Pain Management:Medico-Legal Issues Gaurab Maitra 1 , A Rudra 2 , Saikat Sengupta 3 Summary 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 pf physicians to properly manage pain. Joint Commission on Accreditation of Health Care Organizations (JCAHO) made pain assess- ment 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. Physi- cians are now bound with legal responsibilities to follow pain practice as per the guidelines and to document every- thing 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 patients 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. Key words Pain management, Medico-legal, Guidelines 1,3.Consultant, 2.Hony Consultant, Dept of Anaesthesiology, Perioperative Medicine & Pain, Apollo Gleaneagles Hospitals, Kolkata., Correspondence to: Gaurab Maitra, 63B, Chakraberia Road (North), Kolkata 700 020, E-mail:drgaurabmaitra2002@yahoo.co.in Accepted for publication on: 9.7.08 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 1 . Pain is under treated at all levels : physician of- fices , hospitals and long term care facilities 2 resulting in needless suffering for patients, complications that cause further injury or death and added costs in treat- ment overall. Physicians have long been accused of poor pain management for their patients 3,4 . The term Opiophobia has been coined to describe this remark- able clinical aversion to the proper use of opioids to control pain 5 . Physicians are falling far short in treating pain by accepting myths about the use of opioids in the face of evidence to the contrary. 6 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 7 . Second uncertainty about legitimate opioid use, coupled with a regulatory system that threatens sanctions intimi- dates physicians 8 . Third patients, worried about toler- ance and addiction to the opioids receive little adequate information or education by providers 9 . Fourth lack of insurance coverage may deny patients access to costly long term pain management with its multiple modalities of treatment 10 . Categories of pain Pain is traditionally divided into acute or chronic pain. Acute pain and its associated psychological, au- tonomous 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 Indian Journal of Anaesthesia 2008; 52 (6):768-774 Review Article [Downloadedfreefromhttp://www.ijaweb.orgonMonday,February04,2013,IP:202.43.187.35]||ClickheretodownloadfreeAndroidapplicationforthisjournal 769 pain imposes several physical, emotional or socio-eco- nomic stresses on the patient, family and society. This type of pain is prevalent and very difficult to treat 11 . Cancer pain is one of the largest categories of pain. One estimate is that more than 90 percent of can- cer pain can be controlled with available treatment op- tions 12 . 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 13 . Proper pain management Pain management is defined in the Joint Commis- sion on Accreditation of Health Care Organizations (JCAHO) guidelines as a comprehensive approach to the needs of patients, residents, clients or other indi- viduals served who experience problems associated with acute or chronic pain 14 . 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 15 .Failure to properly manage pain to assess treat and manage it is professional neg- ligence 16 . According to Brenan et al , the relief of pain is a core ethical duty in medicine 17 . 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 frighten- ing, 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 18 . 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 Associations po- sition is that nursing encompasses the alleviation of suffering A virtuous doctor would place the recog- nition, monitoring and treatment plan as a high priority and also inquire regularly about pain, respond appro- priately and refer wisely if unable to control it. More- over, 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 fundamen- tal human right and failure to provide pain relief be con- sidered as professional misconduct. Guidelines and standards of practice should be issued by professional bodies to enforce proper pain management 17 . 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. Sec- ond, tort rules give voice to patients who have been ignored, actively manipulated or cruelly treated by phy- sicians. Third, malpractice litigation drives institutional practice towards convergence on validated standards of practice. Fourth, tort law often articulates new du- ties 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 special- ist, be honest with the patient and watch out for patients interests over those of the providers 19 . Physicians clearly perceive a threat from the sys- tem, judging their risk of being sued as much higher than actually is. The Harvard new York Study, survey- ing New York Physicians, found that physicians who had been sued were more likely to explain risk to pa- tients, to restrict their scope of practice and to order more tests and procedures 20 . Hospitals have instituted risk management offices and quality assurance pro- grams, informed consent forms have become ubiqui- tous, medical record keeping with an eye toward es- tablishing proof of care at trial has become a rule 19 . Gaurab Maitra et al. Pain management:medico-legal issues [Downloadedfreefromhttp://www.ijaweb.orgonMonday,February04,2013,IP:202.43.187.35]||ClickheretodownloadfreeAndroidapplicationforthisjournal 770 Indian Journal of Anaesthesia, Dec 2008 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 21 . An example of statutory prohibition for doctors is contained in the South Australian Consent to Medical Treatment and Palliative Care Act of 1995 which pro- tects 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 with- out negligence and in accordance with proper profes- sional standards of palliative care 22 . A California Stat- ute imposed three obligations. First is a duty for doc- tors 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 treat- ment of pain 23 . 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 con- text of uncontrolled pain, an unreasonable failure to consult an expert in pain management 17 . Public interest litigation In 1998 in India on behalf of nations cancer pa- tients, Drs SR and RB Ghooi and the All India Law- yers 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 appli- cation for licenses and supplies of morphine must be attended to expeditiously and to allot morphine with- out delay and that aggrieved persons were granted freedom to approach court if dissatisfied. Criminal Law Is it possible for a health professional to be crimi- nally culpable in giving analgesia ? Criminal Law con- centrates on intention so that if the intention of the doc- tor is to relieve pain and not to shorten the life of the patient then the act of prescribing and dispensing anal- gesia is not a criminal act 17 . Professional Misconduct Professional misconduct includes conduct that offends against the traditions of the profession 24 , and is more than mere negligence 25 . Negligent misman- agement of pain alone is not sufficient. More likely, poor pain management may fall under unprofessional con- duct. This has occurred twice in United States , State medical boards of Oregon (in 1999) and California (in 2003) have disciplined individual doctors for unpro- fessional conduct related to inadequate pain manage- ment 17 . The most recent update of the US Federation of State Medical Boards Model Policy for the use of Controlled Substances for the Treatment of Pain ad- dresses the balance between patients rights and pa- tient responsibilities with respect to pain management, principally opioid therapy 26 . 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 dissemi- [Downloadedfreefromhttp://www.ijaweb.orgonMonday,February04,2013,IP:202.43.187.35]||ClickheretodownloadfreeAndroidapplicationforthisjournal 771 nation of guidelines on pain management, advocacy of improved access to opioid analgesics and national pro- grams of palliative care and pain relief 17 . Deregulation of Medical Opioid Availability As narcotics, opioids are subject to both interna- tional 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 con- trol 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 17 . 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 27 . In 2006, the DEA issued an informational outline of the Controlled Substances Act that while acknowledging the appro- priateness of prescribing controlled substances for le- gitimate medical purposes devoted far more attention to articulating an array of regulatory requirements for doing so and penalties for non-compliance 28 . Negligent infliction of mental distress Can a patient or family sue for infliction of emo- tional 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 emo- tional distress under particularly egregious circum- stances. One example is Oswald v Legrand 29 . 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 state- ment 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) 30 . Guidelines and Standards of Practice Malpractice is usually defined as an unskillful prac- tice resulting in injury to the patient, constituting a fail- ure to exercise the required degree of care, skill and diligence under the circumstances (Bardessono v Michels) 31 . What a minimally competent practitioner must know has not been derived from an external au- thority like government standard, but rather from medi- cal 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 32 . The guidelines developed by national medical or- ganizations provide a source of standards against which to judge the conduct of the defendant physician. A widely accepted clinical standard may be a presump- tive 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. Organi- zations such as the Agency for Health Care Policy and Research, Agency for Health Care Research and Qual- ity, American Pain Society, American Academy of Pain Medicine and American Society of Anesthesiologists have promulgated pain control standards 19 . Websites have proliferated to help physicians gain efficient and user friendly access to this even greater proliferation of guidelines and medical information 33 . 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 Gaurab Maitra et al. Pain management:medico-legal issues [Downloadedfreefromhttp://www.ijaweb.orgonMonday,February04,2013,IP:202.43.187.35]||ClickheretodownloadfreeAndroidapplicationforthisjournal 772 Indian Journal of Anaesthesia, Dec 2008 guidelines and their relative ease of access (Warrick v Giron) 34 . Physicians legal responsibilities The doctrine of informed consent Physicians are required to disclose alternative methods of treatment along with their risks and conse- quences 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 patients malpractice com- plaint for pain management 19 . 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 at- tempt to obtain and review. In recording patient histo- ries, a good pain history is strongly recommended. At- tention to prior pain symptoms is of significance in legal medical process. Lack of prior pain symptoms is typi- cally used by plaintiffs attorney to support casual rela- tionship between a compensable condition and a le- gally 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 patients legal repre- sentative 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 35 . Medical Report Not infrequently, a doctors first encounter with the lawyer is a written request for a copy of the doctors medical records on the patient and a medical report setting out the course of treatment and the doctors opinion. The accuracy of the medical report is directly dependent on the accuracy and the completeness of the medical records. The medical report should indi- cate history, treatment, diagnosis, causation and progress. The legal system requires that such opinions be offered within the realm of reasonable medical cer- tainty or probability. Every doctor is advised to consult with a respected lawyer with litigation expertise to learn the meaning of reasonable medical certainty or reason- able medical probability because these terms may be used in the legal jurisdiction where the doctor practices medicine 35 . 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 in- stitution whether a hospital, nursing home or clinic is liable to its patients for negligence in maintaining its fa- cilities, providing and maintaining medical equipment, hiring, supervising and retaining nurses and other em- ployees. 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, al- though it need not be state of art 19 . Corporate negligence A hospital is directly liable for the failure of ad- ministrators and staff to properly monitor and super- vise the delivery of health care within the hospital. The liability arises from the hospitals action or inaction re- garding its policies, rather than the specific negligent acts of one of its employees (Moser v. Heistand) 36 . 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 patients safety and well being while [Downloadedfreefromhttp://www.ijaweb.orgonMonday,February04,2013,IP:202.43.187.35]||ClickheretodownloadfreeAndroidapplicationforthisjournal 773 at the hospital 37 . Most jurisdictions have held hospitals to a duty to take reasonable steps to ensure the com- petence of its medical staff 38 . A failure to provide train- ing and feedback and to detect physician reluctance to use proper techniques provides an argument of corpo- rate negligence 19 . 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 tem- perature, pulse, respiration and blood pressure 39 . In 1991, Joint Commission on Accreditation of Health Care Organizations (JCAHO) mandated pain be rou- tinely assessed and outcomes of care be routinely docu- mented 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 evi- dence of the standard of care once they are implemented for the hospitals accreditation 19 . The Emergency Medi- cal Treatment and Labor Act (EMTALA) requires cov- ered hospitals to provide a medical screening exami- nation to any patients coming into the emergency de- partment of the hospital 40 . Severe physical pain that could have been avoided with appropriate medical care is arguably a material deterioration of a patients con- dition (Wey v. Evangelical Community Hospital) 41 EMTALA offers a statutory basis for suit in emergency admissions when patients are not properly screened or stabilized for pain 19 . Progress in pain management has been slow- the result of continued uncertainty by providers as to ap- propriate 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 JCAHOs Statement of Pain Assessment and Management establishes a new stan- dard of pain as the fifth vital sign which must be moni- tored and treated by hospitals for continued accredita- tion. Second, pain management clinical practice guide- lines 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 cur- riculum 19 . References 1. International Association for the Study of Pain. Pain Terms:A List with Definitions and Notes on Usage. Pain 1979; 6 :249-52. 2. Marks RM and Sachar EJ Undertreatment of medical inpatients with narcotic analgesics. Annals of Int Med 1973; 78:173-81. 3. Bernabel R, Gatsonis C, and Mor V. Management of pain in elderly patients with cancer. JAMA 1998; 279: 1877-82. 4. Oden R. 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