Untersuchung des Patientenbenefits bei Entlassung von Arzneimitteln aus der Verschreibungspflicht am Beispiel von Triptanen

Suffering from the symptoms of migraine, the psychological stress of patients is high. In Germany, nearly one million people daily suffer from migraine, representing around 38 % of all people with headaches. Thereof, 100,000 people cannot pursue their daily work. In economic terms, costs of around 43 billion euros per year arise in Europe (Göbel, 2014). Migraine is characterized by paroxysmal headache that repeatedly occurs mostly hemicranic and already starting in the early morning hours. The duration of a migraine attack is hours up to several days. In addition, symptoms such as photo- or phonophobia, neurological deficits, nausea or vomiting may occur (Pschyrembel Klinisches Wörterbuch, 2014). A distinction is made primarily between a migraine with and without aura (Pietrobon & Moskowitz, 2013). They occur episodically to chronically (Yamane, 2014). Since the introduction of the drug sumatriptan in 1993, triptans are a selective therapy. Meanwhile, the group of triptans include a total of seven drugs differing in pharmacokinetics and are used as a first-line medication for acute migraine attacks. Being released from the medical prescription in 2006, naratriptan was the first drug (Tfelt-Hansen & Steiner, 2007). In 2011, almotriptan followed (Pues, 2011). Now, an adequate treatment option is also available for patients refraining visiting or cannot visit their doctor. Still, a preliminary diagnosis of the doctor remains essential for self-medication with triptans. From 2005 till 2014, data show that the overall market of triptans is declining (decrease in turnover of 32 %) and is at about 56 million euros in 2014; on the other hand the OTC market is constantly at about 10 million euros. The number of packing units shows a parity between the Rx and the OTC sector (about 2.5 million PE). Thus, the OTC segment plays an important role for both the economic and especially the patient individual perspective. Triptans have been very well studied in clinical practice. The self-medication area or OTC-patients in pharmacies being previously not or only insufficiently investigated is of similar importance. The aim of this study is to fill this gap. For this purpose, a prospective study to characterize patients using OTC-triptan patients was conducted involving 84 pharmacies in the period of September 2013 till March 2015. The recruitment of pharmacies proved to be difficult. It was mainly carried out in person and on site in the whole of Germany. Buying an OTC-triptan, patients were confronted with the study and a questionnaire with stamped envelope was handed over. 105 questionnaires (10.6 %) were returned of which 84 were evaluable. The questionnaire consisted of three thematic blocks and was based on the fundament of the methodology of the Treatment Satisfaction Questionnaire for Medication (Atkinson et al., 2005). Based on the total number of patients (n=84), the proportion of women is 87 % (n=73) and the one of men is 13 % (n=11). Thus, 6.6 times more women than men took advantage of the self-medication area. In migraine, however the incidence of women is three times higher than among men. The maximum frequency of migraine is in the third decade of life (Egle et al., 2003). In self-medication area, it is a decade later in the fourth decade of life. 85 % of patients are non-smoking (n=71), 68 % regularly take medication (n=57) and on 76 % the diagnosis migraine has been secured by a physician (n=64). The study showed a higher satisfaction (90 % vs. 75 %; n=76 vs. n=63) as well as compliance (57 % vs. 40 %; n=48 vs. n=34) in the self-medication area as in the field of prescription of triptans. Doing an Rx-OTC Switch, the quality of life remained the same or improved in 82 % (n=69) of participants. In the OTC area, 75 % (n=63) of patients have gained experience with naratriptan. The study characterizes the OTC-triptan patients in detail and shows a good care of and confidence in the pharmaceutical staff of a pharmacy. To improve the advice, it should always be ensured that the diagnosis migraine is done by a doctor and that possible contraindications or restrictions are existing. For the patient’s safety and in doubt, it is recommended - regardless of a no longer present prescription - to execute a visit at the doctor. In addition, the OTC-triptans do show a low potential for side effects based on the suspected cases. Summarizing up, the patients benefit from the self-medication.