Oregon Bulletin
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 |