Revised Technical & operational Guidelines for TB

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For VOLUNTARY reporting of Adverse Drug Reactions by healthcare professionals
CDSCO
Central Drugs Standard Control Organization
Directorate General of Health Services,
Ministry of Health & Family Welfare, Government of India,
FDA Bhavan, ITO, Kotla Road, New Delhi
( AMC/ NCC Use only
AMC Report No.
Worldwide Unique no.
A. Patient Information 12. Relevant tests / laboratory data with dates
1.Patient Initials
_____________
2.Age at time of
Event or date of
birth
-------------------
3. Sex M F
4. Weight ____Kgs
B .Suspected Adverse Reaction
5. Date of reaction stated (dd/mm/yyyy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem
13. Other relevant history including pre-existing medical
conditions (e.g. allergies, race, pregnancy, smoking, alcohol use,
hepatic/ renal dysfunction etc)
14. Seriousness of the reaction
Death (dd/mm/yyy)____
Life threatening
Hospitalization-initial or
prolonged
Disability
Congenitial anomaly
Required intervention
to prevent permanent
impairment / damage
Other (specify)
15. Outcomes
Fatal
Continuing
Recovering
Recovered
Unknown
Other (specify)____
C.Suspected medication(s)
8. Name
(brand and /or
generic name)
Manufactu
rer (if
known)
Batch
No./ Lot
No. (if
known)
Exp. Date
(if
known)
Dose
used
Route
used
Frequency Therapy dates (if known give
duration)
Reason for use of
prescribed for
Date
started
Date stopped
i.
ii.
iii.
iv.
As per C
9. Reaction abated after drug stopped or dose
reduced
10. Reaction reappeared after reintroduction
Yes No Unknown NA Reduced dose Yes No Unknown NA If reintroduced
dose
i.
ii.
iii.
iv.
11. Concomitant medical product including self medication and
herbal remedies with therapy dates (exclude those used to treat
reaction)
D. Reporter (see confidentiality section in first page)
16. Name and Professional Address :___________________________
_______________________________________________________
Pin code : ______________ E-mail _______________________
Tel. No. (with STD code): ______________________________
Occupation ________________Signature ______________
17. Causality Assessment 18. Date of this report (dd/mm/yyyy)
Annexure 11
188