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

TY - JOUR

T1 - How much information about the benefits of medicines is included in patient leaflets in the European Union? - A survey

AU - Dickinson, Rebecca

AU - Raynor, David K

AU - Knapp, Peter

AU - MacDonald, Jan

N1 - © 2016 Royal Pharmaceutical Society.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - 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.

AB - 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.

KW - Communication

KW - Decision Making

KW - Drug Labeling/methods

KW - Drug-Related Side Effects and Adverse Reactions/epidemiology

KW - European Union

KW - Humans

KW - Pamphlets

KW - Surveys and Questionnaires

U2 - 10.1111/ijpp.12285

DO - 10.1111/ijpp.12285

M3 - Article

C2 - 27405658

SN - 0961-7671

VL - 25

SP - 147

EP - 158

JO - The International journal of pharmacy practice

JF - The International journal of pharmacy practice

IS - 2

ER -