RLV C.S.H.B. 226 75(R)BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 226 By: Hirschi 3-19-97 Committee Report (Substituted) BACKGROUND Triplicate prescription forms are currently used by the Texas Department of Public Safety (DPS) to monitor the prescription of Schedule II drugs. As the population has grown and new classification of drugs has been implemented, triplicate prescriptions have steadily increased. Yet, the method used to monitor the administration, dispersement or prescription of these drugs is often inefficient and inadequate. Technology is currently available to allow the Department of Public Safety to monitor Class II prescriptions electronically using a central database. PURPOSE CSHB 226 will eliminate the need for paper triplicate prescription forms and allow for the electronic transfer and monitoring of all Schedule II prescription drugs through the creation of a central repository managed by the DPS. RULEMAKING AUTHORITY It is the committee's opinion that this bill expressly grants additional rulemaking authority to the director of the central repository at DPS, under SECTION 2 (Section 481.075(k), Health and Safety Code) and to DPS and its director in SECTION 13 (Subsection(b)). SECTION BY SECTION ANALYSIS SECTION 1. is added and cites Subchapter C, Chapter 481, Health and Safety Code, as the Controlled Substance Accessibility and Anti-Diversion Act. SECTION 2. Amends Section 481.075, Health and Safety Code, as follows: Subsection (a) requires a pharmacist who dispenses a controlled substance listed in Schedule II to transmit specified information to a central repository designated by the DPS. Subsection (b) requires the pharmacist to transmit the information required by Subsection (a) except as provided by Subsection (c) according to the following: (1) by the 15th day after the date the controlled substance was dispensed; and (2) on an electronic devise as specified. Subsection (c) requires a pharmacist to transmit the information listed in Subsection (a) by the 15th day after the date the pharmacist completes dispensing a partial quantity Schedule II controlled substance in accordance with Section 481.074 (f) Health and Safety Code. Subsection (d) requires the director of the central depository administered by DPS to control access to all information submitted under this section. Establishes the information is confidential and prohibits the director from allowing any person to have access to the information except as specified in this subsection. Subsection (e) requires the investigator under Subsection (d)(1) to cooperate with authorized officers of the DPS in obtaining information for investigation of suspected criminal violations of this chapter. Subsection (f) establishes that the information submitted to the central depository may be used only as specified in this subsection. Subsection (g) requires the central repository to: (1) be capable of providing the collected information in formats required by DPS, including dispensations by the entities specified in this subsection. (2) provide DPS with on-line access to the collected information at all times; (3) secure the collected information against access by an unauthorized person; and (4) if the relationship between the central repository is terminated, establishes that the department is provided with all collected information in a timely manner and in a format readily usable by DPS. Subsection (h) allows DPS to: (1) contract with a vendor to serve as or provide the central repository; or (2) purchase necessary equipment to create the central repository within DPS. Subsection (i) requires DPS to ensure that information that reveals the identity of a recipient of a controlled substance is removed from the central repository and destroyed so that the information is irretrievable by the end of the 12th calendar month after the month in which the information is submitted to the central repository. Notwithstanding this, DPS may retain information under specified circumstances. Subsection (j) requires DPS to issue a report semiannually, based on the state fiscal year, to the Legislative Budget Board that certifies compliance with Subsection (i) and provides detailed results of monthly audits showing that identities of recipients have been removed from the central repository and made irretrievable as required by Subsection (i). Requires DPS to correct any failure to comply with Subsection (i) as soon as practicable upon discovery. Establishes that a person who is responsible for failure to comply with Subsection (i) is subject to disciplinary action, including dismissal. Subsection (k) requires the director of the repository to adopt rules to implement this section. Subsection (l) defines "department" as the Department of Public Safety. Deletes original language of this section regarding Triplicate Prescription Program.. SECTION 3. Amends Section 481.068 (b), Health and Safety Code, as follows: Subsection (b) deletes reference to Section 481.075(d) regarding oral prescriptions prescribed as an excepted provision. Makes conforming word change. SECTION 4. Amends Sections 481.074 (b), (c), and (f), Health and Safety Code as follows: Subsection (b) deletes reference to Sec. 481.075(g) regarding the prohibition on the dispensing or administering of a controlled substance listed in Schedule II without a written prescription from a practitioner, and amends it to add that the prescription provide information necessary to enable the person to comply with Section 481.075. Deletes reference to meeting the requirement of sending a copy of the record to DPS by the 30th day after the prescription filled date. Deletes requirement for inclusion of DEA number, name, and address of prescribing practitioner in the written prescription record. Subsection (c) removes provision requiring written prescription to be completed as directed under Section 481.075. Requires the pharmacist to fill and file written prescription upon receipt. Deletes language requiring pharmacists to send a prescription copy to the DPS. Subsection (f) deletes reference to Copy 1 and Copy 2 of the prescriptions. SECTION 5. Amends Section 481.127 (a), Health and Safety Code, to replace reference to "Department of Public Safety" with "central repository". SECTION 6. Amends Section 481.128 (a ), Health and Safety Code, to delete Subdivisions(4), (5)and (7) regarding triplicate prescription counterfeiting and forfeiture of pad. Makes numbered conforming changes. SECTION 7. Amends Section 481.129(a). Health and Safety Code, to delete Subsection(a)(3) regarding the use of another person's triplicate prescription to prescribe a controlled substance. Makes numbered conforming changes. SECTION 8. Amends Section 3.06(d)(6)(J)(i), Medical Practice Act (Article 4495b, Vernon's Texas Civil Statutes), to change reference from "offering" to "providing" in this subsection on physicians delegating certain obstetric services to physician assistants. Deletes provisions for triplicate prescription requirements. Deletes statement that the physician assistant should be board certified in obstetrics. SECTION 9. Amends Section 552.118, Government Code, as follows: Section 552.118. EXCEPTION: CERTAIN PRESCRIPTIONS. Deletes subtitle. Excepts information relating to a prescription for a controlled substance submitted to the central repository under Section 481.075, Health and Safety Code, from the requirements of Section 552. 021, Government Code. Deletes language regarding triplicate prescription form filed at the DPS. SECTION 10. Repeals the following provisions of the Health and Safety Code: (1) Section 481.002(47) regarding the definition of triplicate prescription forms; and (2) Section 481.076 regarding triplicate prescription information. SECTION 11. Establishes that the change in law does not affect the retention, use, or destruction requirements of Sections 481.075 or 481.076, Health and Safety Code, that relate to prescriptions written under the triplicate prescription program before January 1, 1998. Establishes that the provisions of those sections relating to retention of triplicate records by practitioners and pharmacists and the use and destruction of information obtained through this program by DPS continue in effect for purposes defined by this program written before January 1, 1998. SECTION 12. A change in the law by this Act of Sections 481.127(a), 481.128(a), 481.129(a), Health and Safety Code, establishes that an offense committed prior to January 1, 1998 is not considered an offense under this new provision. An offense committed prior to January 1, 1998 is covered by those sections as they existed on the date the offense was committed and the former law is continued in effect for this purpose. Establishes that any portion of an offense committed prior to January 1, 1998 is subject to the law in effect before this Act. SECTION 13. Subsection (a) establishes the effective date of this Act to be January 1, 1998, except as provided under Subsection (b) of this section.. Subsection (b) allows the DPS and its director to adopt rules and take all action necessary to ensure that the central repository is prepared to begin accepting information under Section 481.075, Health and Safety Code, beginning on the date this Act becomes law. SECTION 14. Emergency Clause. COMPARISON OF ORIGINAL TO SUBSTITUTE SECTION 1 is added and entitles Subchapter C, Chapter 481, Health and Safety Code, as the Controlled Substance Accessibility and Anti-Diversion Act. The title is added to allow quick reference to this section. Conforming SECTION number changes are made. SECTION 2. Sec. 481.075(a)(2) adds the words "if available" to the provision regarding National Drug Code number. Sec. 481.075(b)(2) adds the words "facsimile transmission" to the forms of transmittable information. SECTION 4. Sections 481.074(f) reinserts deleted language in the original bill regarding the recording of partially filled prescriptions by pharmacists. SECTION 5. Subchapter D, Chapter 481, Sec. 481.1271 is deleted from the CSHB 226 and replaced with Section 481.127(a). SECTION 12. Makes clarifying language changes and establishes that an offense begun prior to January 1, 1998 is subject to the law in effect before this Act. The changes made in CSHB 226 are to include provisions that are now technologically available, to account for the partial filling of a triplicate prescription, and to make clarifying language changes regarding the committing of an offense.