Page 81 - e-book CPG - Bipolar Disorder

CLINICAL PRACTICE GUIDELINES MANAGEMENT OF BIPOLAR DISORDER (2ND ED.)

ANNUAL RISK ACKNOWLEDGEMENT FORM
PART B. TO BE COMPLETED BY THE PRESCRIBER AND SIGNED
ANNUAL RISK ACKNOWLEDGEMENT FORM
BY THE PATIENT OR CAREGIVER
PART B. TO BE COMPLETED BY THE PRESCRIBER AND SIGNED

BY THE PATIENT OR CAREGIVER
Patients name :______________________
MRN/IC No. :______________________
Patients name :______________________
Address :______________________
MRN/IC No. :______________________
Address :______________________
For girls and women of childbearing age treated with Sodium Valproate < Product Name

>. Please read, complete and sign this form during a visit with the prescriber: at treatment
For girls and women of childbearing age treated with Sodium Valproate < Product Name
initiation, during annual visit and when the woman plans pregnancy or is pregnant.
>. Please read, complete and sign this form during a visit with the prescriber: at treatment
initiation, during annual visit and when the woman plans pregnancy or is pregnant.
I discussed the following with my doctor and understand

o Why I need sodium valproate rather than other medicine.
I discussed the following with my doctor and understand
o I have decided to continue with the treatment after being advised of the risk.
o Why I need sodium valproate rather than other medicine.
o That I should visit the prescriber regularly (at least annually) to review whether sodium
o I have decided to continue with the treatment after being advised of the risk.
valproate treatment remains the best option for me.
o That I should visit the prescriber regularly (at least annually) to review whether sodium
o The overall risk to fetus and children whose mothers took sodium valproate during
valproate treatment remains the best option for me.
pregnancy are :
o The overall risk to fetus and children whose mothers took sodium valproate during
 an approximately 10% chance of birth defects
pregnancy are :
 up to 30 to 40 % chance of a wide range of early developmental problems that can
 an approximately 10% chance of birth defects
lead to significant learning difficulties
 up to 30 to 40 % chance of a wide range of early developmental problems that can
o Why I need a negative pregnancy test at testament initiation and if needed thereafter (if
lead to significant learning difficulties
childbearing age).
o Why I need a negative pregnancy test at testament initiation and if needed thereafter (if
o That I must use effective contraception without interruption during the entire duration of
childbearing age).
my treatment with sodium valproate (if childbearing age).
o That I must use effective contraception without interruption during the entire duration of
o We discussed the possibilities of effective contraception or we planned a consultation
my treatment with sodium valproate (if childbearing age).
with a professional who is experienced in advising on effective contraception.
o We discussed the possibilities of effective contraception or we planned a consultation
o The need for regular ( at least annually) review and the need to continue sodium
with a professional who is experienced in advising on effective contraception.
valproate treatment by the prescriber.
o The need for regular ( at least annually) review and the need to continue sodium
o The need to consult my doctor as soon as I am planning to become pregnant to ensure
valproate treatment by the prescriber.
timely discussion and switching to alternative treatment options prior to conception, and
o The need to consult my doctor as soon as I am planning to become pregnant to ensure
before conception is discontinued.
timely discussion and switching to alternative treatment options prior to conception, and
o That I should request an urgent appointment if I think I am pregnant.
before conception is discontinued.
In case of a pregnancy I have discussed the following with my doctor and understand:
o That I should request an urgent appointment if I think I am pregnant.
 the possibilities of pregnancy support or counseling
In case of a pregnancy I have discussed the following with my doctor and understand:
 the need to appropriate monitoring of my baby if I am pregnant.
 the possibilities of pregnancy support or counseling
 the need to appropriate monitoring of my baby if I am pregnant.
Name of Patient/Caregiver:_________________Signature __________Date___________

Name of Prescriber :_________________Signature __________Date___________
Name of Patient/Caregiver:_________________Signature __________Date___________
Name of Prescriber :_________________Signature __________Date___________
Part B shall be completed.. all boxes shall be ticked, and the form signed by the prescriber and the

patient. This is to make sure that all the risks and information related to the use of sodium valproate
Part B shall be completed.. all boxes shall be ticked, and the form signed by the prescriber and the
during pregnancy have been understood.
patient. This is to make sure that all the risks and information related to the use of sodium valproate
Part B - to be given to the patient
during pregnancy have been understood.
- a copy kept by the prescriber
Part B - to be given to the patient

- a copy kept by the prescriber

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