Document type: / Policy
What does this policy replace? / Update of previous policy.
Staff group to whom it applies: / All staff within the Trust
Distribution: / The whole of the Trust
Version 3
How to access: / Intranet
Issue date: / May 2015
Next review: / May 2017
Approved by: / Drug and Therapeutic Sub Committee
Developed by: / Mark Payne
Sandra Montisci
Joanne Brown
Director leads: / Medical Director
Contact for advice: / Med.information @SWYPFT.nhs.uk
Mark Payne
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Contents
1 Introductions 1
2 Care Planning 1
3 Place in treatment 2
4 Choice of agent 2
5 Administration and monitoring of treatment 3
5.1 Administration
5.2 Post-administration monitoring
5.3 Physical health monitoring guidance
6 Training 4
Appendix 1
Midazolam Information Sheet 5
Appendix 2
Rectal Diazepam Information Sheet 7
Appendix 3
Flumazenil Information Sheet 9
Appendix 4
Different seizure types 10
Appendix 5
Care Plan for Administration of Treatment for Seizures 11
Appendix 6
Administration of Benzodiazepines for the Treatment of Seizures
Assessment and Progress Chart 12
Appendix 7
Benzodiazepines for Seizure Control Standard Operating Procedure 13
Appendix 8
Equality Impact Assessment Tool 15
Appendix 9
Checklist for review and Approval of Procedural Document 17
Appendix 10
Version Control Sheet 18
Appendix 11
List of professional groups approved to administer in SWYT………………………………….19
1
Benzodiazepines for seizure control
1. Introduction
Prolonged or repeated seizures are considered a medical emergency, and as such it is important that there is a clear policy within the organisation for the management of seizures to ensure that all service users receive an appropriate level of care.
Where benzodiazepines are prescribed for the management of seizure there should be a clear, personal care plan, or protocol, for their treatment and monitoring. All healthcare staff involved with their care should be made aware of this plan.
Standard first aid practice applies to all epilepsy medical emergencies with additional specialist consideration to secure the individual’s airway and assess his or her cardiac and respiratory function. This must be monitored closely and effectively.
SWYPFT is not a specialist provider of epilepsy services, and as such will aim to provide the same care as patients would expect to receive in the community, with appropriate referral to specialist services for support with diagnosis and management of ongoing seizure disorders.
Aim
This policy sets out the acceptable use of medication for the management of seizures within SWYPFT, regardless to the aetiology of the seizure. It will also set out the standards for providing treatment to those at an ongoing risk of seizures.
Scope
This policy applies to all staff working in SWYPFT hospital settings.
SWYPFT staff working in the community should consider completing a risk assessment / care plan to cover the requirements that they cannot fulfil.
SWYPFT staff working within other partner organisations should work to the policy of that organisation.
2. Care planning
All patients prescribed benzodiazepines for the management of seizures in the context of an on-going health condition that pre-disposes them to an increased risk of seizures should have a detailed care plan.
Those patients prescribed benzodiazepines for the management of seizures in the context of an acute health condition or medication side effect should have a brief care plan.
Details of the guidance about information for inclusion in a care plan are outlined in Appendix 5.
As epilepsy and other disorders pre-disposing to seizures can present differently in different individuals it is essential to determine the existence of a care plan at the point of admission to service, and to ensure that it is transferred with the individual where care is transferred to a different provider / location.
The requirements of this policy should always be read in conjunction with the individuals care plan; the policy provides the required approach to management, and the care plan details the requirements specific to that individual. Unless otherwise stated all requirements in the policy should be met, but timescales / monitoring / follow-up can be individualised according to the care plan.
3. Place in treatment
Immediate emergency care and treatment including pharmacological management should be administered to children, young people and adults who have prolonged (lasting 5 minutes or more) or repeated (three or more in an hour) convulsive seizures.
Depending on response to treatment, the person's situation and any personalised care plan, call an ambulance, particularly if:
· the seizure is continuing 5minutes after the emergency medication has been administered
· the person has a history of frequent episodes of serial seizures or has convulsive status epilepticus, or this is the first episode requiring emergency treatment or
· there are concerns or difficulties monitoring the person's airway, breathing, circulation or other vital signs
Medication for the acute management of seizures should be prescribed and available for all service users who have a diagnosis of epilepsy or who are at high risk of experiencing seizures due to medical co-morbidities or pharmacotherapy.
Benzodiazepines have a place in regular treatment as an adjunct to anti-epileptic drug treatment; however these are not first-line choices and so should not be initiated except on the advice of a specialist.
4. Choice of agent
As SWYPFT does not have direct access to acute hospital medical facilities, the choices of treatment are the same as those that would be offered to a service user in the community. Where more intensive or specialist treatment is required a referral will be made to a general hospital or epilepsy specialist as appropriate.
Drug / Route / Dose range / Indication / CostDiazepam / Rectal / 5-20mg / High risk individuals
Individuals without a care plan / £7.35 / 5 x 10mg
Midazolam
NB: Different preparations are not interchangeable / Buccal / 2.5-10mg / Individuals with an existing care plan
On specialist recommendation / £91.50 / 4 x 10mg
£55.86 / 5ml x 10mg/ml
Other agents / Oral / Injectable / Variable / Individuals with an existing care plan
On specialist recommendation
Refer to pharmacy for advice / Variable
Rectal diazepam has been chosen as a first line agent due to the risk potential associated with confusion between different forms of midazolam (see Appendix 1), and the practical issues that would be associated with making all forms available to all service users. This is in line with NICE guidance that rectal diazepam is offered where buccal midazolam is unavailable.
5. Administration and monitoring of treatment for the management of an acute seizure
The following principles should be observed for all patients, however where there is a care plan for the use of benzodiazepines for the acute management of seizures then this must also be consulted prior to undertaking any of the specified activities.
5.1 Administration
Treatment should be administered in line with the manufacturer’s guidance.
Requests for routes of administration outside of the manufacturer’s guidance should be referred to the locality pharmacist for individual patient care planning.
5.2 Post-administration monitoring
Care must be taken to secure the child, young person or adult's airway and assess his or her respiratory and cardiac function.
Close monitoring (observation of patient within eyesight) by staff is required. Observations should be particularly frequent when a patient is sedated.
The following should be monitored using standard ABCDE first aid methods and recorded regularly in the patient’s notes (where available), at 15 minute intervals, until the patient becomes active again.
1. Pulse
2. Breathing/Respiratory rate
3. Temperature (inpatient and specialist community units only)
4. Blood pressure (inpatient and specialist community units only)
5. Oxygen saturation (inpatient and specialist community units only)
6. Monitor ECG if equipment available
7. Blood glucose monitoring if equipment available
Where the service user exhibits lowered levels of consciousness post-administration they should be placed into the recovery position.
Where a service user experiences adverse effects that put them at risk medical support should be requested, either by use of locality medical team or the emergency services.
In all inpatient areas administering these medications flumazenil must be available. Flumazenil must be given by intravenous injection so appropriately trained medical or nursing staff must be available (see Appendix 3). This is only likely to be necessary in exceptional circumstances but all areas should have a plan for dealing with these situations.
If the individual’s respiratory rate drops below 10/minute, they do not respond to rectal diazepam or buccal midazolam, or their oxygen saturation is less than 88% and it is not responding to oxygen being administered:
CALL AN AMBULANCE IMMEDIATELY using 999
A Standard Operating Procedure for administration / monitoring is included (Appendix 7)
5.3 Physical health monitoring guidance
Due to the nature of the situation in which these medications are used it is not always possible to take baseline observations (blood pressure, pulse rate, respiratory rate and the level of consciousness) prior to the administration of drugs.
Close monitoring (observation of patient within eyesight) by staff is required. Observations should be particularly frequent when a patient is sedated. A template recording form is provided (See Appendix 6), where this is not used a local solution must be implemented to ensure this data is recorded.
After administration of buccal / rectal benzodiazepines the monitoring of respiratory and cardiac function are essential in an inpatient setting. If observations are difficult then this should be clearly documented in the patient’s notes and discussed with the prescriber or the clinical team. It is particularly important to ensure that wellbeing is maintained if the patient is asleep or appears to be asleep, then the monitoring of vital signs including saturation levels continues.
6. Training
Staff involved in administration of medication to individuals who require emergency rectal diazepam and/or buccal midazolam must have:
· Read the information leaflets for both buccal midazolam and rectal diazepam (Appendix 1 and 2)
· Familiarised themselves with the products
· Been informed of the need for care plans (Appendix 5), and where to find these locally
· Have read and understood the information on different seizure types (Appendix 4)
· Have been trained in basic life support and AED
· Have familiarised themselves with the requirements of the policy.
Local training sessions will be arranged to cover these issues where they are not covered by the individuals professional training and core competencies.
The training requirements automatically include, but are not limited to the following groups of staff:
· Healthcare assistants
· Occupational therapists
· Physiotherapists
For other health professionals who need to undertake this activity, approval must be sought from the SWYPFT lead for the profession, and support for this activity by the professional body must be demonstrated, where appropriate this decision may also be made by the Drugs and Therapeutics Committee. A register of the approved professional groups can be found in Appendix 11.
Where additional learning needs are identified locally these should be referred to the appropriate manager / practice governance coach. As SWYPFT is not a specialist provider of epilepsy services partner organisations will be approached to assist in the development of learning solutions
All carers should be provided with a care plan and an opportunity to discuss the care plan with a member of SWYPFT staff and understand the indications for use.
NB SWYPFT cannot validate training provided by other organisations.
Appendix 1
Midazolam information sheet
There are currently two forms of buccal midazolam available for use; midazolam hydrochloride 5mg/ml (Buccolam®) and midazolam maleate 10mg/ml (Various preparations are available). There is no therapeutic difference between the two preparations.
Buccolam® is the preferred formulation as it is a licensed medical product and comes in pre-filled syringes which reduce the risk of incorrect dose selection / administration in an emergency.
To prevent confusion all prescriptions for buccal midazolam should be made by brand name rather than by drug name or form.
NB: Buccolam (midazolam hydrochloride) is only licensed for use in the under 18’s
NB: Midazolam maleate does not hold a UK product license
Use of both of these products outwith the remit of a UK license is endorsed by NICE and so should not be considered as a barrier to appropriate treatment.
Route of administration
Buccal cavity
Dosing
Age range / Dose / Label colour3 to 6 months
hospital setting / 2.5mg / Yellow
> 6 months to < 1 year / 2.5mg / Yellow
1 year to < 5 years / 5 mg / Blue
5 years to < 10 years / 7.5 mg / Purple
10 years and over / 10 mg / Orange
Common adverse effects
Sedation, somnolence, respiratory depression.
Nausea and vomiting.
Cautions
Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required.
Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.
Midazolam may cause anterograde amnesia.
Contraindiactions
Hypersensitivity to the active substance, benzodiazepines or to any of the excipients.
Myasthenia gravis
Severe respiratory insufficiency
Sleep apnoea syndrome
Severe hepatic impairment
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Instructions for use