Page 6 • DNA Reporter May, June, July 2018 ‘Right to Try’ Laws – An Ethical Dilemma for Nursing Donna Casey, DNP, MA, RN, NE-BC, FABC Donna Casey DNP, MA, RN, NE-BC, FABC is a nurse executive and chair of the American Nurses Association Ethics and Human Rights Advisory Board. She can be reached at docasey@ verizon.net. Donna Casey Terminally ill and dying patients and families are more technologically savvy than previous generations using internet resources to research treatment options (WebMD, 2018). New treatments are rapidly evolving. The process for investigational treatments to become Food and Drug Administration (FDA) approved and available to the public is long (FDA, 2018). Desperate patients who have failed other treatments may be looking to slow the progression of their disease and delay death (Lowes, 2017). Do patients have a right to try investigational treatments as a last-ditch effort, and what are the ethical implications of administering potentially harmful medications? There are multiple pathways for terminally ill patients to obtain investigational medications. The intent of these pathways is to enable dying patients to receive investigational treatments outside of clinical trials and prior to FDA approval (Zettler & Greely, 2014). Right to Try legislation and compassionate use are the common routes. Right to Try legislation empowers patients to bypass the FDA and go directly to drug manufacturers and currently it exists in 36 states. Compassionate use regulations were established by the FDA to provide dying patients with faster access to investigational treatments (Zettler & Greely, 2014). The FDA usually approves requests for unapproved treatments for patients with serious or terminal condition when other treatments have failed or do not exist. Compassionate use regulation enables physicians to request the FDA to approve use of investigational treatments for dying patients. The physician obtains informed consent for compassionate use (Zettler & Greely, 2014). Right to Try laws and compassionate use regulations enable patients to obtain treatments that have completed phase 1 clinical trials. Phase 1 clinical trials evaluate safety, but not efficacy. The main purpose of phase 1 clinical trials is to determine the highest dose that can be safely given without causing serious side effects. Phase II clinical trials determine if the investigational treatment is effective (American Cancer Society, 2017). In phase II and III clinical trials – some patients receive the standard therapy plus the experimental treatment while the control group receives standard therapy plus a placebo. Patients and providers are unaware who receives the active agent versus placebo to assure integrity of the research (Leuty, 2017). Patients using the Right to Try or compassionate use loopholes, subvert the clinical trials process assuring access to the active agent. Drug developers and manufacturers are reluctant to provide access to the investigational treatments. Concerns include negative publicity and impact on future FDA approval from treatment failures and patient harm, impact on supply of investigational agents for clinical trials, diluted clinical trials or confused efficacy studies and decreased availability of appropriate patients to participate in clinical trials (Zettler & Greely, 2014). Fear of negative publicity on social media has been a strong motivator for manufacturers to provide investigational treatment access despite concerns (Zettler & Greely, 2014). The FDA has stringent approval processes developed to protect the public from treatments that cause more harm than benefit. While manufacturers have the ultimate authority to permit or deny access to experimental treatments for dying patients, negative publicity from social media may impact those decisions. Approximately 90% of medications that enter phase 1 safety trials never make it to market because they don’t work or have side effects that outweigh benefit (Leuty, 2017). Cost of medications is another concern for right to try legislation. There is no price limit for investigational treatments under Right to Try legislation. Insurance companies rarely cover investigational treatments (Lowes, 2017). Compassionate use FDA regulations limit what manufacturers can charge. Patients who participate in clinical trials do not pay for investigational treatments or associated testing. This presents a justice concern for patients who cannot afford access to investigational treatments under right to try legislation. Ethically, the challenge is to balance the patients need for hope and potential for benefit with the obligation to not cause harm. Multiple provisions in the American Nurses Association Code of Ethics (ANA, 2015) inform this issue. Provision 1 states that “The nurse practices with compassion and respect for the inherent dignity worth and unique attributes of every person.” Establishing a trusting relationship, considering patients’ needs and respecting their religious, spiritual, and cultural values and right to self-determination would seem to require nurses to advocate for and assist patients to obtain investigational treatments if the request is consistent with their values and the patient and family are fully informed. Provision 2 states that “The nurses’ primary commitment is to the patient…” This would also indicate the nurse would be required to advocate for access to investigational treatments above concerns for the clinical trials process. This is somewhat conflicting as Provision 2 also identifies the patient as a population and community. There is a risk to the population of patients in need of safe and effective treatments when the clinical trials process is subverted for individual, unapproved use. Provision 3: “The nurse promotes, advocates for and protects the rights, health and safety of the patient” addresses the importance of informed consent for participation in research. This would seemingly apply for access to investigational treatments outside the research process as well. Special concern for vulnerable patients is also addressed in provision 3 (ANA, 2015). Terminally ill, desperate patients would be considered vulnerable, raising the bar for assuring fully informed consent to receive investigational treatments. Zettler and Greely (2017) proposed IRB oversight as another layer of protection for informed consent processes. Protection for health and safety addressed in provision 3 seems to indicate that investigational treatments should not be provided. Scientifically complex treatments should be proven through the rigorous clinical trials and FDA approval process (Zettler & Greely, 2014). Provision 4 states “The nurse has authority, accountability and responsibility for nursing practice; makes decisions; and takes action consistent with the obligation to promote health and to provide optimal care.” Nurses bearing primary responsibility for the nursing care provided to patients, their judgments, decisions, and actions require reflection on the provision of unapproved investigational treatments because the harm that can result are unknown. Creating false hope for terminally ill patients and families can be harmful when it prevents preparation for the dying process. Nurses are highly likely to encounter a patient dying from a condition where research and investigational treatments are being developed. Desperate patients and families are more likely to investigate options more so today, than in years past. Nurses need to be prepared to engage in discussions that support patient self-determination with information and an ethical foundation. The ANA Code of Ethics provides the ethical framework to support nurses in these discussions and deliberations in balancing ethical obligations to support self-determination and autonomy while also maintaining patient safety. References American Cancer Society. (2017, February). Clinical Trials: What you need to know. Retrieved from American Cancer Society: https://www.cancer.org/ treatment/treatments-and-side-effects/clinical-trials/what-you-need-toknow/phases-of-clinical-trials.html ANA. (2015). Nursing World. Retrieved from Code of Ethics: http://nursingworld. org/DocumentVault/Ethics-1/Code-of-Ethics-for-Nurses.html FDA. (2018, January). FDA Drug Development and Approval Process. Retrieved from FDA. Gov: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugInnovation/ucm537040.htm Leuty, R. (2017, June 8). The right to try: Terminally ill patients say trying experimental drugs offers hope. But is it just false hope? San Francisco Business Times, NA. Retrieved from https://www.bizjournals.com/ sanfrancisco/news/2017/06/08/biotech-2017-right-to-try-laws-biomarin-fdaca.html Lowes, R. (2017, August). Senate passes right to try bill. Retrieved from Medscape: https://www.medscape.com/viewarticle/883776 Tsakopoulis, A., Han, J., Nodler, H., & Russo, V. (2015). Student Note: The right to try; An overview of efforts to obtain expedited access to unapproved treatments for the terminally ill. Food Drug Law Journal, 70 (4). 617 - 641. WebMD. (2018). WebMD. Retrieved from About WebMD: https://www.webmd. com/about-webmd-policies/default.htm Zettler, P., & Greely, H. (2014). The strange allure of state “Right to Try” laws. JAMA, 174(12). 1885 - 1886.
May, June, July 2018 DNA Reporter • Page 7 DE Board of Nursing Update on Legal Issues Pamela C. Zickafoose, EdD, MSN, RN, NE-BC, CNE, FRE David Mangler, MS, RN Dr. Zickafoose earned her BSN, MSN, and EdD degrees from the University of Delaware. Her MSN is in Nursing Leadership and her doctorate is in Educational Leadership with a Policy and Administration concentration. She is currently certified in Nursing Administration by the American Nurses Credentialing Center and is a Certified Nurse Educator by the National League for Nursing. With over 30 years nursing experience in Delaware, she has been employed in various nursing positions. Currently, Dr. Zickafoose is the Nursing Instructional Director at the Delaware Technical Community College Owens Campus in Georgetown, DE. Prior to this she served as Executive Director of the Delaware Board of Nursing for almost five years. Her clinical expertise is in critical care. For over 25 years she has worked in nursing Pamela C. Zickafoose education, teaching in a hospital staff development department as well as in baccalaureate and associate degree programs preparing students for both RN and LPN licensure. In 2016 she completed a fellowship program sponsored by the NCSBN and she is the only nurse in DE nationally recognized as a Fellow of Regulatory Excellence. Dr. Zickafoose has published articles in peer reviewed journals as well as nursing education textbooks. She can be reached at email@example.com or by phone at (302)259-6620. David Mangler is the Director of the Division of Professional Regulation, a Division under the Delaware Secretary of State. He has held this position since January of 2014. David holds a Bachelor of Science degree in Nursing from The University of Iowa and a Master of Science degree in Administrative Studies from the University of Illinois at Chicago. David served on active duty in the U. S. Navy for 25 years. Assignments included positions on the staffs of the Navy Surgeon General and the Navy Medical Inspector General as well as progressive leadership positions throughout his military career. He also has over 20 years of quality improvement and regulatory compliance experience and has served on regulatory Boards in the State of Delaware David C. Mangler both as a public and a professional member. David was the Executive Director of the Delaware Board of Nursing before joining Geisinger Health System in 2011. Just prior to returning the Division of Professional Regulation he was the Director of Geisinger Health System’s ProvenCare® Program and Clinical Improvement Strategies. leave “nursing” out of this at this legislation, as what is being proposed is not related to nursing delegation. Furthermore, language already exists to allow self-directed activities by competent individuals. The second bill would allow “residences” as an exception to the practice of nursing under subsection 1932 Limited Lay Administration of Medications (LLAM). The DBON was not in support of this bill as written because LLAM is not a delegated activity and all entities who use LLAM have nursing supervision for reporting and monitoring. After listening to various stakeholders at Legislative Hall, the major concern is for persons who are not mentally competent, who live in their homes, to have someone administer medications while family members, significant others, or caregivers are at work. The discussion centered on the differences between home care agencies, who would have nursing supervision available and other alternatives for care in the home. Senator Walsh mentioned a medication aide certification course as one means to train certified nursing assistants to perform medication administration in private residences. The DBON only regulates licensed nurses, not certified nursing assistants. However, the National Council of State Boards of Nursing has a course for medication aide certification. This was considered in the past when the Board initiated changes in LLAM. However, the pilot was never actualized under DHSS. Recently, Bayada in New Jersey implemented a medication administration pilot that was very successful. However, they also noted it was labor intensive and expensive to have a registered nurse train each nursing assistant on individual clients in their homes. The outcome of the stakeholders meeting in January was there was more work to be done. Sheila Grant from AARP is leading the efforts to improve care for patients with dementia in their homes. The primary legal and related health issue affecting the DBON continues to be the substance use disorder (SUD) epidemic. Each month the board discusses and imposes discipline on individuals who have this disease. In 2015, DBON rules required 3 hours of continuing education (CE) in substance abuse. The 2017 audit of RN licensees revealed a few nurses had not completed this requirement. The Board followed the disciplinary process for nurses who did not meet the CE and/or practice hour requirement who attested on renewal they did. In the future, the Board may impose monetary fines for audit failure. The Delaware Professionals Health Monitoring Program (DPHMP) is available to assist nurses and other health care professionals with a SUD. In addition, the NCSBN offers free CE hours for nurses and nurse managers at https://www. ncsbn.org/5127.htm. For further information contact the Delaware Board of Nursing at www.dpr.delaware.gov or call 302-744-4500. References National Council of State Boards of Nursing. (2018). Enhanced nurse licensure compact (eNLC) implementation. Retrieved from: https://www.ncsbn.org/enhanced-nlcimplementation.htm The Delaware Board of Nursing (DBON) is among 29 states who enacted the enhanced nurse licensure compact (eNLC) legislation. This is an improvement to the current NLC that DE has been a member of since 2000. The primary purpose of the new eNLC is patient safety through implementation of uniform licensure requirements. The eNLC requires both state and federal criminal background checks, and it does not allow nurses with a felony criminal conviction or a misdemeanor related to the practice of nursing to hold a multistate license. It also requires new applicants to have a Social Security Number. With uniform licensure requirements added to the eNLC, more states have the ability to join the eNLC. A multistate license allows nurses to work in multiple states without acquiring a license in every state, and it allows for portability of nurses to enhance patient care, especially for telehealth. The eNLC became effective on January 19, 2018, and several other states have introduced legislation. The 29 states who have enacted eNLC legislation are: Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Idaho, Iowa, Kentucky, Maine, Maryland, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin and Wyoming. Rhode Island is the only state from the old compact who has not enacted the eNLC at this time. Illinois, Indiana, Kansas, Massachusetts, Michigan, New Jersey, Rhode Island, and Vermont have pending legislation (NCSBN, 2018). For Delaware licensed nurses, there were no major changes, and those who hold a multistate license will maintain that license. In former NLC compact states nurses were grandfathered to hold the multistate license and to renew it in the state where issued. If a nurse moves to another compact state, the nurse will need to obtain a multistate license in the new primary state of residence using the new eNLC uniform licensure requirements. The Division of Professional Regulation was prepared and ready for the change by the January deadline. There was a rules and regulations hearing in January to update Advanced Practice Registered Nurse (APRN) language throughout the rules. In addition, the requirement for the “maiden name” on DE nursing licenses was eliminated. The DBON Advanced Practice and Practice and Education committees are reviewing model rules pertaining to APRN distance education requirements and faculty credentials for adjuncts teaching in a practical nursing program. If changes are recommended there will be another hearing later this year. Members of the DBON and other interested stakeholders attended a meeting at Legislative Hall regarding an AARP initiative called “Share the Care Act.” The two proposed bills would change the nursing statute. One bill would allow delegation of medication administration to a certified nursing assistant in the home. Although the DBON members understand the need for keeping individuals in their homes as long as possible and being able to care for them at home, the DBON opposed this legislation at the stakeholder meeting, with the understanding this is not a nursing delegated activity. It would be best to
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