Challenging the Status Quo

Posted in Online First,Sponsored Feature on 7th Dec 2017

 

Highlights from the National Epilepsy Nurse Meeting, sponsored and organised by Veriton Pharma
Sponsorship details and prescribing information can be found at end of this article.

28-29 June 2017, St Johns Hotel, Solihull, West Midlands

Chairman: Dr Rohit Shankar


The Epilepsy Specialist Nurse (ESN) plays a critical role in the management of epilepsy, including in children and young adults. This well-attended national ESN meeting considered the development of the ESN role to meet changing demands in today’s NHS, as well as the treatment of status epilepticus and complex prescribing in epilepsy. With lively interactive workshops, the meeting also provided the opportunity to share best practice, particularly in the emergency community management of epilepsy.

Pitfalls of current practical prescribing in epilepsy

Error is part and parcel of the clinician’s life. Outlining the pitfalls of current practical prescribing in epilepsy, meeting chairman Dr Rohit Shankar (Consultant in Adult Development Neuropsychiatry, Truro) stressed that while errors cannot be eliminated, every conscious effort must be made to reduce them.

A recent GMC Report1 suggested that as many as one in 20 prescriptions written by GPs contain an error, and around one in every 550 prescriptions a serious error. Epilepsy involves complex prescribing in people who may have other chronic mental, neurodevelopmental or physical co-morbidity, yet the long-term consequences are often given little consideration. In particular, prescribing of ‘rescue medication’ requires understanding of a multifaceted system where family and carers from diverse settings administer drugs to vulnerable individuals.2

To ensure consistency, checks and balances are vital to take account of the clinician, patient and environmental factors which, individually and together, can impact on prescribing risk and errors. Treating the patient with epilepsy can affect family dynamics, and the clinician must be aware of this. In assessing risks and benefits there must therefore be a partnership between the clinician and the patient/family, rather than a topdown approach.

When buccal (oromucosal) midazolam is prescribed as rescue medication, there is no obvious direct mechanism to reassure the specialist that the drug is used safely and correctly. People (including carers) vary, as does the level of training they receive. Making everyone aware of safety is vital. A holistic plan with appropriate ongoing training will ensure the competence of everyone involved and self-empowerment is key. As Dr Shankar says, safety is everyone’s business. We can’t just manage the epilepsy. We must look at it holistically.

Safety is everyone’s business. We can’t just manage the epilepsy. We must look at it holistically.
Dr Rohit Shankar

Guidelines for treatment of status epilepticus

Discussing the latest guidelines for treatment of status epilepticus, Professor Matthew Walker (Department of Clinical Experimental Epilepsy, UCL Institute of Neurology, London) noted that the definition of status epilepticus was previously accepted as seizures lasting 30 minutes and longer. Treatment should begin sooner however, and early, aggressive treatment of seizures lasting longer than 5 minutes is vital to avoid long-term consequences and improve prognosis.3 This has resulted in a reappraisal of the definition of status epilepticus.

Status epilepticus is not uncommon. Incidence is between 10 and 60 per 100,000 person years,4 with the higher incidences occurring in poorer populations. Over half of patients with status epilepticus have no prior history of epilepsy, and it is often triggered by an acute illness. In children, without a prior diagnosis of epilepsy, the major cause is infections accompanied by fever. In adults, without a prior diagnosis of epilepsy, the main causes include stroke (particularly in the elderly), hypoxia, metabolic disorders and alcohol intoxication or withdrawal (the most common cause in young adults).4,5 In people with a diagnosis of epilepsy, status epilepticus is often precipitated by antiepileptic drug withdrawal.

Pseudostatus is common and can be misdiagnosed as status epilepticus, particularly in A&E. Yet non-convulsive status epilepticus is underdiagnosed in A&E because the symptoms and signs are often subtle (e.g. clouding of consciousness, confusion).

Intramuscular midazolam for injection was superior to intravenous lorazepam in a study of status epilepticus treated by paramedics,6 probably because venous access can be an issue and intramuscular dosing is more easily administered. Midazolam is easy to administer, has a rapid distribution half-life (6 minutes) and a rapid elimination half-life (2-4 hours), meaning buccal midazolam is preferred for community use.

In the only recent guideline for the treatment of status epilepticus (from the American Epilepsy Society) benzodiazepines are the initial therapy of choice.7 For hospital and paramedic administration, intramuscular midazolam for injection or intravenous lorazepam or diazepam is recommended.7 In the community, NICE (UK) recommends this should be buccal midazolam.8

Status epilepticus not responsive to intravenous diazepam or lorazepam should be treated with intravenous phenytoin, valproate or levetiracetam in adequate doses. If the person remains in status epilepticus, then neuronal death and physiological compromise may be occurring and anaesthesia is required in ITU.

Buccal midazolam is the preferred treatment for community use.
Professor Matthew Walker

Promoting the case for the Epilepsy Specialist Nurse

According to a report by Epilepsy Action, at least 60% of people with epilepsy (nearly 280,000 in the UK) will require ongoing access to an adult, paediatric or learning disability ESN.Michelle Knight (Epilepsy Specialist Nurse, Dorset Epilepsy Service) highlighted the value of the ESN in delivering a high standard of care, avoiding admissions, reducing dropout rates, freeing up consultant time, liaising with other services, and providing community services, advice and education, and a point of contact and consistency. (See Figure 1 below):

pg 18 figure 1

As one of two Dorset Epilepsy Service ESNs, Michelle has seen her role change over time to meet the demands of a growing case load. With a population of 765,700 (a high percentage aged over 65) Dorset has 8000 cases of ‘active epilepsy’ in a large and diverse rural area where public transport is limited. Meeting the brief of covering Dorset’s three main hospitals, with six-monthly reviews in clinic, proved challenging. Home visits and rescue medication training were time consuming, administrative delays were frequent and the percentage of DNAs high.

To tackle these issues the MyCareCentric Epilepsy programme is currently being piloted by Poole Hospital and the Dorset Epilepsy Service. This collates patients’ healthcare data, captures lifestyle patterns via a wearable device and uses a smartphone app to provide clinicians with real-time information. Other initiatives include monthly clinics held at local GP surgeries and using home telemetry, both well received by patients.

Providing ongoing training to first responders and paramedics has also proved beneficial in reducing hospital admissions. Regular training has been set up for healthcare professionals across Dorset, with excellent take up. Study days for GPs have also been successful, as well as basic epilepsy awareness days held around Dorset for patients’ friends and family. These include specific rescue medication training.

Michelle’s take home message is that communication is vital – share ideas with others and talk to other professionals. She also urges thinking outside the box. Look at your patient group to see what works and what doesn’t. Above all, don’t be afraid to challenge the norm.

Don’t be afraid to challenge the norm!
Michelle Knight

Summary

In closing the meeting, Dr Shankar stressed that creating innovative programmes like those discussed seems straightforward, particularly with ever-advancing technology. However, the fundamental issue is cost along with many ethical questions in deciding who should get what. The value of epilepsy specialist nurses is clear, as is the case for rescue medication in the community.

References

1. Investigating the prevalence and causes of prescribing errors in general practice. GMC, 2012.

2. Shankar R et al. Epilepsy & Behaviour, April 2017

3. Neligan A, Walker MC. Epilepsia 2016;57(7):e121–e124.

4. DeLorenzo RJ et al. Neurology 1996;46(4):1029-35.

5. Towne AR et al. Epilepsia 1994;35(1):27-34.

6. Silbergleit R et al. N Engl J Med 2012;366:591-600.

7. Glauser T et al. Epilepsy Currents 2016;16:48-61.

8. National Institute for Health and Care Excellence (2012). The epilepsies: the diagnosis and management of epilepsies in adults and children in primary care. NICE clinical guideline CG 137.

9. Best care: The value of epilepsy specialist nurses. Epilepsy Action, June 2010.

 

Epistatus® 10 mg Oromucosal Solution Midazolam was granted UK Marketing Authorisation in April 2017 for use in the treatment of prolonged, acute convulsive seizures in children and adolescents aged 10 to less than 18 years, who have been diagnosed with epilepsy. Ready-to-use Epistatus pre-filled syringes are now available to prescribe.


The sponsorship of the meeting and publication of this article were funded by Veriton Pharma, (formerly known as Special Products Ltd), who have paid for a medical writer, and reviewed the article for factual accuracy and compliance with the ABPI Code of Practice. The views and opinions expressed are those of the authors and not necessarily of Veriton Pharma.


EDM-1035b-2017

Date of preparation: November 2017

Prescribing information can be found below:

Epistatus Prescribing Information

EPISTATUS® 10mg oromucosal solution midazolam (as maleate). Please consult Summary of Product Characteristics before prescribing.

Presentation & composition: oromucosal solution. Each 1mL of solution contains 10mg of midazolam (as maleate). Excipients with a known effect: ethanol 197mg/mL, liquid maltitol 675mg.

Indication: Treatment of prolonged, acute, convulsive seizures in children and adolescents aged 10 to less than 18 years. Epistatus must only be used by parents / caregivers where the patient has been diagnosed to have epilepsy.

Dosage: For children and adolescents aged 10 to less than 18 years the standard dose is 10mg (1.0 mL). Carers should only administer a single dose. If the seizure has not stopped within 10 minutes after administration, emergency medical assistance must be sought. Patients should be kept under supervision by a carer who remains with the patient. A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice.

Administration: For oromucosal use only. Using the pre-filled oral syringe provided, administer, over a period of 2-3 seconds, approximately half of the prescribed dose to each buccal cavity. For detailed instructions please refer to the Summary of Product Characteristics.

Contra-indications: Hypersensitivity to midazolam, benzodiazepines or to any of the excipients. Myasthenia gravis; severe respiratory insufficiency; sleep apnoea syndrome; severe hepatic impairment.

Warnings & Precautions: Caution in patients with chronic respiratory insufficiency (may further depress respiration). For oromucosal use only. Take care to avoid the risk of choking. Midazolam should be used with caution in patients with chronic renal failure or impaired hepatic function (may accumulate); or cardiac function (may decrease clearance). Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required. Midazolam should be avoided in patients with a medical history of alcohol or drug abuse. May cause anterograde amnesia. Contains maltitol and ethanol.

Interactions: Please consult the Summary of Product Characteristics for full details. Midazolam is metabolized by cytochrome P450 3A4 isozyme (CYP3A4). Inhibitors and inducers of CYP3A4 may increase and decrease the plasma concentration respectively. In the presence of CYP3A4 inhibition the duration of effect of a single dose of oromucosal midazolam may be prolonged; careful clinical monitoring is recommended. Midazolam may interact with other hepatically metabolized medicinal products. Co-administration with other sedative / hypnotic agents and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression. Additional alcohol intake should be strongly avoided.

Pregnancy and lactation: Midazolam may be used during pregnancy if clearly necessary. The risk for new-born infants should be considered in the event of administration in the third trimester. Midazolam passes in low quantities into breast milk (0.6%); it may not be necessary to stop breast-feeding following a single dose.

Driving and machines: midazolam has a major influence on the ability to drive or use machines. The patient should be warned not to drive or use machines until fully recovered.

Side effects: Respiratory depression occurs at a rate of up to 5% although this is a known complication of convulsive seizures as well as being related to benzodiazepine use. Common: sedation, somnolence, depressed level of consciousness, respiratory depression, nausea & vomiting. Uncommon: pruritus, rash, urticaria. Following injection, additional adverse reactions have very rarely been reported (including respiratory arrest and cardiac arrest); these may be of relevance to oromucosal administration. Consult the Summary of Product Characteristics before prescribing.

Legal classification: POM. NHS Price: 10mg in 1mL prefilled syringe – £45.76. Marketing authorisation number: PL 16786/0003. Marketing authorisation holder: Veriton Pharma Limited, Unit 16, Trade City, Avro Way, Brooklands Business Park, Weybridge, Surrey, KT13 0YF, United Kingdom. Date of last revision: October 2017.

Adverse events should be reported
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Veriton Pharma Limited. Tel +44 (0)1932 690325.


ACNR 2017;17:2:18-19

First published online: 15/11/17

SIGN UP FOR OUR MAILING LIST

Open Access, for medical professionals: Sign up to receive our email newsletter with links to the latest content. ACNR is free, thanks to the support of advertisers. The editorial content is peer reviewed and remains completely independent unless clearly specified. 

We may infrequently send you news from our sponsors which is relevant to the field of neurology, but you can opt out at any time.

This website is for medical professionals only.