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Buccal Midazolam
July 2015
Tutor: Patrick Doyle
© Training Innovations Ltd 2015 Last updated: 21.07.15
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Epistatus Midazolam Buccal Liquid
16
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
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
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
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
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
• 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
The Buccal Cavity:
between cheek and gums
© Training Innovations Ltd 2015
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
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
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
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
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
28
29
Ethical Issues
• Duty Of Care
• Consent
• Invasive
• Fear of Legal Action
“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
• 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
• www.traininginnovtions.co.uk/news/gemmasstory
• Twitter: @Traininnovate
• Facebook: https://facebook.com/pages/Training-Innovations-Ltd

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Training innovations buccal midazolam training slideshare

  • 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
  • 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 28
  • 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 • www.traininginnovtions.co.uk/news/gemmasstory • Twitter: @Traininnovate • Facebook: https://facebook.com/pages/Training-Innovations-Ltd