14C) www.mhra.gov.uk/yellowcard www.gov.uk/yellowcard

For established (or non-black triangle) medicines the MHRA select signals for further analysis which meet a set of criteria. These criteria include, for example, all ADRs which occur in children or any which involve a fatality. The criteria are constantly refined and validated to ensure that important signals are selected for further analysis.
The burden of adverse drug reactions: Adverse drug reactions are frequently serious enough to result in admission to hospital. It is well recognised that adverse drug reactions place a significant burden on the health service .Studies performed in an attempt to quantify this have shown adverse drug reactions account for 1 in 16 hospital admissions, and for 4% of hospital bed capacity. ADRs themselves are also thought to occur in 10-20% of hospital in-patients, and one study found that over 2% of patients admitted with an adverse drug reaction died, approximately 0.15% of all patients admitted. It is clear that adverse drug reactions adversely affect patients’ quality of life and can also cause patients to lose confidence in the healthcare system. There is a significant impact through increase costs of patient care and the potential to lengthen hospital stays. Adverse drug reactions may also mimic disease, resulting in unnecessary investigations and delays in treatment.