2014 North Dakota Century Code Title 19 Foods, Drugs, Oils, and Compounds Chapter 19-03.5 Prescription Drug Monitoring Program
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CHAPTER 19-03.5
PRESCRIPTION DRUG MONITORING PROGRAM
19-03.5-01. Definitions.
1. "Board" means the state board of pharmacy.
2. "Central repository" means a place where electronic data related to the prescribing
and dispensing of controlled substances is collected.
3. "Controlled substance" means a drug, substance, or immediate precursor defined in
section 19-03.1-01 and nonscheduled substances containing tramadol or carisoprodol.
4. "De-identified information" means health information that is not individually identifiable
information because an expert has made that determination under title 45, Code of
Federal Regulations, section 164.514 or direct identifiers and specified demographic
information have been removed in accordance with the requirements of that section.
5. "Dispense" means to deliver a controlled substance to an ultimate user by or pursuant
to the lawful order of a practitioner, including the prescribing, administering, packaging,
labeling, or compounding necessary to prepare the substance for delivery.
6. "Dispenser" means an individual who delivers a controlled substance to the ultimate
user but does not include a licensed hospital pharmacy that provides a controlled
substance for the purpose of inpatient hospital care or a licensed health care
practitioner or other authorized individual in those instances when the practitioner
administers a controlled substance to a patient.
7. "Individually identifiable health information" has the meaning set forth in title 45, Code
of Federal Regulations, section 160.103.
8. "Patient" means an individual or the owner of an animal who is the ultimate user of a
controlled substance for whom a prescription is issued or for whom a controlled
substance is dispensed.
9. "Prescriber" means an individual licensed, registered, or otherwise authorized by the
jurisdiction in which the individual is practicing to prescribe drugs in the course of
professional practice.
10. "Program" means the prescription drug monitoring program implemented under this
chapter.
19-03.5-02. Requirements for prescription drug monitoring program.
1. The board shall establish and maintain a program for the monitoring of prescribing and
dispensing of all controlled substances.
2. Each dispenser shall submit to the board by electronic means information regarding
each prescription dispensed for a controlled substance. The board shall establish and
update rules to direct dispensers on the version of the American Society for
Automation in Pharmacy Rules-Based Standard Implementation Guide for Prescription
Monitoring Programs in which the dispensing history must be submitted to the central
repository.
3. Each dispenser shall submit the information in accordance with transmission methods
and frequency established by the board.
4. The board may issue an extension of time to a dispenser that is unable to submit
prescription information by electronic means.
19-03.5-03. Access to prescription information.
1. Information submitted to the central repository is confidential and may not be disclosed
except as provided in this section.
2. The board shall maintain procedures to ensure that the privacy, confidentiality, and
security of patient information collected, recorded, transmitted, and maintained is not
disclosed except as provided in this section.
3. Unless disclosure is prohibited by law, the board may provide data in the central
repository to:
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a.
4.
A prescriber for the purpose of providing medical care to a patient, a dispenser for
the purpose of filling a prescription or providing pharmaceutical care for a patient,
a prescriber or dispenser inquiring about the prescriber's or dispenser's own
prescribing activity, or a prescriber or dispenser in order to further the purposes of
the program;
b. An individual who requests the prescription information of the individual or the
individual's minor child;
c. State boards and regulatory agencies that are responsible for the licensing of
individuals authorized to prescribe or dispense controlled substances if the board
or regulatory agency is seeking information from the central repository that is
relevant to an investigation of an individual who holds a license issued by that
board or regulatory agency;
d. Local, state, and federal law enforcement or prosecutorial officials engaged in the
enforcement of laws relating to controlled substances who seek information for
the purpose of an investigation or prosecution of the drug-related activity or
probation compliance of an individual;
e. The department of human services for purposes regarding the utilization of
controlled substances by a medicaid recipient or establishment and enforcement
of child support and medical support;
f. Workforce safety and insurance for purposes regarding the utilization of
controlled substances by a claimant;
g. Judicial authorities under grand jury subpoena or court order or equivalent judicial
process for investigation of criminal violations of controlled substances laws;
h. Public or private entities for statistical, research, or educational purposes after the
information is de-identified with respect to any prescriber, dispenser, or patient
who received a prescription for a controlled substance;
i. A peer review committee which means any committee of a health care
organization, composed of health care providers, employees, administrators,
consultants, agents, or members of the health care organization's governing
body, which conducts professional peer review as defined in chapter 23-34; or
j. A licensed addiction counselor for the purpose of providing services for a licensed
treatment program in this state.
The board shall maintain a record of each person who requests information from the
central repository. The board may use the records to document and report statistics
and outcomes. The board may provide records of the requests for information to:
a. A board or regulatory agency responsible for the licensing of individuals
authorized to prescribe or dispense controlled substances that is engaged in an
investigation of the individual who submitted the request for information from the
central repository; and
b. Local, state, and federal law enforcement or prosecutorial officials engaged in the
enforcement of laws relating to controlled substances for the purpose of an active
investigation of an individual who requested information from the central
repository.
19-03.5-04. Authority to contract.
The board is authorized to contract with another agency of this state or with a private
vendor to facilitate the effective operation of the prescription drug monitoring program. Any
contractor is bound to comply with the provisions regarding confidentiality of prescription drug
information in this chapter and is subject to termination or sanction or both for unlawful acts.
19-03.5-05. Immunity.
Nothing in this chapter requires a prescriber or dispenser to obtain information about a
patient from the central repository prior to prescribing or dispensing a controlled substance. A
prescriber, dispenser, or other health care practitioner may not be held liable in damages to any
person in any civil action on the basis that the prescriber, dispenser, or other health care
practitioner did or did not seek to obtain information from the central repository. Unless there is
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shown a lack of good faith, the board, any other state agency, a prescriber, dispenser, or any
other individual in proper possession of information provided under this chapter may not be
subject to any civil liability by reason of:
1. The furnishing of information under the conditions provided in this chapter;
2. The receipt and use of, or reliance on, such information;
3. The fact that any such information was not furnished; or
4. The fact that such information was factually incorrect or was released by the board to
the wrong person or entity.
19-03.5-06. Data review and referral - Corrections.
1. a. The board shall review the information received by the central repository to
determine if there is reason to believe:
(1) A prescriber or dispenser may have engaged in an activity that may be a
basis for disciplinary action by the board or regulatory agency responsible
for the licensing of the prescriber or dispenser; or
(2) A patient may have misused, abused, or diverted a controlled substance.
b. If the board determines that there is reason to believe that any of the acts
described in subdivision a may have occurred, the board may notify the
appropriate law enforcement agency or the board or regulatory agency
responsible for the licensing of the prescriber or dispenser. The advisory council
described in section 19-03.5-07 shall recommend guidelines to the board for
reviewing data and making determinations with respect to the referral of patients,
prescribers, or dispensers to law enforcement or appropriate regulatory
authorities.
2. A patient, dispenser, or prescriber may request that erroneous information contained in
the central repository be corrected or deleted. The board shall review the request to
determine if the information is erroneous with respect to the patient, prescriber, or
dispenser. The board shall correct any erroneous information the board discovers due
to the request for review by a patient, prescriber, or dispenser.
3. The board shall adopt a procedure to allow information contained in the central
repository to be shared with officials in other states acting for the purpose of controlled
substance monitoring and for requesting and receiving similar controlled substance
monitoring information from other states.
19-03.5-07. Advisory council.
1. An advisory council is established to advise and make recommendations to the board
regarding how to best use the program to improve patient care and foster the goal of
reducing misuse, abuse, and diversion of controlled substances; to encourage
cooperation and coordination among state, local, and federal agencies and other
states to reduce the misuse, abuse, and diversion of controlled substances; and to
provide advice and recommendations to the board regarding any other matters as
requested by the board. The advisory council may have access to central repository
information to fulfill its duties.
2. The advisory council must consist of:
a. One dispenser selected by the board;
b. One physician selected by the North Dakota medical association;
c. One prescriber selected by the board of nursing;
d. A designee of the attorney general;
e. A designee of the department of human services;
f. One prescriber selected by the board of medical examiners;
g. One prescriber selected by the North Dakota nurses association; and
h. Any other prescriber or dispenser determined by the board to be necessary to
meet a mandate of, or avoid a delay in implementing, an appropriations measure.
The number of additional members selected by the board must be limited to the
number necessary to meet the mandate or avoid the delay of an appropriation.
3. The advisory council shall make recommendations to the board regarding:
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a.
4.
Safeguards for the release of information to individuals who have access to the
information contained in the central repository;
b. The confidentiality of program information and the integrity of the patient's
relationship with the patient's health care provider;
c. Advancing the purposes of the program, including enhancement of the quality of
health care delivery in this state; and
d. The continued benefits of maintaining the program in relationship to the cost and
other burdens to the state.
The board may provide reimbursement of expenses and per diem to members of the
advisory council within the limits provided in state law.
19-03.5-08. Extraterritorial application.
The board may provide data in the central repository to a practitioner or controlled
substances monitoring system in another state, if the disclosure to a practitioner or the
prescription drug monitoring program located in this state is authorized by this chapter.
19-03.5-09. Authority to adopt rules.
The board may adopt rules that set forth the procedures and methods for implementing this
chapter.
19-03.5-10. Reporting unlawful acts and penalties.
1. The board may report to a dispenser's licensing board any dispenser who knowingly
fails to submit prescription drug monitoring information to the board as required by this
chapter or who knowingly submits incorrect prescription information to the board.
2. A person, including a vendor, who uses or discloses prescription drug monitoring
information in violation of this chapter is subject to the penalty provided in section
12.1-13-01.
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