Epilepsy - CPPE...Epilepsy ook 1 2 5 About CPPE focal point programmes We have developed focal point...

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CENTRE FOR PHARMACY POSTGRADUATE EDUCATION Epilepsy A CPPE focal point programme Book 1 FP128/1 September 2016

Transcript of Epilepsy - CPPE...Epilepsy ook 1 2 5 About CPPE focal point programmes We have developed focal point...

CENTRE FOR PHARMACYPOSTGRADUATE EDUCATION

Epilepsy

A CPPE focal point programme Book1

FP128/1September 2016

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Content contributorsJuliet Ashton, nurse consultant, epilepsy commissioning and education, Epilepsy SocietyRebecca Case, clinical nurse specialist, University Hospital SouthamptonShelley Jones, neuroscience pharmacist, Kings College Hospital/United Kingdom Clinical Pharmacy AssociationTrudy Thomas, senior lecturer, director of taught graduate studies, Medway School of PharmacyBen Dorward, neuroscience pharmacist, Sheffield Teaching Hospitals/United Kingdom Clinical Pharmacy AssociationDavid Branford, pharmacist advisor for mental health and learning disabilitiesDiar Fattah, head of medicines optimisation, NHS Dartford, Gravesham and Swanley and CPPE tutorGeraldine Flavell, regional manager, CPPERajesh Jethwa, lead pharmacist, Epilepsy Society and the National Hospital for Neurology and Neurosurgery, University College London HospitalsRachel Rose, community pharmacist and CPPE tutorNatasha Ubhoo, community pharmacistTrudi Ward, pharmacy technician lecturer, Birmingham Metropolitan College and CPPE tutor

CPPE programme developer Clare Smith, senior pharmacist, learning development, CPPE

ReviewersBen Dorward, neuroscience pharmacist, Sheffield Teaching Hospitals/United Kingdom Clinical Pharmacy AssociationRajesh Jethwa, lead pharmacist, Epilepsy Society and the National Hospital for Neurology and Neurosurgery, University College London Hospitals

CPPE reviewersPaula Higginson, lead pharmacist, learning developmentAnne Cole, regional manager, South West

Piloted byJanet Rittman, tutor, CPPE

EditorPaddy McLaughlin, assistant editor, CPPE

DisclaimerWe have developed this learning programme to support your practice in this topic area. We recommend that you use it in combination with other established reference sources. If you are using it significantly after the date of initial publication, then you should refer to current published evidence. CPPE does not accept responsibility for any errors or omissions.

External websites CPPE is not responsible for the content of any non-CPPE websites mentioned in this programme or for the accuracy of any information to be found there.

All web links were accessed on 18 August 2016.

Brand names and trademarksCPPE acknowledges the following brand names and registered trademarks mentioned throughout this programme: Buccolam®, Depo-Provera® , Epilim®, Chronosphere®, Epistatus®.

Published in September 2016 by the Centre for Pharmacy Postgraduate Education, Manchester Pharmacy School, The University of Manchester, Oxford Road, Manchester, M13 9PT. www.cppe.ac.uk

ProductionDesign and artwork by Gemini West LtdPrinted by Gemini Print LtdPrinted on FSC® certified paper stocks using vegetable-based inks.

© Copyright Controller HMSO 2016

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Contents

Learning with CPPE 4

About CPPE focal point programmes 5

About this focal point programme on epilepsy 6

Learning objectives 7

Useful resources 8

Checklist for planning 10

Moving into focus 11

What do you want to learn? 13

Learning, practice points and talking points 14

Directing change 35

Checklist for action 36

References 37

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Learning with CPPEThe Centre for Pharmacy Postgraduate Education (CPPE) offers a wide range of learning opportunities in a variety of formats for pharmacy professionals from all sectors of practice. We are funded by Health Education England to offer continuing professional development for all pharmacists and pharmacy technicians providing NHS services in England. For further information about our learning portfolio, visit: www.cppe.ac.uk

We recognise that people have different levels of knowledge and not every CPPE programme is suitable for every pharmacist or pharmacy technician. We have created three categories of learning to cater for these differing needs:

Core learning (limited expectation of prior knowledge)

Application of knowledge (assumes prior learning)

Supporting specialties (CPPE may not be the provider and will direct you to other appropriate learning providers).

This is a 2 learning programme and assumes that you already have some knowledge of the topic area.

Continuing professional development - You can use this programme to support your continuing professional development (CPD). Consider what your learning needs are in this area. You can record your CPD online by visiting: www.uptodate.org.uk

Programme guardians - CPPE has a quality assurance process called programme guardians. A programme guardian is a recognised expert in an area relevant to the content of a learning programme who reviews the programme every six to eight months. Following the regular programme guardian review we develop an update to inform you of any necessary corrections, additions, deletions or further supporting materials. We recommend that you check you have the most recent update if you are using a programme more than six months after its initial publication date.

Feedback - We hope you find this learning programme useful for your practice. Please help us to assess its value and effectiveness by visiting your learning record in the My CPPE section on our website: www.cppe.ac.uk/mycppe/record

Alternatively, please email us at: [email protected]

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About CPPE focal point programmesWe have developed focal point to give you short, clinically focused learning sessions. It will help you learn with your colleagues and improve the services you offer your patients. Each programme presents information and activities that are relevant for pharmacy professionals working in primary care and in the community. There are two types of learning event for you to choose between when using focal point programmes – you can either attend a CPPE tutor-led event or can learn as part of a CPPE learning community. Have a look at the CPPE website: www.cppe.ac.uk for more information about how to set up a learning community.

Reference sources for all the books, articles, reports and websites mentioned in the text can be found at the end of the programme. References are indicated in the text by a superscript number (like this3).

This book gets you started. It provides key information to help you meet the learning objectives presented overleaf, but it also encourages you to identify your own learning needs. It then challenges you to relate what you have learnt to your own area of practice and professional development. We have included practice points and talking points to stimulate your thinking and we will refer to these again at the focal point event. Make sure you have studied these activities before your event.

You will receive Book 2 when you attend the focal point event. It uses case studies and clinical vignettes to help you apply what you have learnt and encourages you to make changes to improve your practice. We also include some suggested answers to the learning activities.

A note about web links

Where we think it will be helpful we have provided web links to take you directly to an article or specific part of a website. However, we are aware that web links can change. If you have difficulty accessing any web links we provide, please go to the organisation’s home page or your preferred internet search engine and use appropriate key words to search for the relevant item.

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About this focal point programme on epilepsy The aim of this focal point programme is to enable you to develop your knowledge and skills in the holistic management of epilepsy, in order to support patients and their relatives and carers more effectively as part of a wider multidisciplinary team.

In this programme we consider:

n the incidence, definition and diagnosis of epilepsy

n the pharmacological and non-pharmacological management of epilepsy

n ways in which to support women considering starting a family, from pre-conception through to pregnancy

n signposting patients living with epilepsy and/or their carers to useful resources.

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Learning objectivesYou can use our programmes to support you in building the evidence that you need for the different competency frameworks that apply across your career. These will include building evidence for your Foundation pharmacy framework (FPF) and supporting your progression through the membership stages of the Royal Pharmaceutical Society (RPS) Faculty.

As you work through the programme consider which competencies you are meeting and the level at which you meet these. What extra steps could you take to extend your learning in these key areas?

After completing this focal point programme, you should be able to:

n list the causes of epilepsy, potential trigger factors and safety risks

n discuss the principles of epilepsy treatment and the various treatments available

n provide individualised information for people with epilepsy on concurrent issues such as contraception, pregnancy and driving

n outline the considerations for children, older people and people with a learning disability who also have epilepsy

n signpost patients, carers and other healthcare professionals to local and national epilepsy pathways and other additional resources for further help and support.

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Useful resourcesWe have selected some resources that you can use when developing improved pharmacy services for people with epilepsy.

Patient support

The two main epilepsy charities have helplines, patient forums and local groups as well as a wealth of other information.

n Epilepsy Action – www.epilepsy.org.uk

n Epilepsy Society – www.epilepsysociety.org.uk

Other sources of information include:

n Young Epilepsy – www.youngepilepsy.org.uk

n Epilepsy and pregnancy register – www.epilepsyandpregnancy.co.uk

n SUDEP Action – www.sudep.org

n DVLA – www.gov.uk/driving-medical-conditions

n Carers Direct – www.nhs.uk/Conditions/social-care-and-support-guide/Pages/carers-direct-helpline.aspx

n Equality and Advisory Service – www.equalityadvisoryservice.com

n Disabled Living Foundation – www.dlf.org.uk

Community pharmacy services support

Epilepsy Society – www.epilepsysociety.org.uk/forpharmacists

The Epilepsy Society has a range of resources for healthcare professionals, particularly pharmacists. You can find out more information by visiting the Services section on the website and then choosing Professionals, followed by For pharmacists.

Here you will find the following resources:

n Medicines use review – epilepsy consultation brief

n Epilepsy Society smartphone app

n Antiepileptic drugs booklet

n Updated MHRA advice on prescribing antiepileptic drugs (AEDs).

More information can be found about the ketogenic diet here – www.gosh.nhs.uk/health-professionals/clinical-guidelines/ketogenic-diet

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Consultation skills for pharmacy practice

www.consultationskillsforpharmacy.com

The Consultation skills for pharmacy practice website has been developed to support you on your journey towards being the best you can be when speaking and consulting with patients and people about their medicines and lifestyle choices. It supports you to meet the practice standards for consultation skills and deliver patient-centred care.

Clinical knowledge and therapeutics support

Clinical knowledge summaries for epilepsy http://cks.nice.org.uk/epilepsy

The CKS website includes information on the following:

n Diagnosis and assessment

n Management of epilepsy

n Women of childbearing age.

National Institute for Health and Care Excellence (NICE) www.nice.org.uk

n Epilepsies: diagnosis and management clinical guideline 137 www.nice.org.uk/guidance/cg137

n Epilepsy in adults quality standard 26 www.nice.org.uk/guidance/qs26

n Epilepsy in children and young people quality standard 27 www.nice.org.uk/guidance/qs27

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a toolkit which includes a booklet for patients to read alongside the patient information leaflet. www.gov.uk/government/publications/toolkit-on-the-risks-of-valproate-medicines-in-female-patients

Royal College of Obstetricians and Gynaecologists

Epilepsy in pregnancy. Green-top Guideline No. 68. June 2016.

www.rcog.org.uk/globalassets/documents/guidelines/green-top-guidelines/gtg68_epilepsy.pdf

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Checklist for planningTo meet the learning objectives you will need to carry out the activities listed in the table below. We’ve given you this list now so that you can start to plan your learning. Although it will only take you about two hours to work through Book 1, feedback from other users suggests that it is useful to plan your activities over a timescale that suits you – perhaps over several days. Try to set yourself a realistic deadline for each task.

Actions This will take I will do this about: by: (Insert date)

Answer the Moving into focus 5 minutes questions

List three learning needs 5 minutes

Read the whole book 60 minutes

Undertake the practice points 20 minutes

Make notes for the talking points 20 minutes

Work through your own 20 minutesDirecting change exercise.

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Moving into focusConsider the following questions. Use them to focus your thoughts and stimulate your learning. Are you confident you know the answers?

1. Would you know how to help a patient having a seizure? Watch this video produced by Epilepsy Action to find out more: www.epilepsy.org.uk/involved/campaigns/take-epilepsy-action

Think about what you and your team could do to support somebody having a seizure. Do you have a seizure response plan in place in your pharmacy?

2. Why is dose titration usually needed when antiepileptic drugs (AEDs) are prescribed?

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3. Evelyn Hughes is 79 and one of your regular patients. She has asked for somebody to review her epilepsy medicine as she is getting confused. How confident do you feel carrying out a review of Mrs Hughes’ medicines? Where would you look to find appropriate information to support you?

4. Aleksy Kowalski, a 21-year-old man, is a regular patient at your pharmacy, having been diagnosed with epilepsy two years ago. He tells you he has been forgetting to take his medicines at times and has recently had a few seizures as a consequence. How could you help him to remember to take them?

5. Where can you signpost patients with epilepsy and their carers for further support and services?

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What do you want to learn?Write down three things that you would like to gain from this focal point programme. These will help you plan your own CPD entry. You will need to tell others about them at the focal point event.

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Now you have completed your reflection and planning for this focal point programme, it’s time to undertake the background learning.

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Learning1. What is epilepsy?In this section we assume that learners have prior knowledge of epilepsy and how seizures are categorised. If you want to refresh your knowledge, we advise that you take a look at the Epilepsy advice and information – epileptic seizures explained section on the Epilepsy Action website.

www.epilepsy.org.uk/info/seizures-explained

1.1 Epidemiology

Epilepsy is the most common neurological condition in the UK, affecting around 600,000 people. This is equivalent to approximately one in 103 people1. The incidence is found to be high in childhood, then decreases in adulthood and rises again in older people2. Epilepsy prevalence is 25 percent higher in the most socially deprived areas, compared to the least socially deprived areas. More than one in five people with epilepsy also have a learning disability1.

1.2 Definition

Epilepsy is characterised by recurrent seizures, caused by a sudden burst of intense electrical impulses in the brain. It is not classed as a single condition. There are over 40 different types of epilepsy, at least 29 syndromes (epilepsies with specific signs and symptoms, including seizure type, age of onset, and a specific electroencephalogram (EEG) pattern), and the management of epilepsy can be complex.

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Talking point A

How do patients feel when they are having a seizure? Watch this series of videos produced by the Epilepsy Society to gain an insight into the different types of seizures, and how they can affect people. Do any of them surprise you?

www.epilepsysociety.org.uk/ seizure-types-videos

1.3 Diagnosis

Epilepsy is primarily a clinical diagnosis based on a detailed description of the events before, during and after a seizure given by the person and/or witness. Investigative tests, such as an electroencephalogram (EEG), can aid in the diagnosis, whereas imaging of the brain using magnetic resonance imaging (MRI) and computed tomography (CT) can identify structural changes in the brain that could be the cause of the seizures. Another useful test in aiding diagnosis is video-telemetry. This involves the patient wearing an ambulatory EEG, while also being recorded by video camera.

1.4 Causes

There are several causes of epilepsy. These include structural lesions such as stroke and trauma, and infection such as meningitis or encephalitis. There is also a growing belief that there is genetic susceptibility for a low seizure threshold.

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Practice point 1

A patient comes into your pharmacy and explains that they have had a ‘funny turn’. They are worried they may have had a seizure. What questions could you ask the patient to help you distinguish between a ‘funny turn’ and a seizure?

1.5 Trigger factors

Some people may experience seizure trigger factors; these include stress, lack of sleep, fatigue, menstruation, flashing lights, excessive alcohol, fever or acute illnesses. Where appropriate, people should be advised about these common seizure triggers in order to support them to self-manage their risk of seizure. This is especially important for people newly-diagnosed with epilepsy3.

1.6 Common co-morbidities

Psychiatric disorders, cognitive disorders, migraine and sleep disorders are more common in people with epilepsy. Mood disorders such as anxiety and depression are also highly prevalent, and they are thought to affect between 20 and 50 percent of people with epilepsy4.

Key points

n Epilepsy is the most common neurological condition in the UK, affecting one in 103 people.

n There are over 40 different types of epilepsy, at least 29 syndromes, and the management of epilepsy can be complex.

n Mood disorders such as anxiety and depression are highly prevalent in patients with the epilepsy.

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Notes2. Management of epilepsy

2.1 Aims of treatment

The aim of epilepsy treatment is to find a balance between preventing seizures while minimising adverse effects. Around 70 percent of people with epilepsy have the potential to be seizure free with antiepileptic drugs (AEDs)5. The choice of AED will depend on different factors, and should be individualised to the patient. By taking into account their age, seizure type and other medicines, treatment can be chosen to help the patient achieve their preferred goals. By also incorporating lifestyle and patient preference, the patient and healthcare professionals can work in partnership to make informed decisions about treatment and care6.

2.2 National guidelines on the pharmacological management of epilepsy

The most up-to-date national guidance on the management of epilepsy is that produced by the Scottish Intercollegiate Guidelines Network (SIGN) group in 20157.

SIGN guidance, unlike NICE guidance from 2012, incorporates evidence from two large, unblinded, randomised controlled trials (RTCs) – the SANAD studies – both published in 20078, 9. The SANAD (standard and new antiepileptic drugs) studies compared treatment between commonly-used first line AEDs over a longer period (at least two years) to try to ascertain effectiveness of treatment and incidence of adverse effects. The SANAD authors recommend lamotrigine as first line in focal epilepsy (ahead of carbamazepine), which represents a substantial shift in practice.

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Figure 1. A diagram of a synapse and synaptic activity

All AEDs can cause dose-related adverse effects, the majority of which directly affect the central nervous system (CNS). Examples include drowsiness, dizziness, ataxia and headache.

2.3 Principles of AED therapy

Wherever possible, monotherapy of an AED is given to all patients. It is introduced at a low dose with cautious dose escalation to reduce the risk of adverse effects, including allergic reactions and toxicity. If first line treatment is unsuccessful, another monotherapy AED treatment is then considered. Caution is advised throughout the changeover period, and it is recommended the second AED is built up to the adequate or maximum tolerated dose, while the first AED is slowly tapered down. If treatment with an AED is being stopped, then withdraw the AED slowly with close monitoring of the patient for any sign of rebound seizures.

2.4 Treatments available

There are over 20 medicines used in the management of epilepsy. They are a diverse group of medicines and do not conform particularly to specific medicine groupings in the way that medicines used in other long term conditions do.

The majority of AEDs work either by modifying the function of voltage-gated ion channels in the cell membrane of the neurone, or by altering excitatory or inhibitory synaptic function.

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2.5 First line medicines for epilepsy

Most patients with focal seizures or with primary generalised seizures will be started on one of the following four medicines.

Lamotrigine

Lamotrigine has a broader therapeutic profile than some of the other AEDs and is the recommended first line treatment for both generalised and focal seizures. It acts on voltage-gated sodium and calcium channels. Lamotrigine itself is not an enzyme inducer or inhibitor; however its clearance can be increased by enzyme inducers such as carbamazepine. Where lamotrigine is given alongside an enzyme inducer, a higher dose of lamotrigine may be required. Sodium valproate inhibits the clearance of lamotrigine when used concomitantly, and in these cases the dose of lamotrigine is reduced accordingly.

Lamotrigine is usually well tolerated, although occasionally it can trigger irritability, aggression and insomnia. There is also an incidence of around five percent of idiosyncratic reactions, including Stevens-Johnson syndrome. Healthcare professionals should discuss with their patients the reporting of any incidence of skin rash, particularly on initiation of treatment or after a dose increase.

Carbamazepine

Carbamazepine use is established in epilepsy, and is considered a first line agent for focal seizures. It is also useful in generalised seizures, with the exception of absence seizures and myoclonic jerks. It is a selective sodium ion channel blocker, and its action on these leads to a reduction in channel conductance and limits repetitive neuronal firing.

Patients have reported significant adverse effects, such as serious allergic skin reactions, blurred vision, dizziness and nausea and vomiting. These effects are normally seen on initiation and may be reduced by offering the patient a modified release formulation.

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Levetiracetam

Levetiracetam is a broad spectrum AED used for both focal seizures as monotherapy (in adults only) and as an adjunctive therapy (in adults and children). It is also licensed for add-on therapy in myoclonic and tonic-clonic seizures. When levetiracetam was first introduced it was unclear how it worked, but has subsequently been shown to bind to synaptic vesicle protein 2A (SV2A), yet the role of SV2A in epilepsy remains unclear.

Levetiracetam is usually well tolerated; however about ten percent of patients taking it can develop mood changes, which may be severe, including depression, irritability and aggression. For this reason levetiracetam is to be avoided in those with a history of mood disorders. Healthcare professionals should encourage patients or their carer and/or family to report any changes in mood.

Sodium valproate

Sodium valproate is a broad spectrum AED, and is used first line in generalised epilepsy in adults and children. The precise link between the pharmacology of sodium valproate and its clinical effect is not clear, but its main action is likely to be related to its potentiation of the inhibitory actions of gamma-aminobutyric acid (GABA), which is an important inhibitory CNS neurotransmitter. Although rare, valproate has been recognised as causing medicine-induced hepatotoxicity. It is therefore contraindicated in patients with a history of severe hepatic dysfunction. Valproate has been known to cause menstrual disturbances, and has been linked to polycystic ovarian syndrome (PCOS). It is also known to increase appetite which may then cause significant weight gain and in particular abdominal adiposity. Transient hair loss (with subsequent curly re-growth) has also been reported, and patients are to be advised that they may find more hair on their pillow, or on their brush.

Healthcare professionals should encourage patients to be alert for and report signs and symptoms of blood or hepatic disorders, and pancreatitis, eg abdominal pain, nausea or vomiting.

2.6 Other medicines used in epilepsy

Examples of other medicines which are used to treat epilepsy are:

n Clobazam n Phenytoinn Ethosuximide n Phenobarbitaln Lacosamide n Topirimaten Midazolam n Vigabatrinn Perampanel n Zonisamide

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For more information on these medicines, take a look at section 1 (epilepsy) in the Northern Ireland Centre for Pharmacy Learning and Development Evidence-based management of neurological disease distance learning book:

www.cppe.ac.uk/programmes/l/ebm-neuro-p-02/

Practice point 2

A patient with epilepsy presents with their first prescription for Epistatus® (buccal midazolam), 10 mg to be administered when required as directed.

In discussing this medicine with the patient and their carer(s), what advice would you offer?

2.7 Interactions

For some patients it may be necessary to combine AEDs. The use of more than one AED increases the risk of drug interactions and adverse drug reactions (ADR). The AEDs that commonly cause interactions are the enzyme inducers (carbamazepine, phenytoin, primidone, phenobarbital and topiramate) and the inhibitor, sodium valproate.

2.8 Consistency of supply

Differences in the bioavailability between products can be an issue for many patients, leading to ADRs or an alteration in the therapeutic efficacy of the medicine. The MHRA has classified AEDs into three categories depending on the potential for the differences in bioavailability to be clinically significant.

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2.9 Non-pharmacological treatments

For patients where AEDs do not control seizures non-pharmacological treatment options may be introduced. These include:

n epilepsy surgery (neurosurgery); via referral to a specialist centre

n vagus nerve stimulation (VNS) therapy or deep brain stimulation (DBS) therapy

n the Ketogenic diet – a specialist diet that helps control seizures for some children with epilepsy. The diet is high in fat, adequate in levels of protein and low in carbohydrate. There are several versions of the diet and it is tailored to the individual child under specialist dietetic supervision. Some medicines can have high carbohydrate content and so will need to be taken into consideration as the diet is planned.

2.10 Developments in epilepsy treatment for the future

It is likely that more medicines which offer different mechanisms of action, ‘cleaner’ ADR and interaction profiles, novel routes of administration (eg nasal sprays) and other possible advantages will continue to emerge. For example brivaracetam, an analogue of levetiracetam was launched in January 2016. It is indicated as an adjunctive therapy in the treatment of focal seizures, and is said to need little or no titration.

The category 1 AEDs, which include carbamazepine and phenytoin, are where there is a recognition that different formulations of oral preparations may vary in bioavailability. For these medicines, prescribers are advised to ensure that the patient is maintained on a specific manufacturer’s product.

The category 2 AEDs are those where the need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with the patient and/or carer, taking into account factors such as seizure frequency and treatment history.

For category 3 AEDs, it is usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific concerns such as patient anxiety, and risk of confusion or dosing errors.

Consistency of supply is an important issue for people with epilepsy. AEDs that change appearance each month can be a cause of anxiety for some people with epilepsy. The issue for some patients may not be switching between the brand and a generic; it may be switching between generics. By maintaining consistency in supply to patients with epilepsy, healthcare professionals can help to reduce anxiety, confusion and risk of seizures.

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Probably the biggest developments to come over the next ten years, however, will not be related to medicines. Detailed genetic profiling, which is possible through developments in technology, looks set to change our understanding of the physiological defects in epilepsy and the way epilepsy is diagnosed. This will lead to improved diagnosis and may highlight new targets for medicines. Surgical developments are also taking this field forward and may potentially mean that surgery is used earlier in more people and is also an option for more patients.

Key points

n Treatment strategies should be individualised to the patient.

n Around 70 percent of people with epilepsy have the potential to be seizure free with AEDs.

n Differences in the bioavailability between products can be an issue for some AEDs, leading to ADRs or an alteration in the therapeutic efficacy of the medicine.

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3. Women and pregnancy

It is highly recommended that all women with epilepsy who are of childbearing age should receive advice on the treatment of their epilepsy during pregnancy. The value of planning a pregnancy is to be emphasised, but information given in acknowledgement that not all pregnancies are planned10. The basic principles of antiepileptic treatment are followed including aiming to control seizures with the minimum dose of AED as monotherapy. Use of two or more AEDs should be avoided wherever possible6, 11. In addition, sodium valproate should be avoided in women of childbearing age. Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 40 percent of cases) and congenital malformations (in approximately ten percent of cases). There are many resources now available to help guide healthcare professionals in discussing the risks of valproate in pregnancy and a card – Key facts – Valproate and Pregnancy – produced by the MHRA should be given to all women who have been prescribed valproate12. The card is available at: www.medicines.org.uk/emc/RMM.422.pdf

3.1 Pregnancy

Antiepileptic therapy in pregnancy is managed with input from the specialist neurologist and the obstetrician6, 10. General AED concerns include changes in the pharmacokinetics of some AEDs, and the possible effects of AEDs on the foetus, and on his or her future development13. When in discussion with women with epilepsy the risk of status epilepticus and sudden unexpected death in epilepsy (SUDEP) (see Section 4.1) if AEDs are stopped suddenly is to be discussed. It is not normally recommended for AED levels to be routinely monitored during pregnancy. However, if seizures increase, or are likely to increase, then serum concentration monitoring of AEDs, particularly lamotrigine and phenytoin which are particularly affected in pregnancy, may be useful to inform dose adjustments6.

Women with epilepsy who are planning a pregnancy are encouraged to join the UK epilepsy and pregnancy register at: www.epilepsyandpregnancy.co.uk

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This is a major study in the UK to investigate which epilepsy treatments show the lowest risk to a baby’s health. Women with epilepsy who become pregnant, whether or not they are on treatment for epilepsy, are eligible to register, but they need to register early in their pregnancy and before the outcome of the pregnancy is known.

Folic acid supplementation is recommended to reduce the risk of neural tube defects and other congenital defects during pregnancy. There is no specific evidence suggesting effectiveness in women with epilepsy, however there is no evidence of harm (except in pernicious anaemia where it may precipitate subacute combined degeneration of the spinal cord) or reason to suspect that it would not be effective in this group. The higher dose of 5mg daily is recommended in women who have previously carried a child with neural tube defects, and this has been extrapolated to women with epilepsy who also have an increased risk associated with AED therapy. Evidence for this is still lacking11, 14.

3.2 Contraception

Efficacy of both combined oral contraception (COC) and progesterone only pill (POP) oral contraceptives can be considerably reduced by interaction with medicines that induce hepatic enzyme activity10. This includes many AEDs.

Where enzyme-inducing medicines are chosen, the risk and benefits of different contraceptive methods, including hormone-releasing intra-uterine devices (IUDs), is to be discussed6.

Women requiring long term treatment with an enzyme-inducing medicine are encouraged to consider a form of contraception that is not affected by hepatic enzyme induction. The POP/implant is not recommended as a reliable contraception in women taking enzyme-inducing AEDs6. Contraceptive injections, such as Depo-Provera® (medroxyprogesterone acetate), given by intramuscular injection are recommended. Although they contain progestogen, they are not affected by AEDs because they are broken down in the blood, rather than in the liver15.

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Where a COC is used this is to include at least 50mcg ethinylestradiol daily with higher doses often required, although this is outside the product license10. Guidance about dosages is to be sought from the summary of product characteristics and the current edition of the British National Formulary (BNF)10. Healthcare professionals are to advise on additional barrier methods for the first few cycles and the COC dose adjusted upwards until the dose is deemed sufficient to suppress ovulation with no mid-cycle bleeding. Tricycling (ie taking three or four packets of monophasic tablets without a break, followed by a short tablet free interval of four days) is also sometimes recommended15.

In addition to enzyme-inducing AEDs reducing the efficacy of hormonal methods of contraception, any oestrogen-based contraceptive can result in a significant reduction of lamotrigine levels. In patients where lamotrigine and hormonal contraception are prescribed together, individualised advice is given. This should include shared discussions around careful monitoring6, 15.

Enzyme-inducing medicines also reduce the effectiveness of hormonal emergency contraception. Where a patient is already taking, or has recently taken, an enzyme-inducing AED, the dose of levonorgestrel is increased to a single total dose of 3mg (unlicensed dose)10.

3.3 Breastfeeding

All new mothers are encouraged to breastfeed, and with the exception of very rare circumstances, this is also the same for new mothers with epilepsy. Each mother is supported in the choice of feeding method that best suits her and her family. The decision regarding AED treatment and breastfeeding is made between the mother and the prescriber, and should be based on the risks and benefits of breastfeeding against the potential risks of the medicine affecting the child, or the mother experiencing seizures6.

For more information take a look at the recently published guideline by the Royal College of Obstetricians and Gynaecologists on Epilepsy in Pregnancy: www.rcog.org.uk/globalassets/documents/guidelines/green-top-guidelines/gtg68_epilepsy.pdf

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Key points

n All women with epilepsy who are of childbearing age are to receive advice on epilepsy, contraception and pregnancy.

n Sodium valproate is to be avoided in women of childbearing age.

n Women requiring long term treatment with an enzyme-inducing medicine are encouraged to consider a form of contraception that is not affected by hepatic enzyme induction.

n Pregnant women are encouraged to notify the UK epilepsy and pregnancy register (UKEPR) early in their pregnancy.

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4 Supporting patients living with epilepsy

4.1 Risks and safety/SUDEP

Patients diagnosed with epilepsy in the UK have a risk of sudden unexplained death in epilepsy (SUDEP). The cause of death in SUDEP is currently unknown, but various risk factors have been suggested. These include16:

n young adulthood

n presence of convulsive attacks (tonic-clonic)

n poor seizure control

n night seizures

n frequent changes of dose or more than one AED

n male gender

n alcohol misuse

n living alone.

Epilepsy is a condition that varies greatly from person to person, so risks due to epilepsy depend on what someone’s epilepsy is like. Pharmacy professionals can support people by offering practical measures to improve safety such as having a medical identity card or medical jewellery, or having a shower instead of a bath17. The epilepsy society has more information on patient safety, and people can download risk assessment forms to help assess safety at home as well as away from home: www.epilepsysociety.org.uk/risk-assessment

4.2 Driving

The driving regulations for epilepsy are complicated and, if the person has comorbidities, these may also have their own regulations. For patients, the loss of their driving license can be associated with strong emotions, loss of job, reduced independence and reduced quality of life.

Patients needing more information regarding epilepsy and driving regulations can be directed to the Epilepsy Society webpage driving and epilepsy at www.epilepsysociety.org.uk/driving-and-epilepsy, and the Gov.uk webpage Epilepsy and driving at www.gov.uk/epilepsy-and-driving

Primarily it is the patient’s responsibility to inform the DVLA if they have had a seizure or a suspected seizure, and healthcare professionals are to encourage the patient to do so. If the patient is unable to understand this

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Notes

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advice, then the healthcare professional should inform the DVLA directly18.

4.3 Bone Health

It is known that people with epilepsy have an increased risk of osteopenia, osteoporosis and fractures as a result of seizures19. Many studies have shown an association between AEDs – particularly carbamazepine, phenytoin, primidone and sodium valproate – and osteoporosis20. Patients on multiple AEDs, or an AED for more than five years are at increased risk of bone loss21. Current NICE guidance states that patients taking enzyme-inducing AEDs should have their vitamin D levels checked every two-five years.

Pharmacy professionals can support people to maintain and improve their bone health by offering advice on regular weight-bearing exercise, healthy eating, maintaining a healthy body weight and spending some time in the sun. They can also offer advice to avoid certain risk factors such as smoking and drinking too much alcohol.

4.4 Learning disability

One in three people with a learning disability will have epilepsy and one in five people with epilepsy will have a learning disability22. The incidence increases with the severity of the learning disability23.

Movement disorders, behaviours, comorbidities, unnoticed subtle seizures, the ability to tolerate diagnostic testing and communication difficulties can make getting an accurate diagnosis and monitoring the condition more difficult24. Misdiagnosis is more common than in the general population and is estimated at around 32 to 38 percent25.

In the management of people with a learning disability, reasonable adjustments need to be made to ensure that all people receive the most appropriate support, advice and treatment available and are therefore offered the same opportunity for improved health.

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Talking point B

You are conducting a consultation with one of your patients with epilepsy who also has a learning disability. What factors would you need to consider to engage and support the patient during the consultation?

4.5 Employment

Having epilepsy does not necessarily stop someone from doing the job they want, but there may be some issues which can affect them at work. These include discrimination and stigma, health and safety, and driving. There are organisations that may be able to support someone with epilepsy to find work. There is also useful guidance regarding employment on the Epilepsy Action and Epilepsy Society websites, which cover applying for jobs, what to tell people, interviews and the law16.

Epilepsy is classed as a disability and is therefore covered by the Equality Act (2010)16 as well as other employment law, such as Health and Safety at Work Act (1974)17 and the Working Time Regulations (1998)26.

4.6 Children

Around one in 240 children under 16 years old in the UK have epilepsy27. Seizures can look different according to the age of the child and they may be more subtle in younger children.

A child’s learning may be affected if they are less able to retain and recall information due to the epilepsy, medication, or missing school due to seizures. They may have behavioural issues that relate directly to their seizures, or behaviour that relates to the burden and stigma associated with having epilepsy. It can be helpful for the child and parent to keep a diary of behaviour and seizures, including when it started, when it occurs, what is happening at the time, what the behaviour is, the duration and what the consequences are.

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Notes

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31

Most children with epilepsy are prescribed AEDs and the dose is generally prescribed according to their weight. AEDs will be chosen according to seizure type, side effect profile and formulation. Extra attention should be paid to girls, who may wish to have a family later, as it can be difficult to change AEDs at a later date. There are other treatments that may be suitable for children, such as epilepsy surgery, vagus nerve stimulation, deep brain stimulation and the ketogenic diet.

At age 11 a child should start the transition process, which generally cumulates them moving to adult services at around 16. It is recommended by NICE that this is done through a transition clinic28.

For more information regarding epilepsy and children, why not take a look at the CPPE Child health e-course: www.cppe.ac.uk/programmes/l/childhlth-e-03

4.7 Older People

One in four people diagnosed with epilepsy are over the age of 65. The incidence is often, but not solely related to cerebral degeneration and dementias. Seizures may present as focal seizures and can often be mistaken for other conditions, such as a transient ischaemic attack (TIA), syncope, dementias or a normal sign of ageing29.

Management is complicated by the changes in pharmacokinetics and pharmacodynamics associated with ageing, and the presence of co-morbidities often seen in these patients. The potential for ADRs is increased and older people are often more likely to experience adverse effects30.

In addition there are often complications related to social difficulties, eg increased impact of driving restrictions and physical restrictions to lifestyle. Seizures that cause falls are more likely to cause injury in older people31.

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Practice point 3

As a pharmacy professional how can you and your team help a patient to remember to stick to their AED treatment?

4.8 Stigma and discrimination

The stigma associated with epilepsy may have reduced over recent years, but for some people it still presents a problem, and can cause them to feel isolated, lonely and lacking in confidence. A recent survey by Epilepsy Action showed that almost one in five people with epilepsy said they still felt uncomfortable talking about their epilepsy with friends. The top three reasons given were fear of discrimination, embarrassment and concerns people won’t understand epilepsy32.

Pharmacy professionals can aid in combatting stigma and discrimination by raising awareness of epilepsy within their teams. Helping increase public knowledge can reduce fear, dispel misconceptions and support people to feel more confident in talking to others about their epilepsy. Getting involved with national campaigns such as National Doodle Day (5 February), Purple Day (26 March) or National Epilepsy Week (around mid-May) can help to reduce stigma and discrimination, and improve the lives of everybody affected by epilepsy.

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NotesKey points

n Patients diagnosed with epilepsy in the UK have a risk of sudden unexplained death in epilepsy (SUDEP).

n It is the patient’s responsibility to inform the DVLA if they have had a seizure or a suspected seizure.

n In the management of people with a learning disability and epilepsy, reasonable adjustments need to be made to ensure that all people have the same opportunity for health.

n Get involved in national campaigns to increase awareness of epilepsy within your community.

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Summary of background learningThere are around 600,000 people in the UK living with epilepsy. This is equivalent to one in 103 people, all with variable causes, ranging from a genetic predisposition to structural damage. Management of epilepsy can be complex, and around 70 percent of patients have the potential to be seizure free with pharmacological treatment.

Epilepsy is a long-term condition and pharmacy teams are ideally placed to be able to help support patients with the management of pharmacological treatment, symptoms and side effects, while also offering advice and guidance on other issues, such as pregnancy and driving.

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Directing change Here we offer you three scenarios that you can use to inform the way you plan to change your practice.

These consider:

n Skill mix – the right person for the task. This scenario is about encouraging pharmacists and pharmacy technicians to work together and share responsibilities.

n Medicines use review (MUR)/medication review. This scenario is about achieving the maximum benefit for patients and pharmacists.

n Advanced practice. This scenario is about preparing for the profession’s future roles or your own future specialty.

Read through the scenarios and choose the one that you would like to discuss further with colleagues at the focal point event. Write down how you would respond to the situation, structuring your response around the following themes:

n the resources you expect to use

n the training required

n the evidence supporting your decision

n the government or national guidelines supporting you

n any local initiatives relevant to the scenario.

Skill mix – the right person for the task

Everyone in the pharmacy has a role to play in improving outcomes for patients. What practical measures could you take to ensure that your whole team are able to identify and support patients with epilepsy?

MUR/medication review

What changes could you make to the way you conduct MURs and medication reviews for people with epilepsy to make them more patient-centred?

Specialist/advanced practice

As a pharmacist with a special interest, a prescriber or a consultant pharmacist, what service could you develop to improve the care you offer to patients with epilepsy?

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Checklist for actionAt this point in the learning programme you will have carried out the following:

Actions I completed this on:

I have answered the Moving into focus questions

I have listed three learning needs

I have read the whole book

I have undertaken the practice points

I have made notes for the talking points ready to share at the event

I have worked through the Directing change exercise

Signed:

Date:

Take this book with you to your focal point event. Make sure that you know when and where it is and what time it starts.

Enjoy your learning.

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References1. Joint Epilepsy Council of the UK and Ireland. Epilepsy prevalence, incidence and other

statistics. 2011.

www.epilepsyscotland.org.uk/pdf/Joint_Epilepsy_Council_Prevalence_and_

Incidence_September_11_(3).pdf

2. MacDonald BK, Cockerell OC, Sander JW. The incidence and lifetime prevalence of

neurological disorders in a prospective community‐based study in the UK. Brain 2000;

123(4): 665-676.

3. Sperling MR, Schilling CA, Glosser D, Tracy JI, Asadi-Pooya AA. Self-perception of

seizure precipitants and their relation to anxiety level, depression, and health locus of

control in epilepsy. Seizure 2008; 17: 302-307.

4. Epilepsy Foundation. Joint content partnership with AES. No date.

www.epilepsy.com/information/professionals/joint-content-partnership-aes/

epilepsy-comorbidities

5. Neligan A, Sander JW. 2013. The prognosis of epilepsy. In Rugg-Gunn FJ, Smalls JE (eds.)

Epilepsy 2013: From membranes to mankind. ILAE. pp 359-67.

6. National Institute for Health and Care Excellence clinical guideline 137. Epilepsies: diagnosis

and management. 2012.

www.nice.org.uk/guidance/cg137

7. Scottish Intercollegiate Guidelines Network (SIGN) guideline 143. Diagnosis and

management of epilepsy in adults. 2015.

www.sign.ac.uk/guidelines/fulltext/143/index.html

8. Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW et al,

for the SANAD study group. The SANAD study of effectiveness of carbamazepine,

gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an

unblinded randomised controlled trial. Lancet 2007; 369(9566): 1000-15.

9. Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW et al, for

the SANAD study group. The SANAD study of effectiveness of valproate, lamotrigine, or

topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled

trial. Lancet 2007; 369(9566): 1016-26.

10. Alarcon G, Nashef L, Cross H, Nightingale J, Richardson S. Oxford Specialist Handbooks in

Neurology, Epilepsy. Oxford University Press: 2009.

11. World Health Organization. Management of epilepsy in women of child bearing age. 2012.

www.who.int/mental_health/mhgap/evidence/resource/epilepsy_q11.pdf?ua=1

12. Medicines and Healthcare products Regulatory Agency. Resources. 2016.

www.gov.uk/government/organisations/medicines-and-healthcare-products-

regulatory-agency

13. Eadie M. Antiepileptic drug safety in pregnancy. Clinical Pharmacist 2016; 8(1): 24-31

14. Harden CL et al. Management issues for women with epilepsy – Focus on pregnancy (an

evidence-based review): III. Vitamin K, folic acid, blood levels, and breast-feeding. Epilepsia

2009; 50(5): 1247-1255.

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15. Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Anti-epileptic

drugs and contraception. CEU Statement: 2010.

16. Gov.uk. Equality Act 2010: guidance. 2013.

www.gov.uk/guidance/equality-act-2010-guidance

17. Health and Safety Executive. Health and Safety at Work etc Act 1974. No date.

www.hse.gov.uk/legislation/hswa.htm

18. GP Notebook. Epilepsy (and driving). No date.

www.gpnotebook.co.uk/simplepage.cfm?ID=-1328545726

19. Epilepsy Foundation. Gender differences in bone health with aging. No date.

www.epilepsy.com/learn/impact/bone-health

20. Epilepsy Action. Bone Health. 2013.

www.epilepsy.org.uk/info/osteoporosis-osteomalacia

21. Pack A, Morrell MJ. Epilepsy and Bone Health in Adults. Epilepsy & Behaviour 2004; 5(2):

24-29.

22. Morgan CL, Baxter H, Kerr MP. Prevalence of epilepsy and associated health service

utilization and mortality among patients with intellectual disability. American Journal on

Mental Retardation 2003; 108(5): 293-300.

23. Ring H. Epilepsy in intellectual disabilities - management topics in epilepsy. ACNR: 2013.

24. Epilepsy Action. Diagnosis and treatment. 2015.

www.epilepsy.org.uk/info/learning-disabilities/causes

25. McDonagh JE, Jordan A. Transition: getting it right for young people. Clinical Medicine

2006; 6: 497-500.

26. Health and Safety Executive. The Working Time Regulations. No date.

www.hse.gov.uk/contact/faqs/workingtimedirective.htm

27. Epilepsy Action. Children with epilepsy. 2013.

www.epilepsy.org.uk/info/children/children-with-epilepsy

28. National Institute for Health and Care Excellence guideline 43. Transition from children’s

to adults’ services for young people using health or social care services. 2016.

www.nice.org.uk/guidance/ng43

29. Epilepsy Action. Older people. (online). No date.

www.epilepsy.org.uk/professionals/healthcare/primary-care-resource-pack/

section-1/background-epilepsy-national-guidance/guidance-special-populations/

older-people

30. Department of Health. National service framework for older people. London: DOH: 2012.

31. Brodie M. Epilepsy in elderly people. BMJ 2005; 331: 1317.

32. Epilepsy Action. People with epilepsy fear discrimination according to national charity poll.

2016.

www.epilepsy.org.uk/news/news/people-epilepsy-fear-discrimination-according-

national-charity-poll-66199

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Epilepsy Book 1.indd 39 25/08/2016 10:04

Contacting CPPEFor information on your orders or bookings, or any general enquiries, please contact us by email, telephone or post. A member of our customer services team will be happy to help you with your enquiry.

Email [email protected]

Telephone 0161 778 4000

By post Centre for Pharmacy Postgraduate Education (CPPE)Manchester Pharmacy School1st Floor, Stopford BuildingThe University of ManchesterOxford RoadManchester M13 9PT

For information on all our programmes and events: visit our website www.cppe.ac.uk

Share your learning experience with us:email us at [email protected]

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