Adverse drug reactions with common terminology

ADRs with common terminology and causality assessment

1. 2/15/2010
Adverse Drug Reaction

2. “Medicines are nothing in
themselves, but are the very
hands of gods if employed with
reason and prudence.”
-Herophilus

3. Allsubstancesarepoisons,
thereisnonethatisnota
poison:therightdose
differentiatesapoisonanda
remedy.
-Paracelsus,16
th
Cent.

4. Historical background
-2000 B.C. Babylonian code of conduct.
-1787 “ digitalis toxicity” by William Withering.
-1961 Thalidomide disaster.
-1968 International drug monitoring centre at Uppsala Sweden
-Nov. 04 National pharmacovigiolance programme .
7/24/2024

5. 7/24/2024

6. Definitions
Adverse drug event
Adverse drug reaction
Side effect
Pharmacovigilance
Signal
7/24/2024

7. Adverse drug event
“Any untoward medical occurrence that may present
during treatment with medicine but does not
necessary have causal relationship with the
treatment. “
7/24/2024

8. Adverse drug reaction
“Any response to drug which noxious & unintended
which occurs at doses normally used for prophylaxis,
treatment, diagnosis, or modification of physiological
function.”
7/24/2024

9. Side effect
“Any undesirable or unintended consequence
of drug administration.”
7/24/2024

10. Pharmacovigilance
“Science & activities relating to the detection,
assessment, understanding & prevention of adverse
effects or any other drug related problem.”
Signal
-reported information on possible causal relation ship
between adverse event & drug.
7/24/2024

11. Factors predisposing to ADR
1] RACE -white more susceptible than black.
-rapid & slow acetylators .
-G6PD Deficiency e.g. Africans /Jews.
2] Genetic influence
–plasma pseudocholine esterase
-malignant hyperthermia
7/24/2024

12. 3] Gender –
women susceptible to digoxin.
Drug induced lupus is common in female.
4] AGE –
Elderly & anticoagulation.
diuretics & Elderly.
Chloramphenicol –gray baby syndrome.
7/24/2024

13. OTHER FACTORS
-allergic disorder.
-previous H/O ADR
-Renal & hepatic disorders
-Plasma protein binding
-Formulation
7/24/2024

14. Classifications of ADR
Rowling & Thomson Classification
7/24/2024 Department of Pharmacology

15. Wills & brown classification
7/24/2024 Department of Pharmacology

16. Incidence
7/24/2024

17. Time dependent classification
7/24/2024

18. Classification based on severity
7/24/2024 Department of Pharmacology

19. Causality assessment scales
WHO Probability scale
Naranjo scale
ABO European scale
Karch & lasagna scale
Kramer's scale
Jones scale
Bayesian scale
7/24/2024

20. WHO scale
Certain
Probable
Possible
Unlikely
7/24/2024

21. Unclassified
Unclassifiable
7/24/2024