C.R.S. Section 12-280-404
Program operation

  • access
  • rules
  • definitions

(1)

The board shall operate and maintain the program.

(2)

Intentionally left blank —Ed.

(a)

The board shall adopt all rules necessary to implement the program.

(b)

The rules adopted pursuant to subsection (2)(a) of this section may:

(I)

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

(II)

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.

(c)

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.

(3)

The program is available for query only to the following persons or groups of persons:

(a)

Board staff responsible for administering the program;

(b)

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.

(c)

Intentionally left blank —Ed.

(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.

(II)

As used in this subsection (3)(c):

(A)

“Client” has the same meaning as set forth in section 12-315-104 (4).

(B)

“Mistreat” has the same meaning as set forth in section 35-42-103 (9).

(C)

“Patient” has the same meaning as set forth in section 12-315-104 (13).

(d)

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;

(e)

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;

(f)

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;

(g)

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;

(h)

The individual who is the recipient of a controlled substance prescription so long as the information released is specific to the individual;

(i)

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;

(j)

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;

(k)

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;

(l)

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:

(I)

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;

(II)

The medical examiner, coroner, or deputy coroner has legitimate access to the individual’s medical record; and

(III)

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:

(a)

The coroner takes reasonable steps to ensure that the deputy coroner is sufficiently competent to use the program; and

(b)

The coroner remains responsible for:

(I)

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

(II)

Any negligent breach of the confidentiality of information obtained from the program by the deputy coroner.

(4)

Intentionally left blank —Ed.

(a)

Each practitioner or the practitioner’s designee shall query the program prior to prescribing an opioid unless the patient receiving the prescription:

(I)

Is receiving the opioid in a hospital, skilled nursing facility, residential facility, or correctional facility;

(II)

Has been diagnosed with cancer and is experiencing cancer-related pain;

(III)

Is undergoing palliative care or hospice care;

(IV)

Is experiencing post-surgical pain that, because of the nature of the procedure, is expected to last more than fourteen days;

(V)

Is receiving treatment during a natural disaster or during an incident where mass casualties have taken place; or

(VI)

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.

(b)

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.

(c)

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.

(d)

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.

(e)

Repealed.

(5)

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.

(6)

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.

(7)

Intentionally left blank —Ed.

(a)

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.

(b)

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.

(8)

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.

(9)

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:

(a)

Not public records under the “Colorado Open Records Act”, part 2 of article 72 of title 24;

(b)

Not discoverable in any criminal or administrative proceeding against a prescribing practitioner; and

(c)

Not admissible in any civil, criminal, or administrative proceeding against a prescribing practitioner.

Source: Section 12-280-404 — Program operation - access - rules - definitions, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-12.­pdf (accessed Oct. 20, 2023).

12‑280‑101
Public interest - rules 12‑280‑102
Applicability of common provisions 12‑280‑103
Definitions - rules 12‑280‑104
State board of pharmacy - creation - subject to review - repeal of parts 12‑280‑105
Membership of board - removal - compensation - meetings 12‑280‑106
Veterinary pharmaceutical advisory committee - creation - appointments - rules - repeal 12‑280‑107
Rules 12‑280‑108
Powers and duties - rules 12‑280‑109
Drugs, devices, and other materials 12‑280‑110
Publications 12‑280‑111
Malpractice claims information - not public - exception 12‑280‑112
Fees 12‑280‑113
Approval of schools 12‑280‑114
Licensure, certification, or registration - applicability - applications - licensure and certification requirements - rules 12‑280‑115
Exemptions from licensure - hospital residency programs - home renal dialysis - research companies 12‑280‑115.5
Certification of pharmacy technicians - requirements - provisional certification - criminal history record check - rules 12‑280‑116
Expiration and renewal of licenses, certifications, or registrations 12‑280‑117
Continuing education - exceptions - inactive status 12‑280‑117.5
Continuing education for pharmacy technicians - exceptions - inactive status 12‑280‑118
Prescription drug outlet under charge of pharmacist - rules 12‑280‑119
Registration of facilities - rules 12‑280‑120
Compounding - dispensing - sale of drugs and devices - rules - definition 12‑280‑121
Compounding drugs for office use by a veterinarian - rules - definitions 12‑280‑122
Limited authority to delegate activities constituting practice of pharmacy to pharmacy interns or pharmacy technicians 12‑280‑123
Prescription required - exception - dispensing opiate antagonists - selling nonprescription syringes and needles 12‑280‑124
Labeling - rules 12‑280‑125
Substitution of prescribed drugs and biological products authorized - when - conditions 12‑280‑125.3
Pharmacists’ authority - minor prescription adaptions 12‑280‑125.5
Pharmacists’ authority to dispense chronic maintenance drugs - rules - liability 12‑280‑125.7
Pharmacists’ authority to prescribe and dispense HIV prevention drugs - definitions - rules 12‑280‑126
Unprofessional conduct - grounds for discipline 12‑280‑127
Disciplinary actions 12‑280‑128
Judicial review 12‑280‑129
Unlawful acts - civil fines 12‑280‑130
Unauthorized practice - penalties 12‑280‑131
New drugs - when sales permissible 12‑280‑132
Advertising of prescription drug prices 12‑280‑133
Nonresident prescription drug outlet - registration 12‑280‑133.5
Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules 12‑280‑133.7
Third-party logistics providers - registration - denial, revocation, or suspension - rules 12‑280‑134
Records 12‑280‑135
Unused medication - licensed facilities - correctional facilities - reuse - definitions - rules 12‑280‑136
Confidential agreement to limit practice 12‑280‑137
Investigations of suspicious drugs 12‑280‑138
Patient counseling - pharmacists required to perform - patient may decline - rules 12‑280‑139
Insulin affordability program - record keeping - reimbursement - definitions 12‑280‑140
Emergency prescription insulin supply - eligibility - record keeping 12‑280‑141
Prescription drugs - automated pharmacy dispensing system - rules - definition 12‑280‑142
Epinephrine auto-injector affordability program - record keeping - reimbursement - definitions 12‑280‑201
Legislative declaration 12‑280‑202
Definitions 12‑280‑203
Pharmacy peer health assistance fund - rules 12‑280‑204
Eligibility - participants 12‑280‑205
Liability 12‑280‑206
Immunity 12‑280‑301
Definitions 12‑280‑303
Wholesaler registration requirements - rules 12‑280‑304
Record check 12‑280‑305
Restrictions on transactions 12‑280‑306
Records - pedigree - compliance with DQSA 12‑280‑307
Penalty 12‑280‑308
Manufacturer, agent, representative, or employee - drug cost information - required - definitions 12‑280‑401
Legislative declaration 12‑280‑402
Definitions 12‑280‑403
Prescription drug use monitoring program - registration required - applications - rules - appropriation - repeal 12‑280‑404
Program operation - access - rules - definitions 12‑280‑405
Prescription drug monitoring fund - creation - fee 12‑280‑406
Violations - penalties 12‑280‑407
Prescription drug outlets - prescribers - responsibilities - liability 12‑280‑408
Exemption - waiver 12‑280‑409
Examination and analysis of prescription drug monitoring program - recommendations to executive director 12‑280‑501
Written guidelines and procedures for making therapeutic interchange and therapeutically equivalent selections 12‑280‑502
Therapeutic interchange and therapeutically equivalent selections for nursing care facility or long-term acute care hospital patients - rules 12‑280‑601
Definitions 12‑280‑602
Collaborative pharmacy practice agreements - pharmacist requirements 12‑280‑603
Rules
Green check means up to date. Up to date

Current through Fall 2024

§ 12-280-404’s source at colorado​.gov