Download ocular leakage - Injectable Medicines Guide

Use of the Injectable Medicines Guide website in clinical areas Medicines given by OCULAR INJECTION monographs (April 2014 v2)
Introduction
The Injectable Medicines Guide website contains monographs which give information on
medicines given by intravenous injection and infusion, intramuscular injection, and ocular injection
and infusion.
This guidance relates to medicines given by ocular injection and infusion only. Each monograph
describes the method of preparation and administration of the given medicine.
Monographs include links to:
 The British National Formulary’s (BNF and BNFc)
 The manufacturer’s Summary of Product Characteristics (SPC) and relevant manufacturer’s
Patient Information Leaflet (PIL), which are produced by the supplier, can be found in the
‘Current Supplier’ section of the monograph.
 The Medicine Compendium UK (emc)
 Other relevant publications
The monographs must be used in conjunction with best practice detailed in injectable medicine
guidelines in use locally. In addition the user should be aware of the content of the following
documents (which can be found on the ‘Documents and Links’ page of the website): The Royal College of Nursing - Standards for Infusion Therapy.
 NPSA Patient Safety Alert 20: Promoting safer use of injectable medicines. March 2007.
 NHS Scotland Clinical Resource and Audit - Good Practice Statement for the Preparation
of Injections in Near-Patient-Areas, including Clinical and Home Environments - December
2002.
Finding a monograph on the website
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Log-in to the website (some organisations have the Guide on the local intranet and log-in is
not required)
Select the ‘OCULAR injection’ (or ‘local guide’ if available) tab on the menu bar on the top
right hand side of the home page or use the quick link ‘Injectable Medicines Guide’ on the
left hand side of the website home page.
EITHER
o Type in the first few letters of the medicine into the search box and click ‘Go’
o Click on the down arrow on the ‘Medicine index’ box below to see all the
preparations with names beginning with those letters
o Select the relevant monograph with the required strength and route of
administration from the list displayed
OR
o Click on the down arrow in the ‘Medicine index’ box
o Type in the first letter of the medicine name and scroll through the list of
monographs
o Select the relevant monograph with the required strength and route of
administration from the list displayed
Viewing a monograph


When the relevant monograph is selected in the ‘Medicine index’ box (see above), click on
the ‘Show monograph’ button.
When the monograph is displayed use the blue buttons at the top left hand side of the
monograph to switch between the detailed monograph ‘Display Full Monograph’ and
the short monograph ‘Display Short Monograph’. The short monograph is designed to
show only information absolutely essential for the safe preparation and administration of the
medicines.
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Once in the monograph, clicking on any of the blue ‘underlined’ monograph headings opens a new
window which gives an explanation of the terms used and some general background information.
The content of each of these windows is reproduced in the following pages.
Printing a monograph
Printing can be done when the monograph is open for viewing:
 Click on the orange ‘Print Monograph’ button at the top left hand side of the
monograph.
 Then use the browser print function from the tool bar.
Printing can also be done as follows:
 When the relevant monograph is selected in the ‘Drug name’ search box (see above), click
on the ‘Print monograph’ button.
 Then use the browser print function from the tool bar.
N.B. Do not use the print option from the browser tool bar without first selecting the ‘Print
monograph’ button as pages may not display correctly and information may be missed off the right
hand side of the printed page.
Printing other pages from the website:
For printing items from the ‘documents and links’ page of the website first set the printing options to
‘Landscape’. This will enable the correct display and avoid unintentional loss of information at the
right hand margin of the printed page.
Important: printed copies of monographs may not be up-to-date. If possible always check with
the electronic version of the Injectable Medicines Guide.
Comments on the Injectable Medicines Guide website
If you have any comments on the Injectable Medicines Guide, or have any suggestions for
improvement please contact: Gill Bullock, Pharmacy, Charing Cross Hospital, Tel: 020 331 11142
[email protected]
Disclaimer
The information in the Injectable Medicines Guide has been carefully checked. No responsibility
can be accepted for any errors or omissions. The reader is assumed to possess the necessary
knowledge to interpret the information that this document provides.
APPENDIX
Headings used in the Injectable Medicines Guide monographs for
OCULAR INJECTION medicines
Monograph ‘Banner’:

Use to highlight important notes, for example, the product is an unlicensed medicine, or
there is a relevant NPSA alert.
PRESENTATION OF MEDICINE:
 This section gives the final concentration of the medicine when prepared that is suitable for

the administration route into the eye
Gives a description of the final presentation of the medicine for the administration route into
the eye
METHOD OF ADMINISTRATION (adult):
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Provides a brief summary of the therapeutic indication for the medicine given by the ocular
injection route
Provides the dose and volume to be given with no overage
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General ocular injection administration advice The method of administration for an ocular injection is dependent on the product’s
marketing authorisation if applicable and/ or local procedure policy.

Ocular injections must be administered by a qualified ophthalmologist or healthcare
professional trained and validated and experienced in such injections.

The injection procedure should be carried out under aseptic conditions. This includes using
surgical hand disinfection, sterile gloves, sterile drape, and a sterile eyelid speculum (or
equivalent) and sterile paracentesis.

Routine povidone iodine 5% ophthalmic solution is indicated for cutaneous, peri-ocular and
conjunctival antisepsis prior to ocular surgery to support post- operative infection control (or
as local policy)
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Prescribing of pre- and post-injection topical antibiotics for the patient is required if
applicable (or as local policy)
Royal College of Ophthalmologists Guidelines available at http://www.rcophth.ac.uk/page.asp?section=451&sectionTitle=Clinical+Guidelines accessed 31/10/13

Guidelines for intravitreal injections procedure 2009

College statement on Intra-ocular injections by non-medical health care professionals April
2013
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Local anaesthesia for ocular surgery. Joint guidelines for the Royal college of Anaesthetists
and Royal College of Ophthalmologists 2012
INSTRUCTIONS FOR RECONSTITUTION (adult):
Some medicines are presented as dry powders and must be reconstituted before use. The volume
of diluent required for reconstitution and the recommended diluent to use is described.
DISPLACEMENT VALUE:
Where reconstitution is necessary and the dose of the medicine required is less than a complete
vial it may be necessary to calculate the displacement value of the medicine. This information is
given in the instructions for reconstitution.
INSTRUCTIONS FOR DILUTION AND SUITABLE DILUENT (adult):
Many medicines require further dilution before they can be given by ocular injection. This section
indicates if the medicine can be diluted before use in water for injections, glucose 5%, sodium
chloride 0.9%, balanced salt solution, Hartmann’s Solution for injection (the most common diluents
in ophthalmic practice).
Details of the volume of diluent to be used are given where this is important.
When preparing an ocular injection medicine for administration, do not mix vials/ampoules from
more than one manufacturer to make up the required dose.
EXPIRY TIME WHEN PREPARED IN A CLINICAL AREA:
Administration of a dose prepared in a clinical area should be started immediately (exceptions; see
NPSA Patient Safety Alert 20: Promoting safer use of injectable medicines. March 2007).
Information on the expiry time of an ocular injection prepared by a specialist manufacturer or
supplied by Pharmacy is as stated on the presentation.
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ADVERSE EFFECTS WHICH MAY BE CAUSED BY INJECTABLE ADMINISTRATION
AND SUGGESTED MONITORING:
This section includes details of adverse effects that may occur acutely, either during or very shortly
after, administration of a medicine by the ocular injection route and suggested appropriate
monitoring.
Use this information carefully as it is not intended to be an exhaustive list of all possible adverse
effects resulting from administration of the medicine, or all required monitoring.
Be aware that the monitoring suggested may not be possible in all clinical areas.
OCULAR LEAKAGE

:
Provides information that may be relevant to the misplacement of the ocular injection
Notes - The following have the potential to cause tissue injury if leakage from the site of the ocular
injection occurs: medicines that have an extreme pH (less than 5 and greater than 9)
 medicines with high osmolarity (greater than 600mOsmol/L)
 cytotoxic medicines
 vasoconstrictors e.g. adrenaline
 preparations which contain alcohol, polyethylene glycol and certain other injection
excipients.
The ‘National Extravasation Information Service’ provides information on factors which may result
in tissue damage if a medicine is accidentally extravasated and suggested treatment. This may be
relevant to ocular leakage. The Service can be accessed via the ‘documents and links’ page of the
website.
COMPATIBILITY INFORMATION USEFUL IN ROUTINE CLINICAL PRACTICE:
A medicine given by ocular injection or infusion should not be mixed with an additional medicine,
unless identified in the appropriate monographs .
This section
 Provides information that may be relevant when medicine injections or infusions meet in the
relevant compartment of the eye
 Only relates to medicines that may be used routinely in ophthalmic care areas and
available in the UK
The following summarises specific points to be considered when interpreting the
compatibility information provided:1) The information is provided as a guide only and is not exhaustive.
2) Medicine compatibility information is mainly based on physical compatibility i.e. there are no
visible sign of incompatibility. However, clinical efficacy is not implied as this may not have
been demonstrated.
3) When stated as compatible (or incompatible) in the Ocular injection section of the Injectable
Medicines Guide it is assumed that medicines meet close in the relevant compartment of the
eye) and not in an infusion bag, burette or syringe.
4) pH values have been included in the Injectable Medicines Guide. Medicines with widely
differing pH values are usually incompatible.
SPECIAL HANDLING PRECAUTIONS:
This section details any special handling precautions described in the manufacturer’s COSHH data
sheet (or SPC if relevant), and should be used in addition to aseptic procedures when preparing
and administering a medicine for ocular injection or infusion.
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OSMOLARITY/ OSMOLALITY:

Osmolarity (mOsmol/L) and osmolality (mOsmol/Kg) are similar. Osmolality is cited if the
only data available
It is recommended that solutions for intraocular use are isotonic.
If the osmolality of the product administered is lower than 200mOsmol/kg or greater than
400 mOsmol/kg, an appropriate entry will be included in the ‘Method of administration’
section and ‘Adverse effects ; Ocular leakage’ section of the monograph, indicating that the
final preparation has low or high osmolality.
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pH:
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It is recommended that solutions for intraocular use are isotonic and have a pH between
6.8 and 8.2. If the pH of the product administered is extreme (<6.0 and > 9.0), an
appropriate entry will be included in the method of administration section and ‘Adverse
effects ; Ocular leakage’ section of the monograph, indicating that the final preparation
has low or high pH
OTHER COMMENTS:
This section:
 Includes storage temperature range of the original product and/ or final diluted product for
ocular administration if relevant, and if should be protected from light during storage.
(If light protection is needed during administration, this information is included in the
‘Instructions for dilution’ section).
 Includes information if available on all excipients and concentrations in the original product
and/ or final diluted product for ocular administration
 Highlights any SPC changes or a significant NPSA/MHRA alert which has become
available since a monograph was last published.
PRODUCT RISK FACTORS:
This section describes the risk category that the injectable product has been allocated using the
NPSA risk assessment tool described in the NPSA Patient Safety Alert 20; Promoting safer use
of injectable medicines.
 This section is only accessible using a ‘pharmacy’ password.
 This section is intended to provide an example product risk assessment only and is not
intended to replace a locally performed product risk assessment.
OTHER INJECTABLE ROUTES OF ADMINISTRATION:
This section is only accessible using a pharmacy password. It includes ocular injection routes,
(both licensed and unlicensed) which have been used.
PHARMACY NOTES:
This section is only accessible using a ‘pharmacy’ password. It includes:
 Notes on identified inconsistencies e.g. information differs in BNF and SPC.
 Information, if available, on how long the reconstituted/ diluted preparation can be stored
before use
CURRENT SUPPLIERS:
This section includes electronic links to the following:Summary of Product Characteristics (SPC)
Patient Information Leaflets (PILs) if relevant
LATEX STATUS:
This section includes information, if available, on the latex status of the original product used to
prepare the ocular injection and/or the ocular injection presentation
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LINKS TO EXTERNAL RESOURCES:
The following electronic links are included. This information can only be accessed via the internet:British National Formulary (BNF)
BNF for children (BNFc)
Electronic medicines compendium (emc)
Other useful links, can be found on the ‘Documents and Links’ page of the website.
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