Suspected Adverse Drug Reaction Reporting Form for Healthcare Professionals

for

Nature of Event
Please tick () the box(es) as applicable
Adverse event (Side effect)
Lack of drug efficacy
Drug overdose
Drug misuse
Unintended use while being pregnant / lactating / breastfeeding
Other   

A. Patient Information
Patient Initials

Date of Birth

Gender
Male    Female    Other

Body-Weight (kgs.)

B. Suspected Adverse Reaction
Reaction started on Date

Date of recovery

Describe reaction or problem
C. Suspected Medication(s)
Sr.
Name
(brand and/or generic name)
Manufacturer
(if known)
Batch No. /
Lot No.
(if known)
Exp. Date
(if known)
Dose used
Route used
Frequency
Therapy dates
(if known, give duration)
Date started
Date stopped
Reason for use or prescribed for
 1.
 2.
 3.
 4.
Action taken with suspected drug
Dose reduced    Drug discontinued    Continued in same dose

Reaction abated after
drug stopped or dose reduced

(Sr. No. in continuation to listed above)
1. » Yes    No    Unknown    NA    Reduced dose  

2. » Yes    No    Unknown    NA    Reduced dose  

3. » Yes    No    Unknown    NA    Reduced dose  

4. » Yes    No    Unknown    NA    Reduced dose  

Reaction reappeared after reintroduction

(Sr. No. in continuation to listed above)
1. » Yes    No    Unknown    NA    If reintroduced, dose  

2. » Yes    No    Unknown    NA    If reintroduced, dose  

3. » Yes    No    Unknown    NA    If reintroduced, dose  

4. » Yes    No    Unknown    NA    If reintroduced, dose  

Concomitant medicinal product including self-medication and herbal remedies with therapy dates (excluding those used to treat reaction)
Relevant tests / laboratory data with dates
Please mention other relevant history including pre-existing medical conditions (e.g. allergies, race, pregnancy, smoking, alcohol use, hepatic/renal dysfunction, etc.)
If the patient is a female, whether pregnant?
Yes    No
If 'Yes',   
   

Seriousness of the reaction
Death  

Congenital Anomaly
Life Threatening
Persistent or Significant
Hospitalization - Initial or Prolonged
Disability or Incapacity
Required intervention to prevent permanent impairment / damage
Other  

Outcomes
Fatal
Recovering
Unknown
Continuing
Recovered
Other  

D. Reporter
Name of Reporter

Professional Address

PIN Code

Email address

Tel. No. (with STD code)

Occupation

Causality Assessment

Date of this report (dd/mm/yyyy)

NOTE: PLEASE DO NOT LEAVE ANY FIELD BLANK. STRIKE OUT WHERE INFORMATION IS ‘NOT AVAILABLE’ OR ‘NOT APPLICABLE’

Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. The pharmacovigilance staff at INTAS is not expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.