m. elizabeth m. younger crnp, ph.d the johns hopkins university baltimore, maryland development of...
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M. ELIZABETH M. YOUNGER CRNP, PH.DTHE JOHNS HOPKINS UNIVERSITY
BALTIMORE, MARYLAND
Development of National Guidelines for Immunoglobulin
Therapy
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Disclosures
CSL Behring: Consultant and Research Support
RMS: Clinical Advisory Panel Immune Deficiency Foundation: Chair, Nurse
Advisory Committee
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Immunoglobulin Replacement Therapy
The Standard of Care for treatment of those immunodeficiencies
characterized by hypogammaglobulinemia and impaired antibody responses to antigenic
stimuli
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Immunodeficiencies requiring Ig replacement
Primary Immunodeficiencies: Common variable immunodeficiency Agammaglobulinemia (X-linked or autosomal
recessive) Severe combined immunodeficiency (pre-transplant
and post transplant until humoral immune reconstitution occurs)
Hyper IgM deficiencySecondary immunodeficiencies
Agammaglobulinemia secondary to monoclonal antibody therapy (e.g. rituximab)
Hypogammaglobulinemia secondary to CLL
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Goal of Therapy
To deliver therapy safely and effectively
To achieve this goal: therapy should be facilitated by professionals who have been educated regarding the
rationale for therapy and its administration
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Considerations
Site of care Home Hospital Infusion Suite Medical Office
Mode of Administration Intravenous
Peripheral Line Central Venous Line
Subcutaneous Pump Push
Facilitated subcutaneous
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More Considerations
Administered by Physician Nurse Practitioner Registered Nurse Vocational Nurse Patient Other trained lay person
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And Still More
Intravenous Infusions Frequency: every 2-4 weeks Product (excipients, stabilizers) Product Concentration (5, 6, 10%) Rate of Infusion Pre-medications (?) Patient risk factors/co-morbidities
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Still More…
Subcutaneous Infusions Frequency: Daily to every 4 weeks Product Concentration (10, 16 or 20%) Number of Sites (1 to ……) Time of Infusion (rapid push to hours) Premedication?
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Process
Guidelines were developed to achieve the goal for therapy while taking into account all the
considerations
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Process
Literature reviewExplore regional variationsEvidence based practiceDraft guidelinesCirculate guidelinesCome together to reach consensus
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Beth Younger, Kris Epland, Amy Meyer, Maggie Dodds, Carla Duff, Deb Sedlak, William Blouin, Jeanette Scott, Loris Aro