1. Handling calls about medicines during pregnancy & breast feeding Caroline Riddle & Alison Alvey South West Medicines Information Service

2. Handling calls about medicines during pregnancy & breastfeeding Timetable 9.30Introduction & learning outcomes Medicines during pregnancy Workshop 1 11.00Tea break Medicines when breast feeding Workshop 2 12.30Review of learning outcomes and close

3. Handling calls about medicines during pregnancy & breastfeeding Learning Outcomes By the end of this session participants will be able to: Provide general advice on the use of medicines during pregnancy and breast feeding. List the resources available to assist with these types of enquiries. Gather necessary background information to be able to clarify the question.

4. Handling calls about medicines during pregnancy & breastfeeding Types of Enquiries Which is the most appropriate medicine for a particular condition in pregnancy or breast feeding? e.g. choice of antihistamine in pregnancy? e.g. choice of analgesic in breast feeding? Assessing the risk of a medicine when exposure during pregnancy or breast feeding has already occurred? e.g. risks of exposure from a course of antibiotics when lady had not realised she was pregnant? e.g. possible effects in breast fed baby from the mum’s analgesic use?

5. Handling calls about medicines during pregnancy & breastfeeding Medicines during pregnancy Increased public awareness and concern since the thalidomide tragedy. Background rate of 2-3% for major congenital malformations. Over 75% of these are of unknown aetiology. Virtually all medicines cross the placenta and reach the foetus in measurable concentrations. Medicines do not need to cross the placenta to affect the foetus. Many pregnancies are unplanned and medicines will have been taken inadvertently Medicines can not always be avoided, especially in the treatment of long-term conditions.

6. Handling calls about medicines during pregnancy & breastfeeding Teratogen Any agent which given in pregnancy that directly or indirectly causes structural or functional abnormalities in the foetus or child after birth. CocaineCNS, intestinal & kidney damage Anticonvulsants (carbamazepine, valproate, phenytoin) Facial defects, mental retardation RetinoidsCranio-facial, CVS & CNS defects NSAIDsClosure of ductus arteriosis WarfarinFoetal warfarin syndrome

7. Handling calls about medicines during pregnancy & breastfeeding Identification Of Teratogens Many possible causes for a birth defect (genetic, physiological, nutrition, medicines, pollutants). Extremely difficult to determine whether or not a particular agent is a teratogen. Clinical trials of medicines in pregnant women is usually unethical. Difficult to extrapolate findings in animal studies to a human pregnancy. Risk of teratogenecity may increase if the number of different medicines is increased.

8. Handling calls about medicines during pregnancy & breastfeeding Timing Of Exposure 1st Trimester (1- 12 weeks post LMP) Up to 2 weeks, “all or nothing” effect Weeks 3-8, major organ systems being formed 2nd Trimester (4th – 6th month) Cerebellum & urogential system still forming Growth and functional development 3rd Trimester (6th – 9th month) Specific effects e.g. NSAIDs (pulmonary hypertension) B- blockers (hypoglycaemia) Near Term/During labour Adverse effects on labour or on neonate after delivery.

9. Handling calls about medicines during pregnancy & breastfeeding Potential Adverse Effects Spontaneous abortions Intra-uterine growth retardation Prematurity Stillbirths Obstetric complications Neonatal side effects Withdrawal reactions Drug side effects in neonate

10. Handling calls about medicines during pregnancy & breastfeeding General Advice for Medicines in Pregnancy Consider non-drug treatments. Only prescribe medicines if absolutely necessary. Avoid all medicines in the 1 st trimester if possible. Assess benefit/risk ratio for both mother & infant. Avoid new medicines as usually more experience with well- established ones. Use the lowest effective dose for as short a time as possible. Avoid polypharmacy

11. Handling calls about medicines during pregnancy & breastfeeding Essential questions to ask Is lady pregnant or planning to become pregnant? Her age? Has she already taken the medicine(s)? Has this been prescribed or self-treating? Medicine(s), indication, dose, frequency, route & duration of exposure? Number of weeks pregnant at time of exposure? How is pregnancy progressing? Any previous pregnancies & outcomes?

12. Handling calls about medicines during pregnancy & breastfeeding Information sources eBNF (Appendix 4 -pregnancy) www.medicinescomplete.com www.medicinescomplete.com NHSD Medicines Q&As – can be used as a sole resource. Access through NHSD intranet Electronic Medicines Compendium (eMC) www.medicines.org.uk www.medicines.org.uk Toxbase www.spib.axl.co.ukwww.spib.axl.co.uk

13. Handling calls about medicines during pregnancy & breastfeeding Limitations of Information sources eBNF – Appendix 4: Not all medicines are listed If a medicine is not listed cannot assume it is safe Medicine may be listed under class rather than individual medicine name Not very detailed information Manufacturer’s information is often quoted (often very cautious) Info not usually suitable to read out to caller – may alarm them unnecessarily NHSD Q&As: Only a limited number available

14. Handling calls about medicines during pregnancy & breastfeeding Limitations of Information sources eMC: Statements often based on legal concerns rather than evidence Advice normally very cautious Where no information available usually advise to avoid Toxbase: Some monographs not been updated Requires evaluation/interpretation

15. Handling calls about medicines during pregnancy & breastfeeding When to refer If there is no information or information is unclear or conflicting Medicine has been taken but info sources say to avoid in pregnancy. If pregnant lady has taken a known teratogen If pregnant lady is on medicines to control long term conditions. Will need to discuss treatment plan with her Dr. Many pregnancy enquiries will require referral to GP/midwife or onto UKMI.

16. Handling calls about medicines during pregnancy & breastfeeding Workshop: Medicines during Pregnancy

17. Handling calls about medicines during pregnancy & breastfeeding Tea Break

18. Handling calls about medicines during pregnancy & breastfeeding Timetable 9.30Introduction & learning outcomes Medicines during pregnancy Workshop 1 11.00Tea break Medicines when breastfeeding Workshop 2 12.30Review of learning outcomes and close

19. Handling calls about medicines during pregnancy & breastfeeding Medicines when breastfeeding Distinct from medicines use in pregnancy Most medicines are unlicensed for use in breast- feeding Information is sparse on the effects, so often prefer older medicines that have more data

20. Handling calls about medicines during pregnancy & breastfeeding

21. Advice on infant feeding Breast milk is the best form of nutrition for infants. Exclusive breastfeeding for the first 6 months. Breastfeeding (and/or formula milk) with appropriate solid food after 6 months, ideally for up to 1 year. Mothers unable (or choose not) to breastfeed should be helped to optimise infant feeding.

22. Handling calls about medicines during pregnancy & breastfeeding How much of the medicine reaches the baby? Depends on: Plasma concentration of medicine in the mother. Characteristics of the medicine. Amount of medicine passed into breast milk. Amount of milk taken by baby per feed (approx 150mL/kg).

23. Handling calls about medicines during pregnancy & breastfeeding General advice Avoid unnecessary use of medicines. Assess risk / benefit for mother and baby. Higher risk for premature babies. Check if medicine licensed for babies. Avoid long-acting medicines Avoid black-triangle medicines. Try to time feed to avoid when drug levels in milk are highest. Monitor baby for adverse effects.

24. Handling calls about medicines during pregnancy & breastfeeding Essential questions to ask Has mum already taken the medicine(s) or is she wanting to take? Medicine(s), indication, dose, frequency, route & duration of exposure? Has this been prescribed or self-treating? Have any other medicines been considered or tried? What age is the baby? Full term & healthy? How often is baby feeding? – Totally breast fed or bottle too?

25. Handling calls about medicines during pregnancy & breastfeeding Information sources eBNF (Appendix 5 – Breast feeding) Electronic Medicines Compendium (eMC) NHSD Medicines Q&As UKMi Central www.ukmicentral.nhs.uk

26. Handling calls about medicines during pregnancy & breastfeeding Limitations of Information sources eBNF – Appendix 5 Not all medicines are listed If a medicine is not listed cannot assume it is safe Not very detailed information Good place to start eMC Statements often based on legal concerns rather than evidence Where no information available usually advise to avoid When it is known that the medicine appears in breast milk, but no further details are available, caution is usually advised NHSD Q&As Only a limited number available

27. Handling calls about medicines during pregnancy & breastfeeding Information sources – UKMi central Web site of the MI services that jointly provide the UK Drugs in Lactation Advisory Service Provides brief guidance for a number of drug groups such as anti-asthma agents & NSAIDs Includes preferred agents for use in lactation & monitoring advice A quick reference guide lists meds by pharmacological group Each medicine or group is then classified according to risk

28. Handling calls about medicines during pregnancy & breastfeeding Guide to Assessing Risk Medicines unsuitable for BF mothers - to be avoided Use with caution and monitor baby Medicines which appear safe - may be given 1 UKMi Drugs in Lactation Advisory Service 1

29. Handling calls about medicines during pregnancy & breastfeeding When to refer If there is no information or information is unclear or conflicting. Medicine has been taken but info sources say to avoid in breast feeding. Mother is taking multiple medicines Baby was born pre-term and/or has medical conditions. Many breast feeding enquiries may need to be referred on to GP/midwife etc.

30. Handling calls about medicines during pregnancy & breastfeeding Quiz & Workshop 7: Medicines when Breastfeeding

31. Handling calls about medicines during pregnancy & breastfeeding Learning Outcomes By the end of this session participants will be able to: Provide general advice on the use of medicines during pregnancy and breast feeding List the resources available to assist with these types of enquiries Gather necessary background information to be able to clarify the question