Legal and Ethical Aspects of Pain Management

Clinical science Review article Acta Medica Academica 2018;47(1):18-26 DOI: 10.5644/ama2006-124.211

Marko Jukić1, Livia Puljak2,3

1Department of Anesthesiology and In this manuscript we presented legal and ethical aspects of pain man- Intensive Care Medicine, University agement. Pain is a global public health problem because the burden of Hospital Split, Split, Croatia, 2Laboratory acute and chronic pain is considerable and is continuously increasing. for Pain Research, University of Split It has been postulated that pain management is a fundamental human School of Medicine, Split, Croatia, 3Agency right, and that health systems are obliged to ensure universal access for Quality and Accreditation in Health to pain management services. The suggestion that pain management Care and Social Welfare, Zagreb, Croatia is a right was fuelled by ample evidence about inadequate treatment of pain. Undertreatment and underprescribing in the context of pain can potentially have serious legal consequences, including charges about negligence, elder abuse, manslaughter and euthanasia. Multiple Correspondence: international declarations by professional societies have outlined pain [email protected] management as a core ethical duty in medicine. Therefore, healthcare Tel.: + 385 21 557 807 professionals need to be aware of multiple facets of pain-related ethics, Fax.: + 385 21 557 811 including appraisal of patient’s decision-making capacity. The worldwide opioid crisis also calls for careful consideration of specific ethical issues. Finally, healthcare workers need to be aware of the the risks associated with promoting pain management as a human right because patients and their caretakers can mistakenly perceive that they Received: 30 December 2017 have right to total analgesia. Conclusion. Patients do have the right to Accepted: 11 April 2018 pain management, but patient rights have limits, which may interfere with other competing rights, and also rights of their physicians. Treat- ment of pain must be medically, ethically and economically justified. Healthcare workers have an obligation to continuously improve their Key words: Pain ■ Ethics ■ Law ■ Patient- knowledge about pain management, including medical, legal and ethi- physician relationship. cal aspects of pain.

Introduction pain (2). This analysis included 119 research reports from 28 LMICs, and the authors The treatment of pain is a public health pri- highlighted a high heterogeneity in results ority because the global burden of acute and and assessment of global chronic pain (2). chronic pain is considerable and it is continu- The burden of chronic pain is pervasive ously increasing (1). A recent analysis of the not only in LMICs, but across the globe. This burden of chronic pain without clear etiol- is supported by results of the Global Burden of ogy in individuals living in low and middle- Disease Study 2013, published in 2015, which income countries (LMIC) indicated that the analyzed global, regional and national inci- prevalence of unspecified chronic pain is 34% dence, prevalence and years lived with disabil- in the general population living in LMICs, ity for as many as 301 diseases, both acute and with 42% of the general population suffer- chronic, and injuries in 188 countries between ing from a headache, and 21% from low back 1990 and 2013 (3). Their results indicated that

among the top ten diseases/conditions that 300 billion USD. They valued lost produc- caused disability, low back pain was ranked tivity with three different estimates, includ- at the first place, while chronic neck pain and ing missed days of work (estimated at up to migraine were ranked 4th and 6th, respec- 12.7 billion USD), lost hours of work (up tively. Two mental health conditions were also to 96.5 billion USD and lower wages (up to among the top 10, including major depressive 225 billion USD). The total calculated cost disorder and anxiety (3); this is important in of pain to society, including healthcare costs the context of pain because it is known that and all three productivity estimates, ranged depression and anxiety are important comor- from 560 to 635 billion USD in 2010 dollars bidities with chronic pain (4). (16). Based on the authors’ results, the an- Chronic pain commands attention be- nual cost of pain in the USA was higher than cause it is usually difficult to treat, particu- the annual cost of heart disease (estimated at larly certain types such as neuropathic pain 309 billion USD), cancer (243 billion USD) (5). Currently, there is an ongoing debate or diabetes (188 billion USD) (16). whether chronic pain is a disease in its own It needs to be emphasized that while right (6-9). However, acute pain is also a attention to pain has increased in the in- significant burden, despite myriad avail- ternational research community, the atten- able treatment options for the management tion is shifting to different topics. For ex- of such pain. Numerous recent studies have ample, analysis of manuscripts published shown that acute pain is very prevalent in a prominent pain-related journal from across the globe, even when it is preventable. 1975 to 2007 indicated that the percentage For example, a systematic review of acute of studies analyzing interventions in hu- pain in hospitalized patients, published in mans declined precipitously with time as a 2016, indicated that the prevalence of such percentage of publications, replaced with an pain ranged from 38 to 84%, while preva- increased number of animal studies about lence of severe pain ranged from 9 to36% behavioral pharmacology (17). Further- (10). The manuscript analyzed 14 studies more, it was recently emphasized that atten- published from 1990 to 2013, included data tion to pain is swinging between extremes from 9 countries, which involved a total of and represents a moving target, with most 23,523 patients from 56 hospitals (10). of the articles in lay press highlighting the Newer studies show similar data trends, problems associated with opioid analgesics, indicating the high prevalence of pain in the while neglecting significant benefits that can hospital setting, lack of attention to available be accrued from their appropriate use (18). guidelines, and insufficient prescribing of There are still areas of the world where the pain medications (11-13). This is even found use of opioids is insufficient considering the in the case of postoperative pain after major estimated burden of disease (19). surgical procedures (14). The aim of this manuscript was to pres- Furthermore, the socioeconomic impact ent legal and ethical aspects of pain manage- of acute and chronic pain is severe. Pain is ment, with regards to relevant references one of the leading reasons for absence from and new developments in the field of pain. work in the USA, where lost productive time from common pain conditions among Pain management is a fundamental active workers translates into major costs human right (15). Gaskin and Richard have shown that the total incremental cost of healthcare that It has been postulated that pain manage- can be attributed to pain ranged from 261 to ment is a fundamental human right, and

19 Acta Medica Academica 2018;47:18-26

that health systems are obliged to ensure by failing to consult an expert in pain man- universal access to pain management servic- agement (26). Several such cases of legal es on a nondiscriminatory basis including actions involving pain-related negligence provision of basic medications for treatment have already appeared; they have even been of pain and implementation of national pain described in medical literature, reporting policies (20,21). that millions in damages were paid because After recognizing that pain management of gross negligence associated with under- is a human right, the next challenge is to en- treatment of pain and suffering (27). Ben A. sure implementation of appropriate medical Rich has warned physicians: “Another mes- and social changes that will make pain man- sage to physicians implicit in these verdicts agement a core component of healthcare is that there is a standard of care for pain (22). Pain management is a core ethical duty management, a significant departure from in medicine (20). Frustrated by the slow which constitutes not merely malpractice pace of medical, cultural, legal, and politi- but gross negligence. Even if professional cal change, many within the community of boards might not hold their licensees to that pain clinicians have begun to promote the standard, juries will” (27). status of pain management beyond that of One of those cases indicates that geriatric appropriate clinical practice or even an ethic setting is yet another area of jurisprudence of good medicine (20). that may be associated with legal aspects of pain management (27, 28). In a case of Berg- Law and management of pain: man vs Chin it was argued that according to California’s Elder Abuse and Dependent Negligence, elderly abuse, euthanasia Adult Civil Protection Act, inadequate pain In common law, the suggestion of negligence management of an elderly person may be provides a further possible legal foundation considered a case of elderly abuse (28). that should ensure adequate pain manage- Pain management of terminal patients is ment. Margaret Somerville, Professor of yet another potential legal problem because Law and Medicine at McGill University, has some pain medications can be life threaten- long argued that the unreasonable failure to ing. Severe adverse events, including deaths, provide adequate pain management con- are the most commonly reported adverse ef- stitutes negligence (23). The law of medical fects of opioids (29). It has been argued that negligence emphasizes taking reasonable giving pain medication to terminal patients care in all aspects of patient management. could be mistaken for a manslaughter and When approaching a physician, patients ex- a sort of euthanasia (30). This legal prob- pect medical treatment that will relieve their lem for physicians could be prevented by medical problems. A physician owes certain consulting physicians specialized in pain duties to patients and breach of these duties management such as those employed in may give a cause of action for negligence pain clinics (31). Furthermore, physicians against a physician (24). Undermedication need to take due care to avoid such risk of of pain has also been called a moral negli- being liable, including taking an informed gence (25). consent for treatment, observing a propor- With respect to pain control, doctors tionality rule, and accurate keeping of medi- may breach their standard of care by failing cal records (30). With time, more cases may to take an adequate pain history from the emerge to better outline the boundaries of patient; by treating the pain inadequately; reasonable action by doctors, nurses, and and, in the context of uncontrolled pain, pharmacists in pain management (26).

20 Mario Jukić and Livia Puljak: Pain, law and ethics

Ethics and management of pain of a researcher regarding protection of hu- mans as research subjects. The DoH defined The management of pain has been postu- requirement to obtain informed consent lated as a “core ethical duty in medicine” of participants, as a measure for protecting (22). The responsibilities of doctors to their an individual’s autonomy. Initially this was patients are primarily ethical. Right to a meant as a protection against unwanted in- pain management could be considered as an clusion in experimentations, but informed example of a bioethical principle of benefi- consent later became generally accepted cence, or doing good for others, which is an standard for consenting to a medical treat- ethical principle that is particularly promi- ment, as specified in the WMA’s Declaration nent in medicine (32). This principle was of Lisbon on the rights of the patient, which ingrained in a number of key documents was first adopted in 1981 (37). and declarations adopted by relevant inter- Together with the bioethical principle national medical organizations. of beneficence, the principle of nonmalefi- According to the Americal Medical As- cence is also crucial in medicine, which pro- sociation (AMA)’s Code of Ethics, ‘phy- hibits the infliction of harm (38). Failure to sicians have an obligation to relieve pain reasonably treat patients’ pain and suffering and suffering“ (33). Since 1947, the World causes harm could, therefore, be considered Medical Association (WMA) has been de- an ethical breach of maleficence (39). veloping a system of ethical obligations or The American Academy of Pain Medi- a professional deontology, which elaborates cine (AAPM) has therefore adopted the eth- the physician’s role versus the rights of in- ics charter, which requires all physicians to dividual patients. In 1948, the WMA pub- improve in a number of pain-related areas, lished a Declaration of Geneva, which was including assessment of pain, treatment proclaimed to be “the contemporary succes- of pain with competence and compassion, sor to the 2500-year-old Hippocratic Oath“ education in principles of pain medicine, (34). One of the principles of the Declara- support to pain-related research and en- tion of Geneva is “the health and well-being gagement in advocacy that will ensure ac- of my patient will be my first consideration” cess to pain management and its continuous (34). Professional associations of healthcare improvement (40). personnel in many countries have adopted a International Association for the Study similar ethical basis for the management of of Pain (IASP) also took a stand on the issue pain (20). The WMA has also brought for- of ethics and pain, by adopting a Declara- ward the International Code of Medical Eth- tion of Montreal during the First Interna- ics in 1949, last updated in 2006 (35). Both tional Pain Summit on September 3, 2010, in this Code and in Declaration of Geneva, which states that access to pain management patient rights are presented as the result of is a fundamental human right (41). IASP the matrix of obligations of a physician to- was founded in 1973 and it is the largest wards a patient (34,35). multidisciplinary international organization In 1964, the WMA adopted a Declaration in the field of pain, which “brings together of Helsinki (DoH) as the first international scientists, clinicians, health-care providers, document prescribing rules for medical re- and policymakers to stimulate and support search involving human subjects (36). The the study of pain and translate that knowl- purpose of DoH was to provide guidance edge into improved pain relief worldwide” to those involved in clinical research, and (42). As the foremost global organization therefore its main focus was a responsibility devoted to pain research and management,

21 Acta Medica Academica 2018;47:18-26

IASP has endorsed numerous ethical prin- Ethics of opioid prescribing for pain ciples and declarations about including hu- management mans in research endeavours (43). Use of opioids for pain management has recently emerged as a particular ethical prob- Decision-making capacity in patients lem, particularly in the setting of treating with pain: Ethical and legal issue non-malignant chronic pain (46, 47). Over- prescription and overmarketing of opioids Physicians who treat patients suffering from in certain areas such as North America and pain need to be aware about their patients’ Australia and has lead to “opioid crisis”, and decision-making capacity. Pain can also be a science is called upon to resolve this public factor that negatively affects decision-making capacity. Iatrogenic causes can contrib- health threat (48). Although opioids are ef- ute to diminished patient’s decision-making fective painkillers, their side effects necessi- capacity. Therefore, physicians treating pain tate a careful approach in chronic non-can- have an ethical and legal obligation to as- cer pain states (49). sess and evaluate patient’s decision-making In USA, the number of opioid prescrip- capacities (40). Assessing whether a patient tions written in 1998 was 100 million, in- has capacity to make informed decisions creasing to 190 million prescriptions in 1998 about his or her medical care is something and 290 million prescriptions in 2017. Con- that physicians are frequently required to sequently, more then ten million USA citi- do (44). According to the AAPM, giving au- zens are using prescription opioids for non- tonomous informed consent requires from a medical reasons, and about 2 million people patient: i) understanding of information and were diagnosed with opioid addiction (47). consequences, ii) demonstration of insight, According to the Centers for Disease Pre- iii) reason and judgment, iv) the ability to vention (CDC), more than 33,000 Ameri- evince a decision or articulate a preference cans died from an opioid overdose in 2015, and v) voluntariness (40). a number similar to the 35,000 and 36,000 Physician needs to respect patient’s wish- deaths that were attributed to motor vehicle es and values. All five criteria must be met for accidents and firearms in the same year (50). informed decision-making. If a patient can- These figures are a call to action and not meet these criteria, a surrogate decision- CDC has issued a guideline for primary maker needs to be involved. Alternatively, care physicians with the aim to reduce opi- autonomy of patients with diminished or im- oid prescriptions for chronic pain except paired decision-making capacity can be pro- in cases of cancer treatment, palliative care moted by giving them degree of autonomy and end of life care (51). This guideline is commensurate with their capabilities (45). supported by weak evidence about efficacy Sometimes, a physician may perceive that of opioids for long-term management of a surrogate decision-maker is not suggesting chronic non-cancer pain (52). Furthermore, actions that are in the patient’s best interest. systematic review that analyzed randomized Ethical and legal obligation of a physician is controlled trials and observational studies to advance welfare of a patient. If necessary, about effectiveness and risks of long-term an attending physician may consult institu- opioid therapy for chronic pain was recently tional ethics committee to seek help regard- published (53). After searching the litera- ing medical decisions. Ethics committee ture, the authors reported that they could needs to be the first instance to refer such a find „no study of opioid therapy versus no dispute before resorting to legal actions (45). opioid therapy evaluated long-term (>1

22 Mario Jukić and Livia Puljak: Pain, law and ethics

year) outcomes related to pain, function, limited doses, for carefully selected patients. quality of life, opioid abuse, or addiction“, Additionally, patients need to be advised on and therefore there is “insufficient evidence safe use of opioids (55). Pain community to determine the effectiveness of long-term has reached a broad consensus that opioid opioid therapy for improving chronic pain epidemics that we are witnessing in certain and function“ (53). countries need to be addressed urgently and Based on these data, Erdek and Prono- that other countries should be protected vost have suggested that the dilemma re- from similar negative outcomes (55). garding overprescribing and undeprescrib- The problems with opioid crisis may not ing of opioids requires “a balanced approach generalize to the rest of the world; hopefully based on an ethical framework; policy there are mechanisms in place in each coun- changes will need to be implemented in or- try to prevent this. This also depends on der to effect a more rational approach to the health care resources of each country. The use of opioids; and as with any change, the opioid crisis in the USA is a consequence of new policies will likely defend against some direct to consumer advertising, untruthful risks and introduce new ones, often requir- marketing of opioids to physicians and the ing iterative policy changes” (47). lack of physician education about pain and Policy changes that have been introduced its treatment. Each of these factors needs to to halt opioid crisis appear to be effective. be studied by every country to make sure Drug monitoring programs introduced in that they do not replicate these mistakes. Ul- USA were associated with lower opioid-re- timately, it could be argued that pain educa- lated mortality rates (54). Particularly states tion in curricula of healthcare professionals where these drug monitoring programs had needs due attention. robust characteristics, such as monitoring higher numbers of drugs with abuse poten- Precariousness of promoting pain tial and updating their data at least weekly, management as a right had greater reductions in deaths, compared to other states whose drug monitoring pro- We now have sufficient evidence about in- grams did not have these characteristics (54). adequate treatment of pain that we can talk If opioid therapy has to be prescribied for about “ethics of undertreatment” and “ethics chronic noncancer pain, physicians need to of underprescribing” (26). However, we also schedule frequent follow-up visit to assess see now how opioid crisis is raising addi- improvement and perform urine drug test- tional set of ethical questions. Thus, promoting to monitor patient compliance (47). Fur- ing pain management as a human right as a thermore, physicians need to engage in open legal right may lead to patients and public to discussions with patients and their families request any analgesic they want. The erro- about benefits and harms of opioid therapy. neous interpretation of “right to pain relief” Healthcare systems and all its relevant stake- may potentially disrupt the basic tenets of holders have an obligation to optimize pa- clinical assessments by physicians and other tient satisfaction, while minimizing harms healthcare workers (26). to individuals suffering from chronic pain Likewise, it is important to balance the and to society at large (47). Countries in dif- message regarding pain management as a ferent continents have started responding to right because not all types of pain can be opioid epidemic with prescribing guidelines adequately treated (56). Therefore, while that need to ensure that opioids will be pre- promoting pain management as a human scribed for appropriate indications only, in right, we have to be careful to also convey

23 Acta Medica Academica 2018;47:18-26

the message that “pain relief is not the right Conclusion to a pain-free life” as there is no guarantee of perfection in medicine (26). If pain man- Pain management is fundamental to good agement as a human right is interpreted as a clinical practice. Patients do have the right right to total analgesia, this will easily lead to to pain management, but also patient rights frustration among patients and their carers have limits, which may be limited by other and potentially to litigation (56). Therefore, competing rights, and also rights of their whenever we talk about pain management physicians. Treatment of pain must be med- as a human right, healthcare professionals ically, ethically and economically justified. need to make clear that this right implies Attending physician always needs to evalu- “reasonable and proportionate” response to ate a patient thoroughly, and recommend the intensity and type of pain a person is ex- evidence-based treatment for pain, while periencing (26). educating patients about what realistically On the other side, it has been argued can be expected from the treatment. Health- that promoting pain management as human care workers have an obligation to continu- right can also have negative unintended ously improve their knowledge about pain consequences among healthcare profession- management, including medical, legal and als who may see such movements as a po- ethical aspects related to pain. tential threat to their clinical judgment and autonomy, and in response become more What is already known on this topic For almost two decades now the pain management has been rigid and defensive, ignoring the clinical promoted as a fundamental human right. Legal issues and guidelines and recommendations for best ethical declarations related to pain have also been accumu- practices (26). lating, as well as elaborations about precarious issue of pain Thus, education is crucial, both of pa- management, particularly in sensitive cases such as care for tients and their carers, as that of healthcare terminally ill patients. Major international organizations real- ized that they need to devote particular attention to ethics and workers. Patients and their carers need to be legal aspects of pain. educated by their attending healthcare staff in what they can realistically expect from What this study adds In this review we summarized the main legal and ethical as- the current state of medical science. For ed- pects of pain management, with particular focus on relevant ucation of healthcare workers we need insti- international declarations and ethical codes and specific cases tutional acceptance of pain-related curricula that physicians should be aware of. Underprescribing and on all levels of professional education. In overprescribing of pain therapies can be associated with accu- this respect, IASP made significant advances sations of negligence, elderly abuse and euthanasia attempts. We also addressed novel controversies related to ethics of the towards improving professional training current opioid crisis, perils of promoting pain management as about pain by publishing multiple curricula, a human right, and pointed out what major international or- which cover both core curriculum about ganization for the study of pain recommends as curricula for pain education and discipline-specific cur- adequate education of healthcare workers about pain manage- ricula. These curricula are intended to help ment. in establishing teaching courses on acute, Authors’ contributions: Conception and design: MJ; chronic and cancer pain at various educa- Acquisition, analysis and interpretation of data: MJ tional levels, including both undergraduate and LP; Drafting the article: MJ and LP; Revising it and graduate level. All these curricula are critically for important intellectual content: MJ and freely available online, and they were last LP; Approved final version of the manuscript: MJ and L P. updated in May 2012. These curricula in- clude medical, legal and ethical aspects re- Conflict of interest: The authors declare that they lated to pain assessment and treatment (57). have no conflict of interest.

24 Mario Jukić and Livia Puljak: Pain, law and ethics

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