The document outlines the importance of adverse drug reaction (ADR) reporting in India, highlighting the country's leading position in pharmaceutical production and the need for a robust pharmacovigilance system. It provides definitions, reporting procedures, and the roles of healthcare professionals in identifying and documenting ADRs, emphasizing the collective responsibility to ensure patient safety. The document also includes case studies and tools to facilitate ADR reporting and assessment.

1. ADVERSE DRUG REACTION-
REPORTING

2. CONTENTS
1.ADR(ADVERSE DRUG REACTION)
2.REPORTING OF ADR
3.ADR REPORTING FORM
4..CAUSALITY ASSESMENT OF ADR
2

3. •India ranked 1St
in World Population
•Indian pharmaceutical industry is growing about 8 – 9%.
•Producing more than 20% of the world’s generics.
•The total pharma market is expected to rise to US$70 billion by 2025.
•It ranks very high amongst all the third world countries, in terms of
technology, quality and vast range of medicines that are manufactured.

4. But reporting ADRs………?

5. ADR-DEFINITION
 ADR is any response to a drug that is noxious and unintended
and that occurs at normal doses used in humans for
prophylaxis, diagnosis for treatment.
 “A harmful or significantly unpleasant effect caused by a drug.
which warrants Reduction of dose or withdrawal of the drug.”
 This requires a well organized pharmacovigilance system.
5

6. “Pharmakon” is a Greek word means a drug.
“Vigilare” is a Latin word meaning to be observant, to
keep awake or alert , to keep watch, care, caution,
process of paying close and continuous attention.
A drug may act or may not act, but it should not harm
the patient. God has given the knowledge to us only to
protect the patient and not to harm him.
Whether we cure the disease or not we must not create
a new problem for the patient.

7. Pharmacovigilance: Definition
Science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
possible drug-related problems
WHO

10. Objectives of Pharmacovigilance
1. To improve patient care and safety in relation to the
use of medicines, all medical and paramedical
interventions.
2. To improve public health and safety in relation to the
use of medicines.
3. To detect problems related to the use of medicines
and report the same.
4. To help in assessing the benefits, harm, effectiveness,
and risk of medicines to prevent harm and maximize
the benefit.

11. Ultimate Goals of pharmacovigilance
1. To promote rational and safe use of
medicines
2. To sensitize, educate and inform patients
about drug safety issues
3. Analyse the risk-benefit ratio of marketed
medicines to safeguard the health of our
Indian population

12. Who can report ?
Why to report ?
What to
report ?
How and whom
to report ?
12

13. Who can report?
PvPI
Clinicians Pharmacists
Nurses
Pharmaceutical Industry

14. WHO CAN REPORT?
Any health care professional
Doctors including interns,
Residents,
Dentists,
Nurses and
Pharmacists

15. REPORT EVEN IF:
•The drug is an established one and the
adverse drug reaction is well known
•You are not certain the product caused
adverse event
•You don’t have all the details

16. What to report?
 All types of suspected ADRs (whether
known /unknown, serious /non-serious,
frequent /rare)
 Although primarily concerned with
allopathic medicines, ADRs with traditional
medicines (herbal remedies etc) is also
being considered

19. • The peripheral centres will record the
adverse events and send to regional
centres.
• They in turn correlate and send the data
and submit to the zonal centres.
• Zonal centres analyse the data submit a
consolidated information to the national
pharmacovigilance centre.
• The zonal centres also provide training,
support and coordinate the functioning of
regional centres.

21. Whom to report?
By using the ‘Suspected Adverse Drug Reaction
Reporting Form’
A reporter who is not a part of AMC can submit
the ICSR to the nearest AMC or directly to the
NCC.
Toll free help line number 1800-180-3024

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23. Android Application
ADR Reporting App. can be downloaded from Google play store (free To Download)
NCC-PvPI in technical collaboration
With NSCB Medical College, Jabalpur
In May 2015 developed a Mobile
Application for all healthcare
Professionals to report adverse drug
Reactions.

24. PVPI and WHO-UMC collaboration
The following softwares tools are provided by WHO-UMC to acheive the objectives of
PV In a more efficiency way.
VIGIFLOW – Based on the ICH E2B standared
VIGIBASE - Containing
medical drug classification VIGIMINE -
Give statistical data of all drug-ADR
VIGIMED - For checking regulatory staus,drug information
VIGISEARCH- For report searching across mutiple drugs
VIGILYZE - Include conventional medicine,traditional
medicine 24

25. Suspected Adverse Drug Reaction Reporting Form
For Health Care Professionals
This form is divided into four
sections:
A. Patient Information
B. Suspected Adverse Reaction
C. Suspected Medication(s)
D. Reporter Details

26. A. Patient
Information
A. Patient Information
1. Patient
Initials
2. Age at
time of event or date
of birth
3. M □ F □ Other □
4. Weight Kgs

27. B. Suspected Adverse Reaction
B. Suspected Adverse Reaction
5. Date of reaction started (dd/mm/yy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem

28. C. Suspected
Medications
C. Suspected medication(s)
S. 8.
Name No.
(Brand
/Generic)
Manufa
cturer
(If
known)
Batch
No./
Lot no.
Exp. Date
(if known)
Dose
used
Route
used
Frequency
(OD,BD,
etc.)
Therapy dates Indica
tion
Causalit
y
assessm
ent
Date Date
starte
stopped d
i
ii.

29. C. Suspected Medications
Action taken- Mark the appropriate option for the action taken with Respect
to Suspected drug.
S.No.
as per
C
9. Action Taken ( Please Tick)
Drug
withdrawn
Dose
increased
Dose
reduced
Dose not
changed
Not
applicable
Unknown
i
ii

30. C. Suspected Medications
 Rechallenge/ Reintroduction - The point at which a drug is again Given to a
patient after its previous withdrawal.
 Mark the appropriate option whether the suspected drug reintroduced &
Reaction occurred or not or effect unknown.
10. Reaction reappeared after reintroduction ( Please Tick)
S.No. Yes No Effect Unknown Dose
(If reintroduced)
i
ii

31. Concomitant medications
Concomitant medical product (s) information given in the Following tabs.
11. Concomitant medical product including self medication
and herbal remedies with therapy dates (exclude those
used to treat reaction)
S.No. Name
(Brand
/Generic)
Dose
used
Route
used
Frequency
(OD, BD, etc.)
Therapy dates Indication
Date
started
Date
stopped
i
ii

32. D. Reporter Details
D. Reporter Details
16. Name and professional address
Pin E - mail
Tel. No. (With STD code)
Occupation Signature
17. Date of this Report (dd/mm/yyyy)

34. CAUSALITY ASSESSMENT OF ADR
34
Causality assessment is defined as “the evaluation of the likelihood that
a Medicine or drug was the causative agent of an observed adverse reaction”.
To detect signals in order to minimise harm to patients through ADRs
Basic terminologies in WHO-UMC Causality Assessment scale
Challenge: Giving of the drug to the patient during the AE or treatment.
Dechallenge: Stopping of the drug, usually after an adverse event (AE) or at
The End of a planned treatment.
Dechallenges may be complete or partial, i.e. the drug is fully stopped or
Decreased in dose and the AE may fully disappear or only partially
decrease.
Positive dechallenge: AE disappears after the stopping of the drug.
Negative dechallenge: This refers to the AE dose not disappear after the
Stopping of the drug.

35. Rechallenge: Restarting of the same drug after having stopped it, usually for An
AE.
Rechallenges may also be complete or partial.
Negative rechallenge: This is the case where the AE does not recur after the
Drug
is restarted.
Positive rechallenge: AE recurrs after restarting the drug.
Prechallenge: This is a new term that refers to the use of the same drug at some
point in the past.
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36. Causality Assessment scales
1)Kerch and lasagna scale
2Naranjo scale
3)WHO Probability scale
4)Jones Scale
Kerch and Lasagna Scale
A= causality is highly probable
B= Not adequate proof of causality
C= data are not adequate to asses causality

37. WHO-UMC Causality Assessment System
This method includes the following 4 criteria:
1. Time relationships between the drug use and the adverse event.
2. Presence/Absence of other competing causes (medications, disease process
itself).
3. Response to drug withdrawal or dose reduction (dechallenge).
4. Response to drug Readministration (rechallenge).

48. CASE STUDY-1
XYZ, a 35-year-old male, 60 kg, was diagnosed as a case of bacterial meningitis.
He was started empirically with Inj Ceftriaxone 1g iv BD and Inj Vancomycin 500
mg iv QID on 18.02.2020. First dose of Inj. Ceftriaxone was given at 8 am and
Inj. Vancomycin was given at 9 am on 18.02.2020. After10 min of second drug
administration, he started developing chills, rigors, fever, urticarial, and intense
flushing. He was treated with Inj. Pheniramine 25 mg im, following which the
reaction completely subsided. Inj. Ceftriaxone was continued. However, next
doses of Inj. Vancomycin scheduled on day 1were not given. On day 2, Inj.
Vancomycin was re-introduced at 9 am to the patient. Similar symptoms
developed again and quickly resolved after Inj. Pheniramine 25 mg im.
It was noted:Inj Ceftriaxone
Brand Name: Cefogram
Manufacturer: ZYDUS
Expiry date: July 2025
Batch number: ADFO345 Inj Vancomycin
Brand Name: Forstaf
Manufacturer: GSK
Batch number: GETP098
Expiry date: May 2024

50. CASE STUDY-2
ABC,28-year-old unmarried female was admitted in the female Psychiatry ward for
treatment of bipolar affective disorder on 20.01.2020. From the day of admission,
she received tab divalproex sodium 1000mg /day and tab lorazepam 2 mg at bed
time. On physical examination all the findings were within normal limits. The
laboratory investigations showed total white blood cell count- 12120-cells/cu mm
and hemoglobin- 12.4 gm/dl. The platelet count and blood glucose were normal.
Urine routine showed: urine sugar – negative, protein – negative. With the
treatment, the psychiatric problems improved & her discharge was planned on
10.02.2020 with due advice. However, due to appearance of red spots on the skin
that looked burnt, the discharge was withheld. The next day, blisters were seen on
the skin, in the mouth & nose, & she was referred to medicine ward & case was
diagnosed as SJS. Divalproex sodium was stopped on the same day. She was admitted
in the medicine ward & given supportive treatments. Skin care was provided with
regular dressings, topical steroids & antibiotics in consultation with dermatologists.
She was discharged after improvement on 15.03.2020 with the advice to attend
psychiatry OPD.
Drug details
Drug Name: Divalproex sodium
Batch No: 123 ABC
Expiry Date: 10/2023
Manufacturer Details: CDX pharmaceuticals Pvt. Ltd., ZZ city, Tel: 919191

51. Sample case-3
ABC, 60-year-old hypertensive and diabetic was on
tablet Enalapril 10mg twice daily since 02/04/2020. His
BP 140/90 and Fasting blood sugar 130 mg/dl, HbA1c
7%.CBC Test shows Hb 10gm,Serum Creatinine 1.5
mg/dl. He developed dry cough after 2 months of taking
the drug. It was replaced with tablet losartan 50mg once
daily on10/06/2020. The cough subsided.
Drug details
Drug Name: Enalapril
Batch No: 123 ABC
Expiry Date: 10/2023
Manufacturer Details: CDX pharmaceuticals Pvt. Ltd., ZZ city, Tel: 919191

52. CASE STUDY-4

53. CASE STUDY-5

54. Dying from disease is some times
unavoidable , BUT dying from
medicine/adverse drug reaction is
unacceptable.

55. TAKE HOME
MESSAGE
TAKE TO HEART MESSAGE
KEEP REPORTING ADVERSE DRUG REACTIONS
…………………………….thank u

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