22 TAC §§222.1 - 222.12
The Board of Nurse Examiners adopts on an emergency basis
new §§222.1 - 222.12, concerning Advanced Practice Nurses with Prescriptive
Authority. The Board met July 24 and 25, 2003, and approved the rule change.
New Chapter 222 is necessary on an emergency basis as a result of the implementation
of House Bill (HB) 1095 that expanded prescriptive authority for advanced
practice nurses and became effective immediately upon signature by the Governor
on May 20, 2003. The repeal of the current Chapter 222 is being adopted on
an emergency basis concomitant with this adoption.
Prior to the passage of HB 1095, advanced practice nurses had been limited
to prescribing dangerous drugs only. Dangerous drugs were defined in §222.1(5)
as: Dangerous drug - A device or a drug that is unsafe for self medication
and that is not included in schedules I-V or penalty groups I-IV of chapter
481 Texas Health and Safety Code (Texas Controlled Substances Act). The
term includes a device or a drug that bears or is required to bear the legend:
'Caution: federal law prohibits dispensing without prescription.' The authority
to authorize or issue prescription drug orders for controlled substances was
prohibited.
House Bill 1095 amended the Medical Practice Act to permit physicians to
delegate authority to prescribe controlled substances listed in schedules
III through V to advanced practice nurses provided certain criteria are met.
These criteria include:
(1) Limiting prescriptions for controlled substances to those listed in
Schedules III, IV, or V as established by the commissioner of public health
under Chapter 481, Health and Safety Code (Texas Controlled Substances Act);
(2) Prescriptions are issued for a period not to exceed 30 days;
(3) The advanced practice nurse shall not authorize the refill of a prescription
for a controlled substance prior to consultation with the delegating physician
and notation of the consultation in the patient's chart; and
(4) The advanced practice nurse shall not authorize the prescription of
a controlled substance for a child less than two years of age prior to consultation
with the delegating physician and notation of the consultation in the patient's
chart.
Staff has been in communication with individuals from the Texas Department
of Public Safety (DPS) and the Drug Enforcement Administration (DEA) to gain
information regarding the regulatory requirements imposed on individuals who
prescribe controlled substances by the state and federal entities with regulatory
authority over these substances. Based on statutory changes to the Medical
Practice Act and information provided by DPS representatives, the Board adopts
new Chapter 222 on an emergency basis.
The Board's emergency adoption of new Chapter 222 includes limiting the
authority to prescribe medications listed in schedules III through V to only
those advanced practice nurses who hold full authorization to practice and
prescriptive authority. Under the proposed revisions, graduate advanced practice
nurses who hold provisional authorization to practice pending successful national
certification would be limited to prescribing categories of dangerous drugs
only. This limitation is imposed due to concerns regarding graduates whose
provisional authorization to practice is rescinded based on failure to pass
the national certification examination on the first attempt. Should a graduate
advanced practice nurse continue to practice after he/she is notified that
he/she failed the national certification examination, he/she is in violation
of §221.5 and is subject to disciplinary action against the RN license.
If the same graduate authorized or issued a prescription for controlled substances
while practicing after the provisional authorization expired or was rescinded,
he/she would also be in violation of state and federal laws relating to the
prescribing of controlled substances. The DPS enforcement personnel indicate
that, depending on the substance prescribed, the penalty could be either a
third-degree or state jail felony conviction.
Prior to submitting the proposed new rule for the Board's consideration,
staff shared this information and requested input from the Advanced Practice
Nursing Advisory Committee (APNAC). There was much "discussion" via e-mail
from committee members regarding this issue without any formal resolution.
The committee members will discuss this issue further at their next meeting
in September.
The new sections are adopted on an emergency basis under the
authority of Texas Occupations Code §301.151 and §301.152 which
authorize the Board of Nurse Examiners to adopt, enforce, and repeal rules
consistent with its legislative authority under the Nursing Practice Act.
§222.1.Definitions.
The following words and terms when used in this chapter shall have
the following meanings unless the context clearly indicates otherwise:
(1)
Advanced practice nurse--A registered nurse approved by
the board to practice as an advanced practice nurse based on completing an
advanced educational program acceptable to the board. The term includes a
nurse practitioner, nurse-midwife, nurse anesthetist, and a clinical nurse
specialist. The advanced practice nurse is prepared to practice in an expanded
role to provide health care to individuals, families, and/or groups in a variety
of settings including but not limited to homes, hospitals, institutions, offices,
industry, schools, community agencies, public and private clinics, and private
practice. The advanced practice nurse acts independently and/or in collaboration
with other health care professionals in the delivery of health care services.
(2)
Alternate site--A practice site:
(A)
Where services similar to the services provided at the
delegating physician's primary practice site are provided; and
(B)
Located within 60 miles of the delegating physician's primary
practice site.
(3)
Board--The Board of Nurse Examiners for the State of Texas
(4)
Carrying out or signing a prescription drug order--Completing
a prescription drug order presigned by the delegating physician or signing
(writing) a prescription by an advanced practice nurse after that person has
been designated to the Board of Medical Examiners by the delegating physician
as a person delegated to sign a prescription.
(5)
Controlled substance A substance, including a drug, an
adulterant, and a dilutant, listed in Schedules I through V or Penalty Groups
1, 1-A, or 2 through 4 of chapter 481 Texas Health and Safety Code (Texas
Controlled Substances Act). The term includes the aggregate weight of any
mixture, solution, or other substance containing a controlled substance.
(6)
Dangerous drug--A device or a drug that is unsafe for self
medication and that is not included in schedules I-V or penalty groups I-IV
of chapter 481 Texas Health and Safety Code (Texas Controlled Substances Act).
The term includes a device or a drug that bears or is required to bear the
legend: "Caution: federal law prohibits dispensing without prescription."
(7)
Diagnosis and management course--A course offering both
didactic and clinical content in clinical decision-making and aspects of medical
diagnosis and medical management of diseases and conditions. Supervised clinical
practice must include the opportunity to provide pharmacological and non-pharmacological
management of diseases and problems considered within the scope of practice
of the advanced practice nurse's specialty and role.
(8)
Eligible sites--Sites serving medically underserved populations;
a physician's primary practice site; or a facility-based practice site.
(9)
Facility-based practice site--A licensed hospital or licensed
long term care facility that serves as the practice location for the advanced
practice nurse.
(10)
Health Manpower Shortage Area--An urban or rural area,
population group, or public or nonprofit private medical facility or other
facility that the Secretary of the United States Department of Health and
Human Services (USDHHS) designates as having a health manpower shortage, as
described by 42 USC Section 254e(a)(1) or a successor federal statute or regulation.
(11)
Medically Underserved Area (MUA)
(A)
An urban or rural area or population group that the Secretary
of the United States Department of Health and Human Services (USDHHS) designates
as having a shortage of those services as described by 42 USC Section 300e
-1(7) or a successor federal statute or regulation; or
(B)
an area defined as medically underserved by rules adopted
by the Texas Board of Health (Texas Department of Health) based on demographics
specific to this State, geographic factors that affect access to health care,
and environmental health factors.
(12)
Pharmacotherapeutics course--A course that offers content
in pharmacokinetics and pharmacodynamics, pharmacology of current/commonly
used medications, and the application of drug therapy to the treatment of
disease and/or the promotion of health.
(13)
Physician's primary practice site--
(A)
the practice location at which the physician spends the
majority of the physician's time;
(B)
a licensed hospital, a licensed long-term care facility,
or a licensed adult care center where both the physician and the APN are authorized
to practice;
(C)
a clinic operated by or for the benefit of a public school
district to provide care to the students of that district and the siblings
of those students, if consent to treatment at that clinic is obtained in a
manner that complies with Chapter 32, Family Code;
(D)
the residence of an established patient; or
(E)
another location at which the physician is physically present
with the advanced practice nurse.
(14)
Protocols or other written authorization--Written authorization
to provide medical aspects of patient care that are agreed upon and signed
by the APN and the physician, reviewed and signed at least annually, and maintained
in the practice setting of the APN. Protocols or other written authorization
shall be defined to promote the exercise of professional judgment by the APN
commensurate with his/her education and experience. Such protocols or other
written authorization need not describe the exact steps that the APN must
take with respect to each specific condition, disease, or symptom and may
state types or categories of drugs that may be prescribed rather than just
list specific drugs.
(15)
Shall and must--Mandatory requirements.
(16)
Should--A recommendation.
(17)
Site serving a medically underserved population--
(A)
a site located in a medically underserved area;
(B)
a site located in a health manpower shortage area;
(C)
a clinic designated as a rural health clinic under 42 USC
1395x(aa);
(D)
a public health clinic or a family planning clinic under
contract with the Texas Department of Human Services or the Texas Department
of Health;
(E)
a site located in an area in which the Texas Department
of Health determines there is an insufficient number of physicians providing
services to eligible clients of federal, state, or locally funded health care
programs; or
(F)
a site that the Texas Department of Health determines serves
a disproportionate number of clients eligible to participate in federal, state,
or locally funded health care programs
§222.2.Approval for Prescriptive Authority.
(a)
Credentials: To be approved by the board to carry out or
sign prescription drug orders and issued a prescription authorization number,
a Registered Nurse (RN) shall:
(1)
have full or provisional authorization by the board to
practice as an advanced practice nurse.
(A)
RNs with provisional authorization to practice as graduate
advanced practice nurses who are eligible for prescription authorization numbers
shall be limited to prescribing for categories of dangerous drugs only.
(B)
RNs with Interim Authorization to practice as advanced
practice nurses are not eligible for a prescription authorization number;
(2)
file a complete application for Prescriptive Authority
and submit such evidence as required by the board to verify the following
educational qualifications:
(A)
To be eligible for Prescriptive Authority, advanced practice
nurses must have successfully completed courses in pharmacotherapeutics, pathophysiology,
advanced assessment, and diagnosis and management of problems within the clinical
specialty.
(i)
Nurse Practitioners, Nurse-Midwives and Nurse Anesthetists
will be considered to have met the course requirements of this section on
the basis of courses completed in the advanced educational program.
(ii)
Clinical Nurse Specialists shall submit documentation
of successful completion of separate courses in the content areas described
in subparagraph (A) of this paragraph. These courses shall be academic courses
from a regionally accredited institution with a minimum of 45 clock hours
per course.
(iii)
The board, by policy, may determine that certain specialties
of Clinical Nurse Specialists meet one or more of the course requirements
on the basis of the advanced educational program.
(B)
Clinical Nurse Specialists who have been approved by the
board as advanced practice nurses by petition on the basis of completion of
a non-nursing master's degree shall not be eligible for prescriptive authority.
(b)
Sites: Prescribing privileges are limited to eligible sites
to include sites serving certain medically underserved populations, physician's
primary practice sites, alternate sites, and facility-based practice sites.
(c)
Exceptions Granted by the Texas State Board of Medical
Examiners: Requirements for utilizing limited prescriptive authority may be
modified or waived if a delegating physician has received a modification or
waiver from the Texas State Board of Medical Examiners of any site or supervision
requirements for a physician to delegate the carrying out or signing of prescription
drug orders to the advanced practice nurse.
§222.3.Renewal of Prescriptive Authority.
(a)
The advanced practice nurse shall renew the privilege to
carry out or sign prescription drug orders in conjunction with the RN license
renewal application.
(b)
The advanced practice nurse seeking to maintain prescriptive
authority shall attest, on forms provided by the board, to completing at least
five contact hours of continuing education in pharmacotherapeutics within
the preceding biennium.
(c)
The continuing education requirement in subsection (b)
of this section, shall be in addition to continuing education required under
Chapter 216 of this title (relating to Continuing Education).
§222.4.Minimum Standards for Carrying Out or Signing Prescriptions.
(a)
The advanced practice nurse with a valid prescription authorization
number:
(1)
shall carry out or sign prescription drug orders for only
those drugs that are:
(A)
authorized by Protocols or other written authorization
for medical aspects of patient care; and
(B)
prescribed for patient populations within the accepted
scope of professional practice for the advanced practice nurse's specialty
area; and
(2)
shall comply with the requirements for adequate physician
supervision published in the rules of the Board of Medical Examiners relating
to Delegation of the Carrying Out or Signing of Prescription Drug Orders to
Physician Assistants and Advanced Practice Nurses as well as other applicable
laws,
(b)
Protocols or other written authorization shall be defined
in a manner that promotes the exercise of professional judgement by the advanced
practice nurse commensurate with the education and experience of that person.
(1)
A protocol or other written authorization:
(A)
is not required to describe the exact steps that the advanced
practice nurse must take with respect to each specific condition, disease,
or symptom; and
(B)
may state types or categories of medications that may be
prescribed or contain the types or categories of medications that may not
be prescribed.
(2)
Protocols or other written authorization:
(A)
shall be written, agreed upon and signed by the advanced
practice nurse and the physician
(B)
reviewed and signed at least annually; and
(C)
maintained in the practice setting of the advanced practice
nurse.
(c)
Prescription Information: The format and essential elements
of the prescription shall comply with the requirements of the Texas Board
of Pharmacy. The following information must be provided on each prescription:
(1)
the patient's name and address;
(2)
the name, strength, and quantity of the drug to be dispensed;
(3)
directions to the patient regarding taking of the drug
and the dosage;
(4)
the intended use of the drug, if appropriate;
(5)
the name, address, and telephone number of the delegating
physician;
(6)
address and telephone number of the site at which the prescription
drug order was carried out or signed;
(7)
the date of issuance;
(8)
the number of refills permitted; and
(9)
the name, prescription authorization number, and original
signature of the advanced practice nurse signing or co-signing the prescription
drug order.
(d)
Generic Substitution. The advanced practice nurse shall
authorize or prevent generic substitution on a prescription in compliance
with the current rules of the Texas State Board of Pharmacy relating to Generic
Substitution.
§222.5.Prescriptions for Dangerous Drugs.
Advanced practice nurses with full or provisional authorization to
practice and valid prescription authorization numbers are eligible to carry
out or sign prescription drugs orders for dangerous drugs in accordance with
the standards and requirements set forth in this chapter.
§222.6.Prescriptions for Controlled Substances.
(a)
Advanced practice nurses with full authorization to practice
and valid prescription authorization numbers are eligible to prescribe certain
categories of controlled substances. Graduate advanced practice nurses who
hold provisional authorization to practice shall not authorize or issue prescriptions
for controlled substances until they have been issued full authorization to
practice by the board.
(b)
Advanced practice nurses with full authorization to practice
and valid prescription authorization numbers who authorize or issue prescriptions
for controlled substances shall:
(1)
Limit prescriptions for controlled substances to those
listed in Schedules III, IV, or V as established by the commissioner of public
health under Chapter 481, Health and Safety Code (Texas Controlled Substances
Act);
(2)
Issue prescriptions for a period not to exceed 30 days;
(3)
Not authorize the refill of a prescription for a controlled
substance prior to consultation with the delegating physician and notation
of the consultation in the patient's chart; and
(4)
Not authorize the prescription of a controlled substance
for a child less than two years of age prior to consultation with the delegating
physician and notation of the consultation in the patient's chart.
(c)
All other standards and requirements as set forth in this
chapter relating to carrying out or signing prescription drug orders by advanced
practice nurses must be met. In addition, advanced practice nurses with full
authorization to practice and valid prescription authorization numbers must
comply with all federal, state and local laws and regulations relating to
the prescribing of controlled substances, including but not limited to, requirements
set forth by the Texas Department of Public Safety and the Drug Enforcement
Administration.
§222.7.Prescribing at Sites Serving Certain Medically Underserved
Populations. When carrying out or signing prescription drug orders
at a site serving a medically underserved population, the advanced practice
nurse shall:
(1)
maintain Protocols or other written authorization that
must be reviewed and signed by both the advanced practice nurse and the delegating
physician at least annually;
(2)
have access to the delegating physician or alternate delegating
physician for consultation, assistance with medical emergencies, or patient
referral;
(3)
provide a daily status report to the physician on any problems
or complications encountered that are not covered by protocol; and
(4)
shall be available during on-site visits by the physician
which shall occur at least every 10 business days that the advanced practice
nurse is on site providing care.
§222.8.Prescribing at Physicians' Primary Practice Sites.
When carrying out or signing prescription drug orders at a physician's
primary practice site, the advanced practice nurse shall:
(1)
maintain Protocols or other written authorization that
must be reviewed and signed by both the advanced practice nurse and the delegating
physician at least annually;
(2)
sign or co-sign prescription drug orders only for those
patients with whom the physician has established or will establish a physician-patient
relationship although the physician is not required to see the patient within
a specified time period.
§222.9.Prescribing at Alternate Sites.
When carrying out or signing prescription drug orders at an alternate
site, the advanced practice nurse shall:
(1)
maintain Protocols or other written authorization that
must be reviewed and signed by both the advanced practice nurse and the delegating
physician at least annually;
(2)
be on-site with the physician at least twenty percent of
the time; and
(3)
have access to the physician through direct telecommunication
for consultation, patient referral, or assistance with a medical emergency;
§222.10.Prescribing at Facility-based Practice Sites.
When carrying out or signing prescription drug orders at a facility-based
practice site, the advanced practice nurse shall:
(1)
maintain Protocols or other written authorization developed
in accordance with facility medical staff policies and reviewing the authorizing
documents with the appropriate medical staff at least annually;
(2)
sign or co-sign prescription drug orders in the facility
in which the delegating physician is the medical director, the chief of medical
staff, the chair of the credentialing committee, or a department chair; or
a physician who consents to the request of the medical director or chief of
the medical staff to delegate; and
(3)
sign or co-sign prescription drug orders for the care or
treatment of only those patients for whom physicians have given their prior
consent.
§222.11.Conditions for Obtaining and Distributing Drug Samples.
The advanced practice nurse with a valid prescription authorization
number may request, receive, possess and distribute prescription drug samples
provided:
(1)
all requirements for the advanced practice nurse to sign
prescription drug orders are met;
(2)
Protocols or other physician orders authorize the advanced
practice nurse to sign the prescription drug orders;
(3)
the samples are for only those drugs that the advanced
practice nurse is eligible to prescribe in accordance with the standards and
requirements set forth in this chapter; and
(4)
a record of the sample is maintained and samples are labeled
as specified in the Dangerous Drug Act (Health and Safety Code, chapter 483).
§222.12.Enforcement.
(a)
Any nurse who violates these rules shall be subject to
removal of the authority to prescribe under this rule and disciplinary action
by the board under Texas Occupations Code §301.452.
(b)
The board shall report to the Texas Department of Public
Safety and the Drug Enforcement Administration any of the following:
(1)
Any significant changes in the status of the RN license/advanced
practice authorization, or
(2)
Disciplinary action impacting an advanced practice nurse's
ability to authorize or issue prescription drug orders
(c)
The practice of the advanced practice nurse approved by
the board to carry out or sign prescription drug orders is subject to monitoring
by the board on a periodic basis.
This agency hereby certifies that the emergency adoption
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State on August 4, 2003.
TRD-200304700
Katherine Thomas
Executive Director
Board of Nurse Examiners
Effective Date: August 4, 2003
Expiration Date: December 2, 2003
For further information, please call: (512) 305-6823