1) The document discusses several scenarios involving adverse drug reactions and reporting. It emphasizes the importance of reporting all suspected adverse reactions to the appropriate authorities, even if the patient recovers, to further drug safety. 2) In one scenario, a resident witnesses a child develop loose motions after amoxicillin, but the consultant dismisses reporting it. The document says the resident should still report the reaction. 3) In another scenario, a person faints after a COVID vaccine but recovers. The doctor considers not reporting due to fears of negative publicity, but the document says all suspected reactions should be reported to identify potential new adverse reactions.

1. IMA Perspective of Pharmacovigilance
Prof Subramanya N K
Member of National IMA PV Cell
Dr Subramanya NK

2. Scenario 1
Resident in wards reports in rounds to the consultant that a 9 month old child
developed loose motions once next day after the prescription of Amoxicillin.
The baby is well hydrated.
He asks the consultant, “ I recently attended a CME and was told to report the
reaction”
Clinician says” How does it matter to me, Don't you know its fine for
amoxicillin”
1. Resident should obey the orders of the consultant and avoid/ scared of
investigations by PV team
2. Resident can bypass the consultant and report to authorities
3. The resident agrees with clinician he gets nothing out of reporting since
the child is safe and its expected
4. Resident tells staff nurse to report
Dr Subramanya NK

3. Adverse effect
Due to drugs
Unexpected
Harmful
Adverse event
Unintended
May or not be due
drug
Side Effects
Due to drugs
Expected
Dr Subramanya NK

4. Scenario 2
• A doctor in PHC gives COVID vaccine and the 20 year old who faints.
However 2-5 minutes later, he is fine sipping a cup of coffee.
• The government doctor is afraid of authorities, press and public and
decide to play down the incident since recipient is fine with examination
and decide that he is safe
1. The doctor is right since the fall may be due to vasovagal effect
2. There can be medication error in syringe and we will know if investigated
only
3. The doctor should report since it can be a new adverse drug reaction to
COVID vaccine
4. The doctor is right since we should not publicize the right motives like
vaccination
Dr Subramanya NK

5. Dr Subramanya NK

6. Scenario 3
• A private practitioner prescribes antibiotic ciprofloxacin to teenager for 5
days suffering from UTI not evaluated.
• 7 days later, young girl develops rashes over the face and the parents
pickup a fight with the doctor.
• The doctor coughs up huge amount to avoid unnecessary publicity of the
situation and decide not to prescribe ciprofloxacin
1. The Doctor should have read the leaflet of Ciprofloxacin before
prescribing and should have lab confirmed UTI
2. The doctor should have called police and reported the incident to IMA
and Pharmacovigilance
3. The doctor can relax and prescribe Ciprofloxacin since the event
happened after7 days and believes that its rare side effect
4. The parents can go court and doctor is safe if and only if he reports the
case
Dr Subramanya NK

7. • Unexpected
• Expected
ADR
• Not specified
• Not reported
earlier
Unexpected ADR
• Preventable
• Not
preventable
Harm to the
patient
Dr Subramanya NK

8. Scenario 4
• Dr X is a busy practioner and the whole community respects him. He can
handle any untoward incident since he is cousin of local MLA. After
Prescription of an Ointment, the lesion increased and 30 year old lady
started complains that the there was negligence in media. To complicate
matters the lady is discovered to be pregnant. Years of practice, local MLA
pressure and knowledge of the ointment is not helping him
1. The doctor should update and understand that the lesion can be
evolution of the disease than ADR
2. The bit of increase in the size is a matter of anxiety and should have been
avoided by good practice habits including counseling
3. The doctor should later file the case on the company for compensation
4. The doctor should reduce practice and increase the fees
Dr Subramanya NK

9. ADR can be
1 Onset: Acute/Sub acute/Latent
2.Severity: Mild, Moderate/Severe
3.Type: Augmented, Bizarre, Chronic, Delayed, End of treatment, failure, Genotoxicity,
Hypersensitivity, Unclassified
Is confirmation of ADR a prerequisite for reporting?
Dr Subramanya NK

10. Scenario 5
• An anesthetist found that following spinal anesthesia, there is persistent
paresis on day2 and is worried of consequences
• She has just recently married to a surgeon who was operating and the
matters are worse when there was fights in the family.
• She decides to commit suicide
1. She should call up Pharmacovigilance team and they will help her
2. The PV team decide to investigate the drug, but found that the needle and
technique are at fault. However they can alter the report as drug induced to
protect the colleague
3. Get a multi disciplinary team approach to support the event
4. Social interventions needed than medical evaluations
Dr Subramanya NK

11. Dr Subramanya NK

12. Scenario 6
• A physician prescribes a drug x and was not decoded by the pharmacist
and he gives whatever he seem to understand. The treatment failure goes
to consumer court. You are the expert witness in the court
• What will be your opinion?
1. Mistake is on part of physician for legible writing and he is punishable
2. The pharmacist should have called and taken telephonic advice
3. The pharmacist should have asked the patient to show the medicines to
the physician before administration
4. You will blame that medicine is spurious and should be investigated
Dr Subramanya NK

13. Doctor Pharmacist
Patients name missing Wrong Medication
Dosage Excessive dose
Short forms labeling
Omission of units Dispensed, not prescribed
Missing information on diluent Non delivery of drugs
Route of administration Wrong strength
Duration of infusion Wrong direction dispensing
HAND WRITING Non communicating

14. • A staff nurse asks “Why all these additional headaches of reporting”.
• A patient thinks that “ I can exhort some compensation”
• A doctor thinks “Now a days its tough to practice”
• Pharmacovigilance team thinks, “Why there is no reporting in spite of our
efforts”
Scenario 7
1. The better drugs will emerge from research
2. Better drugs will emerge from Pharmacovigilance
3. Nothing like an Ideal drug, every drug will have side effects, so relax
4. It’s the responsibility of Pharma companies to worry
Dr Subramanya NK

15. Dr Subramanya NK

16. Question( Y/N)
1. All ADRs are Known before a drug is marketed
2. We cant say drug is the cause
3. Report only when certain
4. A stray report is of no significance
Dr Subramanya NK

17. Why there are so many ADRs?
1. Almost every patient gets a prescription
2. Poly pharmacy increases the chances of ADR
Dr Subramanya NK

18. How can we increase the reporting of ADRs?
1. Make it easy & simple process
2. Provide feedback to clinicians
3. Collaborate with organizations like IMA
4. Involve all layers of health care professionals
Dr Subramanya NK

19. Dr Subramanya NK

20. 9448207993
Prof Subramanya N k
Subramanya.nk@gmail.com
Dr Subramanya NK