PILs that give you a headache? The lay-friendliness of non-pharmacy restricted, over-the-counter information leaflets

Abstract

Background: Over-the-counter (OTC) medication, and in particular non-pharmacy restricted OTC medicines, sold in supermarkets or online, is subject to the same EU legislation as prescription medication. However, it seems that due care is often not taken to ensure maximum patient comprehension even though the Patient Information Leaflet (PIL) is potentially more important due to lack of access to the advice of pharmacy staff. Aim: The aim of this article is to explore the legislative background and practice of the PILs of non-pharmacy restricted OTC medicines in a European context. Methods: It provides a qualitative textual analysis of Danish PILs for the potentially most dangerous products with a view to finding out to which extent the PILs comply with current legislation and guidelines. Findings: The textual analysis shows that the PILs are far too complex to stand alone as a source of information. Discussion: The article discusses the nature of non-pharmacy restricted OTC medicines, the potential consequences of a lack of understandable patient information, and whether it is in the interest of consumers that these products are available outside the pharmacy. Conclusion: It is recommended that the potentially most harmful non-pharmacy restricted OTC medicines, such as analgesics, are restricted to pharmacies.