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OREGON STATE BOARD OF NURSING

 

DIVISION 56

ADVANCED PRACTICE REGISTERED NURSE AUTHORITY TO PRESCRIBE AND DISPENSE

851-056-0000

Definitions

(1) “Addiction” means a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Neither physical dependence nor tolerance alone, as defined by these rules, constitutes addiction.

(2) “Administer” means the direct application of a drug or device, whether by injection, inhalation, ingestion, or any other means to the body of a patient or research subject.

(3) “Advanced Practice Registered Nurse (APRN)” means a clinical nurse specialist, certified registered nurse anesthetist, or nurse practitioner licensed or state certified by the Board.

(4) “Assessment” means a process of collecting information regarding a client's health status including, but not limited to, illness, response to illness, health risks of individuals, families and groups, resources, strengths and weaknesses, coping behaviors, and the environment. The skills employed during the assessment process may include, but are not limited to, obtaining client histories, conducting physical examinations, and ordering, interpreting, and conducting a broad range of diagnostic procedures (e.g., laboratory studies, EKGs, and X-rays).

(5) “Client(s) or patient(s)” means a family, group or individual who has been assessed by and has a client or patient record established by the clinical nurse specialist or nurse practitioner.

(6) “Clinical education in patient management and pharmacotherapeutics” means a set of structured learning activities, including but not limited to, supervised clinical practice in the pharmacological management of individual clients, as well as other learning activities to promote understanding of pharmacological interventions congruent with the role and population sought for prescriptive authority.

(7) “Compounded Drug” means a combination preparation of the active ingredients of which are components of an FDA approved drug, or a drug which is still in common usage and predates the FDA approval process.

(8) “Diagnosis” means identification of actual or potential health problems or need for intervention based on analysis of the data collected.

(9) “Differential diagnosis” means the process of determining a medical diagnosis from among similar diseases and conditions based upon collection and analysis of clinical data.

(10) “Discrete pharmacology course” means an advanced pharmacology course with pharmacologically specific requirements, objectives, and content, which is offered for academic or continuing education credit, and is not integrated into other coursework.

(11) “Dispense” or “dispensing” means the labeling and distribution of a medication to the clinical nurse specialist’s or nurse practitioner's client which is prepackaged by a manufacturer registered with the State Board of Pharmacy, or repackaged by a pharmacist licensed with the State Board of Pharmacy.

(12) “Dispensing authority” means to prepare and deliver substances to the client provided the authority is exercised in compliance with applicable federal and state laws.

(13) “Distribute” means the delivery of a drug other than by administering or dispensing, such as prepackaged samples.

(14) “Functional impairment” means:

(a) Practicing nursing when unable or unfit to perform procedures and/or make decisions due to physical impairment as evidenced by documented deterioration of functioning in the practice setting and/or by assessment of a health care provider qualified to diagnose physical condition or status.

(b) Practicing nursing when unable or unfit to perform procedures and/or make decisions due to psychological or mental impairment as evidenced by documented deterioration of functioning in the practice setting, and/or by the assessment of a health care provider qualified to diagnose mental condition or status.

(c) Practicing nursing when physical or mental ability to practice is impaired by use of drugs, alcohol, or mind-altering substances.

(15) “Legend Drug” means:

(a) A drug which is required by federal law, prior to being dispensed or delivered, to be labeled with the following statement: “Caution: federal law prohibits dispensing without a prescription” or

(b) A drug which is required by any applicable federal or state law or regulation to be dispensed by prescription only or restricted to use by practitioners only.

(16) “Off Label” means the use of an FDA approved drug for other than FDA approved indications or dosing.

(17) “Orphan Drug” means a drug which has received orphan status from the US Food and Drug Administration because it targets a disease which affects less than 200,000 persons in the US.

(18) “Pain” means an unpleasant sensory and emotional experience related to adverse nociceptive or neuropathic stimuli. It may also be idiopathic in nature.

(a) “Acute pain” is brief and responds to timely intervention or subsides as healing takes place. Inadequate treatment may delay recovery. Such pain responds to anti-inflammatory and opioid medications, as well as to other approaches.

(b) “Chronic pain” is ongoing or frequently recurring and may become unresponsive to intervention over time.

(c) “Intractable pain” means a pain state in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts.

(19) “Pharmacodynamics” means the study of the biochemical and physiologic effects of drugs and their mechanism of action.

(20) “Pharmacokinetics” means the action of drugs in the body over a period of time.

(21) “Pharmacotherapeutics” means the study of the uses of drugs in the treatment of disease.

(22) ”Pharmacogenomics” means the study of the relationship between a specific person's genetic makeup and his or her response to drug treatment.

(23) “Physical dependence” means the physiologic adaptation to the presence of a medication characterized by withdrawal when its use is stopped abruptly.

(24) “Prescribe” means a written, verbal, or electronic legal directive to procure or designate for use legend drugs or controlled substances. Additionally, a prescription may be issued or required for use of over-the-counter medications.

(25) “Prescribing authority” means the legal permission to determine which drugs and controlled substances shall be used by or administered to a client.

(26) “Specialty” means the defined area of expertise such as that provided by academic education, clinical training, and may include additional legal or professional credentialing mechanisms.

(27) “Structured contact hours” means Continuing Medical Education (CME), or Continuing Education Unit (CEU) and other activities for which you receive academic or continuing education credit as evidenced by certificate or transcript.

(28) “Target audience” means a population for whom an educational program is designed.

(29) “Therapeutic device” means an instrument or an apparatus intended for use in diagnosis or treatment and in the prevention of disease or maintenance or restoration of health.

(30) “Tolerance” means the physiologic adaptation to a controlled substance over time, resulting in the need to increase the dose to achieve the same effect, or in a reduction of response with repeated administration.

Stat. Auth.: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.370, 678.372, 678.375, 678.380, 678.385, 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10; BN 3-2011, f. & cert. ef. 10-6-11; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0004

Prescriptive Authority Scope of Practice

(1) Prescribing, procuring or authorizing use of legend drugs, controlled substances, therapeutic devices, and other measures, and dispensing drugs consistent with the individual’s scope of specialty practice, and competency.

(2) Standing orders, protocols, or written prescriptions may also be given for over-the-counter medications as clinically necessary.

Stat. Auth.: ORS 678.150, 678.285
Stats. Implemented: ORS 678.370, 678.372, 678.375, 678.380, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0006

Application Requirements for Prescriptive Authority in Oregon

(1) Current, unencumbered registered nurse license in the State of Oregon.

(2) Currently has or is eligible for an unencumbered nurse practitioner, certified registered nurse anesthetist or clinical nurse specialist certificate in the State of Oregon.

(3) Submission of application and fees required by the Board. Fees are nonrefundable. An application not completed after one calendar year will be considered void.

(4) Evidence of successful completion of 45 contact hours of pharmacology at the APRN level as defined in OAR 851-056-0008 including content related to the specialty scope of practice which shall be met through:

(a) Completion within two years prior to the application date; or

(b) Evidence of completion of a 30 hour discrete pharmacology course congruent with the specialty role sought with:

(A) An additional 15 CE hours in pharmacological management congruent with the area of clinical specialty completed in the two years prior to the application date; or

(B) Current prescriptive authority in another state or U.S. jurisdiction, including a U.S. federal institution or facility; or

(c) Evidence of completion of a clinical nurse specialist, certified registered nurse anesthetist or nurse practitioner program within two years prior to application date, which included a 45 hour pharmacology course and subsequent clinical practicum in pharmacologic management of individual patients prior to graduation.

(5) Evidence of successful completion of required clinical education in patient management. An applicant may be considered to meet this requirement through:

(a) Completion of a directly supervised clinical practicum of no less than 150 hours which includes differential diagnosis and applied pharmacological management of patients congruent with the specialty role sought for academic or continuing education credit; or

(b) Evidence of unencumbered prescriptive authority in another state or U.S. jurisdiction, including a U.S. federal institution or facility with a minimum of 150 hours utilizing applied pharmacological management of patients congruent with their specialty role within the past two years; or

(c) Validation of prescribing competencies by a licensed independent prescribing practitioner (NP, CNS, CRNA, MD, DO) that demonstrates 150 hours of the applicants clinical expertise to include differential diagnosis and the applied pharmacological management of patients congruent with their specialty role. Applicants must complete the OSBN APRN Pharmacological Management Evaluation Form.

(6) Evidence of successful completion of accredited graduate level nursing courses documented by CE or academic credit. Such courses must include physical assessment, pathophysiology, and clinical management sufficient to prepare the applicant for safe prescribing with individual patients. Courses may be accredited or approved by any of the appropriate entities specified in OAR 851-050-0142. Integrated courses taken before January 1, 1996 may be considered if content otherwise meet all requirements for equivalency.

(7) Applicants for initial certification as a nurse practitioner shall meet all requirements for prescriptive authority. Clinical nurse specialists and certified registered nurse anesthetists may obtain and renew certification with the Board without prescriptive authority.

(8) Initial applicants seeking prescriptive authority who do not meet Oregon's pharmacology requirements shall complete a pharmacology course from a list approved by the Board, equal to a minimum of 45 contact hours.

(9) Nurse practitioners who were certified in Oregon prior to July 1, 1997, and who did not have prescriptive authority as of that date, are not required to obtain or renew with prescriptive authority.

Stat. Auth.: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.370, 678.372, 678.375, 678.380, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 7-2008, f. & cert. ef. 11-26-08; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0008

Pharmacology Course Requirements

(1) 45 contact hours may be obtained as part of a discrete offering within the formal advanced educational program or through structured continuing education programs approved by any of the appropriate entities specified in OAR 851-050-0142.

(2) Accredited graduate level pharmacology course content shall include:

(a) Applicable federal/state laws;

(b) Prescription writing;

(c) Pharmacokinetic, pharmacodynamic, pharmacotherapeutic, and pharmacogenomic principles;

(d) Use of prescriptive pharmacological agents in the prevention of illness and restoration and maintenance of health;

(e) Informational resources; and

(f) Clinical application related to specific scope of practice.

(A) Specific tests are used to determine successful completion of the course.

(B) The target audience includes the APRN.

(C) Learner objectives include the specialty scope of advanced practice for which the applicant seeks certification.

(D) Written verification of participation and successful completion of the course is provided by the course sponsor.

Stat. Auth.: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.372 & 678.380
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0010

Prescription Requirements

(1) A written prescription shall include the date, printed name, legal signature, specialty category/title, business address, and telephone number of the prescribing APRN, in addition to the required patient and drug information.

(2) An electronically transmitted prescription as defined in OAR 855-006-0015 of the Pharmacy Act shall include the name and immediate contact information of the prescriber and be electronically encrypted or in some manner protected by up-to-date technology from unauthorized access, alteration or use. Controlled substances have additional restrictions as defined by the DEA which shall be followed.

(3) A tamper resistant prescription shall meet criteria as defined in OAR 855-006-0015 of the Pharmacy Act.

(4) Prescriptions may be written for over the counter drugs, durable medical equipment (DME) and devices.

(5) Prescriptions shall be signed by the prescriber with the abbreviated specialty title of the nurse practitioner, the title CRNA, or the title CNS.

(6) The APRN shall comply with all applicable laws and rules in prescribing, administering, and distributing drugs, including compliance with the labeling requirements of ORS Chapter 689.

(7) An APRN shall only prescribe controlled substances in conjunction with their own valid and current DEA registration number appropriate to the classification level of the controlled substance.

(8) Clinical nurse specialists and nurse practitioners with prescriptive authority are authorized to prescribe legend and controlled substances in Schedule II-V. Additionally, they may prescribe:

(a) Over-the-counter drugs;

(b) Appliances and devices;

(c) Orphan drugs;

(d) Limited access drugs;

(e) Antibiotics to partner(s) of patients diagnosed with a sexually transmitted infection without first examining the partner of the patient, consistent with Department of Human Services guidelines regarding Expedited Partner Therapy; and

(f) Off label.

(9) Certified registered nurse anesthetists with prescriptive authority may prescribe to established patients:

(a) Legend and controlled substances in Schedule II-V; and

(b) For a supply of not more than 10 days with no refills.

(10) All prescribed, dispensed, and distributed drugs shall have Food and Drug Administration (FDA) approval except the following:

(a) Compounded drugs;

(b) Drugs provided through a United States IRB approved clinical trial;

(c) Drugs prescribed under limited access programs;

(d) Drugs which are still in common usage and predate the FDA approval process.

Stat. Auth.: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.370, 678.372, 678.375, 678.380, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10; BN 3-2011, f. & cert. ef. 10-6-11; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0012

Standards for APRNs with Prescriptive Authority

Evaluation of appropriate prescribing by the Board is constructed based on the following premises:

(1) APRNs may prescribe the drugs appropriate for patients within their scope of practice as defined by OAR 851-050-0005; or OAR 851-054-0020 and 0021; and OAR 851-052-0010.

(2) APRNs shall be held independently accountable for their prescribing decisions;

(3) All drugs prescribed shall have Food and Drug Administration (FDA) approval unless mentioned as an exception in OAR 851-056-0010.

Stat. Auth.: ORS 678.385 & 678.285
Stats. Implemented: ORS 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 2-2007, f. & cert. ef. 3-13-07; BN 4-2007, f. & cert. ef. 5-2-07; BN 6-2007, f. & cert. ef. 6-26-07; BN 9-2007, f. & cert. ef. 10-1-07; BN 12-2007, f. & cert. ef. 11-21-07; BN 1-2008, f. & cert. ef. 2-25-08; BN 5-2008, f. & cert. ef. 6-24-08; BN 3-2011, f. & cert. ef. 10-6-11; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0014

Renewal of Prescriptive Authority

Prescriptive authority may be renewed by the Board provided there is satisfactory compliance with the following:

(1) Evidence that all requirements for renewal of the Oregon nurse practitioner, certified registered nurse anesthetist or clinical nurse specialist certificate have been met and the certificate has been renewed; and

(2) Evidence that there are no encumbrances on the certificate which would affect prescription writing; and

(3)(a) Evidence of active national certification for specialty role as required by applicable licensure, attesting to completion of continuing education required for maintaining national certification; or

(b) 45 structured contact hours of continuing education in the two years prior to renewal of their license. At least 15 of the completed CE hours must be in pharmacotherapeutic content at the APRN level congruent with their specialty role; and

(4) Evidence of a minimum of 150 hours utilizing applied pharmacological management of patients congruent with their specialty role within the two years preceding renewal; or

(a) Completion of a 45 contact hour pharmacology course within the two years preceding renewal which meets Board requirements; or

(b) Graduation from a clinical nurse specialist, certified registered nurse anesthetist or nurse practitioner program within the two years preceding renewal.

(5) APRNs who have the authority from the Drug Enforcement Administration (DEA) to prescribe controlled substances shall submit evidence of the most current DEA Certificate to the Board office. Prescriptive authority renewal must be accompanied by evidence of DEA certification, if held.

(6) APRNs who do not hold DEA certification must verify this to the Board in writing at the time of renewal.

(7) Submission of an application and fees required by the Board. Fees are nonrefundable.

(8) Applicants who fail to renew their prescriptive authority on or before the biennial birthdate deadline shall be delinquent and pay a delinquent fee. Successful renewal requires that all other criteria for eligibility are met. Practice with expired prescriptive authority is subject to a civil penalty and potential discipline.

Stat. Auth.: ORS 678.101, 678.150 & 678.285
Stats. Implemented: ORS 678.370, 678.372, 678.375, 678.380, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0016

Conduct Derogatory to the Standards for Prescriptive or Dispensing Authority

(1) The Board may deny, suspend or revoke the authority to write prescriptions and/or dispense drugs for the causes identified in ORS 678.111(1) or with proof that the authority has been abused.

(2) The abuse of the prescriptive or dispensing authority constitutes conduct derogatory to nursing standards and is defined as:

(a) Prescribing, dispensing or distributing drugs which are not FDA approved unless done in accordance with the Boards policies and regulations on exceptions.

(b) Prescribing, dispensing, administering, or distributing drugs for other than therapeutic or prophylactic purposes;

(c) Prescribing, dispensing, or distributing drugs to an individual who is not the APRN’s client unless written under Expedited Partner Therapy guidelines from the Department of Human Services; or under the Oregon Health Authority Programs to Treat Allergic Response OR Hypoglycemia and Opiate Overdose in ORS 433.800–433.830.

(d) Prescribing, dispensing or distributing drugs to an individual not within the scope of practice or type of client population served by state certification and licensure as an APRN;

(e) Prescribing, dispensing, or distributing drugs for personal use;

(f) Prescribing, dispensing, administering, or distributing drugs while functionally impaired;

(g) Prescribing, dispensing, administering, or distributing drugs in an unsafe or unlawful manner or without adequate instructions to the client according to acceptable and prevailing standards or practice;

(h) Prescribing, dispensing, or distributing drugs which are specifically restricted under federal law;

(i) Failure to properly assess and document client assessment when prescribing, dispensing, administering, or distributing drugs;

(j) Selling, purchasing, trading, or offering to sell, purchase or trade any drug sample;

(k) Dispensing medications without dispensing authority granted by the Board or other dispensing authority issued by the State of Oregon; and

(l) Charging a client or any third party payer in a grossly negligent manner.

Stat. Auth: ORS 678.111, 678.113, 678.150 & 678.285
Stats. Implemented: ORS 678.350, 678.370, 678.372, 678.375, 678.380 & 678.385
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10; BN 3-2011, f. & cert. ef. 10-6-11; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0018

Distributing Drug Samples

(1) Any APRN who has prescription writing authority may receive prepackaged complimentary samples of drugs and distribute these samples to clients.

(2) Drug samples which are controlled substances must be maintained in accordance with OAR 851-056-0026 and any applicable state and federal requirements.

(3) All sample distribution shall be clearly documented in the patient’s chart and the patient shall be provided with information needed for safe use.

(4) Drug samples distributed by a certified registered nurse anesthetist are limited per ORS 678. 285.

Stat. Auth: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.372 & 678.380
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0020

Dispensing Authority for APRNs

(1) An "applicant" for dispensing authority must be an unencumbered Oregon state certified nurse practitioner or clinical nurse specialist with prescriptive authority in good standing with the Oregon State Board of Nursing.

(2) Applicants shall submit an application and information as required by the Board.

(3) The applicant shall show evidence of completion of the following dispensing program:

(a) Documented review of content regarding safe dispensing listed below:

(A) Board of Nursing handbook “Advance Practice Registered Nurse Prescriptive and Dispensing Authority in Oregon";

(B) The Drug Enforcement Administration Pharmacist's Manual (2010);

(C) OAR 851 Division 56;

(D) ORS Chapter 689 and OAR chapter 855;

(E) U.S. Consumer Product Safety Commission publication "Poison Prevention Packaging: “A Guide for Healthcare Professionals" and;

(F) The Institute for Safe Medication Practices (ISMP) "List of Error-Prone Abbreviations, Symbols, and Dose Designations" (2013); and

(G) Information on available electronic or hard copy prescription drug references which provide information to professionals authorized to dispense prescription medications.

(b) Successful completion of the self-examination as provided by the Board on these materials.

(4) The staff of the Board shall provide written notice to the Oregon Board of Pharmacy upon receipt and again upon approval of such application.

(5) Applicants must provide complete and accurate information requested by the Board. Failure to complete application material as requested or failure to meet criteria in this rule shall be grounds for denial, suspension, or revocation of dispensing authority.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 678.390
Stats. Implemented: ORS 678.670, 678.375, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10; BN 12-2013, f. 12-3-13, cert. ef. 1-1-14; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0022

Renewal of Dispensing Authority

Dispensing authority may be renewed with each renewal of prescriptive authority upon submission of application, and documentation that the nurse practitioner or clinical nurse specialist and their patients continue to meet criteria. Failure to complete application material as requested or failure to meet criteria in this rule shall be grounds for denial, suspension, inactivation or revocation of dispensing authority.

Stat. Auth.: ORS 678.390
Stats. Implemented: ORS 678.670, 678.675, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 7-2008, f. & cert. ef. 11-26-08; BN 12-2013, f. 12-3-13, cert. ef. 1-1-14; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

851-056-0024

Drug Delivery and Dispensing

(1) Policies and procedures: A nurse practitioner or clinical nurse specialist with dispensing authority shall follow procedures established by federal and state law for:

(a) Drug dispensing, storage, security and accountability;

(b) Maintenance of all drug records;

(c) Procedures for procurement of drugs.

(2) Dispensing:

(a) Drugs shall be prepackaged by a pharmacy or manufacturer registered with the Oregon State Board of Pharmacy, and provide on the label:

(A) The name and strength of the drug. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be on the label.

(B) The quantity of the drug;

(C) Cautionary statements, if any, required by law;

(D) The name, address, and phone number of the practitioner's practice site; and

(E) The manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug.

(b) The nurse practitioner or clinical nurse specialist shall personally dispense drugs which require hand labeling with the following information:

(A) Name of the patient;

(B) Directions for use; and

(C) Physical description, including any identification code that may appear on tablets and capsules.

(c) The nurse practitioner or clinical nurse specialist may delegate the dispensing function to staff assistants under limited circumstances where the staff assistant performs technical support that does not require prescriptive judgment. The staff assistant can dispense only those drugs that are pre-labeled by the dispensing pharmacy with the following information:

(A) Name of the patient;

(B) Name of the prescriber;

(C) Directions for use; and

(D) A physical description, including any identification code that may appear on tablets and capsules.

(E) Staff assistants may complete and label the drug with the patient’s address, date of dispensing, and initials of dispensing personnel and distribute them to the patient.  

(d) Drugs shall be dispensed in containers complying with the federal Poison Prevention Packaging Act unless the patient requests a non-complying container.

(e) The nurse practitioner or clinical nurse specialist shall provide a means for patients to receive verbal and written information on drugs dispensed to the patient. The written drug information shall include:

(A) Drug name and class;

(B) Proper use and storage;

(C) Common side effects;

(D) Precautions and contraindications; and

(E) Significant drug interactions.

(3) Drug security, storage and disposal:

(a) In the absence of the person authorized to dispense and prescribe, drugs shall be kept in a locked cabinet or drug room which is sufficiently secure to deny access to unauthorized persons.

(b) Controlled substances shall be maintained in a secure, locked container at all times.

(c) All drugs shall be stored in areas which will assure proper sanitation, temperature, light, ventilation, and moisture control.

(d) Drugs which are outdated, damaged, deteriorated, misbranded, or adulterated shall be physically separated from other drugs until they are destroyed or returned to their supplier.

(e) Controlled substances, which are expired, deteriorated, or unwanted, shall be disposed of in conformance with current State and Federal Regulations, including but not limited to, 21 CFR 1307.21 and OAR 855-080-0105.

(4) Drug records:

(a) A drug dispensing record shall be maintained separately from the patient record and kept for a minimum of three years. The dispensing record shall show, at a minimum, the following:

(A) Name of patient;

(B) Brand name of drug, or generic name and manufacturer or distributor;

(C) Date of dispensing; and

(D) Initials of nurse practitioner or clinical nurse specialist.

(b) A physical copy of the prescription for each medication dispensed shall be retained in the patient chart and shall be produced upon request.

(c) All records required by these rules or by federal or state law shall be readily retrievable and available for inspection by the Board and the Board of Pharmacy.

(d) A patient record shall be maintained for all patients to whom the nurse practitioner or clinical nurse specialist dispenses medications.

(5) Clinical nurse specialists and nurse practitioners with dispensing authority shall be responsible for safe storage, distribution, and destruction of all drugs under their authority.

(6) Clinical nurse specialists and nurse practitioners granted dispensing authority under this rule shall comply with the labeling and record keeping requirements of OAR 851-050-0164.

(7) A person granted dispensing authority under this rule shall have available at the dispensing site a hard copy or electronic version of prescription drug reference works commonly used by professionals authorized to dispense prescription medications.

(8) A person granted dispensing authority under this rule shall permit representatives of the Oregon State Board of Pharmacy, upon receipt of a complaint about that person’s dispensing practices and notice to the Board of Nursing, to inspect a dispensing site.

Stat. Auth.: ORS 678.390
Stats. Implemented: ORS 673.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 13-2009, f. 12-17-09, cert. ef. 1-1-10

851-056-0026

Rules Relating to Controlled Substances

(1) In the administration, distribution, storage, prescribing, and dispensing of controlled substances, APRNs shall comply with all applicable requirements in the Code of Federal Regulations (CFR), Title 21, and state law, including but not limited to, ORS Chapter 430 and 475 and OAR chapter 415 and 855.

(2) Nurse practitioners and clinical nurse specialists shall not dispense a controlled substance without current dispensing authority. Distribution of prepackaged, complimentary drug samples is not considered dispensing (ORS 689.005(9)).

(3) APRNs who have authority from the Drug Enforcement Administration (DEA) to prescribe controlled substances must verify evidence of such with their prescriptive authority renewal application. A nurse with prescriptive authority may choose to decline DEA certification and must verify so in writing.

(4) Storage and inventory of controlled substances:

(a) Samples or quantities of controlled substances shall be stored in a securely locked cabinet on the premises of the APRNs practice location.

(b) APRNs who receive samples or quantities of controlled substances shall be responsible for the security, inventory, and disposal of these drugs.

(c) APRNs shall maintain inventory records of controlled substances that they receive or distribute for a period of three years. The records shall include:

(A) Drug name, amount received, date received, drug expiration date;

(B) Drug name, amount distributed, date distributed, to whom distributed;

(C) Drug name and the date and place where it was returned for destruction.

(d) Controlled substances that are expired, deteriorated, or unwanted shall be returned to a DEA registered disposal site or disposal system or law enforcement authorities. This does not include controlled substances which are properly wasted at the facility where they were to be administered. In this context, “properly wasted” means that on-site destruction of a controlled substance in conformance with applicable state and federal law. APRNs shall not personally destroy controlled substances.

(e) Controlled substances must be transported in a secured, locked container.

(f) Client records shall state the distribution of controlled substance samples.

(g) Theft of controlled substances shall be immediately reported upon discovery to the DEA and to any other required authorities.

(h) APRNs who receive controlled substances shall cooperate with the Board in their inspection of records and physical inventory of controlled substances. Inventory of all controlled substances shall be taken by the prescriber responsible for their receipt and storage every year on the same date as the biennial inventory required by 21 CFR 1304.13.

(i) If requested by the Board, any APRN who receives controlled substances shall submit a copy of inventory records from the preceding two years for review.

(5) Prescribing controlled substances:

(a) APRNs shall only prescribe the controlled substances from Schedules II-V, as authorized by the Oregon State Board of Nursing. APRNs shall only prescribe at the level provided for on their DEA certificate.

(b) Schedule II controlled substances shall not be prescribed for the purpose of weight reduction or control. Schedule III-IV controlled substances may be prescribed for weight reduction in accordance with FDA product guidelines.

(c) APRNs shall not prescribe dispense, or order controlled substances, including Methadone.

(6) Intractable or chronic pain management:

(a) APRNs may prescribe or administer controlled substances to a person in the course of their treatment for a diagnosed condition causing pain, defined in OAR 851-056-0000(18).

(b) The diagnosis and treatment of intractable or chronic pain requires documentation of the following:

(A) A recent diagnosis of the condition (if acute or unstable), or past diagnosis (if chronic and stable) causing pain, by one or more licensed practitioners specializing in the treatment of the body area, system, or organ perceived as the source of pain; and

(B) A written material risks notice specific to the patient’s condition and treatment; and

(C) A consultation and review of the pain treatment plan where clinically indicated if the patient shows limited or no improvement.

(c) APRNs must have a complete discussion with the patient or person authorized to make health care decisions for the patient regarding the diagnosis, as well as the risk, benefits, alternatives, side effects, and potential for addiction and withdrawal of the controlled substance, along with any other applicable precautions. These discussions must be documented in the patient record. Documentation must include a plan for period review of patient response and follow-up.

(d) APRNs shall document patient use of controlled substances for chronic or intractable pain, including history and assessment to rule out substance abuse. Evidence of patient addiction or abuse requires referral and/or transfer of care for further diagnosis and treatment.

Stat. Auth.: ORS 678.150 & 678.285
Stats. Implemented: ORS 678.111, 678.370, 678.372, 678.375, 678.380, 678.385 & 678.390
Hist.: BN 10-2006, f. & cert. ef. 10-5-06; BN 5-2008, f. & cert. ef. 6-24-08; BN 9-2014, f. 12-5-14, cert. ef. 1-1-15

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