Maria Wójcik-Jawień, Małgorzata Sokal

Ulotka o leku dla pacjenta - zalecenia, oczekiwania, rzeczywistość
2008-05-27

Leaflets enclosed to drugs - guidelines, expectations and reality. Since January 1999, drugs dispensed in the European Union (EU) must be accompanied by printed information, directed to the patient. The package insert has to reinforce the warnings, instructions and explanations already given to medicine users by doctors and pharmacists. Therefore patients must to be able to read and understand this information. The aim of the present study is to evaluate the readability and conformity with EU directives of leaflets enclosed to drugs available in Poland. The assessment of 70 leaflets and interviews with 33 patients demonstrated that appearance of many leaflets is not very attractive. The criticism of the content concerns the recommendations to a doctor (77.14%), specialist terminology (98.57%) and an old verification date or lack of it. The respondents do read leaflets (90.9%) but usually they do it only on the first use of the drug (78.79%). In their opinion leaflets are essential. They criticize incomprehensible terminology or useless information. Preparing an acceptable and attractive leaflet requires many factors to be considered (linguistic problems, reading skills, legibility of texts, cultural aspects and psychological predispositions of a patient). It is indispensable to take patients opinion into consideration while preparing leaflets.