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Information on the use of medicines in human pregnancy is generally lacking, especially for new or infrequently used products.

Bumps is provided by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of the UK Health Departments. UKTIS answers enquiries from health professionals (e.g. doctors, nurses, midwives) on the effects on the unborn baby of medicines and other chemicals that the mother may use or otherwise be exposed to. Somerset NHS Foundation Trust have produced printable leaflets. Choice and Medication© leaflets are designed to help service users, carers and family members understand their medicines better, and to make more informed decisions, best as part of a discussion with a healthcare professional.

Please see the Traffic Light System for categorisation of individual drugs which defines where responsibility for prescribing between primary and specialist clinicians should lie.

Please expand the topics below for more detailed information.

Information resources for safe prescribing

UK Teratology Information Service (UKTIS) provides various maternal exposure abstracts openly available as well as paternal exposure abstracts. Healthcare professionals can contact the service Monday to Friday.

Best Use of Medicines in Pregnancy (Bumps) is provided by the UKTIS, various patient information leaflets are available suitable for the public, useful for all.

Specialist Pharmacy Service SPS has published significant resources on many areas of prescribing in pregnancy, including the prescribing in pregnancy and safety in pregnancy- training and treatment resources in pregnancy

For comprehensive advice and training materials Safety in Pregnancy – Specialist Pharmacy Service (SPS) has resources on:

Questions to ask when giving advice on medicines in pregnancy

Information resources that give advice about medicines in pregnancy

Assessing risk and informing the risk versus benefit decision for medicines in pregnancy

The principles of prescribing in pregnancy

Royal College of Gynaecologists (RCOG) Green-top Guideline No.69 The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum. Also see formulary guidance below under Nausea and Vomiting.

Electronic Medicines Compendium (EMC) – Individual drug data sheets, contain information published by manufacturers.

Somerset NHS Foundation Trust have commissioned – Choice and Medication© leaflets which are designed to help service users, carers and family members understand their medicines better, and to make more informed decisions, best as part of a discussion with a healthcare professional.

Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review MHRA January 2021 update.

Allergic rhinitis

Allergic rhinitis in pregnancy access information from Specialist Pharmacy Service for safety and first line choices in pregnancy – Hayfever or allergic rhinitis: treatment during pregnancy

Asthma

Specialist Pharmacy Service – Asthma: treatment during pregnancy

NHS Somerset Respiratory webpage

Formulary Chapter 3: Respiratory system

Constipation

Specialist Pharmacy Service – Constipation: treatment during pregnancy

Diabetes

Specialist Pharmacy Service – Diabetes: treatment during pregnancy

The MHRA published a report in March 2022 showing no safety concerns with the use of metformin in pregnancy.

Dyspepsia

NICE Clinical Knowledge Summary: Management of Dyspepsia in pregnancy

Self-care first line:

Patient information link: NHS Indigestion and heartburn in pregnancy

  • Eat smaller meals more frequently (every 3 hours), do not eat late at night (or less than 3 hours before bedtime), and avoid known irritants (for example alcohol, caffeine, fruit juices and carbonated drinks, chocolate, and fatty and spicy foods). Keep a food diary to identify triggers.
  • Try raising the head of their bed by 10–15 cm.
  • Avoid medications that may cause or worsen symptoms, if appropriate (for example calcium-channel antagonists, antidepressants, and nonsteroidal anti-inflammatory drugs).
  • Stop smoking (if applicable).

Antacids and alginates are recommended as first-line treatments if symptoms are relatively mild and are not controlled adequately by lifestyle changes suitable for self-care.

If symptoms are severe, or persist despite treatment with an antacid or alginate, consider prescribing an acid-suppressing drug.

UKTIS: Use Of Proton Pump Inhibitors In Pregnancy

Specialist Pharmacy Service: Heartburn and Dyspepsia: treatment during pregnancy

Epilepsy in pregnancy

Update on MHRA review into safe use of valproate – Update on MHRA review into safe use of valproate 12/12/22:

The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.

Valproate use by women and girls MHRA updated guidance 11/02/2021 – Information about the risks of taking valproate medicines during pregnancy.

2022/23 Community Pharmacy Contractual Framework National Clinical Audit – Reducing the potential for harm from valproate prescribing in patients of childbearing age who are biologically able to be pregnant.

Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review MHRA January 2021 update.

Valproate use by women and girls March 2018 MHRA update on Information about the risks of taking valproate medicines during pregnancy.

General Medical Council: Discussing the risk of sodium valproate this case study developed by the GMC with the General Pharmaceutical Council and the Nursing and Midwifery Council highlights the risk of harm created by taking sodium valproate during pregnancy.

The Epilepsy medicines and pregnancy leaflet above, aims to help support patients in understanding the risks for epilepsy medicines in pregnancy. It contains important information, including do not stop taking epilepsy medicines until you have talked to your specialist, GP or epilepsy specialist nurse.

Specialist Pharmacy Service: Epilepsy: treatment during pregnancy signposts evidence based information on the treatment of epilepsy in pregnancy.

NHS Somerset formulary Contraception page

NHS Somerset formulary Mental Health page

Refer to the Somerset Traffic Lights System Document located on this page for details on individual drugs

Chapter 4.2 Epilepsy and other seizure disorders formulary page

Folic acid

Folic acid should be taken by all women and people assigned female at birth who may become pregnant to reduce the risk of having a baby with a neural tube defect.

Usually folic acid 400 micrograms daily should be started 3 months before pregnancy (where possible) and continued throughout the first 12 weeks of pregnancy, this is available over the counter and suitable for self-care.


NICE Public Health Guideline [PH11] advise that GPs should prescribe 5mg of folic acid a day for women and people assigned female at birth who are planning a pregnancy (3 months before conception where possible), or are in the early stages of pregnancy, continuing for the first 12 weeks if they:

  • (or their partner) have a neural tube defect
  • have had a previous pregnancy with a neural tube defect
  • (or their partner) have a family history of neural tube defects
  • have diabetes type 1 or 2
  • have epilepsy Epilepsy in Pregnancy Green-top guideline No. 69 RCOG or take anti-epilepsy medication
  •  have a BMI 30kg/m2 or greater RCOG Green-top Guideline No.72
  • Individuals taking sulfasalazine
  • Individuals treated with low dose methotrexate (≤25mg/ week) within one month prior to conception.
  • Individuals treated with low dose methotrexate at time of conception, note- these individuals should be advised to stop methotrexate immediately and referred to their specialist for urgent review.

GP’s should also prescribe for people who may become pregnant/ planning pregnancy ideally 3 months prior to conception and throughout the entire pregnancy for:

  • Individuals with sickle cell disease, thalassaemia or thalassaemia trait

Herbal Medicines

Herbal medicines: safety during pregnancy information shared from the SPS

Hypertension (prevention of pre-eclampsia)

Hypertension in pregnancy NICE guidance.

Pregnant women at increased risk of pre-eclampsia at the booking appointment are offered a prescription of 75–150 mg of aspirin to take daily from 12 weeks until birth. NICE Quality statement 2.

GPs should prescribe 75-150mg of aspirin (unless contra-indicated) from twelve weeks of pregnancy until birth for women with one high risk factor, or more than one moderate risk factor for pre-eclampsia.

High risk factors include:

  • hypertensive disease in a previous pregnancy
  • chronic kidney disease
  • autoimmune disease, such as systemic lupus erythematosus or antiphospholipid syndrome
  • type 1 or type 2 diabetes
  • chronic hypertension.

Moderate risk factors include:

  • first pregnancy
  • age 40 years or older
  • pregnancy interval of more than 10 years
  • body mass index (BMI) of 35 kg/m2 or more at first visit
  • family history of pre-eclampsia
  • multi-fetal pregnancy.

Specialist Pharmacy Service: Hypertension: treatment during pregnancy

See our Shared Care and Patient Group Directions webpage for patient information leaflets on ‘Taking aspirin to reduce the risk of pre-eclampsia’, available in two different formats for printing purposes, for patients accessing the community pharmacy PGD. Includes the use of aspirin in patients who have low levels of placental protein (Low PAPP-A) identified by blood tests taken at the 11-14 week scan screening, as well as people with sickle cell disease.

LGBT+ and having a baby

The NHS website has some useful information on becoming a parent and discusses testosterone and fertility.

People assigned female at birth (AFAB) can become pregnant while taking testosterone if they do not use contraception.

Somerset’s Fertility Policy can be accessed through the Evidence Based Interventions Service page, under policies and applications.

Managing acute medical problems in pregnancy

Acute care toolkit 15. Managing acute medical problems in pregnancy Nov 2019. This toolkit is intended to be used widely, including by front-line NHS Healthcare professionals and those involved in local and national planning and policy.

Mental health

Please see the Mental Health Page for more information on Perinatal Mental Health in including NHS Somerset’s guide to preferred antidepressants while pregnant and lactating as well as further resources for healthcare professionals and parents.

Preconception advice for women with serious mental illness

Guide for healthcare professionals involved in the care of women with serious mental illness (SMI) in primary and secondary care, developed by King’s College London in partnership with Public Health England, NHS England and Tommy’s.

Perinatal Mental Health Treatment provides free evidence-based resources for new parents and clinicians.

Healthier Together provides maternal mental health patient information and resources.

Specialist Pharmacy Service – Depression: treatment during pregnancy

Also see the Mental Health Page for further links.

Nausea and vomiting

Nausea and vomiting of pregnancy is very common. It is characterised by nausea and vomiting and while it can be worst in the first trimester (12 weeks), most cases resolve by 16-20 weeks however some women suffer from it throughout their pregnancy.

By the time people seek advice from healthcare professionals about nausea and vomiting in pregnancy, they may have already tried several different interventions including ginger for mild to moderate symptoms (ginger is not suitable for severe nausea or vomiting of pregnancy).

A few women experience a severe version of pregnancy sickness called Hyperemesis Gravidarum and may require hospital treatment. For patients experiencing moderate-to-severe nausea and vomiting, they may require fluids. Acupressure may be used as an adjunct treatment. Inpatient care may be required if vomiting is severe and not responding to primary care or outpatient management.

Pregnancy sickness support is a useful resource for support and advice on pregnancy sickness.

RCOG GTG 69 RCOG guideline link and PDF: RCOG guidelines to the management of nausea and vomiting of pregnancy and Hyperemesis Gravidarum GTG69 PDF. SPS has also developed a Q&A on nausea and vomiting in pregnancy.

NICE NG201 Recommendations: Antenatal care  has summarised the advantages and disadvantages of different pharmacological treatments for nausea and vomiting in pregnancy NG201 Table 1 Advantages and disadvantages of different pharmacological treatments for nausea and vomiting in pregnancy

UKTIS statement on the use of ondansetron in the first 12 weeks of pregnancy, it remains second line where first line treatments have failed, provided discussion is had with the parent over risks and benefits.

Hyperemesis and breastfeeding

Yeovil District Hospital NHS Foundation Trust: Hyperemesis Gravidarum

Drugs available for treating nausea and vomiting in pregnancy taken from NICE and RCOG guidance

See Appendix III of RCOG Green-top Guideline No. 69 for recommended antiemetic dosages for nausea and vomiting of pregnancy.

First line options:

DrugLicensed indicationsDoses for licensed indicationsIs this licensed for nausea and vomiting in pregnancy?
Promethazine hydrochlorideNausea and vomitingOrally: 12.5 – 25mg up to 4 times dayNo, but established practice and used for many years.
BUMPS – best use of medicine in pregnancy
CyclizineNausea and vomitingOrally: 50mg up to 3 times a dayNo, but established practice and used for many years.
BUMPS – best use of medicine in pregnancy
ProchlorperazineSevere nausea and vomitingOral tablets: 5-10mg given 2-3 times a day, max 30mg/day
Buccal tablets: 3-6mg twice a day.
No, but established practice and used for many years.
BUMPS – best use of medicine in pregnancy

Second line options:

DrugLicensed indicationsDoses for licensed indicationsIs this licensed for nausea and vomiting in pregnancy?
MetoclopramideNausea and vomitingMaximum duration of treatment: 5 days.
Dose in adults >18 years of age and >60kg body weight:
Orally: 10mg up to 3 times a day
No, but established practice as second-line treatment for nausea and vomiting in pregnancy. BUMPS – best use of medicine in pregnancy
DomperidoneNausea and vomitingMaximum duration of treatment: one week.
Doses for adults and adolescents ≥35kg:
Orally 10mg given 3 times a day, maximum 30mg/day
No, domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Domperidone 10mg Tablets – Summary of Product Characteristics
OndansetronNausea and vomiting associated with chemotherapy, radiotherapy and post-operativeOrally: up to 4-8mg twice a day

RCOG guidance for use The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum ondansetron orally: 4–8 mg 6–8 hourly
No, but established practice as treatment for severe nausea and vomiting in pregnancy.
BUMPS – best use of medicine in pregnancy
Increased chance of the cleft lip or cleft palate when taken in the first 12 weeks. This is an increase of 3 extra cases per 10,000 from 11 in 10,000 to 14 in 10,000, so with ondansetron 9,986 out of 10,000 babies would not have this.

Pain

SPS – Pain: treatment during pregnancy the Specialist Pharmacy Service have published signposting evidence based information on the treatment of pain in pregnancy.

Vitamin D

Vitamin D should be taken throughout pregnancy. Advise pregnant people to take Vitamin D 10 micrograms per day. PH56 Vitamin D: supplement use in specific population groups. Also suitable for self-care.

Healthy Start vitamins are available for families who qualify for free, see how to apply. Healthy Start women’s vitamin tablets contain folic acid and vitamins C and D (Children’s drops also available). FAQs. The application form must be signed by a midwife, health visitor, doctor or nurse.

Treatment of deficiency (Vitamin D <25nmol/l) formulary options available on the Somerset Prescribing formulary. The SPS have also published information on dosing and monitoring of vitamin D deficiency in pregnancy. Patients to continue a daily supplement of vitamin D 400iu daily as self-care after their course of treatment for deficiency.

 

The information and links provided are for guidance, clinical decisions remain the responsibility of the practitioner; the intention is to help prescribers find evidence based information and does not replace input from appropriate professionals or constitute medical advice for individual patients.