Failings in treatment advice, SPCs and black triangles

Drug and Therapeutics Bulletin

Abstract

When Drug and Therapeutics Bulletin reviews a new medicine, one of our sources of information is the summary of product characteristics (SPC). This legal document provides advice about the product, including its unwanted effects and how these might be avoided. When referring to a new medicine, we include a [symbol: see text] in the text (see page 30, this issue). The Committee on Safety of Medicines/Medicines Control Agency (CSM/MCA) asks that this symbol be used to indicate when healthcare professionals should use a 'Yellow Card' to report any suspected adverse reaction. Here, we present evidence of weaknesses in the safety aspects of the SPC system and accompanying flaws in the Black Triangle Scheme.

Citations

Nov 9, 2002·Lancet·Joe Collier, Ike Iheanacho
Jan 14, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Rianne A WeersinkSander D Borgsteede
Oct 12, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Robin E Ferner, Jeffrey K Aronson
Dec 8, 2019·Expert Opinion on Drug Metabolism & Toxicology·Rianne A WeersinkSander D Borgsteede
Nov 10, 2020·Hepatology Communications·Kelly L Hayward, Rianne A Weersink

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