1. Patient/consumer identification (please complete or tick boxes below as appropriate)

Complete Address

2. Description of the suspected Adverse Reactions

Date and time of initial observation

Description of reaction

3. Whether the patient is suffering with any chronic disorders?
HepaticRenalCardiacDiabetesAny Other

Specify, if others


4. Addictions, if any? If yes, please specify

5. H/O previous allergies / Drug reactions, if any

6. Name of all ASU & H drugs used by the patient during the period of one month

7. Name of other drugs used by the patient during the period of one month

8. Details of the drug suspected to cause ADR

g. Any other relevant information associated with drug use:

9. Management provided / taken for suspected adverse reaction

10. Please indicate outcome of the suspected adverse reaction (tick appropriate)

Severe:
---yesNo

Was the patient admitted to the hospital? If yes, give the name and address of the hospital

11. Any abnormal findings of relevant laboratory investigations related to the episode done pre and post-episode of ADR

12. The ADR Probability Scale
(Program Coordinator has to fill this scale)

a. Are there previous conclusive reports on the reactions?
---Yes +1No 0Don't Know 0

b. Did the ADR appear after the suspected drug was administered?
---Yes +2No -1Don't Know 0

c. Did the ADR improve when the drug was discontinued a specific antagonist was administered?
---Yes +1No 0Don't Know 0

d. Did the adverse reaction reappear when the drug was re-administered?
---Yes +2No -1Don't Know 0

e. Are there alternatives causes that could solely have caused the ADR?
---Yes -1No +2Don't Know 0

f. Was the drug detected in the blood (or other fluids) in a concentration known to be toxic?
---Yes +1No 0Don't Know 0

g. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?
---Yes +1No 0Don't Know 0

h. Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
---Yes +1No 0Don't Know 0

i. Was the adverse event confirmed by objective evidence?
---Yes +1No 0Don't Know 0

Calculate and Fill Total Score

13.The Suspected Adverse Event
Level
---Grade - 1 (Mild)Grade - 2 (Moderate)Grade - 3 (Severe)Grade - 4 (Threatening)
Type
---SeriousNon-Serious
The Suspected Adverse Event is due to :
---PhysicianPatientDrugOther factors*

Other Factors, If any:

14. Particulars of ADR Reporter
Please select
---PatientAttendantNurseDoctorPharmacistHealth workerDrug ManufacturerAny others

if any other, please specify

Name

Address

Email

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