Preparation

Complete an individual, evidence-based risk assessment before providing advice on the medicine.

In order to minimise the risks associated with the use of medicines in prescribing it is also recommended that any advice adheres to the principles of prescribing in pregnancy.

Structure

This is a complex topic for which communication can be challenging. It is useful to think of the key elements that your answer should include. These ensure that the advice is helpful in informing the decision about the medicine a woman may take or want to take.

Key elements

Your advice should include summaries of:

• Background risk of congenital malformation (birth defects)
• Information found relevant to the individual patient and covering possible scenarios including:
  • needing to continue a medicine throughout the pregnancy
  • stopping the medicines completely
  • pausing the medicine for the first trimester
  • switching to a suitable alternative treatment about which more is known and/or which is associated with lower risk
• Risk assessment
• Recommendation
• Information on any additional pregnancy scans or drug monitoring.

Phrasing

Difference in approach

The advice you provide is phrased differently depending on whether it is for:

• a woman who is pregnant already, or one may become pregnant
• a woman who is pregnant or considering pregnancy, or a healthcare professional.

Timing of advice

Not pregnant yet and taking a medicine

Pre-pregnancy counselling is preferable. It allows for discussion on the pros and cons, benefits and risks of the current medicine or alternative possible therapeutic options.

Pregnant and not taken a medicine yet

You can provide a clear and simple recommendation, based on available evidence; this may include alternative therapeutic options.

Pregnant and already taken a medicine

The advice may need to be conveyed more sensitively, depending on the information about potential risk to the fetus.

For healthcare professionals

It may be useful to use standard statements for common situations when providing advice to healthcare professionals about the use of a medicine in pregnancy.

Standard statements are helpful when formulating your answer but remember to stop and think about your overall message: you want to support an informed discussion between the healthcare professional and the woman about the medicines she is taking or may want to take.

For women and/or their partners

The content and language used when providing advice to a pregnant woman is necessarily different to that for a healthcare professional. It is important to communicate this complex information in a way that the woman will understand.

Resources such as Best Use of Medicines in Pregnancy (BUMPS) and NHS Medicines A-Z.  provide appropriate ways of phrasing information about common situations, to facilitate discussions on the use of medicine(s) with a woman (and her partner).

Standard statements

Here are some useful standard statements you can use when providing advice about use of a medicine in pregnancy to health care professionals

Talking about risk

“All pregnancies have some risk”

“There is a background risk for a young, healthy woman for major malformations of 2-3% and 10-20% for miscarriage, irrespective of any medicines she may take”

 “Prescribing in pregnancy must balance the risk to the fetus against the benefit to the mother” 

You can never say that a medicine is totally safe in pregnancy. You can say the medicine:

“is not associated with a risk above the normal background risk of 2- 3% for malformations and 10-20% for spontaneous abortion or miscarriage”

When maternal conditions need to be carefully controlled

e.g. depression, psychosis, diabetes, epilepsy, hypertension. The following statements may be useful:

“If the mother is stable on this medicine, then the benefit to the mother in terms of managing her condition and the risk to mother and baby of destabilising her condition, outweighs the direct risk to the fetus.”

“As the mother is stable on ‘medicine X’, risking destabilising her condition by switching to a different medicine at this stage is not necessarily recommended; however the lowest possible effective dose is always recommended”.

Example Case Study

Scenario

A practice pharmacist has been asked by a GP to look into what information there is about prescribing X for a woman with Y condition who has just been confirmed as pregnant.

• Woman is 29 years old and 6 weeks pregnant
• First pregnancy
• Condition Y which requires close control but is currently well controlled
• Has been taking medicine X until now. X is a known teratogen.

Sample answer

“All pregnancies have some risk. There is a background risk for a young, healthy woman for major malformations of 2-3% and 10-20% for miscarriage, irrespective of any medicines she may take.

Inadequate treatment of condition Y may pose a significant risk to both mother and fetus. As the mother is stable on ‘medicine X’, risking destabilising her condition by switching to a different medicine at this stage is not necessarily recommended; however the lowest possible effective dose is always recommended.

The information found suggests that the pharmacokinetics of X may alter during the pregnancy and so you should monitor for effect and adjust the dose accordingly. The main risk noted in the recommended resources is for ‘adverse effect on Z’ and at 6 weeks the Z is already formed.

However, as there is an increased risk a detailed ultrasound scan to screen for major structural malformations is recommended.”