Failings in treatment advice, SPCs and black triangles.
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.
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D011787:Quality of Health Care