Scribd
Upload
93 views2 pages

Pharmacovigilance Report

The document is a Pharmacovigilance Report Form designed to collect detailed patient information, case narratives, adverse drug reactions, suspected medications, concomitant medications, medical history, and reporter information. It includes sections for documenting the patient's demographics, the nature and outcome of adverse reactions, and actions taken in response to those reactions. The form emphasizes the importance of capturing comprehensive data for effective pharmacovigilance.

Uploaded by

bahaa mousa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
93 views2 pages

Pharmacovigilance Report

The document is a Pharmacovigilance Report Form designed to collect detailed patient information, case narratives, adverse drug reactions, suspected medications, concomitant medications, medical history, and reporter information. It includes sections for documenting the patient's demographics, the nature and outcome of adverse reactions, and actions taken in response to those reactions. The form emphasizes the importance of capturing comprehensive data for effective pharmacovigilance.

Uploaded by

bahaa mousa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 2

Pharmacovigilance Report Form

1.Patient information **
Patient Initials: Male
Female pregnant which trimester/week?......
patient phone no : Lactating

File no ( JUH patient ) : Age at onset of reaction: Date of Birth : / /


‫رقم ملف المريض في مستشفى الجامعة‬ OR Age : ………….. years
2.Case narrative ( use patient’s words ) // ( Arabic / English )**

3.Adverse drug reaction **


Reactions / event:

Date of Reaction onset :


Duration of Reaction :
Is the ADR serious : Yes No
If yes , specify : Results in death / Date of death ……………
Disabling / incapacitating
Congenital anomaly / birth defect
Life threatening
Caused / prolonged hospitalization
Other medically important condition…………………………………………………...

Outcome of ADR:
Recovered / Resolved
Recovering/ Resolving
Not recovered /Not resolved/Ongoing
Recovered / Resolved with sequelae
Fatal
Unknown
Action taken to treat ADR:
Medical treatment (please, specify): …………………………………………………………………………………………
Drug stopped
Dose changed (increased / reduced)
None
Tests and Procedures: (tests and procedures performed to confirm the reaction/event)

Page 1|2
Pharmacovigilance Report Form

4. Suspected Medication **
Drug name Generic name Dose + Start date Stop date Indication
(Brand/trade ) + strength of Frequency
the active
ingredient(s) + Route

Did reaction(s) disappear after stopping the drug? Yes NO Unknown


Did reaction(s) reappear after reintroduction? Yes NO Unknown
5.Concomitant Medication (s)
Drug name Generic name Dose + Start date Stop date Indication
(Brand/trade ) + strength of Frequency
the active
ingredient(s) + Route

6. Medical history : ( diagnosis, allergies, smoking, hepatic /renal dysfunction etc. )


Condition Onset ( D/M/Year) Details Present (Y/N)

7.Additional information / Notes

8. Reporter information**
Reporter Name: (student (Full name + no)): Email address OR Telephone no. :

Date of Report:

** Must be filled

Page 2|2

You might also like