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REPORTING FORM FOR SUSPECTED ADVERSE REACTIONS TO MEDICINES/COMPLEMENTARY PRODUCTS/ MEDICAL DEVICES
If you suspect an adverse event, please complete this form. Do not put off reporting because some details are not known. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the adverse reaction. Identity of the patient and or/the reporter is kept strictly confidential.
PATIENT INFORMATION
BHT / Prescription no. / Record no.
Email
Name / Initials
*
Address
Age
*
Weight - Kg
Gender
*
Male
Female
Ethnicity
SUSPECTED MEDICINE
Generic Name
*
Trade Name
Batch No
Expiry Date
Indication / Reason for use
*
Name of the manufacturer
*
Address of the manufacturer
Dose
*
Frequency
Route of administration
*
- Select Route -
Oral
IV
IM
SC
Topical
Other-specify
Therapy Dates
Date Begun
Date Stopped
OTHER MEDICINES TAKEN AT TIME OF REACTION WITH THERAPY DATES (EXCLUDE TREATMENT OF EVENT)
DETAILS OF THE ADVERSE REACTION
Date of onset of event
*
Date of this report
System involved
Resp
CVS
GIT
CNS
GUT
SKIN
OTHER (Specify)
Time deference between the last dose and the onset of reaction
Describe event
*
Lab investigations if any
Do you consider the reaction to be serious
*
Yes
No
If yes please tick why the outcome of the adverse event is serious
Death
Life threatning
Medicaly significant(Specify)
Death Date
Hospitalisation
Hospitalisation prolonged
Congeital abnomality
Birth defect(specify)
Disability
Permanent damage
Required intervention to prevent permanent damage
Result on discontinuation of suspect drug
Recovered
Improved
Disappeared
Persisted
Not Known
Alternative diagnosis
Result on reintroduction of drug Reappeared
Yes
No
Not Known
Risk factors present
Renal dysfunction
Cardiac dysfunction
Hepatic dysfunction
Previous Allergies
Smoking
Alcohol
Drug addict
Pregnant
Other
REPORTING DOCTOR/ PHARMACIST/ NURSE/DENTIST/ OTHER
Name
*
Designation
*
- Select Designation -
Doctor
Pharmacist
Nurse
Dentist
Patient
Address
Telephone Number
*
Institute
*
- Select Institute -
Government Hospitals
Private Hospitals
Pharmacy
Clinic
Ward No.
*
Room No.
*
Institute Name
*
Email
Date of reporting
Confirm & Submit
SUMMARY
PATIENT INFORMATION
BHT / Prescription no. / Record no.
:
Age
:
Email
:
Weight - Kg
:
Name / Initials
:
Gender
:
Address
:
Ethnicity
:
SUSPECTED MEDICINE
Generic Name
:
Address of the manufacturer
:
Trade Name
:
Dose
:
Batch No
:
Frequency
:
Expiry Date
:
Route of administration
:
Indication / Reason for use
:
Therapy Dates
Name of the manufacturer
:
Date Begun
:
/
Date Stopped
:
OTHER MEDICINES TAKEN AT TIME OF REACTION WITH THERAPY DATES (EXCLUDE TREATMENT OF EVENT)
DETAILS OF THE ADVERSE REACTION
Date of onset of event
:
Do you consider the reaction to be serious
:
Date of this report
:
If yes please tick why the outcome of the adverse event is serious
:
System involved
:
Result on discontinuation of suspect drug
:
Time deference between the last dose and the onset of reaction
:
Result on reintroduction of drug Reappeared
:
Describe event
:
Alternative diagnosis
:
Lab investigations if any
:
Risk factors present
:
REPORTING DOCTOR/ PHARMACIST/ NURSE/DENTIST/ OTHER
Name with Initial
:
Institute
:
Address
:
Ward No.
:
Room No.
:
Designation
:
Institute Name
:
Email
:
Telephone Number
:
Date of reporting
:
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:
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+94 11 2676498
+94 11 2676498
info@nmra.gov.lk
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011-2687743
info@nmra.gov.lk
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