Importance of Ancillary Supplies
for Subcutaneous
Immunoglobulin Infusion:
Management of the Local
Infusion Site
Diane Ochoa,1* Christine Curtis,2 Carla Duff,3 Patty
Riley,4 Elyse Murphy,4 Annette Zampelli4
Allergy and Immunology, Dallas, TX; 2Cook Children’s Medical
Center−Infectious Disease Clinic, Fort Worth, TX; 3University of South
Florida, Tampa, FL; 4CSL Behring, LLC, King of Prussia, PA
1Dallas
The International Nursing Group for Immunodeficiencies
October 3-6, 2012, Florence, Italy
*Current affiliation is Maxim Healthcare, Dallas, TX
Disclosures and Acknowledgments
• DO, CC, and CD are nurse consultants for CSL
Behring. EM, PR, and AZ are employees of CSL
Behring.
• This presentation was supported by CSL
Behring, LLC.
• Medical writing and editorial support was
provided by Daniel McCallus, PhD, of Complete
Publication Solutions, LLC, and was funded by
CSL Behring, LLC.
Ancillary Supplies Use During SCIG
Administration
• Subcutaneous immunoglobulin
(SCIG)
– An effective treatment for patients with
primary immunodeficiency disease
(PIDD)
• Ancillary supplies for SCIG
therapy
– May contribute to the development of
issues at the local infusion site
– Adjustment may reduce the incidence
and severity of infusion related issues
SCIG administration
to the abdomen
Ancillary Supplies Used During SCIG
Administration
Ancillary supplies for SCIG therapy
– Disposable
• Needle sets
• Tubing
• Antiseptic preparation
• Post-infusion dressing
• Tape
– Non-disposable
• Roller/cassette pump
• Syringe driver pump
Common Disposable Ancillary Supply
Options for SCIG Administration
Item
Option(s)
SCIG administration sets
(tubing + needle)
Butterfly needles
Needle length (mm): 4, 6, 9, 12,
14
Needle gauge: 24, 25, 26, 27
Needle tip: lancet, tricuspid
Pump disposables
Skin preparation
Tape
Crono proprietary syringe
60 cc syringes;
Flow rate tubing: F120−F2400 for
Freedom 60® pump
Alcohol or antiseptic wipe
Paper tape or transparent
dressing
Contributions of Needle Properties to
Patient Tolerability
Needle Length
– Must adequately reach into the
subcutaneous tissue
– Improper length may cause:
• Leaking at infusion site1
• Discomfort or pain from
intradermal or intramuscular
infusion 2,3
Needle Diameter
– Smaller diameter needles are
associated with less pain and
leakage 4
Tissue Layers and Depth
http://juvenation.org/juvenation_forums/general/f/130/t/10017.aspx
1. Juul KAP, et al. Skin Res Technol. 2012. [Epub ahead of print]
2. Murphy E, et al. Infusion. 2007;13(4 suppl):1-8.
3. Schwartz S, et al. Clin Ther. 2004;26(10):1663-1678.
4. McKay M, et al. Diabetes Technol Ther. 2009;11(3):195-201.
Impact of Needle Properties on Patient
Tolerability
Puncture in Simulated
Tricuspid
Skin1
Needle Type
– Type of skin puncture may affect
the development of infusion
related issues
– Lancet needles result in more
coring, bleeding, and tissue
necrosis than tricuspid needles1
Lancet
1. Selafon A and Baker PM. Presented at National Home Infusion
Association Annual Conference, Phoenix, AZ, April 23-26, 2012.
Impact of Flawed Needles on Patient
Tolerability
Needles “Out of the Box” Damaged
During Manufacturing3
Needles may be made inconsistently1
– Tip damage may occur during
manufacturing or handling
Flawed/damaged/blunted needles
– May cause pain
– Result in inefficient or improper
delivery of product
200X
Needle tip damage (~ 10 microns)
– Associated with patients’ perception
of pain2
Patients or caregivers
– Should thoroughly inspect needles
1. Parker RK and White PF. Anesth Analg. 1997;85(5):1101-1104.
– Use only if undamaged
2. Kinast P. Med Device Technol. 1992;3(6):46-49.
3.
Selafon A and Baker PM. Presented at National Home Infusion
Association Annual Conference, Phoenix, AZ, April 23-26, 2012.
Contributions of Other Ancillary
Supplies to Patient Tolerability
• Tubing
– Size is a determinant of infusion rate, which may
influence tolerability
• Antiseptic preparation and post-infusion
dressing
– May affect skin sensitivity
• Tape
– May lead to local irritation at the site of
application
Case Studies Demonstrating the Effects of
Ancillary Supplies on Local Tolerability
Case Study 1
Patient
Description
•10-year-old
•18-kg female
Diagnosis
Common
variable
immunodeficiency
disease
Initial SCIG and
Technical/
Ancillary
Clinical
Supplies
Complaints
Lyophilized IVIG • Redness,
reconstituted to
swelling, and
16% given SC
leaking at
infusion sites
•3g
• 20 mL
• Resolved by
• 2 sites (inner
the evening of
thigh)
infusions
• 6-mm needle
• Weekly
Treatment
Adjustment(s)
Changed from a
6-mm to a 9-mm
needle
Outcome
• Decreased
swelling and
leaking from
sites
• Patient has
tolerated SCIG
infusions well
• Switched to
20% SCIG after
product available
Case Studies Demonstrating the Effects of
Ancillary Supplies on Local Tolerability
Case Study 2
Patient
Description
• 5-year-old
• 18-kg
Diagnosis
Hypogammaglobulinemia
Initial SCIG and
Technical/
Ancillary
Clinical
Supplies
Complaints
20% SCIG
• Tegaderm tape
not sticking to
•3g
skin
• 15 mL
• 2 sites (thigh)
• SCIG needle
• 26-gauge, 12displaced during
mm needle
infusion
• Weekly
• Use of thigh
sites limited
mobility of child
Treatment
Adjustment(s)
• Changed from
Tegaderm tape
to silk tape
attached in “x”
pattern over
needle
• Used tincture
of benzoin on
edges of silk
tape to secure
• Switched to
abdomen sites
Outcome
Improvement
and resolution of
all issues
reported
Case Studies Demonstrating the Effects of
Ancillary Supplies on Local Tolerability
Case Study 3
Patient
Description
•9-year-old
•27-kg male
•Naive to SCIG
treatment
Diagnosis
•X-linked
agammaglobulinemia
Initial SCIG and
Technical/
Ancillary
Clinical
Supplies
Complaints
20% SCIG
•Swelling
•5g
• 24 mL
• 3 sites
(abdomen)
• 6-mm needle
• F180-rate
tubing (4
mL/hr/site)
• Weekly
•Redness
•Severe
discomfort
•Leakage at site
Treatment
Adjustment(s)
• Reduced
infusion rate by
changing to
F120-rate tubing
(2.32 mL/hr/site)
• Reduced site
volume by
adding a fourth
site; leaking at
site still occurred
• Secondary
adjustment of a
6-mm to a 9-mm
needle
Outcome
Improvement
and resolution of
issues reported
Case Studies Demonstrating the Effects of
Ancillary Supplies on Local Tolerability
Case Study 4
Patient
Description
• 25-year-old
• 67-kg female
•Avid runner
Diagnosis
Common
variable
immunodeficiency
disease
Initial SCIG and
Technical/
Ancillary
Clinical
Treatment
Supplies
Complaints
Adjustment(s)
10% SCIG
• Severe burning • Changed from
a 6-mm to a 9• 10 g
• Edema
mm needle; no
• 100 mL
improvement
• 4 sites
• Pain lasting 2-3
• 27-gauge, 6days
• Changed to
mm needle
16% SCIG
• Biweekly
• Interfered with product once
running
available
Outcome
• Improvement
and resolution of
issues reported
• Able to run
same day as
infusion
• Switched to
20% SCIG after
product
available; well
tolerated
Treatment Algorithm for Patients With
Technical or Clinical Complaints During or
Following Initial SCIG Regimen
• Should be followed for patients who experience tolerability problems beyond
the mild, transient effects that may occur after SCIG
Conclusions
• Careful attention to technical or clinical complaints at the local infusion
site warrants reassessment of infusion regimen including supplies.
• Case studies demonstrate that adjustment of, or changes to, ancillary
supplies may decrease the occurrence and/or severity of infusion
related issues.
• Ancillary supplies should be adjusted before changing the SCIG
product.
• Alterations in the choice of ancillary supplies can:
o Improve the patient experience with SCIG administration
o Positively impact patient quality of life and medication adherence