Advice about Reporting:

 Report adverse experiences with medications

 Report serious adverse reactions. A reaction is serious when the patient outcome is:
o death o disability (significant, persistent or permanent
o life-threatening (real risk of dying) o congenital anomaly
o hospitalization (initial or prolonged)
o required intervention to prevent permanent impairment or damage
 Report even if you’re not certain that the product caused adverse drug reaction
Who can report?
 Any healthcare professional (Doctors including Dentists, Nurses and Pharmacists)
Where to report?
 Please return the completed form to Pharmacovigilance Centre (PVC), Department of Pharmacy, Alkhidmat Hospital
Peshawar
What happens to the submitted information?
 Information provided in this form is handled in strict confidence. The causality assessment is carried out at the
Pharmacovigilance centre (PVC) ALKHIDMAT HEALTH FOUNDATION by using specific scale (recommended by WHO).
The analysed forms are forwarded to Drug regulatory authority of Pakistan (DRAP) and further reported to WHO ADR
monitoring centre.
 The reports are periodically reviewed by the Pharmacovigilance centre (PVC) ALKHIDMAT HEALTH FOUNDATION. The
information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of medicines.
 The information is submitted to the Pharmacy & Therapeutic Committee (P&TC) ALKHIDMAT HOSPITAL PESHAWAR.
The Committee is entrusted with the responsibility to review the data and suggest any interventions that may be required.

Date: Reporting Person & Designation:

Patient Name: MR No. Ward:

Gender: Age (Years): Weight (Kg):

Date of ADR: Suspected Drug(s):

Date of Recovery:

Analgesic Bronchodilator IV Solution Other (specify)

Antimicrobial Cardiovascular Laxative
Anticoagulant Contrast Media Narcotic
DRUG TYPE Anticonvulsant Corticosteroid Oxytocics
Antidepressant Diuretic Radionuclide
Antiemetic Immunization Sedative
Antihistamine Insulin Vasodilator
Antineoplastic Investigational Vasopressor

Description of Reaction: Seriousness of the Reaction:

Death
Life Threatening
Reaction Management: Prolonged Hospitalization
Disability
Congenital abnormality
Required intervention to prevent
Reaction severity: permanent impairment/damage
Fatal Recovering Unknown Other (specify)
Continuing Recovered
Other (specify) Type of ADR:
Augmented (A) Bizzare (B)
False Alarm (F) Hypersensitivity

Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not
expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not
constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

Reverse side to be completed by PVC-Pharmacist and to be returned to DPIC

 TO BE COMPLETED BY PVC (AKH PESHAWAR) PHARMACIST

Form No.: , Date: , Pharmacist:

Probability of the adverse drug reaction being due to the suspected drug*:

Yes No Do not Score

Know
1. Are there any conclusive reports on this reaction? +1 0 0

2. Did the adverse event appear after the suspected drug was +2 -1 0
administered?

3. Did the adverse reaction improve when the drug was +1 0 0

discontinued or a specific antagonist was administered?
4. Did the adverse reaction reappear when the drug was re- +2 -1 0
administered?
5. Are there alternative causes (other than the drug) that could -1 +2 0
on their own have caused the reaction?
6. Did the reaction reappear when placebo was given? -1 +1 0
7. Was the drug detected in the blood (or other fluids) in +1 0 0
concentrations known to be toxic?

8. Was the reaction more severe when the dose was increased +1 0 0
or less severe when the dose was decreased?

9. Did the patient have a similar reaction to the same or +1 0 0

similar drugs in any previous exposure?

10. Was the adverse event confirmed by any objective +1 0 0

evidence?
* Naranjo Algorithm
Total Score Circle One
Highly probable ≥9 Highly probable
Probable 5-8 Probable
Possible 1-4 Possible
Doubtful 0 Doubtful

FOR DRUG & POISON INFORMATION CENTRE (DPIC), AKH PESHAWAR

DPIC No. Pharmacist (Name, Sign and Stamp) DPIC Seal and Date