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 6.5% of hospital admissions
are in some way due to an adverse effect of a medicine. Between 5
and 15% 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 0.4% 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 Medicines and Healthcare Regulatory products Agency 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 MHRA definition of an adverse reaction
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Key
Personnel