Paper for Ethics & Legal issues of nursing

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Paper for Ethics & Legal issues of nursing
Week Three Paper will address the following (1-4):   1. Read the Case Presentation on page 63 (in 4th Edition)  of Burkhardt & Nathaniel. This is in Chapter 3 Part 1, the section titled Noncompliance vs Autonomy a.What does Autonomy mean to you? b. Comment on the statement: It is easy to honor a patient’s autonomy when they agree with us. c. Was Cora’s autonomy being infringed? d. What provisions of the ANA Code of Ethics and Interpretative Statements offers the nurse guidance in this case? 2   .Read the Case Presentation on page 72 (in 4th Edition)  of Burkhardt & Nathaniel. This is in Chapter 3, Part 1, the case presentation entitled “Beneficence and Nonmaleficence”. a.  Describe in your own words, Beneficence and Nonmaleficence. b.   Answer all the questions presented in the Think About It section following the case presentation.   3. Read the Case Presentation of Burkhardt & Nathaniel  on page 179 in (4th Edition) on moral distress, moral outrage and moral reckoning.  Read the case study of Joanna which is the last case study in Chapter 7  entitled “Trying to be Heard”. a.  Does the ANA Code of Ethics, Provision Three offer any guidance for the nurse? Why or why not? b. Were the nurse’s actions sufficient in this situation? c. Read the article titled, “Pathways to Moral Courage” and apply the “CODE” analysis to this case to determine if a different outcome was possible. Article link: Pathways to Moral Courage, found at:  Pathways_to_Moral_Courage.pdf 4. After reading the article links relating to Placebos that follow, please address: a.       Compare the two articles and argue for or against the use of placebos, including discussion of applicable ethical principles, e.g. autonomy, beneficence, etc. b.      Specify what provisions of the ANA Code of Ethics offer guidance on the use of placebos in health care Article links: Read the American Society for Pain Management Nursing’s Position Statement on Use of Placebos in Pain Management, found at: UseofPlacebosinPainManagement.pdf Read “US Doctors Use Placebo Treatments but Don’t Always Inform Patients” found at: http://www.medicalnewstoday.com/articles/126791.php (Links to an external site.) Links to an external site. 5. Discuss Informed Consent after reading Burkhardt & Nathaniel’s pages 139-143, and 300-301 (4th ed., 2014) a.   Describe in your own words what constitutes informed consent. b.   What are the possible legal ramifications for failing to obtain informed consent?     Week 3 paper Rubric Criteria Ratings Pts This criterion is linked to a Learning Outcome Case presentation- student adequately addresses questions a through d in relation to case study of Cora. 2.0 pts This criterion is linked to a Learning Outcome Case presentation- student adequately addresses both questions in case study of beneficience and non-maleficence. 0.5 pts This criterion is linked to a Learning Outcome Case presentation-student adequately addresses questions a through c in case study of Joanna and applies CODE analysis. 3.0 pts This criterion is linked to a Learning Outcome Placebos- student adequately discusses topic of placebos, applying ANA Code of Ethics. 2.0 pts This criterion is linked to a Learning Outcome Consent- student adequately discusses informed consent questions a&b, citing text readings. 2.0 pts This criterion is linked to a Learning Outcome Professional Writing: A. Correct grammar, spelling , and professional terms B. Correct APA formatting for papers 0.5 pts Total Points: 10.0
Paper for Ethics & Legal issues of nursing
From the *Massachusetts General Hospital, Boston, MA; †New York University School of Medicine, New York, NY; ‡Columbia University Medical Center, New York, NY; §Seton Medical Center, Austin, TX. Address correspondence to Paul Arnstein, PhD, RN, FAAN, Clinical Nurse Specialist for Pain Relief, Massachusetts General Hospital GRB-1034, 55 Fruit Street, Boston, MA 02114. E-mail: [email protected] partners.org Received September 14, 2010; Revised July 1, 2011; Accepted September 14, 2011. 1524-9042/$36.00 2011 by the American Society for Pain Management Nursing doi: 10.1016/j.pmn.2010.10.033 Use of Placebos in Pain Management — Paul Arnstein, PhD, RN, FAAN, * Kathleen Broglio, ANP-BC, ACHPN, CPE, † Elsa Wuhrman, MS, FNP, BC, ‡ and Mary Beth Kean, DNP, ACNS-BC § – ABSTRACT : The American Society for Pain Management Nursing (ASPMN) holds the position that a placebo should not be used by any method to assess and/or manage an individual’s pain regardless of their age or diag- nosis. The only justi able use of placebos is for participants enrolled in a blinded clinical trial. These clinical trials must be Institutional Review Board (or equivalent) approved with participants clearly in- formed that they may receive a placebo before they consent to par- ticipate and actually have the sham treatment administered. 2011 by the American Society for Pain Management Nursing BACKGROUND AND HISTORY Pain is a complex multidimensional phenomenon with physical, emotional, so- cial, and spiritual aspects ( Arnstein, 2010). It is universal in prevalence but a uniquely subjective experience. Health professionals and family members are consistently unable to precisely determine the intensity of a patient’s pain. For these reasons, assessments of pain should be based, when possible, on the pa- tient’s self-report. Behavioral and observational indices are reserved for use in nonverbal or noncommunicative patients who are unable to convey their per- ception of pain ( Herr, Coyne, Key, Manworren, McCaffery, Merkel, et al., 2006 ). One of the ways that pain is erroneously assessed and improperly treated is by administering placebos outside the context of an Institutional Review Board (IRB)–approved clinical trial. Placebos administered in this manner are often in- tended to discredit the patient’s report of pain or discomfort and cast doubt on its validity. In these cases, it is actually the professional’s deception that de es the precept of truth-telling. Position statements and clinical guidelines calling for a stop to using place- bos as a method to assess and manage pain have been published and widely dis- seminated for greater than 20 years. The federal Agency for Health Care Policy and Research (1992) , theOncology Nursing Society, (1996) , theAmerican Society of Pain Management Nurses (1998) , theAmerican Pain Society (1999) , and other reputable medical, nursing, and interdisciplinary organizations consis- tently denounce the practice of placebos outside the context of clinical trials. F € assler, Meissner, Schneider, & Linde, (2010) recently revealed an astounding pervasiveness, with the vast majority of doctors, nurses and even some care- givers treating pain and other health problems with placebos. Even more Pain Management Nursing, Vol 12, No 4 (December), 2011: pp 225-229 Position Statement alarming is that some medical students are being taught that prescribing and administering placebos is clinically appropriate (Sherman & Hickner, 2008 ). DEFINITIONS Aplacebo is any sham medication or procedure de- signed to be void of any known therapeutic value. Placebos often take the form of sugar pills, saline in- jections, or minuscule doses of drugs expected to have no bene cial effect based on their physical or chemical properties ( Hrobjartsson & Gotzsche, 2001 ). The placebo effect is the positive response some patients/participants experience after receiving a pla- cebo. When present, this response has a perceptible and measurable bene cial effect that may be subjective (e.g., pain reduction) or objective (e.g., improved blood pressure). These effects are believed to be re- lated to intrinsic factors (e.g., personal expectations or learned responses) and/or extrinsic (e.g., provider, environment, technology, and contextual) factors ( McCaffery & Arnstein, 2006 ). The nocebo effect is the negative response some patients/participants experience after receiving a pla- cebo. These effects range from minor discomforts (e.g., headache, nausea) to life-threatening complica- tions (e.g., cardiac arrest) ( Barsky, Saintfort, Rogers, & Borus, 2002 ). An IRB-approved clinical trial is a research study that protects human subjects from having their rights violated. Most countries, including the United States, have laws requiring an IRB (or similar decision- making authority) to approve all research before it is conducted. These boards are composed of a diverse group of at least ve specially trained members who are quali ed to safeguard the welfare of human sub- jects ( National Institutes of Health, 2005 ). The IRB may be within the researcher’s institution, or part of an external group that monitors research activities and has the authority to permit, prohibit, and stop any investigation at any time. Informed consent is the voluntary process by which a fully informed individual (or a surrogate deci- sion maker) participates in making choices about health care. Casarett, Karlawish, Sankar, Hirschman, & Asch (2001) delineated the IRB elements of informed consent as research study participants who: 1) are told of the study’s design, potential bene ts, and risks or burdens; 2) fully understand the information provided, including alternatives; and 3) agree to participate in the study voluntarily without coercion. The participant retains the right to refuse to participate or withdraw participation at any time without adversely affecting the quality of care provided. This requirement includes ‘‘n-of-1’’ trials ( McCaffery & Arnstein, 2006 ). ELABORATED POSITION STATEMENT In response to concerns raised by nurses in clinical practice, the American Society for Pain Management Nursing (ASPMN) convened a group of professionals to examine the literature, re ect on the realities of clin- ical practice, and create a document to support the nurse who is ordered to administer a placebo. The morally distraught nurse who brought the issue for- ward was put in a position of deciding between violat- ing her own commitment to providing the best possible treatment, and the possibility of being repri- manded or red for not carrying out a medical order. She is not alone, because more than one-half of nurses sampled from 22 research studies have been asked to administer a placebo at some point during their career (Fassler et al. 2010 ). The use of ineffective treatments violates the Pain Management Nursing Scope and Standards of Practice ( ASPMN & ANA, 2005 ) which calls for all nurses to promote the high quality of pain relief through collab- oration, facilitation of access to quality care, and inter- vention by using methods known to control pain. Nurses in this workgroup report rsthand knowledge that concealed placebos are sometimes used diagnosti- cally to determine who will and will not get access to interventions known to relieve pain. Therefore, it is the ASPMN position that a placebo should not be used by any method to assess and/or manage an indi- vidual’s pain regardless of age or diagnosis. The only justi able use of placebos is for participants enrolled in an IRB (or equivalent)–approved study. Those partic- ipants will have been clearly informed before they con- sent to participate in the study, and before actually having the sham treatment administered, that they may receive a placebo. Legal and Ethical Considerations Regulatory bodies consistently af rm that patients have basic rights when seeking health care. These in- clude the right to receive appropriate pain assessment and treatment. The evaluation and treatment of pain must be commensurate with the nature of pain and the resources available in the setting. In places where required pain treatments are not available, patients can be referred to other settings where pain control needs can be met ( The Joint Commission, 2010 ). Professional nursing standards uphold the pa- tient’s right to receive respectful care regardless of race, gender, age, or other medically/nonmedically rel- evant factors. As part of their duty, nurses must protect 226 Arnstein et al. patients from incompetent or unethical practices (American Nurses Association, 2001 ). The use of place- bos to assess and manage pain represents a failure to demonstrate the skilled use of available methods de- scribed in standards and guidelines regarding pain ( Agency for Health Care Policy and Research, 1992 ; American Nurses Association, 2001 ;American Pain Society, 2008; ASPMN & ANA, 2005; Joint Commission, 2010 ). Ethical arguments could be made for using place- bos, but they are hard to defend. The most common ethical argument examines the con ict between benef- icence (bene ting the patient by relieving pain) and nonmale cence (avoiding the potential harm of treat- ment). This is often referred to as the principle of the ‘‘double effect.’’ This same principle could be used to argue against placebo use, because: 1. Deceptive placebo administration is morally wrong. 2. An innocuous sham (placebo) treatment is not the saf- est and most effective available treatment. 3. Tenuous bene ts do not outweigh foreseeable harm, including nocebo effects, uncontrolled pain, and the loss of trust which is the foundation of therapeutic relationships. The deceptive use of placebos is morally wrong. It violates the ethical principles of honesty (veracity), trustworthiness ( delity), and fairness (justice) ( Grace, 2006 ). The nurse may experience moral dis- tress when these values are violated by a prescriber who orders a placebo to be administered, or asks the nurse to assist with a sham procedure while telling the patient it will relieve pain. This concealed use of placebos violates the nurses’ duty to respect the auton- omy and dignity of patients and protect their right to self-determination ( American Nurses Association, 2001 ). Nurses are uniquely situated to coordinate and initiate crucial conversations to address the con- ict of values when ethical dilemmas exist. Getting in- volved parties together to engage in meaningful dialogue, though dif cult, often has a positive long- term impact. The concealed use of placebos carries the risk of liability for fraud, malpractice, breach of contract, and the violation of informed consent requirements. As health care consumers become more sophisticated, they reject the notion that pain should be endured and are less reluctant than earlier generations to use the civil court system when their rights to pain manage- ment are violated ( Vaglienti & Grinberg, 2004 ). Although there have been cases brought against physi- cians for improper placebo use, medical boards have acknowledged poor judgment but declined to take ac- tion against doctors. Nurses, on the other hand, have been held legally accountable when they administered placebos. Multimillion-dollar damages have been awarded in claims of nursing negligence; and disciplinary actions resulting in the loss of nurses’ license to practice have resulted from the deceptive use of placebos ( Rich, 2003; Tucker & Pasero, 2001 ). These cases illustrate that ‘‘following doctors’ orders’’ does not absolve nurses from their professional duties. In essence, the nurse who administers a placebo deceptively is more directly involved in harming the patient than the doctor who wrote the order. Recommendations for Practice Nursing Practice. Nurses are often faced with con- icting expectations from patients, families, other health care team members, and employers ( American Nurses Association, 2001 ). Nurses may nd it dif cult to act in a way that is consistent with their values and knowledge. Nurses may experience moral distress when they are expected to act in a manner inconsis- tent with personal and professional values. Even when the nurse knows the correct course of action, he or she may feel reluctant to take that action, owing to a perceived lack of authority in the organization’s hi- erarchy. The resultant moral distress can lead to emo- tional suffering, burnout, and loss of nurses from the workforce ( Corley, Elswick, Gorman, & Clor, 2001 ). Actively addressing the unethical use of placebo analgesia in clinical practice advocates for the patient and preserves the professional integrity of the nurse, nursing colleagues, and other health care team mem- bers ( Grace, 2006 ). Nurses faced with the use of place- bos outside of the context of an IRB study should consider taking the following steps: Identify the clinical, ethical and moral issues in the case: 1. Clinical facts regarding pain and its effect on the patient. 2. Placebo use is not the best choice among therapeutic alternatives. 3. Placebo use violates the duty to alleviate pain. 4. How placebo use con icts with the values of honesty and providing respectful care aligned with best prac- tices and the patient’s wishes. Identify the resources that can support your position: 1. Trusted colleagues, supervisors, clinical specialists, etc. 2. Patient advocates and Ethics Committee members in your setting. 3. Policy, mission, and patient rights statements in your setting. 4. Relevant position papers, clinical and ethical literature. 227 Use of Placebos in Pain Management Assertively communicate concerns to the pre- scriber and your supervisor: 1. Focus on patient’s need for effective pain relief. 2. Discuss potential harm to patient, professional integ- rity, and institution. 3. Offer reasonable clinically appropriate alternatives. Refuse to administer placebos in the absence of in- formed consent as part of an IRB-approved research study. Prescriber Practice. ASPMN urges prescribers to not prescribe placebos outside the context of an IRB- approved clinical trial. Doing so undermines the trust needed to develop and maintain a therapeutic relation- ship with the patient. Prescribing treatments that are not believed to be effective not only reinforces un- healthy notions that drugs or medical interventions are the only way to treat discomforts, but it also wastes valuable health care resources and exposes the patient to potentially harmful nocebo effects. Institutional Recommendations. Establish policies to ensure that no patient will receive a placebo unless it is in the context of an IRB -approved clinical trial. For example, the policy could state: It is the policy of [name of organization] to prohibit the administra- tion of placebos unless it is done within the context of an IRB -approved clinical trial. The policy should include at least the following elements: 1. Mechanisms of reporting policy violations by a pre- scriber or clinician, including noti cation of the appro- priate supervisor/managers. 2. Delineate the appropriate venue(s) where violations of the policy will be discussed (e.g., Ethics Committee, Risk Management, Quality Assurance, Utilization Man- agement, Credentialing Departments, HR Performance Evaluations, etc.). 3. De ne actions taken to censure those who prescribe and/or administer placebos, including penalties for re- peated violations. 4. Delineate the rationale for withholding placebos based on current literature, position papers, policies, and co- des of professional behavior, regulations, and evidence- based clinical practice guidelines. 5. Protect the rights of professionals who refuse to permit the administration of placebos. 6. Protect the anonymity of those who report the use of placebos outside the context of an IRB- approved clini- cal trial. 7. Educate members of the IRB about the need for more transparency in the informed consent procedures to ensure that patients understand what a placebo is and whether they will possibly, probably, or certainly receive a placebo. This is necessary to protect pain pa- tients from the physical and mental harm of unre- lieved pain or nocebo effects. To establish these policies and procedures, involve key stakeholders such as: 1. Pharmacy and Therapeutics Committee. 2. Ethics Committee. 3. Risk Management/Legal Department. 4. Quality Assurance and Utilization Management profes- sionals. 5. Credentialing Departments. 6. Clinical Practice Committees (or equivalent commit- tees addressing the clinical practice of nurses, pharma- cists and physicians). SUMMARY Placebo use for the clinical assessment and/or treat- ment of pain represents substandard care and consti- tutes fraud or deceptive practices. The ASPMN adamantly opposes the use of placebos outside the con- text of an IRB-approved clinical trial. Professionals are urged to refuse to administer placebos. Institutions are advised to establish policies that prohibit their use outside of a blinded IRB-approved clinical trial in which informed consent is obtained and that support the health care professional who upholds these policies. REFERENCESAgency for Health Care Policy and Research (1992). Acute pain management: Operative or medical procedures and trauma (AHCPR pub. no. 92-0032; clinical practice guide- line no. 1) . Rockville, MD: Department of Health and Human Services. American Nurses Association (2001). Code of ethics for nurses with interpretive statements . Washington, DC: ANA. Retrieved March 31, 2010, from. http:// nursingworld.org/ethics/code/protected_nwcoe813. htm#1.5 . American Pain Society (1999). Principles of analgesic use in the treatment of acute pain and cancer pain , (4th ed.) Glenview, IL: APS. American Pain Society (2008). Principles of analgesic use in the treatment of acute pain and cancer pain , (6th ed.) Glenview, IL: APS. American Society of Pain Management Nurses (1998). ASPMN position statement use of placebos for pain management. Ostomy Wound Management, 44 (2), 56–57. American Society for Pain Management Nursing (ASPMN) & American Nurses Association (ANA) (2005). Pain man- agement nursing: Scope and standards of practice . Silver Spring, MD: Nursingbooks.org. Arnstein, P. (2010). Clinical coach for effective pain management . Philadelphia, PA: FA Davis. 228 Arnstein et al. Barsky, A. J., Saintfort, R., Rogers, M. P., & Borus, J. F. (2002). Nonspeci c medication side effects and the nocebo phenomenon. Journal of the American Medical Associa- tion, 287 (5), 622–627. Casarett, D., Karlawish, J., Sankar, P., Hirschman, K. B., & Asch, D. A. (2001). Obtaining informed consent for clinical pain research: Patients’ concerns and information needs. Pain, 92 , 71–79. Corley, M. C., Elswick, R. K., Gorman, M., & Clor, T. (2001). Development and evaluation of a moral dis- tress scale. Journal of Advanced Nursing, 33 (2), 250– 256. F€ assler, M., Meissner, K., Schneider, A., & Linde, K. (2010). Frequency and circumstances of placebo use in clinical practice—A systematic review of empirical studies. BMC Medicine, 8 , 15. Grace, P. J. (2006). The clinical use of placebos. American Journal of Nursing, 106 (2), 58–61. Herr, K., Coyne, P. J., Key, T., Manworren, R., McCaffery, M., Merkel, S., Pelosi-Kelly, J., & Wild, L. (2006). Pain assessment in the nonverbal patient: Position statement with clinical practice recommendations. Pain Management Nursing, 7 , 44–52. Hrobjartsson, A., & Gotzsche, P. (2001). Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. New England Journal of Medicine, 344 (21), 1594–1602. McCaffery, M., & Arnstein, P. M. (2006). The debate over placebos in pain management. American Journal of Nurs- ing, 106 (2), 62–66. National Insitutes of Health (2005). Regulations and ethi- cal guidelinesRetrieved April 7, 2010, from. http://ohsr.od. nih.gov/guidelines/45cfr46.html . Oncology Nursing Society (1996). Use of placebos for pain management in patients with cancer . Pitts- burgh, PA: ONS. Rich, B. A. (2003). A placebo for the pain: A medico-legal case analysis. Pain Medicine, 4 (4), 366–372. Sherman, R., & Hickner, J. (2008). Academic physicians use placebos in clinical practice and believe in the mind-body connection. Journal of General Internal Medicine, 23 (1), 7–10. Tucker, K. L., & Pasero, C. (2001). Deceptive placebo ad- ministration. American Journal of Nursing, 101 (8), 55–56. Vaglienti, C. S., & Grinberg, M. (2004). Emerging liability for the undertreatment of pain. Journal of Nursing Law, 9,7–18. The Joint Commission (2010). Comprehensive accredi- tation manual: The e-edition (standard PC.01.02.07). Oakbrook Terrace, IL. Retrieved July 29, 2010, from http:// e-edition.jcrinc.com. 229 Use of Placebos in Pain Management

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