BG C.S.H.B. 2319 75(R) BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 2319 By: Van de Putte 4-17-97 Committee Report (Substituted) BACKGROUND Currently, the Controlled Substances Act, Chapter 481 of the Health and Safety Code requires that prescriptions written for Schedule II Controlled Substances be issued on a special, serially numbered triplicate prescription form. When a prescription is issued one copy is sent to the Department of Public Safety (DPS), one is kept by the doctor, and one kept by the pharmacist. At DPS the information is entered by data clerks into an electronic monitoring system. In 1988, there were 626,105 prescriptions entered into the system. That number increases annually and in 1996 there were 1,347,086 prescriptions entered into the program with a 115% increase. Today, however, there are technological advances that make it possible for that information to be collected electronically eliminating the need for data entry clerks and others to manually enter and track the information. A second aspect to the Triplicate Prescription Program is the enforcement of laws relating to the use and abuse of Controlled Substances that are in Schedule II. When passed the law strictly limited the dissemination of any information collected through this program, even the release of statistical information is prohibited. For DPS to enforce drug diversion laws and other abuse laws, they were required to request permission from the practitioner board prior to reviewing the data collected by the prescription monitoring program. PURPOSE C.S.H.B. 2319 changes the triplicate prescription form to a sequentially numbered nontransferable sticker that attaches to a normal prescription form. C.S.H.B. 2319 also establishes an electronic reporting mechanism for Schedule II prescription information to DPS and increases the amount of the fee paid to fund the program. Additionally, the bill broadens the ability of DPS to access prescription program information for law enforcement purposes. RULEMAKING AUTHORITY It is the committee's opinion that this bill expressly grants additional rulemaking authority to the Director of the Department of Public Safety in SECTION 2 ( Subchapter A, Chapter 481, Sec. 481.003, Health and Safety Code) and in SECTION 3 (Sec. 481.064(a) Health and Safety Code). In SECTION 5 (Sec. 481.075, Health and Safety Code) rulemaking authority is granted to the director of DPS in Subsection (g); new rulemaking is referenced in Subsections (a),(f), and (l). Additional rulemaking authority is also granted to the DPS director in SECTION 6 (Sec. 481.076(c), Health and Safety Code) and in SECTION 7 (Subchapter C, Chapter 481, Sec. 481.0761(a),(b),(c),(d), and (e), Health and Safety Code). SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 481.002, Health and Safety Code, as follows: Subdivision (47) replaces "Triplicate" in the name of the prescription form with "Official" and redefines that official form as a prescription form "that contains the prescription information required by Section 481.075 with an attached prescription sticker as specified. Removes language regarding DPS and uses involving administering, dispensing, prescribing, or delivering a controlled substance. Subdivision (50) is added to define "patient identification number" as specified. Subdivision (51) is added to define "department" as DPS. Subdivision (52) is added to define "drivers licence" as referenced in the Transportation Code, Section 521.001. Subdivision (53) is added to define "personal identification certificate" as specified. Subdivision (54) is added to define "prescription sticker" as specified. SECTION 2. Amends Subchapter A, Chapter 481, Health and Safety Code, by adding Section 481.003, entitled " RULES," to allow the director to adopt rules to administer and enforce this Chapter. SECTION 3. Amends Section 481.064, Health and Safety Code, by revising the heading title and subsections as follows: Sec. 481.064. REGISTRATION FEES. Subsection (a) removes language regarding the adoption of reasonable rules by the director. Revises the amount the director is allowed to charge for an annual registration fee to be no more than $25, instead of $5. Requires the director, to set the fee amount, by rule, at an amount necessary to cover administration and enforcement costs as specified. Replaces the reference to the "chapter" with "subchapter." Makes conforming changes. Subsection (b) replaces the reference to "DPS" with the "department" and makes a conforming change. Subsection (c) removes "in the state treasury" in reference to where collected fees are deposited. Revises language to establish that fees are to the credit of the operator's and chauffeur's license "account in the general revenue" fund. Makes conforming changes. SECTION 4. Amends Section 481.074, Health and Safety Code, as follows: Subsection (a)(4) removes language pertaining to a person without identification and the pharmacist's determination of a substance being needed for immediate well-being. Adds language to specifically state "except as provided by Subsection (n)." Subsection (b) replaces reference to Section 481.075(g) with 481.075(j). Adds language to clarify that the form is "an official prescription" form. Adds to clarify circumstances and obligations concerning the person who is a prescribing practitioner or pharmacist, and promptly complies with Subsection (c); or if the person is not a prescribing practitioner or pharmacist, and as required, promptly writes the oral or telephonically communicated prescription as specified. Revises the section references as specified, removes the requirement that the person send a copy of the written record to DPS and makes nonsubstantive language changes. Subsection (c) adds language to the provision concerning the requirements for actions within 72 hours after authorizing an emergency prescription to clarify that "all information required by the director, including information as specified, to be sent electronically or on a universal claim form or other approved form" to the director. Subsection (f) revises language to clarify that the prescription the pharmacist records must be "on an official prescription form and must indicate on the form" if the patient is on terminally ill or long term care status as specified. Omits a reference to "copy 1 and copy 2" and makes conforming change. Subsection (m) is added. Allows a pharmacist to permit delivery of a controlled substance by a person known to the pharmacist, by an authorized person as specified, or by mail as specified. Requires that records as specified be retained by the pharmacist for at least two years. Subsection (n) is added to allow a pharmacist to permit the delivery of a controlled substance to a person not known to the pharmacist, an intern, or authorized individual without first requiring identification as specified, if the pharmacist determines it to be an emergency as specified. Requires the pharmacist to retain records of such a delivery in the pharmacy for at least two years. Requires the records to contain identifying information as specified. SECTION 5. Amends Section 481.075, Health and Safety Code, as follows: Sec. 481.075. OFFICIAL PRESCRIPTION PROGRAM. Subsection (a) adds the exception to the requirement concerning Schedule II controlled substances as provided by rule adopted under Section 481.0761. Adds language to clarify that the prescription form include required information as specified and have an issued sticker affixed as specified. Omits language to conform. Subsection (b) establishes that each sticker be sequentially numbered and produced as specified. Subsection (c) replaces DPS with the "director" and "the forms" with "prescription stickers" in regards to the requirement that they be issued to practitioners as specified. Revises language to require that before mailing or otherwise delivering sticker packages as specified, the director print on each sticker the number and any other information determined necessary. Makes conforming changes. Subsection (d) makes conforming changes and adds reference to the definition in Section 481.002(39)(A). Subsection (e) makes conforming changes, removes language pertaining to triplicate forms, and adds "schedule II" to clarify which controlled substances are being addressed. Revises language to establish the information, as specified, provided by the prescribing practitioner. Subsection (f) makes conforming changes, adds language to clarify the form to be "an official" prescription form, adds language to provide an exception as specified. Subsection (g) makes conforming changes. Revises language to state that each item of information required to be provided by the prescribing practitioner under subsection (e)(1) be on the official prescription form and as specified, unless the practitioner determines under rule adopted by the director, that it is unnecessary or determines that it is not in the best interest of the patient as specified. Subsection (h) makes a conforming change. Subsection (i) makes conforming changes. Adds language to clarify that each item of information given orally to the dispensing pharmacy as specified, the date filled, and the dispensing pharmacist's signature is to be filled in on the official prescription form and retained with records of the pharmacy as specified; and sent as specified to the director by electronic transfer, or as specified. Subsection (j) is relettered to conform. Subsection (k) makes conforming changes. Replaces "seventh" with "30th" in reference to the maximum number of days after which all prescription stickers are to be returned to the department. Subsection (l) is added to specify that the prescribing practitioner may only use the prescription sticker to prescribe a controlled substance. Requires each prescribing practitioner to date or sign an official prescription form only on the date the prescription is issued, and to take reasonable precautionary measures as specified. Subsection (m) is added to allow dispensing pharmacists in this state to fill a prescription issued in another state as specified. Requires a dispensing pharmacist to send information as specified to the director. Subsection (n) is added to establish expiration of this section expires 9/1/03. Omits the provision which allowed the director to adopt implementation rules. SECTION 6. Amends Section 481.076, Health and Safety Code, as follows: Sec. 481.076. OFFICIAL PRESCRIPTION INFORMATION. Subsection (a) makes conforming and nonsubstantive language changes. Adds language in clarification of the exceptions on the prohibition to permit someone access to submitted information as specified. Subsection (b) establishes that this section does not prohibit the director from creating, using, or disclosing statistical dat as specified. Removes language concerning an investigator and cooperation requirements. Subsection (c) revises language to require that the director, by rule, design and implement a system for the submission of information, as specified. Replaces "department" with "director" and adds reference to Sec. 481.075. Subsection (d) makes conforming changes and adds language to specify that information submitted may be used only for "the administration, investigation and enforcement of this chapter and laws governing illicit drugs", for investigatory purposes as was in the existing language, or for dissemination in the form of a statistical tabulation as specified. Subsection (e) makes conforming changes, revises the time schedule by which the record of the identity or a patient is made irretrievable to be 36 calendar months, rather than 12. Adds "the 30th day after" the end of the month in reference to the provision for a specific ongoing investigation. Subsection (f) is added to require the director to notify and cooperate with an agency as specified, regarding the disposition of a matter before taking action against the person, unless the director finds that the notification might interfere with or jeopardize an investigation or prosecution. Subsection (g) is added. Requires the director to notify an agency as specified of the disclosure of information not later than the 10th working day after the date the information is released, if the director permits access as specified. Provides exceptions for requests to withhold notification as specified and determinations of interference with an administrative or criminal action as specified. Subsection (h) is added. Requires the director to notify the agency, as specified, if notification is withheld under subsection (g). Subsection (i) is added to provide that information submitted to the director under Sec. 481.075 is confidential and remains confidential regardless of whether the director permits access to the information under this section. Subsection (j) is added to establish that this section expires 09/01/03. Omits text regarding a departmental semiannual report requirement and audits. 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 Department to consult with the Board of Pharmacy to develop a standardized database format for the electronic transfer of controlled substance information as specified. Subsection (b) requires the director, to consult with the Department of Health, State Board of Pharmacy and the Board of Medical Examiners and allows, by rule, the removal of controlled substance listed in Schedule II from the official prescription program as specified or return a substance previously removed to the program as specified. Subsection (c) allows the director, by rule, to permit more than one prescription to be on the official form; remove from or return to the program any aspect of the practitioner's or pharmacist's professional practice; waive or delay the reporting requirements; establish compatibility protocols for the electronic system; permit the use of a transitional period as specified; establish a procedure to control the release of information as specified; and establish a minimum level of prescription activity below which reporting may be modified. Subsection (d) requires the director, by rule, to authorize a prescribing practitioner to determine whether it is necessary to obtain and record a particular patient identification number as specified. Subsection (e) requires the director to consider the economic impact of a rule relating to electronic transfer of information on practitioners and pharmacists and act to minimize any negative impacts as specified. Prohibits the adoption of a rule, as specified, that imposes an additional fee than that authorized in Sec. 481.064. Subsection (f) allows the director to authorize a contract between the department and another state agency or private vendor as necessary to ensure effective operation of the prescription program. Subsection (g) establishes that this section expires on September 1, 2003. SECTION 8. Amends Section 481.127(a), Health and Safety Code, by deleting the word "intentionally" in regards to the commission of an offense, and replacing "DPS" with "director." SECTION 9. Amends Section 481.128(a), Health and Safety Code, by deleting the word "intentionally" in regards to the commission of an offense, with conforming and section references changes and removal of a reference to a past date. SECTION 10. Amends Section 481.129(a), Health and Safety Code, by striking references to previous triplicate forms and other conforming changes, including deletion of the word "intentional." SECTION 11. Amends Section 552.118, Government Code, to conform in heading title and language use in terms of "an official" prescription form filed with the "director." SECTION 12. Amends Section 3.06(d)(6)(J)(i), Medical Practice Act (Article 4495b, Vernon's Texas Civil Statutes), by changing the language concerning the prohibition of physician delegation of the prescription form use from a restrictive "shall" to a permissive "may." Removes references to the triplicate prescription program and adds language pertaining to the official prescription program. SECTION 13. Establishes this Act takes effect September 1, 1999, except for Section 7 which takes effect September 1, 1997. SECTION 14. Establishes that the changes made by this this Act do not affect retention, use, or destruction requirements as specified relating to prescriptions written under the triplicate prescription program prior to September 1, 1999. A provision, as specified, continues in effect for those purposes. SECTION 15. Provides that changes made by this Act apply only to an offense committed on or after September 1, 1999. Previous sections of the code remain in effect for offenses committed prior to that date. SECTION 16. Provides that changes in law established by this measure does not affect the dispensing of a Schedule II controlled substance by a pharmacist to a certified nurse anesthetist or a certified nurse midwife or a physicians assistance as currently authorized by the Medical Practice Act. SECTION 17. Emergency clause. COMPARISON OF ORIGINAL TO SUBSTITUTE C.S.H.B. 2319 first requires re-establishment of Sections 481.075 and 481.076 and 481.0761 in 2003. Additionally, the measure changes the definition of "official form" from a pre-printed numbered form to a normal prescription form with a sequentially numbered non-transferable sticker issued by DPS transferring the required information previously need on the old printed form to the new stickered form and the liability for the old form to the new sticker and makes conforming changes in the code for the establishment of and regulation of the sticker in a manner similar to the regulation of the form. C.S.H.B. 2319 also clarifies the requirement for out of state or mail order prescriptions and it clarifies that the measure does not affect the prescribing practice of certain practitioners that currently have the authority to prescribe Schedule II drugs.