The Federal Council has made a decision to change the drug prescription regulations for the migraine drugs sumatriptan and zolmitriptan. This will be decided at the Federal Council meeting on November 8, 2013. The leading health committee of the Federal Council has currently spoken out against changing the drug prescription regulation - in contrast to the relevant ministries involved.
As justification, the lead health committee states that the Expert Committee on Prescription Requirements has very narrowly limited its recommendations for the removal of the prescription requirement. These are recommendations that the legislature does not have to follow. He could deviate from the recommendations of the expert committee, especially if the recommendations cannot be implemented.
The Health Committee further states that the conditions for the exemption from the prescription requirement would include, among other things, the use of a triptan under medical observation and the extensive information on contraindications and warnings provided for in the consumption and technical information in the regulation. These conditions for the exemption from the prescription requirement would show that the substances could endanger human health even when used as intended if they were used without medical, dental or veterinary supervision.
In addition, these conditions cannot be implemented because seven triptans are currently named in the regulation. Three triptans (Rizatriptan, Frovatriptan and Eletriptan) require a prescription without exception. With some exceptions, the two triptans Naratriptan and Almotriptan require a prescription without changing the package leaflet and the specialist information. According to the proposals of the specialist ministries, sumatriptan and zolmitriptan should require a prescription with partial exceptions and extensive changes to the package leaflet and specialist information.
The technical committee stated that the overall consideration of the seven triptans was not understandable; the regulations can no longer be overseen. Misjudgments in practice are inevitable. Furthermore, the drug prescription regulation is not an instrument for specifying the information in the package leaflet and the specialist information. This makes it unreadable.
In addition, in the event of liability, the pharmacist must prove that he or she has ensured that the use of a triptan was carried out under the supervision of a doctor. This means that it is mandatory to contact a doctor before each delivery. This in turn is not possible because, due to the freedom from prescriptions, there is currently no regulation that shows a doctor and their contact details.
Comment : As part of medical treatment, it is important that the diagnosing and prescribing doctor provides appropriate information about tolerability and safety as well as the given contraindications. In the event of possible cardiovascular or cerebrovascular complaints that occur over the course of life, the patient is then clearly referred to the doctor for further clarification. This situation with non-prescription triptans is not significantly different from patients who are treated with prescription triptans, because here the patients even receive significantly larger packs or repeat prescriptions. Here, too, the patient must consult the doctor independently based on his own observations in the event of possible cardiovascular or cerebrovascular problems.
Overall, the availability of triptans as part of self-medication improves the care of migraine patients. As part of self-medication for patients accompanied by a doctor, patients have time-effective access to effective therapy. Significant safety differences between the triptans have not been identified. There can therefore be no justified different safety concerns regarding the exemption of individual triptans from prescription requirements. With this in mind, it is scientifically and clinically unjustifiable for some triptans to be exempted from prescription, but not others. A consistent decision on this issue is made more difficult by the concerns now raised.
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