Download Shared care available. Brand prescribing

Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Buccolam®
Reduced Shared Care Guideline for the use of Buccolam® (Buccal Midazolam)
in children.
Introduction
Indication/Licensing information
 Buccolam® is licensed for the treatment of prolonged convulsive seizures in patients aged 3 months to
less than 18 years.1
NICE Clinical Guideline CG137. Epilepsy. January 2012.2
The Clinical Guideline, produced by NICE, for the treatment of epilepsy describes the place in therapy of buccal
midazolam. Buccal midazolam or rectal diazepam can be used in the community for children, young people and
adults who have had a previous episode of prolonged or serial convulsive seizures. Administer buccal
midazolam as first-line treatment or rectal diazepam, if preferred or if buccal midazolam is not available. If
intravenous access is already established and resuscitation facilities are available, administer intravenous
lorazepam.
Dosage and Administration
Age
3-6 months
Hospital setting
only
Dosage
300mcg/kg
(max 2.5mg)
6-12 months
2.5mg
(0.5ml)
5mg (1.0ml)
Available as Buccolam® pre-filled
Syringe 2.5mg in 0.5ml. (Yellow label)
Available as Buccolam® pre-filled syringe 5mg in 1.0ml. (Blue label)
7.5mg
(1.5ml)
10mg (2.0ml)
Available as Buccolam® pre-filled syringe 7.5mg in 1.5ml (Purple
label)
Available as Buccolam® pre-filled syringe 10mg in 2.0ml (Orange
label)
1-5 years
5-10 years
10 years to <18
years
Comments
In infants less than 6 months buccal midazolam should only be used
within a hospital and where equipment is available for resuscitation
and monitoring of the patient due to an increased risk respiratory
depression.3
Buccolam® is for oromucosal use. The full amount of solution should be inserted slowly into the space between
the gum and the cheek. Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the
solution. If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given
slowly into one side of the mouth, then the other half given slowly into the other side.
Buccolam® Reduced Shared Care Guideline (Amber-G)
Date Prepared: August 2012
Page 1 of 5
Review Date: August 2014
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Responsibilities of the specialist* initiating treatment
*Specialist refers to either a Consultant or an Epilepsy Specialist Nurse
Summary
 To assess the suitability of the patient for treatment, including potential drug interactions with other current
medication.
 To discuss the benefits and side effects of treatment with the patient/carer.
 To perform baseline tests.
 To fully educate and train the patient/carer in administering the Buccolam® Oromucosal solution.
 To ask the GP whether they are willing to participate in shared care.
 To provide the GP with a summary of information relating to the individual patient to support the GP in
undertaking reduced shared care (See Reduced Shared Care request form in Appendix A).
 To advise the GP of any dosage adjustments required, when to refer back, when and how to stop treatment
(if appropriate) and when the patient will next be reviewed by the specialist.
 To monitor the patient for adverse events and report to the GP and where appropriate Commission on
Human Medicines/MHRA (Yellow card scheme).
 To provide the GP with contact details in case of queries.
Baseline Tests
None
Routine Tests (if applicable)
None
Disease monitoring
The patient will be reviewed by the Specialist every 3-6 months. Patients also have access to Epilepsy
specialist nurses as required.
Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on
shared care only if they are willing and able.
Summary
 To reply to the request for shared care as soon as possible.
 To prescribe and adjust the dose as recommended by the specialist.
 To ensure there are no interactions with any other medications initiated in primary care.
 To refer back to the specialist where appropriate. For example:
o Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects.
o The patient experiences any unmanageable side effects.
 Discontinue the drug as directed by the specialist if required.
 To identify adverse events if the patient presents with any signs and liaise with the specialist where
necessary. To report adverse events to the specialist and where appropriate the Commission on Human
Medicines/MHRA (Yellow card scheme).
Buccolam® Reduced Shared Care Guideline (Amber-G)
Date Prepared: August 2012
Page 2 of 5
Review Date: August 2014
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Adverse drug reactions, precautions, contraindications and interactions
Please see the full Summary of Product Characteristics for more information. 1
The most common side effects with Buccolam (seen in 1/100 to 1/10) are sedation,
Adverse Drug
somnolence, depressed levels of consciousness, respiratory depression and nausea
Reactions
and vomiting.
Contraindications
Precautions and
Contraindications  Hypersensitivity to the active substance, benzodiazepines or to any of the




excipients.
Myasthenia gravis
Severe respiratory insufficiency
Sleep apnoea syndrome
Severe hepatic impairment
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.
Interactions
Midazolam is metabolized by CYP3A4. Inhibitors and inducers of CYP3A4 have the
potential to respectively increase and decrease the plasma concentrations and,
subsequently, the effects of midazolam thus requiring dose adjustments accordingly.
Careful monitoring of the clinical effects and vital signs is recommended during the use
of midazolam with a CYP3A4 inhibitor even after a single dose. (Refer to SPC for
details of specific drugs:
http://www.medicines.org.uk/EMC/searchresults.aspx?term=buccolam&searchtype=Qui
ckSearch )
Buccolam® Reduced Shared Care Guideline (Amber-G)
Date Prepared: August 2012
Page 3 of 5
Review Date: August 2014
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Communication
Specialist to GP
The specialist will inform the GP when they have initiated Buccolam® and will write to the GP to request
they take over prescribing. The Specialist will also send a Shared care request form to support the GP in
undertaking reduced shared care. (Appendix A).
GP to specialist
If the GP has concerns over the prescribing of Buccolam®, they will contact the specialist as soon as
possible.
Contact names and details
Contact Name
Telephone number
Email
Dr S Iqbal
Consultant Paediatric Epilepsy
01226 433184
[email protected]
Phil McNulty
Specialist Nurse Paediatric Epilepsy
01226 436591
[email protected]
[email protected]
Sharron Hoyle
01226 436591
[email protected]
Gillian Smith
Medicines Information Pharmacist
01226 432857
[email protected]
References
1. Summary of Product Characteristics. Buccolam® December 2011. Available at:
http://www.medicines.org.uk/EMC/searchresults.aspx?term=buccolam&searchtype=QuickSearch
Accessed <19.7.12>
2.
Epilepsy. NICE Clinical Guideline CG137. January 2012 Available at:
http://guidance.nice.org.uk/CG137/NICEGuidance/pdf/English Accessed <19.7.12>
3. Buccolam product information. European Medicines Agency. September 2011. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002267/human_m
ed_001479.jsp&mid=WC0b01ac058001d124&murl=menus/medicines/medicines.jsp&jsenabled=true
Accessed <19.7.12>
Development Process
This guidance has been produced by Caron Applebee, Prescribing Support Pharmacist and Dr Iqbal (Lead
Consultant for Paediatric Epilepsy) following an AMBER-G classification status of Buccolam® by the Barnsley
Area Prescribing Committee in July 2012. This guideline has been subject to consultation and endorsement by
the Area Prescribing Committee on 8th August 2012.
Buccolam® Reduced Shared Care Guideline (Amber-G)
Date Prepared: August 2012
Page 4 of 5
Review Date: August 2014
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Appendix A – Reduced Shared Care (Amber-G) request form



Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosed condition:
Amber-G Drug details
Drug name:
Date of initiation:
Dose:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone number(s) for contact:
The patient should be reviewed by the GP by:
Consultant:
Date:
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist name:
Specialist signature:
Date:
GP name:
GP signature:
Buccolam® Reduced Shared Care Guideline (Amber-G)
Date Prepared: August 2012
Date:
Page 5 of 5
Review Date: August 2014