PSP/MRP Adverse Event* Report Form

PSP/MRP Adverse Event* Report Form
*Additional safety reports required by PV - overdose, abuse/misuse, drug dependency, lack of efficacy, pregnancy and/or breastfeeding exposure, paternal exposure, inadvertent/ accidental/occupational exposure, unexpected clinical benefit, medication errors (inc. near miss), off label use, drug-drug or drug-food interactions.
PROGRAM INFORMATION
Service Provider Case ID (To be completed by compliance team):
Date service provider was first notified of AE (DDMMMYYYY):*
REPORTER INFORMATION
Name*

First NameLast Name
Country:*
Email address:*
example@example.com
Telephone No.:

Area CodePhone Number
Fax No.:

Area CodePhone Number
Address:
Reporter State and Province:
Reporter type:*

PhysicianNursePharmacistOther Healthcare ProfessionalPatientOther
Permission to contact reporter for follow up?*

YesNo
Permission to contact HCP?*

YesNo
Please provide contact information (name, phone, address, email):*
Provider type:
PATIENT INFORMATION

PATIENT INFORMATION*

Rows	Patient Initials	Sex	Date of Birth (DDMMMYYYY)	Age	Units
1

SUSPECT DRUG INFORMATION*

Rows	Drug Name	Lot Number	Dose	Route of administration	Administration Start Date / Time (DDMMMYYYY)	Administration Stop Date / Time (DDMMMYYYY)	Indication	Action taken with Product
A
B
C
D
E
F
G

ADVERSE EVENT and/or OTHER SAFETY INFORMATION

Rows	Event Term	Event Start Date (DDMMMYYYY)	Event Stop Date (DDMMMYYYY)	Outcome	Event Seriousness (Non Serious or Serious Criteria)	Is the event related to the Baxter product?	To which Baxter drug (refer to table above)
1
2
3
4
5

ADVERSE EVENT and/or OTHER SAFETY INFORMATION
Date of death (DDMMMYYYY):
Cause of death:
Was an autopsy done?

YesNoUnknown
Was the patient treated with a drug due to the adverse events?*

Yes, please specify belowNoUnknown