ADR Flashcards
What is ADR?
A response to a medicinal product which is noxious and unintended
How are ADR’s classified?
- Rawlins and Thompson
- DoTS
Describe Type A of Rawlins and Thompson ADR?
- Dose related
- Common, predictable
- Related to the pharmacology
- Low mortility
Give examples of drugs that cause type A Rawlins and Thompson ADR?
Digoxin toxicity
Constipation from morphine
Sedation from a hypnotic
Describe Type B of Rawlins and Thompson ADR?
- Not dose related
- Uncommon, unpredictable
- Not related to pharmacology
- High mortality
Give examples of drugs that cause type B Rawlins and Thompson ADR?
- Penicillin hypersensitivity
- Malignant hyperthermia
- Hepatitis
Can ACE-inhibitor induce angioedema. TRUE OR FALSE?
TRUE
ACE-inhibitor induced angioedema is is life threatning, rare and unlikely to to be picked up in clinical trials. TRUE OR FALSE?
TRUE
What are the 4 other types of Rawlins and thompson ADR classifications?
-Type C,D,E AND F
Describe type C,D,E and F of Rawlins and thompson ADR classification?
Type C - Long term
Type D - Delayed
Type E - End of use (withdrawal)
Type F -Failure of treatment
What does DoTS stand for?
- D - Dose
- T - Time
- S - susceptibility
Dose (response), When can ADR occur? and provide an example for each occurance.
- At doses below therapeutic doses e.g anaphylaxis with penicillin
- In the therapeutic dose range e.g Nausea with morphine
- At high doses e.g Liver failure with paracetamol
Time (course) can be characteristic; with the first dose, early or after a time or with long term treatment or delayed. TRUE OR FALSE?
TRUE
Time is relevant to pharmacovigilance and drug development. TRUE OR FALSE?
TRUE
Time can be independent or immediate. TRUE OR FALSE?
TRUE
provide an example for time-independent?
eg Increased risk of haemorrhage with change in effective dose of warfarin, should monitor closely throughout
provide an example for time-immediate?
This is due to rapid administration e.g red man syndrome from vancomycin, therefore infuse slowly
What are the increased risks due to with susceptibility?
- Genetic variation
- Age
- Sex
- Physiological variation
- Exogenous factors
- Disease
With susceptibility, more than one fcator can be present. TRUE OR FALSE?
TRUE
Provide examples of each:
- Genetic variation
- Age
- Sex
- Exogenous factors
- Disease
- Genetic variation - Malignant hyperthermia
- Age - Elderly - hypnotics
- Sex - Mefloquine (used to treat malaria)
- Exogenous factors - Drug intercations/intercations with food
- Disease - Renal insufficiency e.g lithium
Provide an example of DoTS with regards to Osteoporosis due to corticosteriods?
- Osteoporosis due to corticosteriods
Dose - Collateral effect
Time - Late
Susceptibility - older people / women
Provide an example of DoTS with regards to Anaphylaxis due to penicillin?
Dose - hypersusceptibility
Time - First dose of a course
Susceptibility - Not understood; needs previous sensitisation
Provide an example of DoTS with regards to Hepatoxicity due to isoniazid?
Dose - Collateral effect
Time - Intermediate
Susceptibility - Genetics (drug metabolism), age, exogenous (alcohol), disease (malnutrition)
Why are ADRs reported?
-Important for patient safety
-Allow continous monitoring of old and new drugs
-Provide data on ADRs to new drugs
-Provide data in special patients groups
(young and old, pregnant and with co-morbidities or polypharmacy)
What does the yellow card scheme collect information on?
Collects reports of suspected problems or incidents involving;
- ADRs
- Medical device adverse incidents
- Defective medicines (those that are not of an acceptable quality)
- Counterfeit or fake medicines or medical devices
What is a serious reaction?
- includes prolonged hospitalisation
- fatal
- life-threatning
- disabling/incapacitating
- Cause congenital abnormalities
- medically significant
Medical significance can be mild, moderate, severe or lethal. TRUE OR FALSE?
TRUE
Describe mild (medical significance)
-No antidote or treament is required
Describe moderate (medical significance)
- A change in treatment, but necessarily discontinuation of drug
- Hospitalisation may be prolonged
- Or specific treatment may be required
Describe severe (medical significance)
- An ADR is potentially life threatning and requires discontinuation of drug
- Specific treament of ADR
Describe lethal (medical significance)
-An ADR directly or indirectly contributes to patients death
What is the meaning of a black triangle?
-Means intensive monitoring
When are medications given a black triangle?
- When contains new active substance
- Is a biological medicine
- New indications
- Has conditional approval
- Company been asked for more data
What type of reports are the MHRA keen on?
- Children
- Over 65s
- Biological medicines and vaccines
- Delayed ADRs and interactions
- Complimentary and herbal medicines
