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7 Articles in Volume 5, Issue #5
Effective Non-Drug Treatment of Depression
First Line Treatment of Musculoskeletal and Neuropathic Pain
Pain Drug Use Policy
Targeted Peripheral Analgesics in Chronic Pain Syndromes
Therapeutic Drug Monitoring
Tiredness and Chronic Pain Management
TMD/Facial Pain and Forward Head Posture

Pain Drug Use Policy

While state boards of medical examiners are responsible for adopting and enforcing a policy for the use of controlled substances for the treatment of pain, each state board must do so within the limits of federal-controlled substance laws and regulations.

Many state medical boards have based their pain drug policies on—or adopted outright—the model policy developed by the Federation of State Medical Boards (FSMB) and last updated in May 2004. The purpose of updating the model policy was done to assure currency and adequate attention to the undertreatment of pain. The FSMB has been promoting adoption of this latest model policy by sponsoring workshops around the country (visit www.FSMB.com for further information). Given the evolving nature of pain management, it is recommended that each doctor be informed of the applicable state medical board policy and whether it has been updated to be compatible with the current FSMB model policy.

The latest model drug use policy describes guidelines under the following basic headings:1

  • Evaluation of the Patient
  • Treatment Plan
  • Informed Consent and Agreement for Treatment
  • Periodic Patient Evaluation
  • Consultation
  • Medical Records
  • Compliance with Controlled Substances Laws and Regulations

While diligence in adhering to these guidelines will serve the doctor well in conforming to existing law, therapeutic blood serum drug levels (currently being compiled by Dr. Forest Tennant, MD, Dr.PH, Editor in Chief of this journal) are still a point of contention in the medical and enforcement community. Results of this ongoing study of chronic pain patients will be documented and disseminated by the end of this year to help establish reference blood ranges of therapeutic drugs for normal functioning. Until authoritative blood serum ranges are established, the typically high quantity of drugs prescribed for such patients continues to be a red flag for DEA investigation of possible drug diversion.

Model Policy for the Use of Controlled Substances for the Treatment of Pain

Reprinted with permission of Federation of State Medical Boards of the United States, Inc., www.fsmb.org. The recommendations contained herein were adopted as policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., May 2004.

Introductory Comments

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 health care in the United States. In 1997, the Federation undertook an initiative to develop model guidelines and to encourage state medical boards and other health care 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 health care regulatory boards, patient advocacy groups, pharmaceutical companies, state and federal regulatory agencies, and practicing physicians and other health care 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 State Controlled Substances Authorities. Many states have adopted pain policy using all or part of the Model Guidelines.1 Despite increasing concern in recent years regarding the abuse and diversion of controlled substances, pain policies have improved due to 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.2 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.3 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 state 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 better 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.

  1. As of January 2004, 22 of 70 state medical boards have policy, rules, regulations or statutes reflecting the Federation’s Model Guidelines for the Use of Controlled Substances for the Treatment of Pain and two (2) states have formally endorsed the Model Guidelines.
  2. SUPPORT Study Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients: JAMA, 274(20) (1995): p. 1591-1598.
  3. A.M. Gilson, D.E. Joranson, and M.A. Mauer, Improving Medical Board Policies: Influence of a Model, J. of Law, Medicine, and Ethics, 31 (2003): p. 128.

Section I: Preamble

The (name of board) recognizes that principles of quality medical practice dictate that the people of the State of (name of state) 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 those patients who suffer from 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, and the continued use of ineffective treatments.

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 have 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 due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. 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 non-pharmacologic 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, 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 (name of board) is obligated under the laws of the State of (name of state) to protect the public health and safety. The Board recognizes that the use of opioid analgesics for other than legitimate medical purposes pose 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 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 the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state or 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 the 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 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 and physical examination must be obtained, evaluated, and documented 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 if 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 etiology 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. The patient should receive prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including urine/serum medication levels screening when requested; number and frequency of all prescription refills; and reasons for which drug therapy may be discontinued (e.g., violation of agreement).

Periodic Review. The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health. 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. 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 in order 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. the medical history and physical examination, 2. diagnostic, therapeutic and laboratory results, 3. evaluations and consultations, 4. treatment objectives, 5. discussion of risks and benefits, 6. informed consent, 7. treatments, 8. medications (including date, type, dosage and quantity prescribed), 9. instructions and agreements, and 10. periodic reviews.

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

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 regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

Section III: Definitions

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

Acute Pain. Acute pain is the normal, predicted physiological 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 physiological 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. 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, does not equate with addiction.

Pseudoaddiction. 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 non-therapeutic 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.

DEA Perspectives

While state medical boards develop policy and enforce doctor compliance to a standard of care, the DEA is charged with enforcement of the Federal Controlled Substances Act (CSA) that is meant to balance the legitimate needs of pain patients versus the prevention of drug diversion.

The DEA has tried to accomplish this balancing act with limited success. On the one hand, DEA took pains on October 30, 2003 to assure the medical community that the “chilling effect” from their enforcement actions against doctors was a “myth” and then, 10 months later, posting a helpful, collaborative, 2-years-in-the-making FAQ titled ‘Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel,’ before yanking it two months later due to “misstatements.” Following are the two DEA postings.

The Myth of the “Chilling Effect”2 Doctors Operating Within Bounds of Accepted Medical Practice Have Nothing to Fear From DEA

Drug Enforcement Administration (DEA) statistics show that the vast majority of practitioners registered with DEA comply with the requirements of the Controlled Substances Act (CSA) and prescribe controlled substances in a responsible manner in treating their patients’ medical needs.

One of the the missions of the Drug Enforcement Administration (DEA), Diversion Control Program (DCP), is to prevent, detect and investigate the diversion of legitimately manufactured controlled substances. The Controlled Substances Act (CSA) requires doctors to become registered with DEA in order to prescribe, dispense or administer controlled drugs to their patients for legitimate medical reasons.

The DEA may initiate an investigation of a practitioner upon receipt of information of an alleged violation of the provisions of the CSA and may pursue sanctions against the practitioner based upon the facts determined from that investigation.

Since FY 1999 the DEA registrant population has continually increased reaching almost 1 million doctors (as of June 30, 2003). During this same time, DEA has pursued sanctions on less than one tenth of one percent of the registered doctors. The pie charts pictured put this in graphic perspective.

Table 1. Patient Characteristics Prior to Prolotherapy
  Number Percent
Total number of doctor registrants 963,385 100.0%
Investigations of doctors initiated FY 2003* 557 0.06%
Actions taken against doctors FY 2003* 441 0.05%
Arrests of doctors in FY 2003* 34 0.01%

Actions taken by DEA include: letters of admonition, informal hearings, civil penalties, voluntary surrenders of registration for cause, revocations of registrations, and arrests.

DEA Reversal on Collaborative FAQ

In August, 2004, The Drug Enforcement Administration (DEA) posted a 48-page FAQ titled ‘Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel’ on its website. This document had been jointly written with the University of Wisconsin Pain and Policy Studies Group and the Last Acts Partnership and had gone thru numerous iterations to satisfy DEA concerns over a period of two years. Once posted, DEA administrator Karen Tandy declared: The medical and law enforcement communities continue to work together to carefully balance the needs of legitimate patients for pain medications against the equally compelling need to protect the public from the risk of addiction and even possible death from these medications. ... The DEA is committed to assisting the overwhelming majority of health care providers who successfully strike that balance every day, as well as the law enforcement officers investigating diversion and abuse of pain medications.”3

However, this document was withdrawn within two months of it’s release without notification of the original collaborators with the following message posted on the website:

The document contained misstatements and has therefore been removed from the DEA Web site. DEA wishes to emphasize that the document was not approved as an official statement of the agency and did not and does not have the force and effect of law.

DEA recognizes that the proper use of controlled substances in the treatment of pain remains an extremely important issue. Accordingly, DEA intends to address this matter in the future.4

Finally, in the November 2004 issue of the Federal Register (Vol. 69, No. 220), the DEA addressed the “misstatements” that had caused the demise of the original document.5 Below is the verbatim entry from the November 2004 Federal Register:

Drug Enforcement Administration

[Docket No. DEA-258S]

Dispensing of Controlled Substances for the Treatment of Pain

Agency: Drug Enforcement Administration (DEA), Department of Justice.

Action: Interim policy statement.

Summary: In August 2004, DEA published on its Office of Diversion Control Web site a document entitled: ‘’Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel’’ (August 2004 FAQ). The August 2004 FAQ was not published in the Federal Register and was not an official statement of the agency. DEA subsequently withdrew the document because it contained misstatements. This interim policy statement explains how some of the statements in the August 2004 FAQ were erroneous. In addition, this interim statement explains how DEA plans to address in a future Federal Register document the issue of dispensing controlled substances for the treatment of pain.

For further information contact: William J. Walker, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537; telephone, (202) 307-7165.

Supplementary Information: In August 2004, DEA published on its Office of Diversion Control Web site a document entitled: ‘’Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel’’ (August 2004 FAQ). For the reasons provided below, the August 2004 FAQ was not an official statement of the agency and DEA subsequently withdrew the document because it contained misstatements. Nonetheless, the subject matter—dispensing controlled substances for the treatment of pain—is extremely important to the public health and welfare. As the agency primarily responsible for enforcement and administration of the federal laws and regulations governing controlled substances, DEA believes that further discussion of the subject is warranted for two fundamental reasons. First, the abuse of pharmaceutical narcotics and other prescription controlled substances is increasing in the United States. According to the latest National Survey on Drug Use and Health, which is published by the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), the number of Americans aged 12 or older who have engaged in illicit (nonmedical) use of pain relievers during their lifetime has risen to more than 31 million.1 A portion of this type of drug abuse is directly facilitated by a small number of physicians who dispense controlled substances for other than legitimate medical purposes and then fraudulently claim that the drugs were dispensed for the treatment of pain.

Second, chronic pain is a serious problem for many Americans. It is crucial that physicians who are engaged in legitimate pain treatment not be discouraged from providing proper medication to patients as medically justified. DEA recognizes that the overwhelming majority of physicians dispense controlled substances lawfully for legitimate medical reasons, including the treatment of pain. Accordingly, DEA plans to address the subject of dispensing controlled substances for the treatment of pain in a future Federal Register document, taking into consideration the views of the medical community. The document will be aimed at providing guidance and reassurance to physicians who engage in legitimate pain treatment while deterring the unlawful conduct of a small number of physicians and other DEA registrants who exploit the term ‘’pain treatment’’ as a pretext to engage in prescription drug trafficking. In the meantime, the agency wishes to correct here a few of the significant misstatements contained in the August 2004 FAQ.

Misstatements in the August 2004 FAQ

Although not an exhaustive discussion, the following is an explanation of some of the misstatements that were contained in the August 2004 FAQ.

Commencement of investigations. The August 2004 FAQ erroneously stated: ‘’The number of patients in a practice who receive opioids, the number of tablets prescribed for each patient, and the duration of therapy with these drugs do not, by themselves, indicate a problem, and they should not be used as the sole basis for an investigation by regulators or law enforcement.’’ In fact, each of the foregoing factors—though not necessarily determinative—may indeed be indicative of diversion. As one federal appeals court has correctly stated, one can glean from the reported cases in which physicians have been convicted of dispensing controlled substances for other than a legitimate medical purpose ‘’certain recurring concomitance of condemned behavior,’’ such as the following:

  1. An inordinately large quantity of controlled substances was prescribed.
  2. Large numbers of prescriptions were issued.
  3. No physical examination was given.
  4. The physician warned the patient to fill prescriptions at different drug stores.
  5. The physician issued prescriptions to a patient known to be delivering the drugs to others.
  6. The physician prescribed controlled drugs at intervals inconsistent with legitimate medical treatment.
  7. The physician involved used street slang rather than medical terminology for the drugs prescribed.
  8. There was no logical relationship between the drugs prescribed and treatment of the condition allegedly existing.
  9. The physician wrote more than one prescription on occasions in order to spread them out.

United States v. Rosen, 582 F.2d 1032, 1035-1036 (5th Cir. 1978) (citations omitted). Moreover, it is a longstanding legal principle that the Government ‘’can investigate merely on suspicion that the law is being violated, or even just because it wants assurances that it is not.’’ United States v. Morton Salt Co., 338 U.S. 632, 642-643 (1950). It would be incorrect to suggest that DEA must meet some arbitrary standard or threshold evidentiary requirement to commence an investigation of a possible violation of the Controlled Substances Act (CSA).

Refills of schedule II prescriptions. The August 2004 FAQ stated: ‘’Schedule II prescriptions may not be refilled; however, a physician may prepare multiple prescriptions on the same day with instructions to fill on different dates.’’ (Italics added.) The first part of this sentence is correct, as the CSA expressly states: ‘’No prescription for a controlled substance in schedule II may be refilled.’’ 21 U.S.C. 829(a). However, the second part of the sentence (italicized above) is incorrect. For a physician to prepare multiple prescriptions on the same day with instructions to fill on different dates is tantamount to writing a prescription authorizing refills of a schedule II controlled substance. To do so conflicts with one of the fundamental purposes of section 829(a). Indeed, as the factors quoted above from the Rosen case indicate, writing multiple prescriptions on the same day with instructions to fill on different dates is a recurring tactic among physicians who seek to avoid detection when dispensing controlled substances for unlawful (nonmedical) purposes. It is worth noting here that the DEA regulations setting forth the requirements for the issuance of a controlled substance prescription are set forth in 21 CFR 1306.01-1306.27.

Reselling of controlled substances. The August 2004 FAQ listed a number of behaviors, or ‘’red flags,’’ that are ‘’probable indicators of abuse, addiction, or diversion.’’ These behaviors include ‘’selling medications.’’ The document suggested that certain steps be taken to deal with such indicators, including ‘’appropriate management’’ and possible referral to an addiction specialist. The document went on to state that these behaviors (including reselling medications) ‘’should not be taken to mean that a patient does not have pain, or that opioid therapy is contraindicated.’’ The document also stated: ‘’Management may or may not include continuation of therapy, depending on the circumstances.’’ Finally, the document stated that ‘’if continued opioid therapy makes medical sense, then the therapy may be continued, even if drug abuse has occurred. Additional monitoring and oversight of patients who have experienced such an episode is recommended.’’ (Italics added.)

The behaviors listed in the August 2004 FAQ as ‘’red flags’’ are indeed indicators of possible diversion. However, the August 2004 FAQ understated the degree of caution that a physician must exercise to minimize the likelihood of diversion when dispensing controlled substances to known or suspected addicts. If a physician is aware that a patient is a drug addict and/or has resold prescription narcotics, it is not merely ‘’recommended’’ that the physician engage in additional monitoring of the patient’s use of narcotics. Rather, as a DEA registrant, the physician has a responsibility to exercise a much greater degree of oversight to prevent diversion in the case of a known or suspected addict than in the case of a patient for whom there are no indicators of drug abuse. Under no circumstances may a physician dispense controlled substances with the knowledge that they will be used for a nonmedical purpose or that they will be resold by the patient.

In a similar vein, the August 2004 FAQ incorrectly minimized the potential significance of a family member or friend expressing concern to the physician that the patient may be abusing the pain medication.

The document stated: “Family and friends, or health care providers who are not directly involved in the therapy, may express concerns about the use of opioids. These concerns may result from a poor understanding of the role of this therapy in pain management or from an unfounded fear of addiction; they may be exacerbated by widespread, sometimes inaccurate media coverage about abuse of opioid pain medications.”

While it is true that concerns of family members are not always determinative of whether the patient is engaged in drug abuse, the above-quoted statement is incorrect to the extent it implies that physicians may simply disregard such concerns expressed to them by family members or friends. Indeed, a family member or friend might be aware of information that the physician does not possess regarding a patient’s drug abuse. Given the addictive and sometimes deadly nature of prescription narcotic abuse, the tremendous volume of such drug abuse in the United States, and the propensity of many drug addicts to attempt to deceive physicians in order to obtain controlled substances for the purpose of abuse, a physician should seriously consider any sincerely expressed concerns about drug abuse conveyed by family members and friends. It bears emphasis that none of the principles summarized above is new. Rather, these are concepts that have been incorporated for more than 80 years into the federal laws and regulations governing drugs of abuse and are reflected in published federal court decisions and DEA final administrative orders. A more detailed recitation of these principles, as they relate to the dispensing of controlled substances for the treatment of pain, will be provided in a future Federal Register document to be published by the agency.

Nature of this Document and the August 2004 FAQ Under the Administrative Procedure Act

This document is a statement of policy within the meaning of the Administrative Procedure Act (APA). It is termed an ‘’interim’’ statement to indicate that a more complete statement on the subject will subsequently be issued by the agency. (Given the misstatements in the August 2004 FAQ, and the significant questions DEA has received following the withdrawal of that document, an immediate preliminary explanation is warranted.) The APA expressly requires agencies to make available to the public and publish in the Federal Register statements of general policy and interpretations formulated and adopted by the agency. 5 U.S.C. 552(a)(1)(D). Further, the APA contemplates that agencies shall issue policy statements without engaging in the notice-and comment proceedings that are required for legislative rules. 5 U.S.C. 553(b)(A). This is because policy statements, unlike legislative rules, are not binding. Consistent with these APA principles, this document does not create any new substantive requirements or change the rights and duties of any member of the public; nor is DEA applying the CSA or DEA regulations in a new manner as a result of this document. Rather, this document provides the public with DEA’s policy for ensuring that the law administered by the agency relating to the subject matter of this document is faithfully executed.

It also bears emphasis that the August 2004 FAQ was not an official statement of the agency. As indicated above, the APA requires publication in the Federal Register of agency policy statements or interpretations of the law administered by the agency. The August 2004 FAQ was not published by the agency in the Federal Register and did not constitute an authoritative or official statement of the agency.

Dated: November 12, 2004; Michele M. Leonhart, Deputy Administrator. [FR Doc. 04-25469 Filed 11-12-04; 10:57 am]

Conclusion

It is most unfortunate that the most efficacious drugs for patients suffering severe, unrelenting chronic pain are also the very same drugs subject to diversion and abuse. And yet it is clear from the most recent revision of FSMB model policy that there is a recognition by the medical community of the undertreatment of pain patients in the U.S. While the state boards of medical examiners are receptive to adopting or incorporating the FSMB model policy as guidelines of behavior for doctors under their jurisdiction, current DEA policies regarding aggressive enforcement of the Federal Controlled Substances Act (CSA) continues to have an effect on the prescribing habits of pain doctors. Those most impacted, out of the almost one million DEA registrants, are the small subset of pain doctors who prescribe for chronic pain patients. The latter, by the very nature of their condition, require high doses of controlled substances to function in daily living.

Despite recent setbacks, the DEA has indicated that they will continue the dialogue with the medical community to ensure those requiring pain medication receive it unhindered. To that end, we anticipate that Dr. Tennant’s ongoing study to collect blood therapeutic drug ranges of chronic pain patients will help establish a benchmark and confirm that the overwhelming majority of high-prescribing pain doctors are simply providing the necessary standard of care to those in desperate need of pain relief.

Last updated on: December 20, 2011
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