adverse drug reactions

Question 1

define ADRs

Answer 1

unwanted or harmful reactions following the administration of drugs or combination of drugs under normal conditions of use and are suspected to be related to the drug. Has to be noxious and unintended .

Question 2

define side effects

Answer 2

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

Question 3

are side effects and ADRs the same thing?

Answer 3

they can be

but side effects can be beneficial but ADRs are always unpleasant

Question 4

what are the 3 possible effects of ADRs and side effects?

Answer 4

1. toxic effects -
2. collateral effects
3. hyper-suscepatbiplity effects

Question 5

what is meant by toxic effects? when do toxic effects occur?

Answer 5

occur when Above therapeutic range

eg. Patient has too high levels of drug, or drug excretion is impaired

Question 6

what is meant by collateral effects? when do collateral effects occur?

Answer 6

when within Therapeutic range, ie. standard therapeutic doses

Question 7

what is meant by Hyper-susceptibility effects? when do Hyper-susceptibility effects occur?

Answer 7

Below therapeutic range, haven’t taken enough to see the benefit expected, and then they have an ADR

Eg. anaphylaxis from a small dose of penicillin

Question 8

risk factors for ADRs

PATIENT FACTORS

Answer 8

Gender - higher risk for women
Elderly
Neonates
Polypharmacy
Genetic predisposition
hypersensitivity/allergies
Hepatic or renal impairment

Adherence problems - when patient doesn’t follow dose correctly

Question 9

risk factors for ADRs

DRUG FACTORS

Answer 9

If the drug has a steep dose-response curve
If the drug has a low therapeutic index - easy to reach toxic range
If the drug is known to commonly cause ADRs

Question 10

risk factors for ADRs

PRESCRIBER FACTORS

Answer 10

Prescriber risks → doctor makes a mistake when prescribing

Question 11

give 5 examples of causes of ADRs

Answer 11

1. a contaminant in drug
2. patient has receptor abnormality
3. Abnormal biological system unmasked by drug
   (Problem with patient that is unknown until the ADR highlights it )
4. Immunological
   eg. penicillin induced anaphylaxis
5. Drug-drug interactions

Question 12

what are the different categories of time dependent reactions

Answer 12

• rapid reaction
• 1st dose
• early
• intermediate
• late
• delayed

Question 13

give an example of a delayed ADR

Answer 13

thalidomide in pregnancy

Question 14

give an example of a common ADR drug

Answer 14

beta blockers
antibiotics
NSAIDS

Question 15

name the classification system for ADRs

Answer 15

Rawlins Thompson classification A-F

Augemented
Bizzare
Continous
Delayed
End of treatment
Failure of therapy

Question 16

describe type A class of ADRs

Answer 16

Augmented

• an exaggeration of primary drug effect
• common
• dose dependent
• eg. bleeding with warfarin

Question 17

describe type B class of ADRs

Answer 17

bizarre

• no predictable
• not dose dependent
• life threatnetning eg. anaphylaxis to penicillin

Question 18

describe type C class of ADRs

Answer 18

continuous/chronic

• uncommon
• relative to cumulative dose and time
• eg. osteroperosis from long term steroid use

Question 19

describe type D class of ADRs

Answer 19

delayed

• uncommon
• shows up after time
• eg. teratogenesis from thalidomide taken in first trimester

Question 20

describe type E class of ADRs

Answer 20

End of treatment

• occurs after abrupt drug withdrawal
• eg. opiate withdrawals

Question 21

describe type F class of ADRs

Answer 21

Failure of therapy

• common
  -dose related
• often caused by drug interactions
• eg. failure of oral contraceptive pill in presence of enzyme inducer medication

Question 22

what is DoTS?

Answer 22

another way to classify ADRs. stands for:

dose relatedness
timing
susceptibility of patient - host factors?

Question 23

give 3 signs that would cause you to suspect ADR?

Answer 23

Symptoms soon after a new drug is started
Symptoms after a dosage increase
Symptoms disappear when the drug is stopped

Question 24

6 actions to take if ADR

Answer 24

Assess if urgent action required ABC
Take history
Review medication history
Review the adverse effect profile of suspected drug
Modify dose, stop or swap
Report

Question 25

common ADR symptoms

Answer 25

Confusion
Nausea
Balance problems
Diarrhoea
Constipation
Hypotension

Question 26

name the scheme that is used for reporting ADRs

Answer 26

the yellow card scheme - a voluntary reporting system of suspected ADRs

Question 27

what are the 4 critical pieces of info to record on. a yellow card?

Answer 27

Suspected drug
Suspect reaction
Patient details
Reporter details

Question 28

for which suspected reactions should you report for?

Answer 28

Report ALL suspected reactions for
Herbal medicines
Black triangle drugs

Report SERIOUS suspected reactions for
Established drugs, vaccines
Drug interactions

Question 29

what are black triangle drugs?

Answer 29

medicine is undergoing additional monitoring

eg. it contains a new active substance, it has been given under exceptional circumstances

Question 30

what does a serious reaction look like ?

Answer 30

Fatal,life threatening, disabling, incapacitating, results in hospitalisation, prolongs hospitalisation

Question 31

who can report a yellow card?

Answer 31

Drs,dentists,coroners,pharmacists,nurses,midwives,health visitors, radiographers, optometrist, PATIENTS, and parents/carers of the patient