The proposed rule amendments are intended to set forth the appropriate standards for all physicians who prescribe or dispense controlled substances for the treatment of pain.

DEPARTMENT OF HEALTH
Board of Medicine

Rule No.: RULE TITLE
64B8-9.013: Standards for the Use of Controlled Substances for the Treatment of Pain
PURPOSE AND EFFECT: The proposed rule amendments are intended to set forth the appropriate standards for all physicians who prescribe or dispense controlled substances for the treatment of pain.
SUMMARY: The proposed rule amendments clarify the Board’s rule with regard to the appropriate standards for all physicians who prescribe or dispense controlled substances for the treatment of pain.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board has determined that the proposed rule amendments will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 458.309(1), 458.331(1)(v) FS.
LAW IMPLEMENTED: 458.326, 458.331(1)(g), (t), (v) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Jr., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

64B8-9.013 Standards for the Use of Controlled Substances for the Treatment of Pain.

(1) through (2) No change.

(3) Standards. The Board has adopted the following standards for the use of controlled substances for pain control:

(a) Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record shall 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 shall should document the presence of one or more recognized medical indications for the use of a controlled substance.

(b) Treatment Plan. The written treatment plan shall should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall should adjust drug therapy, if necessary, 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.

(c) Informed Consent and Agreement for Treatment. The physician shall 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 incompetent. The patient shall should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician shall should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:

1. through 3. No change.

(d) Periodic Review. Based At reasonable intervals based on the individual circumstances of the patient, the physician shall should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy shall should depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician shall should reevaluate the appropriateness of continued treatment. The physician shall should monitor patient compliance in medication usage and related treatment plans.

(e) Consultation. The physician shall should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.

(f) Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:

1. The complete medical history and a physical examination, including history of drug abuse or dependence, as appropriate;

2. through 7. No change.

8. Instructions and agreements; and

9. Drug testing results; and

10.9. Periodic reviews. Records must remain current, and be maintained in an accessible manner, and readily available for review, and must be in full compliance with Rule 64B8-9.003, F.A.C., and Section 458.331(1)(m), F.S.

(g) No change.

Rulemaking Specific Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.326, 458.331(1)(g), (t), (v) FS. History–New 12-21-99, Amended 11-10-02, 10-19-03,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Rules Committee, Board of Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 6, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: June 18, 2010