PART 10. TEXAS FUNERAL SERVICE COMMISSION

CHAPTER 205. CEMETERIES AND CREMATORIES

22 TAC §205.3

The Texas Funeral Service Commission (commission) proposes an amendment to §205.3, Crematory License Requirement and Procedure.

The proposed amendments to §205.3 are designed to delete requirements for licensure of crematory establishments that have become obsolete and to streamline the process of license renewal.

O.C. "Chet" Robbins, Executive Director, has determined that for the first five-year period the amendment is in effect, there will be no fiscal implication for state or local governments as a result of enforcing or administering the proposed amendment.

Mr. Robbins further has determined that for each year of the first five-year period the amendment is in effect, the public benefit anticipated as a result of enforcing the amendment will be increased efficiency in the handling of the licensing of crematory establishments. Mr. Robbins also has determined that there will be no effect on large, small or micro-businesses, that there is no anticipated economic costs to persons who are required to comply with the amendment as proposed and that there will be no impact on local employment or economies.

Comments on the proposal may be submitted to Mr. Robbins at P.O. Box 12217, Capitol Station, Austin, Texas 78711-1440, (512) 479-5064 (fax), or electronically to chet.robbins@tfsc.state.tx.us.

The amendment is proposed under Texas Occupations Code, §651.152. The commission interprets §651.152 as authorizing it to adopt rules as necessary to administer Chapter 651.

No other statutes, articles, or codes are affected by the proposal.

§205.3.Crematory License Requirement and Procedure.

(a) - (b) (No change.)

[(c) The establishment shall submit the licensing fee after it has passed inspection. The amount of the licensing and renewal fees are posted on the commission's website at www.tfsc.state.tx.us.]

(c) [(d)] A license is for one year.

(d) [(e)] The license may be renewed by filing with the commission a renewal application accompanied by the renewal fee and the Crematory Annual Report required by Texas Occupations Code, §651.658(a)(1) and §205.9 of this chapter (relating to Crematory Annual Report, Extensions for Good Cause, and Late Fees).

(e) [(f)] The renewal application must contain the information required by Texas Occupations Code, §651.657 and subsection (a) of this section or a statement that the information previously furnished has not changed.

(f) [(g)] The commission may not renew an application until the applicant has met the requirements of Texas Occupations Code, §651.658(a).

(g) [(h)] A crematory that fails to renew its license by its renewal date shall pay, in addition to the renewal fee, a late payment penalty equal in amount to the renewal fee.

(h) [(i)] The license that is not renewed within 30 days of its expiration date may [ not] be renewed by paying the renewal fee and late payment penalty. [ In this circumstance a new license is required.]

This agency hereby certifies that the proposal 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 November 10, 2009.

TRD-200905183

O.C. Robbins

Executive Director

Texas Funeral Service Commission

Earliest possible date of adoption: December 27, 2009

For further information, please call: (512) 936-2466

CHAPTER 222. ADVANCED PRACTICE REGISTERED NURSES WITH PRESCRIPTIVE AUTHORITY

22 TAC §§222.1 - 222.12

INTRODUCTION. The Texas Board of Nursing (Board) proposes amendments to Chapter 222, §§222.1 - 222.12, concerning Advanced Practice Nurses With Prescriptive Authority. These amendments are proposed 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 proposed 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 October 2009, Board meeting, the Board approved the proposed amendments to Chapter 222.

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 proposed 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 of 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, proposed amended §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, proposed amended §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 proposed 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 proposed amendments to §222.1(14) are necessary for consistency with the new definition of primary practice site in §157.053(a). Proposed amended §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, proposed amended §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. Proposed amended §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 certain distance from the physician's residence. The proposed 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). The Medical Practice Act, §157.0541(b), 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 proposed amendments to §222.9 are necessary for consistency with the requirements of §157.0541(c). Proposed amended §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, proposed amended §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 proposed new §222.4(e) in order to address this serious public health issue. The proposed new subsection to §222.4 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, proposed 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. Proposed 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, this issue has also been addressed by the Texas Medical Board. The provisions of proposed new §222.4(e) are consistent with amendments that were adopted by the Texas Medical Board on June 24, 2009, to address this 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 proposed new §222.4(f) in order to provide additional clarification to APRNs regarding this issue. Proposed 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. Proposed 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 Texas Medical Board has also addressed this issue. The provisions of proposed new §222.4(f) are consistent with the rules that have been adopted by the Texas Medical Board, located at 22 Texas Administrative Code §190.8(1)(K), to address this issue. Those rules 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 proposal amends and adds several new definitions to Chapter 222. The proposed amended and new definitions are necessary for consistency with (i) the 2008 National Council of State Boards of Nursing (NCSBN) APRN Model Act/Rules and Regulations and (ii) other Board rules relating to APRNs. The proposed amended and new definitions are also necessary to clarify Board intent and meaning.

Proposed new §222.1(1) and (2) adds a definition of advanced health assessment course and advanced pathophysiology course to the chapter. These proposed new definitions are necessary for consistency with the requirements of §222.2 of this chapter (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) refers to advanced health assessment and pathophysiology courses. The proposed 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). Specifically, advanced health assessmentcourse is defined in proposed 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 proposed 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 proposed 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 proposed new definitions of advanced health assessment course and advanced pathophysiology course in §222.1(1) and (2).

The proposed amendment to §222.1(3) is also necessary for consistency with the requirements of §222.2 of this chapter. 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) refers to advanced pharmacotherapeutics courses. The proposed 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). Specifically, advanced pharmacotherapeutics course is defined in proposed amended §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 proposed amended 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 proposed amended definition of advanced pharmacotherapeutics course in §222.1(3).

The proposal also amends the existing definition of advanced practice registered nurse and adds two new definitions of population focus area and prescribing to the chapter. The proposed amendments to §222.1(4) and proposed 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 proposed amended definition of advanced practice registerednurse in Chapter 222 after the APRN Model Act/Rules and Regulations. The proposed 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 proposed amended definition of advanced practice registered nurse contains all of the substantive components set forth by the APRN Model Act/Rules and Regulations. The proposed 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 the terms.

The remaining amendments to §222.1 add clarity to existing definitions, correct references to reflect current state agency names, and re-designate the remaining paragraphs appropriately.

November, 2008 Amendments

The proposal also eliminates references to "provisional authorization" and "provisional authority" throughout the chapter and includes references to advanced practice registered nurses (APRNs). These proposed 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 proposal also replaces 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.

Remaining Amendments

The remaining proposed amendments are necessary for clarification of existing Board rules and for consistency with state laws relating to controlled substances. Section 222.2(a)(2) currently prescribes the requirements that a registered nurse must meet in order to be eligible to receive prescriptive authority from the Board. The proposed 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 proposed amendments clarify that a Clinical Nurse Specialist's course content must consist of separate, dedicated, graduate level courses. Further, the proposed 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 proposed 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 proposed amendments clarify the educational requirements that have been, and are currently, in place for Clinical Nurse Specialists seeking prescriptive authority from the Board. The 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 requirement of §222.2(a)(2).

The proposed 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, proposed amended §222.4(c)(9) requires DPS and DEA numbers to be included on each prescription written by an APRN. Further, proposed amended §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 proposed amendments reiterate an APRN's responsibility to know and meet all federal and state regulations related to the prescription of controlled substances. Further, the proposed 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. Proposed amended §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 amendments in the proposal are necessary to update outdated references and correct grammatical and typographical errors.

Section-by-Section Overview. The following is a section-by-section overview of the proposal.

The proposed amended title of Chapter 222 reads as: Advanced Practice Registered Nurses with Prescriptive Authority. Proposed amended §222.1 defines the terms to be used throughout Chapter 222. Proposed amended §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. RNs with Interim Approval to practice as advanced practice registered nurses are not eligible for prescriptive authority. Further, proposed amended §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). 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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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). Proposed amended §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. Proposed amended §222.4(b) provides that protocols or other written authorization shall be defined in a manner that promotes the exercise of professional judgment 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. Proposed amended §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. Proposed amended §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. Proposed new §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 proposed new §222.4(e) shall be construed to require the advanced practice registered nurse to issue prescriptions for partners of patients. Proposed new §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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. Proposed amended §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 Occupations Code §301.452. Proposed amended §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. Proposed amended §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.

FISCAL NOTE. Katherine Thomas, Executive Director, has determined that for each year of the first five years the proposed amendments are in effect, there will be no additional fiscal implications for state or local government as a result of implementing the proposed amendments.

PUBLIC BENEFIT/COST NOTE. Ms. Thomas has also determined that for each year of the first five years the proposed amendments are in effect, there will be public benefits, and there will be potential costs for individuals required to comply with the proposal.

Anticipated Public Benefits. The anticipated public benefits will be the adoption of requirements that: (i) promote consistency with APRN national nursing standards; (ii) provide guidance to APRNs regarding their prescriptive authority in this state; and (iii) promote consistency among Board rules.

The proposed amendments to Chapter 222 promote consistency with the APRN standards promulgated and adopted by NCSBN during its August, 2008, Delegate Assembly. APRNs have expanded in number and capability over the past several decades and have become increasingly more important in meeting the healthcare needs of the public. As a result, NCSBN has promulgated model rules and regulations designed to promote a common understanding of the appropriate scope of practice of APRNs, assist in the standardization of programs leading to APRN preparation, facilitate the mobility of APRNs, ensure public safety, and increase access to health care. The proposed amendments to Chapter 222 incorporate many of the definitions contained in the model rules and regulations promulgated by NCSBN, including the definition of APRN. By adopting definitions that are consistent with the model rules and regulations promulgated by NCSBN, the proposed amendments promote a common understanding of the scope of practice of an APRN and facilitate the standardization of APRN regulation across jurisdictions.

Many significant changes affecting an APRN's prescriptive authority in Texas were enacted during the 81st Legislative Session. The proposed amendments to Chapter 222 clarify the effect of these changes on an APRN's prescriptive authority. For example, the proposed amendments clarify 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, the proposed amendments prohibit an APRN from authorizing the refill of a prescription for a controlled substance beyond 90 days without consulting the delegating physician. The proposed amendments also specify new locations where an APRN meeting certain conditions may prescribe medications. The proposed amendments also clarify the additional supervision requirements prescribed by SB 532. Collectively, the proposed amendments are designed to inform APRNs of these changes in law and provide guidance to APRNs regarding the changes that may affect their practice. By clarifying these changes in law, the proposed amendments promote compliance with these requirements, which results in more effective regulation and better protection of the public.

The proposed amendments to Chapter 222 also address two important public health concerns that many APRNs routinely encounter in their day to day practice. Further, the Board has received an increasing number of inquiries from the public regarding these public health issues. By directly addressing these public health concerns, the proposed amendments provide guidance to APRNs so that they may be better able to respond to these issues. First, the proposed amendments clarify that an APRN may prescribe medications for the treatment of a sexually transmitted infection for the partner of an established patient. This proposed amendment is designed to provide for the treatment of a sexually transmitted infection at the earliest possible time and to prevent the further transmission of a sexually transmitted infection. Because this proposed amendment makes clear that an APRN may provide such treatment, members of the public may be able to receive treatment more quickly. Second, the proposed amendments clarify the restrictions that apply to the prescription of "off label" medications, or medications that have not been approved by the FDA. Because such medications may be inappropriate or ineffective for the treatment of certain illnesses and sicknesses, the proposed amendments make clear that such medications should only be prescribed in certain, limited circumstances. By providing this additional clarification and guidance, the proposed amendments seek to protect members of the public from dangerous or ineffective treatment and care. Further, the proposed amendments also clarify that the prescription of "off label" medications may be used 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. These limitations serve to protect the public from the use of potentially dangerous or ineffective medications.

The proposed amendments to Chapter 222 also correct and eliminate outdated or incorrect references for consistency with other Board rules. Consistency among Board rules results in clear and more efficient regulation, which benefits regulated individuals, as well as the public at large.

Potential Costs for Individuals To Comply with the Proposal.

The proposal requires an APRN signing or co-signing a prescription drug order to include his or her DPS and DEA numbers on the prescription. Further, the proposal requires an APRN to comply with all federal and state laws and regulations relating to prescribing controlled substances in Texas, including but not limited to, requirements set forth by the DPS and DEA. A registered nurse is not required by law to obtain prescriptive authority from the Board in order to practice as an APRN in this state. For those APRNs who choose to obtain prescriptive authority from the Board, there may be associated costs of compliance with proposed amended §222.4(c)(9) and §222.6(a). The probable costs of compliance with proposed amended §222.4(c)(9) and §222.6(a) will result from registering and obtaining a DPS and DEA number. The costs to comply with these proposed amendments, however, result from the enactment of the Health and Safety Code §481.074(k)(9) and are not a result of the adoption, enforcement, or administration of the proposal. Section 481.074(k)(9) provides that a prescription for a controlled substance must show: (i) the quantity of the substance prescribed; (ii) the date of issue; (iii) the name, address, and date of birth or age of the patient or, if the controlled substance is prescribed for an animal, the species of the animal and the name and address of its owner; (iv) the name and strength of the controlled substance prescribed; (v) the directions for use of the controlled substance; (vi) the intended use of the substance prescribed unless the practitioner determines the furnishing of this information is not in the best interest of the patient; (vii) the legibly printed or stamped name, address, DEA registration number, and telephone number of the practitioner at the practitioner's usual place of business; (viii) if the prescription is handwritten, the signature of the prescribing practitioner; and (ix) if the prescribing practitioner is licensed in this state, the practitioner's department registration number. The Board anticipates the costs of registering and obtaining a DPS number to be $25 per yearly registration period. DPS requires all persons that dispense controlled substances in Texas to register and receive a registration number. The Board anticipates that the total probable cost of registering with DPS will include completing an application and sending in payment to DPS. The Board anticipates this cost to be minimal. The issuance of a DEA registration to prescribe controlled substances is predicated on the successful completion of all of the requirements imposed by the state in which a practitioner will conduct business and obtain a state license. If the practitioner fails to obtain the required state license or has the license revoked or rescinded, then the DEA cannot issue the requested registration. The Board anticipates the cost of registering and obtaining a DEA number to be $551 per every three year registration period. Further, the Board anticipates that the total probable cost of registering with DEA will include completing an application and sending in payment to DEA. The Board anticipates this cost to be minimal. Any other costs to comply with the proposal result from the enactment of the Occupations Code Chapters 157 and 301 and the Health and Safety Code Chapter 481 and are not a result of the adoption, enforcement, or administration of the proposal.

ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS FOR SMALL AND MICRO BUSINESSES.

As required by the Government Code §2006.002(c) and (f), the Board has determined that the proposal will not have an adverse economic effect on any individual, Board regulated entity, or other entity required to comply with the proposal because no individual, Board regulated entity, or other entity required to comply with the proposal meets the definition of a small or micro business under the Government Code §2006.001(1) or (2). The Government Code §2006.001(1) defines a micro business as a legal entity, including a corporation, partnership, or sole proprietorship that: (i) is formed for the purpose of making a profit; (ii) is independently owned and operated; and (iii) has not more than 20 employees. The Government Code §2006.001(2) defines a small business as a legal entity, including a corporation, partnership, or sole proprietorship, that: (i) is formed for the purpose of making a profit; (ii) is independently owned and operated; and (iii) has fewer than 100 employees or less than $6 million in annual gross receipts. Each of the elements in §2006.001(1) and (2) must be met in order for an entity to qualify as a micro business or small business. The only entities subject to the proposal are individuals. Because individuals are not independently owned and operated legal entities that are formed for the purpose of making a profit, no individual licensee or applicant qualifies as a micro business or small business under the Government Code §2006.001(1) or (2). Therefore, in accordance with the Government Code §2006.002(c) and (f), the Board is not required to prepare a regulatory flexibility analysis.

TAKINGS IMPACT ASSESSMENT. The Board has determined that no private real property interests are affected by this proposal and that this proposal does not restrict or limit an owner's right to property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking or require a takings impact assessment under the Government Code §2007.043.

REQUEST FOR PUBLIC COMMENT. To be considered, written comments on the proposal or any request for a public hearing must be submitted no later than 5:00 p.m. on December 27, 2009, to James W. Johnston, General Counsel, Texas Board of Nursing, 333 Guadalupe, Suite 3-460, Austin, Texas 78701, or by e-mail to dusty.johnston@bon.state.tx.us, or faxed to (512) 305-8101. An additional copy of the comments on the proposal or any request for a public hearing must be simultaneously submitted to Jolene Zych, Advanced Practice Consultant, Texas Board of Nursing, 333 Guadalupe, Suite 3-460, Austin, Texas 78701, or by e-mail to jolene.zych@bon.state.tx.us, or faxed to (512) 305-8101. If a hearing is held, written and oral comments presented at the hearing will be considered.

STATUTORY AUTHORITY. The amendments are proposed 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.

CROSS REFERENCE TO STATUTE. The following statutes are affected by this proposal: §§222.1 - 222.12, Occupations Code §§157.0511(b), 157.053(a), 157.0541(a) - (c), 301.151, 301.152, and 305.001, Article 2(a)

§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 health assessment course--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.

[(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) Advanced pathophysiology course--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.

[(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) Advanced pharmacotherapeutics course--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.

[(3) Board--The Board of Nurse Examiners for the State of Texas.]

(4) Advanced practice registered nurse--A registered nurse who:

(A) has completed a graduate-level education program accredited by an organization recognized by the Board that prepares him/her for one of the four following recognized advanced practice roles:

(i) nurse anesthetist,

(ii) nurse-midwife,

(iii) nurse practitioner; or

(iv) clinical nurse specialist;

(B) has demonstrated current competence by:

(i) passing a national certification examination recognized by the Board that measures advanced practice role and population-focused competencies and demonstrating continuing competence as evidenced by certification maintenance/recertification in the role and population through a national certification program; or

(ii) meeting requirements set forth by the Board for those advanced practice registered nurses not required by §221.7 of this title (relating to Petitions for Waiver and Exemptions) to hold national certification;

(C) has acquired advanced clinical knowledge and skills preparing him/her to provide direct and indirect care to patients with greater role autonomy;

(D) has been educationally prepared to assume responsibility and accountability for health promotion and/or maintenance as well as the assessment, diagnosis, and management of patient problems that includes the use and prescription of pharmacologic and non-pharmacologic interventions;

(E) has clinical experiences of sufficient depth and breadth to reflect the area of licensure; and

(F) holds current licensure in one of the four advanced practice roles and a Board-approved population focus area.

[(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) Alternate site--A practice site:

(A) where the services provided are similar to the services provided at the delegating physician's primary practice site; and

(B) located within 75 miles of the delegating physician's residence or primary practice site.

(6) Board--The Texas Board of Nursing.

(7) [(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.

(8) [(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" or "RX only" or another legend that complies with federal law.

(9) [(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 conditions [problems] considered within the scope of practice of the advanced practice registered nurse's population focus area [ specialty] and role.

(10) [(8)] Eligible sites--Sites serving medically underserved populations; a physician's primary practice site; an alternate site; or a facility-based practice site.

(11) [(9)] Facility-based practice site--A licensed hospital or licensed long term care facility that serves as the practice location for the advanced practice registered nurse.

(12) [(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.

(13) [(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 Department of State Health Services [ Texas Board of Health (Texas Department of Health)] based on demographics specific to this state [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.]

(14) [(13)] Physician's primary practice site--

(A) the practice location at which the physician spends the majority of his/her [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 advanced practice registered nurse [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 registered nurse; and [.]

(F) provided an advanced practice registered nurse spends at least 50 percent of the time in a setting with the delegating physician, she/he may also prescribe in the following settings:

(i) a site in which health care services are provided for established patients only;

(ii) a clinic run or sponsored by a nonprofit organization that provides voluntary charity health care services where the advanced practice registered nurse is not remunerated; or

(iii) a setting where voluntary health care services are provided 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 where the advanced practice registered nurse is not remunerated.

(15) Population focus area--The section of the population with which the advanced practice registered nurse has been licensed to practice by the Board.

(16) Prescribing--Determining the dangerous drugs or controlled substances that shall be used by or administered to a patient exercised in compliance with state and federal law.

(17) [(14)] Protocols or other written authorization--Written authorization to provide medical aspects of patient care that are agreed upon and signed by the advanced practice registered nurse [APN] and the physician, reviewed and signed at least annually, and maintained in the practice setting of the advanced practice registered nurse [APN]. Protocols or other written authorization shall be defined to promote the exercise of professional judgment by the advanced practice registered nurse [APN] commensurate with his/her education and experience. Such protocols or other written authorization need not describe the exact steps that the advanced practice registered nurse [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.

(18) [(15)] Shall and must--Mandatory requirements.

(19) [(16)] Should--A recommendation.

(20) Signing a prescription drug order--Completing a prescription drug order presigned by the delegating physician or the signing of a prescription by an advanced practice registered nurse. The advanced practice registered nurse must be designated to the Texas Medical Board by the delegating physician as a person delegated to sign a prescription.

(21) [(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 Health and Human Services Commission [ Texas Department of Human Services] or the Texas Department of State Health Services [ Texas Department of Health];

(E) a site located in an area in which the Texas Department of State Health Services [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 State Health Services [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 [board] to [ carry out or] sign prescription drug orders and issued a prescription authorization number, a Registered Nurse (RN) shall:

(1) have full licensure from [or provisional authorization by] the Board [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.

[(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 [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 [ problems] within the role and population focus area [ 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 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 subsection (a) [(A)] of this section. 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 [regionally accredited institution with a minimum of 45 clock hours per course].

(iii) The Board [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 [ have been] approved by the Board [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) (No change.)

(c) Exceptions Granted by the Texas Medical [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 Medical [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 registered nurse.

§222.3.Renewal of Prescriptive Authority.

(a) The advanced practice registered nurse shall renew the privilege to [carry out or] sign prescription drug orders in conjunction with the RN and advanced practice license renewal application.

(b) The advanced practice registered nurse seeking to maintain prescriptive authority shall attest, on forms provided by the Board [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 Competency [Education]).

§222.4.Minimum Standards for [Carrying Out or] Signing Prescriptions.

(a) The advanced practice registered nurse with a valid prescription authorization number:

(1) shall [carry out or] sign prescription drug orders for only those drugs that are:

(A) (No change.)

(B) prescribed for patient populations within the accepted scope of professional practice for the advanced practice registered nurse's license [specialty area]; and

(2) shall comply with the requirements for adequate physician supervision published in the rules of the Texas Medical 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 registered 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 registered nurse must take with respect to each specific condition, disease, or symptom; and

(B) (No change.)

(2) Protocols or other written authorization shall be:

(A) [shall be] written, agreed upon and signed by the advanced practice registered nurse and the physician;

(B) (No change.)

(C) maintained in the practice setting of the advanced practice registered nurse.

(c) Prescription Information: 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:

(1) - (4) (No change.)

(5) the name, address, telephone number, and, if the prescription is for a controlled substance, the United States Drug Enforcement Administration [DEA] number of the delegating physician;

(6) - (8) (No change.)

(9) 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 [DEA number] of the advanced practice registered nurse signing or co-signing the prescription drug order.

(d) Generic Substitution. 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.

(e) 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. Nothing in this subsection shall be construed to require the advanced practice registered nurse to issue prescriptions for partners of patients.

(f) 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. "Off label" use, or prescription of FDA-approved medications for uses other than that indicated by the FDA, is permitted when such practices are:

(1) within the current standard of care for treatment of the disease or condition, and

(2) supported by evidence-based research.

§222.5.Prescriptions for Dangerous Drugs.

Advanced practice registered nurses with full licensure [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 registered nurses with full licensure [authorization to practice] and valid prescription authorization numbers are eligible to obtain authority to prescribe certain categories of controlled substances. 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. [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 registered 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 medications listed in Schedules III through [, 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, including a refill of the prescription, for a period not to exceed 90 [30] days;

(3) 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; and

(4) (No change.)

(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] Advanced practice registered nurses with [full authorization to practice and ] valid prescription authorization [numbers] must comply with all federal[ ,] and state [and local ] 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.

§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 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) - (3) (No change.)

(4) shall 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.

§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 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; and

(2) (No change.)

§222.9.Prescribing at Alternate Sites.

When [carrying out or] signing prescription drug orders at an alternate site, 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) be available on-site with the physician at least 10 [twenty] percent of the hours of operation of the site each month that the advanced practice registered nurse is acting with delegated prescriptive authority [time]; and

(3) have access to the delegating 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 registered nurse shall:

(1) maintain Protocols or other written authorization developed in accordance with facility medical staff policies and review [reviewing] the authorizing documents with the appropriate medical staff at least annually;

(2) - (3) (No change.)

§222.11.Conditions for Obtaining and Distributing Drug Samples.

The advanced practice registered nurse with a valid prescription authorization number may request, receive, possess and distribute prescription drug samples provided:

(1) all requirements for the advanced practice registered nurse to sign prescription drug orders are met;

(2) Protocols or other physician orders authorize the advanced practice registered nurse to sign the prescription drug orders;

(3) 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 this chapter; and

(4) (No change.)

§222.12.Enforcement.

(a) Any advanced practice registered nurse who violates these sections or prescribes in a manner that is not consistent with the standard of care [rules] shall be subject to removal of the authority to prescribe under this section [rule] and disciplinary action by the Board [board] under Texas Occupations Code §301.452.

(b) The Board [board] shall report to the Texas Department of Public Safety and the United States Drug Enforcement Administration any of the following:

(1) Any significant changes in the status of the RN license or [/] advanced practice license [authorization], or

(2) Disciplinary action impacting an advanced practice registered nurse's ability to authorize or issue prescription drug orders.

(c) The practice of the advanced practice registered nurse approved by the Board [board] to [carry out or] sign prescription drug orders is subject to monitoring by the Board [board] on a periodic basis.

This agency hereby certifies that the proposal 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 November 13, 2009.

TRD-200905235

Jena R. Abel

Assistant General Counsel

Texas Board of Nursing

Earliest possible date of adoption: December 27, 2009

For further information, please call: (512) 305-6822