IML S.B. 1245 75(R) BILL ANALYSIS PUBLIC HEALTH S.B. 1245 By: Madla (Van de Putte) 5-8-97 Committee Report (Unamended) BACKGROUND Currently, the Controlled Substances Act requires that prescriptions written for Schedule II Controlled Substances be issued on special, serially numbered, triplicate prescriptions. It also closely restricts dissemination to use by specific agencies for drug-related investigations, even prohibiting release of statistical information. When a prescription is issued, one of the copies is sent to the Department of Public Safety (DPS) where the information on it is automated by data entry clerks. In 1988, 626,105 prescriptions were received, and each subsequent year, the number increased until, in 1996, 1,347,086 prescriptions were received, an increase of 115 percent. There is now technology available that will allow automated information to be collected directly from pharmacies and ultimately eliminate the need for most manual data entry. PURPOSE S.B. 1245 changes the triplicate prescription process to a single-copy, official prescription, and allows pharmacies to electronically transmit prescriptions to DPS. In addition, this bill allows DPS to better manage the increase in prescriptions, by increasing the fees collected. S.B. 1245 also provides for more recent and current information than is presently possible, and broadens rulemaking authority regarding the official prescription program. RULEMAKING AUTHORITY It is the committee's opinion that rulemaking authority is granted to the director of the Department of Public Safety in SECTION 2 (Section 481.003, Health and Safety Code), SECTION 3 (Section 481.064(a), Health and Safety Code), SECTION 5 (Section 481.075(g), Health and Safety Code), SECTION 6 (Section 481.076(c), Health and Safety Code) and SECTION 7 (Section 481.0761(a)(d), Health and Safety Code), and referenced in SECTION 5 (Sections, 481.075(a), (f), and (l), Health and Safety Code), and SECTION 7 (Section 481.0761(e), Health and Safety Code) of this bill. SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 481.002, Health and Safety Code, by amending Subdivision (47), and adding Subdivisions (50)-(54), to define "official prescription form," "patient identification number," "department," "driver's license," "personal identification certificate," and "prescription sticker." Deletes the definition of "triplicate prescription form." SECTION 2. Amends Chapter 481A, Health and Safety Code, by adding Section 481.003, RULES, allowing the director of the Department of Public Safety (director) to adopt rules to administer and enforce this chapter. SECTION 3. Amends Section 481.064, Health and Safety Code, as follows: Sec. 481.064. New heading: REGISTRATION FEES. Deletes the provision authorizing the director to adopt reasonable rules. Authorizes the director to charge an annual registration fee of not more than $25. Requires the director, by rule, to set the amount of the fee at the amount necessary to cover the cost of administering and enforcing this subchapter. Deletes the provision authorizing the director to charge a fee of not more than $5 for the costs necessary to administer this chapter. Requires the director of the Department of Public Safety (department) to deposit the collected fees to the credit of the operator's and chauffeur's license account in the general revenue fund, rather than in the state treasury. Makes conforming changes. SECTION 4. Amends Section 481.074, Health and Safety Code, by amending Subsections (a)-(c) and (f), and adding Subsections (m) and (n), as follows: Subsection (a) prohibits a pharmacist from permitting the delivery of a controlled substance to certain persons, except as provided by Subsection (n). Deletes the provisions regarding delivery made for the immediate well-being of a patient; and delivery by mail. Subsection (b) requires the person who administers or dispenses the substance, if the person is a prescribing practitioner or a pharmacist, to promptly comply with Subsection (c); or if the person is not a prescribing practitioner or a pharmacist, promptly write the prescription and include certain information in the written record of the prescription. Deletes the provision requiring the person to send a copy of the written record to the department by a certain date. Makes conforming changes. Subsection (c) requires the pharmacist or pharmacy that employs the pharmacist to send all information required by the director to the director by specified means by a certain date, rather than sending to the department the department's copy by a certain date. Subsection (f) makes conforming changes. Subsection (m) allows a pharmacist to permit the delivery of a controlled substance by certain persons, and requires a pharmacist to retain in pharmacy records certain information regarding the delivery for a period of not less than three years. Subsection (n) allows a pharmacist to permit the delivery of a controlled substance to a person not known, without requiring identification, in the case of an emergency. Requires the pharmacist to retain records as specified under this subsection. SECTION 5. Amends Section 481.075, Health and Safety Code, to delete the provisions regarding the triplicate prescription program, make conforming changes, and amend and add subsections as follows: Sec. 481.075. New heading: OFFICIAL PRESCRIPTION PROGRAM. (a) Requires a practitioner who prescribes certain controlled substances to record the prescription on a prescription form that includes the information required by this section and affix to the form a prescription sticker issued by the director. Provides for exception under Section 481.0761, and deletes reference to Subsection (b). Subsection (b) requires prescription stickers to be numbered and produced in a certain manner. Subsection (c) requires the director, rather than the department, to issue prescription stickers for a fee to cover certain costs. Makes conforming changes. Subsection (d) makes conforming and clarifying changes. Subsection (e) requires each form used to prescribe a Schedule II controlled substance to contain certain information to be provided by the prescribing practitioner; information provided by the dispensing pharmacist; and the signatures of the prescribing practitioner and the dispensing pharmacist. Subsection (f) makes a conforming change and refers to the exceptions provided under Section 481.0761. Subsection (g) requires the prescribing practitioner, with certain exceptions, to fill in certain information on the form. Makes conforming changes. Subsection (h) makes a conforming change. Subsection (i) requires each dispensing pharmacist to fill in certain information on the form; retain the form and certain patient identification information within pharmacy records for a set period; and send certain information to the director by electronic transfer by a specified date. Subsection (j) makes a conforming change. Subsection (k) requires a practitioner whose number or license has been denied, suspended, canceled, surrendered, or revoked, to return to the department all forms that have not been used for prescriptions not later than the 30th, rather than the seventh, day after the suspension, cancellation, or revocation. Subsection (l) Allows each prescribing practitioner to use a prescription sticker only to prescribe a controlled substance; requires each prescribing practitioner to date or sign the form only on the date the prescription is issued, and to take other precautionary measures. Subsection (m) allows a dispensing pharmacist to fill a prescription issued in another state as specified. Requires a dispensing pharmacist who fills a prescription under this subsection to send certain information to the director. Subsection (n) provides that this section expires September 1, 2003. SECTION 6. Amends Section 481.076, Health and Safety Code, to delete the provisions regarding triplicate prescription information, make conforming changes, and amend and add subsections as follows: Sec. 481.076. New heading: OFFICIAL PRESCRIPTION INFORMATION. (a) Prohibits the director from permitting any person to have access to information submitted to the director under Section 481.075 except an investigator from certain boards; an authorized officer or member of the department engaged in the administration, investigation, or enforcement of this chapter or another law governing illicit drugs in this state or another state; or certain law enforcement officials, prosecutorial officials, pharmacists, or practitioners, if the director finds that proper need has been shown. Subsection (b) provides that this section does not prohibit the director from creating, using, or disclosing statistical data about information received, provided certain conditions are met. Deletes existing language. Subsection (c) requires the director, rather than the department, by rule, to design and implement a system for submission of information to the director by electronic or other means and for retrieval of information. Makes conforming changes. Subsection (d) Allows information submitted to the director to be used only for the administration, investigation, or enforcement of this chapter, or another law governing illicit drugs in this state or another state; investigatory purposes in connection with certain agencies; or dissemination of a statistical tabulation or report, provided certain conditions are met. Subsection (e) requires the director to remove certain information from the information retrieval system not later than a certain date, and allows the director to retain certain information necessary for an investigation until a certain date. Subsection (f) requires the director, if the director releases certain information under Subsection (a)(2), to notify and cooperate with that agency regarding the disposition of the matter before taking action against the person, unless notification is likely to interfere with an administrative or criminal investigation or prosecution. Subsection (g) requires the director, if the director permits access to information under Subsection (a)(3)(A), to notify the agency of the disclosure of the information by a certain date unless certain circumstances exist. Subsection (h) requires the director, if the director withholds notification under Subsection (g), to notify the agency of the disclosure and the reason for withholding notification. Subsection (i) provides that information submitted to the director under Section 481.075 is confidential. Subsection (j) establishes that this section expires September 1, 2003. SECTION 7. Amends Subchapter C, Chapter 481, Health and Safety Code, by adding Section 481.0761, as follows: Sec. 481.0761. RULES; AUTHORITY TO CONTRACT. (a) Requires the director to consult with the Texas State Board of Pharmacy (board) and, by rule, establish and revise as necessary a standardized database format that may be used by a pharmacy to transmit the information required by Section 481.075(i) to the director. Subsection (b) requires the director to consult with certain entities, and to be allowed, by rule, to remove a controlled substance listed in Schedule II from the official prescription program; or return a substance previously removed from Schedule II to the official program. Subsection (c) Allows the director, by rule, to permit more than one prescription to be administered or dispensed and recorded on one form; remove from or return to the program any aspect of the professional practice of practitioners or pharmacists, including administering or dispensing; waive or delay any requirement relating to the time or manner of reporting; establish compatibility protocols for electronic data transfer hardware, software, or format; permit the use of triplicate or single prescription forms; establish a procedure to control the release of information under Sections 481.075 and 481.076; and establish a minimum level of prescription activity. Subsection (d) requires the director, by rule, to authorize a prescribing practitioner to determine the necessity of obtaining and providing a particular patient identification number. Subsection (e) requires the director, in adopting a rule under this subchapter, to consider the economic impact of the rule on practitioners and pharmacists. Prohibits the director from adopting a rule relating to certain electronic transfers of information. Subsection (f) allows the director to authorize a contract between the department and another agency or a private vendor as necessary. Subsection (g) provides that this section expires September 1, 2003. SECTION 8. Amends Section 481.127(a), Health and Safety Code, to provide that a person commits an offense if the person knowingly gives, permits, or obtains unauthorized access to information submitted to the director under Section 481.075. Deletes reference to intentional violations. Makes conforming changes. SECTION 9. Amends Section 481.128(a), Health and Safety Code, to provide that a registrant or dispenser commits an offense if he knowingly distributes, delivers, administers, or dispenses a controlled substance in violation of Sections 481.070-481.075. Makes conforming changes regarding prescription sticker or official prescription, deleting reference to the triplicate form. Deletes reference to June 1, 1991. SECTION 10. Amends Section 481.129(a), Health and Safety Code, by deleting the reference to intentional violations, deleting reference to the triplicate form, and adding reference to the prescription sticker and a Schedule II substance. SECTION 11. Amends Section 552.118, Government Code, as follows: Sec. 552.118. New heading: EXCEPTION: OFFICIAL PRESCRIPTION FORM. Makes conforming changes to refer to the prescription form and the director. SECTION 12. Amends Section 3.06(d)(6)(J)(i), Medical Practice Act (Article 4495b, V.T.C.S.), to establish that a physician "may" not, rather than "shall" not, delegate the use of a prescription sticker or the use or issuance of an official prescription form. Deletes reference to triplicate prescription program. SECTION 13. Effective date is September 1, 1999, except for SECTION 7, which takes effect September 1, 1997. SECTION 14. Makes application of this Act prospective to September 1, 1999, regarding a prescription written under the triplicate prescription program. SECTION 15. Makes application of this Act prospective to September 1, 1999 regarding an offense. SECTION 16. Provides that the change in law made by this Act to Section 3.06(d)(6)(J)(k), Article 4495b, V.T.C.S., does not affect the dispensing of a Schedule II controlled substance by a pharmacist to certain persons. SECTION 17. Emergency clause.