SH CP 04. Version: 5. Summary: How to train in administering and administer buccal midazolam for tonic - clonic status epilepticus.

Transcription

1 SH CP 04 Guidelines for training in and administration of Midazolam Hydrochloride Oromucosal Solution (Buccolam )10mg/2ml for the Management of Tonic - Clonic Status Epilepticus in Adults with a Learning Disability Summary: Keywords (minimum of 5): (To assist policy search engine) Target Audience: How to train in administering and administer buccal midazolam for tonic - clonic status epilepticus. Epilepsy; Status epilepticus; tonic-clonic seizures; learning disability; buccal midazolam. Heads of Professions, Medical Staff, Inservice user and community nursing staff, Pharmacists. Next Review Date: February 2021 Approved & Ratified by: Medicines Management Committee Chair approval Date issued: February 2017 Date of meeting: 16 November January 2017 Author: Director: Dr Jennifer Dolman and Ian Wheeler Dr Sarah Constantine, Medical Director 1

2 Version Control Change Record Date Author Version Page Reason for Change June and through out Updated in order that principles can be applied to any service user. June Epidemiology updated. Deleted reference to use of injectable to avoid confusion. 4 Prescribed changed to initiation by an epilepsy specialist. Specific wording on when to use intra-nasal route added. 5 Deleted list of specific drug interactions. Reference made to review current BNF instead. 6 Inserted advice to refer to PIL for up to date information regarding storage. 7 Training requirements updated. October 2011 November 2011 November To contact designated nursing service annually to arrange training changed to recommend individuals attend refresher course every 2 years, but will depend on frequency of use, due to considerable training resource required for original statement. 3 5 The usual dose for a person aged 10 years and over is 10mg (ten milligrams) of Epistatus. However, the dose should be checked if other products are prescribed. 4 9 Acknowledgments with thanks to Shire Pharmaceuticals Ltd for the use of the administration diagrams in Appendix2 January Juliet Wells 4 7 Review. Storage requirements of midazolam buccal 2017 Feb Added new updated version control page. Amendment to title May Updated reviewer/contributors list. Updated trust logo Nov Updated 4.7 to remove Ideally the service user should remain supine for at least an hour after administration and replace with appropriate direction. Updated Medical Director details on front page Reviewers/contributors Name Position Version Reviewed & Date Juliet Wells Principal Pharmacist MH & LD V4 January 2017 Carol Bailey Lead LD Nurse V4 January 2017 Dr Muzafar Hawramy Consultant Psychiatrist in Learning Disability V4 January 2017 Vanessa Lawrence Deputy Chief Pharmacist V5 November 2017 John Stagg ADON, AHP & Quality V5 November 2017 Hayley Stockford Resuscitation Officer V5 November

3 Contents Page 1 Purpose 4 2 Background 4 3 Requirements 5 4 Initial treatment 5 5 Repeat doses 6 6 Drug interactions 6 7 Side effects / contraindication / precautions and treatment of overdoses 6 8 Advice to the service user and / or carer 7 9 Storage of midazolam 7 10 Legal status 7 11 Responsibilities 8 12 Training 8 13 References 8 14 Acknowledgments 8 Appendix 1 Buccal midazolam treatment plan 10 Appendix 2 Instructions for administering buccal midazolam 17 Appendix 3 Responsibilities for the prescription and administration of buccal midazolam 18 3

4 Guidelines for training in and administration of Midazolam Hydrochloride Oromucosal Solution (Buccolam ) 10mg/2ml for the Management of Tonic - Clonic Status Epilepticus in Adults with a Learning Disability 1. Purpose Throughout this document, midazolam hydrochloride oromucosal solution, or Buccolam, will be referred to as buccal midazolam This policy provides a protocol for the training in, safe prescribing and administration of buccal midazolam for tonic - clonic status epilepticus in Southern Health NHS Foundation Trust adult service users with a learning disability. However, the principles could be applied to any Southern Health NHS Foundation Trust adult service user to whom it was clinically applicable. This policy applies to all doctors and nurses employed in Southern Health NHS Foundation Trust. This policy should be read in conjunction with the Southern Health NHS Foundation Trust Medicines Control, Administration and Prescribing Policy. 2. Background 2.1 Epilepsy is a common condition. At least 20% of people with a learning disability across the lifespan have epilepsy, with higher prevalence figures in institutional settings and with decreasing IQ 2. Chronic epilepsy is more likely to occur in people with a learning disability than the general population 3. Tonic - clonic status epilepticus is defined as prolonged or recurrent tonic clonic seizures persisting for 30 minutes or more. Approximately 5% of all adult service users attending an epilepsy clinic will have at least one episode of tonic - clonic status, increased in people with a learning disability Tonic - clonic status has a mortality of approximately 20%, with the risk of morbidity increasing with the duration of the status episode 1. Early treatment of tonic - clonic seizures in the premonitory stage of status epilepticus in the community reduces morbidity and mortality. 2.3 Until recently the most commonly used medication was rectal diazepam. Buccal midazolam provides an alternative treatment to, but not a replacement for, rectal diazepam for tonic - clonic status epilepticus. This is an unlicensed use of midazolam, but there is evidence that it is effective and well tolerated. It is being used increasingly both in the community and specialised epilepsy units. It is clinically shown to be as effective as rectal diazepam in the acute treatment of seizures Administration via the mouth is more socially acceptable and convenient than the rectal route. 4

5 2.5 It is crucial to be aware of, and to raise awareness about, differences between the two proprietary brands; Epistatus and Buccolam. Epistatus Buccolam. Midazolam salt is maleate Midazolam salt is hydrochloride 10mg in 1ml 10mgs in 2mls Unlicensed for all ages Licensed for infants over 3mths and children and adolescents up to 18yrs Buccal midazolam must always be prescribed by brand name to avoid confusion and the risk of administering the wrong dose. 2.6 At physiological ph midazolam becomes highly lipophilic permitting rapid transfer across the blood-brain barrier an advantage over other benzodiazepines. The anticonvulsant action is thought to be due to enhancement of GABA (gamma aminobutyric acid), the main inhibitory neurotransmitter in the brain. This causes hyperpolarisation of neurons, reducing their chance of firing and propagating a seizure. Buccal administration allows absorption directly into the systemic circulation, bypassing first pass hepatic extraction thus increasing the amount of active drug at the site of action. 3. Requirements 3.1 Buccal midazolam is initiated on a named service user basis by an epilepsy specialist (usually a learning disability consultant or higher trainee), who will determine the suitability of the service user for buccal midazolam and the dose required. 3.2 The epilepsy specialist will explain to the carers and service user that midazolam is not licensed for buccal use and is a controlled drug. 3.3 The service user will have a personalised rescue management protocol agreed by the epilepsy specialist, community nurse, carer and where possible service user (see Appendix 1). 3.4 The training of carers to administer buccal midazolam will be tailored to each individual service user. 3.5 There is a current and valid prescription that specifies the brand and is compliant with CD regulations see section The efficacy and use of midazolam will be monitored by the carers informing nursing staff, who will ensure the epilepsy specialist is updated. 3.7 Normal procedures to ensure safe drug administration should be followed. 4 Initial Treatment (Appendix 2) 4.1 As buccal midazolam can cause severe drowsiness, the solution should not normally be administered until after the seizure has lasted 5 minutes. 4.2 However, in exception to the recommended 5 minute delay, carers of service users known to suffer tonic-clonic seizures that usually last more than 5 minutes with loss of consciousness, should be advised to administer midazolam immediately or even at the 5

6 first indicative signs of seizure onset. For those service users, until experience indicates otherwise, it may be advisable to call an ambulance without delay. 4.3 The usual dose for a person aged 10 years and over is 10mg (ten milligrams) of midazolam. However, the dose should be checked if other products are prescribed. 4.4 Using the oral syringe provided, administer half of the prescribed dose to each side of the buccal cavity (between the lower gums and cheeks). If this is not possible, the whole dose should be administered to the buccal cavity on one side of the mouth. The dose must not be administered below the tongue since the teeth may clamp shut and break the syringe in the mouth. 4.5 In cases of excessive salivation Buccolam can be administered intra-nasally. This must be documented within the individual treatment plan of prolonged or serial seizures and staff must have appropriate knowledge, training and guidance. 4.6 In normal circumstances an ambulance should be called at the same time as the first dose of midazolam is administered. However, if it is known that the service user usually responds positively to the first dose then the call for an ambulance should wait until the second dose is needed. 4.7 The service user will be drowsy for several hours after administration and may be protected from recurring seizures for up to four hours. Depending on the service user s level of consciousness they may require to be placed into the recovery position to protect the person s airway. 5 Repeat doses 5.1 Initial effects become apparent after approximately 5 minutes. If no beneficial effect (that is reduction in seizure activity) is apparent 10 minutes after administering midazolam, a second dose of 10mg (ten milligrams) may be administered. If calling the ambulance was delayed at administration of the first dose, it must be called at administration of the second. 5.2 No more than two doses of 10mg (ten milligrams) of midazolam should be administered in any 24 hour period. 6 Drug Interactions Refer to current BNF, anxiolytics and hypnotics for interactions. Of particular note are midazolam s interactions with certain antibiotics (e.g. erythromycin, clarithromycin), some blood pressure medications (e.g. ramipril) and anticoagulants. 7 Side Effects/Contraindication/Precautions and Treatment of Overdoses 7.1 Drowsiness, prolonged sedation and ataxia are the most commonly reported side effects. 7.2 Nausea, vomiting, constipation, dry mouth and hiccup have also been reported. 7.3 Respiratory depression may occur after 3 doses administered closely together. Therefore a third dose should only be administered in hospital. Buccal midazolam should be used with caution in service users with chronic respiratory insufficiency. 6

7 7.4 Severe irritation to mucous membranes may occur after nasal administration. 7.5 Paradoxical reactions (e.g. agitation, involuntary movements, hyperactivity, hostility, aggression and excitement) have been reported, although these are rare. 7.6 Contraindications include hypersensitivity and acute narrow angle glaucoma. 7.7 The safety of midazolam in pregnancy and breastfeeding has not been established. 7.8 Signs of respiratory depression and overdose may be indicated by excessive somnolence, confusion, hypotension, decreased respiratory rate and paradoxical excitation. An ambulance should be called immediately. 8 Advice to the Service User and/or Carer A Service user Information Leaflet (PIL) is provided with each Buccolam pack dispensed. It is recommended that carers read the contents of the PIL to familiarise themselves with its contents prior to the first administration. 9 Storage of Midazolam 9.1 Buccolam is available in cartons containing four pre-filled, orange-coloured syringes. The pack should be stored upright at o C and never be refrigerated or frozen. Up to date information regarding the storage of buccal midazolam should always be obtained from the PIL provided with each pack. Buccal midazolam oral syringes must be kept in the protective plastic tube which must have an intact tamper evident seal. 9.2 Buccal midazolam must be kept in a locked controlled drugs cupboard and recorded in the controlled drugs register. Where buccal midazolam is used for leave purposes, it must be entered in and out of the controlled drugs register to maintain an audit trail. 9.3 Any buccal midazolam that needs to be destroyed must be done in accordance with Trust guidelines for the destruction of controlled drugs (MCAPP SH CP1) 10 Legal Status 10.1 Midazolam is a schedule 3 controlled drug and should be stored, dispensed and administered in line with Trust and Organisational Policy and Procedures on controlled drugs (MCAPP SH CP 1) Midazolam is not licensed for buccal use in adults and this will be explained to the carers and service user by the epilepsy specialist. However it is recommended by NICE for use in the community for adults and children who have had previous episodes of prolonged and serial seizures As buccal midazolam is a schedule 3 CD, prescriptions must contain the following information: dose; form; strength; total quantity or dosage units in words and figures. The brand name should be specified to comply with good practice. Prescriptions are only valid for 28 days from date of signing. 7

8 11 Responsibilities All professionals and carers involved in the prescription and administration of buccal midazolam should be aware of their responsibilities, detailed in appendix Training 12.1 Southern Health NHS Foundation Trust staff who wish to be deemed as trainers will be registered nurses (usually within the Community Learning Disabilities Healthcare Teams or inpatient services.) 12.2 The nurses training will be approved by the Trust Chief Pharmacist and their Directorate lead nurse Appropriate staff members will be able to give formal training to staff employed by private care providers in the community. Training will incorporate both general epilepsy awareness and the administration of buccal midazolam as suggested by the Joint Epilepsy Council On successful completion of training, staff not employed by the Trust will be given a certificate stating they have received training in the administration of buccal midazolam and observed practicing the procedure within the classroom. However as not observed in clinical practice, competence cannot be confirmed. It is the responsibility of the individual s line manager to determine their suitability to administer buccal midazolam according to the organisation s own policies and procedures. 13 References 1. Shorvon, S. (2010). Handbook of Epilepsy Treatment. (3 rd edition). Oxford: Blackwell Publishing Limited. 2. Working Group of the International Association of the Scientific Study of Intellectual Disability (IASSID) (2001). Clinical Guidelines for the Management of Epilepsy in Adults with an Intellectual Disability. Seizure, 10: Stokes, T., Shaw, E.J., Juarez-Garcia, A., Camosso-Stefinovic, J., and Baker, R. (2004). Clinical Guidelines and Evidence Review for the Epilepsies: diagnosis and management in adults and children in primary and secondary care. London: Royal College of General Practitioners. 4. NICE clinical guideline 137.(2012). The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care (last updated February 2016). 14 Acknowledgements This policy has been written using documents from the following: Colchester Learning Disability Service The Joint Epilepsy Council Cornwall Partnership NHS Trust Southampton and Winchester Districts Prescribing Committee Fareham and Gosport PCT 8

9 Northamptonshire Partnership NHS Trust Bristol Royal Hospital For Children Community Paediatric Neurology Team Gloucestershire Partnership NHS Trust Acknowledgments with thanks to Shire Pharmaceuticals Limited for the use of the administration diagrams in Appendix 2 9

10 Appendix 1 Buccal Midazolam Treatment Plan The Treatment Plan must clearly specify the exact intervals when medication is to be administered in an epileptic seizure. The individual Treatment Plan is prescribed by an epilepsy specialist (learning disability consultant or higher trainee), in collaboration with the community nurse, carer and service user. (Please use language appropriate to the lay person when completing this form) Service user s Name: Date of Birth: Address: Photo Date operational from: Review Date: Completed by: Seizure classification and description of seizures which may require buccal midazolam: After how long of seizure activity should buccal midazolam be administered? What is the first dose of midazolam that should be administered? If there are difficulties in the administration of midazolam what actions should be taken? 10

11 What is the service user s usual reaction to buccal midazolam? Can a second dose of buccal midazolam be given? After how long can a second dose of buccal midazolam be given? How much buccal midazolam is given as a second dose? What is the maximum dose that can be given in 24 hours? When should 999 be dialled for emergency help? When should the service users GP be consulted? Who should witness the administration of buccal midazolam? Who needs to be informed? (Parent/Carer/GP/Community Nurse etc. and contact details) Under what circumstances should buccal midazolam NOT be given e.g. Rectal diazepam already recently administered? ALL OCCASIONS WHEN BUCCAL MIDAZOLAM IS ADMINISTERED MUST BE RECORDED 11

12 This Plan has been agreed by the following: Prescribing Doctor: Name (please print) Signature Date Community Nurse: Name (please print) Signature Date Parent/Carer/Guardian: Name (please print) Signature Date Day Services: Name (please print) Signature Date Respite Care: Name (please print) Signature Date Service user: Name (please print) Signature Date If the service user does not have the capacity to consent to the use of buccal midazolam a statement to that effect should be written here by the epilepsy specialist. Signature: Date: 12

13 Suspected reaction to Midazolam given as emergency treatment for Epileptic Seizures. To be completed by the carer or nurse. Service user Name: Address: Date of Birth: Time and dose of midazolam given and administrative route: i.e. buccal/intranasal Time: Dose: Route: Buccal midazolam preparation is unlicensed in adults. Please report all suspected reactions to the consultant. Please give a clear account of the event. Signature: Date: Copy to: consultant and nurse and one copy to remain in the service user notes/epmr 13

14 AUTHORISED PERSON(S) TRAINED TO ADMINISTER BUCCAL MIDAZOLAM Service user s Name: DOB: NAME. Signature. Date (Block capitals NAME. Signature. Date (Block capitals) NAME. Signature. Date (Block capitals) NAME. Signature. Date (Block capitals) NAME. Signature. Date (Block capitals) HEAD OF CARE HOME.. Signature. Date (Block capitals) THIS FORM SHOULD BE KEPT IN THE SERVICE USER S MAIN FILE AND WITH THEIR MEDICATION CHART Expiry date of this form 14

15 When calling 999 to summon an ambulance say: This is (include your name, location address and phone number). We have a service user who has had/ is having an epileptic seizure. Buccal midazolam has/has not been given. We need a paramedic team urgently. The service user s name is and date of birth is Inform ambulance control of the exact location and best entrance to use and state that the crew will be met and taken to the service user (if possible). Speak clearly and slowly and be ready to repeat information if asked. Send a member of staff to wait at the entrance to direct the ambulance crew as necessary. 15

16 EVALUATION SHEET AND RECORD OF USE OF BUCCAL MIDAZOLAM NAME OF SERVICE USER.. D.O.B. DATE RECORDED/ADMINISTERED BY TYPE OF SEIZURE LENGTH AND/OR NUMBER OF SEIZURES INITIAL DOSAGE OUTCOME SECOND DOSAGE (IF ANY) OUTCOME OBSERVATIONS PARENT/GUARDIAN INFORMED PRESCRIBING DOCTOR INFORMED OTHER INFORMATION WITNESS 16

17 Appendix 2- Instructions for administering buccal midazolam Text from Product Administration Leaflet for Buccolam (10mg/2ml) Oromucosal solution. Permission to use the images given by Shire Medical Information) HOW TO GIVE THE MEDICINE 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 of the tip of the syringe and dispose it safely Step 3: Using the finger and thumb gently pinch and pull back the 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 the solution should be inserted slowly into the space between the gum and the cheek. If necessary, for larger volumes or smaller patients, approximately half the dose should be given into one side of the mouth and the other half unto the other side. 17

18 Appendix 3 Responsibilities for the prescription and administration of buccal midazolam Aspects of care for which the epilepsy specialist is responsible Assess suitability of service users for this treatment. Inform the service user and carer of the unlicensed status of buccal midazolam in adults and what this means. Inform the service user and carer of potential side effects. Prescribe the correct dose. Initiate and assess the efficacy of the treatment. Liaise with the GP to agree the service user s shared care. Provide the first supply of medication for use at home. Follow up and monitor. Keep the carers, GP and community nurses informed of any changes in treatment. Aspects of care for which the nurse is responsible The nurse is only to become involved when the service user is under the epilepsy specialist and is only responsible while the service user is open to the nursing service Discuss the provision of the service with parent/carer/service user needing buccal midazolam. Write the Treatment Plan on the advice of the epilepsy specialist, which includes the epilepsy specialist s signature. Advise service user/parent that the Treatment Plan is specific to the service user. Arrange date, time and place for initial training. Train the carer in the method of administration. Train the carer in recognising the need for urgent hospital care. Assess and monitor the service user s response to treatment. Keep a copy of Treatment Plan and training attendance list (approved non-nursing staff) within the file 18

19 Maintain regular contact with the service user and epilepsy specialist in order to monitor the use and effectiveness of buccal midazolam. Monitor the Treatment Plan and evaluate effectiveness, following implementation by volunteers. Aspects of care for which the GP is responsible Prescribing supplies for buccal midazolam once an effective dose has been established. Liaise with the consultant regarding complications or efficacy of treatment if the service user has two or more seizures in any 24 hour period. Care Home and Service providers responsibilities Identify volunteers for training. As recommended by the Joint Epilepsy Council, to attend a refresher course every 2 years, but this will depend on the frequency of use. Ensure amendments/exclusions to Treatment Plan (Appendix 1) requested by service users are clearly documented and, where appropriate, discussed with doctor and the nursing service. Ensure that each service user has an up-to-date Treatment Plan. Ensure that staff are insured to carry out this procedure. Ensure photo of the service user requiring buccal midazolam administration is displayed with a prescription for the medication, in an appropriate place. Develop an action plan to be used in the event of a service user requiring buccal midazolam, which takes into consideration their privacy and dignity, and outings. Ensure that medication is available, stored correctly and is in date. Copy of Treatment Plan and consent/agreement form to be kept with service user s care file. Copy of responsibilities of volunteers to be given to each volunteer. Volunteers' responsibilities Adhere to the guidance. Only undertake the administration of buccal midazolam after satisfactory completion of the training specified in these guidelines and subsequent up-date training. No person other than those named on the buccal midazolam treatment plan for a specific service user can administer the buccal midazolam. Only deliver care specified in the buccal midazolam Treatment Plan (Appendix 1) to the service user identified on the Plan; record, accurately, appropriate information on Evaluation Sheets. 19

20 Contact the designated nursing service for advice, support or queries relating to delivery of care as specified in the Treatment Plan (Appendix 1). The epilepsy training is service user specific. 20