Procedure to ensure Safe and Appropriate Valproate Prescribing in Female Patients Standard Operating Procedure Revision Chronology Version Number Effective Date Reason for Change Version 1.0 November 2017 Version: Author: Designation: Responsible Director: Target Audience: Approved By: Approval Date: November 2017 Review Date: November 2019 V1 Heather Beadle and Lilian Baxendale Clinical Governance Pharmacist Medical Director All qualified healthcare professionals working within CWPT Drug and Therapeutics Groups
CONTENTS Standard Operating Procedure Title Procedure to ensure Safe and Appropriate Valproate Prescribing in Female Patients SOP Number 1 Version 1 Effective Date November 2017 Review Date November 2019 Superseded Version Number & Date (if applicable) Author N/A Heather Beadle and Lilian Baxenadale CONTENT: 1. Purpose 2. Background 3. Procedure 4. Appendices Responsible Personnel Name Date Medicines Management Team November 2017 All prescribers and other qualified healthcare professionals working November 2017 within CWPT
1. PURPOSE This SOP aims to ensure that valproate is appropriately prescribed in female patients in line with current MHRA Guidance. Valproate should not routinely be prescribed to: female children, female adolescents, women of childbearing potential or pregnant women unless there is a positive risk benefit balance and the patient is aware of and accepts that risk. 2. BACKGROUND In January 2015 the MHRA published new guidance regarding the use of sodium valproate in women of child bearing age. Following a Europe-wide review, it was concluded that children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases). A Drug Safety Update was issued by the MHRA advising that valproate, should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated. Despite this, a survey of women taking valproate in 2016 found that 20% were not aware of the risks of valproate in pregnancy and <20% had received any of the educational materials. Subsequently, a Patient Safety Alert (PSA) has been issued, requiring organisations to undertake a systematic identification of girls and women who are taking valproate and to ensure that the resources contained within the toolkit are used to support them to make an informed choice. MHRA guidance states that valproate treatment must be started and supervised by a specialist experienced in managing epilepsy or bipolar disorder. The potential benefits of prescribing valproate MUST be carefully balanced against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans pregnancy or becomes pregnant. The Medicines and Healthcare products Regulatory Agency (MHRA) have developed Communication materials Valproate toolkit to support discussion of these risks with women of childbearing potential and girls who take valproate. The MHRA toolkit aims to help ensure that female patients are better informed about the risks of taking valproate during pregnancy. The materials should be used to support discussion of the risks. CWPT Healthcare Professionals may come into contact with patients who are taking valproate which has been initiated within CWPT (e.g. mental health, learning disability, children s services) or external to CWPT (e.g. neurologists). 3. PROCEDURE This SOP applies to the prescribing of all formulations of valproate, including: sodium valproate, valproate semisodium and valproic acid (thereafter referred to as valproate). It is applicable to all indications including prescribing in: epilepsy, manic episodes associated with bipolar disorder and migraine prophylaxis.
There may be patients who lack capacity to understand the valproate guidance due to a learning disability. For these patients, documentation should be made of the capacity assessment and discussion of Valproate risks with carer so that a Best Interest decision can be made regarding continuing or changing the treatment. ALL female patients MUST be informed of, and understand: The risks associated with valproate during pregnancy The need to use effective contraception The need for regular review of treatment The need to rapidly consult if a pregnancy is planned or is confirmed To achieve this Healthcare Professionals have the following responsibilities: 3.1 Treatment initiated by CWPT services: 3.1.1. Prescribers: 3.1.2. New Valproate patients (See algorithm 1): 3.1.1.1. The Prescriber must use the toolkit to support discussion of the risks of valproate prescribing with female patients 3.1.1.2. The Prescriber must supply the patient/carer with a copy of the Patient s Guide 3.1.1.3. The Prescriber must discuss the risks with the patient and ensure that the patient fully understands the necessary information 3.1.1.4. If the decision is made to start valproate therapy: 3.1.1.4.1. The completed consultation checklist must be added to the patient s medical records as a permanent record of the discussion 3.1.1.4.2. A flag ( valproate- discussion had ) must be added to carenotes to indicate that the patient is prescribed valproate and that a discussion has been had regarding risk of treatment 3.1.3. Existing Valproate Patients (See algorithm 1): A prescriber may also identify female patients who are already prescribed valproate. When this happens the prescriber must clarify if a review has already taken place e.g. by checking on carenotes (i.e. valproate- discussion had is flagged). The above procedure (3.1.2) for new patients must be followed where this has not occurred. At each appointment the prescriber should re-iterate the message about the risks with valproate. The discussion should be documented, noting if the valproate is to be continued. 3.1.4. Patients transferred to GP care: Where a patient is started on valproate, or identified as being on valproate, information about the discussion of risks, where the person has been referred for contraception, etc. should be shared with the GP.
3.1.5. Pharmacists: Pharmacists should supply a copy of the Patient Card when valproate is dispensed. This information should be discussed with the patient to ensure that the message is understood and to clarify if there are any questions. 3.1.6. All Other Healthcare Professionals (See algorithm 3): If a Healthcare Professional identifies a female patient prescribed valproate they should check if the patient has had a discussion with their prescriber about taking valproate. (The Healthcare professional may also be able to check the entry on Carenotes to identify if there is a flag to indicate that the valproate prescribing has been reviewed and the patient has been supplied with the appropriate information). If this has not happened the professional should refer the patient to the CWPT prescriber for review (if still open to that service; if not, to the GP) and create an alert on carenotes ( valproate- no discussion) if their service uses carenotes. If the service does not use carenotes, a record of the referral should be made in the patient notes. 4.1 Treatment initiated external to CWPT (e.g. by neurologist) 4.1. Prescribers (See algorithm 2) 4.1.1. A prescriber may identify female patients who are already prescribed valproate which has been initiated external to CWPT. Unless they are prescribing the valproate they are not responsible for reviewing the appropriateness of the treatment, but are responsible for checking that the patient is aware of the risk of treatment. 4.1.1.1. The prescriber must clarify if a discussion has already taken place with the patient about the risks of treatment e.g. by checking with the patient or on carenotes ( valproate- discussion had is flagged). 4.1.1.2. If the discussion has not already taken place the prescriber should discuss the risks with the patient using the MHRA toolkit. The discussion should be documented and a flag ( valproate discussion had ) created on carenotes (if the service uses carenotes). The prescriber will not be in a position to evaluate the risk:benefit of treatment with valproate. If the patient is considering not taking valproate due to the risks, she should be referred back to the service that initiated the treatment/gp. 4.1.1.3. If the discussion has already taken place, the prescriber should reiterate the message about the risks with valproate at each appointment. 4.2. Pharmacists Pharmacists should supply a copy of the Patient Card when valproate is dispensed. This information should be discussed with the patient to ensure that the message is understood and to clarify if there are any questions. 4.3. All Other Healthcare Professionals (See algorithm 4) If a Healthcare Professional identifies a female patient prescribed valproate they should check if the patient has had a discussion about taking valproate with their
prescriber. (The Healthcare professional may also be able to check the entry on Carenotes to identify if there is a flag to indicate that the valproate prescribing has been reviewed and the patient has been supplied with the appropriate information). If this has not happened the professional should suggest that the patient contacts the initiating service (if still open to that service) or GP for review and create an alert on carenotes ( valproate- no discussion) if their service uses carenotes. If the service does not use carenotes, a record of the discussion should be made in the patient notes.
4. APPENDICES Important Information for Healthcare Professionals on the Risks of Valproate in Female Patients http://www.medicines.org.uk/emc/rmm.420.pdf Treatment with valproate for female patients: Checklist for patients and prescribers http://www.medicines.org.uk/emc/rmm.423.pdf Valproate Patient Guide http://www.medicines.org.uk/emc/rmm.421.pdf Key Facts Valproate and Pregnancy http://www.medicines.org.uk/emc/rmm.422.pdf References: https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes https://www.nice.org.uk/guidance/cg137 https://www.gov.uk/government/publications/toolkit-on-the-risks-of-valproate-medicines-in-female-patient https://www.nice.org.uk/guidance/cg185 http://www.medicinesforchildren.org.uk/sodium-valproate-preventing-seizures Resources to support the safety of girls and women who are being treated with valproate: NHS/PSA/RE/2017/002 6 April 2017
Algorithm 1 - CWPT Prescriber responsibilities for Patients initiated on valproate within CWPT CWPT Prescriber New Patient Existing Patient Use Toolkit to support discussion of the risks of valproate prescribing Enquire whether a discussion has already taken place check for flag in Carenotes Decision made to start valproate prescribing despite risks No Yes Issue MHRA Booklet Use toolkit to support documentation of risk Reiterate risk (Have discussion and document) Create flag on Carenotes to say Valproate discussion had Ensure that the flag on Carenotes says Valproatediscussion had Scan and add the completed consultation checklist to Carenotes If Carenotes is not available then document the discussion and outcomes in the patient s notes Prescriber Responsibilities: Appropriate indication Check Patient is aware of risks
Algorithm 2 - CWPT Prescriber responsibilities for Patients initiated on valproate external to CWPT CWPT Prescriber Check whether the patient is aware of the risks of valproate by asking them/checking flag status on Carenotes Patient aware Patient not aware Discuss risks again Use MHRA toolkit to discuss risks Patient wishes to continue on valproate Patient uncertain or doesn t want to continue on valproate Patient wishes to continue on valproate Flag Valproate-discussion had on Carenotes Refer to initiating service (if still open to patient) or GP to review. Advise patient not to stop valproate until after this review Flag Valproate-discussion had on Carenotes If Carenotes is not available, document the discussion and outcomes in the patient notes. Prescriber Responsibilities: Check Patient is aware of risks
Algorithm 3 - CWPT Healthcare professional responsibilities for Patients initiated on valproate within CWPT If Carenotes is not available, document the discussion and outcomes in the patient notes. Other Healthcare Professional Patient Currently taking valproate Check with patient whether she has had a discussion with prescriber about the risks with valproate Patient says Yes Patient says No Ensure patient requires no further information/support; refer to prescriber if necessary Refer patient to the initiating CWPT prescriber/service for review. (Refer back to GP if not open to service) Create alert on Carenotes Valproatediscussion not had If Carenotes is not available then document the outcomes in the patient s notes
Algorithm 4 - CWPT Healthcare responsibilities for Patients initiated on valproate external to CWPT Other Healthcare Professional Patient Currently taking valproate Check with patient whether she has had a discussion with prescriber about the risks with valproate Patient says Yes Patient says No Ensure patient requires no further information/support; refer to prescriber if necessary Suggest patient contacts GP/initiating prescriber or service for discussion Create alert on Carenotes Valproatediscussion not had If Carenotes is not available then document the outcomes in the patient s notes