A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Vermont

Vermont Board of Medical Practice: Policy for the Use of Controlled Substances for the Treatment of Pain

This policy is adapted from the Model Policy for the Use of Controlled Substances for the Treatment of Pain approved by the Federation of State Medical Boards of the US, Inc. in May 2004. The Introduction to that document may be found in Appendix A. The Vermont Board of Medical Practice Policy for the Use of Controlled Substances for the Treatment of Pain can be found at: http://healthvermont.gov/hc/med_board/documents/pain_policy.pdf

Section I: Preamble

• The Vermont Board of Medical Practice recognizes that principles of quality medical practice dictate that patients have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for patients with pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. For the purposes of this policy, the inappropriate treatment of pain includes nontreatment, undertreatment, overtreatment, the continued use of ineffective treatments, and initiation or continuation of treatment without appropriate evaluation and assessment.
• The diagnosis and treatment of pain is integral to the practice of medicine. The Board encourages physicians to view pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially urgent for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about assessing patients' pain and effective methods of pain treatment, as well as statutory requirements for prescribing controlled substances. Accordingly, this policy has been developed to clarify the Board's position on pain control, particularly as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management. Inappropriate pain treatment may result from physicians' lack of knowledge about pain management. Fears of investigation or sanction by federal, state, and local agencies may also result in inappropriate treatment of pain. Appropriate pain management is the treating physician's responsibility. As such, the Board will consider the inappropriate treatment of pain to be a departure from standards of practice and will investigate such allegations, recognizing that some types of pain cannot be completely relieved, and taking into account whether the treatment is appropriate for the diagnosis.
• The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain (resulting from trauma or surgery) and chronic pain (of cancer or noncancer origin). The Board will refer to current clinical practice guidelines and expert review in approaching cases involving management of pain. The medical management of pain should consider current clinical knowledge and scientific research and the use of pharmacologic and nonpharmacologic modalities according to the judgment of the physician. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain and treatment outcomes. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not the same as addiction.
• The Vermont Board of Medical Practice is obligated under the laws of the State of Vermont to protect the public health and safety. The Board recognizes that the use of opioid analgesics for other than legitimate medical purposes poses a threat to the individual and society and that the inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Accordingly, the Board expects that physicians will incorporate safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances.
• 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 and in the course of professional practice. The Board will consider prescribing, ordering, dispensing, or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician-patient relationship must exist and be appropriately documented, and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state and federal law is required.
• The Board will judge the validity of the physician's treatment of the patient based on available documentation rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors.
• Allegations of inappropriate pain management will be evaluated on an individual basis. The Board will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation. The physician's conduct will be evaluated to a great extent by his or her documentation of the management and outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis as well as any improvement in patient functioning and/or quality of life.

Section II: Guidelines

The Board has adopted the following criteria when evaluating the physician's treatment of pain, including the use of controlled substances:

• Evaluation of the Patient. A medical history must be obtained and a physical examination must be performed, and these should be evaluated, with documentation in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
• Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate whether any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the cause of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
• Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. Physicians should consider whether to enter a formal written agreement with patients that outlines the patients' responsibilities with respect to controlled substances. The following topics should be reviewed with patients orally and documented in the medical record or included in a written agreement (see Appendix B for samples of written agreements):
  • Prescriptions should be obtained from one physician and one pharmacy whenever possible;
  • Urine/serum or other types of toxicology/medication levels screening may be requested;
  • Number and frequency of refills and permissible methods for obtaining prescription refills; and
  • Reasons for which drug therapy may be discontinued and other possible consequences of violating the agreement.

  If discharge from the physician's practice is to be a potential consequence of violating the agreement, the physician must consider the clinical situation and must comply with the Board's policy on Termination of the Physician-Patient Relationship and all other applicable ethical, legal, and contractual obligations.

• Periodic Review. The physician should periodically review the course of pain treatment and any new information about the cause of the pain or the patient's state of health. Patients should be seen at least quarterly and as frequently as warranted by the clinical circumstances. Continuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Adequate documentation of these factors is essential. Objective evidence of improved or diminished function should be monitored, and information from family members or other caregivers should be considered in determining the patient's response to treatment. If the patient's progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.
• Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse, or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.
• Medical Records. The physician should keep accurate and complete records to include:
  1. Medical history and results of physical examination;
  2. Diagnostic, therapeutic, and laboratory results;
  3. Evaluations and consultations;
  4. Treatment objectives;
  5. Discussion of risks and benefits of therapy;
  6. Informed consent;
  7. Treatments given;
  8. Medications, including date, type, dosage, and quantity prescribed, documented in a clear manner in a readily accessible section of the medical record. Some physicians keep copies of all scheduled drug prescriptions in one section of the medical record; others use a flow chart for this purpose, such as the sample in Appendix C;
  9. Instructions and agreements; and
  10. Periodic reviews.

  Records should remain current and should be maintained in an accessible manner readily available for review.

• Prescription Medication Abuse and Diversion. Behaviors such as multiple claims of prescriptions or medications having been lost or destroyed, multiple attempts to obtain prescriptions from other clinicians or emergency rooms, concurrent abuse of alcohol or other drugs, and other behaviors may indicate abuse or diversion of pain medication. Physicians should carefully and objectively evaluate behaviors that may indicate prescription medication abuse or diversion while taking care to avoid misinterpreting attempts to achieve adequate pain relief as drug-seeking behaviors. The physician should review and consider the sensitivity, specificity, and marked limitations of toxicology screening methods used.
• Compliance With Controlled Substances Laws and Regulations.  To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state laws and regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration for specific federal rules governing controlled substances.

Section III: Definitions

For the purposes of these guidelines, terms are defined as follows:

• Acute Pain. Acute pain is the normal, predicted physiologic response to a noxious chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, trauma, and disease. It is generally time-limited.
• Addiction. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy for pain and are not the same as addiction.
• Chronic Pain. Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.
• Pain. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.
• Physical Dependence. Physical dependence is a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, docs not equate with addiction.
• Pseudoaddiction. Pseudoaddiction is the iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief-seeking behaviors resolve upon institution of effective analgesic therapy.
• Substance Abuse. Substance abuse is the use of any substance(s) for nontherapeutic purposes or use of medication for purposes other than those for which it is prescribed.
• Tolerance. Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Appendix A

Introduction from the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain.

The recommendations contained herein were adopted as one policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., May 2004.

Introduction

The Federation of State Medical Boards (the Federation) is committed to assisting state medical boards in protecting the public and improving the quality and integrity of healthcare in the United States. In 1997, the Federation undertook an initiative to develop model guidelines and to encourage state medical boards and other healthcare regulatory agencies to adopt policy encouraging adequate treatment, including use of opioids when appropriate for patients with pain. The Federation thanks the Robert Wood Johnson Foundation for awarding a grant in support of the original project and the American Academy of Pain Medicine; the American Pain Society; the American Society of Law, Medicine, & Ethics; and the University of Wisconsin Pain & Policy Studies Group for their contributions.

Since adoption in April 1998, the Model Guidelines for the Use of Controlled Substances for the Treatment of Pain have been widely distributed to state medical boards, medical professional organizations, other healthcare regulatory boards, patient advocacy groups, pharmaceutical companies, state and federal regulatory agencies, and practicing physicians and other healthcare providers. The Model Guidelines have been endorsed by the American Academy of Pain Medicine, the Drug Enforcement Administration, the American Pain Society, and the National Association of Stale Controlled Substances Authorities. Many states have adopted pain policy using all or part of the Model Guidelines. Despite increasing concern in recent years regarding the abuse and diversion of controlled substances, pain policies have improved because of the efforts of medical, pharmacy, and nursing regulatory boards committed to improving the quality of and access to appropriate pain care.

Notwithstanding progress to date in establishing state pain policies recognizing the legitimate uses of opioid analgesics, there is a significant body of evidence suggesting that both acute and chronic pain continue to be undertreated. Many terminally ill patients unnecessarily experience moderate to severe pain in the last weeks of life. The undertreatment of pain is recognized as a serious public health problem that results in a decrease in patients' functional status and quality of life and may be attributed to a myriad of social, economic, political, legal, and educational factors, including inconsistencies and restrictions in state pain policies. Circumstances that contribute to the prevalence of undertreated pain include:

1. lack of knowledge of medical standards, current research, and clinical guidelines for appropriate pain treatment;
2. the perception that prescribing adequate amounts of controlled substances will result in unnecessary scrutiny by regulatory authorities;
3. misunderstanding of addiction and dependence; and
4. lack of understanding of regulatory policies and processes. Adding to this problem is the reality that the successful implementation of stale medical board pain policy varies among jurisdictions.

In April 2003, the Federation membership called for an update to its Model Guidelines to assure currency and adequate attention to the undertreatment of pain. The goal of the revised model policy is to provide state medical boards with an updated template regarding the appropriate management of pain in compliance with applicable state and federal laws and regulations. The revised policy notes that the state medical board will consider inappropriate treatment, including the undertreatment of pain, a departure from an acceptable standard of practice. The title of the policy has been changed from Model Guidelines to Model Policy to betler reflect the practical use of the document.

The Model Policy is designed to communicate certain messages to licensees: that the state medical board views pain management to be important and integral to the practice of medicine; that opioid analgesics may be necessary for the relief of pain; that the use of opioids for other than legitimate medical purposes poses a threat to the individual and society; that physicians have a responsibility to minimize the potential for the abuse and diversion of controlled substances; and that physicians will not be sanctioned solely for prescribing opioid analgesics for legitimate medical purposes. This policy is not meant to constrain or dictate medical decision-making.

Through this initiative, the Federation aims to achieve more consistent policy in promotion of adequate pain management and education of the medical community about treating pain within the bounds of professional practice and without fear of regulatory scrutiny. In promulgating this Model Policy, the Federation strives to encourage the legitimate medical uses of controlled substances for the treatment of pain while stressing the need to safeguard against abuse and diversion.

State medical boards are encouraged, in cooperation with their state's attorney general, to evaluate their state pain policies, rules, and regulations to identify any regulatory restrictions or barriers that may impede the effective use of opioids to relieve pain. Accordingly, this Model Policy has been revised to emphasize the professional and ethical responsibility of the physician to assess patients' pain as well as to update references and definitions of key terms used in pain management.

The Model Policy is not intended to establish clinical practice guidelines nor is it intended to be inconsistent with controlled substance laws and regulations.

Prescriptions

19.3 Manner of issuance of a prescription drug order:

• 19.3.1 A prescription drug order, to be effective, must be issued for a legitimate medical purpose by a practitioner acting within the course of legitimate professional practice.
• 19.3.1.1 A prescription drug order must be communicated directly to a pharmacist in a licensed pharmacy. This may be accomplished in one of the following ways: A prescription drug order, including that for a controlled substance listed in schedules II through V, may be communicated in written form. A prescription drug order, including that for a controlled substance listed in schedules III through V, and in certain situations, that for a controlled substance listed in schedule II, may be communicated orally (including telephone voice communication) or by way of electronic transmission. See Rule Part A, Definitions for further explanation of "electronic transmission," which does include transmission by e-mail and facsimile.
• 19.3.1.2 If communicated orally or by way of electronic transmission, the prescription drug order shall be immediately reduced to a form by the pharmacist that may be maintained for the time required by laws or rules.
• 19.3.1.4 A prescription drug order for a schedule II controlled substance may be communicated orally or by way of electronic transmission only in the following situations and with the following restrictions. Otherwise, a prescription drug order for a schedule II controlled substance must be communicated in written form.
  1. A prescription drug order for a schedule II controlled substance may be communicated by the practitioner or the practitioner's agent by way of electronic transmission, provided the original written, signed prescription drug order is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in subsection (B) or (C) below in this section. The original, written prescription drug order shall be maintained in accordance with the section below on patient records.
  2. A prescription drug order for a schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be communicated by the practitioner or the practitioner's agent to the home infusion pharmacy by way of electronic transmission. The hard copy of such electronic transmission serves as the original, written prescription drug order for purposes of this subsection, and it shall be maintained in accordance with the section below on patient records.
  3. A prescription drug order for a schedule II controlled substance for a resident of a long-term care facility may be communicated by the practitioner or the practitioner's agent by way of electronic transmission. The hard copy of such electronic transmission serves as the original, written prescription drug order for purposes of this subsection, and it shall be maintained in accordance with the section below on patient records.
  4. In an emergency, a prescription drug order for a schedule II controlled substance may be communicated by the practitioner orally or by way of electronic transmission, provided that:
     1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription drug order signed by the prescribing practitioner);
     2. The orally communicated prescription drug order shall be immediately reduced to writing by the pharmacist, or if necessary, the prescription drug order communicated by way of electronic transmission shall be immediately reduced to a hard copy. The drug order must contain the information required in the subsection above on prescription drug orders;
     3. If the prescribing practitioner is not known to the pharmacist, he or she must make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a callback to the practitioner using the practitioner's phone number as listed in the telephone directory or other good faith efforts to ensure the practitioner's identity; and
     4. Within 72 hours after authorizing an emergency oral prescription drug order, the practitioner shall deliver a written prescription drug order for the emergency quantity prescribed to the dispensing pharmacist. In addition to conforming to the requirements of the subsection above on prescription drug orders, the prescription drug order shall have written on its face "Authorization for Emergency Dispensing," and the date of the orally or electronically transmitted prescription drug order. The written prescription drug order may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach this written prescription drug order to the emergency oral prescription drug order that had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription drug order. The pharmacist shall notify the nearest office of the US Drug Enforcement Administration if the prescribing practitioner fails to deliver a written prescription drug order.
     5. This document is available at: http://www.vtprofessionals.org/opr1/pharmacists/forms/rxrules.pdf

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Author Information

Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee http://www.legalsideofpain.com

Disclosure: Jennifer Bolen, JD, has disclosed that she has received grants for educational activities from King Pharmaceuticals and Cephalon. Ms. Bolen has also disclosed that she has served as an advisor or consultant to King Pharmaceuticals, Abbott Labs, PriCara, Calloway Labs, Millennium Labs, and Cephalon. Ms. Bolen has also disclosed that she serves as a speaker for King Pharmaceuticals, Abbott Labs, PriCara, Calloway Labs, Millennium Labs, and Cephalon.