Med-F-020 Adverse Drug Reaction Reporting Form

NORTHWEST GENERAL HOSPITAL & RESEARCH CENTRE
A Project of Alliance Healthcare Limited
SUSPECTED ADVERSE DRUG REACTION REPORTING FORM
Version 01 DOCUMENT Reference Number# NWGH/MED/F-020/23 ISSUE DATE: 01-06-2023
Department of Pharmacy
Form No: _____________ Date: _____________
A. Patient Details:
Date: Patient Name: Patient Registration Number:

Age: Gender M/F: If female pregnant or not Weight: Ward: Date of ADR:
Date of Recovery Any Known Allergy:
Drug/Vaccine/Alternative Batch No Manufacturer Route of Dosage & Strength Start Date Stop Date Prescribed For
Medicine (Brand Name & Generic Name) /importer Administration &
Daily Doses
B. Suspected Drug(s)/Vaccine(s)/Alternative Medicines(s) (use additional page if necessary):

C. Suspected Reaction(s) (use additional page if necessary):
1. When reaction started (DD/MM/YY):______________________ 2. When recovery started (DD/MM/YY):______________________
3. Describe the reaction (use additional page if necessary) 6. Do you consider the reaction(s) to be serious? Yes / No
If yes, please tick all that apply of the following
Death
Life Threatening
Prolonged Hospitalization
Disability
Congenital abnormality
Other (specify)___________________________________________________
7. Reaction abated after use stopped or dose reduced?
Yes No Doesn’t apply
4. Other relevant history of the patient (Allergies, Smoking, Alcohol Use, 8. Reaction reappeared after reintroduction?
Hepatic /Renal Problems, and Pre-Existing Medical Problems etc. Yes No Doesn’t apply
9. Outcomes:
5. Relevant tests/Laboratory data with dates: (use additional page if necessary) Fatal Recovering Unknown Continuing Recovered
Other _______________________________________________
10. You consider the problem related to which of the following:
Quality Problem Medication Error Adverse Event/Reaction
If other, please specify__________________________________

Drug/Vaccine/Alternative Batch No Manufacturer Route of Dosage & Strength Start Date Stop Date Prescribed For
Medicine (Brand Name & Generic Name) /importer Administration &
Daily Doses
D. Other concomitant drug(s)/Vaccine(s)/Alternative medicine(s) (use additional pages if necessary):
E. Suspected Medical Device(S) fill this area for suspected Device only (use additional pages if necessary):
Medical Device (Common Lot No/Batch Manufacture Model No Unique Serial No If Implanted If Explanted
Name/Brand Name) No r Identifier No enter date enter date
/importer
1
F. Reporter Details:
Name : ______________________________ Designation : ________________________ Date of the report :________________
Cell No/Extension No : _____________________ Email Address :___________________________ Signature: _______________________
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GUIDELINES FOR ADVERSE DRUG REACTION (ADR) REPORTING
“ADVERSE DRUG REACTION (ADR) REPORTING IS ETHICAL AND MORAL DUTY OF HEALTH CARE PROFESSIONALS”
What is Adverse Drug Reaction (ADR)?

“A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or
therapy of disease, or for the modifications of physiological function”
Who can report ADR?
Physicians, Pharmacists, Nurses, and allied health staff can report.
Is there a time frame of reporting ADR?
Yes ADRs should be reported within 48 hrs of identification.
What happens to the submitted information?
The information is submitted to the Pharmacy Therapeutics Committee (P & TC). The committee is entrusted with responsibility to review the
data and suggest any intervention that may be required.
Please use this form for reporting:
 Suspected Adverse Drug Reactions for ALL MEDICINES
 Suspected Adverse Drug Reactions for NEW MEDICINES
 Suspected Adverse Drug Reactions for ALL VACCINES
 Serious* Suspected Adverse Drug Reactions for ALL UNREGISTERED MEDICINES
 Serious* Suspected Adverse Drug Reactions for ALL ALTERNATE REMEDIES used in Homeopathic/Herbal/Unani/Ayurvedic
Treatment
Reactions which are fatal, life threatening, disabling or incapacitating, result in or prolong hospitalization, congenital anomaly or birth defect
and other serious medically important conditions are considered serious.
Health care professionals shall comment on the causal relationship of each suspected drug/vaccines/alternative medicine with each reaction as
per World Health Organization (WHO) causality assessment scale which comprises of the following six categories, namely:
i. Certain ii. Probable iii. Possible iv. Unlikely v. Unclassified vi. Unclassifiable
For the Greater Good & in Public Interest, Please Report ADRs to Pharmacy Department even if you are unsure
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NORTHWEST GENERAL HOSPITAL & RESEARCH CENTRE

A Project of Alliance Healthcare Limited

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

Version 01 DOCUMENT Reference Number# NWGH/MED/F-020/23 ISSUE DATE: 01-06-2023

Date: Patient Name: Patient Registration Number:

Date of Recovery Any Known Allergy:

B. Suspected Drug(s)/Vaccine(s)/Alternative Medicines(s) (use additional page if necessary):

If other, please specify__________________________________

D. Other concomitant drug(s)/Vaccine(s)/Alternative medicine(s) (use additional pages if necessary):

Cell No/Extension No : _______ Email Address :_ Signature: ___________

What is Adverse Drug Reaction (ADR)?

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