All physicians should be concerned about the adverse drug effects and report to warn about use of this drug

1. Revision of adverse drug
reactions
Dr. RANIT BAG
PGT IN PHARMACOLOGY, CNMCH

2. FAQS
Q 1. Define ADR.
Q 2. What is the difference between ADR and ADEs
Q 3. What are the types of adverse drug reaction and give
examples
Q 4. How will you assess the causality of ADRs
Q 5. Define Pharmacovigilance
Q 6. What is signal
Q 7. Explain PVPI cycle.
Q 8. What are the changes in new version of form
Q 9. Fill the form for the example of ADR given in your practical
examination.

3. Definitions
 Adverse drug reactions:-
 Any noxious, unwanted and undesired effect of a drug that occurs at
doses used for prevention, diagnosis and treatment (WHO definitions).
 Adverse drug event:-
It is harm that occurs while a patient is taking a drug, irrespective of
whether the drug is suspected to be the cause.
 Pharmacovigilance :-
Pharmacovigilance is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other
drug related problem.

5. Types/ names Definations Examples Treatment
A - Augmented Increase dose-increase
reaction
Hypoglycaemia- Insulin Reduce dose
?Concomitant drug
B-Bizzare Unpredictable.
Not dose related
Hypersensitivity--
penicillins.
SJS-- phenytoin, PCM
Stop the drug.
To be avoided in future.
C- Chronic Chronic use HPA axis suppression --
steroids
Use lowest dose for
shortest duration.,
Intermittent/ pulse therapy.
D- Delayed Time lag for development Teratogenicity,
Carcinogenicity
Only used if mandatory.
Avoided in pregnancy
E- End of dose Reaction appear when drug
stopped
Rebound HTN with beta
blockers
Tapper the drug slowly
F- Failure of therapy Ineffectiveness of a drug Pregnancy due to failure of
OCP
Consider drug interaction.

6. Causality Assessment
 Causality assessment is the assessment of relationship between a drug
treatment and the occurrence of an adverse event.
 It is also used to evaluate and to check that the particular treatment is
the cause of an observed adverse event or not.
 It is an essential part of ADR report and important task, conducted by
national pharmacovigilance programme in each country.

7. Signal
Reported information on possible causal relationship between an
adverse event and a drug, the relationship being unknown or
incompletely documented previously. Usually more than one single
report is required to generate a signal depending upon the seriousness
of the event and quality of information
Provide better evaluation of the benefit / harm profiles of drugs.
Plays as an essential part of evaluating ADR reports in early warning
systems and for regulatory purposes.

8. WHO UMC Scale
Types Time sequence Presence of
other
drugs/disease
Dechallenge Rechallenge
Certain + + + +
Probable + + + _
Possible + _ _ _
Unlikely _ _ _ _

10. Changes in new version of suspected ADR reporting
form
1. Filling up no. 10 and 12 to 15 spaces, is mandatory
2. Patient’s IPD/OPD/RG no is necessary
3. Causality assessment done by WHO-UMC scale
4. Signature and reporting personal is needed
5. Reporters may use separate page for filling A,B,C,D for more
informations

11. Mr. X, a 60 yrs. old male patient came to OPD with complaints of URTI. He was prescribed tablet
Azithromycin for 1week. After 5days, the patient came to emergency with complaints of
generalized weakness, palpitation and frequent fainting. After doing ECG, it was diagnosed as
QT prolongation. The medicine was stopped immediately and he was treated symptomatically.
Report this ADR using a standard ADR form. What are the common drugs causing QT
prolongation?
ADR case 1

12. Drugs causing QT prolongation
A- AntiArrythmic
(Amiodarone,sotalol,fleicanide),AntiAnginal(Ranolazi
ne)
B- AntiBiotics(Fluoroquinolones, macrolides,
aminoglycosides)
C- AntiCychotics(Haloperidol,quetiapine, risperidone)
D-AntiDepressants(SSRIs, TCAs), Diuretics
E- AntiEmetics(Ondansetron)

13. A 45 year old male patient, Mr. X was diagnosed congestive cardiac failure and he was
on medication Tab Digoxin (0.25 mg OD). After 1 week of treatment, he complained
of abdominal pain, reduced urine output, loss of appetite, constipation, visual
disturbance and delirium. His serum Digoxin level was 3.6 ng/ml (Normal 0.8-2
ng/ml). After admission to hospital, tab Digoxin was stopped immediately and
managed with suitable antidote and ionotrops. Report this ADR by using standard ADR
form.
ADR Case 2

14. An adult male patient aged 21yr (weight 50 kg) was administered
penicillin-G without sensitivity test testing. He developed severe
breathlessness, hypotension and he maintained suggestive of
anaphylactic shock. He was rapidly administered adrenalin 0.5mL
(strength 1:1000; 1mg/mL) IV by a young doctor on duty. However
the patient developed severe bradycardia instead he developed
severe bradycardia instead of improvement. What was the likely
cause of this problem and how it could have been prevented?
ADR Case 3

15. ADR Case 4
An adult asthmatic female patient aged 38yrs (weight 52 kg)
developed severe breathlessness at night (2AM) and brought to
hospital emergency. She was given aminophylline 250mg rapid IV
as it was emergency but patient breathlessness was not
relieved; instead he developed nausea, headache, tachycardia,
palpitations and tremors of fingers. What was the likely cause of
this problem and how it could have been prevented?