Document

QATAR PHARMACEUTICAL INDUSTRIES CO	QPI-PV Report No:	(for QPI use only)
	Health Care Providers Adverse Event Reporting Form
Report type Initial Follow-up Enter the reference No:

1.Suspect Drug Details
Suspected Drug:	Indications:	Start date
Total daily dose/route	Batch number:	Stop date
2.Second Suspect Drug Details (if relevant)
Suspected Drug:	Indications:	Start date
Total daily dose/route	Batch number:	Stop date

3.Reporter
Name:	Profession
Institution/ Hospital:	Address:
Tel:	Fax:	Email:

4.Patient Information
Patient Initials:	Gender F M	Date of Birth	Age:
Height cm	Weight kg	Pregnancy No Yes If yes, pregnancy week:

5.Description of adverse drug reaction(s)
	Date of onset Resolved date Causality: Related Unrelated Unknown Did the reaction reappear after reintroduction of drug? Yes No Unknown Not applicable
	Date of onset Resolved date Causality: Related Unrelated Unknown Did the reaction reappear after reintroduction of drug? Yes No Unknown Not applicable

6.Action Taken with suspect drug
Product discontinued due to AE Dose increased No change Dose decreased Other (please specify):

7.Outcome of ADR:
Fully Recovered Date* Recovered with sequelae Date* Ongoing Improved, but not yet recovered Date* Death Date* Autopsy: Yes No Unknown *Sequelae: a morbid condition following or occurring as a consequence of another condition or event

8. Seriousness: Was the event serious or non-serious? (please indicate below)
Non-serious Serious Death Hospitalization/Prolonged hospitalization Disability Life threatening Congenital anomaly Other medically important condition Other (specify):

9. Relevant Medical History (Concomitant disease(s): Diabetes, Hypertension…. etc.)
1- 2- 3- 4- 5-

10 Relevant Concomitant drug(s)	Dose	Frequency	Route
1-
2-
3-
4-
5-

11. Relevant tests/ laboratory data with dates

ADVICE ABOUT REPORTING

A. What to report

Report serious adverse drug reactions. A reaction is serious when the patient outcome is:
- Death
- Life-threatening
- Hospitalization (initial or prolonged)
- Disability (significant, persistent or permanent)
- Congenital anomaly
- Required intervention to prevent permanent impairment or damage
Report non-serious, known or unknown, frequent or rare adverse drug reactions due to any QPI related products.

B. Who can report

All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) and consumer can report adverse drug reactions

C. Where to report

Please submit the duly filled Suspected Adverse Drug Reaction Reporting Form on the website www.qpi-qa.com under the Pharmacovigilance section to ensure proper documentation and reporting of the adverse event.
Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the MOPH or QPI.
Call on Helpline (+974)-33811461 to report ADRs.
Or can directly mail this filled form to “pharmacovigilance@qpi-qa.com”

D. What happens to the submitted information

Information provided in this form is handled in strict confidence. The causality assessment is carried out at QPI by using WHO-UMC scale. The analyzed forms are forwarded to the MOPH.

E. Mandatory field for suspected ADR reporting form

Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected medication(s) and reporter information

For ADRs Reporting Call on QPIPV Helpline

(+974)-33811461

(9:00 AM to 5:00 PM, (Sat - Thursday) Working Days)