Guideline on the use of Buccolam for Children & Young People with Epilepsy

Transcription

1 Guideline on the use of Buccolam for Children & Young People with Epilepsy

2 Guideline on the use of Buccolam for Children & Young People with Epilepsy Document Type Clinical Guideline Unique Identifier CL-212 Document Purpose To provide clear guidance for Worcestershire Health & Care Trust staff, in the use of Buccolam for Children & Young People with Epilepsy Document Author Debbie Bolt Children s Clinical Practice Facilitator Target Audience Medical & Nursing Staff (Registered & Non Registered) employed by Worcestershire Heath & Care NHS Trust, who are involved in the use of Buccolam for Children & Young People with Epilepsy. Responsible Group Clinical Policies Group Date Ratified 27 th April 2016 Expiry Date 27 th April 2019 The validity of this policy is only assured when viewed via the Worcestershire Health and Care NHS Trust website (hacw.nhs.uk.). If this document is printed into hard copy or saved to another location, its validity must be checked against the unique identifier number on the internet version. The internet version is the definitive version. If you would like this document in other languages or formats (i.e. large print), please contact the Communications Team on or by to communications@hacw.nhs.uk. Guideline on the use of Buccolam for Children & Young People with Epilepsy 1 of 39

3 Version History Version Circulation Date Job Title of Person/Name of Group circulated to Brief Summary of Change Children s Nurse Consultant & Complex Care Manager Community Children s Nurses (Orchard Service) Team Leaders Ludlow Road Short Breaks Team Leader Home Support Team/ Children s Continuing Healthcare Team Leader Clinical Nurse Specialist Children s Palliative Care. WHCT Consider reformatting Emergency Medication Plan No comments received No comments received No comments received No amendments Chief Pharmacist. WHCT Senior Medicines Safety Pharmacist. WHCT Quality Lead Children, Young People & Family SDU Head of Corporate Nursing & Education Epilepsy Specialist Nurse. WAHT Consultant Paediatrician with special interest in epilepsy. WAHT All Community Paediatricians Special School Nurses Team Leader All Special School Nurses Integrated Safeguarding Team Manager Medicines Management Safety Sub Committee Nurse Consultant Infection Prevention & Control Medical Lead/Clinical Director Clinical Policies Group No comments received No comments received Clarification of targeting the guideline for Registered & Non Registered staff Amendment to responsibilities & duties, & monitoring implementation No plans to reformat Emergency Medication Plan No comments received Feedback from one Community Paediatrician.(no amendment) No comments received No amendments Minor amendments Minor amendments to workbook No amendments Request to seek comments from WHCT Epilepsy Specialist Nurse Learning Difficulties Guideline on the use of Buccolam for Children & Young People with Epilepsy 2 of 39

4 Clinical Policies Administrator Deputy Head of Quality Governance Additional comments from Epilepsy Specialist Nurse Amendments considered and made where appropriate. Accessibility Interpreting and Translation services are provided for Worcestershire Health and Care NHS Trust including: Face to face interpreting; Instant telephone interpreting; Document translation; and British Sign Language interpreting. Please refer to the intranet page: for full details of the service, how to book and associated costs. Training and Development Worcestershire Health and Care NHS Trust recognises the importance of ensuring that its workforce has every opportunity to access relevant training. The Trust is committed to the provision of training and development opportunities that are in support of service needs and meet responsibilities for the provision of mandatory and statutory training. All staff employed by the Trust are required to attend the mandatory and statutory training that is relevant to their role and to ensure they meet their own continuous professional development. Co-production of Health and Care Statement of Intent The Trust expects that all healthcare professionals will provide clinical care in line with best practice. In offering and delivering that care, healthcare professionals are expected to respect the individual needs, views and wishes of the patients they care for, and recognise and work with the essential knowledge that patients bring. It is expected that they will work in partnership with patients, agreeing a plan of care that utilises the abilities and resources of patients and that builds upon these strengths. It is important that patients are offered information on the treatment options being proposed in a way that suits their individual needs, and that the health care professional acts as a facilitator to empower patients to make decisions and choices that are right for themselves. It is also important that the healthcare professional recognises and utilises the resources available through colleagues and other organisations that can support patient health Guideline on the use of Buccolam for Children & Young People with Epilepsy 3 of 39

5 Contents 1. Introduction Page 5 2. Purpose of document Page 5 3. Definitions Page 6 4. Scope Page 6 5. Training & Competencies Page 6 6. Responsibilities & Duties Page 7 7. Consent Page 8 8. Administration of Buccolam Page 8 9. Side Effects Page Storage Page Monitoring Page References Page Associated Documentation Page 12 Appendices Appendix 1 Buccolam Workbook Page 13 Appendix 2 Buccolam Competency Document Page 25 Appendix 3 Indemnity form Page 30 Appendix 4 Emergency Plan Page 31 Appendix 5 Record of Buccal Administration at Home Page 32 Appendix 6 Parent Information Leaflet Page 33 Guideline on the use of Buccolam for Children & Young People with Epilepsy 4 of 39

6 1. Introduction a. Epilepsy is the most common serious brain disorder; affecting over 60,000 (approximately 1:220) children aged 3 months 18 years in the UK.(Epilepsy Society 2015) b. It is important to manage the chronic & acute elements of the disease. The majority of seizures will resolve within a short period of time; however there are occasions when seizures don t resolve & emergency /rescue medication is required to resolve this. Buccolam may be prescribed for this purpose. c. Buccolam is the licenced for treatment of severe convulsions & epileptic seizures in children aged 3months to 17years of age inclusive (NPA 2011) & as such is the treatment of choice for children with prolonged seizures, within Worcestershire Health & Care Trust. d. Buccolam (midazolam) oromucosal (buccal) solution 5mg/1ml has been granted a paediatric use marketing authorisation (PUMA) by the European Commission, and as such is now classed as a licensed product. (National Pharmacy Association (NPA) 2011) e. National Patient Safety alert (2012) advised the transfer from unlicensed buccal midazolam 10mg/ml to licensed buccal midazolam 5mg/ml (Buccolam ). f. This guideline takes into account the recommendations made in NICE CG-137 The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care (2012) g. This Guideline is based on Worcester Acute Hospital Trust Guideline Emergency Rescue Medication for Children with Epilepsy Guideline for doctors, nurses and parents/carers on the use of Buccolam in children (2012). h. Many children receiving Buccolam will be cared for/or care shared between Worcester Acute Hospital Trust & Worcestershire Health & Care Trust. Continuity in practices of care will minimise risk & aim to reduce errors. i. Documents to support this guideline are adopted from WHAT guideline to minimise risk & reduce errors 2. Purpose of document a. To ensure that children & young people are prescribed Buccolam where appropriate as recommended by NICE guidelines (2012) b. To ensure that Worcestershire Health & Care Trust staff (medical & nursing) are aware of up to date practice. c. To provide continuity of treatment for children & young people with epilepsy, within Worcestershire, in streamlining care between Worcestershire Acute Hospital Trust & Worcester Heath & Care Trust. d. To provide a clear framework for staff, in supporting parents of children receiving Buccolam. Guideline on the use of Buccolam for Children & Young People with Epilepsy 5 of 39

7 3. Definitions a. Buccolam (midazolam oromucosal solution) used to treat prolonged, acute, convulsive seizures in infants, toddlers, children & adolescents (from 3 months to > 18years of age). b. Midazolam is a medication from the group of drugs called benzodiazepines that affect the central nervous system. Midazolam is a muscle relaxant and has anti-convulsant properties. Midazolam is a Schedule 3 controlled drug (CD) but it is exempt from the safe custody regulations. It is commonly used for sedation of children for medical procedures. c. This guideline will refer only to Buccolam pre filled oral syringes, not other preparations of midazolam. d. Buccal refers to the two spaces in the mouth, between the lower set of teeth/jaw & the cheek. It is a deep vascular space that facilitates the quick absorption of small amounts of medication, without swallowing them. e. For the purposes of this guideline, child/young person refers to 3months to 17years inclusive. 4. Scope a. This guideline is for Medical & Nursing Staff ( Registered & Non Registered) employed by Worcestershire Heath & Care NHS Trust, who are involved in the use (including prescribing and administration) of Buccolam for Children & Young People with Epilepsy. 5. Training/Competencies a. Parents/carers should be taught how to administer Buccolam, by their prescribing doctor. (This may be delegated to a member of nursing staff). Training should include: Ability to recognise and manage prolonged seizures including basic first aid. Familiarisation with the formulation of midazolam in pre-filled syringes. Familiarisation with the buccal route of administration. Knowledge of how & when to call a paramedic ambulance and the correct information to give when making an emergency call. Knowledge of how to record the administration of midazolam and the child s response. Safe Storage Side Effects & cautions for use b. All non-registered staff providing care for children/young people who have been prescribed Buccolam must receive theoretical and practical instruction on how to administer this safely and competently. Their training will be provided by a Registered Nurse. Opportunity to practice are likely to be very limited, due to the nature of the medication being for administration in emergency situations, rather than routine. A record should be kept by the trainer & the trainee, of the training received and competency obtained. Reassessment will be annually or sooner if required. c. Training in epilepsy should be undertaken prior to training in Buccolam Guideline on the use of Buccolam for Children & Young People with Epilepsy 6 of 39

8 d. Training should ensure those administering medication know the difference between milligrams and millilitres. e. Please refer to Appendix 1 for the workbook and Appendix 2 for the competency assessment tool for Buccolam training. These will be used for non-registered staff. f. Buccolam Training packs are available through Community Children s Nurses and Special School Nurses Teams. These contain additional information produced by the manufacturer, including training DVD. g. Registered Health Care professionals who delegate this procedure to a carer (employed or unemployed, i.e. parent) retains the accountability for the delegation of this, & the responsibility for their training. However it is the carers responsibility to ensure that reassessment occurs every 12 months. h. The competency & assessment tools can also be used by carers who are not employed by WHCT, but this may incur a charge. This includes education staff. i. If used for carers employed by the Local Authority or Direct Payments workers, a charge will not be made, but a Liability form should be completed. Appendix 3. j. Registered & non registered staff should only perform this procedure if they feel competent and confident to do so. (NICE 2012) 6. Responsibilities and duties a. Medical staff are responsible in conjunction with other members of the healthcare team, for prescribing the appropriate dose of medication. They are also responsible for training parents/carers on how to administer Buccolam, or this may be delegated to another Healthcare Professional (Epilepsy Specialist Nurse, clinic nurse) b. Registered Nurses should adhere to The Scope of Professional Practice (NMC 1992); The Code of Professional Conduct (NMC 2002); and The Code: Professional Standards of practice and behaviour for nurses & midwives (NMC 2015). c. Registered nurses are responsible for the safe administration of prescribed medication. d. Non registered staff are responsible for ensuring their competencies are reassessed annually and for highlighting any training needs they have. e. Nurses have a responsibility to ensure that they are competent to carry out administration of Buccolam and are willing to be accountable for their practice. They should inform their manager if they feel they are not competent and identify their training needs relating to this area of practice.. f. All Registered Health Care Professionals are responsible for giving consideration to & planning for transition to adult care services, & facilitating a smooth transfer.(nice 2012) g. The Epilepsy Specialist Nurse (Worcestershire Acute Hospital Trust) or Paediatrician (WHAT / WHCT) will review the efficiency of treatment & communicate this to the wider Health Care Team to ensure this is still an appropriate treatment. Guideline on the use of Buccolam for Children & Young People with Epilepsy 7 of 39

9 7. Consent a. This guideline should be read in conjunction with WHCT Consent to Treatment Policy. The Healthcare Professional (HCP), should aim to reduce the child/young person s and carers anxieties and allay their fears before carrying out the procedure. They should explain fully and clearly the reasons for the proposed treatment, risks involved. This must be in terms the child/young person and carer will understand. The child (if appropriate), young person and their carers should understand the reasons for treatment. b. NICE (2012) recommends good communication between the healthcare professional and people with epilepsy (and their family & carers) is essential. It should be supported by evidence - based written information tailored to the person s needs. Treatment and care, and the information people are given about it, should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak English. c. Preparation should include What the procedure entails Expected side effects & reaction to treatment How to manage minor side effects, with the support of relevant agencies i.e. Community Children s Nurses (Orchard Service), Epilepsy Specialist Nurse d. The nursing interventions in these guidelines would not be classified as those requiring written consent but verbal, expressed consent is essential. All interventions should be comprehensively documented in the patient records and written in such a way that demonstrates whether the patient/parent/carer has given their informed consent. e. The HCP should invite and encourage questions from the child/young person and parents/carers and obtain consent before an emergency situation arises requiring the administration of Buccolam. A record of this must be made in the health care record. f. In the case of children and young person with receptive and/or expressive speech or language difficulties, communication tools should be considered and the involvement of a parent/ carer who knows them well. 8. Administration of Buccolam Taken from Buccolam package leaflet (ViroPharma 2014) a. Before use, always check the expiry date stated on the carton, tube and syringe labels. b. Buccolam should not be used if any of the protective plastic tubes containing the syringes have been opened or are damaged. c. Buccolam must be prescribed & documented on an approved WHCT drug administration record, if a WHCT member of staff is going to administer the medication. d. As the indications when to administer medication and dosage will vary for each child, an individual Emergency medication plan is required. The child s Consultant or Epilepsy Specialist Nurse will complete this and it should be reviewed annually. e. The Emergency medication plan (Appendix 4) should clearly state: The preparation, strength, dosage, and amount of the medication to be given. When the Midazolam is to be given e.g. after 5 minutes. Included on the Emergency medication plan should be an indication of when an ambulance should be summoned. Guideline on the use of Buccolam for Children & Young People with Epilepsy 8 of 39

10 f. Buccolam is available in four different sized pre filled syringes as follows: Midazolam 2.5mg in a 0.5ml prefilled syringe packs of 4 (yellow) Midazolam 5mg in a 1ml prefilled syringe packs of 4 (blue) Midazolam 7.5mg in a 1.5ml prefilled syringe packs of 4 (purple) Midazolam 10mg in a 2ml prefilled syringe packs of 4 (orange) These are colour coded for ease of use. g. Medical staff will prescribe the most appropriate dose of Buccolam for the child/young person. h. Training will be given to parents/carers on how to administer Buccolam by their prescribing doctor, or this may be delegated to another Healthcare Professional (Epilepsy Specialist Nurse, clinic nurse). Dispensing Pharmacists may also give advice on how to administer Buccolam. i. If Buccolam is being given for the first time, a paramedic ambulance should be called.buccolam may be given whilst waiting for the ambulance to arrive. j. A check must be made by the person administering the Buccolm as to when the child/young person last had a dose of Buccolam, to ensure they don t exceed a maximum prescribed dose k. Ideally the child s head should be in an upright position, i.e. as when seated, but this may not be possible, if the child is lying or fallen. In this case the child s head should be positioned, as upright as possible, with the support of pillows, or upon the lap of a kneeling carers. l. Break the tamperproof seal & remove the prefilled syringe from the packaging m. Remove oral syringe cap before use to avoid risk of choking. n. Explain to the child/young person what is happening. o. Healthcare Professionals should wear non sterile, non-powdered, non-latex gloves p. Buccolam should be given in the side of the mouth (oromucosal use). Each oral syringe is pre-filled with the exact dose you need to give for ONE treatment. The full amount of medicine should be inserted slowly into the space between the gum and the Guideline on the use of Buccolam for Children & Young People with Epilepsy 9 of 39

11 cheek (see diagram below). If necessary, about half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side. Avoid squirting the liquid into the mouth too quickly as this may result in spillage. Do not put a needle on the oral syringe. Buccolam must not be injected. q. You should call an ambulance if If you cannot give the Buccolam The seizure does not stop within 5 minutes of giving Buccolam If there is a possibility that you have given too much Buccolam If the child/young person s breathing slows down or stops. r. Keep the empty oral syringe to give to the ambulance staff, so that they know how much Buccolam has been given s. If the child/young person is sick (vomits) do not give another dose of Buccolam. t. Do not give a second dose of Buccolam unless it has been prescribed. u. Do not give more than the amount of medicine prescribed by a doctor for the child/young person 9. Side Effects Most medication has the potential to cause side effects. It is difficult to predict how Buccolam may affect the child/young person, until they have their first dose. However not everyone will get side effects. Side effects may include; Nausea & vomiting Skin flushing, rash Respiratory depression Sleepiness &/or reduced level of consciousness Agitation, dizziness, headaches, confusion & hallucinations (rarely) Muscle spasm & tremors Further information can be found on In the community area a second dose should not be given by the carer within 2 hours of receiving Midazolam unless authorised by the Consultant looking after the child because of risk of respiratory depression. Guideline on the use of Buccolam for Children & Young People with Epilepsy 10 of 39

12 This rule does not apply to STATUS EPILEPTICUS when a second dose of rescue medication can be given after 10 minutes by a paramedic who has the equipment to deal with respiratory depression. (WHAT 2014) 10. Storage All medicines must be stored safely out of the reach of children In premises where WHCT staff are located, Buccolam must be stored in a suitable locked medicines cabinet. Buccolam should be stored at room temperature, out of bright sunlight & away from heat. Buccolam must not be refrigerated or frozen The oral syringe must be kept in its protective plastic tube Out of date or Buccolam that is no longer needed should be returned to the dispensing pharmacy, by the childs parent/carer. 11. Monitoring implementation a. Epilepsy Specialist Nurse will collect data annually, of Buccolam administration, of children known to her/him. (Appendix 5) b. Buccolam doses will be administered by WHCT employees as prescribed c. Trust approved documentation will be used in the management of Children & Young People with epilepsy who are prescribed Buccolam d. Any incidents relevant to this guideline will be recorded via trust approved reporting systems. Lessons learned will be shared across relevant clinical areas. 12. References National Pharmacy Association (2011).Buccal Midazolam:FAQ s National Institute for Health and Clinical Excellence (NICE). The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. NICE clinical guideline 137. January 2012.Modified January NHS National Patient Safety Agency (2012). Prevention of Harm with Buccal Midazolam. Signal. ViroPharma Package Leaflet (2014) ViroPharma Patient Leaflet Buccal Midazolam Product Choice for the Worcestershire Health Economy (Feb 2013) Epilepsy Society. WHAT Clinical Guideline - Emergency Rescue Medication for Children with Epilepsy - Guideline for doctors, nurses and parents/carers on the use of Buccolam in children. WAHT-PAE-067. Guideline on the use of Buccolam for Children & Young People with Epilepsy 11 of 39

13 13. Associated documentation Relevant NICE Guidance Worcestershire Health and Care NHS Trust Clinical Record Keeping Guidelines. Worcestershire Health and Care NHS Trust Consent to Treatment Guidelines. Worcestershire Health and Care NHS Trust Infection Control Policy. Worcestershire Health and Care NHS Trust Medicines Policy 14. Appendices Guideline on the use of Buccolam for Children & Young People with Epilepsy 12 of 39

14 Appendix 1 Patients name Buccal Midazolam Competency Work book Carers name Date / / Section 1 Carer to be able to recognise the anatomy and physiology of the mouth Diagram of mouth a b c d Please label and describe the functions of the areas you have labelled a).. b).. c)... d) Why is this drug given in the buccal space? What would happen if it was swallowed accidentally? Describe in simple terms what a seizure is? Guideline on the use of Buccolam for Children & Young People with Epilepsy 13 of 39

15 Section 2 Carer to understand when buccal midazolam is appropriate. Does.. have any warnings of his/her seizure? Yes no If so what signs or symptoms? Does have any triggers? Yes no If yes what are his/her triggers? Where is care plan for the administration of buccal midazolam kept? Is it accessible at all times? Yes no In a short paragraph describe care plan?.... Describe.seizures What must the care plan include? Is there a pattern to..seizures? Yes no Is there anything you could do to try to avoid a seizure? Yes no If yes what?.... Guideline on the use of Buccolam for Children & Young People with Epilepsy 14 of 39

16 Section 3 Carer to understand psychological implications of having a seizure In a short paragraph please describe what you understand by age appropriate? List 3 implications you think that having seizures will have on: a).. 1).. 2).. 3).. b) Parents 1).. 2).. 3).. c) siblings 1) 2) 3) d) other people who care for. 1). 2). 3). Is. excluded from any activities? Yes no If so how does this affect him/her?.... How can we make this a positive time for..? Guideline on the use of Buccolam for Children & Young People with Epilepsy 15 of 39

17 Section 4 Carer to demonstrate awareness of safety issues. NB to care for.. you must have attended Basic Life Support training. Please fill in details below. Date of training. Venue of training.. Trainers name.. List what checks you would do daily Whose responsibility is it to check equipment prior to leaving home? Yours parents CCN child/young person (underline as appropriate) Where is the midazolam stored at home?.. Is it accessible at all times? Yes no Where do you look after.?.. Where is medicine stored when you look after.? List 3 things that you think could happen if the storage was unsafe. a) b) c) Describe how you would transport the medicine safely. How could you avoid any of..known triggers?.. Underline any of the following words you think describe the side effects of midazolam Happiness irritability respiratory depression Pallor incontinence trauma Short term memory loss Guideline on the use of Buccolam for Children & Young People with Epilepsy 16 of 39

18 Describe in simple terms what you would look for when doing a respiratory assessment Underline all of the following that in any combination may lead you to suspect that. is having difficulty in breathing Child tells you Parent tells you Pallor raised respiratory rate cough Irritability increased chest movement cyanosis Wheeze tracheal tug panic Nasal flaring sub costal or intercostal recession If you are concerned at any time what could you do to get emergency help? During a seizure list 5 things you must never do a) b). c). d). e). How much can. understand during a seizure Everything as normal Absolutely nothing We don t know (underline as appropriate) What must you do throughout treatment to reassure.. What must you do as well as caring for.. at the start of a seizure and at the end of a seizure? Why is this important?.... Guideline on the use of Buccolam for Children & Young People with Epilepsy 17 of 39

19 Section 5 Carer to demonstrate safe technique for administration of buccal midazolam. Do you need to wash your hands? Yes no If yes when and how often?.. Do you understand that following Trust hand hygiene procedures is an essential part of this competency? Yes no Discuss the importance of hand hygiene. How often should you cleanse your hands throughout the procedure When can you use alcohol hand gel? a) Any time you could wash your hands b) On clinically clean hands only c) You should not use it at all (please underline appropriate) Should you wear gloves for this procedure? Yes no List what equipment you would need to prepare prior to administration of bucal midazolam List what you need to check on the medication 1). 2) 3) 4).. 5).. 6).. List what you need to check on the prescription sheet/care plan a).. b).. c).. Guideline on the use of Buccolam for Children & Young People with Epilepsy 18 of 39

20 Describe the position that..head should be in to administer buccal midazolam How should the dose be delivered?.... How long should the head stay in that position(ideally)?... How would you reassure throughout the seizure and the administration of the medicine?.... Is a second dose prescribed for? Yes no If yes can you describe the protocol? Section 6 Carer to identify potential problems of seizure and administration of buccal midazolam. List 5 potential problems caused by seizure a) b) c). d) e) List 3 potential problems caused by administration of buccal midazolam a).. b).. c) Guideline on the use of Buccolam for Children & Young People with Epilepsy 19 of 39

21 Section 7 Carer to understand and demonstrate actions to be taken after administration of buccal midazolam In a short paragraph please describe what you would observe whilst.. is recovering from seizure. Is it safe to leave.during his/her recovery? Yes no Whose responsibility is it to re-stock the equipment? Carers Parents CCN child/young persons (underline as appropriate) During a seizure who would you ask your helper to contact? Parents school CCN GP ambulance ( place in order of priority) Following a seizure who would you contact? Parents named nurse CCN (place in order of priority) In a short paragraph list what you would document about a seizure. How would you dispose of used equipment? Where could you find a copy of the waste disposal policy?.. Guideline on the use of Buccolam for Children & Young People with Epilepsy 20 of 39

22 Section 8 Carer to show an awareness of the importance of record keeping What do you understand by accurate, appropriate documentation? Who do you need to write about? Child family interventions Does it matter when you write the document? Yes no If so when should it be written? As soon as possible within shift within 24 hours (please underline all appropriate) Who should read this document? What colour should you write this in? Red blue black purple List 3 things you must do to identify the child a). b). c). Can you leave spaces for others to fill in later? Yes no Who can you share information with about this child? Do you always need parent s permission to share information? Underline the words which apply to good record keeping Factual patient condition Consistent legible Accurate understandable Fiction fit for purpose Consecutive current Abbreviations concise Jargon subjective comments Contemporaneous List 3 things you must do to identify who wrote the record and when the record was written a) b). c) Guideline on the use of Buccolam for Children & Young People with Epilepsy 21 of 39

23 List who you would report record keeping problems to? What information would it be suitable to discuss with teacher in school? Is there ever a time when breaching confidentiality is permissible? Who do you report to normally?... Who could you report to if you could not contact above?. Where can you obtain stationary supplies to ensure records are kept well?. As most of some of these records are kept at home how could we manage this?... Guideline on the use of Buccolam for Children & Young People with Epilepsy 22 of 39

24 Section 9 Specific record keeping 8 things you should record about..seizure a). b). c). d). e). f) g).. h).. Section 10 Carer to demonstrate awareness of issues of privacy and dignity In a short sentence explain what privacy means to you. In a short sentence explain what dignity means to you. List how you would know if was Happy Sad In pain If possible give examples Inserting a syringe in mouth is an intimate procedure how can we try to protect.. dignity List 3 ways in which you would try to protect from other peoples curiosity? a) b)... c) What does child specific mean to you? Guideline on the use of Buccolam for Children & Young People with Epilepsy 23 of 39

25 Questionnaire assessed by print I certify I am currently registered with the NMC sign NB. Your responses to the questions in this document are used to assist in the assessment of your competency to undertake the particular procedures detailed in the accompanying competency document and satisfactory completion of this document is only part of the overall competency assessment. You may NOT carry out child or young persons care independently until the competency document has been signed by your assessor evidencing your competence, yourself, and your employer if you are a non NHS Trainee. (Adapted from Coventry & Warwickshire PCT Competency Tool (2004) Guideline on the use of Buccolam for Children & Young People with Epilepsy 24 of 39

26 Appendix 2 BUCCAL MIDAZOLAM COMPETENCY (MAY BE DEMONSTRATED ON A MANNEQUIN) This competency is for Patient only THIS COMPETENCY EXPIRES ON This competency certifies Carer only E Initial training P Practical Training I(a) Competent to practice (b) Competent and experienced D Competent to teach AREA OF CONCERN REQUIRED SKILLS AND KNOWLEDGE LEVEL REACHED E P I(a) I(b) D 1) Carer to understand why the child needs Buccal Midazolam Carer to demonstrate an awareness of: - Anatomy and Physiology of mouth Q Physiology of seizures Q 2) Carer to understand when Buccal Midazolam is appropriate. Carer can describe why Buccal Midazolam is required. Q Carer can describe warning signs and / or indications for Buccal Midazolam. Q Carer to demonstrate knowledge of health care plan and prescription chart. Q Carer to show understanding of child s individual seizure pattern. Q 3) Carer to understand psychological implications of having a seizure Age appropriate preparation of the child D Demonstrate a clear understanding of the psychological implications of having a seizure and the treatment for child and family Q Demonstrate age appropriate support. Q The impact of exclusion from certain activities Q Guideline on the use of Buccolam for Children & Young People with Epilepsy 25 of 39

27 AREA OF CONCERN REQUIRED SKILLS AND KNOWLEDGE LEVEL REACHED E P I(a) I(b) D 4) Carer to demonstrate awareness of safety issues. Evidence of up to date resuscitation training Date of training... Q/D Daily checks Q/D Safety of care environment including safe storage. Avoidance of triggers Q Carer to demonstrate an understanding of respiratory assessment and action to be taken:- Pallor Q Cyanosis Q Difficulty in breathing Q Irritability Q Panic Q Recession Q Do if concerned dial 999 Do not: leave the child alone place anything in the mouth give food or drink until the child is fully awake Q restrict convulsive movements move the child unnecessarily 5) Carer to demonstrate safe technique for administration of Buccal Midazolam. Note time of start of seizure and duration Q Preparation of equipment Q Hand washing / use of gloves D/Q Checking of prescription / health care plan / when last given Q Guideline on the use of Buccolam for Children & Young People with Epilepsy 26 of 39

28 AREA OF CONCERN REQUIRED SKILLS AND KNOWLEDGE LEVEL REACHED E P I(a) I(b) D Positioning of child, including head position Q Preparation of self Q Safe administration of Buccal Midazolam including maintenance of head position for appropriate time demonstrated on manikin Q/D Observation of child s condition during and after administration Q Indication for subsequent doses Q 6) Carer to identify potential problems of seizure and administration of Buccal Midazolam and action to be taken. Seizure:- respiratory depression Q Physical injury Q Biting of the tongue Q Incontinence Q Choking Q Buccal Midazolam administration:- Trauma to mouth Q Respiratory depression Q Incontinence Q 7) Carer to understand and demonstrate actions to be taken after Buccal Midazolam administration. Observation of child during recovery Q Restocking of equipment Q Inform appropriate people Q Documentation of seizure Q Safe disposal Q Guideline on the use of Buccolam for Children & Young People with Epilepsy 27 of 39

29 AREA OF CONCERN REQUIRED SKILLS AND KNOWLEDGE LEVEL REACHED E P I(a) I(b) D 8) Carer to show awareness of importance of record keeping Accurate, appropriate documentation Q Who to report to Q When to contact General Practitioner/ Community Nurses/ Parent Q 9) Carer to demonstrate awareness of issues of privacy and dignity Carer to be aware of and demonstrate child and family confidentiality Q Carer to be aware of the child / young persons wishes and how they express them Q Carer to recognise intimate nature of procedure Carer to be aware of other peoples curiosity Q Carer to demonstrate understanding of issues: - Q - For the patient & for those around them Individual levels assessed by: - NAME INITIAL SIGNATURE I certify that the person named, as carer on this document is competent to carry out the procedure detailed above and that I have current N.M.C. registration. Overall competency: - Date I the above named carer certify that I am happy to carry out the above procedure within the competencies detailed above. I understand the scope of these competencies. I will only use this training in respect of the child specifically named on the front of this form and I will not carry out procedures, which are contrary to or not covered by this training. I will seek further training if I have any concerns about my competency and in any event six weeks before the expiry date on the front of this form renew my training. Upon the date of expiry of this competency, if my training has not been Guideline on the use of Buccolam for Children & Young People with Epilepsy 28 of 39

30 renewed, or if I have concerns about my competency, I will discontinue undertaking the procedure detailed in this document and seek appropriate advice from a suitably qualified clinician and or my employer. In all other respects I will seek all necessary advice guidance and further training needed from time to time in order for me to continue to operate within these competencies. NAME SIGNATURE DATE EMPLOYERS OF NON NHS TRAINEES. We will use our best endeavours to ensure that our employee /staff member delivers care to the person named within the boundaries of this competency as outlined above. NAME DESIGNATION SIGNATURE DATE (Adapted from Coventry & Warwickshire PCT Competency Tool (2004) Guideline on the use of Buccolam for Children & Young People with Epilepsy 29 of 39

31 Appendix 3 Liability/Indemnity Notice for Training provided free of charge by Worcestershire Health and Care NHS Trust (the Trust) staff to agencies outside the Trust Please note: this liability notice applies to the following Agencies, Care Home Staff, Paid Carers, Businesses forthwith known as Agency 1. We, the (Agency), have requested that Worcestershire Health and Care Trust (the Trust) provide training for our employee/s, staff, volunteer/s (delete as appropriate) in regard to (insert type of training here) (the Training). 2. The Training is provided by the Trust on a voluntary basis and no payment is received by the Trust or any member of the Trust s staff for the provision of such Training. 3. The Trust will only provide the Training requested. No monitoring or review of the Agency employee/s, volunteer/s or staff will be undertaken by the Trust following the Training. The responsibility and liability for all such reviews, monitoring and/or continuous professional development will be the responsibility of the Agency. 4. The Trust will only be responsible for a personal injury or death caused by a direct result of a negligent act or omission by a member of the Trust s own staff whilst providing the Training (as per the Unfair Contract Terms Act 1977 section 2). All other liabilities are excluded by the Trust and retained by the Agency and their employee/s, volunteer/s or staff. 5. In signing this Notice the Agency accepts it is liable as per paragraph 4 above and agrees to indemnify the Trust against any claim that may arise, except for any personal injury or death caused as a direct result of a negligent act or omission by a member of the Trust s staff whilst providing the Training (as per the Unfair Contract Terms Act 1977 section 2). Authorised Agency Signature Date.../ /. Print Name Position/Job Title... Training provided by;. (name and job title of person from the Trust) Print Name. Guideline on the use of Buccolam for Children & Young People with Epilepsy 30 of 38

32 Appendix 4 EPILEPSY EMERGENCY MEDICATION PLAN Child s name Hospital No: DOB: Address: (affix label) Age: Weight: kg Description of seizure(s) requiring emergency medication: If the seizure lasts longer than.. minutes or has a cluster of serial seizures lasting over. minutes GIVE PRESCRIBED DOSE OF BUCCAL MIDAZOLAM (Buccolam pre-filled syringe) Prescribed dose mg Amount to be given in ml Route: Buccal This will take approximately 5-10 minutes to have the desired effect A paramedic ambulance should be called for the very first time Buccolam (midazolam) is given. Individualise plan as required OR If no response to first dose call Paramedic after minutes > give second dose DOSE mg Thereafter for subsequent seizures you may need to call 999 if: Emergency medication fails to have effect or Person experiences breathing difficulties or Recovery is slow, an injury is sustained. Note for PARAMEDIC: Can give Rectal Diazepam if seizure has not ceased 10 minutes after Buccolam (midazolam). IF Buccolam has not been administered by parents and Paramedic is not authorised to use Buccolam then Rectal Diazepam can be given according to Paramedic guideline. Consultant Name : Print Signed. Date: REVIEW DATE Consent given for the implementation of the Guideline by parent/guardian/ Training received by as follows : Parent/Guardian : Print name Parent/Guardian: Print name Name of Professional giving training: Signed: Date: Signed: Date: Print name: Signed Date Copies to: File Parent/s GP School Nurse Health Visitor Other.. Guideline on the use of Buccolam for Children & Young People with Epilepsy 31 of 38

33 Appendix 5 Record of Buccolam (midazolam) Administration at Home Child s name: Child s date of birth: Date and time of seizure: Description of seizure: Date and time of giving Buccolam (midazolam): Dose (ml) given: Preparation used Buccolam PRE-FILLED SYRINGES: Paramedic Ambulance called? Yes No Time: Did the fit stop after the Buccolam (midazolam) was administered? Yes/No If yes, how long after the Buccolam (midazolam)? Any comments, adverse reactions, hospital admission? (Please describe) This form should be returned to: Epilepsy Specialist Nurse Children s Outpatient Clinic Or Dr M Hanlon Consultant Paediatrician Worcestershire Royal Hospital, Charles Hastings Way WORCESTER WR5 1DD. Thank You Guideline on the use of Buccolam for Children & Young People with Epilepsy 32 of 38

34 Appendix 6 Information for parents about Buccolam PRE-FILLED SYRINGES What do I do if my child has a seizure? Stay calm Note the time and keep checking how long the seizure is lasting Loosen any tight clothing around the neck Protect your child from injury Cushion your child s head if he or she has fallen on to the floor. Once fit has stopped gently place your child in the recovery position Stay with your child until he or she is fully recovered DON T try to restrain your child while having the fit DON T force anything between the teeth DON T try to move your child unless he or she is in danger DON T give any drinks until he or she is fully recovered If a seizure continues for more than five minutes, the Buccolam (midazolam) is given to stop the seizure before it leads to status epilepticus. When Buccolam (midazolam) is being given for the first time ever, the paramedic ambulance should be called by dialling 999. If your child has had Buccolam (midazolam) before you do not need to call the ambulance. However, you will need to call the ambulance if the initial dose of Buccolam (midazolam) has not had any effect on stopping the seizure within 10 minutes, or there are difficulties in giving the medication. When you dial 999, state that you need an ambulance for a child having a seizure and that you are giving Buccolam (midazolam). Give your full address and postcode as the control centre may be in another part of the UK. Don t hang up the phone until ambulance control tells you to. What is status epilepticus? Status epilepticus is a seizure (convulsion or fit) or a series of seizures lasting for 30 minutes or more without complete recovery of consciousness. It is a medical emergency. Therefore seizures should be treated after 5 minutes to try and prevent the development of status epilepticus. What is Buccolam? Buccolam (midazolam) comes in a sealed tamper proof plastic tube containing one prefilled ready to use oral syringe, which is colour coded according to strength. Each oral syringe contains one dose of Buccolam (midazolam) which is a colourless liquid. Guideline on the use of Buccolam for Children & Young People with Epilepsy 33 of 38

35 Buccolam is a medication from the group of drugs called benzodiazepines that affect the central nervous system. Buccolam (midazolam) is a muscle relaxant and has anticonvulsant properties. All medication has the potential to cause side effects. What are the side effects? Nausea and vomiting is common. Flushing of the skin or a rash of pink spots can occur which disappear within 15 minutes, uncommon. Agitation, aggression, anger, dizziness, headaches, very rarely Drowsiness and sedation - recovery is fast. Amnesia-short term memory loss is common. Your child may not remember having a seizure. Breathing difficulties - an effect on breathing is very unlikely to occur if midazolam is used in the dose prescribed.this is the reason for calling an ambulance when you give the very first dose. What is the usual reaction to midazolam? Buccal With some sedation, ending of the seizure is expected within a few minutes. Flushing of the skin, or a rash of pink spots may appear but these should subside within 15 minutes. How your child will react to the medication is difficult to describe until the first time Buccolam is given. The Buccal area is the space between the inside of the cheek and the gum of the lower jaw by the back teeth. Buccolam (midazolam) is absorbed directly into the bloodstream from this area. Midazolam should not be swallowed, but if swallowed accidentally will not cause any harm. Instructions and procedure for administering Buccolam (midazolam) Check that the medication is within the expiry date. Give Buccolam (midazolam) when the seizure has been going on for... minutes. Break the tamper-proof seal and remove the oral syringe from the protective plastic tube. Remove and throw away the oral syringe cap before use to avoid choking. Explain to the child what is going to happen Put on latex free gloves (this is optional) Place the tip of the oral syringe into the buccal area of the child s mouth, between the cheek and the gum of the lower jaw by the back teeth. Slowly drip the Buccolam (midazolam) solution into this area until the oral syringe is empty. Guideline on the use of Buccolam for Children & Young People with Epilepsy 34 of 38

36 If the child s teeth are clenched together they do not need to be parted. Remove the oral syringe from the child s mouth. Do not leave the child unattended until he/she has fully recovered. Ensure the child s privacy and dignity is maintained as much as possible at all times If Buccolam (midazolam) does not control the seizure within five minutes, call an ambulance by dialling 999, if you have not done so already. Disposal After administering the Buccolam (midazolam) it is advisable to keep the used oral syringe until the child has fully recovered. Ambulance staff may wish to check which medication has been given. Once checked the used oral syringe can be disposed of in a closed waste bin. Recording After administering the Buccolam (midazolam),it is important to record that you have done so. The form you use should include: the medication you gave the dose/amount given the route of administration the date and time it was given The incident should also be noted, including a description of the seizure and the length of duration and action taken. It should also include information about what happened to the child following the administration of the Buccolam (midazolam). The Epilepsy Specialist Nurse will hold the information and it will be used to audit and monitor the use of Buccolam (midazolam).the child s Consultant or ESN must be informed if there is a significant increase in the frequency or severity of the child s seizures. Reporting The administration of the medication should be reported to the parents as soon as possible. (It may be that friends or relatives have given this medication) If an ambulance has been called the paramedics must be informed of the dose of Buccolam (midazolam) given and time of administration. Important information you should know: Storage Keep medicines in a safe place where children cannot reach them. Keep Buccolam (midazolam) at room temperature, away from bright light or direct sunlight and away from heat. Do not store in a fridge. If the doctor decides your child should stop taking Buccolam (midazolam), return any remaining medicine to your pharmacist. You may not be using Buccolam ) (midazolam) regularly, so please check the expiry date of the product periodically. Guideline on the use of Buccolam for Children & Young People with Epilepsy 35 of 38

37 NB Your child may also have been prescribed rectal diazepam for epileptic fits lasting longer than five minutes. (It is important to remember that either Buccolam (midazolam) or rectal diazepam should be given, not both) Each person reacts differently to medicines and so your child will not necessarily suffer from any or all of the side effects mentioned. Please refer to medication leaflet. If you are concerned about any of the side effects or want more information about how to administer Buccolam (midazolam) by the Buccal route, or have any questions or concerns, please ask your consultant, nurse or pharmacist. Guideline on the use of Buccolam for Children & Young People with Epilepsy 36 of 38