Tablet Press EXTRA The prescribing newsletter for GPs, nurses and pharmacists NHS Northamptonshire Failure to respond to first choice antibiotics March 2017 Use of Buccolam (buccal midazolam) for breakthrough seizures Buccal Midozolam is the drug of choice for emergency treatment of prolonged acute convulsive seizures in children. Previously a variety of unlicensed specials were in use. There is now a licensed formulation and work is underway in NGH to make sure children are changed to the licensed formulation (Buccolam). This Tablet Press Extra outlines how the change is being managed and how GPs can help. Buccolam is the buccal midazolam of choice for use as emergency medication for the treatment of prolonged acute convulsive (breakthrough) seizures in children. Buccolam is licensed for this indication in children from 3 months to 18 years and is more cost effective than unlicensed preparations. There are no currently licensed products for children under 3 months or for adults. Buccolam contains midazolam hydrochloride 5mg/ml in ready to use pre-filled oral syringes. Each oral syringe contains one dose of midazolam to be used to treat one breakthrough seizure. Use of pre-filled oral syringes facilitates rapid administration and reduces the risk of dose errors. Buccolam oral syringes are age banded and colour coded (see appendix 5) The oral syringes are available in boxes of 4. The pharmacy should be requested to label each oral syringe individually so that parents can store individual syringes in different locations if necessary. Patients being newly prescribed buccal midazolam by secondary care will receive a Joint Epilepsy Council protocol, which details their dose and instructions for administration, from the Childrens Epilepsy Specialist Nurse. This will be updated annually. (link) Patients are currently being switched to Buccolam at their annual secondary care reviews. Guidance leaflets are also available for School and Nursery staff where required. (Appendix 3) If patients have previously been prescribed multidose bottles or oral syringes of midazolam 10mg/ml (eg Epistatus or other brand) the GP may switch to Buccolam 5mg/ml pre-filled oral syringes. o The patient/parent/carer must be given all the relevant information using the attached template documents. (Appendices 1 and 2 ) o When a switch from midazolam 10mg/ml to Buccolam is undertaken by the GP they must inform the epilepsy team via Kathy.chantler@ngh.nhs.uk so that she can amend the database that is maintained at NGH and ensure that an amended care plan is issued to parents, schools etc If patients have previously been prescribed multidose bottles of buccal midazolam 5mg/ml (the same strength as Buccolam) and the GP is asked for a new prescription, Buccolam oral syringes may be prescribed. Parents/carers should be given a copy of the standard letter and FAQ sheet (Appendices 1 and 2 - please delete reference to volume change). Please inform the epilepsy team of this switch (email Kathy.chantler@ngh.nhs.uk as above) For most patients use of a licensed preparation is preferred, however, in some adults requiring more than 10mg of midazolam per dose, the higher 10mg/ml strength may be more appropriate. This should be considered on a case by case basis. Contact No 01604 651359
Addressograph Appendix 1 Date Dear Parent/Carer, Change in formulation of buccal midazolam used by your child for seizures. A licensed product called Buccolam (midazolam buccal solution) is now available which has advantages over other preparations that are currently available. It comes as a pre-filled oral syringe making it quicker and easier to give a dose. Buccolam oral syringes are age banded and colour coded. Some of the frequently asked questions about this medicine are listed below, but if you have any further questions, please discuss them with your doctor or one of the healthcare team involved in your child s care. What is the new medicine? Buccolam contains midazolam, the same drug as in the emergency medicine you used before. It is licensed for use in children (from 3 months up to 18 years) to treat prolonged, acute, convulsive (breakthrough) seizures. Will my child receive a different dose of drug? Your child has been prescribed the same dose of midazolam as they received with their previous medicine; however, the amount of liquid to be used with each dose may be different. (delete if patient was previously on 5mg/mls product) How does Buccolam differ from their previous medicine? Buccolam is provided in ready to use (prefilled) oral syringes containing a dose of midazolam. Each syringe contains one dose of midazolam to be used to treat one breakthrough seizure. Four different doses of Buccolam are available. The different doses have different coloured boxes and syringe labels (yellow: 2.5mg, blue: 5mg, purple: 7.5mg and orange: 10mg). Each oral syringe is provided in a separate plastic tube for protection. You may notice that the amount (volume) of liquid in the syringe is different to the amount of liquid that you used to give with the previous midazolam medicine. Do not worry; this is because Buccolam is half the strength of the liquid previously used, and therefore you need twice the amount of liquid to give the same dose of midazolam. (delete if patient was previously on midazolam 5mg/mls formulation) If you are unsure about any aspect of the dose or volume of Buccolam to be given, please contact me or another member of the healthcare team involved in your child s care. Contact No 01604 651359
When you take future prescriptions for Buccolam to your community pharmacy, please ask for each individual tube to be labelled with your child s name and dose information, as well as the box. This will allow you to keep doses in different places, as needed e.g. at your home, at your child s school and/or at another family member s house. Please ensure that Buccolam is stored safely and out of reach of children; do not store in a fridge or freezer. How is Buccolam given? Buccolam should be given in the same way as the previous emergency medicine, by slowly emptying the full amount of liquid from the oral syringe into the space between the gum and the cheek (buccal cavity). If necessary, you can give half the amount slowly into one side of the mouth and the other half slowly into the other side. All of the liquid in the oral syringe should be given at the same time. Further information Before using Buccolam, please read the patient information leaflet which should be supplied. Please do ask any healthcare team member if you have any questions or concerns. Contact No 01604 651359
Appendix 2 Frequently Asked Questions BUCCOLAM (Midazolam Oromucosal Solution) Why has the emergency medication been changed to Buccolam? Buccolam is now the buccal midazolam of choice for use as emergency medication for the treatment of prolonged acute convulsive (breakthrough) seizures in children. Buccolam is the only buccal midazolam licensed for this indication in children aged >3 months to < 18 years. What is Buccolam? Buccolam contains midazolam, as does the previously prescribed buccal midazolam. Buccolam is licensed for use in children (from 3 months up to 18 years) to treat prolonged, acute, convulsive (breakthrough) seizures. Has the dose of midazolam changed? This patient has been prescribed the same/similar dose of midazolam as contained with their previous medicine; however, the volume of liquid to be used with each dose may be different (see below). How does Buccolam differ from the previous medicine prescribed? Buccolam (midazolam hydrochloride 5 mg/ml) is provided in ready to use (pre-filled) oral syringes each containing a single dose of midazolam. Each oral syringe contains one dose of midazolam to be used to treat one breakthrough seizure. Four different age-specific doses of Buccolam are available, each provided in different coloured boxes and oral syringe labels (yellow: 2.5 mg, blue: 5 mg, purple: 7.5 mg and orange: 10 mg). We have prescribed the dose of Buccolam we feel appropriate for this patient. Each box of Buccolam contains four identical oral syringes; each oral syringe is provided in a separate plastic tube for protection. o Please advise your patient s parents/carers to ask for each individual tube to be labelled with the patient s name and dose information, as well as the box, when they take a prescription for Buccolam to pharmacy Contact No 01604 651359
o This allows doses to be kept in different places as needed (e.g. home, school and/or at another family member s house). N.B. Buccolam should be stored safely and out of reach of children; not in a fridge or freezer. How is Buccolam given? Buccolam should be given in the same way as the previous emergency medicine, by slowly emptying the full amount of liquid from the oral syringe into the space between the gum and the cheek (buccal cavity). If necessary, half the amount can be given slowly into one side of the mouth and the other half slowly into the other side. All of the liquid in the oral syringe should be given at the same time. Contact No 01604 651359
Appendix 3 Guidance for Staff working In Schools/Nursery Staff for the use of Emergency Rescue Medication for children with Epilepsy Administration of Buccolam - (Midazolam Oromucosal Solution) pre-filled oral syringe 1.0 Why do we administer Buccal Midazolam? 1.1 The majority of children who have epilepsy usually recover within a short period of time after a seizure. However there are occasions when this does not happen and the child goes into a prolonged seizure and occasionally Status Epilepticus. The definition for a prolonged seizure will vary from child to child. 1.2 A child who has experienced a prolonged seizure or Status Epilepticus may be prescribed a medicine called midazolam which is given via the buccal route (hence the medicine is often referred to as buccal midazolam )for prolonged seizure. This medicine is always prescribed by the patient s doctor. 1.3 There are different preparations of buccal midazolam and it is essential that training is accessed for the preparation prescribed. 2. Buccolam 2.1 Buccolam is a product that contains midazolam, and is used for the majority of children aged more than 3 months. For younger children, other preparations have to be used. 2.2 Each dose comes in a sealed tamper proof plastic tube containing one pre-filled ready to use oral syringe, which is colour coded according to strength. Each oral syringe contains one dose of Buccolam which is a clear colourless liquid. There is a plastic cap on the end of the oral syringe. This must be removed before administering the medication. 2.3 The patient information that comes with Buccolam outlines colour coding for general age ranges. However there may be some circumstances where a pupil may be prescribed a dose outside this age range. 2.4 Buccolam is a medication from the group of drugs called benzodiazepines that affect the central nervous system. It has muscle relaxant and anti-convulsant properties. 2.5 All medication has the potential to cause side effects. The side effects of Buccolam may include drowsiness, shallow breathing (respiratory depression) confusion, nausea and vomiting. 3 Buccal cavity and administration Contact No 01604 651359
3.1 The buccal area is the space between the inside of the cheek and the teeth, which is called the buccal cavity. Ideally, half the amount of Buccolam should be given into one side of the mouth, then the other half slowly into the other side. 3.2 The drug is quickly absorbed directly from the buccal cavity into the bloodstream to stop the seizure. If the Buccolam is incorrectly placed in the middle of the mouth it will not work as well because it cannot get into the bloodstream so quickly. Buccolam should not be swallowed, but if a small amount is inadvertently swallowed accidentally during the administration process, it will not cause any harm. 4 Joint epilepsy careplan (JEC) 4.1 An individual JEC is required for each child. This is because the dose and the point at which the medication should be administered during the seizure, will be different for each child. 4.2 The JEC should clearly state: The child s details. The product and dose to be given. When the Buccolam is to be given Included on the authorisation form should be an indication of when an ambulance is to be summoned. 4.3 The JEC must be updated annually or whenever there are any changes to the child s emergency rescue medication details. 4.4 Whenever emergency rescue medication (Rectal Diazepam or Buccal Midazolam) is being administered to a child for the first time in a school setting, a paramedic ambulance must always be summoned. Contact No 01604 651359
5 Procedure for administering BUCCOLAM (Midazolam Oromucosal Solution) Two members of staff must be involved in this procedure. Check that the child s details match the pharmacy label on the medication and on the authorisation form and ensure it is the correct medication (Buccolam) and dose for the individual child. Check that the medication is within the expiry date. Check at what stage in the seizure it should be given (e.g. after 5 mins). Break the tamper-proof seal and remove the oral syringe from the protective plastic tube. Put on latex free gloves (this is optional). Remove and throw away the oral syringe cap before use, to avoid choking. Explain to the child what is going to happen. Wipe away any excess saliva. Part the child s lips and carefully insert 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 solution into this area until the oral syringe is empty. If the child s teeth are clenched together they do not need to be parted. Remove the oral syringe from the child s mouth. It is not a problem if a small amount of medication is swallowed. Ensure the child s privacy and dignity is maintained as much as possible at all times. Do not leave the child unattended until he/she has fully recovered. Two adults must be present during the procedure to check the medication and its administration. 6 Disposal 6.1 After administering the Buccolam 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. 7 Storage Contact No 01604 651359
7.1 Buccolam should be stored at room temperature (not in a refrigerator) and not exposed to strong sunlight. 7.2 Buccolam should be kept in its original container and be clearly labelled with the child s name. The Buccolam should be kept as part of a kit and stored in an accessible place but must be out of reach of other children. The kit should comprise of: A JEC signed by the child s Clinician or Epilepsy Specialist Nurse. Buccolam oral syringe in its sealed protective plastic tube. Latex free disposable gloves. Paper tissues. 8 Recording 8.1 After administering the Buccolam it is important to record that you have done so. Administration of the medication should be recorded in the back of the JEC, and include details of medication given, the dose give, the route of administration, the date and time it was given and by whom. 8.2 The incident should also be recorded, including a description of the seizure, duration and action taken. Information about what happened to the child following the administration of the Buccolam should also be included. 9 Reporting 9.1 The administration of Buccolam medication should be reported to the parents/carers as soon as possible (as indicated on the yellow epilepsy alert card). 10 Carrying the Buccolam kit e.g. on day trips 10.1 When off school premises, the Buccolam should be kept as part of a kit with the appropriate equipment and paperwork and should always be looked after by the member of staff who has responsibility for administering it (should it be required). It must never be left unattended. 11 Training 11.1 Staff who have volunteered to administer Buccolam (emergency rescue medication) must receive training for each individual child, from a qualified health care professional e.g. Epilepsy Specialist Nurse, CYPN (Children and Young people s Nurse) 12.2 Training must be updated annually. 13.0 AUTHORISATION FORM/JEC 13.1 The JEC must be updated annually or whenever there are any changes to the child s emergency rescue medication details. Contact No 01604 651359