To what extent does the population use and understand patient information leaflets for medicines? A cross-sectional study of adults in Italy
1
Department of Medical and Surgical Specialties, Radiological Sciences and Public Health. Section of Public Health and Human Sciences., University of Brescia, Brescia, Italy
2
Centre of Bioethics Research, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy
3
Forensic Medicine Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia & ASST Spedali Civili of Brescia, Brescia, Italy
4
Clinical Ethics Consultation Service, ASST Spedali Civili of Brescia, Brescia, Italy
Popul. Med. 2026;8(Supplement Supplement 1):A3326
ABSTRACT
BACKGROUND:
Patient information leaflets (PILs) for medicines are legally required across the European Union to support safe medicine use, informed decision-making, and treatment adherence. However, they are often criticised for complexity, poor readability, and anxiety-inducing descriptions of side effects. Health literacy (HL), the ability to access, understand, appraise, and apply health information, may affect how patients engage with PILs. This study examined patterns of PIL use, comprehension, and related behaviours in the Italian adult population, accounting for HL differences.
METHODS:
A cross-sectional survey was conducted between October 2024 and April 2025. Recruitment combined social media dissemination with general practitioner collaboration to reach older and less digitally active individuals. The questionnaire collected sociodemographic data, HL (using the six-item HLS-EU-Q6 and a single-item functional HL screener), and indicators of PIL engagement, including reading frequency, reasons for non-consultation, comprehension of extracts, anxiety, therapy discontinuation, risk interpretation, and perceptions of commercial influence. Data were analysed using descriptive and inferential statistics.
RESULTS:
1977 adults (mean age 46.5 years) completed the survey. Sixty-six percent of respondents reported always reading PILs for prescription medicines, and 71% did so for over-the-counter products. Overall, 17.2% had inadequate HL, 52.4% problematic, and 30.4% sufficient. Higher HL was associated with more frequent PIL reading, greater confidence in medicine use (mean 2.22 vs 1.94; p<0.001), and lower anxiety (2.21 vs 1.97; p<0.001). In contrast, respondents with lower HL more often discontinued therapies after reading PILs (37% vs 28%; p=0.02) and overestimated vaccine risks compared with analgesics (25% vs 9%).
CONCLUSIONS:
HL seemed to have a role in the use of PILs, influencing engagement, confidence, anxiety, and therapy behaviours. Current formats may inadvertently widen inequalities by overburdening readers with limited HL. Public health efforts should prioritise simplification, plain language, balanced risk communication, and perceptions of neutrality to promote equitable and safe medicine use.
Patient information leaflets (PILs) for medicines are legally required across the European Union to support safe medicine use, informed decision-making, and treatment adherence. However, they are often criticised for complexity, poor readability, and anxiety-inducing descriptions of side effects. Health literacy (HL), the ability to access, understand, appraise, and apply health information, may affect how patients engage with PILs. This study examined patterns of PIL use, comprehension, and related behaviours in the Italian adult population, accounting for HL differences.
METHODS:
A cross-sectional survey was conducted between October 2024 and April 2025. Recruitment combined social media dissemination with general practitioner collaboration to reach older and less digitally active individuals. The questionnaire collected sociodemographic data, HL (using the six-item HLS-EU-Q6 and a single-item functional HL screener), and indicators of PIL engagement, including reading frequency, reasons for non-consultation, comprehension of extracts, anxiety, therapy discontinuation, risk interpretation, and perceptions of commercial influence. Data were analysed using descriptive and inferential statistics.
RESULTS:
1977 adults (mean age 46.5 years) completed the survey. Sixty-six percent of respondents reported always reading PILs for prescription medicines, and 71% did so for over-the-counter products. Overall, 17.2% had inadequate HL, 52.4% problematic, and 30.4% sufficient. Higher HL was associated with more frequent PIL reading, greater confidence in medicine use (mean 2.22 vs 1.94; p<0.001), and lower anxiety (2.21 vs 1.97; p<0.001). In contrast, respondents with lower HL more often discontinued therapies after reading PILs (37% vs 28%; p=0.02) and overestimated vaccine risks compared with analgesics (25% vs 9%).
CONCLUSIONS:
HL seemed to have a role in the use of PILs, influencing engagement, confidence, anxiety, and therapy behaviours. Current formats may inadvertently widen inequalities by overburdening readers with limited HL. Public health efforts should prioritise simplification, plain language, balanced risk communication, and perceptions of neutrality to promote equitable and safe medicine use.
| eISSN: | 2654-1459 |
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