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Antiepileptic drug management during pregnancy: A shared decision approach

02 June 2016
Volume 24 · Issue 5


There is an increased risk of morbidity and mortality associated with sudden withdrawal of antiepileptic drugs (AEDs). A decision to change adherence behaviour in pregnancy may be related to overestimating the risk of teratogenicity, lack of pregnancy-related knowledge and a failure by health professionals to facilitate individualised, proactive pre-conception counselling for women with epilepsy of childbearing potential. To demonstrate how women can take part in the active management of their condition, this article explores a complex decision to reintroduce AEDs following the first trimester of pregnancy. The decision has been unravelled and the complexity behind it outlined by gathering pertinent information. The risks and benefits of recommencing AEDs were identified and the evidence critically appraised. The choice of alternatives was discussed and the consequences and clinical judgement related to the decision-making process explored. The decision was evaluated for potential health outcome, impact and implications for future practice.

It is estimated that there are 81 500 women of childbearing potential (aged 12–50 years) in England with a diagnosis of epilepsy who are prescribed antiepileptic drugs (AEDs) (National Institute for Health and Care Excellence (NICE), 2013). However, lack of pre-conception counselling and failure to refer women during pregnancy for specialist support is a recurring factor for the increased risk of maternal death associated with this condition. In the 3-year period 2009–12, seizures or epilepsy were associated with 14 maternal deaths in the UK during pregnancy and the first 6 weeks postnatal; a further 12 women died between 6 weeks postnatal and 1 year following birth (Knight et al, 2014). Women from often marginalised groups were at particular risk of morbidity, as well as women who were concerned about exposing their pregnancy to AEDs (Knight et al, 2014).

The decision to continue taking AEDs during pregnancy can pose an ethical dilemma to women with epilepsy and health professionals, due to the increased risk of teratogenesis—the process by which congenital malformations are produced in an embryo or fetus—versus the risks of untreated epilepsy. Studies have found that these risks are often overestimated by women with epilepsy and clinicians, which can result in women deciding to remain nulliparous, making misguided decisions about treatment, or opting for unjustified termination of pregnancy (Sanz et al, 2001; Widnes et al, 2012). This is not helped by a paucity of literature regarding women's reproductive decision-making and their pregnancy-related knowledge (Lee et al, 2013).

National guidelines state that the majority of women who are well-informed, supported, fully counselled and receiving optimal treatment for their epilepsy have uncomplicated pregnancies, normal births and healthy children (NICE, 2013). To achieve this, Tomson and Battino (2009) suggest that pregnant women with epilepsy receive balanced information regarding the risks and benefits of AEDs to reduce what are often unnecessary concerns about their treatment, and to encourage their participation in therapeutic decisions. This requires a collaborative approach to care, especially as the continuance of AEDs is usually recommended to reduce the risk of potential harm from uncontrolled tonic–clonic seizures (Widnes et al, 2012).

To demonstrate how women can take part in the active management of their condition, a complex decision has been chosen to reintroduce lamotrigine (LTG) following the first trimester of pregnancy. The advanced clinical practitioner (ACP) aims to demonstrate a proactive approach by encouraging and empowering the woman to share the decision about her treatment and care, in line with recommendations from the Nursing and Midwifery Council (NMC, 2015). Sandman and Munthe (2009) identify that this approach to assisted decision-making is in contrast to paternalism, where the professional makes the decision based on what he or she considers is in the patient's best interest.

During the unravelling of the decision, the complexity behind it will be outlined by gathering information, the risks and benefits will be identified and the evidence critically appraised. The choice of alternatives will be discussed and the clinical judgement related to the decision-making process underpinning the ACP's practical and theoretical experience will be explored. The decision will be evaluated for potential health outcome and impact. The ACP will review the consequences of the decision and reflect on the implications for future practice. The woman in the case described in this article has been given the pseudonym ‘Beth’, to maintain her privacy and confidentiality (NMC, 2015).

Clinical decision-making process

In recent years, the NHS has encouraged health professionals to move away from a paternalistic approach to decision-making by placing patients and their families at the centre of care (Coulter et al, 2013). This approach supports the integration of patients' preferences and values, clinical expertise and the best available research evidence to enable individuals to make informed choices about their shared care (Sackett et al, 2000).

To demonstrate a shared approach to care provision, a framework was used to capture the deconstruction of a complex decision (Figure 1). This enabled the ACP to focus thoughtfully on the decision, define the alternatives, compose a hypothesis and structure a research question to determine the best available evidence that supported the woman's choice. In contrast, a more linear model for decision analysis would have been less sensitive to the woman's characteristics and the influences of the health professionals involved in her care (Tiffen et al, 2014).

Figure 1. Decision-making model.

1. Identify the decision to be made

The ACP would usually take a normative approach to clinical processing when making judgements and decisions; however, when confronted with a patient with an unpredictable health status, the complexity would be recognised. An intuitive solution would be formed, while acknowledging that diagnostic, prognostic, treatment and interventional uncertainty are likely to occur (Thompson and Dowding, 2009; Kahneman, 2012). This form of anticipation about unexpected clinical eventualities demonstrates clinical forethought and is embedded in intuitive thinking (Thompson and Dowding, 2009).

The ACP made the judgement that Beth would be at high risk of seizures if LTG was not recommenced, but acknowledged that this recommendation needed to be unravelled and supported with evidence before empowering Beth to make an informed decision. The ACP has the knowledge that LTG is one of the safer AEDs to which a developing fetus can be exposed during pregnancy, in terms of fetal malformations and postpartum cognitive development, making it the first-choice AED for women planning pregnancy and for whom this medication is appropriate (Moore and Aggarwal, 2012).

2. Gather information

The ACP facilitated an urgent appointment after receiving a referral from the community midwife. Before conducting an assessment, she documented Beth's consent and explained that her extended role as an ACP was to work in partnership with Beth, her family and her other health-care providers (NMC, 2015).

Careful consideration was given to optimise a comfortable environment with no barriers for therapeutic communication (Rushforth, 2009). This technique for patient interview embraces a collaborative approach to care, where the patient feels at ease. A detailed health history review was obtained through the collection of subjective and objective data, and an assessment of Beth's current health status was made (Appendix 1). This was a deliberate reflective investigation which started the process of formulating alternative modes of treatment management.

Paying careful attention to Beth's non-verbal behaviour, the ACP sensitively acknowledged and expressed empathy; it had taken specialists 2 years to diagnose Beth's epilepsy, during which time she lost her job and became socially isolated. The ACP conveyed understanding of Beth's frustration regarding the lack of conveyance of evidence-based contraceptive advice resulting in unplanned pregnancy, but recognised Beth's obvious joy about this unexpected surprise.

Beth stopped LTG without medical advice through fear of the baby having spina bifida, but now she was frightened of her seizures returning. Her mother endorsed this as she had witnessed the majority of Beth's seizures and expressed the impact this had on the family. However, having watched a television programme about women with epilepsy and sodium valproate, Beth's mother understood her decision.


The process of shared decision-making in prescribing and medication-taking is based on the formation of a professional partnership between the ACP, other health-care provider(s) and the patient, to help form a concordant relationship. The patient's values are fundamental in providing informed consent and the ACP, as prescriber, takes on the role of informant of the best available evidence to support choice. To reflect this process in clinical decision-making, Gillespie (2010) suggests analysis of possible professional influences, which the ACP captured on a micro, meso and macro level (Appendix 2). This process affirmed the concept that non-adherence to medication is a property of the intervention and not of the patient (May et al, 2009). As a consequence, the autonomous process of the ACP's prescribing support needed to be sustained, focusing on Beth's experience of her condition rather than the objective facts of her medication (MacDonald, 2007; Felzmann, 2012). This analysis also confirmed that the ACP is influenced by the ethical issues of autonomy, non-maleficence, beneficence and justice, and that professional standards are upheld through working within the boundaries of practice and the wider health organisation (NMC, 2015).

Gillespie (2010) proposes that nurses should move beyond simply having knowledge and develop a sense of knowing, especially through the acquisition of new knowledge specific to the patient and their individual situation. To assess the effect of this experience, a summary of knowing was formulated to capture the ACP's existing and acquired knowledge (Appendix 3). Expertise and retention of accumulative knowledge assists the decision-making process through the ability to recognise patterns and collate relevant cues and concepts (Hoffman et al, 2009). However, despite being knowledgeable and experienced, the quality of the ACP's decision-processing can still be affected by the complexities and uncertainties encountered in clinical practice (Appendix 4).


To guide the decision analysis and calculate the recurrent risk of symptomology, an explanation was provided using a hypothetico-deductive method to clinical decision-making. This included cue recognition and acquisition to help generate a hypothesis (Tanner et al, 1987). An alternative approach taken by clinicians is the use of heuristics, but this can result in an overestimation of the exactitude of their knowledge (Thompson and Dowding, 2009). Shah and Oppenheimer (2008) also identify that heuristics diminish the process of retrieving and storing information in memory.

The ACP demonstrated sensitivity to Beth's non-verbal and verbal cues (Figure 2). This required integrity, commitment and an ability to recognise, listen and respond appropriately. It was important to absorb her story and capture the emerging themes without passing judgement to help identify the risks and benefits of LTG treatment.

Figure 2. Non-verbal and verbal cues

3. Identify the alternatives

A risk assessment has been formulated from the emerging themes following clarification of the context of the decision (Figure 3). The key drivers for the decision have been explored and the general constraints considered.

Figure 3. Risk/benefit analysis

To assist with the conceptualisation and design of a research question to resolve the enquiry of risks versus benefits, a directional hypothesis was formulated: ‘women with epilepsy not treated with AEDs in pregnancy would have a significantly increased risk of seizures compared to women with epilepsy prescribed AEDs.’ This hypothesis was then adapted into a research question.

4. Weigh the evidence

Formulating the focused question

The clinical question was structured to focus on the key issues and develop an evidence-based enquiry using the population, intervention, comparator and outcome (PICO) framework (Table 1). Sackett et al (2000) explain that breaking down the question into four components facilitates the identification of relevant information.

PICO element Question Search terms Refined search
Population Pregnant woman with epilepsy Pregnan* Epilep* Pregnan*Epilep*
Intervention Prescribe lamotrigine in pregnancy Prescrib* lamotrigine Prescrib*lamotrigine
Comparison No antiepileptic drug treatment in pregnancy Untreated
  • Prevent uncontrolled seizures and associated risk factors to pregnant woman and fetus
  • Minimise exposure of developing fetus to lamotrigine
  • Seizure*Risk*

    Using the search engine DelphiS, the original search terms yielded only two relevant results, therefore further searches were made to expand evidence in the quantitative paradigms to address the enquiry. The studies identified were critiqued pragmatically for trustworthiness and evaluated in order to address the enquiry: What are the risks of untreated epilepsy versus the risks of lamotrigine treatment during pregnancy?

    Risk/benefit analysis of untreated epilepsy

    Seizure recurrence

    Vajda et al (2015) investigated seizure control and fetal malformations in pregnant women with epilepsy not treated with AEDs who enrolled on the Australian Pregnancy Register. For the analysis, there were 148 women not taking AEDs in pregnancy and 1532 taking AEDs; therefore, the results failed to reach clinical significance in some parameters. Unsurprisingly, the authors detected a significantly increased risk of seizure recurrence in the untreated group, the significance of which may have been reduced if the treated group were not fully adherent. Change in adherence behaviour related to pregnancy was identified by Man et al (2012). They researched the secular trends in AED prescribing, identifying that pregnant women with epilepsy were twice as likely to stop receiving AEDs, compared to non-pregnant women with epilepsy.

    There was no information on morbidity or mortality associated with non-adherence of AEDs in the Vajda et al (2015) study. This is in contrast to findings from a large cohort study of people with epilepsy, which determined more than a threefold increased risk of mortality compared to adherent patients. Time periods of non-adherence were also significantly associated with an increased risk of emergency department admissions as a result of injuries and fractures (Faught et al, 2008).

    Risk of congenital malformations

    Vajda et al (2015) identified that the withdrawal of AEDs before pregnancy did not reduce the hazard of fetal malformations unless it avoided topiramate or valproate.

    Risk to mental health

    As AEDs have a positive modulating effect on psychiatric comorbidity, continuing to be non-adherent may have a negative impact on mental wellbeing. Women with epilepsy are at increased risk of depression and anxiety, which has been linked to reduced gestational age at birth (Broekman et al, 2014; Chang et al, 2014). A large cohort study highlighted that epilepsy is associated with psychiatric disease and adverse social factors before and during pregnancy (Reiter et al, 2013).

    Risks associated with lamotrigine treatment


    Data from the eighth report of the Confidential Enquiries into Maternal Deaths in the UK revealed 9/14 women who died through epilepsy were taking LTG; seven in monotherapy and two in polytherapy (Lewis, 2012). The report concluded that LTG was associated with an increased number of maternal deaths and suggested this may be due to fluctuating AED blood levels. In contrast, findings from the 2009–12 report identified 4/14 women who died were taking LTG (Knight et al, 2014). The publication of the earlier findings was detrimental for many women initiating LTG following epilepsy diagnosis, and many women with epilepsy already established on LTG underwent medication changes without assessment of individual risk factors. It is inevitable that LTG will dominate pregnancy statistics, because it has been progressively prescribed for women of childbearing potential in preference to older AEDs (Man et al, 2012).

    Risk of congenital malformation

    The International Lamotrigine Pregnancy Registry enrolled 3416 pregnancies from 43 countries in 18 years (Sinclair et al, 2014). The prevalence of major congenital malformations following first trimester LTG monotherapy exposure was 2.2% (95% confidence interval (CI): 1.6–3.1%). These data were from 2444 known outcomes; a further 972 (28.5%) outcomes were lost to follow-up (Sinclair et al, 2014), and this attrition may have affected the validity of these statistics. Despite this, major congenital malformation outcomes from the main epilepsy pregnancy registers were comparable for LTG exposure during the first trimester. However, the differing methodology may affect the reliability of this comparison (Campbell et al, 2014). The rate of major congenital malformations with LTG is comparable to a 2.4% prevalence rate in the European population without epilepsy (Dolk et al, 2010).

    There are no published data on LTG exposure exclusively to 6 weeks' gestation or following introduction beyond the first trimester. This is in contrast to studies published for other drugs prescribed during pregnancy (Cooper et al, 2006; Nakhai-Pour and Bérard, 2008).

    Neural tube defect risk

    Neural tube defects affect approximately 1/1000 pregnancies (Copp et al, 2013). Closure of the posterior neuropone occurs at 26–28 days post-fertilisation, so the critical time of medication exposure is before most women realise they are pregnant (Greene and Copp, 2009). In January 2015, there were 2362 completed pregnancies registered with the UK Epilepsy and Pregnancy Register on LTG monotherapy, along with one termination of pregnancy at 21 weeks' gestation for spina bifida and one termination at 13 weeks' gestation for acrania (Irwin, 2015, personal communication). This information confirmed the same incidence as maternities not exposed to LTG.

    Risk of long-term cognitive effects on fetus

    Valuable data have been published from the first prospective study documenting cognitive abilities of children of school age exposed to either sodium valproate, carbamazepine or LTG in utero (Baker et al, 2015). This study demonstrated that LTG did not have a significant effect on IQ or specific verbal, non-verbal or spatial awareness, in comparison to control children. The authors suggest more research is required to see whether there is a dose relationship with child IQ and higher executive functioning, as is the case with sodium valproate.

    5. Choose from alternatives

    A decision tree has been graphically created to capture the alternative choices of treatment management that were presented to Beth in a ‘think aloud’ technique during the consultation (Figure 4). Lundgrén-Laine and Salanterä (2010) have researched the use of this verbal decision-making method in combination with protocol analysis and report that it functions well among health professionals in acute care settings.

    Figure 4. Decision tree

    After being presented with evidence, Beth was asked about her perception of risks in comparative terms; this method has been shown to be more accurate and less likely to be overestimated than using numerical terms in assessment of accurate risk judgement. She was asked whether she believed the risk was higher if she remained unmedicated or lower if LTG was recommenced. She decided it was higher if she remained unmedicated. This may have been influenced by situational cues as being asked her opinion in a health-care setting was new territory for Beth (Slovic, 2000). Her estimation may also have been different had her mother not been present.

    A spontaneous, methodological approach was taken in discussing the alternative treatment option which embraced respect of Beth's choice(s) and facilitated engagement in the decision about her care (Richmond Group and The King's Fund, 2012). The ACP advised that a decision would not have to be made immediately; it was important that Beth had time to share and reflect on the information with her husband and family.

    Following this discussion, the ACP helped Beth navigate her baby's development week by week from conception on the NHS Choices (2014) website. This demonstrated how reintroduction of LTG beyond the first trimester is associated with a dramatic reduction of congenital malformations as the fetus is fully formed.

    6. Implement alternative chosen

    Having made the decision to reinstate LTG, Beth decided she would delay this until at least 12 weeks unless she had seizure recurrence, in which case she would take emergency medication on a temporary basis until LTG was titrated to a therapeutic dose. As a non-medical prescriber, it is ethical and a professional requirement to share the decision process with the health professionals involved in the health-care partnership. The widely used communication tool SBAR (situation, background, assessment and recommendation) was used to frame a conversation with the clinician regarding Beth's decision (NHS Institute for Innovation and Improvement, 2008) (Figure 5).

    Figure 5. Situation, background, assessment and recommendation (SBAR)

    The response of the clinician was to say the forgotten appointment demonstrated that Beth was not taking responsibility for her epilepsy and probably never takes her medication. The clinician did not want to see Beth in clinic but suggested the GP re-refer her in 11 months and added: ‘She did not tell me that she wanted to get pregnant.’ Croskerry and Chisholm (2005) suggest a disaffected relationship between clinician and patient may be multi-factorial. The triggers may have included stereotyping of non-attendees or disconnection with the patient. This behaviour was dispassionate and in contrast to clinical acumen. It could also be argued the clinician had little experience in shared decision-making despite awareness of its importance. The merging of this method with medicine has not been fluid and the barriers in place maintain a heuristically paternal approach represented in this clinical situation.

    A shared care plan was formed with Beth to inform other health partners of her management. The GP was faxed a transcript of the prescribing decision and information of the risk/benefit discussion; this was copied to Beth, her clinician and obstetrician. A copy was placed in her handheld maternity notes and entered in the obstetric records. Beth was advised that this information would be updated if her decision changed.

    7. Review the decision

    Beth did not receive pre-conception counselling and confirmed that her decision to discontinue LTG in pregnancy was associated with low-level pregnancy-related knowledge, highlighting the importance of timely education on pregnancy-related issues. The ACP's fear of risks associated with non-adherence to AEDs may have influenced Beth's choice of alternatives due to her ethics and professional responsibilities of non-maleficence and beneficence. Pre-conception counselling would have enabled Beth to make an informed choice about suitable contraception and facilitated informed, shared decision-making regarding AED treatment options.

    The drawback of using the hypothetico-deductive method was that the cues may have been misinterpreted and the subsequent trajectory may have led to an inaccurate or misinformed decision (Carnevali and Thomas, 1993). Banning (2008) explained that if reliant solely on memory, the technique of cue and pattern recognition in decision-making can be inaccurate. Although representative of paternalism, the use of heuristics would have only been useful in channelling the decision-making process. This can be seen as taking mental shortcuts to reduce the burden of information gathering, especially within clinical appointment time constraints.

    The decision tree to assess the alternatives was unique to Beth, and calculation of her individual preferences will limit its reproducibility. To reflect on the decision, the ACP conducted further sensitive analysis of the probabilities and utilities by considering the collated data using the PROACTIVE mnemonic (Hunink et al, 2001) (Appendix 5). This helped define the problem from multiple perspectives, focus on the objectives and explore the alternatives, and consider the consequences and trade-offs. There were limitations to this method of analysis but, given the complexity and uncertainty of the decision of health status, it demonstrated the evaluation of evidence-based practice and provided a systematic approach that incorporated the alternatives and consequences enriched from information collated from the risk/benefit assessment.

    When choice and control is extended to patients, they usually embrace this with enthusiasm. Health professionals should ensure that patients or clients always come first by fully involving them, their families, carers, communities and professionals inside and outside the NHS (Department of Health, 2014).

    Conclusions and implications for practice

    There are potentially significant risks to the health and wellbeing of women with epilepsy and their unborn babies related to the clinical decision discussed in this article. Reconstructing these processes throughout this reflective article was valuable as it enabled the ACP to reflect externally on social and cultural influences that constituted the judgement competencies, in addition to identifying internal personal flaws and biases.

    The structuring of this decision through the identification of choices and values can improve future decision quality. However, as there is no clinical guidance for this type of decision-making in pregnancy, a reliance on non-linear reasoning and intuition will continue, with the danger of overuse of heuristics leading to inaccurate estimation of risk and intervention. In contrast, the increased availability of evidence-based information regarding the teratogenicity of AEDs in pregnancy exposure improves the ACP's ability to support pre-conception prescribing decision-making in women with epilepsy. A degree of uncertainty will always remain, however, and this will continue to be explained to patients in an open, transparent manner.

    Currently, referrals are received from across England but future efforts will be made on increasing the visibility of specialist services for women with epilepsy, to ensure more women benefit from proactive pre-conception and pregnancy counselling. This type of service facilitates timely reassessment of diagnosis and treatment and the opportunity of a risk/benefit analysis to embrace informed shared decision-making, ideally before women with epilepsy consider planned pregnancy.

    Key Points

  • Lack of pre-conception counselling and failure to refer women during pregnancy for specialist support is a recurring factor for the increased risk of maternal death associated with epilepsy
  • Women who are well-informed, supported, fully counselled and receiving optimal treatment for their epilepsy are more likely to have uncomplicated pregnancies, normal births and healthy children
  • There has been a move away from a paternalistic approach to decision-making to placing individuals and families at the centre of care
  • In the case discussed in this article, a spontaneous, methodological approach was taken in discussing alternative treatment options, which embraced choice and facilitated engagement in decision-making
  • The increased availability of evidence-based information regarding teratogenicity of antiepileptic drugs improves the advanced clinical practitioner's ability to support pre-conception prescribing decision-making in women with epilepsy
  • Appendices: For Appendices 1, 2, 3, 4 and 5, please see the online version of this article at