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 f 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.
The following questions are useful to ask the mother (or the person enquiring):
- Has the mother taken the medicine already or are they considering taking it?
- Is the mother still pregnant or already given birth? Has the mother taken the medicine during pregnancy?
- Is the mother taking any other medicines (herbal, Over-The-Counter, supplements)?
- How often are they breastfeeding? Exposure to medicines in breastmilk is greatest for infants who are exclusively breastfed.
It is just as important to take a full medical and medication history of the infant:
- How old is the infant?
- Were they born prematurely or full term? If premature, how many weeks gestation were they born?
- Is the infant at increased risk of harm from a medicine (e.g. kidney or liver dysfunction)?
- Is the infant prescribed any medicines themselves?
If a mother has not started the medicine, it is easier to suggest a more suitable alternative, if one is available. If a mother is already established on a medicine, switching to an alternative because of breastfeeding may not be a suitable clinical option and may also not be practical.
Medicine considerations include:
- The proposed medicine(s) and any other medicines (including over the counter medicines or complementary medicines) the mother is taking or wants to take.
- What is the indication?
- Dose and frequency
- Route of administration
- Long or short-term administration?
- Has the medicines been taken already / taken through pregnancy or before the pregnancy or is it newly prescribed?
- Have other therapies or medicines been tried?
Know where to go for reliable breastfeeding resources.
Look at the information resources to find out if the medicine(s) are excreted into breastmilk or if there is any advisory information.
Evaluate the evidence alongside the information you have gathered about the mother, infant and medicine(s).
Use the evidence found and the information gathered to do a risk assessment for the use of the medicine during breastfeeding.
Use all the information gathered to reach an informed conclusion.
The risk assessment will enable you to formulate your answer and provide advice that informs the decision about the use of a medicine for that individual.
This will include whether there need to be any additional options to reduce the risk and what infant monitoring might be required.
Ensure you have gathered as much information as possible by completing steps 1 to 4 before contacting the service so our team can help you further.
Types of enquiry our specialist team can help with include:
- Risk assessment for breastfed infants exposed to maternal medication via breast milk for preterm and health compromised infants.
- Excretion of medicines, diagnostic agents and chemicals into breast milk.
- Effects of medicines on milk production, including the enhancement and suppression of lactation.
- Selection of the most appropriate medication in lactation for specific disease states.
- Management of breastfeeding-related conditions, e.g. pain, nipple/breast infections, engorgement, etc.
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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