Influence of Government Regulations On Pain Treatment Requiring Opioids
C. Stratton Hill, Jr., M.D.
Professor Emeritus of Medicine University of Texas M. D. Anderson Cancer Center Houston, Texas
Influence of Government Regulations on Pain Treatment Requiring Opioids
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Pre-operative Period
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Patient physically dependent on opioids
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Acute pre- and intraoperative management of dependency Intraoperative management of adequate analgesia
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Code of Federal Regulations (CFR) 21 CFR 1306.07
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Applicable law for this situation t Implication for surgeon and hospital staff • Treatment of known drug addict • Legally, must have special license to prescribe for maintenance • Special provisions in CFR allow maintenance for surgical treatment
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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AHCPR Guidelines for Acute Pain –
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Surgery – Trauma – Medical Procedures t Recommendations only – have no official status in terms of sanctions
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JCAHO Pain Standards – 12 Requirements u Necessary for hospital & facility accreditation t Requires health care organizations to recognize the rights of patients to appropriate assessment & management of pain 4
Influence of Government Regulations on Pain Treatment Requiring Opioids
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What government agencies regulate opioids?
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State
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Licensing/disciplinary boards Local & state law enforcement Cancel DEA prescribing of Schedule drugs and criminal charges
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Federal
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Nature of Penalties Meted Out by Respective Agencies
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State t Suspension, revocation, canceling of medical license (administrative – civil) t Violation of state Controlled Substance Act (criminal) Federal t Violation of federal Controlled Substance Act (administrative/criminal)
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Why is treatment of acute pain less likely to fall below the “standard of practice” than treatment of chronic pain?
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Acute pain is self-limiting New “standard” that a few regulatory boards are taking cognizance of is “under treatment” of pain – California & Oregon t California – “elder abuse” – license sanctions t Oregon - license sanctions
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Are surgeons likely to run afoul of opioid prescribing regulations? – If so, when?
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Answer to first part of question – No, so long as acute post-operative pain is treated Answer to second part of question – Any physician who treats chronic pain is vulnerable to running afoul of regulatory/law enforcement agencies
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What is present regulatory/legal climate for prescribing opioids for chronic pain?
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Quasi friendly for treatment of chronic pain of cancer origin Hostile for treatment of chronic pain of noncancer origin
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Is such a legal/regulatory dichotomy rational?
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Evidence for the intensity and characteristics of pain being related to the etiology of the pain?
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Is not the goal of treating all types of pain to relieve it?
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Why then should the etiology of the pain be a consideration?
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Is there justification for dealing differently with pain caused by cancer compared to pain caused by equally painful non-cancer medical conditions?
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One possible justification??? - Since life expectancy is presumed to be limited with a diagnosis of cancer, death is predictable within a finite time and the patient has limited exposure and participation in “addiction”
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Limited exposure to “addiction” therefore obviates:
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Threat to our society t Time participating in Criminal activity is self limited (death not far away!) Time of cognitive impairment and poor quality of life is shortened t Limited time that family will have to endure loved one being a “drug addict”
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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By factoring death in the justification for opioid prescribing, death, then, becomes a part of the treatment plan
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Treatment plan for 8/10 chronic pain caused by cancer –
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Supportive therapy + OPIOID analgesic
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Treatment plan for 8/10 chronic pain caused by noncancer
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Supportive therapy + NON -OPIOID analgesic
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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States Control the Practice of Medicine by Licensing and Disciplining Physicians
A state law making body (state legislature) creates a law (medical practice act) and an agency (board of medical examiners) to fulfill this function The agency is given rule making authority to implement provisions of the law (medical practice act)
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What Are The Basic State Laws Applicable to Opioid Prescribing?
Model Example: Texas
INSTRUMENT Medical Practice Act Basic Instrument Intractable Pain Treatment Act Authority of Physician to Prescribe for Treatment of Pain IPTA Amended Electronic Monitoring Substituted For Paper Schedule II Rx TYPE Law Law Rules Law Law YEAR 1991 1989 1995 1997 1997
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What Federal Laws Apply to Opioid Prescribing? Title 21 – Part 1300 to End Code of Federal Regulations Rules & Regulations of the Drug Enforcement Administration
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Manifestations of regulatory and lawenforcement hostility to treating chronic non-cancer pain with opioids
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Failure of state and federal agencies to follow their own laws, rules, policy statements, and guidelines
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Manifestations of hostility……….cont’d
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Absence of due process in board proceedings
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Informal Settlement Conferences not subject to rules of legal procedure
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Law enforcement officials interpret medical decisions
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Determine: legitimate medical purpose and in usual course of medical practice
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Manifestations of hostility……….cont’d
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Selective punitive use of components of medical practice acts
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Documentation requirements
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Physical examination • ENT specialist doing rectal exams??? • Psychiatrist doing pelvic exams???
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Manifestations of hostility……….cont’d
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Refusal to accept prescribing of opioids to active drug addicts or persons with history of drug abuse who develop subsequent chronic painful medical conditions
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Though claiming documentation of such circumstances is all that is required to prescribe for such individuals, physicians are liable for sanctions for prescribing to known addicts and charges of drug diversion
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Influence of Government Regulations on Pain Treatment Requiring Opioids
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Solution to problem of inadequate treatment of chronic pain when opioids are required:
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Serious overall of legal proceedings at state level for physicians accused of inappropriate prescribing of opioids Serious overall of federal DEA procedures for criminal investigation of physicians
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SUMMARY
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State & Federal law allow drug dependent patients to be maintained on drugs (including alcohol) during pre - intra - and post-operative acute care Non-government guidelines impact institutional accreditation State disciplinary boards now recognizing inadequate pain treatment as practicing below the standard
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SUMMARY – Cont’d
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Both State & Federal Agencies regulate opioid use
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Consequences of State sanctions likely to impact practitioner more harshly than Federal Restriction - to - loss of license t Cost of defending against charges may be devastating despite ultimately prevailing
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SUMMARY – Cont’d
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Illogical distinction made between prescribing of opioids for pain of cancer origin and non-cancer origin despite characteristics and intensity of pain being the same.
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Physician more at risk of sanctions for treating patient with intractable non-cancer pain Reluctance to treat results in patient experiencing unnecessary pain & suffering
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SUMMARY – Cont’d
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Physicians charged with violating state medical practice acts should be concerned about their encounter with the disciplinary board because:
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Initial encounter is not subject to due process protection Board commonly ignores its own policies, guidelines, rules, and laws
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SUMMARY – Cont’d
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Physicians should be concerned with the freedom of the DEA to draw medical conclusions
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Charges and action taken before medical authorities have evaluated physician’s conduct DEA interpretation of physician’s action as illegal delivery of a controlled substance and conspiracy (with patients) to illegally deliver controlled substances
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CONCLUSIONS
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Treatment of acute pain is probably the only “safe harbor” for treating pain with opioids Educational efforts to inform state regulatory and state and federal law enforcement agencies about pain treatment have, at best, only been marginal and transitory
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CONCLUSIONS
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Efforts to date that have failed to provide a guide to a “safe harbor” for prescribing opioids for chronic non-cancer pain are:
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Policy statements issued separately by pain specialty societies Joint statements made by pain specialty societies with regulatory and law enforcement agencies
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CONCLUSIONS
Failed efforts to date (cont’d) Laws passed by state legislatures t Rules adopted by state regulatory boards t Guidelines issued by such boards
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CONCLUSIONS
If a “friendly climate” is to be developed for prescribing opioids for chronic non -cancer pain, the house of medicine must have the political will to effect a major overhaul of the states' medical practice acts to assure due process for physicians charged with inappropriate prescribing. This is the only chance the physician has to fairly have his/her conduct presented and judged
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