ADVERSE DRUG REACTION

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LOGO REPORTING FORM LOKBBHXahxav

A. Patient Information 12. Relevant tests/ laboratory data, including dates

1. Patient Name: 2. Age at the time of 3. Sex: M F
____________________ event/DOB
In Confidence _________________
4. Weight: ________kg
B. Suspected Adverse Reaction 13. Other relevant history, including pre-existing medical conditions (e.g.
5. Date of reaction Started (dd/mm/yy): allergies, race, pregnancy, smoking, alcohol use, hepatic/ renal
dysfunction, etc)
6. Date of recovery (dd/mm/yy):
7. Describe Reaction

14. Seriousness of the Reaction

Death (dd/mm/yy) _______ Congenital anomaly
Life threatening Required intervention to prevent
Hospitalization – initial or permanent impairment/ damage
prolonged Other (specify) _________
Disability
15. Outcomes
Fatal Recovering Unknown
Continuing Recovered Other (Specify) ____
C. Suspected Medication(s)
Sl. No. 8. Name (brand and/ or Manufact- Batch Exp. Date Dose Route Frequency Therapy dates (If unknown, Reason for use or
generic name) urer (If No. / (If known) used used give duration) prescribed for
known) Lot No. Date Started Date Stopped
(If
known)
I

II

III

IV

Sl. No. 9. Reaction abated after drug stopped or dose reduced 10. Reaction reappeared after reintroduction
As per C Yes No Unknown NA Reduced Dose Yes No Unknown NA If reintroduced,
dose
I
II
III
IV
11. Concomitant medical products and therapy dates including self D. Reporter (See confidentiality section)
medication and herbal remedies (exclude those used to treat reaction) 16. Name & Professional Address:
____________________________________________________________
____________________________________________________________
____________________________________________________________
Pin: __________________ E-mail: _______________________________
Mob./Tel. No. with STD code: ___________________________________
UHID/IP No.: ___________________ Speciality: ____________________
Signature: ____________________________________
17. Occupation: 18. Date of this report
(dd/mm/yy)

GH/F54/2016,Rev.01(2017), Page 1 of 2

(To be filled by the higher authority)

1. Root Cause Analysis
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2. Comments and recommended Corrective and preventive action

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3. Action Taken (By __________________________________)

Nil Urgent Immediate

Name ________________________________________ Signature with Date _________________________

Designation ___________________________________

4. Review by Drug Committee

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Name ________________________________________ Signature with Date _________________________

Designation ___________________________________