• PROTOCOL FOR THE


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BARNET PRIMARY CARE TRUST
PROTOCOL FOR THE ADMINISTRATION OF
EMERGENCY RESCUE MEDICATION
BUCCAL MIDAZOLAM
FOR ADULTS AND CHILDREN
WHO HAVE EPILEPSY
To be read in conjunction with: Medicines Policy - 2006
For Barnet PCT employees
Compliance with all PCT documents is a condition of employment.
Breach of document may result in disciplinary action
Document Reference Information
Version 3.0
Status Final Protocol
Version 3
0
Christine Cole
Author/Lead
In partnership with
Lesley Haigh –Senior Practitioner
Brenda O’Mahoney Barnet Children & Family
Community Service Nurses.
Directorate Responsible Barnet Community Services
Ratified By and Date Professional Executive Committee
10-04-2008
Date Effective 10-04-2008
Date of Next Formal March 2010
Review
Target Audience Clinical Workforce Trust Wide
Version Control Record
Version Description of Reason for Change Author Date
Change(s)
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INDEX
Administration of Buccal Midazolam
1. Training staff to Administer Buccal Midazolam in Epileptic 3-4
Emergencies
2. The use of Buccal Midazolam and Status Epilepticus 5-6
3. Buccal Midazolam Prescription, Individual Care Plan & 6-10
Administration
a. Pre requisites
b. Prescribing Buccal Midazolam
c. Administration of Buccal Midazolam
Equipment Required
Procedure
Appendix 1
Patient information leaflet for EPISTATUS® (formerly EPISTAT)
11-13
Appendix 2
Epilepsy Training Courses.
Objectives & Content 14-17
Introduction, Basic Awareness, Update 1 Course.
Appendix 3 Recording Charts 18-23
Recording monitoring of epileptic seizures
Types of Epileptic Seizures
Epilepsy Recording Charts instructions to complete forms
Epilepsy Month Seizure Chart
Epilepsy Written Monitoring Chart
Epilepsy Year Chart
Bibliography 24-25
Barnet PCT Assurance Form and Ratification Flow Chart 26-27
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1. PROTOCOL FOR TRAINING STAFF TO ADMINISTER
EMERGENCY RESCUE MEDICATION BUCCAL MIDAZOLAM
FOR PEOPLE WHO HAVE EPILEPSY
Introduction
This is a Barnet PCT trust-wide protocol for the provision of training for the
emergency administration of buccal midazolam, which applies to employees
of Barnet Primary Care NHS Trust. It is available for reference to other
agencies and professionals. This protocol complies with the guidelines on
training standards for the administration buccal midazolam (see below).
Joint Epilepsy Council 2005 “A Guideline on training standards for the administration of
Buccal Midazolam”.
“It is recognised that the administration of buccal midazolam for the control of
prolonged or continuous seizures is an effective treatment which can be life
saving. Given promptly this simple procedure can prevent the major disruption
of daily life resulting from hospital emergency treatment”
JEC 2005:5.
Employing organisation’s insurance needs to cover public liability in relation to
staff (who are trained) to carry out this procedure. Barnet Primary Care Trust
indemnity assurance will provide liability to cover staff who administers buccal
midazolam in accordance with this protocol.
Training Courses
This protocol is in alliance with the Basic Epilepsy Awareness and Update
training courses provided by Barnet Primary Care Trust. Both of these
courses are delivered through the PCT annual training programme.
Trainers
Professionals currently providing the training within the Trust include:
Community Nurses for People with Learning Disabilities, Children & Family
Community Services, and District Nurses.
Attendance
A database holds the names of people who have attended the training and
the date of issue of their certificate.
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Aims of the training
 To enable carers and professionals to gain knowledge and a general
understanding of epilepsy and status epilepticus.
 To provide carers with practical skills to administer buccal /nasal
midazolam in a safe and effective manner, for the emergency treatment of
seizures.
Related Policy
This protocol should be read in conjunction with the Local Authority Policy on
“Intrusive Medication” in day and residential care settings, Managing
Medicines in Schools & Early Years Settings, Department of Health (2005),
National Care Standards Act (NCSA) (2000), Primary Care Trust (PCT)
Medicines policy (2006) and relevant policies in other establishments.
Guidance on Managing Health in Schools and Settings, LBB and PCT [March
2007]
Controlled Drug Status
From the 1st January 2008 Buccal Midazolam became a schedule three
controlled drug. This policy should be viewed in conjunction with Barnet PCT
medicines policy especially looking at sections on: - controlled drugs,
unlicensed medicines, administration, storage, clinical management plan, and
incident reporting and risk management.
Storage requirements
Each setting will carry out a storage risk assessment for Midazolam. When
setting up procedures within community services, advice can be sought from
the Community Pharmaceutical Adviser or Clinical Nurse Epilepsy Specialist
at Barnet PCT.
Acknowledgements are made to:
Community Learning Disability Nurses, Commission for Social Care Inspection (CSCI), Colin
Daff & Michele Bubb Pharmaceutical Advisers, Consultant Paediatricians Jackie Taylor &
Juliet Pearce, Children & Family Community Services, Consultant Psychiatrists, GPs and
Consultant Neurologist Dr. Angus Leppan.
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2. THE USE OF BUCCAL MIDAZOLAM AND STATUS
EPILPETICUS
Status epilepticus or continuous prolonged seizures are defined as:
“Status epilepticus is seizures occurring continuously or reoccurring for
at least 30 minutes without recovery. Most seizures stop within 5
minutes and there is significant risk of evolving into status epilepticus if
a seizure lasts longer than 5 minutes.”
Manford (2003): 243.
or
“A series of closely spaced seizures or a continuous seizure
lasting more than 30 minutes.”
Gluberman & Bruni (1999): 167.
Buccal Midazolam
Buccal Midazolam will be the term used throughout this document.
However, buccal midazolam is also known as Epistatus.
Buccal applies to the area between the lower gums and the inner cheek area
of either side of the mouth.
Buccal midazolam (Epistatus) is not a licensed product but Scottish
Intercollegiate Guidelines Network (Sign, 2005)' guidelines, National Institute
for Health and Clinical Excellence (NICE, 2004) Clinical Guideline 20 and
guidelines from Royal College of Paediatrics and Child Health (RCPCH) as
well as the British National Formulary (BNF) all recommend using rectal
diazepam or buccal midazolam for the management of prolonged or serial
seizures.
“The administration of buccal midazolam is considered to be less invasive
procedure than the administration of rectal diazepam. The issues of privacy
and dignity are less compromised and in situations where it is not acceptable
or convenient to use rectal diazepam, buccal midazolam is an effective
alternative.” JEC (2005): 5
NB: Buccal midazolam can also be administered into each nostril if there is
excessive salivation. See Special Products Leaflet (SPL) Appendix 1.
INDICATIONS FOR USE OF BUCCAL MIDAZOLAM
Treatment of potentially life threatening tonic-clonic
seizures, which are likely to progress to status epilepticus,
by buccal administration as an alternative to rectal administration of
diazepam.
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3. BUCCAL MIDAZOLAM PRESCRIPTION, INDIVIDUAL CARE
PLAN AND ADMINISTRATION GUIDANCE
PREREQUISITES
1. Buccal midazolam must be prescribed for the named individual
2. The medicine administration chart must be used in the relevant
establishments
3. The patient information leaflet from the Buccal midazolam pack
will be given to the individual and their carer, by the prescriber,
and discussed with them (Nice clinical guideline 20, 2004).
4. Medicine must be prescribed for the named individual and the
medicine administration chart must be used in the relevant
establishments.
5. Letter from prescriber stating that they authorise trained staff to
administer buccal midazolam.
6. Current individual emergency epilepsy management plans or
health care plans for designated patients/clients must be dated
with details of seizure/seizure types, and where the use of
buccal midazolam is indicated.
7. The person/carer must have undertaken and satisfactorily
completed the Barnet PCT epilepsy buccal midazolam training.
Training is valid for 2 years.
8. It is recommended that the person/carer undertake Life support
training either before attending the Buccal Midazolam training,
or within three months after attending this course.
9. It is recommended that each service conducts a risk
assessment of the storage requirements for Buccal Midazolam,
this should be done on an individual basis.
PRESCRIPTION OF PRN (i.e. when required) BUCCAL MIDAZOLAM
Buccal midazolam is usually prescribed “as and when required” (PRN)
medication for prolonged seizures and as part of an emergency intervention
care plan for the prevention of status epilepticus or to lessen the duration of
prolonged / cluster seizures.
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Buccal midazolam can only be prescribed by a qualified medical practitioner,
e.g. Consultant Neurologist/Psychiatrist, Paediatrician or Specialist / GP, or
authorised prescriber.
Before prescribing Buccal Midazolam the patient and their family should be
informed that this is both an:-
 Unlicensed medicine.
 Controlled drug
The details of the drug treatment must be written on a medication form used
within the relevant establishments in the NHS Trusts/Other organisations.
For early years, educational and residential settings in the community a
standard PCT letter will be available with the following information:
- Name of the person
- Name and form of the prescribed medication
- Dose to be given, time and by which method
Authorisation Letter
This must be accompanied with an „individual care plan‟ with a current
accurate description or pattern of seizure.
 Named person/people authorised to carryout this procedure i.e.
parents, carers, and nurses.
 Interval between doses
 Maximum number of doses to be given before medical assistance is
sought.
ADMINISTRATION OF PRN BUCCAL MIDAZOLAM
The following persons only can administer buccal midazolam:
1. A doctor
2. A nurse,
3. A paramedic who has undergone appropriate training
4. A named carer or person who has attended training in the
administration of buccal midazolam, delivered by Barnet Primary Care
Trust.
Staff who hold a nursing qualification but are not employed as nurses will be
considered as part of category 4 and must have attended the training in the
administration of buccal midazolam.
Administration should be consistent with the individual epilepsy management
plan, which is current and agreed between the prescribing medical practitioner
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and the appropriate service manager(s), social care staff, community nurses
and parents.
EQUIPMENT FOR THE ADMINISTRATION OF BUCCAL MIDAZOLAM
The equipment required is as follows:
- Disposable gloves
- Buccal Midazolam
- Topical swabs or a box of tissues
We recommend a record/book be kept to monitor expiry dates of medication
and any special requirements on the bottle.
HOW LONG CAN I KEEP THE PACK AFTER IT HAS FIRST BEEN USED?
You can use the pack until the expiry date on the bottle. The liquid contains
anti-microbial compounds to prevent contamination by bacteria and yeasts. If
the cap is not replaced immediately, then the liquid will evaporate and some
of the midazolam will precipitate. The liquid will become milky. The pack
must be discarded if the liquid is not clear.
We recommend that:-
Carers should wear disposable gloves and ensure that they have short
fingernails. They should not wear jewellery that is likely to cause abrasions
etc. whilst carrying out this procedure.
PROCEDURE FOR ADMINSTRATION OF BUCCAL MIDAZOLAM
I. Check airway is clear, and assess his or her breathing and heart
function.
II. Maintain person’s safety, dignity and privacy.
III. If possible have someone else with you.
IV. Tell the person what you are doing and reassure them.
V. Put the person in the recovery position during a seizure (if possible
taking into consideration the individual’s disabilities).
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HOW TO GIVE BUCCAL MIDAZOLAM
 Check the dosage of the buccal midazolam.
 Hold the bottle upright
 Remove the child-resistant cap by pushing it down and turning it anti-
clockwise
 Put on the disposable gloves
 Insert the tip of the oral dispenser into the hole in the white plastic
bottle adaptor.
 Hold the bottle and the oral dispenser securely and turn the bottle up-
side-down.
 Pull the plunger out slowly until the oral dispenser contains the
prescribed amount of liquid e.g. 7.5mg in 0.75mL of liquid
 Turn the bottle upright
 Remove the oral dispenser from the bottle.
METHOD OF ADMINISTRATION
1. Insert the syringe gently into the buccal cavity of the mouth. (between the
lower gums and inside of cheeks)
2. Administer about half of the prescribed dose to each side of the buccal
cavity. If this is not possible, then administer the whole dose to one
side of the buccal cavity.
3. Support the cheek/lips whilst giving the buccal midazolam and
afterwards to reduce the amount of leakage.
4. Maintain close observation after administration to monitor person’s
condition and breathing. They must be in the recovery position until
recovery of consciousness
5. Initial effect of the midazolam should be apparent after approximately 5
minutes. If there is no change in the person’s condition within
approximately 10 minutes, and the person continues to have seizures
another buccal midazolam dose may be required in accordance to
prescriber’s instructions. It may be necessary to seek medical
intervention or call emergency services.
(Refer to individual’s epilepsy management plan for further
information).
NB It is essential for clients/patients with uncontrolled epilepsy to
have individual epilepsy guidelines.
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6. The administering carer must write down the date, time and route of
giving the buccal midazolam and sign that they have given it in the
record book, the person’s medication chart and the management plan.
7. The administering carer must ensure that all used equipment and
bottles of medicines are disposed of safetly.
8. Relatives/carers should also be informed at the earliest opportunity that
buccal/nasal midazolam has been administered. It is important that
this information is recorded in writing.
9. The frequency of administration should be brought to the attention of
the prescribing clinician and GP (if different).
Alternatively buccal midazolam can be administered intra-nasally (into the
nostril) if the patient has excessive salivation. This route of administration
is covered within the Barnet PCT Epilepsy Training Programme.
Possible side effects of Buccal Midazolam
1. Drowsiness
2. Confusion (which may lead to changes in behaviour)
3. Ataxia (unsteadiness - especially in the elderly)
4. Headache and lowering of blood pressure occasionally
5. Respiratory depression (breathing is slower and more shallow)
British National Formulary (BNF)
For more information and advice on buccal midazolam please refer to the
patient information leaflet (appendix 1), BNF, and/or the dispensing
pharmacist.
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Appendix 1 Patient information leaflet for EPISTATUS®
(formerly EPISTAT)
MIDAZOLAM BUCCAL LIQUID
10mg (base) in 1ml sugar-free liquid
Chemical Name
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo
[1,5-a][1,4]-benzodiazepine
Chemical Group
Midazolam is a short-acting benzodiazepine.
Indication
Treatment of potentially life threatening tonic-clonic
seizures, which are likely to progress to status epilepticus,
by buccal administration as an alternative to rectal administration of diazepam.
Midazolam Oral liquid (2.5mg in 1ml) is also available for the treatment of all types of partial
seizures.
Presentation
Carton (with instructions for use on one panel) containing:
30ml amber glass bottle (large enough to hold firmly) with a child-resistant closure
5ml of liquid (sufficient overage to deliver 4 x 1ml doses)
4 x 1ml oral syringes (syringes without needles)
Patient information leaflet
Each 1ml dose delivers 10mg Midazolam (base). Demonstration packs are available.
Prescriptions
Prescriptions should be written as:
Midazolam 10mg in 1ml liquid for buccal administration
Mitte: X packs of 4 x 10mg doses
Sig: N ml to be administered to the buccal cavity as directed.
Available from Special Products Ltd (Tel: 01932 820666)
(This information will help the pharmacist to order the product)
Route of Administration
Using the oral syringe provided, administer about half of the prescribed dose quickly to each
side of the buccal cavity (between the lower gums and cheeks). If this is not possible, then
administer the whole dose quickly to one side of the buccal cavity. Retain in the buccal cavity.
Alternatively, buccal midazolam can be administered intra-nasally if the patient has excessive
salivation.
Storage of the Pack
Store the pack upright at 15-250C. The cap must be replaced immediately otherwise, the liquid
will evaporate and some of the sweetener will precipitate. This will be exhibited as white
particles in the liquid. The pack must be discarded if the solution is not clear.
Midazolam is slowly adsorbed onto plastic, but if necessary, a pre-measured dose can be stored
in a capped syringe for 2 months.
Expiry
2 years
The product is microbiologically preserved to maintain the shelf life after the first dose has been
removed and until the expiry date on the label.
Onset of Action
Initial effects become apparent after approximately 5 minutes. About 80% of seizures are
terminated within 10 minutes.
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Duration of Action
The patient may be drowsy for several hours after administration and may be protected from
recurring seizures for up to four hours.
Dental Care
The solution has a pH of 5.0-5.5, which is mildly acidic (as acidic as vinegar). It is sugar-free.
Ketogenic Diet
The carbohydrate content and energy value (


Use: 0.1079