POSTER PRESENTATION Open Access Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe

Good information on the harm of a drug is vital to inform risk-benefit decisions and undertake robust cost effectiveness analysis. Clinical trials reported in peer-reviewed articles are not useful for this purpose [1,2]. Regulators require pharmaceutical companies to pro-duce product information documents (Europe:SmPC, US:USPI). These documents contain comprehensive and valuable publicly available information on the known harm of a drug and have the potential to inform impor-tant risk-benefit decisions. We reviewed the usefulness of the data presented and compared the harm profile reported in documents for brand drugs marketed in Europe and the US. Method Inclusion: Antidepressants/antiepileptic brand drug