The System for Reporting Adverse Drug Reactions should come with a Warning - 1

The cost to the health system of adverse drug and device reactions is substantial, and failure to act will only lead to more harm.

Adverse drug reactions (ADRs) are a major cause of hospital admissions, with 6.5% due to adverse drug reactions. Analysis of inpatient stays also shows that 15% of patients experienced one or more ADRs - half of them were definitely or possibly avoidable.

In 1964, the Yellow Card Scheme (YCS) was created to act as an early warning system for unexpected adverse drug reactions (ADRs). 

The YCS reporting site allows the submission of reports of suspected adverse reactions to the Medicines and Healthcare  Regulatory Agency (MHRA). They say the system ensures the safe and effective use of medicines, vaccines and medical devices. But does it ensure such safety?

To inform our answer, we searched for publications since 2010 (see here).

The reporting of suspected ADRs by the public is a valuable source of information about the possible harms of pharmaceuticals.

A 2011 Health Technology Review of patient reporting showed that in a two-year (Oct 2005 to Sep 2007) period, 5,180 patients and 20,949 hea…