64B15-14.005: Standards for the Use of Controlled Substances for Treatment of Pain
PURPOSE AND EFFECT: The proposed rule amendments clarify the rule with regard to the appropriate standards to be utilized in the use of controlled substances for the treatment of pain.
SUMMARY: The proposed rule amendments clarify the Boards 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 adverse impact on small business, nor will the proposed rule amendments be likely to directly or indirectly increase regulatory costs in excess of $200,000 in the aggregate in this state within 1 year after the implementation of the rule.
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: 459.005(1) FS.
LAW IMPLEMENTED: 459.003(3), 459.015(1)(g), (x) 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: Anthony Jusevitch, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256
THE FULL TEXT OF THE PROPOSED RULE IS:
64B15-14.005 Standards for the Use of Controlled Substances for Treatment of Pain.
(1) through (2) No change.
(3) Guidelines. The Board has adopted the following guidelines when evaluating 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 osteopathic physician shall should adjust drug therapy, if necessary, to the individual medical needs of each patient. Other treatment modalities, including osteopathic manipulative treatment and applications, 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 osteopathic 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 patients surrogate or guardian if the patient is incompetent. The patient shall should receive prescriptions from one osteopathic 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 osteopathic physician shall may 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 osteopathic 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 osteopathic physicians evaluation of progress toward stated treatment objectives such as improvement in patients pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living, and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the osteopathic physician shall should reevaluate the appropriateness of continued treatment. The osteopathic physician shall should monitor patient compliance in medication usage and related treatment plans.
(e) Consultation. The osteopathic 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 may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.
(f) Medical Records. The osteopathic 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 64B15-15.004, F.A.C., and Section 459.015(1)(o), F.S.
(g) No change.
Rulemaking Specific Authority 459.005(1) FS. Law Implemented 459.003(3), 459.015(1)(g), (x) FS. HistoryNew 3-9-00, Amended 11-14-06,_______.
