85R14363 JSC-D     By: Gonzales of Williamson H.B. No. 3208       A BILL TO BE ENTITLED   AN ACT   relating to powers and duties of certain prescribers and dispensers   of controlled substances and the regulatory agencies that issue a   license, certification, or registration to the prescriber or   dispenser; following the recommendations of the Sunset Advisory   Commission.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Sections 481.074(k) and (q), Health and Safety   Code, are amended to read as follows:          (k)  A prescription for a controlled substance must show:                (1)  the quantity of the substance prescribed:                      (A)  numerically, followed by the number written   as a word, if the prescription is written;                      (B)  numerically, if the prescription is   electronic; or                      (C)  if the prescription is communicated orally or   telephonically, as transcribed by the receiving pharmacist;                (2)  the date of issue;                (2-a)  if the prescription is issued for a Schedule II   controlled substance to be filled at a later date under Subsection   (d-1), the earliest date on which a pharmacy may fill the   prescription;                (3)  the name, address, and date of birth or age of the   patient or, if the controlled substance is prescribed for an   animal, the name, species, gender, and actual or estimated date of   birth of the animal and the name and address of the animal's [its]   owner;                (4)  the name and strength of the controlled substance   prescribed;                (5)  the directions for use of the controlled   substance;                (6)  the intended use of the substance prescribed   unless the practitioner determines the furnishing of this   information is not in the best interest of the patient;                (7)  the name, address, Federal Drug Enforcement   Administration number, and telephone number of the practitioner at   the practitioner's usual place of business, which must be legibly   printed or stamped on a written prescription; and                (8)  if the prescription is handwritten, the signature   of the prescribing practitioner.          (q)  Each dispensing pharmacist shall send all required   information, including any information required to complete the   Schedule III through V prescription forms, to the board by   electronic transfer or another form approved by the board not later   than the next business [seventh] day after the date the   prescription is completely filled.          SECTION 2.  Section 481.075(i), Health and Safety Code, is   amended to read as follows:          (i)  Each dispensing pharmacist shall:                (1)  fill in on the official prescription form or note   in the electronic prescription record each item of information   given orally to the dispensing pharmacy under Subsection (h) and   the date the prescription is filled, and:                      (A)  for a written prescription, fill in the   dispensing pharmacist's signature; or                      (B)  for an electronic prescription,   appropriately record the identity of the dispensing pharmacist in   the electronic prescription record;                (2)  retain with the records of the pharmacy for at   least two years:                      (A)  the official prescription form or the   electronic prescription record, as applicable; and                      (B)  the name or other patient identification   required by Section 481.074(m) or (n); and                (3)  send all required information, including any   information required to complete an official prescription form or   electronic prescription record, to the board by electronic transfer   or another form approved by the board not later than the next   business [seventh] day after the date the prescription is   completely filled.          SECTION 3.  Subchapter C, Chapter 481, Health and Safety   Code, is amended by adding Section 481.0751 to read as follows:          Sec. 481.0751.  DISPENSING VETERINARIANS. (a)  This section   applies to a veterinarian who holds a registration issued by the   Federal Drug Enforcement Administration and dispenses Schedule II,   III, IV, or V controlled substances directly to the owner or handler   of an animal.          (b)  Not later than the next business day after the date the   veterinarian dispenses a controlled substance, the veterinarian   shall submit to the board:                (1)  the name, strength, and quantity of the substance   dispensed;                (2)  the date the substance was dispensed;                (3)  the name of the animal;                (4)  the species, gender, and actual or estimated date   of birth of the animal;                (5)  the name and address of the animal's owner;                (6)  the directions for the use of the substance;                (7)  the intended use of the substance; and                (8)  the name, address, Federal Drug Enforcement   Administration number, and telephone number of the veterinarian at   the veterinarian's usual place of business.          (c)  A veterinarian shall retain a record of the information   submitted to the board under Subsection (b) for a period of not less   than two years after the date the substance is dispensed.          (d)  Failure to comply with this section is grounds for   disciplinary action by the State Board of Veterinary Medical   Examiners.          SECTION 4.  Sections 481.076(a), (a-3), (a-4), (c), (d),   (i), and (j), Health and Safety Code, are amended to read as   follows:          (a)  The board may not permit any person to have access to   information submitted to the board under Section 481.074(q), [or]   481.075, or 481.0751 except:                (1)  [an investigator for] the board, the Texas Medical   Board, the Texas State Board of Podiatric Medical Examiners, the   State Board of Dental Examiners, the State Board of Veterinary   Medical Examiners, the Texas Board of Nursing, or the Texas   Optometry Board for the purpose of:                      (A)  investigating a specific license holder; or                      (B)  monitoring for potentially harmful   prescribing or dispensing patterns or practices under Section   481.0762;                (2)  an authorized officer or member of the department   or authorized employee of the board engaged in the administration,   investigation, or enforcement of this chapter or another law   governing illicit drugs in this state or another state;                (3)  the department on behalf of a law enforcement or   prosecutorial official engaged in the administration,   investigation, or enforcement of this chapter or another law   governing illicit drugs in this state or another state;                (4)  a medical examiner conducting an investigation;                (5)  provided that accessing the information is   authorized under the Health Insurance Portability and   Accountability Act of 1996 (Pub. L. No. 104-191) and regulations   adopted under that Act:                      (A)  a pharmacist or a pharmacy technician, as   defined by Section 551.003, Occupations Code, acting at the   direction of a pharmacist; or                      (B)  a practitioner who:                            (i)  is a physician, dentist, veterinarian,   podiatrist, optometrist, or advanced practice nurse or is a   physician assistant described by Section 481.002(39)(D) or an   employee or other agent of a practitioner acting at the direction of   a practitioner; and                            (ii) is inquiring about a recent Schedule II,   III, IV, or V prescription history of a particular patient of the   practitioner[, provided that the person accessing the information   is authorized to do so under the Health Insurance Portability and   Accountability Act of 1996 (Pub. L. No.   104-191) and rules adopted   under that Act];                (6)  a pharmacist or practitioner who is inquiring   about the person's own dispensing or prescribing activity; or                (7)  one or more states or an association of states with   which the board has an interoperability agreement, as provided by   Subsection (j).          (a-3)  The board shall ensure that the department has   unrestricted access at all times to information submitted to the   board under Sections 481.074(q), [and] 481.075, and 481.0751.  The   department's access to the information shall be provided through a   secure electronic portal under the exclusive control of the   department.  The department shall pay all expenses associated with   the electronic portal.          (a-4)  A law enforcement or prosecutorial official described   by Subsection (a)(3) may obtain information submitted to the board   under Section 481.074(q), [or] 481.075, or 481.0751 only if the   official submits a request to the department.  If the department   finds that the official has shown proper need for the information,   the department shall provide access to the relevant information.          (c)  The board by rule shall design and implement a system   for submission of information to the board by electronic or other   means and for retrieval of information submitted to the board under   this section and Sections 481.074, [and] 481.075, and 481.0751.     The board shall use automated information security techniques and   devices to preclude improper access to the information. The board   shall submit the system design to the director and the Texas Medical   Board for review and comment a reasonable time before   implementation of the system and shall comply with the comments of   those agencies unless it is unreasonable to do so.          (d)  Information submitted to the board under this section   may be used only for:                (1)  the administration, investigation, or enforcement   of this chapter or another law governing illicit drugs in this state   or another state;                (2)  investigatory, [or] evidentiary, or monitoring   purposes in connection with the functions of an agency listed in   Subsection (a)(1);                (3)  the prescribing and dispensing of controlled   substances by a person listed in Subsection (a)(5); or                (4) [(3)]  dissemination by the board to the public in   the form of a statistical tabulation or report if all information   reasonably likely to reveal the identity of each patient,   practitioner, or other person who is a subject of the information   has been removed.          (i)  Information submitted to the board under Section   481.074(q), [or] 481.075, or 481.0751 is confidential and remains   confidential regardless of whether the board permits access to the   information under this section.          (j)  The board may enter into an interoperability agreement   with one or more states or an association of states authorizing the   board to access prescription monitoring information maintained or   collected by the other state or states or the association,   including information maintained on a central database such as the   National Association of Boards of Pharmacy Prescription Monitoring   Program InterConnect.  Pursuant to an interoperability agreement,   the board may authorize the prescription monitoring program of one   or more states or an association of states to access information   submitted to the board under Sections 481.074(q), [and] 481.075,   and 481.0751, including by submitting or sharing information   through a central database such as the National Association of   Boards of Pharmacy Prescription Monitoring Program InterConnect.          SECTION 5.  Section 481.0761, Health and Safety Code, is   amended by amending Subsections (a) and (c) and adding Subsections   (h), (i), and (j) to read as follows:          (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), and 481.0751 to the board   electronically or to deliver the information on storage media,   including disks, tapes, and cassettes.          (c)  The board by rule may:                (1)  permit more than one prescription to be   administered or dispensed and recorded on one prescription form for   a Schedule III through V controlled substance;                (1-a)  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, 481.0751, and   481.076; and                (6)  establish a minimum level of prescription activity   below which a reporting activity may be modified or deleted.          (h)  The board, in consultation with the department and the   regulatory agencies listed in Section 481.076(a)(1) shall identify   potentially harmful prescribing or dispensing patterns or   practices that may suggest drug diversion or drug abuse. The board   shall develop indicators for levels of prescriber or patient   activity that suggest that a potentially harmful prescribing or   dispensing practice may be occurring or that drug diversion or drug   abuse may be occurring.          (i)  The board may, based on the indicators developed under   Subsection (h), send a prescriber or dispenser an electronic   notification if the information submitted under Sections   481.074(q), 481.075, and 481.0751 indicates that a potentially   harmful prescribing or dispensing pattern or practice may be   occurring or that drug diversion or drug abuse may be occurring.          (j)  The board by rule may develop guidelines identifying   behavior that would suggest that drug diversion or drug abuse is   occurring. A person described by Section 481.076(a)(5)(A) who   observes that behavior by a person to whom a controlled substance is   to be dispensed shall access the information under Section   481.076(a)(5) regarding the patient for whom the prescription for   the controlled substance was issued.          SECTION 6.  Subchapter C, Chapter 481, Health and Safety   Code, is amended by adding Sections 481.0762, 481.0763, and   481.0764 to read as follows:          Sec. 481.0762.  MONITORING BY REGULATORY AGENCY. (a)  A   regulatory agency that issues a license, certification, or   registration to a prescriber shall periodically access the   information submitted to the board under Sections 481.074(q),   481.075, and 481.0751 to determine whether a prescriber is engaging   in potentially harmful prescribing patterns or practices.          (b)  The State Board of Veterinary Medical Examiners shall   periodically access the information submitted to the board under   Sections 481.074(q), 481.075, and 481.0751 to determine whether a   veterinarian is engaging in potentially harmful prescribing or   dispensing patterns or practices.          (c)  In determining whether a potentially harmful   prescribing or dispensing pattern or practice is occurring, the   appropriate regulatory agency, at a minimum, shall consider:                (1)  the number of times a prescriber prescribes or a   veterinarian dispenses opioids, benzodiazepines, barbiturates, or   carisoprodol; and                (2)  for prescriptions and dispensations described by   Subdivision (1), patterns of prescribing or dispensing   combinations of those drugs and other dangerous combinations of   drugs identified by the board.          (d)  If, during a periodic check under this section, the   regulatory agency finds evidence that a prescriber may be engaging   in potentially harmful prescribing or dispensing patterns or   practices, the regulatory agency may notify that prescriber.          (e)  A regulatory agency may open a complaint against a   prescriber if the agency finds evidence during a periodic check   under this section that the prescriber is engaging in conduct that   violates this subchapter or any other statute or rule.          Sec. 481.0763.  DUTIES OF PRESCRIBERS, PHARMACISTS, AND   RELATED HEALTH CARE PRACTITIONERS. (a)  A person authorized to   receive information under Section 481.076(a)(5) shall access that   information with respect to the patient before prescribing or   dispensing opioids, benzodiazepines, barbiturates, or   carisoprodol.          (b)  A person authorized to receive information under   Section 481.076(a)(5) may access that information with respect to   the patient before prescribing or dispensing any controlled   substance.          (c)  A veterinarian subject to this section is required to   access the information for prescriptions dispensed only for the   animals of an owner and may not consider the personal prescription   history of the owner.          (d)  A violation of Subsection (a) is grounds for   disciplinary action by the regulatory agency that issued a license,   certification, or registration to the person who committed the   violation.          Sec. 481.0764.  EXCEPTIONS. (a) A prescriber is not subject   to the requirements of Section 481.0763(a) if:                (1)  the patient has been diagnosed with cancer or the   patient is receiving hospice care; and                (2)  the prescriber clearly notes in the prescription   record that the patient was diagnosed with cancer or is receiving   hospice care, as applicable.          (b)  A dispenser is not subject to the requirements of   Section 481.0763(a) if it is clearly noted in the prescription   record that the patient has been diagnosed with cancer or is   receiving hospice care.          SECTION 7.  A person is not required to comply with a rule   adopted under Section 481.0761(j), Health and Safety Code, as added   by this Act, before January 1, 2018.          SECTION 8.  Section 481.0763, Health and Safety Code, as   added by this Act, applies only to:                (1)  a prescriber who issues a prescription on or after   September 1, 2018;                (2)  a veterinarian who dispenses a controlled   substance on or after September 1, 2018; or                (3)  a person other than a veterinarian authorized by   law to dispense a controlled substance who dispenses the substance   on or after January 1, 2018.          SECTION 9.  This Act takes effect September 1, 2017.