BILL ANALYSIS C.S.H.B. 1508 By: Van de Putte 04-04-95 Committee Report (Substituted) BACKGROUND Under current Texas law, physicians may delegate certain acts to pharmacists, including medication management. This relationship already exists in many inpatient and outpatient clinical settings such as total parenteral nutrition services, aminoglycoside antibiotic monitoring services, diabetic clinics, coagulation clinics, and hypertension clinics to name just a few. When, however, this service is performed by a pharmacist under the law as it exists today, it is deemed to be the "delegated practice of medicine" under the Medical Practice Act and not the practice of pharmacy. Given the highly litigious nature of our society, that definition is an important distinguishing factor. Pharmacists, like most health care professionals, find it necessary to protect themselves from malpractice suits by purchasing professional liability or druggist liability insurance. Currently, most pharmacy malpractice insurance coverage is limited to what state law defines as the "Practice of Pharmacy" and not delegated medical acts. Consequently, it is of considerable importance from a liability perspective that the Texas definition of the "Practice of Pharmacy" be changed to include the performance of a specific act delegated to the pharmacist through a written protocol by a practitioner licensed in this state. PURPOSE H.B. 1508, as substituted, would recognize within the Pharmacy Practice Act acts delegated to the pharmacist by a practitioner under written protocol. It is not the purpose of this bill to create independent authority. The practitioner decides whether to participate in medication management protocols and the practitioner controls the terms and parameters of the protocol relationship. Those who do not comply with the defined parameters would be disciplined by their respective licensing board. RULEMAKING AUTHORITY It is the committee's opinion that this bill grants additional rulemaking authority to the Texas State Board of Medical Examiners in SECTION 1 (Section 5, Subdivision (50), Texas Pharmacy Act), and in SECTION 3 (Section 3.061(a) and (f), Subchapter C, Medical Practice Act) and to the Texas State Board of Pharmacy in SECTION 2 (Section 17(x), Texas Pharmacy Act). SECTION BY SECTION ANALYSIS SECTION 1. The definition of the practice of pharmacy in Section 5 of the Texas Pharmacy Act (Article 4542a-1, VTCS) is amended by adding subsection (F) and (50). (F) The performance of a specific act of drug therapy management for a patient can be delegated to a pharmacist by a licensed physician. (50) Assigns the definition of written protocol currently defined by the State Board of Medical Examiner's rule under the Medical Practice Act. SECTION 2. Subsection (x) is added to Section 17 of the Texas Pharmacy Act (Art. 4542a-1 VTCS) as follows: (x) Specifies that the Board of Pharmacy shall adopt rules regarding records to be maintained by a pharmacist performing a specific act under a written protocol. SECTION 3. Adds Sec. 3.061 to Subchapter C of the Medical Practice Act, as follows: Sec. 3.061 (a) Allows physicians to delegate specific acts of drug therapy management to qualified and trained pharmacists under adequate physician supervision. Outlines the circumstances under which such delegation can take place, including under protocol as defined by Board of Medical Examiners rule. (b) Specifies that the application of drug therapy must comply with existing applicable laws. (c) Defines the confines under which physician supervision is considered adequate for purposes of this section. (d) States that this section is not meant to be restricted to specific health care sites. States that a physician may delegate this authority in a preestablished program of health care and in a licensed hospital in accordance with Subsection (c) of this section. (e) States that this section may not be construed to limit, expand, or change any provision of law concerning or relating to therapeutic drug substitution or administration of medication. (f) Requires the board by rule to establish the content of the written order or protocol. Prohibits the delegation of medical diagnosis. (g) Assigns the definition of pharmacist under the Pharmacy Practice Act for the purposes of this section. SECTION 4. Effective date: September 1, 1995. SECTION 5. Emergency clause. COMPARISON OF ORIGINAL TO SUBSTITUTE The substitute bill amends (in SECTION 1) the Texas Pharmacy Act by adding Subdivision (F) to clarify that the practice of pharmacy includes "the performance of a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state..." Subsection (50) is added to clarify the definition of written protocol. In SECTION 2 of the bill, the substitute for H.B. 1508 removes a stipulation that the Board of Pharmacy shall adopt rules in conjunction with the Texas State Board of Medical Examiners regarding the content of a written protocol, and a provision which states that a practitioner licensed in Texas is not liable for the actions of a pharmacist practicing under written protocol. SECTION 3 of the substitute adds a new section to the proposed bill. The section provides authorization in the Medical Practice Act for a physician, under certain circumstances, to delegate the performance of specific acts of drug therapy management to a pharmacist acting under physician supervision. SUMMARY OF COMMITTEE ACTION H.B. 1508 was considered by the committee in a public hearing on March 28, 1995. The following persons testified in favor of the bill: Representative Van de Putte, author of the bill. Diane Ginsburg, representing self. The following persons testified neutrally on the bill: James Willmann, representing Texas Nurses Association. Anita Bradberry, representing Texas Association for Home Care, Inc. The bill was left pending in committee on March 28, 1995. H.B. 1508 was considered by the committee in public hearing on April 4, 1995, as pending business. The committee considered a complete substitute for the bill. The substitute was adopted without objection. The bill was reported favorably as substituted with the recommendation that it do pass and be printed and be sent to the Committee on Local and Consent Calendars, by a record vote of 8 Ayes, 0 Nays, 0 PNV, and 1 Absent.