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Adverse Drug Reaction
Adverse Drug Reaction (ADR) is any response to a drug which is noxious, unintended, and which occurs at doses normally used in man for preventive treatment, diagnosis or therapy of disease or for the modification of physiological function.

People vary in their individual responses to medications. Pre-approval testing with a limited number of subjects does not reveal all possible adverse side-effects of the medication being researched. Only when the new medication hits the market and millions of people use it, ADR becomes apparent.

If you suspect an adverse drug-related event, particularly if unusual, report it to us.

A. Patient Information
1. Name of patient:
2. Age at time of event:
3. Sex: Male Female
4. Weight: kgs.
5. Other relevant history, including pre-existing medical conditions (e.g., allergies, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
B. Adverse event or product problem
1. Adverse event and/or product problem (e.g. Defects/malfunctions):

2. Outcome attributed to adverse event (tick all that apply):

death If any allergy
life-threatening Did he/she require further medical treatment
hospitalisation - Immediate/prolonged disability
Other:
3. Date of event:

4. Date of this report:

C. Suspect medication (s)
1. Name (give labelled strength & mfr/label, if known): 1
2
Please send sample/label of suspect medicine

2. Dose frequency:

1
2
3.Therapy dates (if unknown, route used give duration) from/to (or best estimate): 1
2

4. (a) Diagnosis:

1
2

(b) Doctors reference doses:

Yes No doesn’t apply

5.(a) Event occurred after first (indication) dose: Yes No doesn’t apply

(b) Event occurred after many:

Yes No doesn’t apply

6. Batch/lot (if known):

1
2

7. Exp. date (if known):

1
2
8. Event eliminated after use stopped or dose reduced: Yes No doesn’t apply
9. Event reappeared after reintroduction: Yes No doesn’t apply

10. Other medicines given along with the above drug:

Your information:
Name:

Address:

PINcode:

Tel: (O)

(R)
Fax:
E-mail:
Membership No. (If any):
Health Professional?: Yes No
Your Occupation:

Describe event or problem:

Also reported to:
Doctor Manufacturer
Any other:
Has doctor given any advice?:
If you do not want your identity to be disclosed to the manufacturer, please tick this box
Consumer Education and Research Society
Tel.: 27489945-46 Fax: 27489947 Email: cerc@cercindia.org

 

 

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