Connecticut Medical Examining Board
Adopted: February 15, 2005
Revised: June 21, 2005

Statement of the Connecticut Medical Examining Board on the Use of Controlled Substances for the Treatment of Pain
Section I: Preamble

The Connecticut Medical Examining Board (Board) recognizes that principles of quality medical practice dictate that the people of the State of Connecticut have access to appropriate and effective pain relief. The purpose of this statement is to express the Board’s support for the development and implementation of practices to assure the appropriate application of up-to-date knowledge and treatment modalities which 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 Statement, 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. Therefore, 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 in conjunction with terminal illness. All physicians and health care professionals should become knowledgeable about assessing patients’ pain and effective methods of pain treatment, as well as statutory and regulatory requirements for prescribing controlled substances. Accordingly this Statement has been developed to encourage physicians to consider the importance of pain control, particularly as related to the use of controlled substances and to encourage comprehensive pain management.

The Board recognizes that applicable standards of care permit the use of controlled substances including opioid analgesics in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. The Board also believes that physicians should be able to prescribe, dispense or administer controlled substances, including opioid analgesics, when done for a legitimate medical purpose and in accord with applicable standards of care and applicable law. The Board recognizes that the aim of current practice guidelines 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. Current practice guidelines accept that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not pathognomonic of addiction.

The Board acknowledges the medical community’s view that the goals of effective pain management include (i) pain is to be assessed and treated promptly; (ii) the amount of medication and frequency of dosing adjusted according to the intensity, duration of the pain, and treatment outcomes; (iii) consideration of current clinical knowledge and scientific research; and (iv) the use of pharmacologic and non-pharmacologic modalities.

The Board is obligated under the laws of the State of Connecticut to protect the public health and safety. Connecticut law reflects the public policy 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, current practice guidelines also note that effective pain management incorporates safeguards into the practice to minimize the potential for the abuse and diversion of controlled substances such as periodic reviews and written agreements outlining patient responsibility. However, physicians may face serious questions as to the legitimate medical purpose of a prescription where no physician-patient relationship exists or the prescription is not based on a diagnosis and clear documentation of pain.

As in all proceedings, matters involving issues of pain management will be reviewed and decided on a case-by-case basis. The Board may consider clinical practice guidelines, expert opinions, witness testimony, medical records and other relevant evidence. In accord with its case-by-case approach to such cases, the Board may not judge the validity of treatment solely on the quantity and duration of medication administration; may take into account whether the drug used is appropriate for the diagnosis as well as the outcome of pain treatment including improvement in patient functioning and/or quality of life; and will not assume that all types of pain can be completely relieved.

Section II: Treatment of Pain Practices

The Board recognizes that the medical community has encouraged the following practices as appropriate for the treatment of pain, including the use of controlled substances:

1. 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.

2. 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.

3. 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).

4. 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 may 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.

5. 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 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.

6. Medical Records
The physician should keep accurate and complete records to include

• the medical history and physical examination;
• diagnostic, therapeutic and laboratory results;
• evaluations and consultations;
• treatment objectives;
• discussion of risks and benefits;
• informed consent;
• treatments;
• patient response to treatments;
• medications (including date, type, dosage and quantity prescribed);
• instructions and agreements; and
• periodic reviews.

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

7. Compliance With Controlled Substances Laws and Regulations
To prescribe, dispense or administer controlled substances, the physician must be licensed in Connecticut and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration for specific rules governing controlled substances as well as applicable state statutes and regulations.

Section III: Definitions
For the purposes of this statement, 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.

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.