Medicine package inserts from the users' perspective: are they read and understood?

Tatiane Da Silva Dal Pizzol,Maria Auxiliadora Oliveira,Cassia Garcia Moraes,Paulo Sérgio Dourado Arrais,Luiz Roberto Ramos,Sotero Serrate Mengue,Andréa Dâmaso Bertoldi,Noemia Urruth Leão Tavares,Mareni Rocha Farias,Vera Lucia Luiza

doi:10.1590/1980-549720190009

Abstract

The written information on medicines has been acknowledged as an important tool for health education. To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

Highlights

The written information on medicines has been acknowledged as an important tool for health education
The initial sample in the Promotion of Rational Use of Medicines (PNAUM) was 41,433 individuals, of whom 28,427 met the inclusion criteria to answer the questions related to the medication package leaflets, by whom the sample analyzed in this study was composed
The non-use of medication was the main reason cited (40%), followed by reading difficulty (31%) and size of the material (20%). Among those who read the medicine package inserts (MPI), more than half found it difficult to see (57.4%; 95% confidence interval (95%CI) 55,2 – 59,6) and understand (54.1%; 95%CI 52.1 – 56.1) what was written in it (Table 2)

Summary

Introduction

The written information on medicines has been acknowledged as an important tool for health education. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 – 59,6) and readability (54.1%; 95%CI 52.1 – 56.1). Conclusion: The larger portion of the population usually read medicine package inserts. The written information on medicines has been acknowledged as an important tool for health education, and their drug regulatory agencies have established guidelines and standards for the production and delivery of medicine package inserts (MPI). In the United States there are three types of written materials that accompany medicines, of which two (Medication Guides and Patient package inserts) are developed by the pharmaceutical industry, regulated and approved by the Food and Drug Administration (FDA). The manufacturer produces one MPI for the health professional and another one for the patient, and the National Agency of Sanitary Surveillance (ANVISA) is responsible for the approval of these materials’ format and content[5]

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Conclusion