Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study

Abstract

Data on side effects of newly launched drugs are limited,1 highlighting the need for effective postmarketing surveillance. An inverted black triangle (▾) on product literature identifies new products. Suspected adverse reactions to these drugs, however minor, should be reported to the Committee on Safety of Medicines through the yellow card scheme.2 Adverse reactions are underreported,3 and few doctors in the United Kingdom know the meaning of the “black triangle” symbol.4 We assessed the degree of underreporting of suspected adverse reactions to new drugs in general practice and determined if reporting varied when reactions were severe or previously unrecognised. The Drug Safety Research Unit performs observational cohort studies (prescription event monitoring) on selected newly marketed drugs in general practice. All patients in England who have been dispensed selected new drugs are identified for these studies by the Prescription Pricing Authority. Questionnaires (“green forms”) are subsequently sent to …