ba7c5557-6039-4f7f-8a3c-a3f9fcda38f9Valproate Annual Review for female patients of childbearing potential June 262025-10-21T11:12:16.035097+01:00EMISWEBHARIA-SHAH, Avani (Ms)ARAFfalsefalseInformationfalse618616ed-f2bb-43f8-8a82-58fd2cf5fa3efalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}{\f1\fswiss\fprq2\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\b\f0\fs18 Background information\par
\b0 The MHRA advises Valproate medicines must not be prescribed to females of childbearing potential (under 55) unless there is a Pregnancy Prevention Programme (PPP) in place. As part of the PPP, an annual risk assessment form (ARAF) is to be completed by the specialist when starting valproate and at annual review. \kerning2\f1\par
Patients should also receive a copy of the Patient Guide.\par
\kerning0\f0\par
}
9bfb48ad-f74d-4e60-84f4-bb3bddbed077falsefalseMHRA Valproate- reproductive risks guidancehttps://www.gov.uk/guidance/valproate-reproductive-risks668ffd85-a093-42c4-86d9-806c8d0f1e00falsefalseMHRA ARAF formhttps://www.medicines.org.uk/emc/rmm/104331/Documentdf4e2dd8-2fa8-4866-b7e3-ad36b57d84acfalsefalsePatient Guidehttps://www.medicines.org.uk/emc/rmm/104335/Document5e1bd306-e37b-4b47-af98-df8dc2352db6falsefalseSNOMED_CONCEPTfalsetrueASfalsefalseCoding historyfalse44aed301-d84b-4017-a422-2bd0aaeca2cdfalsefalseSNOMED_CONCEPTfalse6756eb44-7813-4d90-be4c-d0608739ff9afalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\f0\fs18 ARAF to be completed every 12 months. \par
Please note: completion of form is specialist, not a GP, responsibilty. Please see section below on how to refer for ARAF\cf0\par
}
ced4abc7-b9a9-4205-9b90-992353b114bbfalsefalseSNOMED_CONCEPTfalsef41907cf-4f01-4073-a659-06e2fc691d67falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\f0\fs18 One-off shared care agreement form needed for females under 55 years of childbearing potential. \cf0\fs20\par
}
2ccd6ea4-a5cc-45b4-8c9b-41c93904f86bfalsefalseSNOMED_CONCEPTfalsec9b62edf-0d0d-4273-8b13-9b0941482a10falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\f0\fs18 This code may be used for post-menopausal patients or for those after hysterctomy or sterilisation where the absence of risk is permanent.\par
If coded , no further action needed\cf0\par
}
falsefalseReferral for ARAFfalsefdfd821c-b0e9-483c-98c9-80a69d3131bdfalsefalseSNOMED_CONCEPTfalsetrue30745dc4-21f5-460d-89cc-b1e521118f80falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\f0\fs18 Please see Valproate Primary Care guide for contact details and further information\par
\par
\kerning2\par
}
a468b1d6-78ba-4f24-8c15-ad5fb9fbba7ffalsefalseValproate Primary Care guidehttps://www.covwarkformulary.nhs.uk/docs/chapter04/RD063-%20Primary%20Care%20guide%20for%20Prescribing%20Valproate%20(in%20female%20patients%20under%2055%20years).pdf?UNLID=27464315520266171013356e443d0d-f4e7-47e1-8d58-ec4f40130dcdfalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}{\f1\fswiss\fprq2\fcharset0 Tahoma;}}
{\colortbl ;\red70\green120\blue134;}
\viewkind4\uc1\pard\f0\fs18 Example wording for referral\par
\par
\pard\sa160\sl252\slmult1\kerning2\f1 The MHRA have updated their guidance on valproate and require an Annual Risk Acknowledgment Form (ARAF) to be completed. On reviewing this patient\rquote s notes I can find no record of one in the last 12 months.\par
I would be grateful if you or a member of your team could complete the ARAF which is available on the link below and return a copy to the surgery \par
\pard\cf1\f0 <https://www.medicines.org.uk/emc/rmm/104331/Document>\cf0 \par
\kerning0\par
}
fa5af09e-0c47-464f-8783-fb6c32df302cfalsefalseLink to ARAF template https://www.medicines.org.uk/emc/rmm/104331/DocumentfalsefalseCode for ARAFfalse928f93d1-2765-4ee8-8d08-915494052034truetrueEnter date on which ARAF was doneSNOMED_CONCEPTfalsetrue8abe31de-3338-43d6-a631-c8fb0df37d0afalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\f0\fs18 Suggest adding a screen message on the medication screen e.g ARAF Expiry Date: XXXX\par
Suggest adding Pharmacy Info message ' PPP in place, ARAF expires xx/x/xx'\par
\cf0\par
Please ask the ICB medicines optimisation team for guidance on this if needed.\par
\par
}
304e8afe-2251-42af-99f3-8f58f621c000falsetruefalsetrue2fee7069-ff12-44cd-b70f-25a409a459cftruetrueSNOMED_CONCEPTfalsetrueContraceptionfalsefalseIntroductionfalse9b72ffdf-11bc-4850-95aa-4d2a7acd0f82falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fswiss\fprq2\fcharset0 Tahoma;}{\f1\froman\fprq2\fcharset2 Symbol;}{\f2\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\sa160\sl252\slmult1\kerning2\b\f0\fs18 The UK Valproate Pregnancy Prevention Programme (\lquote Prevent\rquote ) aims to minimise exposure of pregnancies to valproate.\b0 Prevent mandates that:-\par
\pard\fi-360\li720\sa160\sl252\slmult1\f1\'b7\tab\f0 Valproate can be prescribed for individuals who have the potential to conceive a pregnancy \b\f2 only\b0\f0 if two specialists consider that valproate is their only effective treatment option. For women of childbearing age on Valproate there is a requirement for an annual review and completion of the patient's Annual Risk Assessment Form\par
\pard\li720\sa160\sl252\slmult1 AND\par
\pard\fi-360\li720\sa160\sl252\slmult1\tx720\f1\fs20\'b7\tab\f0\fs18 Individuals with potential to conceive must use effective contraception continuously throughout valproate use.\par
\pard\kerning0\f2 https://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-actions-required-now-from-gps-specialists-and-dispensers\par
}
falsefalseFurther information and linksfalsece960529-9a95-4258-957d-5661a977fc2dfalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\f0\fs18 For definition of highly effective contraception, please see additional information tab or \kerning2 FSRH position statement.\cf1\par
\cf0\kerning0\par
}
e168ffbd-80ab-4496-93a6-326ebe413636falsefalseFSRH position statement on contraception for women using a teratogenic drug or drugs with known teratogenic effecthttps://www.cosrh.org/Common/Uploaded%20files/documents/teratogenic-medication-and-contraception-fsrh-ceu-statement-february-2018.pdf3246f0ae-937c-4d88-8512-56a735da6c73falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\f0\fs18 Complete details of current contraception below.\par
\par
\par
}
f265dde4-aed8-455f-a144-431af41cd8b5falsefalseSNOMED_CONCEPTfalsetrue6e6c4245-cae7-41c0-93a7-44ec743b209bfalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\f0\fs18 When reviewing contraception also consider any other current medication that could alter efficacy of contraceptives\par
}
c57f85eb-5b76-4d08-96dd-4ee8ce620214falsefalseSNOMED_CONCEPTfalsetrueStressed importance of using continuous highly effective contraception whilst on valproate4efe5359-ddef-46a9-aaea-e42117a5ab94falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
{\colortbl ;\red0\green114\blue188;}
\viewkind4\uc1\pard\cf1\f0\fs18 Add review date if contraception review needed before next ARAF due\par
}
846e680f-c92b-4a15-bed5-c1311d4b60e7truefalseSNOMED_CONCEPTfalsetruefalsefalseLocal contraception pathway informationfalsebe25055f-6952-4d4d-82d8-c489086868aefalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\f0\fs18 A comprehensive pathway has been drafted and is currently undergoing due process via the provider (HCRG). In the meantime, please refer into the service using the following route:\par
Email: \cf1 hcrg.cwsexualhealthhub@nhs.net \cf0 Mark email as \lquote urgent\rquote .\par
\par
\par
}
77ab0e0a-6c8b-4053-8bc8-6f6d9b3a2e46falsefalseCoventry and Warwickshire sexual health hubhttps://thesexualhealthhub.co.uk/coventry-and-warwickshireBackground informationfalsefalseMHRA Guide for HCPsfalsea5a835fd-c43c-4479-ba67-14719d131047falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fswiss\fprq2\fcharset0 Tahoma;}{\f1\fnil\fcharset0 Tahoma;}}
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\viewkind4\uc1\pard\cf1\kerning2\ul\f0\fs18 The MHRA guide for for HCPs states \par
\cf0\ulnone Female patients of childbearing potential who are prescribed valproate must use effective contraception \b without interruption during the entire duration of treatment with valproate\b0 . These patients must be provided with comprehensive information on pregnancy prevention and \b should be referred for contraceptive advice if they are not using effective contraception\b0 .\par
\par
At least one effective method of contraception, preferably a highly effective user independent form such as an intra-uterine device or implant or two complementary forms of contraception including a barrier method should be used.\par
\par
Individual circumstances should be evaluated in each case when choosing the contraception method with the patient, involving the patient in the discussion to support her engagement and compliance with the chosen measures. Even if she has amenorrhea, she must follow all the advice on effective contraception. \par
\kerning0\f1\par
}
a3c28e9a-dfe3-4bf7-9f87-2f2c2afc27aefalsefalseMHRA Guide for Health care Professionalshttps://www.medicines.org.uk/emc/rmm/104333/Document#gref554ce1d4-34da-4e5d-a724-101fb9c24565falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\f0\fs18 Health professionals should check that the patient has received a copy of the Patient Guide\par
}
501de06a-a259-42c3-8969-22a31b80f87bfalsefalsePatient Guide for female patientshttps://www.medicines.org.uk/emc/rmm/104335/DocumentfalsefalseCollege of Sexual & reproductive Healthcare(formerly FSRH)falsef04dca04-9621-43cb-83e7-9da10a5ba109falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fswiss\fprq2\fcharset0 Tahoma;}{\f1\froman\fprq2\fcharset2 Symbol;}{\f2\fmodern\fprq1\fcharset0 Courier New;}{\f3\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\sa160\sl276\slmult1\kerning2\f0\fs18 The College of Sexual & Reproductive Healthcare (formerly FSRH) position statement on contraception for women using a teratogenic drug states: \par
Women should be made aware that no method of contraception is 100% effective.\par
Always advise the use of \lquote highly effective\rquote contraceptive methods. These have a failure rate of less than 1% with typical use and include:\par
\pard\fi-360\li720\sa160\sl252\slmult1\tx720\f1\fs20\'b7\tab\f0\fs18 Copper intrauterine device (Cu-IUD)\par
\pard\fi-360\li720\sa160\sl252\slmult1\f1\fs20\'b7\tab\f0\fs18 Levonorgestrel intrauterine device (LNG-IUD)\par
\f1\fs20\'b7\tab\f0\fs18 Progestogen-only implant (IMP)\par
\pard\fi-360\li1440\sa160\sl252\slmult1\tx1440\f2\fs20 o\tab\f0\fs18 Women using IMP \b must not take any interacting drugs\b0 that could reduce contraceptive effectiveness. \par
\pard\fi-360\li720\sa160\sl252\slmult1\tx720\f1\fs20\'b7\tab\f0\fs18 Male and female sterilisation\par
\pard\sa160\sl276\slmult1 The typical use failure rate of combined hormonal contraception (CHC) and the progestogen-only pill (POP) is 9%; for progestogen-only injectables including depot medroxyprogesterone acetate (DMPA) it is 6%:\par
\pard\fi-360\li720\sa160\sl252\slmult1\tx720\f1\fs20\'b7\tab\f0\fs18 Advise women using the CHC (pills, vaginal ring or patch), POP or DMPA to use \b additional contraceptive\b0 precautions (e.g. condoms)\par
\pard\fi-360\li720\sa160\sl252\slmult1\f1\fs20\'b7\tab\f0\fs18 Women using CHC (pills, vaginal ring or patch) or POP \b must not take any interacting drugs\b0 that could reduce contraceptive effectiveness. See link below for advice on drug interactions.\par
\pard\kerning0\f3\par
}
bff1c748-2374-4cb6-90db-ab2c64e0f823falsefalseFSRH CEU statement : Contraception for women using known teratogenic drugshttps://www.cosrh.org/Public/Documents/fsrh-ceu-statement-contraception-for-women-using-known-teratogenic-drugs.aspx?WebsiteKey=f858b086-d221-4a83-9688-824162920b1bba98a9e4-2f03-4db8-94ec-71dfbc2a5a09falsefalseFSRH CEU Guidance : Drug Interactions with Hormonal Contraceptionhttps://www.cosrh.org/Public/Public/Documents/ceu-clinical-guidance-drug-interactions-with-hormonal.aspx96347bc4-9737-4a7f-aff7-4b925ebb92befalsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fswiss\fprq2\fcharset0 Tahoma;}{\f1\froman\fprq2\fcharset2 Symbol;}{\f2\fnil\fcharset0 Tahoma;}}
{\colortbl ;\red0\green0\blue0;}
\viewkind4\uc1\pard\cf1\f0\fs18 The CoSRH (formerly FSRH) recommends that: \par
\pard\fi-360\li720\tx720\f1\fs20\'b7\tab\f0\fs18 If amenorrhoea is experienced in patients between 40-50 years of age, contraception should be continued for a further two years before stopping. If amenorrhoea is experienced in patients >50 years of age, contraception should continue for one year before stopping. \par
\pard\fi-360\li720\sa160\sl252\slmult1\tx720\cf0\kerning2\f1\fs20\'b7\tab\f0\fs18 Where using a contraceptive method that obscures menopause (e.g. progestogen-only implant, progestogen-only pill or levonorgestrel intrauterine-system), contraception can be stopped at age 55.\par
\pard\kerning0\f2\par
}
1f3af222-9238-491a-8c2e-65799f810a54falsefalseFSRH Clinical Guideline: Contraception for Women Aged over 40 yearshttps://www.cosrh.org/Public/Documents/fsrh-guidance-contraception-for-women-aged-over-40-years-2017.aspxb2cbb4bb-a7e3-4b97-9cc4-54c5e15864d2falsefalse{\rtf1\ansi\ansicpg1252\deff0\deflang2057{\fonttbl{\f0\fswiss\fprq2\fcharset0 Tahoma;}{\f1\fnil\fcharset0 Tahoma;}}
\viewkind4\uc1\pard\kerning2\f0\fs18 Note that valproate is \b not\b0 an enzyme-inducing drug. If, however, an individual using valproate is also using a drug that is an enzyme inducer this would reduce contraceptive effectiveness of some contraceptive methods. For further information see link below\kerning0\f1\par
}
fb5e8506-4e75-45d4-be9c-a16745ea0be7falsefalseFSRH CEU Guidance: Drug Interactions with Hormonal Contraceptionhttps://www.cosrh.org/Public/Public/Documents/ceu-clinical-guidance-drug-interactions-with-hormonal.aspx