Patient Information Leaflets of Drugs Used in Cardiometabolic Disorders: Suitability for Use by Older Persons.

Abstract

In the European Union, all medicines must include appropriate labelling and the respective patient information leaflet (PIL), which is the most reachable source of medicine's information for patients. This document includes a set of information understandable by their potential users and complementary to the information provided by health professionals. The ageing of the Portuguese population raises the need for the appropriateness of medicine's information for older consumers, taking into account their specific needs arising from physiological changes impacting drug action. This project aimed to analyse the content of medicines' PILs, specifically directed at older persons. A sample of medicines was selected considering the 100 active substances more consumed in Portugal by patients with chronic pathologies such as diabetes mellitus, hypertension, and dyslipidaemia. The analysis included readability, legibility, and content (directly and indirectly related to the use of medicines by older persons). A total of 69 PILs were analysed, and it was observed that the information provided about the drugs was included in most of these PILs (95.7%; n = 66) but without any specific information for patients belonging to different age groups. Signalling-specific warnings for older persons were only available in less than half of the PILs (46.4%; n = 32). The presence of relevant information on the appropriate use of the drug such as the recommended dose was only specified for older persons in 28% (n = 19) of the analysed PILs. The information available in PILs which can be considered as specifically directed to older persons is relatively scarce, even in areas as critical as the instructions for use. Hopefully, these results will contribute to increasing awareness regarding the need to adapt PILs' content to specific consumers and to test them to guarantee that they are adequate for all potential consumers.