GENERAL LICENSING RULES, RELATING TO CONTROLLED SUBSTANCES
Scheduled II Controlled Substance — Bariatrics Practice
(1) A licensee shall not utilize a Schedule II controlled substance for purposes of weight reduction or control.
(2) A violation of any provision of this rule, as determined by the Board, shall constitute Unprofessional Conduct as the term is used in ORS 677.188(4)(a), (b), or (c), whether or not actual injury to a patient is established.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.188 & 677.190
Hist.: ME 1-1987, f. & ef. 1-20-87; ME 1-1995, f. & cert. ef. 2-1-95; OMB 8-2016, f. & cert. ef. 7-8-16
Schedule III or IV Controlled Substances — Bariatrics Practice
(1) A licensee shall not utilize a Schedule III or IV controlled substance for purposes of weight reduction, other than in accordance with federal Food and Drug Administration (FDA) product guidelines in effect at the time of utilization and with all the provisions of this rule.
(2) A licensee may utilize a Schedule III or IV controlled substance for purposes of weight reduction in the treatment of Exogenous Obesity in a regimen of weight reduction based on caloric restriction, behavior modification and prescribed exercise, provided that all of the following conditions are met:
(a) Before initiating treatment utilizing a Schedule III or IV controlled substance, the licensee thoroughly reviews the licensee’s own records of prior treatment, or thoroughly reviews the records of prior treatment which another treating health care professional or weight-loss program has provided to the licensee, that one of the following conditions exist:
(A) Patient's body mass index exceeds 30 Kg/M sq; or
(B) Patient's body mass index exceeds 27 Kg/M sq and the excess weight represents a threat to the patient's health (as with hypertension, diabetes, or hypercholesterolemia.)
(b) Before initiating treatment utilizing a Schedule III or IV controlled substance, the licensee obtains a thorough history, performs a thorough physical examination of the patient, and rules out the existence of any recognized contraindications to the use of the controlled substance to be utilized.
(3) Continuation of Schedule III or IV designated as FDA short term use controlled substances beyond three (3) months requires documentation of an average two (2) pound per month weight loss during active weight reduction treatment, or documentation of maintenance of goal weight. Use of Schedule III or IV controlled substances with FDA approval for bariatric therapy and designated for long term use where FDA guidelines are followed may also be used beyond three months.
(4) A violation of any provision of this rule, as determined by the Board, shall constitute Unprofessional Conduct as the term is used in ORS 677.188(4)(a), (b), or (c), whether or not actual injury to a patient is established.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.188(4) & 677.190(24)
Hist.: ME 1-1987, f. & ef. 1-20-87; ME 1-1995, f. & cert. ef. 2-1-95; ME 1-1997, f. & cert. ef. 1-28-97; BME 9-1998, f. & cert. ef. 7-22-98; BME 17-2000(Temp), f. & cert. ef. 10-30-00 thru 2-28-01; BME 4-2001, f. & cert. ef. 1-25-01; OMB 8-2016, f. & cert. ef. 7-8-16
Maintenance of Controlled Substances Log by Prescribing Practitioners
Any practitioner dispensing or administering controlled substances from the practitioner's office must have a Drug Enforcement Administration registration indicating the address of that office. The practitioner shall maintain an inventory log showing all controlled substances received, and administered or dispensed. This log shall also list for each controlled substance, the patient's name, amounts used, and date administered or dispensed. This log shall be available for inspection on request by the Oregon Medical Board or its authorized agents. Controlled substances samples are included in this rule.
Stat. Auth.: ORS 677
Stats. Implemented: ORS 475.165
Hist.: ME 15-1987, f. & ef. 8-3-87
Maintenance of Controlled Substances Log — Ambulance and Medical Rescue Services Receiving Controlled Substances from Physicians
Any physician providing controlled substances for use by ambulance and medical rescue services must have a Drug Enforcement Administration registration for the address where the controlled substances and inventory log are stored. The inventory log at the registered address shall be maintained showing all controlled substances received, or dispensed to the emergency vehicle. The administration log shall also show for each controlled substance, the patient's name and amount used, date, and by whom administered or dispensed, and may be maintained in the emergency vehicle. This log should be reviewed for accuracy on a monthly basis and be readily retrievable for inspection on request by the Board, the ambulance licensing authority as specified in ORS 682.015, or their authorized agents.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 682.245
Hist.: ME 10-1987, f. & ef. 4-28-87; ME 1-1997, f. & cert. ef. 1-28-97; BME 8-2001, f. & cert. ef. 7-18-01
Dispensing, Distribution and Administration
(1) Any actively licensed physician or podiatric physician who dispenses drugs must register with the Board as a dispensing physician before beginning to dispense drugs.
(2) A physician must register with the Board as a dispensing physician before supervising a physician assistant or any other health care provider with dispensing privileges.
(3) At the time of license registration renewal, all dispensing physicians must indicate their status as a dispensing physician on the registration renewal form.
(4) Dispensing of drugs must be documented in the patient record. Documentation must include the name of the drug, the dose, the quantity dispensed, the directions for use and the name of the physician or physician assistant dispensing the drugs. The physician or physician assistant must verbally counsel the patient concerning any new medications and must provide written information on the directions for use.
(5) Distribution of samples, without charge, is not dispensing under this rule. Distribution of samples must be documented in the patient record. Documentation must include the name of the drug, the dose, the quantity distributed and the directions for use. The physician or physician assistant must verbally counsel the patient concerning any new medications and must provide written information on the directions for use.
(6) Administering drugs in the physician's or podiatric physician's office is not dispensing under this rule. Administration of drugs must be documented in the patient record. Documentation must include the name of the drug, the dose and the quantity administered.
(7) Any physician or podiatric physician who dispenses drugs or who supervises a physician assistant with drug dispensing authority without first registering with the Board will be fined $195 and may be subject to further disciplinary action by the Board.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.010, 677.089, 677.510, 677.515
Hist.: ME 22-1987, f. & ef. 10-29-87; ME 9-1993, f. & cert. ef. 7-27-93; BME 1-2005, f. & cert. ef. 1-27-05; BME 24-2007, f. & cert. ef. 10-24-07; OMB 30-2011, f. & cert. ef. 10-27-11; OMB 32-2013, f. & cert. ef. 10-15-13
Written Notice Disclosing the Material Risks Associated with Prescribed or Administered Controlled Substances for the Treatment of “Intractable Pain”
(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):
(B) Central Nervous System;
(H) Pregnancy, and
(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.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.097, 677.190, 677.470, 677.474, 677.480
Hist.: ME 4-1996, f. & cert. ef. 7-26-96; BME 8-2000, f. & cert. ef. 7-27-00; BME 6-2004, f. & cert. ef. 4-22-04; BME 9-2008, f. & cert. ef. 4-24-08; OMB 8-2016, f. & cert. ef. 7-8-16
Attending Physicians Prescribing Medications to Physician-Assisted Death with Dignity Patients
Attending physicians prescribing medications pursuant to ORS 127.800–127.897 must:
(1) Dispense medications directly, including ancillary medications intended to facilitate the desired effect to minimize the patient's discomfort, provided the attending physician is registered as a dispensing physician with the Oregon Medical Board, has a current Drug Enforcement Administration (D.E.A.) certificate, and complies with the provisions of ORS 677.089, OAR 847-015-0015 and 847-015-0025; or
(2) With the patient's written consent:
(a) Contact a pharmacist, and inform the pharmacist of the purpose of the prescription; and
(b) Deliver the written prescription personally or by mail to the pharmacist who will dispense the medications to either the patient, the attending physician, or an expressly identified patient's agent.
Stat. Auth.: ORS
Stats. Implemented: ORS 127.800 - 127.995
Hist.: BME 3-1998(Temp), f. & cert. ef. 4-8-98 thru 10-5-98; BME 10-1998, f. & cert. ef. 7-22-98; OMB 29-2012, f. & cert. ef. 11-22-12
Collaborative Drug Therapy Management
(1) "Collaborative Drug Therapy Management" as used in this section means the participation by a physician and a pharmacist in the management of drug therapy pursuant to a written protocol that includes information specific to the dosage, frequency, duration and route of administration of the drug, authorized by a physician and initiated upon a prescription order for an individual patient and:
(a) Is agreed to by one physician and one pharmacist; or
(b) Is agreed to by one or more physicians in a single organized medical group, such as a hospital medical staff, clinic or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee, and one or more pharmacists at a single pharmacy registered by the Board of Pharmacy.
(2) A physician shall engage in collaborative drug therapy management with a pharmacist only under a written arrangement that includes:
(a) The identification, either by name or by description, of the participating pharmacist(s);
(b) The identification, by name, of the participating physician(s);
(c) The name of the physician and principal pharmacist who are responsible for development, training, administration, and quality assurance of the arrangement;
(d) A detailed description of the collaborative role the pharmacist(s) shall play, including but not limited to:
(A) Written protocol for specific drugs pursuant to which the pharmacist will base drug therapy management decisions for an individual patient;
(B) Circumstances which will cause the pharmacist to initiate communication with the physician, including but not limited to the need for new prescription orders and reports of patients' therapeutic responses or adverse effects;
(C) Training requirement for pharmacist participation and ongoing assessment of competency, if necessary;
(D) Quality assurance and periodic review by a panel of the participating physicians(s) and pharmacist(s).
(e) Authorization by the physician(s) for the pharmacist(s) to participate in the collaborative drug therapy;
(f) A provision for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years; and
(g) A description of the mechanism for the pharmacist(s) to communicate to the physician(s) and for documentation of the implementation of the collaborative drug therapy.
(3) Collaborative drug therapy management is valid only when initiated upon the prescription order of a participating physician for each individual patient.
(4) Nothing in this rule shall be construed to allow therapeutic substitution.
(5) The collaborative drug therapy protocol must be filed with the Board of Pharmacy, kept on file in the pharmacy and made available to the Board of Pharmacy and the Oregon Medical Board upon request.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 689.005(30)
Hist.: BME 12-1999, f. & cert. ef. 7-23-99
State Archives • 800 Summer St. NE • Salem, OR 97310