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Ethical Dilemmas in Gerontology
Veronika Valdova • January 19, 2020
Ethical Dilemmas in Gerontology
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
In geriatric care, nurses and other healthcare workers, including support staff, witness the decline of terminally ill patients regularly. Patients who are gradually approaching the end of their lives express a wide variety of attitudes, wishes, and preferences regarding their care. Considerable differences exist in the level and quality of support from family and friends, overall fitness and resilience, personal values and philosophical beliefs, and religious and spiritual affiliations.
Every geriatric nurse can expect to face patients whose ability and willingness to continue their journey has ended. The circumstances and motivations may vary, depending on personal and cultural background and life experiences as well as a set of beliefs and attitudes of family members the patient would have to depend on. However, the desire to leave peacefully is innate to all humans, regardless of accent, complexion, or cuisine. Confining thoughts of suicide in a nurse is a logical step for a patient. Nurses are usually the closest and most familiar people geriatric patients have at this point in their lives. For nurses, however, such knowledge can represent significant distress due to professional obligations, personal beliefs, and religious affiliation.
In an institution dedicated to geriatric care, it is reasonable to expect that a nurse would not have to handle such requests alone. Short of disclosing the identity of the patient in his or her care, a nurse can request assistance from the institution’s dedicated functions, typically through her supervisor or manager. Procedures for how to handle decision-making in end-of-life care and conditions necessary for its cessation, as well as relevant disclosures, have to be in place to protect the institution from liability due to malpractice, medical error, or negligence. Appropriate training on existing procedures provided to staff shall define roles and responsibilities as applicable in specific situations, and prevent improvisation and human error.
Where end-of-life decisions are concerned, the considerations include the mental competency of the individual to make decisions regarding his or her care previously expressed wishes recorded in Medical Power of Attorney and locally applicable laws in regards to assisted suicide.
According to Euthanasia Research & Guidance Organization (ERGO), an organization dedicated to providing resources and educational materials on assisted suicide and euthanasia, only Canada, Colombia, six U.S. states, and five European countries currently allow some form of assisted suicide. The site is instrumental in clarifying some of the terminologies and explaining the distinction between assisted suicide and physician-assisted suicide, voluntary and non-voluntary euthanasia, and terminal sedation. According to the site, terminal sedation means the use of medications to induce deep sleep, during which the patient dies of the underlying illness, dehydration, or starvation. Terminal sedation is widely practiced and is generally accepted as ethical and lawful (“Assisted Suicide”, n.d.).
Switzerland is often cited as a country with the most liberal euthanasia laws in the world. According to Article 115 of the Penal Code of Switzerland, “Whoever, from selfish motives, induces another to commit suicide or assist him therein shall be punished, if the suicide was successful or attempted, by confinement in a penitentiary for not more than five years or by imprisonment.” Organization Patient Rights Council argues that assisted suicide is not legal, only unpunishable unless a selfish motive is proven. (“Patients Rights Council”, n.d.).
The situation in Switzerland is explained in detail by Andorno (2013). While active euthanasia (killing on request) is illegal, the administration of medication to relieve the severe pain of a terminal patient is accepted as morally and legally justified. The law does not provide for punishment for the withdrawal or withholding of life-sustaining treatments. The peculiarity of Swiss laws is in the fact that no terminal medical condition is required and in the limited role of physicians. Unlike in the Netherlands and Belgium, in Switzerland, the physician can only prescribe the lethal drug and assess the patient’s mental capacity (Andorno, 2013).
Schwarzenegger and Summers (2005) explain in detail the legal difference between Intentional killing (Article 111), Murder (Article 112), Manslaughter (Article 113), Killing on request (Article 114), Inciting and assisting someone to commit suicide (Article 115) and Negligent killing (Article 117). Legal problems related to assisted suicide include a question of whether or not a person has the legal capacity to request such assistance. It matters whether it was the victim or the person who assists who performed the act of self-termination and details and circumstances of prescription of deadly barbiturates to eliminate pain. Assistance provided by Swiss organizations such as EXIT or Dignitas is considered lawful because of the absence of selfish motive, should it be pecuniary profit, publicity, or inheritance (Schwarzenegger & Summers, 2005).
Similar rules apply in the State of Oregon in the U.S. The Death with Dignity Act, enacted in October 1997. The act allows the residents of Oregon to self-administer a lethal dose of medications, prescribed for that purpose by a physician, providing they are terminally ill and that such deed is voluntary (“Oregon Health Authority”). Experience with this law shows that most of the 204 patients who received prescriptions under the Death With Dignity Act opted for this kind of end were 65 years of age or older, and nearly 80% of them had cancer. (Oregon Health Authority, 2017).
The mental capacity of elderly patients to decide is a problem that nurses face daily. The cognitive ability of elderly patients can deteriorate gradually over time and is not necessarily consistent during the day. For example, patients who are not legally incapacitated can experience periods of confusion. On the other hand, patients who are no longer considered competent to make their own decisions can still have a good understanding of their condition and options at some time of day. Whether or not a patient has the capacity to request assistance with suicide is a question that needs to be answered by a physician.
In general, the situation is much easier if there is a Medical Power of Attorney available that details the patient’s desires and preferences in a way that is clear and unambiguous. The document may empower a specific individual to decide about the withdrawal or withholding of life-saving treatment, and allow the administration of pain relief that may lead to the patient’s death. Medical Power of Attorney also makes it clear who is entrusted with the person’s medical care and end-of-life decisions. In instances, when family relationships are less than straightforward, powers granted to a trusted friend are the only way to ensure the protection of the patient’s rights and interests. Relevant examples include family disputes over inheritance, unfinished separation or divorce proceedings due to family honor concerns, or unaddressed paternity issues.
Financial toxicity of many end-of-life treatments and especially innovative cancer therapies introduces additional ethical dilemmas. Patients’ ability to sustain their end-of-life care often comes at the expense of other family members. Pressures to maintain the family quality of life and sustainable finances, including preservation of inheritance that may be passed on to survivors, may be one motivation to refuse prolonged and aggressive treatments, especially if these therapies are invasive, expensive, and likely futile.
A survey of more than 10.000 patients conducted by the Center for Disease Cancer care found that financial problems caused by cancer were the strongest predictor of quality of life (“Cost of Cancer Care”). Besides, innovative cancer care does not always bring the expected benefits. For example, gemtuzumab ozogamicin (Mylotarg) was a drug approved in 2000 for the treatment of Acute Myeloid Leukemia. Mylotarg was eventually withdrawn from the U.S. market in 2010 because of no clinical benefit to patients (“GEN”).
In December 2012, Amgen Inc. pleaded guilty to the federal charge in Brooklyn, N.Y., and paid $762 Million to resolve criminal liability and False Claims Act allegations arising from the sale and off-label promotion of its product Aranesp. Aranesp is a drug that stimulates erythropoiesis that was approved by the U.S. Food and Drug Administration for a specific patient population with anemia. According to the Department of Justice Amgen also marketed the drug to patients with anemia caused by cancer chemotherapy, for which it was never approved, exposing these patients to a higher risk of death (United States Department of Justice, 2012).
Ethical dilemmas relating to medical care for terminally ill patients are not a new problem. In the late 1800s, German physician Albert Moll collected numerous case studies on medical ethics as practiced in his days in Germany, and in 1902 published his 650-page book Medical Ethics: The Doctor’s Duties in All Relations of His Work. Moll fiercely rejected social Darwinism and eugenic theories so widespread in his time and advocated the contractual relationship between physicians and their patients. This relationship extended to truth-telling and deception when dealing with incurably ill patients and their families. Moll rejected heroic treatment efforts that only led to prolonged suffering on terminally ill patients as unethical and would not undertake them even if the relatives were asking for them. In regards to medical experimentation on dying patients, Moll condemned such experiments as shameful, brutal, and entirely unacceptable (Maehle, 2012).
In 2012, the Liverpool Care Pathway made headlines in the United Kingdom. The National Health Service program was intended to deliver palliative care to dying patients. However, in practice, the guideline was not implemented with fidelity, and many patients and their families felt they and their loved ones were denied care and left to die without their knowledge or consent (“Nursing Times”).
Patient’s wishes aside, if a nurse faces a request from a patient for assistance with suicide, he or she may decide to opt-out from the patient’s care based on conscience. Healthcare providers and physicians, but also individual staff such as nurses, administrative staff, emergency medical technicians, and pharmacists, can object to providing certain medical services. Most often, healthcare professionals object to providing abortions, reproductive healthcare services, sterilizations, contraceptives, or blood transfusions. U.S. federal law allows conscientious objectors may request exemptions from policy and even legal obligations and excuses such individuals and even institutions from the provision of services they find morally objectionable. Galston and Rogers (2012) argue that not just doctors, but also nurses and other healthcare workers, can be excused from performing such duties if they find them morally or religiously objectionable. (Galston & Rogers, 2012)
If a patient confides plans to commit suicide to a nurse, or even requests assistance to do so, nurses should be able to turn to supervisors for support rather than tackling the dilemma alone. Geriatric nurses are likely to encounter such requests at some point in their careers and should receive specialized training for such situations. Institutions that treat the geriatric patient population should prepare relevant procedures and train staff to ensure legal compliance and appropriate and ethical medical practice. In some states, assisted suicide is legal and subject to strict regulation. Mental competence is a major issue in geriatric patients. It is the responsibility of a physician to decide whether the patient requesting assistance with suicide is of sound mind or not. Medical Power of Attorney makes it clear what the patient’s preferences are in regards to end-of-life care, including withholding and withdrawing life-sustaining treatment and administering a potentially lethal dose of pain relief. For a nurse, however, such requests can represent a significant moral dilemma. A conscientious objection can be used to opt-out of providing care to a patient who wishes to die.
References
Andorno, R. (2013). Nonphysician-Assisted Suicide in Switzerland. Cambridge Quarterly of Healthcare Ethics,22(03), 246-253. doi:10.1017/s0963180113000054
Dutton, G. (2010). Mylotarg Withdrawal Raises Questions | GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business. Retrieved March 23, 2017, from http://www.genengnews.com/gen-articles/mylotarg-withdrawal-raises-questions/4489
Euthanasia Research & Guidance Organization (ERGO). (n.d.). Assisted Suicide - Information on right-to-die and euthanasia laws and history. Retrieved March 23, 2017, from http://assistedsuicide.org/
Galston, W. A., & Rogers, M. (2012). Health Care Providers’ Consciences and Patients’ Needs: The Quest for Balance (pp. 22-35, Rep.). Governance studies at Brookings.
Maehle, A. (2012). ‘God’s Ethicist’: Albert Moll and His Medical Ethics in Theory and Practice. Medical History,56(02), 217-236. doi:10.1017/mdh.2011.34
NHS Choices. (2012). What is the Liverpool Care Pathway? Retrieved March 23, 2017, from https://www.nursingtimes.net/clinical-archive/end-of-life-and-palliative-care/what-is-the-liverpool-care-pathway/5051586.article
Oregon Health Authority. (n.d.). Death with Dignity Act. Retrieved March 23, 2017, from https://public.health.oregon.gov/ProviderPartnerResources/Evaluationresearch/deathwithdignityact/Pages/index.aspx
Oregon Health Authority, Public Health Division, Center for Health Statistics. (2017). Oregon Death with Dignity Act Data summary 2016 (p. 3, Rep.). OR: Oregon Health Authority.
Patients Rights Council. (n.d.). Switzerland Current law regarding assisted suicide. Retrieved March 23, 2017, from http://www.patientsrightscouncil.org/site/switzerland/
Schwarzenegger, C., & Summers, S. J. (2005). Criminal Law and Assisted Suicide in Switzerland. Hearing with the Select Committee on the Assisted Dying for the Terminally Ill Bill, House of Lords Zurich, 3 February 2005. In Universität Zürich. Retrieved March 23, 2017, from http://www.rwi.uzh.ch/lehreforschung/alphabetisch/schwarzenegger/publikationen/assisted-suicide-Switzerland.pdf
The United States Department of Justice. (2012). Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations. Retrieved March 23, 2017, from https://www.justice.gov/opa/pr/amgen-inc-pleads-guilty-federal-charge-brooklyn-ny-pays-762-million-resolve-criminal
The University of Chicago Cost of Cancer Care. (n.d.). Financial Toxicity Facts. Retrieved March 23, 2017, from https://costofcancercare.uchicago.edu/page/financial-toxicity-facts
Nařízení (EU) 2017/745 o zdravotnických prostředcích vstoupilo v platnost 26. května 2021. Platnost certifikátů vydaných podle stávajících směrnic vyprší nejpozději 24. května. Toto je třeba provést ve lhůtě, která odpovídá době nezbytné pro přezkoumání dokumentace a před vypršením platnosti současných certifikací. Česká republika stále nemá svůj oznámený subjekt. Jakmile dojde k akreditaci, bude ITC zavalen ohromným počtem nevyřízených podání v českém jazyce. Zajisdtěte si pomoc s podáním od týmu Arete-Zoe, který má s přípravou klinické dokumentace dle MDR bohaté zkušenosti.
History of EU device legislation, definitions, obligations of economic subjects
Introduction & Orientation
More than 500,000 medical technologies are available on the European market, from hospitals to community care settings and people's homes. The products range from syringes, pregnancy tests, and wheelchairs to X-Ray machines and body scanners, pacemakers, hip implants, and pharmacogenomic tests. The medical technology industry is the source of a constant flow of innovations. The sector spends about 8% of its sales on R&D. Typical product lifecycle is about 18 to 24 months when a new, improved version becomes available. In 2020, the European Patent Office (EPO) accepted nearly 14,200 patent applications in the medical technology sector, trumping pharmaceutical patents (8,500 applications) and biotechnology (7,200). European and U.S. entities filed almost 80% of the applications (38% EU and EEA, 39% U.S.) [ 1 ]. The European medical technology sector employs more than 760,000 people, mainly in Germany (210,000), the United Kingdom (102,800), Italy (94,000), France (89,000), Switzerland (63,000), and Ireland (40,000), accounting for 0.3% of total employment. In comparison, the European pharmaceutical industry employs around 795,000 people. These jobs reach a value-added of about €184,000 per employee. More than 33,000 medical technology exist in Europe, of which 95% qualify as small, medium, and micro-sized companies (SMEs). The majority of these enterprises employ less than 50 people [ 1 ]. In 2020, Europe had a positive trade balance in the medical technology sector of € 8.7 billion. Compared to 2019, the European trade balance dropped by 27.5% (€ 12 billion in 2019). The most important trading partners for Europe are the United States, China, Japan, and Mexico. Germany, Ireland, the Netherlands, Belgium, and Switzerland have the highest trade share, both within and outside the EU [ 2 ]. Until May 2021, the medical device sector was regulated by Medical Device and In Vitro Diagnostic Device Directives 93/42/EC and 90/385/EEC (MDD and IVDD), when the new Regulations replaced these: Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Device Regulation (IVDR) 2017/746 [ 3 ],[ 4 ]. The new regulations introduced numerous changes, including the reclassification of some devices, requiring additional obligations for manufacturers to comply with. About 85% of in-vitro diagnostic devices will now require Notified Body involvement, compared to ~20% under the IVDD. Existing MDD/IVDD certificates remain valid until May 2024. After this date, all devices on the EU market must comply with the new MDR/IVDR regulations [ 5 ]. For some manufacturers, the costs associated with keeping some of their devices on the market under MDR/IVDR may no longer justify the expense considering their profitability. Others may not be able to obtain new CE Mark certification in time due to decreased capacity of notified bodies. These factors combined are already reducing the number of devices on the EU market and limiting the certification of innovative products. The number of notified bodies available to review new certifications and recertifications dropped significantly under the MDR/IVDR. Of 51 notified bodies designated to MDD [ 6 ] and ten to AIMDD [ 7 ], only 29 obtained designation for MDR, of which seven operate in Germany, seven in Italy, and three in the Netherlands [ 8 ].
The Medical Device industry produces a vast number of products, ranging from bandages and surgical instruments to life function monitors to imaging technology. The technology currently in use varies from devices that have been in use for decades to highly innovative products. Innovations in the medical device field are frequent and typically incremental in response to feedback from physicians. Mordor Intelligence estimated the global Medical Devices market at USD 532.62 billion in 2021, growing at a CAGR of around 5.5%, to reach USD 734.39 billion in 2027 [1]. Fortune Business Insights projects the global medical devices market growth from $455.34 billion in 2021 to $657.98 billion in 2028 at a CAGR of 5.4%. This development follows a decline from 2020, when CAGR dropped to 3.7% due to the pandemic [2]. The key drivers of market growth include the rising prevalence of chronic diseases, increased disability throughout the population, technological advancements in medical devices, and population aging. The U.S. medical device market was valued at USD 186.5 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 5.0% over the forecast period to reach USD 262.4 billion in 2028 [4]. The Medical Device sector is even larger than Biopharmaceuticals, that by comparison, employed over 224,000 people, earning $21.2 billion [3]. The rising prevalence of chronic diseases and the increasing geriatric population in the country are the key market drivers. The Medical Device industry has a significant impact on the U.S. economy and supports hundreds of thousands of jobs. More than 80 percent of U.S. medical device companies have fewer than 100 employees [5]. In 2020, the U.S. Medical Device industry supported over 329,000 jobs, with an annual payroll of $25.8 billion [3]. Employment and payroll for Medical Device Subsectors, 2020 ( SelectUSA ):
U.S. Pharmaceutical Dependency on Foreign Sole-Source Production of Essential Materials Imposes Vulnerable Exposure to Interruption by Both Natural and Man-Made Threats
In the high consequence environment of pharmaceutical development, any assumption made earlier in the process can prove extremely costly if uncorrected once more information becomes available. From a business perspective, it is essential to create a safe avenue for communication of concerns regarding the drug candidate’s efficacy, safety, toxicity, or pharmacological function immediately as the researchers become aware of them.
Innovation always involves the risk of failure. It is an art to see what the data show, and what they don't, and which projections are the result of our wishful thinking or unsubstantiated assumptions. It may be just my impression that 14th-century logician William of Ockham whispers in my ear that entities shall not be multiplied unnecessarily.
Companies are growing in size due to acquisitions and mergers. Operations routinely span across geographical, jurisdictional, and cultural boundaries. The trend of industry consolidation continues in 2015 and 2016: the total number of deals flattened and remained even at around 600 mergers a year. Geographically, mergers, and acquisitions have been shifting from the U.S. to Western Europe. This shift is the result of transactions driven by the need to add complementary products to the core business areas and tax inversions.
Yes indeed. The reason is that critically important products such as active pharmaceutical ingredients and medical devices are manufactured in regions that are being shut down. Just-in-time supply chain and very few alternative suppliers for many off-patent generics make significant, long-term disruption much more likely.