Patient Information Leaflets: How Do Patients Comprehend and Understand Drug Information?

Pharmaceutical manufacturers are obligated by national drug regulations to provide package information leaflets (PIL), which is a patient-friendly form of the Summary Product Characteristics (SmPC). The main objective of this study was to evaluate whether and how these patients in Montenegro read PILs and to get insight into patients' opinions regarding comprehension and usefulness of said leaflets. The survey was conducted on randomly recruited patients at a private pharmacy in Podgorica, Montenegro. The survey was conducted in September 2019 on randomly recruited patients (>18 years of age) at the private pharmacy in Podgorica. Number of patients who read PILs, way and frequency of reading PILs, patients' opinions on clearness and usefulness of PILs. Of the 200 patients asked to participate in this research, 126 (63% response rate) filled out the questionnaire. The majority of the respondents thought that it is important to read the patient information leaflet (76.2%) and most of them (75.4%) reported that they always read the leaflet. Less than half of those who read the PIL read it thoroughly (47.9%). Around half of patients reported that the terms and expressions in leaflets are partially understandable (53.7%). After reading the leaflet, around a third of the patients often feel confused (28.1%) or anxious (32.5%). To improve the quality of the information, PILs need to convey the potential risk information in a language that is less fear-provoking. Keywords: Patient information leaflet, Pharmaceutical manufacturers, Comprehension, Anxiety