Adverse Drug Reactions

Question 1

define adverse drug reaction

Answer 1

an unwanted or harmful reaction following the administration of a drug or combination of drugs

Question 2

give 3 facts about ADRs

Answer 2

• relatively common
• account for 5-7% of all admissions to hospital and 10-20% of inpatients
• mortality rate of 0.5-2%

Question 3

what is pharmacovigilance?

Answer 3

the science and activities relating to the detection, education and prevention of ADRs or other drug related problems

Question 4

what topics does pharmacovigilance cover? (6)

Answer 4

• ADRs
• medication errors
• counterfeit medications
• interaction of medications
• abuse + misuse of medications
• lack of efficacy

Question 5

what is a side-effect?

Answer 5

any effect caused by a drug other than the intended therapeutic effect whether good, neutral or bad

Question 6

side-effect vs ADR?

Answer 6

side-effect usually implies predicable, less harmful effects that can allow the continuation of the medication

Question 7

what groups are at risk for ADRs?

Answer 7

-elderly
-children
-patients with more than 1 medication
-liver disease
-renal failure

Question 8

what is a Type A ADR?

Answer 8

Augmented: predicted by the pharmacology of the drug, dose dependant

Question 9

what is a Type B ADR?

Answer 9

Bizarre: unpredictable for individuals, due to inherited abnormalities (idiosyncrasy/drug allergy)

Question 10

what is a Type C ADR?

Answer 10

Chronic: reaction due to long time exposure

Question 11

what is a Type D ADR?

Answer 11

Delayed reaction: due to prolonged exposure or accumulation

Question 12

what is a Type E ADR?

Answer 12

End of Use reaction: occur on withdrawal or abrupt discontinuation of drug

Question 13

what is a Type F ADR?

Answer 13

Failure of Therapy: drug undesirably increases or decreases in efficacy (tolerance/resistance/sensitivity)