Document Detail


Comprehensibility of the package leaflets of all medicinal products for human use: a questionnaire survey about the use of symbols and pictograms.
MedLine Citation:
PMID:  10816339     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Directive 92/27EEC establishes that the package leaflet is a document, which must be included in the package of medicinal products for human use in EU countries. This informative leaflet is directed at the users and it must give full and comprehensible information. The Law suggests the use of symbols but it does not give advice about the subjects to be represented. In order to evaluate the attitude of patients towards package leaflets provided with symbols, we planned a survey interviewing 1004 patients in pharmacies. The data suggest that Italian patients usually read the package leaflet but they neither understand it easily nor find the needed information readily. Most respondents (74.3%) considered the use of symbols helpful in finding the needed information. We proposed five symbols for each heading (therapeutic indications, side effects, paediatric use, contraindications, use in pregnancy) and asked to select which symbol could be used. In the case of 'side effects', 'paediatric use', 'use in pregnancy' and 'dose', most of the respondents chose the same symbol. In the case of 'therapeutic indications' and 'contraindications' there was no uniformity in the answers. The choice depends greatly on education, age and employment of respondents.
Authors:
C Bernardini; V Ambrogi; L C Perioli; M C Tiralti; G Fardella
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmacological research : the official journal of the Italian Pharmacological Society     Volume:  41     ISSN:  1043-6618     ISO Abbreviation:  Pharmacol. Res.     Publication Date:  2000 Jun 
Date Detail:
Created Date:  2000-08-28     Completed Date:  2000-08-28     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8907422     Medline TA:  Pharmacol Res     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  679-88     Citation Subset:  IM    
Copyright Information:
Copyright 2000 Academic Press.
Affiliation:
Istituto di Chimica e Tecnologia del Famaco, University of Perugia via del Liceo, Perugia, 1 06123, Italy.
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MeSH Terms
Descriptor/Qualifier:
Adult
Attitude
Child
Communication
Drug Labeling* / standards
European Union
Female
Humans
Male
Middle Aged
Pilot Projects
Pregnancy
Questionnaires

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