ANNEX 1: FORM FOR ADRs reported in written form
RECEIPT DATE
TIME OF RECEIPT
PATIENT INFORMATION
Sex:
Initials:
Duration:
Age:
Suspect medicine
Indication:
Product Name:
Daily Dose:
Route of administration:
Duration of administration:
CLASSIFICATION OF REPORT:
 Pregnancy
 Off label use
 Lactation
 Drug/food product interaction
 Lack of efficacy
 Falsified (counterfeit) product
 Overdose
 Unexpected therapeutic benefit
 Medication error
 Occupational exposure `
 Misuse
 Quality Defect
 Abuse
 Other…………………………………..
CONCOMITTANT MEDICATION
Product Name:
Daily Dose:
Route of administration:
Duration of administration:
MEDICAL HISTORY
OUTCOME of reaction
Stopped
 Non-Serious
 Reduced dose
 Treatment continues
 Unknown
 Serious
If serious please thick off seriousness
criteria:
 Hospitalization
 prolongation of hospitalization
 recovered without sequelae
 ADRs was treated
 ADR is not treated
 life-threatening condition
 healed with consequences
 congenital anomalies
 treatment of ADRs continues
 significant / permanent disability
 unknown
 other medical significance / requiring
intervention
 death-date
 none of the above
REPORTER
Physician/Name:
Tel:
Assistant:
Other (specify):
E-mail:
MEDICINAL PRODUCT:
MA NUMBER:
BATCH NUMBER:
DESCRIPTION OF ADRs
Name of contact person: ______________________________________________
Signature
ANNEX 2: FORM FOR ADRs reported by phone, fax, OR ANSWERING machine
FORM FOR REPORTING ADRs RECEIVED BY PHONE
PATIENT INFORMATION
Sex:
Initials:
Duration:
Age:
Suspect medicine
Indication:
Product Name:
Daily Dose:
Route of administration:
Duration of administration:
CLASSIFICATION OF REPORT:
 Pregnancy
 Off label use
 Lactation
 Drug/food product interaction
 Lack of efficacy
 Falsified (counterfeit) product
 Overdose
 Unexpected therapeutic benefit
 Medication error
 Occupational exposure `
 Misuse
 Quality Defect
 Abuse
 Other…………………………………..
CONCOMITTANT MEDICATION
Product Name:
Daily Dose:
Route of administration:
Duration of administration:
MEDICAL HISTORY
OUTCOME of reaction
Stopped
 Non-Serious
 Reduced dose
 Treatment continues
 Unknown
 Serious
If serious please thick off seriousness
criteria:
 Hospitalization
 recovered without sequelae
 ADRs was treated
 ADR is not treated
 prolongation of hospitalization
 healed with consequences
 life-threatening condition
 treatment of ADRs continues
 congenital anomalies
 unknown
 significant / permanent disability
 death-date
 other medical significance / requiring
intervention
 none of the above
Product:
MA Number:
Batch:
Contact person :
Patient _______Physician _______Assistant ________
Others________________Specify:________________________________________________
Date/Hour:
Report:
Necessary follow-up
Signature
:
Name: