Editorial: Risk management

Abstract

The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the pharmacovigilance systems we have today. A key aspect of pharmacovigilance – the safety monitoring of drugs after their licensing – is risk management, which aims to better understand the benefit-risk profiles of drugs and minimise their risks to patients. A rapidly evolving area, risk management is the theme of both this issue of Medical Writing and the 3rd EMWA Symposium in Dublin. In December 2008 the European Commission unveiled the so-called ‘EU Pharma Package’, a set of proposals to give EU citizens better access to information on medicines and better protection from the harms caused by genuine and fake medicines. This package was followed by new pharmacovigilance legislation – Directive 2010/84/EU and Regulation (EU) 1235/2010 – which came into force in July 2012, and a revised good pharmacovigilance practices (GVP) guideline from the EMA, published in April 2014: Module V – Risk management systems (Rev 1). Writing in this issue ofMedicalWriting,Tizianavon Bruchhausen andKerstin Prechtel explore how these recent changes have affected safety medical writing, increasing document complexity and helping to create a new role: the pharmacovigilance medical writer. They identify some of the personal qualities pharmacovigilance writers require and outline the processes by which they can prepare Risk Management Plans (RMPs) for different purposes. In Europe, an RMPmust be submitted to the EMA with each new marketing authorisation application. Since July 2012, the EMA’s RMP has had a modular format. Sandra Gotsch guides us through its seven parts (I–VII) and eight modules (SI–SVIII), providing insights, tips, and – for those of us who are new to RMPs – reassurance! RMPs are further covered in a feature article by Lesley Wise, who describes how the risk management of approved medicines has seen an increasing focus on continued benefit-risk activities throughout a medicine’s lifecycle. Lesley examines the historical background to benefit-risk assessment, changes to the content and format of RMPs in the EMA’s revised GVP guideline (see above), and the new ICH standard for periodic benefit-risk evaluation: the Periodic Benefit-Risk Evaluation Report (PBRER). Looking to the future (perhaps the not-so-distant future), Massoud Toussi, Lisa Chamberlain James, andAlasdair Breckenridge explore the possible role of social media in adverse event (AE) reporting. They explain the value of AE data from social media and highlight technological and other developments that are needed for such data to be properly captured and used, potentially revolutionising pharma’s pharmacovigilance activities.