Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting.

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Although these results allow for the development of a framework to describe the perceptions of community pharmacy users, further research is needed to determine the prevalence of these and other possible results.

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OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

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The goal of this study was to adapt, improve and validate a short, self-administered health literacy assessment tool for European Portuguese-speaking adults. Health literacy tools are of great importance to health authorities and professionals, as low or inadequate health literacy, that is, a limited capacity to handle health-related information, is associated with higher morbidity and mortality. The 18-item Short Assessment of Health Literacy for Brazilian Portuguese-speaking adults (SAHLPA-18) was adapted into European Portuguese. The European Portuguese tool (SAHLPA-23) includes five additional items. The SAHLPA-23 was tested in a convenience sample of 503 participants from two Portuguese regions. Socio-demographic data, literacy and cognitive indicators were collected. Participants also completed a questionnaire on comprehension of written health materials. Construct validity was assessed through correlations between SAHLPA-23 scores and education, literacy, and cognitive variables and score on the comprehension questionnaire. The psychometric properties of the new tool were compared with those of the SAHLPA-18. The mean SAHLPA-18 and SAHLPA-23 scores were 13.9 (77.2%; SD=2.9) and 18.3 (79.6%; SD=3.8), respectively. Both tools showed adequate reliability (Cronbach's α>0.7). SAHLPA-23 was more highly correlated with all study variables than SAHLPA-18. Although both instruments displayed acceptable discriminative power, SAHLPA-23 had better accuracy than SAHLPA-18 (DeLong's method: ΔAUC=0.09, Z=3.36; P<0.001). The SAHLPA-23 is an independent, feasible and innovative tool for estimation of health literacy in the Portuguese adult population.