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CLINICAL PRACTICE GUIDELINES MANAGEMENT OF BIPOLAR DISORDER (2ND ED.)
Appendix 10a
APPENDIX 10a
APPENDIX 10a
BPFK/PPP/07/25 (21) Jld 3 APPENDIX 10a
BPFK/PPP/07/25 (21) Jld 3
APPENDIX 10a
BPFK/PPP/07/25 (21) Jld 3
ANNUAL RISK ACKNOWLEDGEMENT FORM
ANNUAL RISK ACKNOWLEDGEMENT FORM
BPFK/PPP/07/25 (21) Jld 3
PART A. TO BE COMPLETED AND SIGNED BY THE PRESCRIBER
PART A. TO BE COMPLETED AND SIGNED BY THE PRESCRIBER
ANNUAL RISK ACKNOWLEDGEMENT FORM
Patients name :______________________
Patients name :______________________
ANNUAL RISK ACKNOWLEDGEMENT FORM
PART A. TO BE COMPLETED AND SIGNED BY THE PRESCRIBER
MRN/IC No. :______________________
MRN/IC No. :______________________
PART A. TO BE COMPLETED AND SIGNED BY THE PRESCRIBER
Patient’s name :______________________
:______________________
Address
:______________________
Address
Patient’s name :______________________
MRN/IC No. :______________________
MRN/IC No. :______________________
Address
:______________________
For girls and women of childbearing age treated with Sodium Valproate < Product Name
For girls and women of childbearing age treated with Sodium Valproate < Product Name
Address :______________________
>. Please read, complete and sign this form during a visit with the prescriber: at treatment
>. 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.
initiation, during annual visit and when the woman plans pregnancy or is pregnant.
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
>. 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.
Name of patients or care-giver:_________________________________________________
Name of patients or care-giver:_________________________________________________
initiation, during annual visit and when the woman plans pregnancy or is pregnant.
I confirm the above-named patient needs sodium valproate because:
I confirm the above-named patient needs sodium valproate because:
Name of patient or care-giver:_________________________________________________
o this patient does not respond adequately to other treatments, or
o this patient does not respond adequately to other treatments, or
Name of patient or care-giver:_________________________________________________
I confirm the above-named patient needs sodium valproate because:
o this patient does not tolerate other treatments,
o this patient does not tolerate other treatments,
I confirm the above-named patient needs sodium valproate because:
o this patient does not respond adequately to other treatments, or
o that this patient is stable on .......... dose and she is reluctant to change to other,
o that this patient is stable on .......... dose and she is reluctant to change to other,
o this patient does not respond adequately to other treatments, or
o this patient does not tolerate other treatments,
o Other reasons.........................................................................(to specify)
o Other reasons.........................................................................(to specify)
o this patient does not tolerate other treatments,
o that this patient is stable on .......... dose and she is reluctant to change to other,
o that this patient is stable on .......... dose and she is reluctant to change to other,
o Other reasons.........................................................................(to specify)
I have discussed the following information with the above-named patient or caregiver:
I have discussed the following information with the above-named patient or caregiver:
o Other reasons.........................................................................(to specify)
o The overall risk to fetus and children whose mothers are exposed to sodium valproate
o The overall risk to fetus and children whose mothers are exposed to sodium valproate
I have discussed the following information with the above-named patient or caregiver:
during pregnancy are :
during pregnancy are :
I have discussed the following information with the above-named patient or caregiver:
o The overall risk to fetus and children whose mothers are exposed to sodium valproate
approximately 10% chance of birth defects and
approximately 10% chance of birth defects and
o The overall risk to fetus and children whose mothers are exposed to sodium valproate
during pregnancy are :
up to 30% to 40%, chance of a wide range of early developmental problems that can
up to 30% to 40%, chance of a wide range of early developmental problems that can
during pregnancy are :
approximately 10% chance of birth defects and
lead to learning difficulties.
lead to learning difficulties.
approximately 10% chance of birth defects and
up to 30% to 40%, chance of a wide range of early developmental problems that can
o Sodium valproate should not be use in pregnancy (except in rare situations such as
o Sodium valproate should not be use in pregnancy (except in rare situations such as
up to 30% to 40%, chance of a wide range of early developmental problems that can
lead to learning difficulties.
epileptic
epileptic
o Sodium valproate should not
lead to learning difficulties. be used in pregnancy (except in rare situations such as
o patients that are resistant or intolerant to other treatments)
o patients that are resistant or intolerant to other treatments)
o Sodium valproate should not be used in pregnancy (except in rare situations such as
epilepsy)
o The need for regular (at least annually) review and the need to continue sodium valproate
o The need for regular (at least annually) review and the need to continue sodium valproate
epilepsy)
o Patients who are resistant or intolerant to other treatments
treatment by the prescriber
treatment by the prescriber
o Patients who are resistant or intolerant to other treatments
o The need for regular (at least annually) review and the need to continue sodium valproate
o The need for a negative pregnancy test at treatment initiation and as required there-after
o The need for a negative pregnancy test at treatment initiation and as required there-after
o The need for regular (at least annually) review and the need to continue sodium valproate
treatment by the prescriber
(if child-bearing age)
(if child-bearing age)
treatment by the prescriber
o The need for a negative pregnancy test at treatment initiation and as required there-after
o The need for an effective contraception without interruption during the entire duration of
o The need for an effective contraception without interruption during the entire duration of
o The need for a negative pregnancy test at treatment initiation and as required there-after
(if child-bearing age)
sodium valproate (if childbearing age).
sodium valproate (if childbearing age).
(if child-bearing age)
o The need for an effective contraception without interruption during the entire duration of
o To need to arrange an appointment with her doctor as soon as she is planning pregnancy
o To need to arrange an appointment with her doctor as soon as she is planning pregnancy
o The need for an effective contraception without interruption during the entire duration of
sodium valproate (if childbearing age).
to ensure timely discussion and switching to alternative treatment options prior to
to ensure timely discussion and switching to alternative treatment options prior to
sodium valproate (if childbearing age).
o To need to arrange an appointment with her doctor as soon as she is planning pregnancy
conception, and before contraception is discontinued.
conception, and before contraception is discontinued.
o To need to arrange an appointment with her doctor as soon as she is planning pregnancy
to ensure timely discussion and switching to alternative treatment options prior to
o The need to contact her doctor immediately for an urgent review of the treatment in case
o The need to contact her doctor immediately for an urgent review of the treatment in case
to ensure timely discussion and switching to alternative treatment options prior to
conception, and before contraception is discontinued.
of suspected or inadvertent pregnancy
of suspected or inadvertent pregnancy
conception, and before contraception is discontinued.
o The need to contact her doctor immediately for an urgent review of the treatment in case
In case of pregnancy , I confirm that this patient:
In case of pregnancy , I confirm that this patient:
o The need to contact her doctor immediately for an urgent review of the treatment in case
of suspected or inadvertent pregnancy
received the lowest possible effective dose of sodium valproate to minimise the possible
received the lowest possible effective dose of sodium valproate to minimise the possible
of suspected or inadvertent pregnancy
In case of pregnancy , I confirm that this patient:
harmful effect on the unborn
harmful effect on the unborn
In case of pregnancy , I confirm that this patient:
receives the lowest possible effective dose of sodium valproate to minimise the possible
is informed about the possibilities of pregnancy support or counselling and appropriate
is informed about the possibilities of pregnancy support or counselling and appropriate
receives the lowest possible effective dose of sodium valproate to minimise the possible
harmful effect on the unborn
monitoring of her baby if she is pregnant
monitoring of her baby if she is pregnant
harmful effect on the unborn
is informed about the possibilities of pregnancy support or counselling and appropriate
is informed about the possibilities of pregnancy support or counselling and appropriate
monitoring of her baby if she is pregnant
Name of Prescriber :_________________Signature__________Date___________
Name of Prescriber :_________________Signature__________Date___________
monitoring of her baby if she is pregnant
Name of Prescriber :_________________Signature__________Date___________
Part A and B shall be completed.. all boxes shall be ticked, and the form signed by the prescriber. This
Part A and B shall be completed.. all boxes shall be ticked, and the form signed by the prescriber. This
Name of Prescriber :_________________Signature__________Date___________
is to make sure that all the risks and information related to the use of sodium valproate during pregnancy
is to make sure that all the risks and information related to the use of sodium valproate during pregnancy
Part A and B shall be completed. All boxes shall be ticked, and the form signed by the prescriber. This
have been understood.
have been understood.
Part A and B shall be completed. All boxes shall be ticked, and the form signed by the prescriber. This
is to make sure that all the risks and information related to the use of sodium valproate during pregnancy
Part A - to be kept by the prescriber
Part A - to be kept by the prescriber
is to make sure that all the risks and information related to the use of sodium valproate during pregnancy
have been understood.
have been understood.
Part A - to be kept by the prescriber
Part A - to be kept by the prescriber
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