SECTION 510:5-9-2. Guidelines and requirements  


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  •   This rule requires that diagnosis be documented, it requires that certain records be maintained, and it requires that the physician must discuss the risks and benefits with the patient or the patient's guardian.
    (1)   To treat a patient's intractable pain, as long as the benefit of the expected relief outweighs the risk, even if the use of the drug increases the risk of death, so long as it is not furnished for the purpose of causing, or the purpose of assisting in causing death, the physician may prescribe or administer Schedule II, III, IV or V controlled dangerous substances or other pain relieving drugs in higher than normal dosages when, in that physician's judgment, the higher dosages are necessary to produce the desired therapeutic effect.
    (2)   The determination of intractable pain must include a complete medical history and physical examination which includes an assessment of the patient's pain, physical and psychological function, substance abuse history, underlying or co-existing diseases or conditions and the presence of a recognized medical indication for the use of an analgesic.
    (3)   The treatment plan must state objectives by which treatment success can be evaluated, such as pain relief and or improved physical and psychological function, and must indicate what further diagnostic evaluations or other treatments are planned. The drug therapy must be tailored to the individual needs of each patient.
    (4)   The course of treatment and any new information about the etiology of the intractable pain must be reviewed periodically, at least annually, with consideration given to referral for a current second opinion. The continuation or modification of treatment will depend on the results of this review and the evaluation of the patient's progress toward the treatment objectives. If the patient has not improved, the physician must assess the appropriateness of continuing the current therapy and the trial of other modalities.
    (5)   The management of intractable pain in patients with a history of substance abuse requires extra care, monitoring, documentation and consultation with addiction medicine specialists, and may include the use of agreements between the physician and patient specifying rules for medication use and consequences for its misuse.
    (6)   The physician must discuss the risks and benefits of the use of controlled substances with the patient or the patient's guardian and obtain informed consent prior to proceeding if it substantially increases the risk of death.
    (7)   Accurate and complete records documenting these requirements must be kept.
    (8)   To prescribe controlled substances, the physician must be licensed in Oklahoma, have a valid controlled substances registration and comply with federal and state regulations for issuing controlled substances prescriptions.
    (9)   Expert clinical testimony may be used to prove a violation of this rule. As used herein, a "clinical expert" is a physician who, by reason of specialized education or substantial relevant experience in pain management, has knowledge regarding current standards, practices and guidelines.
    (10)   Nothing in this rule shall limit a physician's authority to prescribe or administer prescription drug products beyond the customary indications as noted in the manufacturer's package insert for use in treating intractable pain, provided the drug is recognized for treatment of intractable pain in standard reference compendia or medical literature.
[Source: Added at 16 Ok Reg 2539, eff 6-25-99]