Information should be gathered on both the mother and the infant. Questions are provided to help determine clinical details

Importance of the risk assessment

Breastfeeding women might have taken medicines through pregnancy or may be newly prescribed medicines after the birth. Sometimes the mother may need to restart a medicine which had been stopped or changed through the pregnancy. The ideal scenario is to complete a risk assessment before the medicine is started, or during pregnancy, so that a care plan is already in place.

Challenges of the risk assessment

Assessing risk is particularly challenging because of the lack of information on excretion of drugs into breastmilk and how much of this may get into the infant’s body.

Risk is assessed on an individual basis and so it is not possible to produce lists of ‘safe’ or ‘unsafe’ medicines. Other factors, particularly the age and prematurity of the infant, must be also be considered. The pharmacokinetics, and therefore any advice, will be very different for a newborn or premature infant being fed on demand compared with an older infant having night-time comfort feeds.

The overall aim should be to allow the mother to continue breastfeeding where possible. Advising the mother to stop breastfeeding is not a ‘no-risk’ option as it denies the infant and mother all the benefits of breastfeeding.

Importance of asking questions

Full details about the mother, the infant and the medicine are needed to inform the risk assessment for each individual situation.

Identifying risk factors

Most medicines will be excreted into breastmilk to a greater or lesser extent.

It cannot be assumed that a medicine that was safe or unsafe during pregnancy will have the same risk during breastfeeding. This is because the infant now has to rely on its own excretion and metabolism, rather than the maternal systems through pregnancy.

The mother can continue to breastfeed whilst receiving treatment in the majority of cases. Adverse outcomes can often be avoided by appropriate therapy or careful monitoring, informed by a good risk versus benefit assessment.

Informing risk versus benefit assessment

It is important to consider the (usually poorly defined) risk of medicine exposure to the infant through breastmilk when prescribing for a breastfeeding woman, balanced against the risks to both mother and infant from either failing to treat the maternal condition or from having to discontinue breastfeeding.

A risk assessment for the use of a medicine in breastfeeding is still required, even if the medicine was taken throughout pregnancy.

Gathering and using information

The information you need to establish if medicine(s) are compatible with breast feeding and therefore formulate a suitable response to your enquiry indicated in the following sections. You might not be able to get all this information, but it is important to get as much as possible.

We have produced a template on which you can record your findings and attach to the patient records, where available.

Checklist to download

The template below can be downloaded and used to record responses during discussions with mothers or others. The completed form can be uploaded to a person’s medical record.

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