- Email: [email protected]
Development of nursing guidelines for administration of enfuvirtide
Clinical Issues Column
Development of Nursing Guidelines for Administration of Enfuvirtide Toni Kempner RN, BSN, CCRC
E
nfuvirtide (Fuzeon, T-20) is the first entry, or fusion, inhibitor to be used in the treatment of HIV infection. Food and Drug Administration approval for general distribution in the United States was granted in March 2003, providing a new class of antiretroviral agent for HIV treatment-experienced patients (Celano, 2003; Lalezari, 2003). Enfuvirtide is prescribed as part of an antiretroviral therapy regimen and should not be used as monotherapy. Because of the complex protein structure of enfuvirtide, the drug must be injected subcutaneously in a twice-a-day regimen. The major complication is the development of injection-site reactions (ISRs), which occur in 98% of patients at some time during therapy (Roberts, 2003). As with all antiretroviral therapy, adherence is a primary concern; an adherence rate of 95% or better provides the best outcome. Enfuvirtide must be mixed before administration by the patient, requiring both visual and manual dexterity in the manipulation of syringes, sterile water, and enfuvirtide. Additionally, subcutaneous injection can be difficult for patients who often have lipoatrophy and little subcutaneous fat (New Mexico AIDS InfoNet, 2003). This combination of characteristics establishes the need for calculated, patient-centered, and comprehensive education programs for patients with enfuvirtide prescriptions. The manufacturers of enfuvirtide (Roche Laboratories, Nutley, NJ; Trimeris, Inc., Durham, NC) recognized that the key to success for enfuvirtide use would be extensive patient education, preferably by nurses, and provided an unrestricted educational grant to the Association of Nurses in AIDS Care (ANAC) to develop nursing guidelines in the use of
the drug. To that end, the ANAC Enfuvirtide Working Group and the ANAC Expert Panel on Enfuvirtide were convened. These groups, made up of nursing experts in the use of enfuvirtide, were charged with the tasks of developing nursing guidelines, publishing them in an easily accessible format, and distributing them to nurses who work with patients infected with HIV.
ANAC Enfuvirtide Working Group The task of the working group, which consisted of 13 nurses with extensive experience in enfuvirtide patient education, was to discuss and make recommendations for product optimization, office management, patient education, strategies to minimize ISRs, and product modification. All discussions were based on a review of available patient education materials, steps in the reconstitution and administration of enfuvirtide, and issues related to injection equipment, time requirements, and storage of supplies. Suggestions for product optimization included the ability to store the drug at room temperature, less frequent dosing through polyethylene glycol modification (PEGylation), packaging variations for ease of use, and strategies to simplify mixing and injecting the drug. Discussions about office management tactics included scheduling and timing of patient education visits, providing appropriate space, coordinatToni Kempner RN, BSN, CCRC, is HIV Research and Program Coordinator at Oregon Health & Sciences University in Portland.
JOURNAL OF THE ASSOCIATION OF NURSES IN AIDS CARE, Vol. 16, No. 2, January/February 2005, 49-51 doi:10.1016/j.jana.2004.11.006 Copyright © 2005 Association of Nurses in AIDS Care
50
JANAC Vol. 16, No. 2, January/February 2005
ing logistics of the initial injection, training personnel, and using educational materials. Nursing education issues included assessing patient readiness, preventing and caring for ISRs, using nursing guidelines and patient education activities for reconstitution and administration of subcutaneous injections, documentation considerations, and providing ongoing patient education. Product optimization recommendations included furnishing syringes prefilled with the required volume of the sterile water diluent, decreasing problems in safety syringe usage, marketing patient education, and developing new patient educational materials including photos of ISRs. The key outcome of the working group was to acknowledge the complexity of enfuvirtide administration and the subsequent need for thorough, consistent, and ongoing patient education. The working group recommended the use of regional nurse experts to teach about enfuvirtide and the related patient education and nursing documentation requirements. Future activities recommended by the working group included developing nursing guidelines for patient education, publishing a collection of helpful strategies, and identifying key components to be discussed in education programs for nurses.
ANAC Expert Panel on Enfuvirtide The ANAC Expert Panel on Enfuvirtide met 3 months after the working group with the goal of creating an education tool to guide nurses in the process of helping patients use enfuvirtide successfully. The six-person panel included nurses from around the United States with extensive enfuvirtide experience. The Expert Panel developed a framework of four nursing steps in the successful use of enfuvirtide: Step 1: Assess and educate for decision-making/ informed consent. Step 2: Prepare for the first enfuvirtide injection. Step 3: Educate about enfuvirtide administration. Step 4: Provide follow-up. The program provides a solid base of knowledge for the patient and goes beyond initial education to an
ongoing program, lending itself to an assisted empowerment for the patient to make the most of an antiretroviral regimen that includes enfuvirtide. The expert panel used these steps to create a pocket guide (Stepwise Progression to Successful Enfuvirtide Treatment), which was made available at the ANAC conference in November 2003. The pocket guide will be supported with a handbook (currently in development) to further discuss points made in the pocket guide.
Conclusion A formal nursing foundation for patient education is critical to the initiation and maintenance of patients on enfuvirtide antiretroviral therapy. Nurses who work in HIV care will now have the opportunity to use an expert guide for patient education that covers assessment of readiness, reconstitution of the drug, subcutaneous administration, and ISR prevention and care. More importantly, it will help patients maintain the consistent and effective use of a new class of antiretroviral agent.
Acknowledgment The ANAC Enfuvirtide Working Group Regina Anthony, BSN, RN Philadelphia, PA Madeline Bronaugh, RN, MSN, ACRN Cincinnati, OH James Bruce, RN, MSN, ACRN Oak Park, IL Cynthia Geist, ACRN, BS Santa Fe, NM Amy Liebmann, LPN, CRC Miami, FL Meaghan Morton, RN St. Louis Park, MN Beverly Putnam, RN, APN Denver, CO Kerry Upton, RN Birmingham, AL Dominick Varsalone, RN, ACRN Newark, NJ Laurie Wojtusik, RN, MSN, ACRN Florence, MA
Kempner / Nursing Guidelines Enfuvirtide
ANAC Expert Panel on Enfuvirtide Karlissa Foy, RN, BSN Boston, MA LuAnn Gahagan, RN, CCRC Norfolk, VA Toni Kempner RN, BSN, CCRC Portland, OR Lyn Stevens, MS, ACRN, NP Camillus, NY Lucy Bradley-Springer, PhD, RN, ACRN Denver, CO
51
References Celano, S.A. (2003). FDA approves enfuvirtide (Fuzeon, ENF, T-20), the first HIV fusion inhibitor. Hopkins HIV Report. Retrieved from www.hopkins-aids.edu/publications/report/ may03_1.html Roberts, J.R. (2003, Apr 8). What should I know about enfuvirtide (T-20) injection site reactions? Medscape Nurses, 5(1). Lalezari, J.P. (2003). Enfuvirtide, an HIV-1 fusion inhibitor for drug resistant HIV infection in North and South America. New England Journal of Medicine, 348(22), 2175. New Mexico AIDS Infonet. (2003, Mar 25). Enfuvirtide (Fact Sheet # 461). Retrieved from www.aidsinfonet.org
Development of Nursing Guidelines for Administration of Enfuvirtide Toni Kempner RN, BSN, CCRC
E
nfuvirtide (Fuzeon, T-20) is the first entry, or fusion, inhibitor to be used in the treatment of HIV infection. Food and Drug Administration approval for general distribution in the United States was granted in March 2003, providing a new class of antiretroviral agent for HIV treatment-experienced patients (Celano, 2003; Lalezari, 2003). Enfuvirtide is prescribed as part of an antiretroviral therapy regimen and should not be used as monotherapy. Because of the complex protein structure of enfuvirtide, the drug must be injected subcutaneously in a twice-a-day regimen. The major complication is the development of injection-site reactions (ISRs), which occur in 98% of patients at some time during therapy (Roberts, 2003). As with all antiretroviral therapy, adherence is a primary concern; an adherence rate of 95% or better provides the best outcome. Enfuvirtide must be mixed before administration by the patient, requiring both visual and manual dexterity in the manipulation of syringes, sterile water, and enfuvirtide. Additionally, subcutaneous injection can be difficult for patients who often have lipoatrophy and little subcutaneous fat (New Mexico AIDS InfoNet, 2003). This combination of characteristics establishes the need for calculated, patient-centered, and comprehensive education programs for patients with enfuvirtide prescriptions. The manufacturers of enfuvirtide (Roche Laboratories, Nutley, NJ; Trimeris, Inc., Durham, NC) recognized that the key to success for enfuvirtide use would be extensive patient education, preferably by nurses, and provided an unrestricted educational grant to the Association of Nurses in AIDS Care (ANAC) to develop nursing guidelines in the use of
the drug. To that end, the ANAC Enfuvirtide Working Group and the ANAC Expert Panel on Enfuvirtide were convened. These groups, made up of nursing experts in the use of enfuvirtide, were charged with the tasks of developing nursing guidelines, publishing them in an easily accessible format, and distributing them to nurses who work with patients infected with HIV.
ANAC Enfuvirtide Working Group The task of the working group, which consisted of 13 nurses with extensive experience in enfuvirtide patient education, was to discuss and make recommendations for product optimization, office management, patient education, strategies to minimize ISRs, and product modification. All discussions were based on a review of available patient education materials, steps in the reconstitution and administration of enfuvirtide, and issues related to injection equipment, time requirements, and storage of supplies. Suggestions for product optimization included the ability to store the drug at room temperature, less frequent dosing through polyethylene glycol modification (PEGylation), packaging variations for ease of use, and strategies to simplify mixing and injecting the drug. Discussions about office management tactics included scheduling and timing of patient education visits, providing appropriate space, coordinatToni Kempner RN, BSN, CCRC, is HIV Research and Program Coordinator at Oregon Health & Sciences University in Portland.
JOURNAL OF THE ASSOCIATION OF NURSES IN AIDS CARE, Vol. 16, No. 2, January/February 2005, 49-51 doi:10.1016/j.jana.2004.11.006 Copyright © 2005 Association of Nurses in AIDS Care
50
JANAC Vol. 16, No. 2, January/February 2005
ing logistics of the initial injection, training personnel, and using educational materials. Nursing education issues included assessing patient readiness, preventing and caring for ISRs, using nursing guidelines and patient education activities for reconstitution and administration of subcutaneous injections, documentation considerations, and providing ongoing patient education. Product optimization recommendations included furnishing syringes prefilled with the required volume of the sterile water diluent, decreasing problems in safety syringe usage, marketing patient education, and developing new patient educational materials including photos of ISRs. The key outcome of the working group was to acknowledge the complexity of enfuvirtide administration and the subsequent need for thorough, consistent, and ongoing patient education. The working group recommended the use of regional nurse experts to teach about enfuvirtide and the related patient education and nursing documentation requirements. Future activities recommended by the working group included developing nursing guidelines for patient education, publishing a collection of helpful strategies, and identifying key components to be discussed in education programs for nurses.
ANAC Expert Panel on Enfuvirtide The ANAC Expert Panel on Enfuvirtide met 3 months after the working group with the goal of creating an education tool to guide nurses in the process of helping patients use enfuvirtide successfully. The six-person panel included nurses from around the United States with extensive enfuvirtide experience. The Expert Panel developed a framework of four nursing steps in the successful use of enfuvirtide: Step 1: Assess and educate for decision-making/ informed consent. Step 2: Prepare for the first enfuvirtide injection. Step 3: Educate about enfuvirtide administration. Step 4: Provide follow-up. The program provides a solid base of knowledge for the patient and goes beyond initial education to an
ongoing program, lending itself to an assisted empowerment for the patient to make the most of an antiretroviral regimen that includes enfuvirtide. The expert panel used these steps to create a pocket guide (Stepwise Progression to Successful Enfuvirtide Treatment), which was made available at the ANAC conference in November 2003. The pocket guide will be supported with a handbook (currently in development) to further discuss points made in the pocket guide.
Conclusion A formal nursing foundation for patient education is critical to the initiation and maintenance of patients on enfuvirtide antiretroviral therapy. Nurses who work in HIV care will now have the opportunity to use an expert guide for patient education that covers assessment of readiness, reconstitution of the drug, subcutaneous administration, and ISR prevention and care. More importantly, it will help patients maintain the consistent and effective use of a new class of antiretroviral agent.
Acknowledgment The ANAC Enfuvirtide Working Group Regina Anthony, BSN, RN Philadelphia, PA Madeline Bronaugh, RN, MSN, ACRN Cincinnati, OH James Bruce, RN, MSN, ACRN Oak Park, IL Cynthia Geist, ACRN, BS Santa Fe, NM Amy Liebmann, LPN, CRC Miami, FL Meaghan Morton, RN St. Louis Park, MN Beverly Putnam, RN, APN Denver, CO Kerry Upton, RN Birmingham, AL Dominick Varsalone, RN, ACRN Newark, NJ Laurie Wojtusik, RN, MSN, ACRN Florence, MA
Kempner / Nursing Guidelines Enfuvirtide
ANAC Expert Panel on Enfuvirtide Karlissa Foy, RN, BSN Boston, MA LuAnn Gahagan, RN, CCRC Norfolk, VA Toni Kempner RN, BSN, CCRC Portland, OR Lyn Stevens, MS, ACRN, NP Camillus, NY Lucy Bradley-Springer, PhD, RN, ACRN Denver, CO
51
References Celano, S.A. (2003). FDA approves enfuvirtide (Fuzeon, ENF, T-20), the first HIV fusion inhibitor. Hopkins HIV Report. Retrieved from www.hopkins-aids.edu/publications/report/ may03_1.html Roberts, J.R. (2003, Apr 8). What should I know about enfuvirtide (T-20) injection site reactions? Medscape Nurses, 5(1). Lalezari, J.P. (2003). Enfuvirtide, an HIV-1 fusion inhibitor for drug resistant HIV infection in North and South America. New England Journal of Medicine, 348(22), 2175. New Mexico AIDS Infonet. (2003, Mar 25). Enfuvirtide (Fact Sheet # 461). Retrieved from www.aidsinfonet.org