PART 11. TEXAS BOARD OF NURSING
CHAPTER 222. ADVANCED PRACTICE REGISTERED NURSES WITH PRESCRIPTIVE AUTHORITY
INTRODUCTION. The Texas Board of Nursing (Board) adopts amendments to Chapter 222, §§222.1 - 222.12, concerning Advanced Practice Registered Nurses With Prescriptive Authority. Sections 222.1, 222.3 - 222.6, and 222.8 - 222.12 are adopted without changes to the proposed text published in the November 27, 2009, issue of the Texas Register (34 TexReg 8437) and will not be re-published. Sections 222.2 and 222.7 are adopted with two minor changes to correct typographical errors.
REASONED JUSTIFICATION. The amendments to Chapter 222 are adopted under the Occupations Code §301.151 and §301.152 and are necessary to: (i) clarify changes made to the Medical Practice Act by Senate Bill (SB) 532, enacted by the 81st Legislature, Regular Session, effective September 1, 2009, which amends the Occupations Code Chapter 157; and (ii) provide guidance to advanced practice registered nurses (APRNs) who exercise prescriptive authority in this state. Specifically, the adopted amendments: (i) amend and add new definitions to Chapter 222; (ii) eliminate references to "provisional authorization" throughout Chapter 222; (iii) clarify the content requirements of a Clinical Nurse Specialist's course work; (iv) clarify the content requirements of a prescription for a controlled substance; (v) clarify the circumstances under which an APRN may issue a prescription for the partner of an established patient; (vi) clarify the limitations associated with prescribing "off label" medications; and (vii) update outdated references and correct grammatical and typographical errors.
The proposed amendments were considered at the July 30, 2009, and September 23, 2009, meetings of the Advanced Practice Nursing Advisory Committee (Committee). The Committee reviewed SB 532 and considered its impact on the prescriptive authority of APRNs in this state. The Committee also considered issues associated with prescribing medications for the treatment of sexually transmitted infections for the partners of established patients. Further, the Committee considered limitations associated with writing "off label" prescriptions. Following its discussions, the Committee approved the proposed amendments and recommended their adoption to the Board. At the January 2010, Board meeting, the Board approved the adoption of the proposed amendments.
The Board has made changes to §222.2 and §222.7 as adopted to correct minor typographical errors. First, the word "subsection" in §222.2(a)(2)(A)(ii) as proposed has been changed to "subparagraph" and the reference to "(a)" has been restored to "(A)". This change is necessary to correctly reference §222.2(a)(2)(A), which corresponds to the content areas referenced in §222.2(a)(2)(A)(ii). Second, the word "shall" in §222.7(4) as proposed has been struck in order to eliminate redundancy.
SB 532
SB 532, enacted by the 81st Legislature, Regular Session, effective September 1, 2009, amends portions of the Medical Practice Act relating to a physician's delegation of prescriptive authority. These amendments directly impact the prescriptive authority of APRNs in this state. The adopted amendments to Chapter 222 are necessary: (i) to clarify the provisions of SB 532 that affect the prescriptive authority of APRNs; and (ii) for consistency with the provisions of SB 532.
Prior to the enactment of SB 532, a physician was not able to delegate the carrying out or signing of a prescriptive drug order for a controlled substance if the prescription period exceeded 30 days. Further, it was unclear as to whether a refill of the prescription was included in this restriction. SB 532 amends the Occupations Code §157.0511(b) to permit a physician to delegate the carrying out or signing of a prescriptive drug order for a controlled substance for a period not to exceed 90 days. SB 532 also clarifies that this time period includes a refill of the prescription. A physician may delegate the carrying out or signing of a prescriptive drug order for a controlled substance to an APRN. In such event, the limitations of §157.0511(b) also apply to the APRN prescribing the medication. As such, adopted §222.6(b) clarifies that an APRN may not authorize or issue a prescription for a controlled substance, including a refill of the prescription, for a period exceeding 90 days. Further, adopted §222.6(b) prohibits an APRN from authorizing the refill of a prescription for a controlled substance beyond 90 days without consulting the delegating physician. These adopted amendments are necessary for consistency with the limitations imposed by §157.0511(b).
SB 532 also expands the definition of primary practice site in §157.053(a). Under the new definition, a physician's primary practice site may include a location where an APRN, who practices on-site with the physician more than 50 percent of the time, provides health care services for established patients. The physician's primary practice site may also include a location where an APRN practices on-site with the physician more than 50 percent of the time and provides, without remuneration, voluntary charity health care services at a clinic run or sponsored by a nonprofit organization or voluntary health care services during a declared emergency or disaster at a temporary facility established for that purpose. The adopted amendments to §222.1(14) are necessary for consistency with the new definition of primary practice site in §157.053(a). Adopted §222.1(14) clarifies that an APRN may prescribe medications in a setting in which health care services are provided for established patients if the APRN spends at least 50 percent of the time in a setting with the delegating physician. Further, adopted §222.1(14) clarifies that an APRN may prescribe medications in a clinic run or sponsored by a nonprofit organization that provides voluntary charity health care services if the APRN spends at least 50 percent of the time in a setting with the delegating physician and if the APRN is not remunerated for his or her services. Adopted §222.1(14) also clarifies that an APRN may prescribe medications in a setting where voluntary health care is provided during a declared emergency or disaster, at a temporary facility operated or sponsored by a governmental entity or nonprofit organization, if the APRN spends at least 50 percent of the time in a setting with the delegating physician and if the APRN is not remunerated for his or her services. SB 532 also amends §157.0541(a) to expand the allowable distance between a delegating physician's residence or primary practice site and the physician's alternate practice site. Prior to the enactment of SB 532, a delegating physician's alternate site was required to be located within 60 miles of the physician's primary practice site. SB 532 amends §157.0541(a) to allow a delegating physician's alternate site to be located within 75 miles of the physician's residence or primary practice site. This change expands the permitted distance between a delegating physician's alternate site and primary practice site and allows a delegating physician's alternate site to be located within a stated distance from the physician's residence. The adopted amendments to §222.1(5), which require an alternate practice site to be located within 75 miles of a delegating physician's residence or primary practice site, are necessary for consistency with the provisions of §157.0541(a).
Section 157.0541(b) of the Medical Practice Act permits a physician at an alternate site to delegate the act of administering, providing, carrying out, or signing a prescription drug order to an APRN, provided that the APRN acts under adequate physician supervision. SB 532 enacts several new requirements that a delegating physician must meet in order to comply with the supervision requirements of §157.0541(b). First, §157.0541(c) requires the delegating physician to be on-site with the APRN at least 10 percent of the hours of operation of the site each month that the APRN is acting with delegated prescriptive authority. Further, §157.0541(c) requires the delegating physician to be available while on-site to see, diagnose, treat, and provide care to patients whose services are provided, or will be provided, by the APRN to whom the physician has delegated prescriptive authority. Section 157.0541(c) also requires the delegating physician to be available through direct telecommunication for consultation, patient referral, or assistance with a medical emergency. The adopted amendments to §222.9 are necessary for consistency with the requirements of §157.0541(c). Adopted §222.9 requires an APRN to be available on-site with a delegating physician at least 10 percent of the hours of operation of the site each month that the APRN is acting with delegated prescriptive authority. Further, adopted §222.9 requires an APRN to have access to a delegating physician through direct telecommunication for consultation, patient referral, or assistance with a medical emergency.
Limitations on Prescriptive Authority
Over time, the Board has received multiple inquiries regarding the ability of an APRN to prescribe medications for the treatment of a sexually transmitted infection for the partner of an established patient. The Committee considered this issue at its July 30, 2009, and September 23, 2009, meetings and recommended the Board's adoption of new §222.4(e) in order to address this serious public health issue. Adopted new §222.4(e) is intended to permit APRNs to treat sexually transmitted infections as early as possible and to prevent individuals from contracting sexually transmitted infections from their partners. Specifically, adopted new §222.4(e) authorizes an APRN to prescribe medications for a sexually transmitted infection for the partner of an established patient, if the APRN assesses the patient and determines that the patient may have been infected with a sexually transmitted infection. Adopted new §222.4(e) also makes clear that an APRN is not required to issue such prescriptions. APRNs who elect to issue prescriptions for the partners of established patients, however, are required to do so in compliance with current laws relating to a physician's delegation of prescriptive authority. Further, the provisions of adopted new §222.4(e) are consistent with amendments that were adopted by the Texas Medical Board on June 24, 2009, to address this same issue. Those amendments, located at 22 Texas Administrative Code §190.8(1)(L)(iii), permit a physician to prescribe medications for sexually transmitted diseases for partners of a physician's established patient, if the physician determines that the patient may have been infected with a sexually transmitted disease.
The Board has also received an increased number of inquiries regarding the prescription of medications for "off label" use, as well as prescriptions for medications that have not been approved by the Food and Drug Administration (FDA). The Committee considered issues associated with prescribing "off label" medications at its July 30, 2009, and September 23, 2009, meetings and recommended the Board's adoption of new §222.4(f) in order to provide additional clarification to APRNs regarding this issue. Adopted new §222.4(f) makes clear than an APRN may prescribe only those medications that are FDA approved or are part of a United States Institutional Review Board approved research protocol. Adopted new §222.4(f) also clarifies that the prescription of "off label" medications are acceptable only if such use is within the current standard of care for the disease or condition and there is evidenced based research to support such practices. The provisions of adopted new §222.4(f) are consistent with the rules that have been adopted by the Texas Medical Board to address this issue. Those rules, located at 22 Texas Administrative Code §190.8(1)(K), prohibit the prescription or administration of a drug in a manner that is not approved by the FDA for use in human beings or does not meet standards for "off-label" use, unless an exemption has otherwise been obtained from the FDA.
Definitions
The adopted amended and new definitions in Chapter 222 are necessary for consistency with the 2008 National Council of State Boards of Nursing (NCSBN) APRN Model Act/Rules and Regulations and other Board rules relating to APRNs. The adopted amended and new definitions also clarify Board intent and meaning.
Adopted new §222.1(1) and (2) adds a definition of advanced health assessment course and advanced pathophysiology course to the chapter. These adopted new definitions are necessary for consistency with the requirements of §222.2 (relating to Approval for Prescriptive Authority). Section 222.2(a)(2) prescribes the graduate level courses that an APRN must successfully complete in order to be eligible to receive prescriptive authority. In particular, §222.2(a)(2)(A) refers to advanced health assessment and pathophysiology courses. The adopted new definitions of advanced health assessment course and advanced pathophysiology course provide additional guidance to APRNs regarding the specific content that a course must contain in order to meet the requirements of §222.2(a)(2)(A). Specifically, advanced health assessment course is defined in adopted new §222.1(1) as a course that offers content supported by related clinical experience such that students gain the knowledge and skills needed to perform comprehensive assessments, including histories and physical examinations, to make diagnoses and formulate effective clinical management plans. Advanced pathophysiology course is defined in adopted new §222.1(2) as a course that offers content that provides a comprehensive, systems-based study of pathophysiology that provides students with the knowledge and skills to analyze the relationship between normal physiology and pathophysiological phenomena. These adopted new definitions are also necessary for consistency with the APRN educational requirements of §221.3 of this title (relating to Education). Section 221.3(e) requires applicants for APRN authorization to demonstrate evidence of the completion of separate, dedicated courses in advanced assessment and pathophysiology. Further, §221.3(e)(5)(A) and (C) contain definitions of the terms advanced assessment course and pathophysiology, which are consistent with the adopted new definitions of advanced health assessment course and advanced pathophysiology course in §222.1(1) and (2).
The adopted amendment to §222.1(3) is also necessary for consistency with the requirements of §222.2. Section 222.2(a)(2) prescribes the graduate level courses that an APRN must successfully complete in order to be eligible for prescriptive authority. In particular, §222.2(a)(2)(A) refers to advanced pharmacotherapeutics courses. The adopted new definition of advanced pharmacotherapeutics course provides additional guidance to APRNs regarding the specific content that a course must contain in order to meet the requirements of §222.2(a)(2)(A). Specifically, advanced pharmacotherapeutics course is defined in adopted §222.1(3) as a course that offers advanced content in pharmacokinetics and pharmacodynamics, encompassing a broad range of drug classifications, including the application of drug therapy to the treatment of disease and/or the promotion of health. Further, the adopted definition is necessary for consistency with the APRN educational requirements of §221.3 of this title. Section 221.3(e) requires applicants for APRN authorization to demonstrate evidence of the completion of separate, dedicated courses in advanced pharmacotherapeutics. Further, §221.3(e)(5)(B) contains the definition of the term pharmacotherapeutics, which is consistent with the adopted amended definition of advanced pharmacotherapeutics course in §222.1(3).
This adoption order also amends the existing definition of advanced practice registered nurse and adds two new definitions, population focus area and prescribing, to Chapter 222. The adopted amendments to §222.1(4) and adopted new §222.1(15) and (16) are necessary for consistency with the 2008 NCSBN APRN Model Act/Rules and Regulations. The APRN Model Act/Rules and Regulations were promulgated by NCSBN during its August, 2008, Delegate Assembly. NCSBN is comprised of 60 member boards and operates as the collective voice of nursing regulation in the United States and its territories. Collectively, NCSBN develops nursing examinations, monitors trends in nursing practice and education, promotes uniformity in the regulation of nursing, conducts research on nursing practice issues, provides opportunities for collaboration among its members and other nursing and health care organizations, and promulgates model rules and regulations. The APRN Model Act/Rules and Regulations, which were promulgated by NCSBN, are designed to promote a common understanding of the appropriate scope of practice for an APRN, assist in the standardization of programs leading to APRN preparation, facilitate the mobility of APRNs, ensure public safety, and increase access to health care. As such, the Board has determined that it is important to model the adopted amended definition of advanced practice registered nurse in Chapter 222 after the APRN Model Act/Rules and Regulations. The adopted amended definition of advanced practice registered nurse in §222.1(4) more fully describes the scope of practice of an APRN and clarifies the requirements that a registered nurse must meet in order to qualify as an APRN. Further, the adopted amended definition of advanced practice registered nurse contains all of the substantive components set forth by the APRN Model Act/Rules and Regulations. The adopted new definitions of prescribing and population focus area in §222.1(15) and (16) are also consistent with the definitions of prescribing and population focus contained in the APRN Model Act/Rules and Regulations and better clarify the meaning of these terms.
The remaining adopted amendments to §222.1 add clarity to existing definitions, correct references to agency names, and re-designate the remaining paragraphs appropriately.
November, 2008 Amendments
This adoption order also eliminates references to "provisional authorization" and "provisional authority" throughout Chapter 222 and includes references to advanced practice registered nurses (APRNs). These adopted amendments are necessary for consistency with changes made to Chapter 221 of this title (relating to Advanced Practice Nurses) in November, 2008.
In October, 2007, the Board charged the Committee with considering whether Texas should refer to nurses in advanced practice as APRNs rather than as APNs (advanced practice nurses). In order to be consistent with the Occupations Code Chapter 305, the Committee recommended that the Board refer to such nurses as APRNs. Chapter 305 utilizes the term APRN to refer to nurses in advanced practice and prescribes requirements related to the APRN Compact. As a result, the Board adopted amendments to Chapter 221 in November, 2008, that replaced references to APNs with references to APRNs. In order for the Board to ensure consistency among its rules, the adopted amendments to Chapter 222 also replace references to APNs with references to APRNs. Further, based upon additional Committee recommendations, the Board adopted amendments in November, 2008, that eliminated provisional authorization for practice for new graduates. As such, references to "provisional authority" and "provisional authorization" were removed from Chapter 221. In order for the Board to ensure consistency among its rules, references to "provisional authority" and "provisional authorization" have also been removed from Chapter 222 as adopted.
Remaining Amendments
Section 222.2(a)(2) currently prescribes the educational requirements that a registered nurse must meet in order to be eligible to receive prescriptive authority from the Board. The adopted amendments to §222.2(a)(2)(A) are necessary to further clarify the course content that a Clinical Nurse Specialist must successfully complete before being eligible to receive prescriptive authority from the Board. Specifically, the adopted amendments clarify that a Clinical Nurse Specialist's course content must consist of separate, dedicated, graduate level courses. Further, the adopted amendments specify that the courses must be academic courses with a minimum of 45 clock hours per course from a nursing program accredited by an organization recognized by the Board. These adopted amendments do not prescribe new or additional educational requirements that a Clinical Nurse Specialist must meet in order to be eligible to receive prescriptive authority from the Board. Rather, the adopted amendments clarify the educational requirements that have been, and are currently, in place for Clinical Nurse Specialists seeking prescriptive authority from the Board. The adopted amendments to §222.2(a)(2)(A) are intended to provide additional guidance to Clinical Nurse Specialist regarding the specific content that a course must contain in order to satisfy the requirements of §222.2(a)(2)(A).
The adopted amendments to §222.4(c) are necessary for consistency with state laws regarding prescriptions for controlled substances. Pursuant to the Health and Safety Code §481.074(k)(9), the Texas Department of Public Safety (DPS) and United States Drug Enforcement Administration (DEA) numbers of a delegating physician must be provided on each prescription written by an APRN. As such, adopted §222.4(c)(9) requires DPS and DEA numbers to be included on each prescription written by an APRN. Further, adopted §222.6(a) makes clear that APRNs must comply with all federal and state laws and regulations relating to the prescription of controlled substances in Texas, including requirements set forth by the DPS and DEA. These adopted amendments re-iterate an APRN's responsibility to know and meet all federal and state regulations related to the prescription of controlled substances. Further, the adopted amendments clarify that the receipt of prescriptive authority from the Board does not, by itself, permit an APRN to prescribe controlled substances. Rather, all requirements of state law relating to the prescription of controlled substances must be met before an APRN may prescribe controlled substances in this state. Adopted §222.6 makes clear that an APRN who receives prescriptive authority from the Board may be eligible to receive DPS and DEA registrations in compliance with state and federal law.
The remaining adopted amendments are necessary to update outdated references and correct grammatical and typographical errors.
HOW THE SECTIONS WILL FUNCTION. The adopted title of Chapter 222 reads as: Advanced Practice Registered Nurses with Prescriptive Authority. Adopted §222.1 defines the terms to be used throughout Chapter 222. Adopted §222.2(a) provides that, to be approved by the Board to sign prescription drug orders and be issued a prescription authorization number, a Registered Nurse (RN) shall have full licensure from the Board to practice as an advanced practice registered nurse. Further, RNs with Interim Approval to practice as advanced practice registered nurses are not eligible for prescriptive authority. Further, adopted §222.2(a) provides that, to be approved by the Board to sign prescription drug orders and be issued a prescription authorization number, a Registered Nurse shall file a complete application for prescriptive authority and submit such evidence as required by the Board to verify the following educational qualifications: (i) to be eligible for prescriptive authority, advanced practice registered nurses must have successfully completed graduate level courses in advanced pharmacotherapeutics, advanced pathophysiology, advanced health assessment, and diagnosis and management of diseases and conditions within the role and population focus area; (ii) Nurse Practitioners, Nurse-Midwives and Nurse Anesthetists will be considered to have met the course requirements of §222.2 on the basis of courses completed in the advanced practice nursing educational program; and (iii) Clinical Nurse Specialists shall submit documentation of successful completion of separate, dedicated, graduate level courses in the content areas described in §222.2(a)(2)(A). Such courses shall be academic courses with a minimum of 45 clock hours per course from a nursing program accredited by an organization recognized by the Board. Further, 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 practice nursing educational program. Additionally, Clinical Nurse Specialists who were previously approved by the Board as advanced practice registered nurses by petition on the basis of completion of a non-nursing master's degree shall not be eligible for prescriptive authority. Adopted §222.2(c) provides that requirements for utilizing prescriptive authority may be modified or waived if a delegating physician has received a modification or waiver from the Texas Medical Board of any site or supervision requirements for a physician to delegate the carrying out or signing of prescription drug orders to the advanced practice registered nurse. Adopted §222.3(a) provides that the advanced practice registered nurse shall renew the privilege to sign prescription drug orders in conjunction with the RN and advanced practice license renewal application. Adopted §222.3(b) provides that the advanced practice registered 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. Adopted §222.3(c) provides that the continuing education requirement in §222.3(b) shall be in addition to continuing education required under Chapter 216 of this title (relating to Continuing Competency). Adopted §222.4(a) provides that the advanced practice registered nurse with a valid prescription authorization number shall (i) sign prescription drug orders for only those drugs that are prescribed for patient populations within the accepted scope of professional practice for the advanced practice registered nurse's license and (ii) comply with the requirements for adequate physician supervision published in the rules of the Texas Medical Board 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. Adopted §222.4(b) provides that protocols or other written authorization shall be defined in a manner that promotes the exercise of professional judgement by the advanced practice registered nurse commensurate with the education and experience of that person. Further, a protocol or other written authorization is not required to describe the exact steps that the advanced practice registered nurse must take with respect to each specific condition, disease, or symptom. Further, protocols or other written authorization shall be written, agreed upon and signed by the advanced practice registered nurse and the physician and maintained in the practice setting of the advanced practice registered nurse. Adopted §222.4(c) provides that the format and essential elements of the prescription shall comply with the requirements of the Texas State Board of Pharmacy. The following information must be provided on each prescription: (i) the name, address, telephone number, and, if the prescription is for a controlled substance, the United States Drug Enforcement Administration number of the delegating physician; and (ii) the name, prescription authorization number, original signature, and, if the prescription is for a controlled substance, the Texas Department of Public Safety and United States Drug Enforcement Administration numbers of the advanced practice registered nurse signing or co-signing the prescription drug order. Adopted §222.4(d) provides that the advanced practice registered 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. Adopted §222.4(e) provides that an advanced practice registered nurse may prescribe medications for sexually transmitted diseases for partners of an established patient, if the advanced practice registered nurse assesses the patient and determines that the patient may have been infected with a sexually transmitted disease. Further, nothing in adopted §222.4(e) shall be construed to require the advanced practice registered nurse to issue prescriptions for partners of patients. Adopted §222.4(f) provides that advanced practice registered nurses may prescribe only those medications that are FDA approved unless done through protocol registration in a United States Institutional Review Board or Expanded Access authorized clinical trial. Further, "off label" use, or prescription of FDA-approved medications for uses other than that indicated by the FDA, is permitted when such practices are (i) within the current standard of care for treatment of the disease or condition and (ii) supported by evidence-based research. Adopted §222.5 provides that advanced practice registered nurses with full licensure and valid prescription authorization numbers are eligible to sign prescription drugs orders for dangerous drugs in accordance with the standards and requirements set forth in Chapter 222. Adopted §222.6(a) provides that advanced practice registered nurses with full licensure and valid prescription authorization numbers are eligible to obtain authority to prescribe certain categories of controlled substances. Further, the advanced practice registered nurse must comply with all federal and state laws and regulations relating to the prescribing of controlled substances in Texas, including but not limited to, requirements set forth by the Texas Department of Public Safety and the United States Drug Enforcement Administration. Adopted §222.6(b) provides that advanced practice registered nurses who authorize or issue prescriptions for controlled substances shall: (i) limit prescriptions for controlled substances to those medications listed in Schedules III through V as established by the commissioner of public health under Chapter 481, Health and Safety Code (Texas Controlled Substances Act); (ii) issue prescriptions, including a refill of the prescription, for a period not to exceed 90 days; and (iii) not authorize the refill of a prescription for a controlled substance beyond the initial 90 days prior to consultation with the delegating physician and notation of the consultation in the patient's chart. Adopted §222.7 provides that, when signing prescription drug orders at a site serving a medically underserved population, the advanced practice registered nurse shall: (i) maintain protocols or other written authorization that must be reviewed and signed by both the advanced practice registered nurse and the delegating physician at least annually; (ii) provide a daily status report to the physician on any problems or complications encountered that are not covered by protocol; and (iii) be available during on-site visits by the physician which shall occur at least once every 10 business days that the advanced practice registered nurse is on site providing care. Adopted §222.8 provides that when signing prescription drug orders at a physician's primary practice site, the advanced practice registered nurse shall maintain protocols or other written authorization that must be reviewed and signed by both the advanced practice registered nurse and the delegating physician at least annually. Adopted §222.9 provides that, when signing prescription drug orders at an alternate site, the advanced practice registered nurse shall: (i) maintain Protocols or other written authorization that must be reviewed and signed by both the advanced practice registered nurse and the delegating physician at least annually; (ii) be available on-site with the physician at least 10 percent of the hours of operation of the site each month that the advanced practice registered nurse is acting with delegated prescriptive authority; and (iii) have access to the delegating physician through direct telecommunication for consultation, patient referral, or assistance with a medical emergency. Adopted §222.10 provides that, when signing prescription drug orders at a facility-based practice site, the advanced practice registered nurse shall maintain protocols or other written authorization developed in accordance with facility medical staff policies and review the authorizing documents with the appropriate medical staff at least annually. Adopted §222.11 provides that the advanced practice registered nurse with a valid prescription authorization number may request, receive, possess and distribute prescription drug samples provided: (i) all requirements for the advanced practice registered nurse to sign prescription drug orders are met; (ii) protocols or other physician orders authorize the advanced practice registered nurse to sign the prescription drug orders; and (iii) the samples are for only those drugs that the advanced practice registered nurse is eligible to prescribe in accordance with the standards and requirements set forth in Chapter 222. Adopted §222.12(a) provides that any advanced practice registered nurse who violates these rules or prescribes in a manner that is not consistent with the standard of care shall be subject to removal of the authority to prescribe under this rule and disciplinary action by the Board under the Occupations Code §301.452. Adopted §222.12(b) provides that the Board shall report to the Texas Department of Public Safety and the United States Drug Enforcement Administration any of the following: (i) any significant changes in the status of the RN license or advanced practice license, or (ii) disciplinary action impacting an advanced practice registered nurse's ability to authorize or issue prescription drug orders. Adopted §222.12(c) provides that the practice of the advanced practice registered nurse approved by the board to sign prescription drug orders is subject to monitoring by the Board on a periodic basis.
SUMMARY OF COMMENTS AND AGENCY RESPONSE. The Board did not receive any comments on the proposal.
STATUTORY AUTHORITY. The amendments are adopted under the Occupations Code §§157.0511(b), 157.053(a), 157.0541(a) - (c), 301.151, 301.152, and §305.001, Article 2(a).
Section 157.0511(b) provides that a physician may delegate the carrying out or signing of a prescription drug order for a controlled substance only if: (i) the prescription is for a controlled substance listed in Schedule III, IV, or V as established by the commissioner of public health under Chapter 481, Health and Safety Code; (ii) the prescription, including a refill of the prescription, is for a period not to exceed 90 days; (iii) with regard to the refill of a prescription, the refill is authorized after consultation with the delegating physician and the consultation is noted in the patient's chart; and (iv) with regard to a prescription for a child less than two years of age, the prescription is made after consultation with the delegating physician and the consultation is noted in the patient's chart.
Section 157.053(a) provides that "primary practice site" means: (i) the practice location of a physician at which the physician spends the majority of the physician's time; (ii) a licensed hospital, a licensed long-term care facility, or a licensed adult care center where both the physician and the physician assistant or advanced practice nurse are authorized to practice; (iii) 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; (iv) the residence of an established patient; (v) another location at which the physician is physically present with the physician assistant or advanced practice nurse; or (vi) a location where a physician assistant or advanced practice nurse who practices on-site with the physician more than 50 percent of the time and in accordance with board rules provides health care services for established patients; without remuneration, voluntary charity health care services at a clinic run or sponsored by a nonprofit organization; or without remuneration, voluntary health care services during a declared emergency or disaster at a temporary facility operated or sponsored by a governmental entity or nonprofit organization and established to serve persons in this state.
Section 157.0541(a) provides that "alternate site" means a practice site: (i) where services similar to the services provided at the delegating physician's primary practice site are provided; and (ii) located within 75 miles of the delegating physician's residence or primary practice site. Section 157.0541(b) provides that at an alternate site, a physician licensed by the board may delegate to an advanced practice nurse or physician assistant, acting under adequate physician supervision, the act of administering, providing, or carrying out or signing a prescription drug order as authorized through a physician's order, a standing medical order, a standing delegation order, or another order or protocol as defined by the board. Section 157.0541(c) provides that physician supervision is adequate for the purposes of §157.0541 if: (i) the delegating physician is on-site with the advanced practice nurse or physician assistant at least 10 percent of the hours of operation of the site each month that the physician assistant or advanced practice nurse is acting with delegated prescriptive authority and is available while on-site to see, diagnose, treat, and provide care to those patients for services provided or to be provided by the physician assistant or advanced practice nurse to whom the physician has delegated prescriptive authority; and is not prohibited by contract from seeing, diagnosing, or treating a patient for services provided or to be provided by the physician assistant or advanced practice nurse under delegated prescriptive authority; (ii) the delegating physician reviews at least 10 percent of the medical charts, including through electronic review of the charts from a remote location, for each advanced practice nurse or physician assistant at the site; and (iii) the delegating physician is available through direct telecommunication for consultation, patient referral, or assistance with a medical emergency.
Section 301.151 authorizes the Board to adopt and enforce rules consistent with Chapter 301 and necessary to: (1) perform its duties and conduct proceedings before the Board; (2) regulate the practice of professional nursing and vocational nursing; (3) establish standards of professional conduct for license holders under Chapter 301; and (4) determine whether an act constitutes the practice of professional nursing or vocational nursing.
Section 301.152(a) provides that "advanced practice nurse" means a registered nurse approved by the Board to practice as an advanced practice nurse on the basis of completion of an advanced educational program. The term includes a nurse practitioner, nurse midwife, nurse anesthetist, and clinical nurse specialist. The term is also synonymous with "advanced nurse practitioner." Section 301.152(b) authorizes the Board to adopt rules to: (i) establish any specialized education or training, including pharmacology, that a registered nurse must have to carry out a prescription drug order under §157.052 and a system for assigning an identification number to a registered nurse who provides the Board with evidence of completing the specialized education and training requirement under §301.152(b)(1)(A); (ii) approve a registered nurse as an advanced practice nurse; and (iii) initially approve and biennially renew an advanced practice nurse's authority to carry out or sign a prescription drug order under Chapter 157. Section 301.152(c) provides that the rules adopted under §301.152(b)(3) must: (i) require completion of pharmacology and related pathology education for initial approval; (ii) require continuing education in clinical pharmacology and related pathology in addition to any continuing education otherwise required under §301.303; and (iii) provide for the issuance of a prescription authorization number to an advanced practice nurse approved under this section. Section 301.152(d) provides that the signature of an advanced practice nurse attesting to the provision of a legally authorized service by the advanced practice nurse satisfies any documentation requirement for that service established by a state agency.
Section 305.001, Article 2(a) defines advanced practice registered nurse or APRN as a nurse anesthetist, nurse practitioner, nurse midwife, or clinical nurse specialist to the extent a party state licenses or grants authority to practice in that APRN role and title.
§222.2.Approval for Prescriptive Authority.
(a) Credentials: To be approved by the Board to sign prescription drug orders and issued a prescription authorization number, a Registered Nurse (RN) shall:
(1) have full licensure from the Board to practice as an advanced practice registered nurse. RNs with Interim Approval to practice as advanced practice registered nurses are not eligible for prescriptive authority.
(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 registered nurses must have successfully completed graduate level courses in advanced pharmacotherapeutics, advanced pathophysiology, advanced health assessment, and diagnosis and management of diseases and conditions within the role and population focus area.
(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 practice nursing educational program.
(ii) Clinical Nurse Specialists shall submit documentation of successful completion of separate, dedicated, graduate level courses in the content areas described in subparagraph (A) of this paragraph. These courses shall be academic courses with a minimum of 45 clock hours per course from a nursing program accredited by an organization recognized by the Board.
(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 practice nursing educational program.
(B) Clinical Nurse Specialists who were previously approved by the Board as advanced practice registered 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 Medical Board: Requirements for utilizing prescriptive authority may be modified or waived if a delegating physician has received a modification or waiver from the Texas Medical Board of any site or supervision requirements for a physician to delegate the carrying out or signing of prescription drug orders to the advanced practice registered nurse.
§222.7.Prescribing at Sites Serving Certain Medically Underserved Populations.
When signing prescription drug orders at a site serving a medically underserved population, the advanced practice registered nurse shall:
(1) maintain Protocols or other written authorization that must be reviewed and signed by both the advanced practice registered 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) be available during on-site visits by the physician which shall occur at least once every 10 business days that the advanced practice registered nurse is on site providing care.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January 25, 2010.
TRD-201000316
Jena R. Abel
Assistant General Counsel
Texas Board of Nursing
Effective date: February 14, 2010
Proposal publication date: November 27, 2009
For further information, please call: (512) 305-6822