RESUMO
Introduction: Patient information leaflets (PILs) of medicinal products are informative documents that accompany medicines and explain their components, modes of use, interactions with other medicines, and other relevant issues. When patients do not adequately understand the information in the leaflets, they may engage in behaviors that affect their health (e.g., self-medication). Objective: To identify patient-related factors and characteristics of PILs that can promote cognitive, emotional, and behavioral changes that lead to appropriate drug use practices. Additionally, we aimed to determine strategies that could be implemented to design leaflets that convey adequate information and are easier to understand. Method and Results: We evaluated scientific articles published in databases and containing information on PILs suitability to be used in a patient population. A total of 51 articles were selected as the sample. Certain leaflet factors that favored or hindered understanding were identified (e.g., format in which the leaflets are presented, their structure, their adaptation to the sociodemographic and linguistic characteristics of the population, their wording ). Similarly, we also identified patient factors, such as previous experience taking the drugs referred to in the leaflet; the type of emotions experienced when reading the leaflets; the emphasis on the adverse effects of the medications; sociodemographic variables (i.e., age or educational level); and degree of interest in their own healthcare. Conclusion: Patient and leaflet factors influence the comprehension of information in the PIL; hence, emphasis should be placed on these factors to increase treatment and medication adherence and to reduce health-risk behaviors.
RESUMO
De acordo com a definição de uso off label (ou seja, quando um medicamento é indicado ao paciente de maneira diferente daquela que foi autorizada pelo órgão regulatório em um país), o objetivo deste estudo foi identificar a presença desse tipo de prescrição, diferente da recomendação aprovada pela FDA e ANVISA, para crianças e adolescentes do nascimento até 18 anos. Para isso, foram analisadas as solicitações de medicamentos feitas por ordem judicial ao CEMEPAR/ SESA-PR (Centro de Medicamentos do Paraná / Secretaria de Saúde do Paraná) no ano de 2008. Foram impetradas 934 solicitações, sendo que, destas, 142 (15,20%) tinham indicação diferente da recomendada quando comparadas com informações da FDA, além de outras 112 (12%) quando comparadas com informações da ANVISA. Das prescrições analisadas, 22,54% estavam relacionadas à faixa etária diferente da recomendada de acordo com a FDA e 26,79% de acordo com a ANVISA. Considerando-se a importância do tema para a saúde pública, ressalta-se a necessidade da divulgação de informações e regulamentações sobre o assunto no Brasil.
Noting the definition of off-label use (ie, when a drug is indicated for a patient with a condition for which it has not been authorized by the regulatory agency of the country), the aim of this study was to identify the presence of this type of prescription, at variance with the recommendations of the FDA and (in Brazil) ANVISA, for children and adolescents from birth up to 18 years of age. To this end, the requests for drugs made by court order to CEMEPAR / SESA-PR (Paraná State Medicine Center) in 2008 have been analyzed. A total of 934 requests were filed, out of which 142 (15.20%) contained indications other than the recommended ones, according to information from FDA, and another 112 (12%) indicated a use conflicting with information from ANVISA. Out of the prescriptions analyzed, 22.54% were for patients whose age differed from the range recommended by FDA and 26.79% from the ANVISA range. Considering the importance of the issue to public health, the study highlights the need to spread information on the regulations on these practices in Brazil.