medicines use and safety webinar - sps · congenital malformation, specifically of orofacial...
TRANSCRIPT
www.sps.nhs.uk
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 [email protected] 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??
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).
www.sps.nhs.uk
Poll Question Number 1
Overall I found the webinar content useful to me:
• Agree strongly
• Agree
• Disagree
• Disagree strongly
08/11/2017 41
www.sps.nhs.uk
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 [email protected] to join
networks and receive mailings
08/11/2017 43