert committee stated that the overall assessment of the seven triptans was incomprehensible; the regulations were no longer easy to understand. Misjudgments in practice were inevitable. Furthermore, the prescription drug regulations are not a suitable instrument for determining the information required in the package leaflet and the prescribing information. This would render them unreadable.

Furthermore, in the event of liability, the pharmacist would have to prove that they ensured the use of a triptan was under the supervision of a physician. This would make contacting a physician mandatory before each dispensing. However, this is not possible because, due to the over-the-counter nature of the medication, there is no prescription form that identifies a physician and their contact information.

Comment : As part of medical treatment, it is important that the diagnosing and prescribing physician provides appropriate information regarding tolerability, safety, and contraindications. If cardiovascular or cerebrovascular problems arise during the course of the patient's life, the patient is then clearly referred to the doctor for further evaluation. This situation is not significantly different for over-the-counter triptans compared to patients treated with prescription triptans, as the latter often receive considerably larger packages or repeat prescriptions. In both cases, the patient must independently consult their doctor if they experience any cardiovascular or cerebrovascular problems based on their own observations.

Overall, the availability of triptans for self-medication improves the care of migraine patients. For patients under medical supervision, self-medication offers time-efficient access to effective therapy. No significant safety differences have been identified between triptans. Therefore, there can be no justified differing safety concerns justifying the removal of individual triptans from prescription-only status. From this perspective, it is neither scientifically nor clinically justifiable that some triptans should be made available without a prescription while others remain unavailable. The concerns now being raised make a consistent decision on this issue more difficult.