Factors influencing subjects’ comprehension of a set of medicine package inserts
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Background Package inserts (PIs) should promote the safe and effective use of medicines. The comprehension of PIs is related to socio-demographic features, such as education. Objectives To evaluate the participants’ comprehension of a sample of PIs and to build an explanatory model of subjects’ understanding of the content of these documents. Setting The data were collected from municipalities, city halls, firefighters, the military, schools and charities from two Portuguese regions. Methods Cross-sectional descriptive survey: 503 participants, homogeneously distributed by education and gender. The self-administered tool comprised questions on socio-demographic data, literacy tasks and comprehension evaluation of 12 purposively selected PIs. A logistic regression analysis was used. Main outcome measures Scores of numeracy tasks and comprehension. Results The average comprehension score for the PIs was 63 % (±32 %), with 48 % (n = 239) of the participants scoring <75 %. The most important predictors in explaining a comprehension score ≥75 % were having >12 years of education and correctly performing a numeracy task [respectively, OR 49.6 (CI 95 %: 22.8–108) and OR 2.48 (CI 95 %: 1.5–4.2)]. Conclusion An explanatory model of subjects’ knowledge about the content of the tested PIs was built. Given that a high level of education and literacy were found to be the most relevant predictors for acceptable comprehension rates, PIs should be clearly written to assure that they are understood by all potential users, including the less educated. The evaluated PIs may thus need to be simplified.
KeywordsComprehension questionnaire Health literacy Logistic regression Package inserts Portugal Readability
This research was only possible with the collaboration of a number of people and institutions. We are grateful to Estado Maior do Exército Português [Portuguese Army] for authorizing the implementation of a comprehension questionnaire in some military units. INFARMED, I.P. – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. [Portuguese Medicine Authority] provided advice on some materials of this project. Professor Helder Mota Filipe, INFARMED I.P. – Member of the Governing Board and Department of Social Pharmacy – Head of the Department, Faculty of Pharmacy, University of Lisbon for allowing the communication of this work to INFARMED I.P. and recommending diverse advisory experts from INFARMED I.P. Dr. Marta Marcelino, Head of the Premarketing Authorisation Unit, Medicines Evaluation Department, INFARMED I.P. for clarifying some regulatory issues. Dr. Marta Antunes, Premarketing Authorisation Unit, Medicines Evaluation Department, INFARMED I.P. for clarifying some regulatory issues and confirming the adequacy of the questionnaire about package leaflets. For the participation in a panel of experts, with the aim of checking the correctness of the answers of a questionnaire about package leaflets the following persons are acknowledged: MSc Ana Tereza Neres and MSc Paula Barão Sousa Ferreira, Center of Pharmacovigilance, Faculty of Pharmacy, University of Lisbon, Professor António Granado, Research Centre Media and Journalism, Faculty of Social Sciences and Humanities, New University of Lisbon, PhD Bernardo Ratilal, Neurosurgeon and clinical consultant, Professor Isabel Vitória Figueiredo, Pharmacology and Pharmaceutical Care, Faculty of Pharmacy, University of Coimbra, and Professor Maria Augusta Soares, Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon. Professor Maria Armanda Costa, Department of Linguistics, School of Arts and Humanities, University of Lisbon, for collaborating in the final corrections of the template of the questionnaire about package leaflets. All participants of the user testing are acknowledged for their indispensable collaboration. Finally, the following institutions are acknowledged for authorizing the administration of a comprehension questionnaire about package inserts of medicines: Associação Humanitária de Bombeiros Voluntários de Abrantes [Fire station]; Associação Humanitária dos Bombeiros Voluntários de Ferreira do Zêzere [Fire station]; Associação Humanitária dos Bombeiros Voluntários de Vila de Rei [Fire station]; Associação Humanitária dos Bombeiros Voluntários da Sertã [Fire station]; Câmara Municipal de Abrantes [City council]; Câmara Municipal da Azambuja [City council]; Câmara Municipal de Ferreira do Zêzere [City council]; Câmara Municipal de Loures [City council]; Câmara Municipal de Oeiras [City council]; Câmara Municipal de Torres Vedras [City council]; Câmara Municipal de Vila de Rei [City council]; Câmara Municipal do Seixal [City council]; Câmara Municipal da Sertã [City council]; Centro Social e Paroquial da Azambuja [City council]; Centro Social e Paroquial São Maximiliano Koble [Social and parish center]; Centro Social e Paroquial de Santa Beatriz [Social and parish center]; Centro de Tropas Comandos (CTC) [Military Unit]; Faculdade de Letras, Universidade de Lisboa [School of Arts and Humanities]; Filarmónica União Sertaginense [Orchestra]; Núcleo Preparatório do Regimento de Apoio Militar de Emergência (NP/RAME) [Military Unit]; Pólo Permanente do PM 001/VNB - RE 1 (Tancos) [Military Unit]; Regimento de Artilharia Antiaérea Nº1 (RAAA1) [Military Unit]; Santa Casa de Misericórdia de Cardigos [Social and parish center]; Serviços Municipalizados de Abrantes (SMA) [Municipal services]; Serviços Municipalizados da Água e Saneamento da Câmara Municipal de Sintra [Municipal services]; Sociedade Filarmónica Ferreirense [Orchestra]; Universidade Sénior da Amadora – CUTLA [University of the third age]; Universidade da Terceira Idade de Alenquer [University of the third age]; Junta de Freguesia de Ferreira do Zêzere [Civil parish].
This work was supported by FCT (Grants Numbers SFRH/BD/76531/2011, PEst-OE/LIN/UI0214/2013, UID/DTP/04138/2013).
Conflicts of interest
All authors declare to have no potential conflicts of interest.
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