LEGIBILIDADE DOS FOLHETOS INFORMATIVOS DE MEDICAMENTOS EM PORTUGAL: DESENVOLVIMENTO DE MÉTRICAS INOVADORAS PARA A SUA AVALIAÇÃO E APERFEIÇOAMENTO

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Organizational Unit

Publications

Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues

Publication . Pires, Carla; Vigário, Marina; Cavaco, Afonso

The graphical content of the Medicines Package Inserts (MPIs), such as illustrations and typographic features should be legible and appropriate, as required by international pharmaceutical regulations.

2016-06Journal article

Open access

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

Publication . Pires, Carla; Vigário, Marina; Cavaco, Afonso

Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients.

2015Journal article

Open access

Readability of medicinal package leaflets: a systematic review

Publication . Pires, Carla; Vigário, Marina; Cavaco, Afonso

To review studies on the readability of package leaflets of medicinal products for human use. 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. 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. 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.

2015Journal article

Open access

Evaluation of brand names of medicines: linguistic and format issues

Publication . Pires, Carla; Cavaco, Afonso; Vigário, Marina

Objectives: Focusing on the shape of brand names of medicines in the Portuguese market, the aims of this study were: to evaluate the number of words, syllables and letters, to identify the combinations of letters that are not found in Portuguese words and to characterize the use of capital letters in these names. Methods: A descriptive study was conducted using 474 randomized brand names of medicines, approximately 25% of all over-the-counter and prescribed medicines available in Portugal. The number of words, syllables and letters was automatically determined with a dedicated software. The combinations of letters that are not found in Portuguese and the use of capital letters were quantified through visual inspection. Key Findings: The 474 names were formed by 615 words. 74.5% of the words comprised three or less syllables, the most common number of syllables in the Portuguese words (91%). As recommended, 81% (n = 385) names were formed by just one word, 59.2% (n = 281) of the names were composed of 5–8 letters, and 83.1% (n = 394) presented the first letter in capitals or all letters in upper case. Contrary to recommendations, 22% of the names comprised combinations of letters that are not commonly found in Portuguese words. Conclusions: Given the current readability requirements, some of the Portuguese brand names of medicines should be reduced in length, adapted to the native language or capitalized. Equivalent studies are recommended in other European countries, because many brands of medicines are internationally marketed, while their development and approval should be beyond general marketing rules

2017Journal article

Restricted access

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Publication . Pires, Carla M.; Cavaco, Afonso M.

To explore and compare the opinions of physicians, pharmacists and potential users on the readability of a package insert of an over-the-counter medicine.

2014Journal article

Open access