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MEDICINES USE AND SAFETY WEBINAR

• Welcome to the MUS Webinar on Managing common mental

health conditions in pregnancy with Nicola Greenhalgh from

Central and NW London NHSFT

• The webinar itself will start at 1pm – shortly before 1pm Jane Hough will be

doing sound checks – bear with her if you hear this more than once!

• To join the audio call 0203 478 5289 access code 952 359 250

• The webinar will be recorded and both recording and slide set will be

available on the SPS website – under Networks (you need to be logged onto

the SPS site to access it)

• If you want to make a comment or ask a question – please use the “chat”

function (you need to choose to direct your question to “All Participants” from

the drop down box)

• Nicola will answer questions at the end of all the presentations

1

www.sps.nhs.uk

Upcoming MUS Events

No webinar in December

10th January 2018 – Carter in Mental Health and CHS with Prof Ann

Jacklin

14th Feb – Topic TBC

6th February 2018 – PGD Learning Event in London – details to follow

Medicines Use and Safety Update November 2017 - link

Contact LNWH-tr.MUS-SpecalistPharmacyServices@nhs.net to join

networks and receive mailings

08/11/2017 2

Managing

Common Mental

Health Conditions

in Pregnancy

Nicola Greenhalgh

Medicines Information Manager

November 2017

Objectives

Identify the major risks of untreated mental illness in

pregnancy

Understand the importance of undertaking a full risk

assessment before deciding to continue or stop

medicines in pregnancy

Discuss the up to date information on treating the most

common mental illnesses in pregnancy

Know where to find information to support women

making decisions about taking medicines in pregnancy

Why is this important

• Unintended pregnancy rates are high in the general

population and shown to be higher in those with a

mental illness

• Women are at high risk of stopping medicines once

they find out that they are pregnant

• Relapse rates are high for women in the perinatal

period

• Mental health illnesses are common

Taken from https://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html

What Women Think Those who were previously on medication for their mental health received inconsistent and conflicting advice from healthcare professionals about whether to continue or stop A number of women reported being given unhelpful advice or no advice at all about their medication. One respondent reported that her perinatal psychologist considered that the benefits of her medication outweighed the risks to the baby, while a crisis team psychiatrist told her that her medication was hurting her baby. She also faced difficulties when trying to obtain her medication, with her GP reluctant to prescribe her medication and one pharmacist refusing to fill the prescription.

“I felt that very few medical professionals

understood antenatal depression – the

discussion was focused on risk to fetus. I

wanted a termination rather than continue

without antidepressants – GP had to say

that I was likely to ‘self-harm’ to get

additional support, as focus was on

postnatal depression.”

Real Case Study

• A doctor in a community mental health team asks for

advice on switching a woman who is 8 weeks

pregnant from amitriptyline to sertraline

• Patient is well and stable on 75mg Amitriptyline daily

• Patient has asked for a switch as her community

pharmacist told her she should not take amitriptyline

in pregnancy

Valproate • Despite the well shared evidence and

MHRA alert about the risks of valproate in

pregnancy evidence is still showing that a

significant proportion of women are

unaware of the risks

• Survey by epilepsy charities in 2017

found:

– Of the women taking sodium valproate 1 in 5

(20%) said they didn’t know the risks of taking

this medicine during pregnancy. Over a quarter

(27%) of women taking sodium valproate said

they had not had a discussion with their

healthcare professional about the risks in

pregnancy.

• Professionals are still giving unclear and inadequate

advice about the risks of medicines to women who

are or may become pregnant.

Risk vs Benefit

• Untreated illness

– Direct risks

• Growing evidence to show that untreated mental illness

can lead to adverse effects in the unborn child

– Indirect risks

• Risk taking behaviour

• Poor bonding

• Poor self care

Risk Vs Benefit

• Medication

• Most medicines are no longer contraindicated by

manufacturers

– Direct risk

• Teratogenicity

• Birth outcomes

• Developmental effects

– Indirect risk

• Side effects

How do you decide on the risk?

• Individual

– What happens when they become unwell

– How serious is their illness

– What has been tried in the past

• Drug treatments

• Non-Drug treatments

– What are the current treatment options

– Are they on treatments

– What happens when they stop

What about when information is

unclear • If you are not sure of the data or on how this impacts

the individual refer to a specialist

• Be honest – admit what we don’t know

• Give the information in the best available format to

help women make decisions

New illness

• Considerations similar to non-pregnant women

• No clear agent of choice

• Consider

– Any previous history

– Previous treatment trials – what worked?

– Side effects

– Up to date data on risks of individual medicines to the baby

– Do they plan to breast feed?

Established illness

• In most cases a woman who

becomes pregnant on

medication will have taken

medicines through some of

the most vulnerable

pregnancy period

• Decisions need to be made

as to whether to switch and

expose the baby to multiple

medicines, stop the medicine

or continue on them

Depression

• Depression is very common in pregnancy

• The use of antidepressants in pregnancy has

become controversial

• Estimated that between 2-8% of pregnant women will

take antidepressants during their pregnancy

• Increased risk of Post Natal Depression

Antidepressants

• SSRI vs TCA

• Newer antidepressants

• Developmental Effects

• Switching antidepressants

SSRIs and Cardiovascular

malformations • Remains a subject for continuing debate

• Initial data suggested an increased risk of

cardiovascular malformations with paroxetine and

subsequent studies implicated other SSRIs

• Further studies and meta analyses have provided

contradictory findings and many of the studies have

not been able to accurately confound for factors

known to increase the risk of malformations such as

smoking, drug and alcohol abuse

• Any absolute increase in risk remains low

Switching Antidepressants in

Pregnancy

• There is some evidence to suggest exposure to

more than one SSRI in pregnancy poses a greater

risk of septal heart defects.

• It would therefore not be advisable to switch

between SSRIs during the first trimester.

Anxiety and Insomnia

• Anxiety in pregnancy is very common

• Can be specifically related to the

pregnancy or an anxiety condition

• Psychological treatment

• Treatment with antidepressants can be

considered for severe anxiety

• NICE guidelines recommend using

promethazine if treatment for insomnia

is indicated

• https://www.nice.org.uk/guidance/qs115

Benzodiazepines

• Studies investigating the teratogenicity of

benzodiazepines are conflicting as to whether a

possible association with increased risk of

congenital malformation, specifically of orofacial

clefts, exists.

• Older studies suggest possible increased risks of

congenital malformation, including orofacial clefts

and cardiac malformations.

• More recent, better designed studies, have failed to

identify such associations.

Benzodiazepine withdrawal

• Patients taking long term benzodiazepines who

become pregnant should be advised of the risks of

continuing benzodiazepines, particularly of risks of

withdrawal in the infant and floppy baby syndrome if

they are used to term

• Benzodiazepines should be tapered gradually to

reduce the risk of serious discontinuation symptoms

• They should not be stopped abruptly

Schizophrenia and Bipolar Disorders

• Antipsychotics are the main treatment of both

schizophrenia and bipolar disorders during

pregnancy

• Overall the data for the majority of antipsychotics do

not suggest increased risk of major malformations

or adverse foetal outcomes

• Side effects, particularly metabolic adverse effects

and effects on fertility need to be considered

• The risks of stopping antipsychotics in pregnancy

should be carefully considered

Mood Stabilisers • Sodium Valproate and Carbamazepine are

not recommended for the treatment of mood

disorders in women who may become

pregnant

• Lamotrigine may be considered however

– its long titration makes it less suitable to treat

women who become pregnant

– Complex pharmacokinetics in pregnancy

• Lithium treatment in pregnancy is complex

– Some concern over specific malformations

– Pharmacokinetic changes during pregnancy,

labour and the immediate post-natal period require

expert management and very close monitoring

• Decisions about use of medicines in pregnancy are

best made in a planned way prior to conception

• Ask women about their future plans before initiating

medicines

• Having the conversation before conception may help

to prevent patients stopping medication in an

unplanned way once they become pregnant

Consider that all women may become

pregnant

Helping patients make decisions

• Resources are now available to

help patients make informed

decisions about the use of

medicines in pregnancy

Perinatal Mental Health Services • Significant funding has been put into developing

specialist perinatal mental health services

• Many areas now have specific services to cater for

women who are pregnant or are planning a

pregnancy

• https://www.england.nhs.uk/mental-health/perinatal/

Reporting pregnancy exposure

• There is very limited

data on the use of

multiple medicines in

pregnancy

• In a study completed

in our services no

exposures to

medicines were

reported to UKTIS

• The average number

of medicines taken

by our services was

1.8

Reporting pregnancy exposure

• Any professional can report exposures to medicines

during pregnancy

• Can be done during or after the pregnancy has

completed

• http://www.uktis.org/html/reporting_exposure.html

• Patients can also report their own experiences

• http://www.medicinesinpregnancy.org/

Where Can I find Information

Where Can I find Information

Real Case Study

• A doctor in a community mental health team asks for

advice on switching a woman who is 8 weeks

pregnant from amitriptyline to sertraline

• Patient is well and stable on 75mg Amitriptyline daily

• Patient has asked for a switch as her community

pharmacist told her she should not take amitriptyline

in pregnancy

• Is the Risk worth the Benefit??

Take away points

• Consider pregnancy in all patients of child bearing

age

• Don’t panic – very few medicines taken in pregnancy

are a cause for immediate concern

• Consideration of medicines for mental health require

a full risk assessment of both the medicine and the

patient

• If in doubt refer, don’t provide information unless

you are sure it is up to date and appropriate

Questions??

n.greenhalgh@nhs.net

References

• https://www.rcog.org.uk/globalassets/documents/patients/information/mater

nalmental-healthwomens-voices.pdf

• https://www.epilepsy.org.uk/news/news/almost-one-fifth-women-taking-

sodium-valproate-epilepsy-still-not-aware-risks-pregnancy

• https://www.gov.uk/drug-safety-update/valproate-and-developmental-

disorders-new-alert-asking-for-patient-review-and-further-consideration-of-

risk-minimisation-measures

• https://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html

• https://www.nice.org.uk/guidance/qs115

• https://www.england.nhs.uk/mental-health/perinatal/

• http://www.medicinesinpregnancy.org/

• http://www.uktis.org/

• https://www.nice.org.uk/guidance/cg192

• https://www.bap.org.uk/pdfs/BAP_Guidelines-Perinatal.pdf

• http://www.bmj.com/content/339/bmj.b3569 Pedersen, L. H., Henriksen, T.

B., Vestergaard, M., Olsen, J. & Bech, B. H. Selective serotonin reuptake

inhibitors in pregnancy and congenital malformations: population based

cohort study. BMJ 339, (2009).

• Wang, S. et al. Selective Serotonin Reuptake Inhibitors (SSRIs) and the

Risk of Congenital Heart Defects: A Meta-Analysis of Prospective Cohort

Studies. J. Am. Heart Assoc. 4, (2015).

• Shen, Z.-Q. et al. Sertraline use in the first trimester and risk of congenital

anomalies: a systemic review and meta-analysis of cohort studies. Br. J.

Clin. Pharmacol. 83, 909–922 (2017).

• Bérard, A. et al. The risk of major cardiac malformations associated with

paroxetine use during the first trimester of pregnancy: a systematic review

and meta-analysis. Br. J. Clin. Pharmacol. 81, 589–604 (2016).

References

References

• Petersen, I., Evans, S. J., Gilbert, R., Marston, L. & Nazareth, I. Selective

Serotonin Reuptake Inhibitors and Congenital Heart Anomalies. J. Clin.

Psychiatry 77, e36–e42 (2016).

• Jordan, S. et al. Selective Serotonin Reuptake Inhibitor (SSRI)

Antidepressants in Pregnancy and Congenital Anomalies: Analysis of

Linked Databases in Wales, Norway and Funen, Denmark. PLoS One 11,

e0165122 (2016).

• Furu, K. et al. Selective serotonin reuptake inhibitors and venlafaxine in

early pregnancy and risk of birth defects: population based cohort study and

sibling design. BMJ 350, (2015).

• http://bmjopen.bmj.com/content/7/1/e013372 Antidepressant use during

pregnancy and the risk of major congenital malformations in a cohort of

depressed pregnant women: an updated analysis of the Quebec Pregnancy

Cohort

References

• http://www.bmj.com/content/350/bmj.h2298 Antipsychotic drug use in pregnancy: high

dimensional, propensity matched, population based cohort study

• https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2545072 Antipsychotic

Use in Pregnancy and the Risk for Congenital Malformations

• http://onlinelibrary.wiley.com/doi/10.1002/pds.1457/abstract;jsessionid=B3668A22D26

372F78589D80A1A7C6176.f02t01 Use of benzodiazepines and benzodiazepine

receptor agonists during pregnancy: neonatal outcome and congenital malformations

• Rai, D. et al. Parental depression, maternal antidepressant use during pregnancy,

and risk of autism spectrum disorders: population based case-control study. BMJ

346, (2013).

• Clements, C. C. et al. Prenatal antidepressant exposure is associated with risk for

attention deficit hyperactivity disorder but not autism spectrum disorder in a large

health system. Mol. Psychiatry 20, 727–734 (2015).

• Brown, H. K., Hussain-Shamsy, N., Lunsky, Y., Dennis, C.-L. E. & Vigod, S. N. The

Association Between Antenatal Exposure to Selective Serotonin Reuptake Inhibitors

and Autism. J. Clin. Psychiatry 78, e48–e58 (2017).

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Poll Question Number 1

Overall I found the webinar content useful to me:

• Agree strongly

• Agree

• Disagree

• Disagree strongly

08/11/2017 41

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Poll Question Number 2

I would recommend this learning event to others:

• Agree strongly

• Agree

• Disagree

• Disagree strongly

08/11/2017 42

www.sps.nhs.uk

Upcoming MUS Events

No webinar in December

10th January 2018 – Carter in Mental Health and CHS with Prof Ann

Jacklin

14th Feb – Topic TBC

6th February 2018 – PGD Learning Event in London – details to follow

Medicines Use and Safety Update November 2017 - link

Contact LNWH-tr.MUS-SpecalistPharmacyServices@nhs.net to join

networks and receive mailings

08/11/2017 43