Safety Signal Detection: The Relevance of Literature Review

Abstract

Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of €79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit-risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects. Key PointsSeveral safety signals detected in literature reports have had a direct impact on the lifecycle of a drugThe reporting culture of healthcare professionals is usually less prevalent than the publishing culture The wide difference in quality, accuracy, and completeness of scientific publications is one of the biggest challenges of literature search and review 1 Introduction

Analyzing Search Behavior of Healthcare Professionals for Drug Safety Surveillance

“…For example, Twitter has been used as a source for mining drug-AE associations [19] with the recognition that more work is required to establish threshold signal levels from such sources towards validating discovered associations. Another data source that is being investigated for ADE detection is the biomedical literature [20–22]. In addition to examining a larger variety of sources, approaches have also been recently developed to combine signals from data sources such as EHRs, claims, biomedical literature, and Internet search logs with signals from FAERS [18, 23, 24].…”

Literature Monitoring for Pharmacovigilance

“…В результате добавления этих сведений базы данных Embase ® , MEDLINE ® , Scopus ежегодно пополняются миллионами новых записей. 1 Good pharmacovigilance practices. EMA.…”

“…Публикации в рецензируемых медицинских журналах являются вторым по значимости источником информации о нежелательных реакциях (НР) для Европейского агентства по лекарственным средствам (European Medicines Agency, EMA) 1 .…”

Signal management: new responsibilities and tools for marketing authorisation holders – how to prepare for the legal obligation the continuous monitoring of the EudraVigilance database

“…Warunki, w których produkty lecznicze są stosowane w fazie po wprowadzeniu do obrotu mogą być bardziej zróżnicowane. Warunki badania klinicznego mogą nie odzwierciedlać potencjalnych błędów związanych z dawkowaniem leku, okresem stosowania, drogą podania, a także zmienności związanych z wiekiem pacjenta, stosowaniem poza wskazaniami (off label use) lub potencjalnymi interakcjami z innymi lekami lub produktami [5,6]. Dodatkowo, stosunkowo krótki czas obserwacji uczestników badania klinicznego uniemożliwia obserwację zdarzeń niepożądanych o długim okresie latencji, np.…”