(incorporating the pregnancy prevention programme)- v02 ... · 2.6 valproate shared care guidelines...

CNTW(C) 38 PPT-PGN-25

Pharmacological Therapy Policy Practice Guidance Note

Safe Prescribing of Valproate (incorporating the Pregnancy Prevention Programme)-V02

Date Issued

Issue 1–Aug18

Issue 2- Jul 19

Issue 3 – Nov 19

Planned Review

Aug 2021

PPT-PGN-25

Part of CNTW(C)38 Pharmacological Therapies Policy

Author/Designation Claire Thomas, Deputy Chief Pharmacist

Responsible Officer / Designation

Tim Donaldson, Trust Chief Pharmacist

3.5 Monitoring and follow-up

8

4 Dispensing Valproate

9

5 Further information

10

6 References

10

Section

Contents

Page No.

Introduction 1

2 Prescribing Valproate:

2.1 Baseline monitoring prior to commencing valproate

2.2 On-going valproate monitoring

2.3 Therapeutic Drug Monitoring of valproate levels

2.4 Side-effect monitoring

2.5 Drug-drug interactions

2.6 Valproate shared care guidelines

1

2

2

2

3

3 3 Congenital malformations and development disorders:

3.2 Prescribers checklist

3.2.1 Risk assessment

3.2.2 Capacity assessment

3.2.3 Information provision

3.2.4 Obtaining consent

3.2.5 Risk reduction strategies

3.2.6 H i g h l y Effective contraception

3.3 Patients who refuse information

3.4 Sharing information

4

5

5

5

5

6

7

7 8

CNTW(C) 38 PPT-PGN-25

Appendix – listed within practice guidance note

Document No:

Description

Appendix 1

Valproate in women of childbearing potential: Prescribers Checklist

Appendix 2

Valproate information booklet for healthcare professionals (Healthcare Professional’s Booklet)

Appendix 3

Valproate information booklet for patients (Patient’s Guide)

Appendix 4

Annual Risk Acknowledgement Form Patient/Specialist

Appendix 5

Valproate Patient’s Card

Appendix 6

Valproate Side Effect Rating Scale (VSERS)

NTW(C) 38 PPT-PGN-25

2 Cumbria Northumberland, Tyne and Wear NHS Foundation Trust PPT–PGN–25- Safe Prescribing of Valproate V02-Issue 3-Nov 19 Part of CNTW(C)38 Pharmacological Therapy Policy

1 Introduction

1.1 This Practice Guidance Note (PGN) provides step by step guidance and support for those healthcare professionals within Cumbria Northumberland, Tyne and Wear NHS Foundation Trust (the Trust/CNTW) wishing to prescribe valproate for either epilepsy/seizure control, mania or mood-stabilisation.

1.2 Valproate is available in the UK in three distinct forms; sodium valproate and

valproic acid (licensed for treatment of epilepsy) and semi-sodium valproate (licensed for treatment of acute mania).

1.3 Valproate (as sodium valproate) is unlicensed for use as a mood-stabiliser, but is

widely used in the UK for this indication. Further guidance on the use of unlicensed medications can be found in section 9, UHM-PGN-02 Prescribing Medicines.

1.4 To protect public health, the Medicines and Healthcare products Regulatory Agency

(MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands):

Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the Pregnancy Prevention Programme (PPP) and only if other treatments are ineffective or not tolerated, as judged by an experienced specialist.

These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.

Use of valproate in pregnancy is contraindicated for migraine and bipolar disorder and must only be considered for epilepsy if there is no suitable alternative treatment.

Specialists (consultant psychiatrists and neurologists) must book in review appointments at least annually with women and girls under the PPP and re-evaluate treatment as necessary.

Further requirements under the PPP can be found at section 3 Congenital malformation and development disorders.

2 Prescribing valproate

2.1 Baseline monitoring prior to commencing valproate

2.1.1 The following monitoring should be carried out and recorded in the Core Physical

Health Monitoring Record on RiO:

Allergies

Baseline Full Blood Count (FBC) plus bleeding time and coagulation tests

Liver Function Tests (LFTs) Weight/Body Mass Index/waist circumference where possible (an individual



should be referred to a dietitian if they have comorbidities such as diabetes, heart disease or a BMI of 35 or above)

For women of reproductive age, a plasma pregnancy test should be carried out prior to starting valproate (see Section 3, Congenital malformations and developmental disorders)

Side effect baseline (using the VSERS monitoring tool, Appendix 6)

2.2 On-going valproate monitoring

2.2.1 Valproate Summary of Product Characteristics (SPC) recommend frequent

monitoring of LFTs during the first 6 months of therapy, particularly for those at most risk (e.g. young children <3 years) or those with a prior history of liver disease. As with most antiepileptic drugs, increased liver enzymes are common, particularly at the beginning of therapy; they are also often transient. In any event weight/BMI, LFTs and FBCs (plus bleeding time and coagulation tests) should be repeated annually.

2.2.2 Amongst usual investigations, tests which reflect protein synthesis, particularly prothrombin rate, are most relevant. Confirmation of an abnormally low prothrombin rate, particularly in association with other biological abnormalities (significant decrease in fibrinogen and coagulation factors; increased bilirubin level and raised transaminases) requires cessation of valproate therapy.

2.2.3 Following each valproate review, it is good practice to make an entry in the progress

notes stating that the appropriate RIO documents have been updated. 2.2.4 There should be regular (for example at CPA review) monitoring of family planning

including the use of highly effective contraception, risks to pregnancy and plans to conceive a pregnancy. All healthcare staff must contact the specialist immediately if they suspect problems with contraception cover, or that the patient may be pregnant.

2.2.5 Women and girls should be reminded not to stop taking valproate without first discussing

it with their doctor. 2.3 Therapeutic Drug Monitoring of Valproate levels

2.3.1 The pharmacokinetics of valproate is complex, following a three compartment

model and showing protein-binding saturation. R e g u l a r p lasma level monitoring is generally considered of little use, other than where there is evidence of ineffectiveness or for confirming adherence to therapy. Many side effects of valproate appear to be dose-related (peak plasma-level related) and increase in frequency and severity when plasma levels are high; more frequent monitoring of plasma levels might be considered where problems exist despite good clinical management. Further guidance is available from pharmacy.

2.4 Side-effect monitoring

2.4.1 Patients should be asked if they are experiencing any side effects related to valproate at

each appointment. A formal assessment of side effects should be carried out annually. The Valproate Side Effect Rating Scale (VSERS) check list may be used for this purpose (Appendix 6).



2.4.2 Patients/carers should be aware of those symptoms that may indicate serious liver

damage and should be advised to seek immediate medical attention if they develop. The following may precede jaundice:

Non-specific symptoms, usually of sudden onset, such as:

o Asthenia (abnormal physical weakness or lack of strength) o Malaise o Anorexia o Lethargy (lack of energy or vigour) o Oedema o Drowsiness o Patients experiencing nausea, vomiting or acute abdominal pain should

have a prompt medical evaluation (including measurement of serum amylase) to exclude pancreatitis.

In patients with epilepsy; recurrence of seizures

2.4.3 Suspected adverse drug reactions of valproate should be reported via the Yellow

Card reporting scheme https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/

2.5 Drug-drug interactions 2.5.1 Prescribers must have a system for checking, identifying and acting on any concurrent

medications that may interact with valproate. It is good practice to check the BNF for interaction potential when a new medicine is commenced for a patient stabilised on valproate.

2.5.2 Valproate may potentiate the effect of other psychotropics such as antipsychotics, monoamine oxidase inhibitors, antidepressants and benzodiazepines; therefore, clinical monitoring is advised and the dosage of other psychotropics should be adjusted when appropriate.

2.5.3 In particular, a clinical study has suggested that adding olanzapine to valproate therapy

may significantly increase the risk of certain adverse events associated with olanzapine e.g. neutropenia, tremor, dry mouth, increased appetite and weight gain, speech disorder and somnolence. The two drugs may also have an additive detrimental effect on LFTs.

2.5.4 Prescribers should also be aware of valproate’s interaction with other

anticonvulsants (particularly carbamazepine and lamotrigine) and smoking. Further guidance on the effects of smoking can be found in Smoking Cessation and Psychotropic Drug Interactions V03-Iss2- Sep 17- HWB-PGN-02.1 - CNTW(O)13 (excluding clozapine)

2.6 Valproate shared care guidelines

2.6.1 The shared care status of valproate is ‘green’ in all CNTW localities. ‘Green’ drugs

are appropriate for prescribing by GPs

https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/

http://nww1.ntw.nhs.uk/services/?id=6133&p=5539&sp=5545




3 Congenital malformations and development disorders

3.1 In utero exposure to valproate is associated with serious adverse effects for the

developing child, including:

Congenital malformations. Affecting approximately 10% of cases, these

include; neural tube defects (spina bifida, anencephaly), facial dysmorphia and cardiac malformations.

Developmental disorders. Affecting approximately 30-40% of cases, these can

include an increased risk of autistic spectrum disorder (approximately three-fold increase in risk), childhood autism (approximately five-fold increase in risk) and delays in early development. There is evidence that children exposed to valproate in utero will go on to have a lower IQ than children exposed to other antiepileptic drugs.

3.2 Prescriber checklist and annual review

When valproate is prescribed for any female patient between menarche and

menopause, the Valproate in women of childbearing potential: Prescribers Checklist (Appendix 1) must be completed. The checklist should be completed for those who have already been stabilised on the drug and those patients newly started on valproate. Menarche is the time in a girl's life when menstruation first begins, the average age of menarche in the UK is around 13 years.

Additionally, the Annual Risk Acknowledgment Form (Appendix 4) must be completed and signed, with a copy provided to the patient parent/caregiver/responsible person and GP on each occasion.

The completed Prescribers Checklist and Annual Risk Acknowledgment Form must be

scanned and uploaded to the patient’s medical record as per guidance in Records-Keeping Standards PGN - V03 - Issue4 - May 18- RM-PGN-02 - CNTW(O)09

For female patients who have not yet reached menarche, or where the absence of risk

of pregnancy is permanent, the requirements of the PPP do not apply. It is imperative however that this decision is recorded using the Annual Risk Acknowledgement Form (Appendix 4) and communicated to the GP as above.

Where the absence of risk of pregnancy is subject to change (e.g. the patient is pre-menarchal) annual reviews must be undertaken. The patient or patient’s family/carers should be asked to contact the specialist immediately if the situation changes to allow the annual review to be brought forward.

The Prescribers Checklist (Appendix 1) combines the MHRA’s checklist

requirements along with CNTW-specific requirements.

Specialists must book in review appointments at least annually with women and girls under the PPP and re-evaluate treatment as necessary; notifying the patients GP.





Smaller pack sizes will be produced by manufacturers to encourage monthly prescribing.

When valproate is prescribed for a female patient of childbearing potential, it is the

responsibility of the prescriber to ensure she is provided with a Valproate Patient’s Card (Appendix 5), unless she confirms that she already has one. The prescriber must encourage the patient to read the card and enter her name and current date in the spaces provided.

A pan-college guidance document has been produced that seeks to provide practical

information and guidance, and sources of further support, for clinicians involved with valproate: it gathers data, where available, on best practice and summarises consensus opinion from seventeen national bodies across the UK. This document address women who might refuse to participate in the PPP, capacity and consent issues and those patients with intellectual difficulties. The document is available here

3.2.1 Risk assessment

Prescribers must read the Valproate information booklet for healthcare professionals (Healthcare Professional’s Booklet, Appendix 2).

Prescribers must always carefully balance the benefits of valproate treatment against the risks. Valproate should only be initiated or continued when other treatment options have been ineffective or have not been tolerated and pregnancy is excluded by means of a negative plasma pregnancy test.

3.2.2 Capacity assessment

Prescribers must ensure that the patient’s capacity to consent to treatment has been assessed and has been documented in their medical record (CNTW(C)05 Consent to Examination or Treatment Policy).

Specific guidance in relation to children, young people, adults who lack capacity and Best Interest decision making can be found in CNTW(C)05 Consent to Examination or Treatment Policy.

3.2.3 Information provision

Ensure the patient/parent/caregiver/responsible person understands the nature of the

PPP and requirement for strict adherence to allow continued prescribing of valproate.

It is the responsibility of the prescriber to ensure that the patient/parent/caregiver/responsible person is provided with all necessary information about the risk posed by valproate use during pregnancy. The MHRA recommend that this includes understanding the 30–40% risk of neurodevelopmental disorders and 10% risk of birth defects.

Prescribers must ensure that the patient/parent/caregiver/responsible person has

been provided with a copy of the Valproate information booklet for patients (Patient’s

https://www.rcgp.org.uk/about-us/news/2019/march/thirteen-uk-healthcare-bodies-launch-pragmatic-guidance-on-valproate-use.aspx



Guide, Appendix 3).

Prescribers must ensure that the patient/parent/caregiver/responsible person has been informed about the need for highly effective contraception and is prescribed such contraception or referred immediately to a specialist as required.

Prescribers must ensure that the patient/parent/caregiver/responsible person has

been informed to promptly contact them if she is planning a pregnancy or becomes pregnant. Specialists should see the patient urgently (within days) if referred back from healthcare colleagues due to concerns relating to effective contraception, unplanned pregnancy or plans for pregnancy.

The above information should be repeated at regular intervals, for example CPA reviews.

3.2.4 Obtaining consent

Prescribers should document capacity to consent to treatment with valproate,

specifically in women of reproductive age taking into account the potential risks in pregnancy.

Prescribers should ask the patient/carer/parent or responsible person to complete the

Annual Risk Acknowledgment Form – Part A at each annual review (Appendix 4)

The completed consent form must be scanned and uploaded to the patient’s medical record as per guidance in Records-Keeping Standards PGN - V03 - Issue4 - May 18- RM-PGN-02 - CNTW(O)09

3.2.5 Risk reduction strategies

Prescribers must ensure that a patient has had a negative plasma pregnancy test prior to starting valproate and must advise patients on the need for highly effective contraception.

Where there are reasons to suggest lack of compliance with contraception or reduced

effectiveness, the specialist should perform pregnancy testing as required

In the event that any healthcare staff suspect problems with contraception cover, or that

the patient may be pregnant they must contact the specialist immediately.

If a woman is planning to become pregnant, or becomes pregnant on valproate she must

be immediately referred to a specialist to consider alternative treatment options. The prescriber must make every effort to switch the patient to another treatment; where this is not possible the patient should be referred for counselling about the risks. Switching should be achieved prior to conception and before contraception is discontinued. Clear documentation in RiO of the risk vs. benefit in these circumstances is paramount. Further guidance can be found in the RCPsych Position Statement PS04/18 Withdrawal of, and alternatives to, valproate-containing medicines in girls and women of childbearing potential who have a psychiatric illness.

It is recommended that pregnant women taking antiepileptic drugs in general, and valproate in particular, are enrolled in the UK Epilepsy and Pregnancy Register (http://www.epilepsyandpregnancy.co.uk). This should be done as early as possible in





the pregnancy, before the outcome is known.

If, despite the known risks of valproate in pregnancy and after careful consideration of alternative treatment, in exceptional circumstances a pregnant woman must receive valproate for epilepsy:

o There is no dose threshold considered to be without any risk. However, the risk of birth defects and developmental disorders is higher at greater doses

o Use the lowest effective dose and divide the daily dose of valproate into several small doses to be taken throughout the day

o Prescribers must ensure that the patient is prescribed folic acid

The use of a prolonged release formulation may be preferable to other treatment

formulations in order to avoid high peak plasma concentrations

All patients with a valproate exposed pregnancy and their partners should be referred

to a specialist experienced in prenatal medicine.

3.2.6 H i g h l y Effective contraception

Highly effective contraception is considered for regulatory purposes to be those user independent methods such as the long acting reversible contraceptives (LARC), copper intrauterine device (Cu-IUD), levonorgestrel intrauterine system (LNG-IUS) and progestogen only implant (IMP) and female sterilisation, all of which have a failure rate of less than 1% with typical use. The progesterone-only injectable is reported to have a typical use failure rate of 6 pregnancies per 100 women per year of typical use compared to 0.2 pregnancies with perfect use (thought to be due to the 3 monthly requirement for re-injection and lack of compliance with this).

User dependent methods such as the condom, cap, diaphragm, combined oral contraceptive pill (COC) or progestogen-only contraceptive pill (POP) and fertility awareness based methods are not considered highly effective since the typical use incorporates user failure risks. If a user-independent form is not used, two complementary forms of contraception including a barrier method should be used and regular pregnancy testing considered.

Prescribers must discuss the following topics with patients/parent/caregiver/responsible person before valproate is first prescribed :

o Assess the most appropriate timing to provide advice on effective

contraception methods and refer your patient to a specialist if needed.

o Discuss highly effective methods of contraception that best suits the patient’s

individual needs and lifestyle, so making it more likely that they will use contraception and use it effectively.

o Consider NICE Guidance recommending long-acting contraception (which is of

particular benefit where the risks of an unplanned pregnancy are high).

o Ensure your patient understands the importance of using contraception throughout the duration of treatment to avoid unplanned pregnancy



o Advise your patient to contact you immediately if she thinks she might be

pregnant or becomes pregnant.

Further guidance on the full range of effective contraceptive methods to be offered can be obtained from NICE (Public Health guideline PH51: Contraceptives services for under 25s) and the Faculty of Sexual and Reproductive Healthcare guidelines (https://www.fsrh.org/standards-and-guidance/current-clinical-guidance/).

Although specific data are limited, drug-drug interactions between valproate and

contraceptive hormones are unlikely to result in any significant reduction in efficacy of the combined hormonal contraceptive (Baxter, 2017). However, valproate is metabolised by glucuronide conjugation, and therefore its levels may be reduced due to induction of glucuronosyltransferases by ethinylestradiol. (Baxter, 2017; FSRH, 2017)

3.3 Patients who refuse information

Occasionally patients may not wish to receive information when valproate is

prescribed, or they may not currently be receptive to such information. In these circumstances, serious consideration should be given to delaying valproate treatment until the patient is willing and able to accept information about the risks posed by the drug.

However, if the initiation of valproate is considered to be absolutely necessary, then the

prescriber must complete the following actions:

O Consider the need for highly effective contraception throughout treatment with valproate

o Complete as much of the Valproate in women of childbearing potential: Prescribers Checklist (Appendix 1) as possible at the current time, and add this to the patient’s medical record.

o Use the ‘Additional comments’ section of the checklist to make a note of the

information that the patient is currently refusing. o Ensure that another attempt to provide the information to the patient is made at the

earliest possible opportunity. o Make an entry in the patient’s medical record stating why it was not possible to

complete the full checklist, and why it was considered necessary to prescribe the medication despite this.

3.4 Sharing information

A copy of the completed Prescribers Checklist (Appendix 1) and Annua l R i sk Ackno wled gmen t Fo rm (Appendix 4) must be forwarded to the patient’s GP along with their discharge summary or clinic letter.

http://www.fsrh.org/standards-and-guidance/current-clinical-guidance/)

http://www.fsrh.org/standards-and-guidance/current-clinical-guidance/)



A copy of the Prescribers Checklist and Annual Risk Acknowledgment Form must be given to the patient/parent/caregiver/responsible person

The GP should be asked to remind the patient about valproate’s adverse effects at

every consultation in which medication is discussed and review contraception/pregnancy plans.

3.5 Monitoring and follow-up

At all routine treatment reviews, prescribers must ensure that the benefits of

valproate continue to outweigh the risks.

For inpatients, the Valproate in women of childbearing potential: Prescribers Checklist (Appendix 1) must be completed when:

o Valproate is first prescribed and for any newly admitted patients who take the

medication. The risks should be reemphasised to the patient when they first go on

leave, and when they are discharged.

o The Annual Risk Acknowledgment Form (Appendix 4) must be completed for any newly

admitted patient who takes valproate, unless it can be proven that this has already

been completed within the preceding twelve months. Where a form has already been

completed, the annual review date must be scheduled.

For outpatients, the Prescribers Checklist (Appendix 1) must be completed when valproate is

first prescribed and then at least once every 6 months. The Annual Risk Acknowledgment Form

(Appendix 4) is to be completed annually

4 Dispensing valproate

4.1 When valproate is dispensed by a CNTW pharmacy for a female patient of childbearing potential, it is the responsibility of pharmacy staff to ensure she is provided with a Valproate Patient’s Card (Appendix 5), unless she confirms that she already has one.

4.2 Pharmacy staff must encourage the patient to read the card and enter her name and

current date in the spaces provided. 4.3 Pharmacy to ensure that valproate medicines are dispensed in whole packs

wherever possible to ensure warning labels and/or stickers are always visible. Valproate medicines will be available with a detachable patient card from December 2018.

4.4 If the medication is ‘packed down’ from original containers during the dispensing

process, the pharmacy will ensure that a sticker is added and the following warning is added to the regular dispensing label:

‘Warning for women and girls: this medicines can seriously harm an unborn baby, always use effective contraception during treatment, if you are thinking about becoming pregnant, or you become pregnant, talk to your doctor



straight away.’

4.5 Where repackaging cannot be avoided pharmacy will always provide a copy of the

package insert

4.6 Pharmacy staff should discuss the risk of pregnancy with female patients each time

valproate medicines are dispensed and ensure they have a copy of the Patient Guide.

Further, pharmacy staff should ensure the patient has seen their GP or specialist to

discuss their treatment (reminding them of the need for an annual specialist review) and

the need for highly effective contraception.

4.7 If a women or girl of childbearing age reports that they are not taking effective

contraception, pharmacists should advise her to contact her GP or specialist for an urgent

follow-up (contact the GP or specialist directly if necessary)

5 Further information

5.1 Further information can be accessed online via the MHRA’s Guidance: Valproate use by women and girls:

The guidance includes links to printable versions of the communication

materials mentioned in this document:

Valproate information booklet for healthcare professionals

Valproate information booklet for patients

Valproate patient card

Hard copies of these materials can be ordered by contacting the Sanofi Medical Information Department on 0845 372 7101, or via e-mail UK- [email protected]

More detailed information about valproate can be obtained by consulting the most recent Summary of Product Characteristics (SPC), available online through the eMC website.

Details of organisations and support networks providing further information for patients and children about epilepsy or bipolar disorder can be found in Appendix 3, Patient Guide

6

References

Joint Formulary Committee. British National Formulary. [Online]. Available at

<http://www.medicinescomplete.com/> [Accessed 07/03/2017].

Baxter K (ed), Stockley’s Drug Interactions. 2017. [Online] London: Pharmaceutical

Press. Available at <http://www.medicinescomplete.com/> (Accessed 07/03/2017].

mailto:[email protected]

http://www.medicinescomplete.com/

http://www.medicinescomplete.com/



Medicines and Healthcare products Regulatory Agency (MHRA). Drug Safety

Guidance: Valproate use by women and girls [Online]. Available at

https://www.gov.uk/guidance/valproate-use-by-women-and-

girls#historyhttps://www.gov.uk/guidance/valproate-use-by-women-and-girls#history https://www.gov.uk/guidance/valproate-use-by-women-and-girls#history [Accessed 5/06/18)

05/06/201807/03/2017) Medicines and Healthcare products Regulatory Agency (MHRA) and NHS

Improvement. Patient Safety Alert: Resources to support the safety of girls and

women who are being treated with valproate (NHS/PSA/RE/2017/002) [Online].

Available at: https://improvement.nhs.uk/uploads/documents/Patient_Safety_Alert_-

_Resources_to_support_safe_use_of_valproate.pdf

Summary of Product Characteristics (SPC) various [Online]. Available at:

http://www.medicines.org.uk/ [Accessed on 07/03/2017]

National Institute for Health and Care Excellence (NICE) Bipolar disorder:

assessment and management: Clinical guideline [CG185]. 2014. [Online] Available

at https://www.nice.org.uk/guidance/cg185 [Accessed 07/03/2017]

East London NHS Foundation Trust, Medicines Committee 2016. Protocol for using

valproate in women of childbearing potential (version 3.0). Supplied by Jennifer Melville,

Chief Pharmacist. [Unpublished]

The Faculty of Sexual and Reproductive Healthcare (FSRH). Clinical Guidance:

Drug Interactions with Hormonal Contraception. January 2017. [Online] Available at:

https://www. fsrh.org/standards-and-guidance/current-elinica1-guidance/drug

interactions/ [Accessed 26/04/2017]

Royal College of Psychiatry (2018) Position Statement PS04/18 Withdrawal of, and

alternatives to, valproate-containing medicines in girls and women of childbearing potential

who have a psychiatric illness [Online]. Available from:

https://www.rcpsych.ac.uk/docs/default-source/improving-care/better-mh-policy/position-

statements/ps04_18.pdf?sfvrsn=799e58b4_2 [Accessed 07/06/2019]

Royal College of General Practitioners and Association of British Neurologists and Royal

College of Physicians (2019) Guidance Document on Valproate Use in Women and Girls of

Childbearing Years [Online]. Available from: https://www.rcgp.org.uk/about-

us/news/2019/march/thirteen-uk-healthcare-bodies-launch-pragmatic-guidance-on-

valproate-use.aspx

https://www.gov.uk/guidance/valproate-use-by-women-and-girls#history

http://www.medicines.org.uk/

http://www.nice.org.uk/guidance/cg185

http://www.nice.org.uk/guidance/cg185

https://www.rcpsych.ac.uk/docs/default-source/improving-care/better-mh-policy/position-statements/ps04_18.pdf?sfvrsn=799e58b4_2

https://www.rcpsych.ac.uk/docs/default-source/improving-care/better-mh-policy/position-statements/ps04_18.pdf?sfvrsn=799e58b4_2



Appendix 1: Valproate in women of childbearing potential: Prescribers Checklist

This form MUST be completed for ALL female patients who are being treated with valproate who are between menarche and menopause (clinicians should use their own discretion

outside this range).

ir own discretion outside this range). Patient name:

RiO number:

D.o.B:

I confirm that the Pregnancy Prevention Programme applies to this patient (see section 3.2)

I confirm that the patient is not pregnant (as determined by a recent plasma pregnancy test (details to be recorded in RiO)

I confirm that the above named patient has not responded adequately to, or cannot tolerate, other treatments and so requires treatment with valproate

Capacity Assessment

I confirm that I have assessed the above named patient’s capacity to consent to treatment with sodium valproate, and that one of the following statements applies:

(Tick) The patient has capacity to make a decision about the proposed treatment ☐

The patient does not have capacity to consent because of an inability to: Understand information about the decision to be made Retain that information in their mind Weigh that information as part of the decision process Communicate their decision in any way

☐ ☐ ☐ ☐

Information provision I confirm that I have discussed the following points with the above named patient/parent/caregiver/responsible person:

(Tick)

Discuss the licensed status of valproate in this patient; if unlicensed please refer

to UHM-PGN-02 Prescribing Medicines, section 9 for further guidance.

Discuss the risks associated with valproate therapy; the approximate 10% chance of birth defects and up to 30-40% chance of a wide range of early developmental problems in children exposed to valproate during pregnancy

☐



The patient is aware that continued prescription of valproate is subject to strict adherence to the Pregnancy Prevention Programme. This includes taking a highly effective contraceptive throughout the course of treatment, undergoing pregnancy testing when required and reviews with a specialist at least annually

☐

Please detail the highly effective contraceptive currently taken below:

The patient must sign an Annual Risk Acknowledgement Form (Appendix 4), a copy of which must be sent to their GP.

☐

The importance of notifying the specialist or GP for an immediate review (within a few days) in case of unplanned pregnancy or if the patient wants to plan a pregnancy

☐

Further actions I confirm that I have performed the following actions in relation to the above named patient:

(Tick) Obtained a completed Annual Risk Acknowledgement Form (Appendix 4) from the patient, signed and uploaded this to RiO

☐

Provide a copy of the Annual Risk Acknowledgement Form to the patient/parent/caregiver/responsible person and to the GP

☐

Given the patient a copy of the Patient’s Guide (Appendix 3)

☐

Provide the patient with a Valproate Patient’s Card (Appendix 5), unless she confirms that she already has one and encourage the patient to read the card and enter her name and current date in the spaces provided.

☐

Performed a pregnancy test for the patient if necessary, see section 3.5.5 Risk reduction strategies

☐

If patient is pregnant, all risk reduction strategies have been satisfied as per section 3.5.5

☐

Made an entry in the patient’s progress notes indicating that I have addressed the discussion points above and assessed their capacity to consent to treatment with valproate

☐

Additional comments Prescriber’s name

Prescriber’s signature

Date

Upload completed form to RiO under ‘Clinical Documentation’ as per guidance in RM-PGN-02

Records Management



Appendix 2: Valproate information booklet for healthcare professionals (Healthcare Professional’s Booklet)

Available on Prescribing and Medicines Optimisation intranet site Appendix 2

123683_Valproate_HCP_Booklet_DR15.pdf (http://nww1.ntw.nhs.uk/services/?id=6288&p=2780)

The remainder of this page is intentionally blank



Appendix 3: Valproate information booklet for patients (Patient’s Guide)

Available on Prescribing and Medicines Optimisation intranet site Appendix 3

123683_Valproate_Patient_Booklet_DR18.pdf https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/f

ile/708849/123683_Valproate_Patient_Booklet_DR18.pdf


https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708849/123683_Valproate_Patient_Booklet_DR18.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708849/123683_Valproate_Patient_Booklet_DR18.pdf



Appendix 4 Annual Risk Acknowledgement Form – VALPROATE HAS RISKS IN PREGNANCY

A recently updated version of the Annual Risk Acknowledgement Form is available on the Medicines

Optimisation intranet site

http://nww1.ntw.nhs.uk/services/?id=6288&p=2780

Upload completed form on RiO under ‘Clinical Documentation’ as per guidance in RM-PGN-02 Records Management


http://nww1.ntw.nhs.uk/services/?id=6288&p=2780



Appendix 5: Valproate Patient’s Card

Available on Prescribing and Medicines Management intranet site Appendix 5

123683_Valproate_Patient_Card_DR9.pdf https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708848/123683_Valproate_Patient_Card_DR9.pdf


https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708848/123683_Valproate_Patient_Card_DR9.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708848/123683_Valproate_Patient_Card_DR9.pdf



Appendix 6: Valproate Side Effect Rating Scale (VSERS) Patient name

NHS number

RiO number

Staff name

Date of assessment

Side Effect None

Yes Mild Moderate Severe

1 Abnormal weakness

2 Malaise

3 Loss of appetite

4 Lack of energy

5 Oedema

6 Drowsiness

7 Nausea

8 Recurrent seizures

9 Jaundice

10 Weight gain

11 Confusion

12 Tremor(intention/postural)

13 Parkinson’s tremor

14 Cognitive decline

15 Hair loss

16 Peripheral oedema

17 Unexplained bruising

18 Unexplained bleeding

19 Excessive hair growth

20 Unexplained changes to menses

21 Porphyria

22 Repeated vomiting

23 Abdominal pain

24 Suicidal ideation/behaviour

25 Diarrhoea

26 Abnormal behaviour

27 Rash

28 Deafness

29 Gait disturbances

30 Other…..

(incorporating the pregnancy prevention programme)- v02 ... · 2.6 valproate shared care guidelines...

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