|Year : 2008 | Volume
| Issue : 6 | Page : 768
Pain Management: Medico-Legal Issues
Gaurab Maitra1, A Rudra2, Saikat Sengupta1
1 Consultant, Dept of Anaesthesiology, Perioperative Medicine & Pain, Apollo Gleaneagles Hospitals, Kolkata., India
2 Hony Consultant, Dept of Anaesthesiology, Perioperative Medicine & Pain, Apollo Gleaneagles Hospitals, Kolkata., India
|Date of Acceptance||09-Jul-2008|
|Date of Web Publication||19-Mar-2010|
63B, Chakraberia Road (North), Kolkata - 700 020
Source of Support: None, Conflict of Interest: None
Freedom from pain has now emerged as a fundamental human right. Pain has long been under treated and physicians have been accused for poor pain management. There are many reasons for failure of physicians to properly manage pain. Joint Commission on Accreditation of Health Care Organizations (JCAHO) made pain assessment and proper management mandatory. Many statutory regimens have evolved over the time demanding proper pain management and focusing it as a legal right. Standards of care for pain management have evolved and are well established. Websites have also proliferated to help physicians gain user friendly access to these guidelines. Physicians are now bound with legal responsibilities to follow pain practice as per the guidelines and to document everything in medical records. Not only the physicians, the hospitals are also liable to it patients if it fails to uphold the standard of care to ensure patient's safety. Though pain management has been slow to progress, a convergence of forces have now made it possible to incorporate quality pain management in medical practice.
Keywords: Pain management, Medico-legal, Guidelines
|How to cite this article:|
Maitra G, Rudra A, Sengupta S. Pain Management: Medico-Legal Issues. Indian J Anaesth 2008;52:768
| Introduction|| |
Pain is defined as "an unpleasant sensory and emotional experience arising from actual or potential tissue damage or described in terms of such damage. Pain is always subjective. Each individual learns the application of the word through experiences related to in early life. It is questionably a sensation in a part or parts of the body but it is also always unpleasant and therefore an emotional experience"  .
Pain is under treated at all levels : physician offices, hospitals and long term care facilities  resulting in needless suffering for patients, complications that cause further injury or death and added costs in treatment overall.
Physicians have long been accused of poor pain management for their patients , . The term "Opiophobia" has been coined to describe this remarkable clinical aversion to the proper use of opioids to control pain . Physicians are falling far short in treating pain by accepting myths about the use of opioids in the face of evidence to the contrary. 
There are many reasons for failure of physicians to properly manage pain. First physicians are poorly educated in medical school about narcotic and proper pain management and also remain ignorant about the treatment choices for pain management in practice  . Second uncertainty about legitimate opioid use, coupled with a regulatory system that threatens sanctions intimidates physicians  . Third patients, worried about tolerance and addiction to the opioids receive little adequate information or education by providers  . Fourth lack of insurance coverage may deny patients access to costly long term pain management with its multiple modalities of treatment .
| Categories of pain|| |
Pain is traditionally divided into acute or chronic pain. Acute pain and its associated psychological, autonomous and behavioral responses are provoked by noxious stimulation of injury or disease that does not produce actual tissue damage. Effective treatment may abolish it in days or weeks but improper or ineffective therapy may result in persistent or chronic pain. Chronic pain imposes several physical, emotional or socio-economic stresses on the patient, family and society. This type of pain is prevalent and very difficult to treat  .
Cancer pain is one of the largest categories of pain. One estimate is that more than 90 percent of cancer pain can be controlled with available treatment options  . The elderly particularly in nursing homes, suffer high levels of pain - chronic and non-malignant in most cases-that is poorly managed up to 70 percent of the time. As there are many differences in what may be regarded as chronic pain, the definition remains flexible and related to specific diagnoses or cases  .
| Proper pain management|| |
Pain management is defined in the Joint Commission on Accreditation of Health Care Organizations (JCAHO) guidelines as "a comprehensive approach to the needs of patients, residents, clients or other individuals served who experience problems associated with acute or chronic pain  .
Joranson and colleagues stated that the use of opioids in the class of morphine is the cornerstone of pain management yet health professionals are reluctant to prescribe, administer, dispense or stock controlled substances for fear of causing addiction or contributing to drug abuse problem  .Failure to properly manage pain - to assess treat and manage it is professional negligence .
According to Brenan et al , the relief of pain is a core ethical duty in medicine  . Unrelieved pain blocks enjoyment of all other human goods and values. In the words of an oncology nurse who herself suffered from chronic pain,. "This malady has been the most frightening, the most humiliating and the most difficult ordeal of my life.…… I became withdrawn, completely disabled by my terrible, relentless pain. I was unable to function professionally. I was unable to be much of a wife or a mother, a daughter or a friend"  .
The Hippocratic Oath states, "I will keep them from harm", the American Medical Association states that " Physicians have an obligation to relieve pain and suffering" and the American Nurses Association's position is that "nursing encompasses the alleviation of suffering…" A virtuous doctor would place the recognition, monitoring and treatment plan as a high priority and also inquire regularly about pain, respond appropriately and refer wisely if unable to control it. Moreover, Pain management should be promoted as a legal right providing constitutional guarantees and statutory regulations that span negligence law, criminal law and elder abuse. Pain management should be a fundamental human right and failure to provide pain relief be considered as professional misconduct. Guidelines and standards of practice should be issued by professional bodies to enforce proper pain management  .
| Functions of tort(law on civil wrong) liability|| |
The rules developed by courts in malpractice suits serve a range of functions in altering medical practice. First tort rules reinforce good medical practice. Second, tort rules give voice to patients who have been ignored, actively manipulated or cruelly treated by physicians. Third, malpractice litigation drives institutional practice towards convergence on validated standards of practice. Fourth, tort law often articulates new duties of care for providers. Physicians not only must pay attention to emerging practices but must also disclose risks, candidly make a referral to more skilled specialist, be honest with the patient and watch out for patient's interests over those of the providers .
Physicians clearly perceive a threat from the system, judging their risk of being sued as much higher than actually is. The Harvard new York Study, surveying New York Physicians, found that physicians who had been sued were more likely to explain risk to patients, to restrict their scope of practice and to order more tests and procedures  . Hospitals have instituted risk management offices and quality assurance programs, informed consent forms have become ubiquitous, medical record keeping with an eye toward establishing proof of care at trial has become a rule  .
| Pain management as a legal right|| |
| Statutory Regimens|| |
The Medical Treatment Act of 1994 from the Australian Capital Territory states "a patient under the care of a health professional has a right to receive relief from pain and suffering to the maximum extent that is reasonable in the circumstances"  .
An example of statutory prohibition for doctors is contained in the South Australian Consent to Medical Treatment and Palliative Care Act of 1995 which protects medical practitioners, in their care of terminally ill patients from clinical or civil liability if they administer treatment with the intention of relieving pain, providing such treatment is given with consent, in good faith without negligence and in accordance with proper professional standards of palliative care  . A California Statute imposed three obligations. First is a duty for doctors who refuse to prescribe opioids to a patient with severe, chronic intractable pain, to inform the patient that there are physicians who specialize in treatment of such pain. Second is a duty of all doctors to complete mandatory continuing education in pain management and treatment of terminally ill. Third is the requirement of California Medical Board to develop a protocol for investigation of complaints concerning the under - treatment of pain ".
| Negligence|| |
Unreasonable failure to provide adequate pain relief constitutes negligence. Doctors may potentially breach standard of care as-an unreasonable failure to take an adequate history of pain from the patient, an unreasonable failure to adequately treat pain in the context of uncontrolled pain, an unreasonable failure to consult an expert in pain management  .
| Public interest litigation|| |
In 1998 in India on behalf of nation's cancer patients, Drs SR and RB Ghooi and the All India Lawyers Forum for Civil Liberties filed a public interest suit in Delhi High Court requesting a court order to state governments to simplify the procedures for the supply of morphine for cancer patients. Court ordered application for licenses and supplies of morphine must be attended to expeditiously and to allot morphine without delay and that aggrieved persons were granted freedom to approach court if dissatisfied.
| Criminal Law|| |
Is it possible for a health professional to be criminally culpable in giving analgesia? Criminal Law concentrates on intention so that if the intention of the doctor is to relieve pain and not to shorten the life of the patient then the act of prescribing and dispensing analgesia is not a criminal act  .
| Professional Misconduct|| |
Professional misconduct includes conduct that "offends against the traditions of the profession"  , and is "more than mere negligence"  . Negligent mismanagement of pain alone is not sufficient. More likely, poor pain management may fall under "unprofessional conduct". This has occurred twice in United States, State medical boards of Oregon (in 1999) and California (in 2003) have disciplined individual doctors for unprofessional conduct related to inadequate pain management  . The most recent update of the US Federation of State Medical Board's Model Policy for the use of Controlled Substances for the Treatment of Pain addresses the balance between patient's rights and patient responsibilities with respect to pain management, principally opioid therapy  .
| Role of World Health Organization (WHO)|| |
The constitution of WHO defines health as a state of complete physical mental and social well being and not merely the absence of disease or infirmity. Adequate provision of pain management falls comfortably within this definition The WHO has been involved with pain in three overlapping areas ; the promotion and dissemination of guidelines on pain management, advocacy of improved access to opioid analgesics and national programs of palliative care and pain relief  .
| Deregulation of Medical Opioid Availability|| |
As narcotics, opioids are subject to both international and domestic control. The Single Convention on Narcotic Drugs (1961) is the international treaty that regulates the production, manufacture, import, export and distribution of opioids for medical use. It emphasises the importance of a balanced approach to opioid control to ensure availability for medical purposes while preventing abuse and diversion. At the domestic level many countries have restrictive regulatory policies for opioid use. In the United States in recent years there have been concerted efforts to reform. Federally the Drug Enforcement Administration (DEA) has moved to actively pursue a more balanced approach to the use of controlled substances  . In 2001, it issued a joint statement with dozens of professional organizations expressly stating that, while vigilance to prevent illicit diversion of opioid is important, it must be balanced with the reality that effective pain management is an integral and important aspect of quality medical care and pain should be treated aggressively  . In 2006, the DEA issued an informational outline of the Controlled Substances Act that while acknowledging the appropriateness of prescribing controlled substances for legitimate medical purposes devoted far more attention to articulating an array of regulatory requirements for doing so and penalties for non-compliance  .
| Negligent infliction of mental distress|| |
Can a patient or family sue for infliction of emotional distress because of the patients tangible suffering unrelieved by proper pain management? Courts have allowed plaintiffs(person who initiates a law suit) to sue health care providers for the negligent infliction of emotional distress under particularly egregious circumstances. One example is Oswald v Legrand  .
| Referral to pain specialists|| |
It is necessary for the primary care physician and other specialists to be familiar with the existence and expertise of a pain specialist. This is more than a statement of medical necessity for the patient, established tort principles require a physician to make a referral to the appropriate specialist when the physician lacks the knowledge or experience to properly treat the patient (Johnson v Kokemoor) .
| Guidelines and Standards of Practice|| |
Malpractice is usually defined as an unskillful practice resulting in injury to the patient, constituting a failure to exercise the required degree of care, skill and diligence under the circumstances (Bardessono v Michels)  . What a minimally competent practitioner must know has not been derived from an external authority like government standard, but rather from medical standards developed through interaction of leaders in the profession, professional journals and meetings. Over a period of time, a clinical policy takes shape from series of interactions and if it becomes generally accepted, it becomes standard of care  .
The guidelines developed by national medical organizations provide a source of standards against which to judge the conduct of the defendant physician. A widely accepted clinical standard may be a presumptive evidence of due care but expert testimony would still be required to introduce the standard and establish its source and relevancy. Standards of care for pain management are increasingly well established. Organizations such as the Agency for Health Care Policy and Research, Agency for Health Care Research and Quality, American Pain Society, American Academy of Pain Medicine and American Society of Anesthesiologists have promulgated pain control standards  . Websites have proliferated to help physicians gain efficient and user-friendly access to this even greater proliferation of guidelines and medical information  .
A physician who displays ignorance of current treatment guidelines may be attacked by the plaintiff using the results of a computer search to display these guidelines and their relative ease of access (Warrick v Giron)  .
| Physician's legal responsibilities|| |
The doctrine of informed consent
Physicians are required to disclose alternative methods of treatment along with their risks and consequences and their probability of success. Physicians are obligated to discuss with patients the side effects of drug treatments where driving or other life activities might be impaired. Failure to discuss pain management options and the possibility of referral or transfer might well appear as a count in the patient's malpractice complaint for pain management .
| Medical Records|| |
Medical files play an important role in any legal case because they represent observations, opinions and suggestions and are generally the first item lawyers attempt to obtain and review. In recording patient histories, a good pain history is strongly recommended. Attention to prior pain symptoms is of significance in legal -medical process. Lack of prior pain symptoms is typically used by plaintiff's attorney to support casual relationship between a compensable condition and a legally significant event. The destruction or strategic loss of medical records is absolutely wrong and may result in significant legal liability for the doctor. It is important that the doctor co-operate with a patient's legal representative to the extent ethically permissible. In legal-medical matters, accuracy and thoroughness in record keeping are critically important for the doctor as well as the patient .
| Medical Report|| |
Not infrequently, a doctor's first encounter with the lawyer is a written request for a copy of the doctor's medical records on the patient and a medical report setting out the course of treatment and the doctor's opinion. The accuracy of the medical report is directly dependent on the accuracy and the completeness of the medical records. The medical report should indicate history, treatment, diagnosis, causation and progress. The legal system requires that such opinions be offered within the realm of reasonable medical certainty or probability. Every doctor is advised to consult with a respected lawyer with litigation expertise to learn the meaning of reasonable medical certainty or reasonable medical probability because these terms may be used in the legal jurisdiction where the doctor practices medicine .
| Institutional legal responsibilities|| |
| General Duty|| |
The evidence as to under treatment suggests that while physicians may often be at fault, it is primarily the system of care that has failed to reorganize its resources to address the problem. The hospital system has not been designed to recognize pain as a valid indicator of suffering and track and treat it with the intensity with which a fever is treated in a hospital. A health care institution whether a hospital, nursing home or clinic is liable to its patients for negligence in maintaining its facilities, providing and maintaining medical equipment, hiring, supervising and retaining nurses and other employees. Hospitals must have minimum facilities and support systems to treat the range of problems and side effects that accompany the procedures they offer. Equipments must be adequate for services offered, although it need not be state of art .
| Corporate negligence|| |
A hospital is directly liable for the failure of administrators and staff to properly monitor and supervise the delivery of health care within the hospital. The liability arises from the hospitals action or inaction regarding its policies, rather than the specific negligent acts of one of its employees(Moser v. Heistand)  . In Thompson v. Nason, the Pennsylvania Supreme Court held that corporate negligence is a doctrine imposing liability on a hospital if it fails to upload the standard of care to ensure the patient's safety and well being while at the hospital  . Most jurisdictions have held hospitals to a duty to take reasonable steps to ensure the competence of its medical staff . A failure to provide training and feedback and to detect physician reluctance to use proper techniques provides an argument of corporate negligence  .
| Rules and Policies to ensure quality care|| |
The regular charting of pain should be treated as a "fifth vital sign" along with the other vital sign of temperature, pulse, respiration and blood pressure  . In 1991, Joint Commission on Accreditation of Health Care Organizations (JCAHO) mandated pain be routinely assessed and outcomes of care be routinely documented for terminally ill patients. By 1995, JCAHO had written pain management into its guidelines. Finally with 2000 and 2001 editions of JCAHO accreditation manuals, JCAHO now require surveyors inspecting hospitals to include in their surveys a systematic look at pain assessment and management. Failure to follow new JCAHO standards for pain management can lead to liability, with such standards being admissible as evidence of the standard of care once they are implemented for the hospitals accreditation  . The Emergency Medical Treatment and Labor Act (EMTALA) requires covered hospitals to provide a medical screening examination to any patients coming into the emergency department of the hospital  . Severe physical pain that could have been avoided with appropriate medical care is arguably a material deterioration of a patient's condition (Wey v. Evangelical Community Hospital)  EMTALA offers a statutory basis for suit in emergency admissions when patients are not properly screened or stabilized for pain .
Progress in pain management has been slow-the result of continued uncertainty by providers as to appropriate opioid use, lack of institutional attention to pain management and in attention by medical schools. A convergence of forces is now building pressure on health care providers to incorporate pain management into their practices. First JCAHO's Statement of Pain Assessment and Management establishes a new standard of pain as the "fifth vital sign" which must be monitored and treated by hospitals for continued accreditation. Second, pain management clinical practice guidelines are now readily found through the Internet for easy access by health -care providers. One can only hope that medical school education will also incorporate a contemporary version of pain management in to its curriculum .
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