This Course covers the safe administration and management of Buccal Midazolam

1. Buccal Midazolam
July 2015
Tutor: Patrick Doyle
© Training Innovations Ltd 2015 Last updated: 21.07.15

2. Learning Outcomes
By the end of the session candidates will:
• Be able to recognise prolonged and serial
seizures and respond appropriately
• Be able to describe the appropriate conditions
required to participate in the administration
of Buccal Midazolam
• Be able to demonstrate through simulation
the procedure for administering Buccal
Midazolam
LD ESN June 2009 2© Training Innovations Ltd 2015

3. National Institute for Clinical
Excellence(NICE)
• NICE recommends Buccal Midazolam as the
first-line treatment in children, young people
and adults with prolonged or repeated
seizures in the community and
• Only used in those people who have had a
previous episode of prolonged or serial
convulsive seizures NICE (2012)
© Training Innovations Ltd 2015

4. What is Midazolam?
• Is the pharmaceutical name for this drug, from a
family of similar drugs called Benzodiazepines
• Other names and formulations for Midazolam
include Hypnoval and most commonly Buccolam and
Epistatus
• Buccolam comes in pre-filled syringes
• Epistatus comes in a bottle with empty syringes
• Midazolam is licensed as a sedative and is used in
hospitals and clinics before clinical procedures.
• In the brain it acts as an effective anti epileptic
LD ESN June 2009 4© Training Innovations Ltd 2015

5. How was Midazolam developed
for use?
• Used as a sedative since 1988
• Used in epilepsy since 1997
• Community use developed in paediatric services/
school age children
• Gradual introduction in to adult learning disability
• Now the most common form of rescue medication
• Recommendations for use in NICE, included in most
formularies
LD ESN June 2009 5© Training Innovations Ltd 2015

6. Why do we use Midazolam?
• We know that early treatment for seizures is
more effective preventing SE
• We may be preventing brain damage even death
• We may be preventing other poor health (e.g
aspiration infection)
• Prevents disruption, decreasing hospitalisation
• Best outcomes for individual, family and carer
6© Training Innovations Ltd 2015

7. How Does Midazolam Work?
• Slowly dripped into nasal/buccal cavity
• Absorbed through mucosal skin surfaces
• Good blood supply to these areas
• Travels via the heart and lungs to the brain
• Dampens down seizure activity
LD ESN June 2009 7© Training Innovations Ltd 2015

8. Indications for use
• Midazolam is prescribed where the individual
has a history of seizures which are prolonged/
serial , most commonly with people who also
have LD
• Prolonged seizures are around 5 minutes for
tonic clonic seizures. Serial seizures occur one
after the other with no recovery between
LD ESN June 2009 8

9. Indications for Use contd.
• Midazolam is used as a rescue medication early
on in the development of the seizure/s to try to
prevent status epilepticus, improve outcome
from seizure/s and quality of life
• Status Epilepticus is a continued state of seizure
lasting for 30 minutes.
LD ESN June 2009 9© Training Innovations Ltd 2015

10. Care Plan
• Each individual should have an epilepsy care plan.
• Care plans should include details of individual such as:
• Type of epilepsy – if known
• Types of seizure
• Details of prescribed treatment
• Details of who is responsible for monitoring /reviewing
epilepsy
• Details of any known aura
• Known triggers
• Usual length of seizure
• Mental state during recovery etc
© Training Innovations Ltd 2015

11. Protocol
The Prescribing doctor
must provide a clear protocol
for the use of rescue medication in prolonged
or repeated (serial) convulsive seizures
© Training Innovations Ltd 2014

12. This Protocol must include:-
• Details of service user (name, DOB, age, address)
• Details of the prescribing doctor and start date.
• When to give medication (i.e. when seizure is prolonged , 5
minutes or more, repeated/cluster)
• The dose of medication prescribed and the route of
administration.
• Time to allow for drug to take effect (e.g.6 –10 minutes)
• Details of any second dose – when to give and time to allow
for drug to take effect.
• Time allowed between doses and maximum dose in 24
hours
• What to do if rescue medication is not effective
© Training Innovations Ltd 2015

13. Protocol continued
• The protocol should be reviewed annually by
the prescribing doctor.
• The protocol should be kept with the
medication for the specific individual
• Consider copying / reducing / laminating the
protocol to make it easier to take out with
person.
• The protocol must be checked before each
administration of Midazolam
© Training Innovations Ltd 2015

14. Buccolam
• Does not require special storage – do not
refrigerate or freeze
• Buccolam has a shelf life of 18 months (please
check expiry date)
• Buccolam is to be administered into the buccal
cavity
• Buccolam is prescribed off-license for over
18’s
© Training Innovations Ltd 2015

15. Epistatus Midazolam Buccal Liquid
• 10mg (base) in 1ml sugar-free syrup
• Indication
• Treatment of prolonged or repeated (serial) seizures, which
are likely to progress to Status Epilepticus, by buccal
administration
• Presentation
• Box (with instructions for use on one panel) containing:
• 30ml amber glass bottle (large enough to hold firmly) with
a safety closure
• 5ml of liquid (sufficient to deliver 4 x 1ml doses)
• 4 x 1ml oral syringes (syringes without needles)
• Patient information leaflet
© Training Innovations Ltd 2015

16. Epistatus Midazolam Buccal Liquid
16

17. Storage of the Pack
• Store the pack upright at 15-25°C.
• The cap must be replaced immediately after use
otherwise the liquid will evaporate and some of
the Midazolam will precipitate. (This will be
exhibited as white particles in the liquid.)
• The pack must be discarded if the solution is not
clear.
• The last 1ml of solution MUST NOT BE USED, the
pack should be returned to the pharmacist.
© Training Innovations Ltd
2014

18. Possible Adverse Effects
• Depression of respiratory effort
• Restlessness
• Severe drowsiness (possibly for several hours)
• Memory loss
• May irritate nasal passages or cause discomfort to
gums
• Over use can cause dependence and be ineffective
• Recovery rates vary
LD ESN June 2009 18

19. Contra-Indications & Precautions
• Hypersensitivity and acute narrow angle
glaucoma.
• The safety of Midazolam in pregnancy has not
been established.
• Dental Care
• The solution has a pH of 5.0 – 5.5 which is
mildly acidic
• (as acidic as vinegar), it is also sugar-free.
© Training Innovations Ltd 2015

20. Buccal Midazolam: Following onset
• Note the time the seizure starts
• Follow the individuals protocol to see how
long to wait before giving Midazolam
• Decide to give Midazolam
• Check Midazolam package to ensure:
• Dose, expiry date, route, time interval, name
and correct medication
© Training Innovations Ltd 2015

21. Buccal Midazolam: Drawing up
• Ensure syringe plunger is pushed all the way
down syringe
• Insert syringe into bottle and tip whole bottle
upside down
• Following the protocol draw the required
amount of liquid into syringe and replace the
cap on the bottle
© Training Innovations Ltd 2015

22. • Point syringe to back of mouth on insertion then angle
downwards into the buccal cavity
• Administer approximately half the dose buccal cavity
on one side of the mouth.
• Then administer the residual liquid into the buccal
cavity on the other side of the mouth.
• If that is not possible, then administer the whole dose
to the buccal cavity on one side of the mouth
• Do not administer the dose below the tongue since the
teeth may clamp shut and break the syringe in the
mouth
22
Buccal Midazolam: Administration

23. The Buccal Cavity:
between cheek and gums
© Training Innovations Ltd 2015

24. Buccal Midazolam: Post Administration
• Stay with the individual until the seizure has stopped
• Note the time the seizure stops
• Stay with the person until they have returned to usual
functioning
• Be aware that individual may be at risk of respiratory
depression, so will need close observation for several hours.
• Assist the person to dress or tidy themselves (remember: they
may have been incontinent)
• Document the seizure in the notes or care plan, etc
Consideration must be given to:
• Recording amount
• Recording use
• Recording outcome in the epilepsy care plan
© Training Innovations Ltd 2015

25. Onset & Duration of Action
Onset of Action
• Initial effects become apparent after
approximately five minutes. About 80% of
seizures are terminated within ten minutes
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
© Training Innovations Ltd 2015

26. It is vital that Buccal Midazolam is administered
according to the Guidelines because
prolonged convulsive epileptic seizures are
potentially life threatening
© Training Innovations Ltd 2015

27. Convulsive Status Epilepticus
• A continuous Tonic Clonic seizure or repeated
Tonic Clonic seizures lasting 30 minutes
• This can be life threatening and requires
medical attention
27© Training Innovations Ltd 2015

28. Non Convulsive Status Epilepticus
Any seizure can develop into status
• Complex partial status relatively common in
Learning disability.
• This condition can be difficult to diagnose,
consciousness is often impaired but not lost
completely.
• Can continue for long periods.
• Can adversely affect health in vulnerable people
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29. 29
Ethical Issues
• Duty Of Care
• Consent
• Invasive
• Fear of Legal Action

30. “When Midazolam is prescribed there should
be no unreasonable barriers to its use”
Joint Epilepsy Council for the UK and Ireland
30© Training Innovations Ltd 2015

31. • Any questions?
• Please take some time to complete the course evaluation - Thank
you…
• PowerPoint slides available at: www.slideshare.net/TInnovations
• patrickdoyle@traininginnovations.co.uk
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