adverse drug reactions

Question 1

define adverse drug reaction

Answer 1

A response to a medicinal product, or combination of medicinal products, which is noxious and unintended (MHRA 2015)

unwanted or harmful reactions following the administration of drugs or combination of drugs under normal conditions of use and is suspected to be related to the drug

Question 2

impacts of ADRs for patients

Answer 2

• reduced quality of life
• poor compliance
• reduced confidence in clinicians and the healthcare system
• unnecessary investigations or treatments

Question 3

impacts of ADRs for the nHS

Answer 3

• Increased hospital admission
• Longer hospital stays
• GP appointments
• Inefficient use of medication

Question 4

CLASSIFICATION OF ADRS
(Rawlins Thompson )

Answer 4

A
Augmented pharmalogical
B
Bizarre
C
Chronic/continuing
D
Delayed
E
End of use/withdrawal
F
Failure of treatment
G
Genetic

Question 5

Describe type A augmented

Answer 5

most common

predictable

●Exaggerated effect of drugs pharmacology at a therapeutic dose
● Often not life threatening
● Dose dependent and reversible upon withdrawing the drug

Question 6

describe type B Bizarre

Answer 6

• not related to pharmacology
• Not dose related
• Can cause serious illness or mortality
• Symptoms do not always resolve upon stopping drug
• not predictable

Question 7

describe type C chronic/continuing

Answer 7

ADRS that continue after the drug has been stopped

Question 8

describe type D delaye

Answer 8

ADRS that become apparent some time after stopping the drug

malignancies after immunosuppression

Question 9

examples of type C

Answer 9

osteoporosis and steroids

Question 10

describe type E end of use/withdrawal

Answer 10

ADR develops after the drug has been stopped

Question 11

describe type F failiure of treatment

Answer 11

unexpected treatment failiure
could be due to drug to drug interaction or drug to food interaction
poor compliance with administration instructions

Question 12

describe type G genetic

Answer 12

drug causes irreversible damage To genome

Question 13

what is DoTS

Answer 13

an alternative way to classify ADRS
D
Dose relatedness
T
timing
S
Susceptibility

more complex but more detail

Question 14

example of type F

Answer 14

failure of oral contraceptive pill in presence of enzyme inducer

Question 15

when is DoTS more useful

Answer 15

Useful for those working in pharmacovigilance, undertaking research or developing medicines

Question 16

3 categories of dose relatedness

Answer 16

hypersusceptibility
collateral effects
toxic effects

Question 17

describe hypersusceptibility

Answer 17

ADRS at at subtherapeutic doses (eg anaphylaxis with penicillins)

Question 18

describe collateral affects (side effects)

Answer 18

ADRs at therapeutic doses (eg hypokalaemia with loop diuretic)

Question 19

describe toxic affects

Answer 19

ADRs at subpratherapeutic doses (eg

Question 20

describe time dependent

Answer 20

adrs which can develop during any time during treatment
often due to clinical changes in the patient

Question 21

categories of time dependent

Answer 21

rapid
first dose
early
intermediate
late
delayed 1

Question 22

describe rapid

Answer 22

due to rapid administration

Question 23

describe first dose

Answer 23

first dose only

Question 24

describe early

Answer 24

occur early during treatment but resolve as treatment progresses

Question 25

describe intermediate

Answer 25

occur after some delay

Question 26

describe late

Answer 26

risk increases with prolonged or or repeated exposure

Question 27

describe delayed

Answer 27

occur some time after exposure or after drug withdrawal

Question 28

describe susceptibility

Answer 28

Certain patient groups/populations may have a specific susceptibility to ADRs from a drug
- Age (anticholinergics in elderly patients)
- Gender (metoclopramide in females)
- Disease states (eg diclofenac in CVD)
- Physiological states (eg phenytoin in pregnancy)

Question 29

how are ADRs identified

Answer 29

• pre clinical testing
• clinical trial data
• post marketing surveillance
• pharmacovigilance

Question 30

describe toxicity testing

Answer 30

Testing in animals before being given to humans
Long term administration in different species
Toxic doses given to identify likely ‘targets’ of toxic effects
Recovery studies aim to identify irreversible ADRs (e.g. carcinogenesis and
neurodegeneration)
Acceptable level of toxicity depends on intended indication
Findings may halt development of drug or provide focus for future trials

Question 31

define side effects

Answer 31

an unintended effect of a drug related to its pharmacological properties and can include unexpected benefits of treatment

Question 32

2 categories of severity of ADRs

Answer 32

mild
severe

Question 33

3 examples of mild ADRs

Answer 33

nausea, drowsiness, itching rash

Question 34

4 examples of severe ADRs

Answer 34

respiratory depression, neutropenia, catastrophic haemorrhage, anaphylaxis

Question 35

what are the adverse reactions to beta blockers

Answer 35

Bradycardia and heart block are primary adverse effects

Bronchospasm is a secondary pharmacological adverse effect

Question 36

3 causes of ADRs

Answer 36

Pharmaceutical variation
Receptor abnormality
Drug-drug interactions

Question 37

4 times when to suspect an ADR

Answer 37

Symptoms soon after a new drug is started

Symptoms after a dosage increase

Symptoms disappear when the drug is stopped

Symptoms reappear when the drug is restarted

Question 38

6 common ADRs

Answer 38

Confusion
Nausea
Balance problems
Diarrhoea
Constipation
Hypotension

Question 39

describe the yellow card scheme

Answer 39

The first ADR reporting scheme

Collects spontaneous reports

Acts as an ‘early warning system’ for identification of previously unrecognised reactions

Provides information, about factors which predispose patients ADRs

Continual safety monitoring of a product throughout its life span as a therapeutic agent

Question 40

4 critical pieces of info that need to be included on a yellow card

Answer 40

• Suspected drug
• Suspect reaction
• Patient details
• Reporter details