Protocol for Oromucosal (Buccal) Midazolam Solution –
Storage and Handling within the Community in Hertfordshire
This document provides guidance on the storage and handling of oromucosal
midazolam within the community in Hertfordshire. Oromucosal midazolam is
prescribed for the emergency treatment of status epilepticus and is given into the
buccal cavity (the side of the mouth between the cheek and the gum). Extra
precautions have been listed to minimise the risk of abuse and misuse. There are
two brands of oromucosal midazolam available - Epistatus and Buccolam. They
are not interchangeable as the brands contain different strengths of oromucosal
midazolam. Epistatus contains 10mg/ml and Buccolam contains 5mg/ml.
Epistatus 10mg/ml is the brand of choice used by Hertfordshire Partnership
University NHS Foundation Trust (HPFT).The prefilled syringe is now the Epistatus
preparation of choice over the multidose bottle due to the ease of use and the
reduced risk of incorrect dosing and waste from spillage.
Midazolam is a benzodiazepine. Although unlicensed, oromucosal midazolam is
recognised as an effective drug treatment for prolonged or repetitive convulsive
seizures without regaining consciousness. The administration of midazolam through
the oromucosal (buccal) route is less invasive and issues of privacy and dignity are
less compromised compared to the administration of rectal diazepam.
Service users who are being considered for oromucosal midazolam treatment should
be referred to the Specialist Epilepsy Nurse (SEN) for an assessment of suitability
and training on its administration and handling. An administration protocol will also be
provided.
Additionally, the Trust Clinical Pharmacist should be consulted with regards to the
safe storage and handling of this medicine. This would be especially important for
care homes, day centres and colleges.
On receiving the stock of oromucoal midazolam with the necessary handling and
storage requirements in place, rectal diazepam should be discontinued, unless
otherwise advised, and unwanted stock should be disposed of via a community
pharmacy.
Epistatus prefilled syringes are the preferred preparation to be prescribed and
dispensed for HPFT service users. Service users will be initiated on these prefilled
syringes. They are available as 2.5mg, 5mg, 7.5mg and 10mg syringes. However
existing service users may still be receiving the multidose glass bottles. Therefore
this document provides information on both products to avoid any confusion.
APPENDIX 1: Protocol for Oromucosal (Buccal) Midazolam Solution Storage and Handling within the Community in Hertfordshire June 2015
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Ordering:
Person(s) should be specifically designated and responsible for ordering, stock
control and the recording process of oromucosal midazolam.
Storage (multidose glass bottles):
 Oromucosal midazolam is a Controlled Drug (CD) and therefore subject to the
Misuse of Drugs Act. It is liable for misuse and abuse and must be stored in a
locked cabinet with restricted access.
 Oromucosal midazolam must be stored in its original container, as supplied by the
pharmacy. It should not be transferred from one container to another.
 Storage conditions should ensure security, free from contamination and prevent
deterioration by humidity, light, extremes of temperature, or exposure to other
substances. Temperature should be monitored regularly (preferably daily) and kept
at 15-250C.
 Cupboard for medicines and pharmaceuticals must not be used for other items, such
as money, valuables, food or specimens.
 The expiry date and stock levels of midazolam are to be checked at least once
weekly and recorded on the ‘stock control sheet’ provided (see below).
 Store the pack upright. 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.
 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.
Storage (prefilled syringes):
 Oromucosal midazolam is a Controlled Drug (CD) and therefore subject to the
Misuse of Drugs Act. It is liable for misuse and abuse and must be stored in a
locked cabinet with restricted access.
 Oromucosal midazolam must be stored in its container, as supplied by the
pharmacy. It should not be transferred from one container to another.
 Storage conditions should ensure security, free from contamination and
prevent deterioration by humidity, light, extremes of temperature, or exposure
to other substances. Temperature should be monitored regularly (preferably
daily) and kept at 15-250C.
 Cupboard for medicines and pharmaceuticals must not be used for other items,
such as money, valuables, food or specimens.
 The expiry date and stock levels of oromucosal midazolam are to be checked
at least once weekly and recorded on the ‘stock control sheet’ provided (see
below).
APPENDIX 1: Protocol for Oromucosal (Buccal) Midazolam Solution Storage and Handling within the Community in Hertfordshire June 2015
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

The prefilled syringes should be stored at all times in the box that has been
supplied and labelled by the pharmacy.
If it is intended that the syringes will be separated for purposes such as travel
then the community pharmacist must dispense each prefilled syringe in a
separate box labelled and supplied with an information leaflet.
Handling (multidose glass bottles)
 The ‘stock control sheet for glass bottles’ (see below – Figure 1) must be
completed on every occasion that midazolam is handled. Reasons for accessing
the cupboard must be stated clearly. Each person must also sign and print their
name.
 The glass bottle in which oromucosal midazolam is supplied is not calibrated.
Hence it is difficult to estimate the true quantity. An effective way is to use a
permanent marker pen and mark the level of liquid left. Marking must be accurate
and done at eye-level, whilst the bottle is placed on a level, flat surface. Calibrate
using numbers (or letters).
APPENDIX 1: Protocol for Oromucosal (Buccal) Midazolam Solution Storage and Handling within the Community in Hertfordshire June 2015
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Figure 1: Stock Control Sheet
 Do not use the oral syringes to store oromucosal midazolam. A dose should only
be withdrawn at the time of need.
 Whenever possible, two persons should be present to witness the handling
(usage, stock checks and stock removal and returning) of oromucosal midazolam.
Both should sign the stock control sheet.
Handling (prefilled syringes)
 The ‘stock control sheet for prefilled syringes’ (see below – Figure 2) must be
completed on every occasion that oromucosal midazolam is handled.
Reasons for accessing the cupboard must be stated clearly. Each person
must also sign and print their name
Example Stock Record:
Service user name:
Drug name: oromucosal midazolam 10mg/ml
Strength of prefilled syringe
Date
Actual
Quantity in
cupboard
Quantity
received
Quantity
removed
Expiry date
and batch
number
Actual
quantity in
cupboard
02/04/2
009
0
5
0
Exp:05/11
BN: DYS20
5
Reason for
discrepancy
Witness 1
signature
Witness 2
signature
John Smith
Mary Jones
Figure 2: Stock Control Sheet
Finally, only trained personnel should administer oromucosal midazolam. The
Epilepsy Specialist Nurse should be informed after it is given for the 1st time and
every 3rd occasion thereafter. If appropriate it is recommended that the parents or
nearest relative should be informed after every occasion that oromucosal midazolam
is given.
Please note that the stock control sheet is to be used in addition to any other record
sheets (e.g. Medication Administration Record Sheet), even if the information is
duplicated.
APPENDIX 1: Protocol for Oromucosal (Buccal) Midazolam Solution Storage and Handling within the Community in Hertfordshire June 2015
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Protocol agreed by:  Medicines management team, HPFT
 Specialist Epilepsy Nurses
 Consultant psychiatrists, HPFT
June 2015
APPENDIX 1: Protocol for Oromucosal (Buccal) Midazolam Solution Storage and Handling within the Community in Hertfordshire June 2015
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