Download Administration of a subcutaneous injection ofOmalizumab _Xolair

Title:
Administration of a subcutaneous injection of
Omalizumab (Xolair)
Authors Name:
Helen Pyne
Contact Name: Helen Pyne
Contact Phone No:
Michelle Thomson
Respiratory Secretary 63169
Departments/Groups This Document Applies to:
Respiratory Medicine
Scope: Respiratory Directorate
Classification: Guidelines
Keywords: Subcutaneous injection, subcut
Replaces: New
injection, injection, Xolair injection,
Omalizumab injection
To be read in conjunction with the following documents:
ANTT and hand washing policy
Unique Identifier:
TC20(10)
Issue Status: Approved
Review Date: April 2014
Issue No: 1
Authorised by:
Respiratory Clinical Governance
Issue Date: Oct 2010
Authorisation Date: 23rd September 2010
Document for Public Display: YES
After this document is withdrawn from use it must be kept in an archive for10 years.
Archive: Respiratory Medicine
Date added to Archive:
Officer responsible for archive:
Policy Statement
These guidelines are for use when a patient requires subcutaneous injection
for administration of prescribed Anti IgE therapy.
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1. Roles and Responsibilities:
All members of staff are responsible for ensuring their practice complies with
the guidelines
All members of staff are responsible for keeping up to date with current
research and best practice and disseminating this information to colleagues
where appropriate
It is the responsibility of the prescriber to ensure that subcutaneous
medication to be administered is prescribed in line with the Trust medicine
policy.
Nursing staff should follow the guidelines once adequately trained and
assessed as competent in subcutaneous administration of medications. This
can be achieved through education and training that can be carried out in
practice.
Introduction
The patient will receive the prescribed medication safely and correctly by a
qualified nurse in accordance with the Trust Medicine Policy.
The guidelines do includes safe storage, reconstitution and patient
preparation for the drug as outlined in the drug therapy guidelines for highly
atopic asthma patients.
Hands must be washed prior to commencing the procedure to prevent
contamination and cross infection. Hand washing is the single most important
means of reducing hospital-acquired infection.
Equipment required
1. Antiseptic wipes e.g. Chloraprep
2. Sharps bin
3. Clean tray (ANTT)
4. Sani-cloth
5. Luer Lock syringe and needles to prepare medication
6. Needle to administer medication
7. Prescription/administration chart
8. Water for injection
9. Medication vials as prescribed
10. EPR/Medical notes (check for drug allergies/sensitivities)
11. Patient’s own electric razor or scissors
(for hair removal if necessary)
12. Swirler
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Procedure
Rationale
Explain to the patient
• The action of the medication
• The potential side effects of the medication
• The procedure for subcutaneous injection
of this therapy and monitoring required
To ensure the patient is fully aware of all
the important facts about this therapy and
delivery mode to ensure they are able to
make an informed decision
Provide the opportunity for the patient to
clarify any of the issues discussed and
answer all their questions. If unable to
answer any of their questions please discuss
with the asthma team and relay the
information to the patient or ask them to
discuss with the patient if concerns are
portrayed by the patient
To facilitate effective communication and
address any issues or concerns raised by
the patient
Obtain the patient’s consent (verbal) and
clearly document in the medical notes either
on EPR or paper notes if computer not readily
available
To facilitate effective communication and
demonstrate an adequate reference point
for the future management of the patient
Collect all the necessary equipment in
advance
To prevent any delay in treatment
administration
Weigh the patient
To ensure the drug calculation is accurate
at the time of administration
Ensure the patient has a wrist band on that
clearly states their full name, date of birth and
any known drug allergies
To reduce the risk of drug allergy
Calculate the number of vials for the
prescribed dose, this is determined by the
weight of the patient and the total IgE levels
To ensure accurate administration of the
drug therapy
Double check the prescription is correctly
completed with the patient’s full name, date of
birth, hospital number, weight, full name of the
drug, dose, route and any drug allergies
listed.
To reduce the risk of error
It would also be prudent because of the risk of
anaphylaxis if a one off dose of antihistamine,
adrenaline and oral prednisolone were
prescribed to be used if required
To facilitate prompt action if an
anaphylactic reaction occurred as a result
of administration of this drug
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Check the dose is correctly calculated and
medication is in date with no discolouration,
crystallisation or clouding of the liquid.
To reduce the risk of drug administration
error or local reaction to the therapy
Check all packaging is intact and in date
before opening and preparing the equipment
on a clinically clean tray
To prevent contamination or cross
infection
Double check with another member of staff
that the prescription and the amount drawn up
into the syringe is correct prior to
administration
To reduce the risk of drug error
Check the patients name and date of birth
along with their hospital number with the
patient verbally and the wrist band
To reduce the risk of drug error
Wash hands before administration of the drug
therapy
In line with the trust hand washing and
ANTT policies
Injection Sites for Subcutaneous injection
Select the site considering the patients
preference and care needs. Take care to
avoid broken, oedematous, irradiated,
red/sore skin and bony prominences:-
To facilitate effective treatment delivery
Front
Back
Ensure the site has no evidence of bruising,
tenderness,
hard
or
swollen
areas,
inflammation, or scarring, which could hinder
absorption and cause discomfort and injury.
These areas can vary dependant upon the
individual’s body habitus. Multiple injection
sites reduce local reaction and the potential
formation of lipodystorphies in the skin.
•
•
•
•
•
The outer aspect of the upper arm.
The abdomen, just below the costal
margins to the iliac crests. Avoid the area
right around the navel (a 2-inch circle).
The ventrodorsal gluteal area of the
buttocks, just behind the hip bone.
The anterior aspect of the thighs, midway
to the outer side, 4 inches below the top of
the thigh to 4 inches above the knee.
Scapular area as an alternative if patient
has a skin rash, red/swollen sites from
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•
previous administration.
Shave/clip excess hair from the selected
site only where necessary
•
Using ANTT technique clean skin with
ChloraPrep and allow full drying time.
(1.5ml applicator).
•
Insert the needle inverted (bevel up) at an
angle of 30-45 degrees into the
subcutaneous tissue at the selected site.
Early detection of infection or reaction at
the injection site
Reduce risk of infection
Ask the patient to report any discomfort,
swelling, moisture or redness around the
access entry site immediately.
Early detection of side effects to facilitate
appropriate prompt action
Advise the patient to report any increase in
their symptoms or new symptoms
immediately. Adverse reactions to therapies
or side effects must be dealt with promptly
and at an appropriate level of response to the
severity of the reaction
Early detection of side effects to facilitate
appropriate prompt action
Record peak expiratory flow level (best of
three attempts) on chart pre administration of
the drug, and each time the baseline
observations are checked
Early detection of side effects to facilitate
appropriate prompt action
To facilitate accurate and timely
Record basic early warning score
observations as a baseline and for monitoring communication
during observation period on MIU. Report any
deterioration in the patients condition as
outlined in the EWS guidance
Ask the patient to complete a selfadministered asthma symptom questionnaire.
Asthma Control test (ACT)
To facilitate accurate assessment of
response to the treatment
Complete Omalizumab assessment of
treatment chart and file in the patients paper
notes
To facilitate accurate assessment of
response to the treatment
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Reconstitution
• The lyophilised product takes 15-20 minutes to dissolve, although in some cases it may
take longer.
• Each Xolair vial delivers 150mg per 1.2ml, upon reconstitution with 1.4ml water for
injections.
• For a 75mg dose, draw up 0.6ml into the syringe and discard the remaining product.
Step 1
Draw 1.4ml water for injections from the ampoule into a syringe with a
large bore 18 gauge needle.
Step 2
Place the Xolair vial upright on a flat surface. Using standard aseptic
none touch technique (ANTT), insert the needle and transfer the water
for injections into the vial containing the lyophilised powder, directing the
water straight onto the powder.
Step 3
Keeping the vial upright, vigorously swirl but do not shake it for
approximately 1 minute to wet the powder evenly.
Step 4
Place foam insert into the Swirler platform, by firmly pushing the foam
into the holder. The machine has been preset to 450rpm. Place desired
number of vials in the foam holder. Switch unit to “ON” position. Swirl
the vials for a minimum of 15-20 minutes. When the product is fully
dissolved, there should be no visible gel-like particles in the solution.
Small bubbles or foam around the edge of the vial are common. The
reconstituted product will appear clear or slightly opaque. Do not use if
solid particles are present.
All the drug batch numbers used are to be recorded on the prescription/administration chart.
Stability after reconstitution
Xolair 150mg powder in solution is for injection by subcutaneous route only. The product
should be used immediately after reconstitution. If not used immediately, it may be stored for
up to 8 hours at 2 -8°C and for 4 hours at 30°C.
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Administration
Step 1
Invert the vial for at least 15 seconds to allow the solution to drain
towards the stopper. Using a new syringe with a large bore, 18-gauge
needle, insert the needle into the inverted vial.
Step 2
Keep the vial inverted and position the needle tip at the very bottom of
the solution and draw into the syringe slowly. Before removing the
needle from the vial, pull the plunger all the way back to the end of the
syringe barrel to remove all the solution from the inverted vial.
Step 3
Because of the viscosity of the reconstituted product, care must be taken
to withdraw all of the solution before expelling any air or excess solution
from the syringe to obtain the full 1.2ml.
Step 4
Replace the 18 gauge needle with a French fine bore 25 gauge needle
for subcutaneous injection. Expel air, large bubbles and any excess
solution to obtain the required 1.2ml dose. A thin layer of small bubbles
may remain at the top of the solution in the syringe.
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Patient monitoring following administration
•
Observe the patient for potential adverse effects. First and second dose require the
patient to be observed for 2-4 hours.
•
Subsequent doses require the patient to remain in the department or ward for at least 1
hour post injection during the 16 week trial period and 30 minutes thereafter.
•
The potential of Anaphylaxis must be discussed with all patients. Consider providing
appropriate patients with 2 EpiPens® and a course of antihistamines. Provide clear
verbal and written instruction on what to do should anaphylaxis occur.
•
At each visit the patients overall asthma control and response to omalizumab will be
assessed in line with the Xolair Outcomes-Based Reimbursement (OBR) Programme.
•
A formal 16 week assessment of the response to treatment with omalizumab will be
carried out.
•
If the patient’s response is assessed as good or excellent, they should be invited to
continue with the treatment long term.
•
If the patient’s response is assessed as worse, no response, or poor they will not be
invited to continue the therapy and it will be discontinued immediately. Replacement
stock of omalizumab vials will then be requested from Novartis, under the Xolair OBR
Programme.
Acknowledgement
These guidelines have been adapted from guidelines developed at Leeds Teaching Hospital
for the prescribing and administration of Omalizumab anti IgE therapy
Endorsed by:
Name of Lead
Clinician/Manager or
Committee Chair
Position of Endorser
or Name of Endorsing
Committee
Date
Dr Peter Turkington
Consultant Respiratory
Physician and Clinical
Director for respiratory
medicine
23rd September 2010
Dr Michelle Needham
Consultant Respiratory
Physician and lead for
clinical governance in
respiratory medicine
21st September 2010
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Diversity & Equality Screening Questionnaire
The Trust is legally required to ensure that all new policies and documents are assessed
for their impact both positive & negative on equality target groups ;
religion/beliefs, disability, age, gender, religion & sexual orientation & transgender.
When undertaking this assessment you must consider the impact this policy could have
on the equality groups listed above.
If you wish to discuss any aspect of this assessment process please contact the Equality
Advisor, HR dept.
Have you been trained to carryout this assessment:? YES
If 'yes' continue with the assessment, if 'no' arrange to have the training first.
Name of policy, document or leaflet; subcutaneous injection of anti IgE therapy
1
Whom is this document or policy aimed at? Nursing Staff administering
subcutaneous injections
2
Is this document a specific user group? If yes, why ?
To guide nursing staff for administration of subcutaneous injection in the
management of their patients
How will you ensure that this policy is cascaded to the target group?
The guidance will be posted on the Trust website for access by all staff members.
The staff on MIU will be trained in the preparation of this therapy and monitoring
required post administration
3
Is there any evidence to suggest that different groups have different needs in
relation to this policy or document (positive or negative)?
No
4
If you a revising a policy are any the changes to this policy likely to impact on
any groups?
5
Have you undertaken any consultation/involvement with service users or other
groups in relation to the new policy ?
No
If yes, what format did this take? face/face or questionnaire?
Were service users who may require additional support (e.g. visually impaired)
involved ?
No
Have any amendments been implemented as a result of this exercise?
6
Are you aware if a request has been made for the policy to provided in
alternative formats?
No
If yes, how/was this achieved?
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7
Could any individual/group be affected differently by the application of
the document?
The explanation of the procedure to patients may be affected if the patient is
hearing or sight impaired or has learning difficulties or does not speak the English
language. The nursing staff will address this issue with means set in place by the
trust for example interpreter, safeguarding adults team.
8
Does the document require any decision to be made which could result
in some individuals receiving different treatment or care to other individuals?
No
On what basis would this decision be made?
The medical staff or healthcare professional taking responsibility for the
management of the patient will decide on the most appropriate treatment for the patient
Could this impact on any particular group?
No
9
Are you aware of any complaints from service users in relation to the application
of this policy ?
No
If yes, how was the issue resolved?
10
Looking at the above points does this indicate that any of the groups listed below
have different needs, experiences or priorities groups in relation to the document ?
Yes
Age
Disability
Gender
Marital Status
Racial group
Religious belief
Sexual orientation
Transgender
Low Income
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a
a(learning disability)
a
No
Don’t know
a
a
a
a
a
a
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Record of Changes to Document - Issue number: 3
Changes approved in this document by - Corporate Governance and Risk Management
Section Amendment (shown in bold Deletion
Addition
Number italics)
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Date: Sept 2009
Reason