Pain Management and Regulatory Oversight, Tennessee Medicine

Publication Info: 
Tennessee Medicine, January 2008

By Judith Regan, MD, MBA, JD; Edward Hadley, JD; William M. Regan, MD, JD; and Arvis Wright, BS, CAP


INTRODUCTION
Physicians who adhere to well-established guidelines and seek expert help, when indicated, can relieve more than 90 percent of the pain associated with severe or terminal illnesses. Even in the infrequent instances when all palliative care alternatives have been exhausted without adequate relief from the symptoms of an advanced terminal disease, “sedation to the point of comfortable sleep” has been recognized as permissible. Patients with serious illnesses consider uncontrolled pain and other symptoms their primary concern and greatest fear. This article focuses on recent issues in pain management, including the role of state medical boards.

BACKGROUND
Recent studies continue to highlight the problems of inappropriate pain medication in patients, particularly those with terminal illnesses. U.S. Drug Enforcement Agency (DEA) prosecutions against physicians, as well as the legal debate concerning physician-assisted suicide, have exposed patient fears and concerns. The dynamic tension between adequately medicating patients suffering from chronic pain and the need to control illegal narcotic availability has put pain management in the forefront of medicine and law. In particular, physicians remain cautious and concerned about the involvement of the DEA and the state medical board in their treatment practices for their patients.

FEDERATION OF STATE MEDICAL BOARDS
Physicians believe that regulatory oversight of pain management can lead to a high risk of disciplinary action for prescribing narcotics and other controlled substances. Although most physicians know it is unlikely they will become the subject of a DEA investigation (unless they are prescribing for pay without attention to a patient’s overall medical condition or dealing drugs for profit), they remain concerned that aggressive pain management involving the use of narcotics will come to the attention of their state licensure board.

To assist with this concern, the Federation of State Medical Boards of the United States adopted Model Guidelines for the Use of Controlled Substances for the Treatment of Pain (FSMB, 1998). This effort, supported in part by a Robert Wood Johnson Foundation grant, considered in a nationally organized manner the issue of effective pain management relative to standards of practice for medical professionals. The guidelines were submitted to state licensure boards for adoption in the regulation of professional conduct. The guidelines recognize there is a growing problem with abuse of prescription medications and, at the same time, realize physicians who prescribe for legitimate medical purposes in the course of their professional practice should not fear disciplinary action. Tennessee’s Board of Medical Examiners (BME) is an active member of the FSMB.

According to the white paper on Pharmacy costs published by Blue Cross Blue Shield (BCBS), Tennessee has one of the highest per capita utilization of prescription drugs in the United States, including addictive schedule II narcotics such as hydrocodone. According to BCBS, Tennessee’s state prescription use stood at 17.9 prescriptions per individual while the national average was 11.5. Hydrocodone was the number one prescription written in Tennessee. Consequently, the number of disciplinary actions instituted each year against Tennessee physicians arising out of the prescription of controlled substances could be affected in the future.

In many instances, the physician who is the subject of a disciplinary action arising out  of the prescription of narcotic pain medication is not intentionally violating the law by dealing drugs out of the back door of the office. Instead, such physicians are frequently “the inadvertent offender…with a warm heart and a desire to relieve pain and misery, who is always pressed for time and finds himself or herself prescribing controlled drugs on demand over prolonged periods without adequate documentation.” Many such physicians have not received any specific training in pain management since medical school or residency. Consequently, most have failed to document the types of physical findings recognized by the Tennessee BME as justification for long-term narcotic prescriptions. Unfortunately, innocent ignorance is not a defense to a disciplinary action.


TENNESSEE BOARD OF MEDICAL EXAMINERS
The Tennessee Board of Medical  Examiners has published a policy statement for the Management of Prescribing with Emphasis on Addictive or Dependence-Producing Drugs. The policy statement emphasizes that “[I]t is not what you prescribe, but how well you manage the patient’s care, and document that care in legible form, that is important.”6 The Board does not have a list of bad or disallowed drugs, nor does it have a formula for determining whether the dosage and duration of the administration of a drug was appropriate for the patient’s condition. However, the Board outlines a nine-step process to follow and document when prescribing pain medications.

Although practitioners should review the policy statement, the nine-step process includes the following:

  1.  Perform a work-up sufficient to support the diagnosis; if it does not, continue the work-up until a new diagnosis is supported.
  2.  Create a treatment plan that considers non-addictive treatment modalities.
  3.  Include documentation that nonaddictive treatment modalities are not appropriate or do not work before beginning a regimen of controlled drugs.
  4.  Document the absence of drug-seeking behavior at each encounter and your reasoning for determining that a patient who may exhibit a drug-seeking behavior is not a drug-seeker.
  5.  Include and document a discussion of the risks of dependency when obtaining the patient’s informed consent.
  6.  Document regular monitoring of the patient, including physical monitoring.
  7.  Keep detailed records of the type, dose, and amount of the drug prescribed. Keeping a copy of the actual paper prescription given to the patient is helpful in demonstrating that a prescription has been forged.
  8.  Maintain contact with the patient’s family as a source of information regarding the patient’s response to the therapy regimen.
  9.  Document decision-making establishing that these steps have been followed. The Board expressly states it expects the physician to create arecord showing:

                a. Proper indication for use of the drug or other therapy;
                b. Monitoring of the patient where necessary;
                c. The patient’s response to therapy based on follow-up visits; and
                d. All rationale for continuing or modifying the therapy.

Other considerations include documentation of pain complaints in a consistent and replicated form for each visit. Practitioners may also consider reviewing records for consistencies and inconsistencies in patient complaints. Most importantly, when inconsistencies are encountered, practitioners should document their rationale for resolving the issue if addictive modalities are to be continued.


In addition to reviewing the policy statement of the Tennessee BME, practitioners should also consider taking and implementing the teachings of a continuing medical education course in prescribing controlled substances. In particular, the Tennessee Medical Foundation and the Vanderbilt Institute for Treatment of Addiction (VITA) have developed a curriculum and appointed faculty to teach a CME course entitled “Prescribing Controlled Drugs.” A new resource for physicians is the Tennessee Prescription Safety Program (PSP), which offers “Proper Prescribing Practices: Schedule II Prescription Drug Abuse” via online courses or live seminars across the state, which also meets the BME’s new prescribing CME requirement.

Legal representation can be essential when a practitioner’s prescribing patterns become the subject of a board investigation. Practitioners who attempt to defend themselves in disciplinary actions may not obtain favorable outcomes. Practitioners who believe they can merely explain their conduct to their physician peers at a Board hearing may learn too late they are being prosecuted and interrogated by an attorney for the State of Tennessee, and will be held to legal evidentiary and procedural standards. An adverse result can be costly, resulting in civil monetary penalties of between $500 and $1,000 for each offense or suspension, revocation, or other sanction of professional license, which must be reported to the National Practitioner Data Bank, malpractice carriers, third-party payors, and credentialing facilities.

CONCLUSION
Despite the efficacy of narcotics and a commitment by the medical profession to treat pain, abundant evidence suggests that patients’ fears that they will not receive adequate treatment of distressing symptoms are justified. A lack of proper training and education for practitioners may contribute to inadequate or inappropriate pain treatment. In addition, physicians fear the regulatory oversight of pain management may result in disciplinary action and/or prosecution.

However, regulatory bodies at all levels recognize the importance of good pain control. The FSMB states, “Physicians should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose in the course of professional practice.”

To serve the needs of patients with painful conditions and avoid the pitfalls of prescribing controlled substances, practitioners in Tennessee should learn and implement the policy of the BME governing the prescription of controlled substances and take a continuing medical education course in prescribing narcotics. This path will also assist the practitioner and their legal counsel in successfully defending any disciplinary action arising out of the prescribing of pain medications.

References
1. Quill TE, Meier DE: The Big Chill — Inserting the DEA into End-of-Life care. NEJM 354(1):1-3. Jan 5, 2006.
2. McIntire T: Grandma’s Pain: Should claims of under-medication arise in new theories of elder abuse statutes or traditional medical malpractice negligence? Tennessee Bar Journal. Oct 2004. Available at http://www.tba.org/Journal_TBArchives/200410/TBJ-200410-logo.html. Accessed Dec 2007.
3. Edmondson WAD: Policy barriers to pain control. In Pain Management at the End of Life: Bridging the Gap between Knowledge and Practice (Chapter 12). Hospice Foundation, 2006. Available at http://www.hospicefoundation.org/teleconference/books/lwg2006/edmondson.pdf. Accessed Dec 2007.
4. FSMB: State Medical Board Directory – Members’ Listing. Available at http://www.fsmb.org/directory_smb.html#b11. Accessed Dec 2007.
5. Coulter SL: Rx for Pharmacy Costs in Tennessee: White Paper Update. 2002. Available at http://www.bcbst.com/about/news/reports-issues/docs/papers/TN_drug_cost.pdf. Accessed Dec 2007.
6. Tennessee Board of Medical Examiners: Policy Statement: Management of prescribing with emphasis on addictive or dependence producing drugs. Board Approved: Sep 1995. Available at http://health.state.tn.us/Downloads/bme_02.pdf. Accessed Dec 2007.
7. Rules of Tennessee Board Of Medical Examiners: Chapter 0880-2, General Rules And Regulations Governing The Practice Of Medicine. Oct 2007 revised. Available at http://www.tennessee.gov/sos/rules/0880/0880-02.pdf. Accessed Dec 2007.
8. Swiggart W, Spickard A, Jr., Dodd D: LessonsLearned From a CME Course in the Proper Prescribing
of Controlled Drugs. JTMA 95(5):192-93, 2002.
9. Institute for Clinical Systems Improvement (ICSI): Palliative care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI), 2007.

Dr. Judy Regan is an associate clinical professor of psychiatry at Vanderbilt University School of Medicine and an associate with North, Pursell & Ramos, PLC, in Nashville; Mr. Hadley is a partner with NPR with a practice that includes defending physicians in malpractice and licensure actions. Dr. Bill Regan is associate clinical professor of psychiatry at Vanderbilt University School of Medicine; and Ms. Wright is a certified administrative professional in the Division of Clinical Leadership, Tennessee Department of Mental Health and Developmental Disabilities (TDMHDD), Nashville.