CO Code § 12-280-404 (2021)
2021 Colorado Code|Title 12 - Professions and Occupations|Article 280 - Pharmacists, Pharmacy Businesses, and Pharmaceuticals|Part 4 - Electronic Monitoring of Prescription Drugs|§ 12-280-404. Program Operation - Access - Rules - Definitions

  The board shall operate and maintain the program.      The board shall adopt all rules necessary to implement the program.    The rules adopted pursuant to subsection (2)(a) of this section may:   Identify prescription drugs and substances by using evidence-based practices, in addition to controlled substances, that have a substantial potential for abuse and must require pharmacists and prescription drug outlets to report those prescription drugs and substances to the program when they are dispensed to a patient; and    Include a data retention schedule for the information obtained and stored by the program pursuant to this part 4 and the processes for the preservation of de-identified, aggregated data for a period of time as determined by the board.       The board shall determine if the program should track all prescription drugs prescribed in this state. If the board makes such determination, the board shall promulgate rules on or before June 1, 2022, to include all prescription drugs in the program. If the board determines that one or more prescription drugs should not be tracked through the program, the board shall publicly note the justification for such exclusion during the rule-making process.       The program is available for query only to the following persons or groups of persons:   Board staff responsible for administering the program;    Any practitioner with the statutory authority to prescribe controlled substances, or an individual designated by the practitioner to act on his or her behalf in accordance with section 12-280-403 (2)(b), to the extent the query relates to a current patient of the practitioner. The practitioner or his or her designee shall identify his or her area of health-care specialty or practice upon the initial query of the program.      Any veterinarian with statutory authority to prescribe controlled substances, to the extent the query relates to a current patient or to a client and if the veterinarian, in the exercise of professional judgment, has a reasonable basis to suspect the client has committed drug abuse or has mistreated an animal. (c) (I) Any veterinarian with statutory authority to prescribe controlled substances, to the extent the query relates to a current patient or to a client and if the veterinarian, in the exercise of professional judgment, has a reasonable basis to suspect the client has committed drug abuse or has mistreated an animal.    As used in this subsection (3)(c):   “Client” has the same meaning as set forth in section 12-315-104 (4).    “Mistreat” has the same meaning as set forth in section 35-42-103 (9).    “Patient” has the same meaning as set forth in section 12-315-104 (13).          A practitioner, or an individual designated by the practitioner to act on his or her behalf in accordance with section 12-280-403 (2)(b), engaged in a legitimate program to monitor a patient's drug abuse;    The medical director, or his or her designee, at a facility that treats substance use disorders with controlled substances, if an individual in treatment at the facility gives permission to the facility to access his or her program records;    A pharmacist, an individual designated by a pharmacist in accordance with section 12-280-403 (2)(b) to act on his or her behalf, or a pharmacist licensed in another state, to the extent the information requested relates specifically to a current patient to whom the pharmacist is dispensing or considering dispensing a controlled substance or prescription drug or a patient to whom the pharmacist is currently providing clinical patient care services;    Law enforcement officials so long as the information released is specific to an individual patient, pharmacy, or practitioner and is part of a bona fide investigation, and the request for information is accompanied by an official court order or subpoena;    The individual who is the recipient of a controlled substance prescription so long as the information released is specific to the individual;    State regulatory boards within the division and the director, so long as the information released is specific to an individual practitioner and is part of a bona fide investigation, and the request for information is accompanied by an official court order or subpoena;    A resident physician with an active physician training license issued by the Colorado medical board pursuant to section 12-240-128 and under the supervision of a licensed physician;    The department of public health and environment for purposes of population-level analysis, but any use of program data by the department is subject to the federal “Health Insurance Portability and Accountability Act of 1996”, Pub.L. 104-191, as amended, and implementing federal regulations, including the requirement to remove any identifying data unless exempted from the requirement;    A medical examiner who is a physician licensed pursuant to article 240 of this title 12, whose license is in good standing, and who is located and employed in the state of Colorado; a coroner elected pursuant to section 30-10-601; or a deputy coroner who is authorized by the coroner to act on behalf of the coroner in accordance with subsection (3.5) of this section, if:   The information released is specific to an individual who is the subject of an autopsy or a death investigation conducted by the medical examiner, coroner, or deputy coroner;    The medical examiner, coroner, or deputy coroner has legitimate access to the individual's medical record; and    The individual's death or injury occurred under unusual, suspicious, or unnatural circumstances. (3.5) A coroner may authorize a deputy coroner to access the program on behalf of the coroner if:   The coroner takes reasonable steps to ensure that the deputy coroner is sufficiently competent to use the program; and    The coroner remains responsible for:   Ensuring that access to the program is limited to the purposes specified in subsection (3)(l) of this section and that the access occurs in a manner that protects the confidentiality of program information; and    Any negligent breach of the confidentiality of information obtained from the program by the deputy coroner.                  Each practitioner or the practitioner's designee shall query the program prior to prescribing an opioid unless the patient receiving the prescription:   Is receiving the opioid in a hospital, skilled nursing facility, residential facility, or correctional facility;    Has been diagnosed with cancer and is experiencing cancer-related pain;    Is undergoing palliative care or hospice care;    Is experiencing post-surgical pain that, because of the nature of the procedure, is expected to last more than fourteen days;    Is receiving treatment during a natural disaster or during an incident where mass casualties have taken place; or    Has received only a single dose to relieve pain for a single test or procedure.  (a.5) Each practitioner or the practitioner's designee shall query the program before prescribing a benzodiazepine to a patient unless the benzodiazepine is prescribed to treat a patient in hospice or to treat epilepsy, a seizure or seizure disorder, a suspected seizure disorder, spasticity, alcohol withdrawal, or a neurological condition, including a posttraumatic brain injury or catatonia.        The program must use industry standards to allow providers or their designees direct access to data from within an electronic health record to the extent that the query relates to a current patient of the practitioner.    A practitioner or the practitioner's designee complies with this subsection (4) if the practitioner or practitioner's designee attempts to access the program before prescribing an opioid or a benzodiazepine and the program is not available or is inaccessible due to technical failure.    A violation of this subsection (4) does not create a private right of action or serve as the basis of a cause of action. A violation of this subsection (4) does not constitute negligence per se or contributory negligence per se and does not alone establish a standard of care. Compliance with this subsection (4) does not alone establish an absolute defense to any alleged breach of the standard of care.    Repealed.       The board shall not charge a practitioner or pharmacy who transmits data in compliance with the operation and maintenance of the program a fee for the transmission of the data.    The board or the department of public health and environment, pursuant to a written agreement that ensures compliance with this part 4, may provide data to qualified personnel of a public or private entity for the purpose of bona fide research or education so long as the data does not identify a recipient of, a practitioner who prescribed, or a prescription drug outlet that dispensed, a prescription drug.      The board shall provide a means of sharing information about individuals whose information is recorded in the program with out-of-state health-care practitioners and law enforcement officials that meet the requirements of subsection (3)(b), (3)(d), or (3)(g) of this section.    The board may, within existing funds available for operation of the program, provide a means of sharing prescription information and electronic health records through a board-approved vendor and method with the health information organization network, as defined in section 25-3.5-103 (8.5), in order to work collaboratively with the statewide health information exchanges designated by the department of health care policy and financing. Use of the information made available pursuant to this subsection (7)(b) is subject to privacy and security protections in state law and the federal “Health Insurance Portability and Accountability Act of 1996”, Pub.L.104-191, as amended, and any implementing regulations.       The board shall develop criteria for indicators of misuse, abuse, and diversion of controlled substances and, based on those criteria, provide unsolicited reports of dispensed controlled substances to prescribing practitioners and dispensing pharmacies for purposes of education and intervention to prevent and reduce occurrences of controlled substance misuse, abuse, and diversion. In developing the criteria, the board shall consult with the Colorado dental board, Colorado medical board, state board of nursing, state board of optometry, Colorado podiatry board, and state board of veterinary medicine.    Reports generated by the program and provided to prescribing practitioners for purposes of information, education, and intervention to prevent and reduce occurrences of controlled substance misuse, abuse, and diversion are:   Not public records under the “Colorado Open Records Act”, part 2 of article 72 of title 24;    Not discoverable in any criminal or administrative proceeding against a prescribing practitioner; and    Not admissible in any civil, criminal, or administrative proceeding against a prescribing practitioner.        History. Source: L. 2019: Entire title R&RE with relocations,(HB 19-1172), ch. 136, p. 1497, § 1, effective October 1; (3)(l) added,(SB 19-228), ch. 276, p. 2610, § 18, effective October 1. L. 2021: (2), IP(3)(l), (3)(l)(I), (3)(l)(II), and (6) amended and (3.5) added,(SB 21-098), ch. 285, p. 1690, § 2, effective July 1; (3)(l)(I), IP(4)(a), (4)(c), and (7) amended, (4)(a.5) added, and (4)(e) repealed,(HB 21-1276), ch. 364, p. 2401, § 16, effective July 1; (2) amended,(HB 21-1012), ch. 480, p. 3424, § 1, effective September 7.    Editor's note:    This section is similar to former § 12-42.5-404 as it existed prior to 2019.    Before its relocation in 2019, this section was amended in SB 19-228. Those amendments were superseded by the repeal and reenactment of this title 12, effective October 1, 2019. For those amendments to the former section in effect from May 23, 2019, to October 1, 2019, see SB 19-228, chapter 276, Session Laws of Colorado 2019.      Amendments to subsection (2) by SB 21-098 and HB 21-1012 were harmonized. (3) (a) Amendments to subsection (2) by SB 21-098 and HB 21-1012 were harmonized.    Amendments to subsection (3)(l)(I) by SB 21-098 and HB 21-1276 were harmonized.       Section 20 of chapter 364 (HB 21-1276), Session Laws of Colorado 2021, provides that the act changing this section takes effect only if SB 21-098 becomes law and takes effect either upon the effective date of HB 21-1276 or SB 21-098, whichever is later. SB 21-098 became law and both bills have an effective date of July 1, 2021.     Cross references:   For the legislative declaration in HB 21-1276, see section 1 of chapter 364, Session Laws of Colorado 2021.