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Oregon Bulletin

November 1, 2011

 

Board of Nursing
Chapter 851

Rule Caption: Rules to clarify nurse prescriber authority related to off label, compounded, and grandfathered drugs.

Adm. Order No.: BN 3-2011

Filed with Sec. of State: 10-6-2011

Certified to be Effective: 10-6-11

Notice Publication Date: 9-1-2011

Rules Amended: 851-056-0000, 851-056-0010, 851-056-0012, 851-056-0016

Subject: These rules cover the authority of the Clinical Nurse Specialist and Nurse Practitioner to prescribe and dispense drugs. These rule amendments clarify their ability to prescribe off label, compounded, and grandfathered drugs.

Rules Coordinator: Peggy A. Lightfoot—(971) 673-0638

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) “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).

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

(5) “Clinical education in patient management” 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.

(6) “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.

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

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

(9) “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.

(10) “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.

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

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

(13) “Functional impairment” means:

(a) Practicing nursing when unable/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/status.

(b) Practicing nursing when unable/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/status.

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

(14) “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.

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

(16) “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.

(17) “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 on going 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.

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

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

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

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

(22) “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.

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

(24) “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.

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

(26) “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.

(27) “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

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

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 nurse practitioner or clinical nurse specialist 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 as per OAR 851-050-0005(9) or the title CNS as per OAR 851-054-0015.

(6) The nurse practitioner or clinical nurse specialist 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) A nurse practitioner or clinical nurse specialist 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) 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

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. 10-6-1

851-056-0012

Standards for Clinical Nurse Specialists and Nurse Practitioners with Prescriptive Authority

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

(a) Nurse practitioners may provide care for specialized client populations within each nurse practitioner category/scope of practice;

(b) Clinical nurse specialists may provide care for individuals and populations within their specialty scope of practice;

(c) Prescribing is limited by the individual’s scope of practice and knowledge base within that scope of practice;

(d) Clinical nurse specialists and nurse practitioners 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;

(e) Clinical nurse specialists and nurse practitioners shall be held independently accountable for their prescribing decisions;

(f) 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

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. 10-6-1

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 clinical nurse specialist’s or nurse practitioner’s client unless written under Expedited Partner Therapy guidelines from the Department of Human Services or is not within the scope of practice or type of client population served;

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

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

(f) 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;

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

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

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

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

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

Stat. Auth: ORS 678.111, 678.113, 678.150

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. 10-6-1

 

Rule Caption: Rule correction: one incorrect word and one typographical error.

Adm. Order No.: BN 4-2011

Filed with Sec. of State: 10-6-2011

Certified to be Effective: 10-6-11

Notice Publication Date: 9-1-2011

Rules Amended: 851-063-0030

Subject: Under OAR 851-063-0030 Authorized Duties and Standards for Certified Nursing Assistants, (1)(c)(A)(vi) Preventing hydration should read: Preventing dehydration. In addition, OAR 851-063-0030(1)(c)(B)(vi) Providing catheter care including the application of an removal of external urinary catheters should read: Providing catheter care including the application of and removal of external urinary catheters.

Rules Coordinator: Peggy A. Lightfoot—(971) 673-0638

851-063-0030

Authorized Duties and Standards for Certified Nursing Assistants

(1) Under the supervision of a licensed nurse, the CNA may provide care and assist clients with the following tasks:

(a) Tasks associated with infection control and Standard or Transmission Based Precautions:

(A) Bedmaking and handling of linen;

(B) Caring for the client’s environment;

(C) Handling and disposal of hazardous wastes;

(D) Handling of contaminated materials;

(E) Handwashing and hand hygiene;

(F) Maintaining client cleanliness and grooming; and

(G) Utilizing personal protective equipment.

(b) Tasks associated with safety and emergency procedures:

(A) Moving and transferring clients;

(B) Transporting clients in wheelchairs and specialized chairs;

(C) Turning and positioning clients;

(D) Using lifts and safe client handling devices;

(E) Turning oxygen on and off or transferring oxygen between wall and tank at pre-established flow rate for stable clients;

(F) Managing hazards in the workplace;

(G) Preventing burns;

(H) Preventing falls; and

(I) Performing cardiopulmonary resuscitation.

(c) Tasks associated with activities of daily living (ADL):

(A) Assisting with nutrition and hydration:

(i) Assisting with feeding;

(ii) Measuring and recording height and weight;

(iii) Measuring and recording intake and output;

(iv) Positioning clients for nutritional and fluid intake;

(v) Preventing choking and aspiration; and

(vi) Preventing dehydration.

(B) Assisting with elimination:

(i) Administering bowel evacuation suppositories that are available without a prescription;

(ii) Administering enemas;

(iii) Assisting with the use of bedpan and urinal;

(iv) Assisting with toileting;

(v) Collecting specimens; sputum, stool, and urine including clean catch urine specimens;

(vi) Providing catheter care including the application of and removal of external urinary catheters;

(vii) Providing ostomy care for established, healthy ostomy including cleaning the ostomy site and emptying the ostomy bag or changing the ostomy bag which does not adhere to the skin; and

(viii) Providing perineal and incontinence care.

(C) Assisting with personal care:

(i) Bathing;

(ii) Providing comfort care;

(iii) Dressing and undressing;

(iv) Grooming to include: application and care of dentures, eye glasses, and hearing aides.

(v) Nail care;

(vi) Oral hygiene;

(vii) Shampooing and caring for hair;

(viii) Shaving; and

(ix) Skin Care to include: application of non-prescription pediculicides; application of topical, non-prescription barrier creams and ointments for prophylactic skin care; maintenance of skin integrity; prevention of pressure, friction, and shearing; and use of anti-pressure devices.

(D) Assisting with positioning devices and restraints;

(E) Assisting with restorative care:

(i) Ambulating;

(ii) Assisting with and encouraging the use of self-help devices for eating, grooming and other personal care tasks;

(iii) Assisting with bowel and bladder training;

(iv) Assisting with feeding and ADL programs;

(v) Assisting with the use of crutches, walkers, or wheelchairs;

(vi) Caring for, applying, and removing antiembolus stockings, braces, orthotic devices, and prosthetic devices.

(vii) Elevating extremities;

(viii) Maintaining alignment;

(ix) Performing range of motion exercises;

(x) Using footboards; and

(xi) Utilizing and assisting clients with devices for transferring, ambulation, and alignment.

(d) Tasks associated with observation and reporting:

(A) Assisting with coughing and deep breathing;

(B) Observing and reporting changes of condition to licensed nurse; and

(C) Measuring and recording:

(i) Temperature, apical and radial pulse, respiration and blood pressure (manual and electronic-upper arm only and orthostatic blood pressure readings);

(ii) Emesis;

(iii) Liquid stool;

(iv) Pain level using a facility approved pain scale;

(v) Pulse oximetry; and 

(vi) Urinary output, both voided and from urinary drainage systems.

(e) Tasks associated with documentation.

(f) Tasks associated with end of life care.

(2) The CNA may, as an unlicensed person, provide care as delegated or assigned by a nurse pursuant to the terms and conditions in OAR 851-047-0000 through OAR 851-047-0040.

(3) ORS 678.440(5) defines the term “nursing assistant” as a person who assists licensed nursing personnel in the provision of nursing care. Consistent with that definition, a CNA must either:

(a) Be regularly supervised by a licensed nurse; or

(b) Work in a community-based care setting or other setting where there is no regularly scheduled presence of a licensed nurse provided there is periodic supervision and evaluation of clients under the provisions of OAR 851-047-0000 through OAR 851-047-0040.

(4) Under no circumstance shall a CNA work independently without supervision or monitoring by a licensed nurse who provides assessment of clients as described in OAR 851-063-0030(3)(a)(b).

(5) A CNA may accept verbal or telephone orders for medication from a licensed health care professional who is authorized to independently diagnose and treat only when working in the following settings under the specified administrative rule:

(a) When working in Adult Foster Homes, as permitted under OAR Chapter 411, division 050;

(b) When working in Residential Care Facilities, as permitted under OAR Chapter 411, division 054; and

(c) When working in Assisted Living Facilities, as permitted under OAR Chapter 411, division 054.

(6) Standards of Care for Certified Nursing Assistants. In the process of client care the CNA shall consistently:

(a) Apply standard precautions according to the Centers for Disease Control and Prevention guidelines;

(b) Use hand hygiene between episodes of care;

(c) Use appropriate body mechanics to prevent injury to self and client;

(d) Follow the care plan as directed by the licensed nurse;

(e) Use appropriate communication with client, client’s family and friends, and coworkers;

(f) Use alternatives to physical restraints, or apply physical restraints as directed by the licensed nurse;

(g) Determine absence of pulse and/or respiration, and initiate an emergency response;

(h) Report to the licensed nurse any recognized abnormality in client’s signs and symptoms;

(i) Record observations and measurements, tasks completed, and client statements about condition or care;

(j) Apply safety concepts in the workplace;

(k) Report signs of abuse, neglect, mistreatment, misappropriation or exploitation;

(l) Demonstrate respect for rights and property of clients and coworkers; and

(m) Maintain client confidentiality.

Stat. Auth: ORS 678.440, ORS 678.442, 678.444

Stats. Implemented: ORS 678.440, ORS 678.442, 678.444

Hist.: BN 6-1999, f. & cert. ef. 7-8-99; BN 3-2004, f. 1-29-04, cert. ef. 2-12-04; BN 11-2009, f. & cert. ef. 12-17-09; BN 11-2010, f. & cert. ef. 6-25-10; BN 1-2011(Temp), f. 6-6-11, cert. ef. 6-23-11 thru 12-20-11; BN 4-2011, f. & cert. ef. 10-6-11

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.

2.) Copyright 2011 Oregon Secretary of State: Terms and Conditions of Use

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