How much information about the benefits of medicines is included in patient leaflets in the European Union? – A survey

Abstract

Introduction Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU. Methods A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories. Results Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as 'may help'). None communicated numerical benefit information. Conclusion Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.

Internet as a source of medicines information (MI) among frequent internet users

“…Based on previous studies, pagkage leaflets are not necessary unproblematic MI source and may, in fact, cause more questions than give answers to patients . [29][30][31] Internet may then be reached to find answers for th questions that reading package inserts raised. However, the order of MI sources used by the respondents in this study can not be determined and this phenomenon warrants further research.…”

Factors that Facilitate and Hinder the Comprehension of Patient Information Leaflets (PILs): A Brief Scoping Review

“…In terms of sociodemographic variables, information-seeking behavior differs between sexes as women, compared with men, tend to search for more information ( Dickinson et al, 2017 ). Also, natural aging appears to increase cognitive storage and processing of the leaflet’s general idea, rather than the specific details.…”

“…To know how they can feel better, users also prefer to know the benefits of the drug rather than their side effects (Hirsh et al, 2009). Although it is difficult to understand the leaflets, patients showed a great interest in learning about medicinal products (Hirsh et al, 2009), so they tended to search the internet for some prototypes of virtual leaflets that provided them with information easily and quickly (Afreh et al, 2017;Dickinson et al, 2017;Ahmadi et al, 2019). Further, the advice of a health professional that complements the information in the leaflets increases adherence to treatment (Ashok et al, 2017) and the active search for information (Symonds et al, 2011;Potter et al, 2014).…”

Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe

“…Although it is broadly agreed in the literature that patients want high quality information on drug benefits, consensus is lacking on the types of information that are most relevant and useful for patients. 50 We therefore reviewed primary research and systematic reviews on the role and value of written information for patients, as well as the grey literature, including good practice guidelines, reflection papers, and reports produced by regulatory bodies and special interest groups.…”

“… 15 49 An earlier study evaluated the extent to which information on drug benefits is communicated in patient information leaflets in the EU. 50 But that study did not evaluate the quality of reporting in terms of the accuracy or completeness of the information communicated. The question of whether regulated written information reflects critically appraised evidence on the benefits of anticancer drugs, including key clinical uncertainties and evidence gaps, has not been systematically investigated.…”