Prolonged Epileptic Seizures Treatment Guidelines (Administration of buccal midazolam & rectal diazepam for adults who have prolonged epileptic seizures) If you require this document in another format, ie easy read, large text, Braille or a community language please contact the Pharmacy Team on 01243 623349 (Text Relay calls welcome) 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 4.2. Buccolam®: Licensed Indication/Use 4.3. Epistatus®: Licensed Indication/Use 4.4. Administration of Buccal Midazolam 4.5. Supply of Buccal Midazolam 4.6. Storage of Buccal Midazolam 4.7. Disposal of Buccal Midazolam 4.8. Nurses authority to carry stock buccal midazolam p5 p5 p6 p6 p7 p8 p8 p8 5. Rectal Diazepam 5.1. Rectal Diazepam Preparations 5.2. Rectal Diazepam Licensed Indication/Use 5.2.1 Use in the management of patients with a diagnosis of epilepsy 5.2.2 Use in adult detox patients without a diagnosis of epilepsy 5.3. Administration of Rectal Diazepam 5.4. Supply of Rectal Diazepam 5.5. Storage of Rectal Diazepam 5.6. Disposal of Rectal Diazepam p9 p9 p9 p9 p9 p10 p10 p11 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) 2 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 3 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 for the 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 of buccal midazolam and rectal diazepam. The administration of buccal midazolam and rectal diazepam should be given in accordance 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, young people 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 Controlled Drug (CD) and its use is governed by the Misuse of Drugs Regulations 2001. Legally it is exempt from storage and recording regulations, although is treated as a full Controlled Drug on Trust inpatient units. 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 medicines use, (i.e. licensed medication but not being used for the intended indication or patient population). 3.2 Midazolam Prescription 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. 4 In summary, 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 Diazepam Prescription 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 containing 10 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. 2. 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 3 months up to and including 17 years. It is supplied as a single-dose, age-specific, pre-filled needle free oral syringe. Each syringe is colour 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 10 years and over (adult dose-unlicenced) 5-9 years 1-4 years 3 months-12 months Dose of buccal midazolam 10mg in 2ml Colour code of Buccolam syringe & box orange 7.5mg in 1.5ml 5mg in 1ml 2.5mg in 0.5ml purple blue yellow 5 4.2.3 Use of the licensed preparation Buccolam for 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 in 1ml 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. ADMINSTRATION TECHNIQUE FOR BUCCAL MIDAZOLAM PREPARATIONS: SEE APPENDIX 2: BUCCOLAM® SEE APPENDIX 3: EPISTATUS® 6 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 the patient’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. 2. 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. 3. 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. 4. 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. 2. CD ordered for discharge / leave: Medication supplied by Western Sussex Hospitals Trust. 7 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 must not 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: http://www.sussexpartnership.nhs.uk/node/2406/attachment 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: http://www.sussexpartnership.nhs.uk/node/1581/attachment 8 5. RECTAL DIAZEPAM 5.1 RECTAL DIAZEPAM PREPARATIONS 5.1 The 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. 9 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. ADMINSTRATION TECHNIQUE FOR RECTAL DIAZEPAM PREPARATIONS: SEE APPENDIX 4 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 their GP/Consultant).This product must contain a pharmacy dispensed label with the patient’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. 2. 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. 5.4.3 For Sussex Partnership inpatients due for Discharge / Leave In the case of discharge or leave only the following two types of rectal diazepam may be given to the patient to go home with: 1. Patients own medication: brought in to the ward by the client or carers. 2. Rectal diazepam ordered for discharge / leave: Medication supplied by Western Sussex Hospitals Trust. 10 5.5 STORAGE OF RECTAL DIAZEPAM 5.5.1 Diazepam 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 them. 5.5.2 If the product is stored on Sussex Partnership premises then Medicines Code advice on storage of medication must be followed. 5.5.3 Rectal diazepam preparations must be stored in accordance with the manufacturer’s information: Do not store above 25 °C. (Short-term exposure to higher temperatures, e.g. in emergencies, is of no consequence). 5.6 DISPOSAL OF RECTAL DIAZEPAM 5.6.1 Disposal for Community Patients The healthcare professional should advise the parent/individual/carer to return expired tubes of rectal diazepam to a community pharmacy for safe disposal. A link to a letter for the community pharmacy can be found at the following link: http://www.sussexpartnership.nhs.uk/node/2406/attachment 5.6.2 Disposal on NHS Premises Expired stocks of rectal diazepam must be brought to the attention of the ward pharmacist for destruction. 5.6.3 Return to Pharmacy from NHS Premises Stocks of rectal diazepam no longer required must be brought to the attention of the ward pharmacist to return to Pharmacy. 6. PRESCRIBING 6.1 Buccal midazolam / rectal diazepam must be prescribed by a doctor, dentist or non-medical prescriber on either: an individual epilepsy management/care plan where the GP/consultant has signed to authorise administration and patient/parent/carer consent to treatment has been obtained (see Appendix 1). on the patient’s drug chart whilst an inpatient with reference to the client’s epilepsy care plan (see Appendix 1). Either buccal midazolam or rectal diazepam should be prescribed in order to avoid confusion and potential for accidental overdose. 7. AUTHORISATION TO ADMINISTER BUCCAL MIDAZOLAM / RECTAL DIAZEPAM 11 7. AUTHORISATION TO ADMINISTER 7.1 The following staff can administer buccal midazolam / rectal diazepam: A doctor A dentist A registered nurse or dental nurse (in accordance to the prescriber’s directions) A named carer or person who has attended appropriate training in the administration of buccal midazolam / rectal diazepam. 8. DOCUMENTATION 8.1 A record of administration must be made on the relevant documentation provided by the service, i.e. MAR charts for residential placements & drug charts for inpatient services. 8.2 In clinics/clinical areas where buccal midazolam is held as stock on NHS premises, e.g. the Selden Centre, a record of administration must also be recorded in the CD Register as well as the patient’s drug chart & medical records. Please note this is not a requirement for rectal diazepam. 9. REPORTING ADVERSE DRUG REACTIONS (ADRs) 9.1 In the event of adverse reaction, immediate action should be taken to minimise the harm to the patient. Inform the GP of the actions taken and record in the patient’s notes. In the event of any ADR this should be reported in accordance with the Trust’s incident reporting policy. 9.2 Buccolam is a black triangle drug and is subject to additional national monitoring. This will allow quick identification of new safety information. Any side effects should be reported to the MHRA by completing an adverse drug reporting form (Yellow Card https://yellowcard.mhra.gov.uk/ ). All suspected reactions should be recorded in the notes & drug chart allergy box, in line with the Medicines Code. Information regarding a suspected ADR should also be disseminated to the patients GP & consultant, (if currently under secondary care). 9.3 Rectal diazepam is has been licenced for considerably longer than buccal midazolam & as such only serious or unexpected side effects need be reported via the Yellow Card Scheme, (https://yellowcard.mhra.gov.uk/). However, all suspected ADRs should be recorded in the notes & drug chart allergy box in line with the Medicines Code. Information regarding a suspected ADR should also be disseminated to the patients GP & consultant, (if currently under secondary care). 10. DUTIES AND RESPONSIBILITIES 10.1 Sussex Partnership Trust The Trust may provide epilepsy training to meet the needs of Sussex Partnership staff and non Sussex Partnership staff in identified settings where it may be necessary to administer buccal midazolam and/or rectal diazepam. 10.2 Service Managers Service managers will need to ensure Sussex Partnership staff that administer buccal midazolam / rectal diazepam or train others on their administration, attend regular epilepsy update courses organised by the Trust and maintain competency. 12 10.3 Sussex Partnership Staff 10.3.1 All professionals prescribing and administering buccal midazolam and rectal diazepam should adhere to this guideline. They must act in accordance with their professional code of conduct and within their own sphere of competence. 10.3.2 Individuals administering buccal midazolam / rectal diazepam and/or providing training to non Sussex Partnership staff, must be appropriately trained and attend updates. 11. TRAINING 11.1 The training may be delivered by individual healthcare professionals with specialist training in the management of epilepsy. Training can be disseminated to other non-Sussex Partnership staff to administer buccal midazolam / rectal diazepam under an individualised care plan. 11.2. For non Sussex Partnership staff, it is the responsibility of the care home to provide their staff with epilepsy training. This training will not be routinely provided by SPT. 11.3. Family & carers may be provided with epilepsy training on an individual basis as needed. 12. REFERENCES & FURTHER INFORMATION 1. NICE Guideline CG137 The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care, January 2012. 2. Joint Epilepsy Council. A Guideline for the Training Standards for the Administration of Buccal Midazolam, January 2012. 3. National Society for Epilepsy. Emergency Medication: Using Buccal Midazolam to Treat Prolonged Seizures. May 201. 4. Resuscitation Council (UK): Standards for Clinical Practice and Training for Dental Practitioners and Dental Care Professionals in General Dental Practice. December 2012: http://www.resus.org.uk/pages/MEdental.pdf 5. UL Medicines Limited. Product Profile for Buccal Midazolam 10mg/1ml Liquid. 2015 ViroPharma. Information Sheet ‘How to administer BUCCOLAM▼ (midazolam oromucosal solution). December 2015. 6. Specials Products. Data Sheet for Epistatus®. Version 9 27/7/2012 7.Penn Specials. Technical Information Leaflet for Penn Midazolam. Midazolam Buccal Liquid 10mg/ml. August 2010: www.pennpharm.com 8.Holmes G. Buccal route for benzodiazepines in treatment of seizures? Lancet 1999:353:608-009. 9. Scott RC et al. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomised trial. Lancet 1999;353:623-6. 10. Paediatric Medicines Information Advisory Line FAQ Number 39 – as searched on 11/4/03. 13 Appendix 1 Individual Epilepsy Care Plan For Name: Date of birth: Address: PiMS: NHS No: Date written: Review Date: Problems/ diagnosis: The original copy of this document should be completed by a healthcare professional The document is designed to be flexible and adaptable. You will not need to complete every section and are encouraged to delete the parts that are not relevant to this person. Original devised by Georgina Ward, Paediatric Epilepsy Specialist Nurse – East Sussex Healthcare. Adapted for the CLDT by Becky Oxendale, CLDN, Sussex Partnership NHS Foundation Trust. 14 1 Name: ………………………………… Routine Medication: Drug Drug Drug DOB: …………………… PiMS: ……………………… Dose Dose Dose Medicines are Subject to change: Medications listed are correct at time of writing. Parents/ carers are reminded of the importance of informing day services/respite carers/ centres of any changes in treatment/medication or ongoing concerns/changes in seizure patterns. Include any information about how medication is usually taken, eg sprinkled on food, tablet swallowed with a drink Rescue Medication- People who have not had a prolonged seizure (lasting more than 5 minutes) or are not known to have serial seizures (several short seizures within a 2 hour period) do not generally have rescue medications prescribed. Please see care plan for actions to be taken if this occurs. This timeframe will be individual to each person, adapt as necessary/ delete as appropriate Allergies: Description of seizure(s): record all details of seizures e.g. goes stiff, cries out, falls, arms make violent jerking movements, convulses down both sides of body, convulsions usually last 3 minutes. Seizure Type One: Usual duration of seizure: Seizure Type Two: Usual duration of seizure: Seizure Type Three: Usual duration of seizure: Other Useful Information: How the person usually recovers: Triggers for seizures: (Common triggers for seizures are: tiredness, excitement, stress, missing meals or medication and having a temperature or illness). Warning signs that seizures may occur: 15 Adapted from the Joint Epilepsy Council guidelines for Administration of Buccal Midazolam in Epilepsy and the Young Epilepsy Individual healthcare plan by: East Sussex Healthcare December 2013. Author Georgina Ward, Paediatric Epilepsy Specialist Nurse. Review Date: December 2014. Adapted for the CLDT by Becky Oxendale, CLDN July 2014. Name: ………………………………… DOB: …………………… PiMS: ……………………… Delete the Following boxes as appropriate: Action to be taken during and after an absence seizure: Absence seizures are usually very brief and often pass unnoticed If you witness an absence seizure stay with the person for a while to make sure they do not suffer any injury Tell the person what has happened If a person is in the session / conversation, repeat any information they have missed Record as appropriate. Delete the Following boxes as appropriate: Action to be taken during and after a convulsive seizure (with a loss of consciousness): Note time (and follow instructions for giving rescue medication (delete as appropriate). Cushion head and move things out of the way to prevent injury, loosen restrictive clothing. Do not attempt to restrain the convulsive movements, allow the seizure to take its course. Provide reassurance and talk calmly. If breathing is compromised (colour change/ noisy breathing) move the person onto their side (recovery position) and monitor closely. If the seizure stops within 5 minutes place in the recovery position and allow recovery. If the seizure continues for longer than 5 minutes call an ambulance or give rescue medication (see below) delete as appropriate Call Parents/carers. Delete as appropriate Record description of the event, noting time and any possible triggers. Delete the following boxes as appropriate Action to be taken during and after a focal onset seizure (with an altered level of consciousness): Note time Guide the person away from danger Stay with the person until recovery is complete Be calmly reassuring Explain anything that they have missed Do not restrain the person or act in a way that could frighten them, such as making abrupt movements or shouting at them Don’t assume the person is aware of what is happening or what has happened Don’t give them anything to eat or drink until they are fully recovered Don’t attempt to bring them round Call for an ambulance if the person is injured or of you believe they need urgent medical attention Record description of the event, noting time and any possible triggers. Delete the following boxes as appropriate Action to be taken during and after a drop seizure: Check the person for injury – if concerned about injuries, provide first aid and call an ambulance if necessary- call parents / carers (see contact details). Provide appropriate reassurance & comfort particular to the person, detail any specific interventions. Assist the person to their feet, providing reassurance and talking calmly. Don’t give them anything to eat or drink until they are fully recovered. Record description of the event, noting time of seizure and any possible triggers. When Should 999 be dialled for emergency help: If there are no signs of recovery after 5 minutes of administering rescue medication / if seizure continues for longer than 5 minutes Delete as appropriate If injury has occurred / concerns about breathing / other concerns 16 Adapted from the Joint Epilepsy Council guidelines for Administration of Buccal Midazolam in Epilepsy and the Young Epilepsy Individual healthcare plan by: East Sussex Healthcare December 2013. Author Georgina Ward, Paediatric Epilepsy Specialist Nurse. Review Date: December 2014. Adapted for the CLDT by Becky Oxendale, CLDN July 2014. Name: ………………………………… DOB: …………………… PiMS: ……………………… Delete Boxes as appropriate When should rescue medication be administered: If ……………. is having a seizure type ______________as described above lasting longer than 5 minutes. or if ………. has (number of seizures) of seizures over a …………(state time ie 2 hours) period Give __________mg of __________________State Brand and strength ie (Buccolam 2.5mgs/ 0.5ml) Via ______________ie via buccal cavity This plan has been agreed for emergency treatment by: Name of Neurologist_____________________________Date ________________ Documented letter to GP dated______________________(attach copy to this plan where possible) Name and designation of health professional completing this part of form Signed_________________________________Designation_______________________ Print Name_____________________________ This plan should be reviewed regularly and at least every 2 years. (it is the responsibility of the care provider to review. If no changes, care providers are able to review and resign this document). Usual Reactions rescue medication: (e.g.sleepiness, slow shallow breathing, amnesia) Safety Measures: Activities that should be avoided: With appropriate supervision there are no activities that should be avoided, please speak to your GP if you have a specific query. Activities that require special precaution: Swimming – one to one supervision whilst in the water. Horse riding/cycling – wear a helmet and avoid roads. Climbing – wear protective head gear and supervision at all times. Showering is preferable to bathing with the door unlocked and someone nearby. 17 Adapted from the Joint Epilepsy Council guidelines for Administration of Buccal Midazolam in Epilepsy and the Young Epilepsy Individual healthcare plan by: East Sussex Healthcare December 2013. Author Georgina Ward, Paediatric Epilepsy Specialist Nurse. Review Date: December 2014. Adapted for the CLDT by Becky Oxendale, CLDN July 2014. Name: ………………………………… DOB: …………………… PiMS: ……………………… Signature of Parents / Carers.……………………………………...Date……………………….. Print Name …………………………………………………………………………………………... Signature of Person……………… Delete as appropriate …………..Date………...……………….. Print Name …………………………………………………………………………………………... Signature of Healthcare professional ………………………………..Date……………………… Print Name …………………………………………………………………………………………... CONTACT DETAILS Contact 1 – ………………. Phone Number:……………………………………………. Contact 2 – ………………. Phone Number: ……………………………………………. Contact 3 - ………………...Home Phone Number: ……………………………………………... Suggest copies to: Parents / carers, Neurologist, GP, Day-service, Work Placement, Respite Service / Carer, CLDT. Delete the following if appropriate Please record when rescue medication has been administered below ; DATE TIME DOSE MEDICATION GIVEN CHECKED PARENTS REQUEST GIVEN GIVEN BY BY INFORMED REPLACEMENT Please note - seizures can present in many different ways. It is impossible to describe every variant. The descriptions in this care plan are of episodes that have been witnessed. If further advice is needed, please contact the persons GP or Neurologist. For more detailed explanations on seizures, you can find information at: www.epilepsy.org.uk or www.epilepsysociety.org.uk 18 Appendix 2: Administration Technique for Buccolam® Buccal Midazolam (Prefilled Syringe) Step 1 Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube. Step 2 Pull the red cap off the tip of the syringe and dispose of it safely. Step 3 Using the finger and thumb gently pinch and pull back the patient’s cheek. Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum. Step 4 Slowly press the syringe plunger until the plunger stops. The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity). If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Taken from the Summary of Product Characteristics for Buccolam. With kind thanks to ViroPharma for their permission to use this information. Appendix 3: Administration Technique for Buccal Midazolam Supplied in a Bottle with Non Prefilled Oral Syringes, e.g. Epistatus® Unlicensed Indication: The use of buccal midazolam (in place of rectal diazepam) has been reported in the literature to treat convulsive status epilepticus. It has been used successfully within learning disability residential homes in the Trust for a number of years. Presentation: A buccal liquid (brand name Epistatus®) containing 10mg midazolam base in 1ml of sugar-free syrup. The product has a shelf life of 2 years and is presented with oral syringes. Each pack contains sufficient for four doses. Dosage: The adult dose of buccal midazolam liquid is 10mg (1mL). For simplicity, the following regime can also be adopted to calculate dose and volume to administer: Age of patient 10 years and over Dose of buccal midazolam 10mg (1.0ml) Administration of Epistatus® dose: Check that bottle is in date Hold the bottle upright Remove the child-resistant cap by pushing it down and turning it anti-clockwise Push the plunger of the empty 1ml oral dispenser (syringe) completely down towards its tip Insert the tip of the oral dispenser into the hole in the white plastic bottle adaptor Hold the bottle and oral dispenser securely and turn the bottle up-side down Pull the plunger out slowly until the oral dispenser contains the prescribed dose (see regime above) Turn the bottle upright Remove the oral dispenser from the bottle Put about half of the liquid in the oral dispenser between the patient’s gums and cheek (buccal cavity). Do not let the patient bite the oral dispenser Put the remaining liquid between the gums and cheek on the other side of the mouth. If administration is difficult then squirt the whole dose into one side Screw the child-resistant cap back on the bottle immediately to prevent evaporation Put the bottle back in the carton containing the remaining oral dispensers The dose should work within 5 minutes, however if after 10 minutes there is no sign of recovery (gaining consciousness) then a second dose can be administered but only if prescribed . If this is not the case then an ambulance must be called. If a person experiences a prolonged seizure within a 6 hour timeframe from the last dose administered then an ambulance must be called. If it is after 6 hours then the procedure can be repeated. 20 Appendix 4: Administration Technique for Rectal Diazepam 21 Appendix 5: Information for nurses & Carers on the Management of Seizures in Adults with Rectal Diazepam (for use in adult detox’ patients without an epilepsy diagnosis) Maintain a safe environment and consider the dignity of the patient. Note the time that the seizures start Cushion the person’s head if possible to prevent injury Administer rectal diazepam in the range of 10mg -20mg as prescribed, as soon as possible ideally within 2 minutes of the seizures starting. If the seizures continue then administer another dose 15minutes after the first dose. Maximum dose is 30mg per 24 hours. If seizures last longer than 30 minutes then this is called status epilepticus and is a medical emergency, so get help urgently. Remain with the person until they are fully recovered Once convulsions have stopped put the person into the recovery position, check airway and also for injury Attend to any personal hygiene needs Support to sleep if needed Re-orientate the person to their surroundings Monitor for any side-effects due to diazepam e.g. effects on respiration Document as appropriate and inform the relevant medical team Do Not Restrain the person but guide away from danger Put anything in their mouth Give any food or drink until the patient has fully recovered from the seizure for example has regained consciousness and is aware of their surroundings Move the person unless they are in direct danger If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language please contact the Pharmacy Team on 01243 623349 (Text Relay calls welcome). Approved: February 2016 Review date: February 2018 (See Appendix 4 for administration guidance for rectal diazepam) 22 Appendix 6: Easy Read Buccal Midazolam leaflet Buccal Midazolam This is an easy way to read this word… Buc-cal Myddaz-zol-am What is this leaflet for? This leaflet is to help you understand more about your medicine. Your medicine could look different to the photographs on this leaflet. What is the medicine called? Your medicine is called buccal midazolam. It can come as Buccolam in a syringe or as Epistatus in a bottle. Both work well, and are both given from an oral syringe into the space between your gum and cheek (buccal cavity) but it is important to stick to your usual brand. Sticking with your usual brand will help to make sure you get the right dose of medicine. What is buccal midazolam for? Buccal midazolam is used to help stop seizures or fits if they go on for too long. If you need some buccal midazolam one of your carers will help you to have this to stop your seizure. 23 What will buccal midazolam do? Buccal midazolam should help you to stop having a seizure if it is given you to when you are fitting. People only need to take this medicine when they are having a seizure and not at any other time. It is normal that many people do not remember having been given their medication. Your carer should tell you when you have needed your buccal midazolam to help with your seizure. What are the side effects of buccal midazolam? Side effects are effects medicine can have on your body that are not wanted. Not everyone taking a medicine will get side effects. Many side effects will go away with time. Many side effects are rare. You might want to talk to your doctor if you have any side effects. For example, these are some side effects of buccal midazolam Having a headache Feeling very tired Problems remembering things Feeling dizzy and faint Feeling confused Feeling unsteady on your feet Feeling more aggressive or angry 24 Some side effects are more serious. You should tell someone straight away if you… Have a rash or blotches on your skin Have trouble breathing Feel more angry Feel unwell How and when do I take buccal midazolam? Because buccal midazolam is only needed when you have a seizure you will not need to give this medicine to yourself. If you need buccal midazolam when you have a seizure your carer will give this to you by placing the oral syringe into the space between your gum and cheek. The liquid will then start to help with your seizure. Can I have a second dose if I need it? Most seizures stop in about 10 minutes after you have buccal midazolam. If this doesn’t happen and your doctor has prescribed this, a second dose can be given. +1 Information about this will be in your epilepsy care plan and on your prescription. 25 Are there any reasons I should not have buccal midazolam? If you have had a bad reaction to this medication or one like it which are called benzodiazepines (ben-zo-dye-as-a-peen). These might be called diazepam (dye-az-eh-pam), clonazepam (clo-na-zee-pam) or lorazepam (lo-ra-zee-pam). If you are worried about this let your doctor or pharmacist know. Where can I get more information? This leaflet does not tell you everything about buccal midazolam. If you want more information about buccal midazolam… • you can ask your pharmacist, doctor or nurse for more information • you can ask your carer to get more information • you can phone NHS non-emergency number on 111 • you can visit the website below http://www.easyhealth.org.uk/sites/default/files/Epilepsy%20%20EH.pdf Produced February 2016 Review by February 2018 26 Appendix 7: Easy Read Rectal Diazepam leaflet Rectal Diazepam This is an easy way to read this word… Rec-tal Dyeaz-eh-pam What is this leaflet for? This leaflet is to help you understand more about your medicine. Your medicine could look different to the photographs on this leaflet. What is the medicine called? Your medicine is rectal diazepam. It can also be called Stesolid or Desitin. It is a liquid that comes in a tube. You may see 1 of these names on your prescription. What is rectal diazepam for? Rectal diazepam is used to help stop seizures or fits if they go on for too long. If you need some rectal diazepam one of your carers will help you to have this to stop your seizure. 27 What will rectal diazepam do? Rectal diazepam should help you to stop having a seizure if it is given you to when you are fitting. People only need to take this medicine when they are having a seizure and not at any other time. It is normal that many people do not remember having been given their medication. Your carer should tell you when you have needed your rectal diazepam to help with your seizure. What are the side effects of rectal diazepam? Side effects are effects medicine can have on your body that are not wanted. Not everyone taking a medicine will get side effects. Many side effects will go away with time. Many side effects are rare. You might want to talk to your doctor if you have any side effects. For example, these are some side effects of rectal diazepam Having a headache Feeling very tired Problems remembering things Feeling dizzy and faint Feeling confused Feeling unsteady on your feet Feeling more aggressive or angry 28 Some side effects are more serious. You should tell someone straight away if you… Have a rash or blotches on your skin Have trouble breathing Feel more angry Feel unwell How and when do I take rectal diazepam? Because rectal diazepam is only needed when you have a seizure you will not need to give this medicine to yourself. If you need rectal diazepam when you have a seizure your carer will give this to you by placing the end of the tube into your bottom and squeezing the tube so the liquid can get into your body. The liquid will then start to help with your seizure. Everyone is different and some people prefer to have their medication by mouth and others are happy to have medication in their bottom. Rectal diazepam cannot be given by mouth, but there are other medicines to help with fits that can be given by mouth even if you are having a seizure. If you would rather have your medicine by mouth you can ask your doctor to talk about this. 29 Can I have a second dose if I need it? Most seizures stop in about 10 minutes after you have rectal diazepam. If this doesn’t happen and your doctor has prescribed this, a second dose can be given. Information about this will be in your epilepsy care plan and on your prescription. +1 Are there any reasons I should not have rectal diazepam? If you have had a bad reaction to this medication or one like it which are called benzodiazepines (ben-zo-dye-as-a-peen). These might be called midazolam (myd-daz-zol-am), clonazepam (clo-na-zee-pam) or lorazepam (lo-ra-zee-pam). If you are worried about this let your doctor or pharmacist know. Where can I get more information? This leaflet does not tell you everything about rectal diazepam. If you want more information about rectal diazepam… • you can ask your pharmacist, doctor or nurse for more information • you can ask your carer to get more information • you can phone NHS non-emergency number on 111 • you can visit the website below http://www.easyhealth.org.uk/sites/default/files/Epilepsy%20%20EH.pdf Produced February 2016 Review by February 2018 30
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