How common are ADRs?
The frequency of ADRs depends, in part, on how hard one searches for
them and what definition is used for their detection. For example
it has been estimated that approximately 5% of hospital admissions
are in some way due to an adverse effect of a medicine. Between 5
and 10% of patients in hospital are estimated to suffer an ADR. In
an American study 6.7% of patients suffered serious ADRs during their
stay. Up to 0.3% of ADRs in hospitalised patients may be fatal and
in the USA it has been estimated that it is between the 4th and 6th
leading cause of death.
Detection of ADRs is therefore a major health issue.
Why was the Yellow Card Scheme set up?
The Yellow Card Scheme was set up in 1964 after the thalidomide
tragedy highlighted the need for routine monitoring of medicines
safety. More than 400,000 reports of suspected ADRs have been submitted
to the CSM since that time on a voluntary basis. The scheme has
been successful in highlighting a number of toxicity issues, for
example, most recently, potential toxicity of antipsychotic drugs
but previously the cardiotoxicity of clozapine, aplastic anaemia
with remoxipride, hepatotoxicity with cyproterone, oesophageal ADRs
of alendronate, cardiomyopathy with tacrolimus, and convulsions
with quinolone antibiotics.
Complete a Yellow Card here.
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'An unwanted or harmful
reaction experienced following the administration of a medicine
or combination of medicines under normal conditions of use and is
suspected to be related to the medicine'
- The conventional CSM definition of an adverse reaction
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Key
Personnel 