ADR & Yellow cards Flashcards
What is an ADR?
A response to a medicinal product which is noxious and unintended, where a causal relationship between the medicinal product and adverse event is either known or strongly suspected.
ADRs are ALWAYS noxious, adverse and harmful to patient.
What is a side effect?
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is
related to the pharmacological properties of the drug.
What is an allergy?
- immunologically mediated.
- often delay between first exposure and subsequent ADR/allergy.
- very small doses can cause ADR.
- Disappears on drug withdrawal.
Factors affecting chance of ADR?
*Impaired renal function (increased risk toxicity)
*Impaired liver function
*Extremes of age
*Multiple drug therapy
*Gender
*Disease states
*Ethnicity
Type A reactions
Augmented.
* 80% of all ADRs
* an exaggeration of a drug’s normal pharmacological actions
* dose dependent
* readily reversible on reducing the dose or stopping drug
* Often recognised before marketing
Type B reactions
Bizzare.
*unusual and can’t be predicted from the drug’s pharmacology
*Immunological or pharmaco-genetic mechanisms
*Often unrelated to dose
*More serious
*Comparatively rare
*Not often seen prior to marketing
Type C reactions
Chronic.
*Result from long term drug use
*Usually associated with treatment for chronic disease
Type D reactions
Delayed effects.
Can occur many years after therapy has stopped.
Type E reactions.
End of use effects.
Can occur as a result of abrupt cessation.
Type F reactions
Effect Failure.
Failure of drug to achieve therapeutic effect.
How to avoid an ADR
*Use as few concurrent drugs as possible.
*Use the lowest effective dose.
*Check if the patient is pregnant or breastfeeding.
*Is the patient at either extreme of age?
*Do you know of all the drugs used by the patient?
*Check for OTC drugs.
*Check for contra-indications such as renal or hepatic impairment.
*Check for previous ADR.
Who is responsible for monitoring safety of all medicines?
MHRA
What is pharmacovigilance?
the process of:
*monitoring the use of medicines in everyday practice to identify previously
unrecognised adverse effects or changes in the patterns of adverse effects;
*assessing the risks and benefits of medicines in order to determine what
action, if any, is necessary to improve their safe use;
*providing information to healthcare professionals and patients to optimisesafe and effective use of medicines; and
*monitoring the impact of any action taken.
When to use yellow card scheme?
- For suspected serious, significant or harmful ADRs.
- In black triangle products (new medicine/substance/formula/route/indication)
In established products
ALL paediatric reactions
