Sumatriptan (nasal and oral) and zolmitriptan (oral) are to be partially exempted from prescription requirements on October 1, 2013. This is what the 15th regulation amending the drug prescription regulations of the Federal Ministry of Health and the Federal Ministry of Consumer Protection plans.
To date, two triptans have already been available for self-medication: Naratriptan and Almotriptan. The prerequisite for delivery to the pharmacy is a migraine that has previously been clearly diagnosed by a doctor.
According to analyzes by IMS Health, a total of 4.4 million triptan preparations were dispensed in pharmacies in 2012. 2.1 million prescription triptans (most commonly Maxalt®/Rizatriptan) and around 2.3 million non-prescription triptans (most commonly Formigran®/Naratriptan) were requested by migraine sufferers in pharmacies in Germany. This means that self-medication already outweighs prescription by doctors.
The advantage of self-medication is that patients have more options. If the supply runs out on Friday evening, the patient can get the triptan from the pharmacy without a prescription. But there are also a number of disadvantages: Patients have to pay for the triptan themselves. This can be expensive, one tablet costs between 3 and 5 euros and several tablets may be required per attack. The headache diagnosis cannot be confirmed in the pharmacy; a medical examination is essential. Follow-up examinations to record cardiovascular diseases and complications may not be carried out. This particularly includes the recording of headaches caused by medication overuse. Preventative treatments through behavior and medication can be omitted, but are essential components of contemporary therapy. Therefore, migraines always require accompanying medical treatment.
As a rule, triptans are very well tolerated and safe medications. The possible side effects of triptans can include fatigue, dizziness, feelings of heaviness, circulatory reactions or, very rarely, feelings of chest tightness. They must not be used in patients with cardiovascular diseases such as heart attacks, strokes or high blood pressure or liver diseases.
The current change in the drug prescription regulations of the Federal Ministry of Health and the Federal Ministry of Consumer Protection provides for a number of important precautionary measures for self-medication. This is to ensure the security of the application. These are described below for sumatriptan and zolmitriptan:
The heading “ Sumatriptan ” is defined as follows:
“Sumatriptan – except for the acute treatment of the headache phase of migraine attacks with and without aura in adults between 18 and 65 years of age, after the initial diagnosis of migraine by a doctor and after use of a triptan under the observation of a doctor,
a) as a nasal spray for intranasal use in a dosage of 20 mg (calculated as sumatriptan) per divided form and in a total amount of 40 mg per pack, and
b) for oral use in pack sizes with a maximum of 2 tablets of 50 mg sumatriptan each and in a total amount of a maximum of 100 mg sumatriptan per pack, if specified in the specialist information and package leaflet
a) the contraindications state that the medicinal product must not be used
aa) to prevent a migraine attack,
bb) if you have a history of seizures or risk factors that lower the seizure threshold,
cc) in case of liver or kidney dysfunction,
dd) for high blood pressure,
ee) for hemiplegic, basilar or ophthalmoplegic migraines, and
b) is stated under the warnings
aa) that the diagnosis “ migraine ” must be made by a doctor,
bb) that a doctor must be consulted if the typical headache lasts more than 24 hours, the severity of the symptoms has changed or the attacks occur more frequently, last longer or are more severe, as well as in cases in which the symptoms do not appear between attacks disappear completely,
cc) that patients with four or more attacks per month should be medically examined and treated,
dd) a description of symptoms requiring medical consultation, as follows:
“Double vision, clumsy and uncoordinated movements, tinnitus, impaired consciousness, seizure-like movements or sudden onset of skin rashes along with the headache,”
ee) that adults who experience migraine symptoms for the first time after the age of 50 must consult a doctor in order to rule out serious causes of the symptoms,
ff) that an elevated cholesterol level, regular smoking or nicotine replacement therapy, significant obesity and diabetes mellitus (diabetes) are risk factors for heart disease that require a medical assessment before therapy with sumatriptan and that people with a first-degree relative in whom or who developed heart disease before the age of 60 have an increased risk of use,
gg) that the risk of a stroke increases in women who take oral contraceptives at the same time,
hh) that medical advice should be sought in the event of migraine with aura or if the migraine attacks have only occurred in the last 3 months or the symptoms have worsened, and
c) in the section “Fertility, pregnancy and breast-feeding” it is stated that the medicinal product may only be taken during pregnancy and breast-feeding on the express advice of a doctor and
Overdose section it is stated that in the event of an overdose, a doctor must be consulted immediately -”.
The heading “ Zolmitriptan ” is defined as follows:
“Zolmitriptan - except for the acute treatment of migraine headaches with and without aura in adults between 18 and 65 years of age, after the initial diagnosis of migraine by a doctor and after use of a triptan under the supervision of a doctor, in solid preparations for oral use in concentrations of 2 .5 mg per divided form and in a total amount of 5 mg per pack, if specified in the specialist information and package leaflet
a) the contraindications state that the medicinal product must not be used
aa) to prevent a migraine attack,
bb) if you have a history of seizures or risk factors that lower the seizure threshold,
cc) in case of liver or kidney dysfunction,
dd) for high blood pressure,
ee) for hemiplegic, basilar or ophthalmoplegic migraines, and
b) it is stated under the warnings aa) that the diagnosis “ migraine ” must be made by a doctor,
bb) that a doctor must be consulted if the typical headache lasts more than 24 hours, the severity of the symptoms has changed or the attacks occur more frequently, last longer or are more severe, as well as in cases in which the symptoms occur between attacks not disappear completely,
cc) that patients with four or more attacks per month should be medically examined and treated,
dd) a description of symptoms requiring medical consultation, as follows:
“Double vision, clumsy and uncoordinated movements, tinnitus, impaired consciousness, seizure-like movements or sudden onset of skin rashes along with the headache,”
ee) that adults who experience migraine symptoms for the first time after the age of 50 must consult a doctor in order to rule out serious causes of the symptoms,
ff) that elevated cholesterol levels, regular smoking or nicotine replacement therapy, significant obesity and diabetes mellitus (diabetes) are risk factors for heart disease that require medical assessment before therapy with zolmitriptan, and that people with a first-degree relative are also affected who has developed heart disease before the age of 60 has an increased risk of use,
gg) that the risk of a stroke increases in women who take oral contraceptives at the same time,
hh) that medical advice should be sought in the event of migraine with aura or if the migraine attacks have only occurred in the last 3 months or the symptoms have worsened, and
c) in the section “Fertility, pregnancy and breast-feeding” it is stated that the medicinal product may only be taken during pregnancy and breast-feeding on the express advice of a doctor, and
Overdose section it is stated that in the event of an overdose, a doctor must be consulted immediately -”.
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