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.