847-015-0030 Written Notice Disclosing the Material Risks Associated with Prescribed or Administered Controlled Substances for the Treatment of “Intractable Pain” (1) Definitions (a) “Controlled substance” has the meaning given that term under ORS 475.005. (b) “Intractable pain” means a chronic pain state in which the cause of the pain cannot be removed or otherwise treated and for which, in the generally accepted course of medical practice, no relief or cure of the cause of the pain has been found after reasonable efforts, including, but not limited to, evaluation by the treating health care professional. (2) Controlled substances may be prescribed for long term treatment of intractable pain. The records must contain the health care professional’s examination, diagnosis and any other supporting diagnostic evaluations and other therapeutic trials, including records from previous health care professionals. If there is a consulting health care professional, written documentation of his/her corroborating findings, diagnosis and recommendations shall be included in the record. (3) Before initiating treatment of intractable pain with controlled substances or, when it is apparent that pain which is already being treated with controlled substances has now become intractable, the health care professional shall discuss with the patient the procedures, alternatives and risks associated with the prescribing or administering controlled substances for long term management of pain. Following the discussion, the patient will be given an opportunity to request further explanations. When the patient is satisfied with the explanation of the issues related to the prescribing of these drugs over long periods of time, the health care professional shall provide to the person and the person shall sign a written document outlining the issues discussed associated with the prescribed or administered controlled substances. (4) The material risk notice should include but not be limited to: (a) The diagnosis; (b) The controlled substance and/or group of controlled substances to be used; (c) Anticipated therapeutic results; (A) Pain relief; (B) Functional goals; (d) Alternatives to controlled substance therapy; (e) Potential additional therapies to be used in conjunction with controlled substances; and (f) Potential side effects (if applicable): (A) Cardiovascular; (B) Central Nervous System; (C) Gastrointestinal; (D) Endocrine; (E) Respiratory; (F) Dermatologic; (G) Urinary; (H) Pregnancy, and (I) Other. (g) Allergy Potential; (h) Interaction/Potentiation of other medications; (i) Potential for dose escalation/tolerance; (j) Withdrawal precautions; (k) Potential for dependence and addiction; (l) Potential for impairment of judgment and/or motor skills; (m) Satisfaction with or desire for more explanation; and (n) Patient signature (dated). (5) The material risk consent form will be maintained as a permanent component of the patient record as shall documentation of long term follow-up to demonstrate the continued need for this form of therapy. A dispensing record of the amount and dose of the prescribed or administered controlled substances shall be maintained as part of the patient record. Statutory/Other Authority: ORS 677.265 Statutes/Other Implemented: ORS 677.097, 677.190, 677.470, 677.474 & 677.480 History: OMB 8-2016, f. & cert. ef. 7-8-16 BME 9-2008, f. & cert. ef. 4-24-08 BME 6-2004, f. & cert. ef. 4-22-04 BME 8-2000, f. & cert. ef. 7-27-00 ME 4-1996, f. & cert. ef. 7-26-96