(a) The board shall by rule establish and revise as necessary a standardized database format that may be used by a pharmacy to transmit the information required by Sections 481.074(q) and 481.075(i) to the board electronically or to deliver the information on storage media, including disks, tapes, and cassettes.
(b) The director shall consult with the Department of State Health Services, the Texas State Board of Pharmacy, and the Texas Medical Board and by rule may:
(1) remove a controlled substance listed in Schedules II through V from the official prescription program, if the director determines that the burden imposed by the program substantially outweighs the risk of diversion of the particular controlled substance; or
(2) return a substance previously removed from Schedules II through V to the official prescription program, if the director determines that the risk of diversion substantially outweighs the burden imposed by the program on the particular controlled substance.
Terms Used In Texas Health and Safety Code 481.0761
- Contract: A legal written agreement that becomes binding when signed.
- Person: includes corporation, organization, government or governmental subdivision or agency, business trust, estate, trust, partnership, association, and any other legal entity. See Texas Government Code 311.005
- Rule: includes regulation. See Texas Government Code 311.005
(c) The board by rule may:
(1) establish a procedure for the issuance of multiple prescriptions of a Schedule II controlled substance under Section 481.074(d-1);
(2) remove from or return to the official prescription program any aspect of a practitioner’s or pharmacist’s hospital practice, including administering or dispensing;
(3) waive or delay any requirement relating to the time or manner of reporting;
(4) establish compatibility protocols for electronic data transfer hardware, software, or format, including any necessary modifications for participation in a database described by Section 481.076(j);
(5) establish a procedure to control the release of information under Sections 481.074, 481.075, and 481.076; and
(6) establish a minimum level of prescription activity below which a reporting activity may be modified or deleted.
(d) The board by rule shall authorize a practitioner to determine whether it is necessary to obtain a particular patient identification number and to provide that number in the electronic prescription record.
(e) In adopting a rule relating to the electronic transfer of information under this subchapter, the board shall consider the economic impact of the rule on practitioners and pharmacists and, to the extent permitted by law, act to minimize any negative economic impact, including the imposition of costs related to computer hardware or software or to the transfer of information.
(f) The board may authorize a contract between the board and another agency of this state or a private vendor as necessary to ensure the effective operation of the official prescription program.
(g) The board may adopt rules providing for a person authorized to access information under Section 481.076(a)(5) to be enrolled in electronic access to the information described by Section 481.076(a) at the time the person obtains or renews the person’s applicable professional or occupational license or registration.
(h) The board, in consultation with the department and the regulatory agencies listed in Section 481.076(a)(1), shall identify prescribing practices that may be potentially harmful and patient prescription patterns that may suggest drug diversion or drug abuse. The board shall determine the conduct that constitutes a potentially harmful prescribing pattern or practice and develop indicators for levels of prescriber or patient activity that suggest a potentially harmful prescribing pattern or practice may be occurring or drug diversion or drug abuse may be occurring.
(i) The board, based on the indicators developed under Subsection (h), may send an electronic notification to a dispenser or prescriber if the information submitted under Section 481.074(q) or 481.075 indicates a potentially harmful prescribing pattern or practice may be occurring or drug diversion or drug abuse may be occurring.
(j) The board by rule may develop guidelines identifying behavior suggesting a patient is obtaining controlled substances that indicate drug diversion or drug abuse is occurring. A pharmacist who observes behavior described by this subsection by a person who is to receive a controlled substance shall access the information under Section 481.076(a)(5) regarding the patient for whom the substance is to be dispensed.
(k) The board by rule may develop guidelines identifying patterns that may indicate that a particular patient to whom a controlled substance is prescribed or dispensed is engaging in drug abuse or drug diversion. These guidelines may be based on the frequency of prescriptions issued to and filled by the patient, the types of controlled substances prescribed, and the number of prescribers who prescribe controlled substances to the patient. The board may, based on the guidelines developed under this subsection, send a prescriber or dispenser an electronic notification if there is reason to believe that a particular patient is engaging in drug abuse or drug diversion.