Prolonged Epileptic Seizures -

Treatment Guidelines

(Administration of buccal midazolam & rectal diazepam for adults who have prolonged epileptic seizures)

Version 1

Approved by Drugs & Therapeutics Group: April 2016

Date of next review: April 2018

Contents

1. Scope p4

2. Background p4

3. Controlled Drug Status p4

4. Buccal Midazolam p5

4.1. Buccal / Oromucosal Midazolam Preparations p5

4.2. Buccolam®: Licensed Indication/Use p5

4.3. Epistatus®: Licensed Indication/Use p6

4.4. Administration of Buccal Midazolam p6

4.5. Supply of Buccal Midazolam p7

4.6. Storage of Buccal Midazolam p8

4.7. Disposal of Buccal Midazolam p8

4.8. Nurses authority to carry stock buccal midazolam p8

5. Rectal Diazepam p9

5.1. Rectal DiazepamPreparations p9

5.2. Rectal Diazepam Licensed Indication/Use p9

5.2.1 Use in the management of patients with a diagnosis of epilepsy p9

5.2.2 Use in adult detox patients without a diagnosis of epilepsy p9

5.3. Administration of Rectal Diazepam p10

5.4. Supply of Rectal Diazepam p10

5.5. Storage of Rectal Diazepam p11

5.6. Disposal of Rectal Diazepam p11

6. Prescribing p11

7. Authorisation to Administer p12

8. Documentation p12

9. Reporting Adverse Events p12

10. Duties & Responsibilities p12

11. Training p13

12. References & Further Information p13

Appendices

Appendix 1: Individual Epilepsy Care Plan

Appendix 2: Administration Technique for Buccolam (Buccal Midazolam Prefilled Syringe)

Appendix 3: Administration Technique for Buccal Midazolam Supplied in a Bottle with Non Prefilled Oral Syringes, e.g. Epistatus

Appendix 4: Administration Technique for Rectal Diazepam

Appendix 5: Information for nurses and carers on the management of seizures in adults with rectal diazepam without a diagnosis of epilepsy

Appendix 6: Easy Read Buccal Midazolam Leaflet

Appendix 7: Easy Read Rectal Diazepam Leaflet

1. SCOPE

1.1 This guideline has been developed to enable nurses, trained healthcare professionals and carers to administer buccal midazolam preparations or rectal diazepam in an emergency forthe medical treatment of status epilepticus.

1.2 This guideline is applicable to:

Sussex Partnership staff working across the Trust who administer buccal midazolam or rectal diazepam as indicated for the emergency treatment of status epilepticus in inpatient & community settings.

Sussex Partnership staff that provide training to non Sussex Partnership staff for the administration of buccal midazolam and rectal diazepam in non NHS establishments, (e.g. relatives & carers, day centres, care homes), in the community under a care plan.

1.3 The guideline outlines the prescribing, supply, storage and administration ofbuccal midazolam and rectal diazepam. The administration of buccal midazolam and rectal diazepam should be given inaccordance with this document.

2. BACKGROUND

2.1 Midazolam is a short acting benzodiazepine. Pharmacokinetic data following administration of buccal midazolam in adults shows good bioavailability and maximum peak plasma concentration within 30 minutes. It comes in a sugar free liquid form, which is administered to the buccal cavity (between the lower cheek and gum in the mouth). It is usually the preferred option for the treatment of prolonged seizures in Learning Disability services.

2.2 Midazolam administered by the buccal route is indicated for the emergency treatment of status epilepticus. It is the first-line treatment in children, youngpeople and adults with prolonged or repeated seizures in a community setting.This is recommended by the Resuscitation Council (UK), NICE Epilepsy guidelines, National Epilepsy organisations and the Royal College of Paediatrics and Child Health.

2.3 Diazepam is a long acting benzodiazepine. As a rectal solution it is prescribed to manage status epilepticus. It is given rectally in the case of status epilepticus to ensure fast absorption of diazepam without the need for a needle. Rectal diazepam is currently considered a second-line option for treating prolonged seizures in Learning Disability settings, unless chosen by the patient, due to considerations around potential use of a rectal product in a community setting & the dignity of the client. However, it remains the first-line option in substance misuse / alcohol withdrawal settings.

3. CONTROLLED DRUG STATUS

3.1 Midazolam:Midazolam is a Schedule 3 ControlledDrug (CD) and its use is governed by the Misuse of Drugs Regulations 2001. Legally it isexempt from storage and recording regulations, although is treated as a full Controlled Drug on Trust inpatient units. This guideline should be viewedin conjunction with the Medicines Code which offers further advice on CDs & the use of unlicensed medication or off label medicines use, (i.e. licensed medication but not being used for the intended indication or patient population).

3.2 MidazolamPrescription Writing Requirements: To be valid, on top of the normal prescription requirements for prescription only medicines, prescriptions for Schedule 2 and 3 Controlled Drugs must meet certain prescription writing requirements.

Insummary, buccal midazolam prescriptions must contain the dose, form, strength (where appropriate) and a total quantity of the preparation in both words and figures.

The BNF and the Medicines Ethics and Practice Guide, published annually by the Royal Pharmaceutical Society, provide more detailed guidance on these requirements.

3.3 DiazepamPrescription Writing Requirements: Rectal diazepam is a CD Schedule 4 part I: CD Benz POM. It is exempt from storage, recording and prescription writing regulations over and above those that apply to all prescription only medications (POM). This guideline should be viewed in conjunction with the Medicines Code which offers further advice on CDs & the use of unlicensed medication or off label (licenced but not the indication or patient population that the medication is being used for) medicines use.

4. BUCCAL MIDAZOLAM

4.1 BUCCAL/OROMUCOSAL MIDAZOLAM PREPARATIONS

The term buccal midazolam will be used throughout this guideline to mean all the different buccal midazolam preparations available. Buccal midazolam is also known as midazolam oromucosal solution. It is usually the preferred option for the treatment of prolonged seizures in Learning Disability services.

There are two main buccal midazolam products in common use:

  1. Buccolam®: a pre-filled oral syringe containing10 mg midazolam (as hydrochloride) in 2 ml solution. This medication is available in other doses designed for children under 10 years old. The product has a shelf-life of up to 18 months.
  1. Epistatus®:A sugar-free buccal liquid containing 10mg midazolam base in 1ml of sugar free syrup. The product has a shelf life of up to two years and is presented with oral syringes. Each pack contains sufficient for four doses.

It is important to note Epistatus® is twice as strong as Buccolam®.

This has potential for administration errors, particularly if switching between brands.

4.2. BUCCOLAM®LICENSED INDICATION/USE

4.2.1 Buccolam®was the first buccal midazolam licensed product. It has a paediatric licence to treat prolonged, acute convulsive seizures from the ages of 3months up to and including 17 years. It is supplied as a single-dose,age-specific, pre-filled needle free oral syringe. Each syringe iscolour coded and contains the prescribed dose for a particular age range. All preparations contain 5mg of midazolam in 1ml, but are presented in differing volumes. (See below).

4.2.2 Recent NPSA alerts highlighted dosing and administration errors as a result of the wrong type of syringe used. Care should be taken to ensure that the correct dose is used. The different Buccolam preparations are outlined below:

Age of patient / Dose of buccal midazolam / Colour code of Buccolam syringe & box
10 years and over
(adult dose-unlicenced) / 10mg in 2ml / orange
5-9 years / 7.5mg in 1.5ml / purple
1-4 years / 5mg in 1ml / blue
3 months-12 months / 2.5mg in 0.5ml / yellow

4.2.3 Use of the licensed preparation Buccolamfor individuals over the age of 17 years is an ‘off label/off licence’ use for the product and is outside of the recommendations of the marketing authorisation. The recommended dose is the same as that for the older child i.e. 10mg (2ml). This ‘off licence’ use is justified in the emergency situation outlined in this guideline.

4.2.4 The prescriber must take full clinical and professional responsibility for the prescribing of an unlicensed medicine or when a medicine is used off licence. The manufacturer carries no legal liability for the unlicensed use of their product for any harm that ensues.The prescriber should be aware that this alters (and increases) their professional responsibility and potential liability, placing greater responsibility on individual prescribers and the Trust.

4.2.5 Buccal midazolam prescribed by a doctor, dentist or non-medical prescriber may be administered by Trust nursing staff. Use in these circumstances will be supported by the Trust if done in accordance to this guideline and in accordance with the Medicines Code.

4.3. EPISTATUS®® LICENSED INDICATION/USE

4.3.1 Epistatus® is an unlicensed product.

4.3.2 There are a number of buccal midazolam preparations which are unlicensed for this indication and do not have a marketing authorisation (product licence). The only unlicensed buccal midazolam preparation stocked by the Trust is Epistatus®.

4.3.3 The recommended dose for an adult is 10mg. However it is critical to note that 10mg of midazolam is contained in1ml of Epistatus® liquid. This is different to the Buccolam preparation.Care must be taken to avoid confusion. This ‘off licence’ use is justified in the emergency situation outlined in this guideline.

4.3.4 The prescriber must take full clinical and professional responsibility for the prescribing of an unlicensed medicine or when a medicine is used off licence. The manufacturer carries no legal liability for the unlicensed use of their product for any harm that ensues. The prescriber should be aware that this alters (and increases) their professional responsibility and potential liability, placing greater responsibility on individual prescribers and the Trust.

4.3.5 Buccal midazolam prescribed by a doctor, dentist or non-medical prescriber may be administered by Trust nursing staff. Use in these circumstances will be supported by the Trust if done in accordance to this guideline and in accordance with the Medicines Code.

4.4. ADMINISTRATION OF BUCCAL MIDAZOLAM

4.4.1 Ensure that the medication is prepared and administered as rescue medication, following the principles of safe preparation e.g. checking the label, the medicine and the care plan-where applicable are correct for the individual.

4.4.2 The correct administration technique must be followed.

4.5. SUPPLY OF BUCCAL MIDAZOLAM

4.5.1 For non NHS establishments e.g. residential homes

The patient will have their own buccal midazolam (normally prescribed by their GP/Consultant).This product must contain a pharmacy dispensed label with thepatient’s name and clear directions for use.

4.5.2 For Sussex Partnership inpatient units

There are four means by which buccal midazolam may be obtained. These are outlined below:

  1. Patients own medication:brought in to the ward by the client or carers. This medication cannot be used for any other patient.
  1. CD ordered for discharge / leave:Medication supplied by Western Sussex Hospitals Trust. This must be ordered on a discharge prescription with the original sent to pharmacy to allow supply to occur. The resulting medication will have directions for use on the label & can be given to the patient / carer on discharge / leave. This medication cannot be used for any other patient.

All buccal midazolam ordered for a patient should be ordered for discharge / leave to ensure that this medication can be taken on any excursions from the ward as a preventative measure.

To order medication for discharge or leave an original TTO prescription should be sent to Worthing pharmacy department. The CD book does not need to be sent with this, however, a photocopy of medication chart will need to be sent if the CD book has not already been screened by the ward pharmacist.

  1. Inpatient CD: Medication supplied by Western Sussex Hospitals Trust. This must be ordered in the ward CD book. The CD book can either be screened by the ward pharmacist, if available, or if not a photocopy of the patients chart must be sent with the CD book to the pharmacy department. This medication cannot be used for any other patient, with the exception of one dose in emergency as outlined in the Western Sussex Hospitals Controlled Drugs policy. Inpatient CD should not be ordered as this prevents the medication being used outside of the unit. It is preferable to order as a CD for leave to allow the medication to be taken out with the client if needed. Inpatient CD’s MUST NOT be taken into the community with the client. They are for inpatient use ONLY.
  1. Stock CD:Medication supplied by Western Sussex Hospitals Trust. This must be ordered in the ward CD book. This medication is for inpatient use only.

All buccal midazolam irrespective of origin must be recorded in the correct section of the controlled drug register.

4.5.3 For Sussex Partnership inpatients due for Discharge / Leave

In the case of discharge or leave, only the following two types of buccal midazolam may be given to the patient to go home with:

  1. Patients own medication: brought in to the ward by the client or carers.
  1. CD ordered for discharge / leave: Medication supplied by Western Sussex Hospitals Trust.

4.6 STORAGE OF BUCCAL MIDAZOLAM

4.6.1 Midazolam has the potential to be misused therefore storage arrangements must ensure that the products are securely stored but accessible to those who are authorised to administer the medicine.

4.6.2 If the product is stored on Sussex Partnership premises then the Medicines Code advice on storage of medication & controlled drugs must be followed. Buccal midazolam must be kept in the controlled drug cupboard & entered into the controlled drug register in line with the Medicines Code recommendations.

4.6.3 Buccal midazolam preparations must be stored in accordance with the manufacturer’s information:

Buccal midazolam unlicensed preparations stored in a bottle should be kept between 15ºC and 25ºC. The cap must be replaced immediately after use otherwise the liquid will evaporate and some of the midazolam will precipitate. This will be exhibited as white particles in the liquid. The pack must be discarded if the solution is not clear.

  • Buccolam▼: The syringe must be kept in the protective plastic tube until used. The product mustnot be refrigerated or frozen.

4.7 DISPOSAL OF BUCCAL MIDAZOLAM

4.7.1 Disposal for Community Patients

The healthcare professional should advise the parent/individual/carer to return expired bottles of midazolam to a community pharmacy for safe disposal.

A link to a letter for the community pharmacy can be found below:

4.7.2 Disposal on NHS Premises

Expired stocks of buccal midazolam must be brought to the attention of the ward pharmacist for destruction.

4.7.3 Return to Pharmacy from NHS Premises

Stocks of buccal midazolam no longer required must be brought to the attention of the ward pharmacist to return to pharmacy.

4.8. Nurses Authority to carry stock buccal midazolam

in exceptional circumstances it may be permissible for nurses to carry stock buccal midazolam in the community. The following permissions need to be sought as per the following link:

5. RECTAL DIAZEPAM

5.1 RECTAL DIAZEPAM PREPARATIONS

5.1The term rectal diazepam is used throughout this guidance to mean all the different rectal diazepam preparations available in the UK. It generally remains the first-line option in substance misuse / alcohol withdrawal settings for the treatment of prolonged seizures.

5.2 RECTAL DIAZEPAM LICENSED INDICATION/USE

5.2.1 Use in the management of patients with a diagnosis of epilepsy

5.2.1.1 Rectal diazepam is available as a number of licensed products, including Desitin® rectal solution and Stesolid® rectal tubes. It is licensed to treat epileptic and febrile convulsions. Rectal diazepam may be useful in these indications when a rapid effect is required but where intravenous injection is impracticable or undesirable and buccal midazolam is not desirable as the first option.

5.2.1.2 Rectal diazepam is generally supplied as either a 5mg or a 10mg tube suitable for rectal administration.

The dose for adults is usually 0.5mg/kg up to a maximum dose of 30mg in 24 hours. However it is important to note that each person’s care plan may vary dependent on their needs.

This would usually be prescribed as 10-20mg in the first instance. However consideration should be given to the needs of the individual patient. This will be outlined in their epilepsy care plan.

5.2.1.3 Due to the route of administration particular care is required to ensure that the dignity of the client is maintained.

5.2.2 Use in adult detox’ patients without a diagnosis of epilepsy

5.2.1 Rectal diazepam is available as a number of licensed products, including Desitin® rectal solution and Stesolid® rectal tubes. It is licensed to treat epileptic and febrile convulsions. Rectal diazepam may be useful in these indications when a rapid effect is required but where intravenous injection is impracticable or undesirable and buccal midazolam is not desirable as the first option.

5.2.2 Rectal diazepam is generally supplied as either a 5mg or a 10mg tube suitable for rectal administration.

This would usually be prescribed as 10-20mg in the first instance up to a maximum dose of 30mg in 24 hours. However consideration should be given to the needs of the individual patient.See Appendix 5 for further information.

5.2.3 Due to the route of administration particular care is required to ensure that the dignity of the client is maintained.

5.3. ADMINISTRATION OF RECTAL DIAZEPAM

5.3.1 Ensure that the medication prepared and administered as rescue medication follows the principles of safe preparation e.g. checking the label, the medicine and the care plan (where applicable).

5.3.2 The correct administration technique must be followed.

5.4 SUPPLY OF RECTAL DIAZEPAM

5.4.1 For non NHS establishments e.g. residential homes

The patient will have their own rectal diazepam (normally prescribed by theirGP/Consultant).This product must contain a pharmacy dispensed label with thepatient’s name and clear directions for use.

5.4.2 For Sussex Partnership inpatient units

There are two means by which rectal diazepam may be obtained. These are outlined below:

  1. Patients own medication: brought in to the ward by the client or carers. This medication cannot be used for any other patient.
  1. One –stopped / TTA medication dispensed for use on the ward & discharge / leave: Medication supplied by Western Sussex Hospitals Trust. The resulting medication will have directions for use on the label & can be given to the patient / carer on discharge / leave. This medication cannot be used for any other patient.

All rectal diazepam ordered for a patient should be ordered for discharge / leave to ensure that this medication can be taken on any excursions from the ward as a preventative measure.