DEPARTMENT OF PHARMACY PRACTICE – TMCOP

TEERTHANKER MAHAVEER MEDICAL COLLEGE HOSPITAL

MORADABAD, UP

ADVERSE DRUG REACTION REPORTING AND DOCUMENTATION FORM

Patient Name: HP No: Department:

Age: Sex: Weight: IP/OP: Unit:
Reason for admission:
Known allergies:
Brief description of reaction:

Date of onset of treatment: Date of onset of Reaction:

Drugs used Tick

Date Route and
prior to Dose suspected Indication Date stopped
started Frequency
reaction drug(s)

Management of Adverse Drug Reaction:

 Drug withdrawn  Dose altered  No change

Treatment given:
 Specific  Symptomatic  Nil

Outcome:  Fatal  Recovery Continuing

 Unknown  Other

Dechallenge: Rechallenge:
 No dechallenge  No rechallenge
 Definite improvement  Recurrence of symptoms
 No improvement  No occurrence of symptoms
 Unknown  Unknown

Follow up:
Patient interviewed:  Yes  No

Thank you note provided:  Yes  No  N/A

Alert card provided:  Yes  No  N/A

Causality:

A) Naranjo’s Scale
 Definite  Possible
 Probable  Unlikely

C) WHO Scale
 Certain  Unassessable/Unclassifiable
 Probable  Unlikely
 Possible  Conditional/Unclassified

Severity (Hartwing et.al. Scale):

Mild: Moderate: Severe:
 Level 1  Level 3  Level 5
 Level 2  Level 4 (a)  Level 6
 Level 4 (b)  Level 7

Predictability:
 Predictable  Non Predictable

Preventability: (Modified Schumock and Thronton’s Scale):

 Definitely Preventable  Probably Preventable  Not Preventable

Predisposing Factors:
 Age  Gender  Genetic
 Intercurrent Disease  Multiple Drug Therapy  Others (specify)

References consulted:

Name of the Attending Pharmacist: Signature: