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*Current affiliation is Maxim Healthcare, Dallas, TX

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 Zampelli 4

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*Current affiliation is Maxim Healthcare, Dallas, TX

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  1. 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,4Elyse Murphy,4Annette Zampelli4 1Dallas 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 The International Nursing Group for ImmunodeficienciesOctober 3-6, 2012, Florence, Italy *Current affiliation is Maxim Healthcare, Dallas, TX

  2. 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.

  3. 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

  4. 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

  5. Common Disposable Ancillary Supply Options for SCIG Administration

  6. 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.

  7. Impact of Needle Properties on Patient Tolerability 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 Puncture in Simulated Skin1 Tricuspid Lancet 1. Selafon A and Baker PM. Presented at National Home Infusion Association Annual Conference, Phoenix, AZ, April 23-26, 2012.

  8. Impact of Flawed Needles on Patient Tolerability 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 Needle tip damage (~ 10 microns) • Associated with patients’ perception of pain2 Patients or caregivers • Should thoroughly inspect needles • Use only if undamaged Needles “Out of the Box” Damaged During Manufacturing3 200X • Parker RK and White PF. AnesthAnalg. 1997;85(5):1101-1104. • 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.

  9. 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

  10. Case Studies Demonstrating the Effects of Ancillary Supplies on Local TolerabilityCase Study 1

  11. Case Studies Demonstrating the Effects of Ancillary Supplies on Local TolerabilityCase Study 2

  12. Case Studies Demonstrating the Effects of Ancillary Supplies on Local TolerabilityCase Study 3

  13. Case Studies Demonstrating the Effects of Ancillary Supplies on Local TolerabilityCase Study 4

  14. 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

  15. 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: • Improve the patient experience with SCIG administration • Positively impact patient quality of life and medication adherence

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