Guidelines for Submitting Adverse Event Reports for Publication

Kelly, William N.; Arellano, Félix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina M.; Freedman, Stephen B.; Goldsmith, David; Huang, Kui; Jones, Judith K.; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William G.; Puijenbroek, Eugene van; Williams, Frank G.; Wise, Robert P.

doi:10.2165/00002018-200730050-00001

Cited by 113 publications

(62 citation statements)

References 17 publications

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“…Case reports derived from literature can have a significant clinical impact, especially for rare events that might not be detected in preapproval clinical studies [27].…”

Section: Discussion/conclusionmentioning

confidence: 99%

Safety Signal Detection: The Relevance of Literature Review

Pontes¹,

Clément²,

Rollason

2014

Drug Saf

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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

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“…Case reports derived from literature can have a significant clinical impact, especially for rare events that might not be detected in preapproval clinical studies [27].…”

Section: Discussion/conclusionmentioning

confidence: 99%

Safety Signal Detection: The Relevance of Literature Review

Pontes¹,

Clément²,

Rollason

2014

Drug Saf

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“…68 Publications on adverse events are important tools for drug safety monitoring after their release for marketing purposes by the health authorities of each country. 69 This review of medication administration intended to standardize the administration of cyclophosphamide by health professionals, in order to minimize the adverse events caused by drugs, the so-called adverse drug reaction. 19 …”

Section: Fig 2 -Guidelinesmentioning

confidence: 99%

Cyclophosphamide Administration Routine in Autoimmune Rheumatic Diseases: A Review

Teles

Souza

Лима³

et al. 2018

Nefrologiâ (St.-Peterbg.)

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r e v b r a s r e u m a t o l . 2 0 1 7;5 7injetáveis. O trabalho objetivou a estruturação de uma rotina do uso de ciclofosfamida, bem como a criação de um documento de orientaç ões farmacoterapêuticas para o paciente. A rotina foi esquematizada em três fases, a pré-quimioterapia, a administração da ciclofosfamida e a pós-quimioterapia, que levaram em consideração os medicamentos que devem ser administrados antes e depois da ciclofosfamida para prevenção aos efeitos adversos, incluindo náusea e cistite hemorrágica. As reaç ões adversas podem alterar os exames laboratoriais e a rotina incluiu manejo clínico para alteração clínica dos leucócitos, das plaquetas, dos neutrófilos e do sódio incluindo o ajuste de dose de ciclofosfamida em caso de insuficiência renal. A ciclofosfamida é responsável por outras reaç ões adversas raras, mas sérias, como hepatotoxicidade, hiponatremia severa e falência cardíaca. Outras reaç ões adversas incluem perda de cabelo, amenorreia e menopausa. A rotina foi composta também por orientaç ões ao paciente pós-quimioterapia. A compatibilidade dos medicamentos injetáveis com o veículo foi descrita, bem como o tempo de estabilidade e o tempo de infusão.A rotina visou ao uso racional da ciclofosfamida e prevenir os efeitos adversos e os episódios de recidiva, os quais podem onerar o sistema de saúde.

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“…According to Schantz MM et al [7], peaks compatible only with Serenoa repens were revealed: lauric acid (C12:0), myristic acid (C14:0), palmitic acid (C16:0), stearic acid (C12:0), oleic acid (C18:0). UDL, under detectable level.…”

Section: Figurementioning

confidence: 98%

“…All symptoms disappeared within a few weeks and a rapid decrease in all altered markers was also observed; at a follow up conducted 10 days after S. repens discontinuation, all blood tests were found between normal values. Taking into account all these aspects, the attending physician sent an ADR report to the Pharmacovigilance Authority, and causality assessment was graded as 'probable' for S. repens [7,8].…”

mentioning

confidence: 99%