A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Colorado

Summary

Colorado Law -- Controlled Substances Act -- Specific Sections Relating to Medical Treatment With Controlled Substances to Treat Pain (1997)

A practitioner may prescribe a controlled substance only as provided by Colorado law. A practitioner may not dispense a Schedule II controlled substance without a written prescription. Schedule III through V may not be dispensed without a written or oral prescription order, and must not be filled or refilled more than 6 months after the date thereof. Schedule III through V controlled substances may only be refilled 5 times following the filling of the original prescription order.

A practitioner may dispense or deliver a controlled substance to or for an individual for medical treatment or authorized research in the ordinary course of that practitioner's profession.

Colorado law states that "no civil or criminal liability or administrative sanction may be imposed on a pharmacist for action taken in reliance on a reasonable belief that an order purporting to be a prescription was issued by a practitioner in the usual course of professional treatment or in authorized research."

Disciplinary Action Prohibited in Certain Circumstances -- Intractable Pain

Under Colorado law, a physician shall not be subject to disciplinary action by the Board solely for prescribing controlled substances for the relief of intractable pain. "Intractable pain" means a pain state in which the cause of the pain cannot be removed and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts including, but not limited to, evaluation by the attending physician and one or more physicians specializing in the treatment of the area, system, or organ of the body perceived as the source of the pain. This act shall apply to disciplinary actions originating on or after the effective date of this act (August 6, 1997).

Colorado's Medical Board Guideline on the Use of Controlled Medications to Treat Pain (2004)

The Colorado Medical Board believes that all physicians should become knowledgeable about assessing patients' pain and effective methods of pain treatment, as well as statutory requirements for prescribing controlled substances. Thus, the Board developed these guidelines to clarify its position on 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 just as diligently as it would allegations of other misconduct relating to prescribing practices, 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.

Physicians should not fear disciplinary action from the Board for 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. If such prescribing meets these criteria, the Board will support physicians whose use of controlled substances has been questioned by another regulatory or enforcement agency. 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 not adhering strictly to 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.

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

• Patient evaluation should include a history and physical with specific attention to the patient's pain complaints, current and past treatments, underlying or coexisting diseases or conditions, effect of pain on function, and history of substance abuse.
• Treatment plans should state outcome objectives and plans for further evaluation and treatment, and drug therapy should be adjusted to meet individual patient needs. Additional treatment modalities or rehab may be necessary depending on pain etiology and extent of impairment.
• There should be an indication of a discussion of risks and benefits of treatment and informed consent. A written agreement should be considered for patients with a history of abuse or otherwise at high risk for abuse (the Board has a sample patient agreement for using opioid pain medication on the Internet at http://www.dora.state.co.us/Medical/policies/10-14SampleContract.doc), and patients should receive prescriptions from a single physician and pharmacy when possible.
• The physician should periodically review the course of treatment and the patient's health, and continuation or medication of treatment should depend on the assessment of progress toward treatment objectives. Objective evidence of treatment outcomes and information from family progress is unsatisfactory; the physician should reassess the appropriateness of the current treatment plan and consider other modalities.
• The physician should refer patients as necessary in order to achieve treatment objectives, and pay special attention to those patients who are at risk for misuse or diversion. The management of patients with comorbid psychiatric issues or history of substance abuse may require extra care and monitoring as well as consultation with or referral to an expert in pain management.
• The medical record for chronic pain patients should document all the relevant issues with regard to evaluation and treatment as outlined above, including documentation of the presence of 1 or more recognized medical indications for the use of a controlled substance.
• The physician must be aware of and maintain compliance with federal and state regulations with regard to the use of controlled substances. (Refer to the Practitioner's Manual, 2006 of the US Drug Enforcement Administration, found on the Internet at http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html)

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, neurobiological 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.

Colorado Policy Statement on Prescribing Controlled Substances to an Unknown Patient

It is the position of the Colorado Board of Medical Examiners that it is unprofessional conduct for a physician to provide treatment and consultation recommendations, including issuing a prescription, via electronic or other means, unless the physician has obtained a history and physical evaluation of the patient adequate to establish diagnoses and identify underlying conditions and/or contraindications to the treatment recommended/provided.

Issuing a prescription on the basis of a questionnaire, Internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship, does not constitute an acceptable standard of care.

Before prescribing a drug, a physician should make an informed medical judgment based on the circumstances of the situation and on his/her training and experience. Ordinarily, this will require that the physician perform an appropriate history and physical examination, make a diagnosis, and formulate a therapeutic plan, a part of which might be a prescription.

A patient record should be initiated, and this process documented appropriately. Prescribing for a patient whom the physician has not personally examined may or may not be suitable under certain circumstances. These may include, but may not be limited to, admission orders for a newly hospitalized patient, prescribing for a patient of another doctor for whom the physician is taking call, or continuing medication on a short-term basis for a new patient prior to the patient's first appointment. Established patients may not require a new history and physical examination for each new prescription; however, charting of the prescription in the patient record is always required.