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- 02 Nov 2016, 14:35
#1844
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ADR Form should have at least four sections which should be completed:
1. Patient information:
- patient identifier
- age at time of event or date of birth
- gender
- weight
2. Adverse event or product problem:
- description of event or problem
- date of event
- date of this report
- relevant tests/laboratory data (if available)
- other relevant patient information/history
- outcomes attributed to adverse event
3. Suspected medication (s):
- name (Generic and brand name)
- dose, frequency & route used
- therapy date
- diagnosis for use
- event abated after use stopped or dose reduced
- batch number
- expiration date
- event reappeared after reintroduction of the treatment
- concomitant medical products and therapy dates
4. Reporter:
- name, address and telephone number
- speciality and occupation
The completed ADR Report Form should be sent to the national or regional ADR centre or to the manufacturer of the suspected product.
1. Patient information:
- patient identifier
- age at time of event or date of birth
- gender
- weight
2. Adverse event or product problem:
- description of event or problem
- date of event
- date of this report
- relevant tests/laboratory data (if available)
- other relevant patient information/history
- outcomes attributed to adverse event
3. Suspected medication (s):
- name (Generic and brand name)
- dose, frequency & route used
- therapy date
- diagnosis for use
- event abated after use stopped or dose reduced
- batch number
- expiration date
- event reappeared after reintroduction of the treatment
- concomitant medical products and therapy dates
4. Reporter:
- name, address and telephone number
- speciality and occupation
The completed ADR Report Form should be sent to the national or regional ADR centre or to the manufacturer of the suspected product.
Attachments:
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- By Swathi Swaroopa B