19-03.5 Prescription Drug Monitoring Program
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<![CDATA[CHAPTER 19-03.5PRESCRIPTION DRUG MONITORING PROGRAM19-03.5-01. Definitions.1."Board" means the state board of pharmacy.2."Central repository" means a place where electronic data related to the prescribing<br>and dispensing of controlled substances is collected.3."Controlled substance" means a drug, substance, or immediate precursor defined in<br>section19-03.1-01andnonscheduledsubstancescontainingtramadolorcarisoprodol.4."De-identified information" means health information that is not individually<br>identifiable information because an expert has made that determination under<br>title 45, Code of Federal Regulations, section 164.514 or direct identifiers and<br>specified demographic information have been removed in accordance with the<br>requirements of that section.5."Dispense" means to deliver a controlled substance to an ultimate user by or<br>pursuant to the lawful order of a practitioner, including the prescribing, administering,<br>packaging, labeling, or compounding necessary to prepare the substance for<br>delivery.6."Dispenser" means an individual who delivers a controlled substance to the ultimate<br>user but does not include a licensed hospital pharmacy that provides a controlled<br>substance for the purpose of inpatient hospital care or a licensed health care<br>practitioner or other authorized individual in those instances when the practitioner<br>administers a controlled substance to a patient.7."Individually identifiable health information" has the meaning set forth in title 45,<br>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<br>controlled substance for whom a prescription is issued or for whom a controlled<br>substance is dispensed.9."Prescriber" means an individual licensed, registered, or otherwise authorized by the<br>jurisdiction in which the individual is practicing to prescribe drugs in the course of<br>professional practice.10."Program" means the prescription drug monitoring program implemented under this<br>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<br>and dispensing of all controlled substances.2.Each dispenser shall submit to the board by electronic means information regarding<br>each prescription dispensed for a controlled substance. The information submitted<br>for each prescription must include all of the data elements in the American Society<br>for Automation in Pharmacy Rules-Based Standard Implementation Guide for<br>Prescription Monitoring Programs issued August 31, 2005, version 003, release 000.3.Each dispenser shall submit the information in accordance with transmission<br>methods and frequency established by the board.Page No. 14.The board may issue an extension of time to a dispenser that is unable to submit<br>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<br>disclosed except as provided in this section.2.The board shall maintain procedures to ensure that the privacy, confidentiality, and<br>security of patient information collected, recorded, transmitted, and maintained is not<br>disclosed except as provided in this section.3.Unless disclosure is prohibited by law, the board may provide data in the central<br>repository to:a.A prescriber for the purpose of providing medical care to a patient, a dispenser<br>for the purpose of filling a prescription or providing pharmaceutical care for a<br>patient, a prescriber or dispenser inquiring about the prescriber's or dispenser's<br>own prescribing activity, or a prescriber or dispenser in order to further the<br>purposes of the program;b.An individual who requests the prescription information of the individual or the<br>individual's minor child;c.State boards and regulatory agencies that are responsible for the licensing of<br>individuals authorized to prescribe or dispense controlled substances if the<br>board or regulatory agency is seeking information from the central repository<br>that is relevant to an investigation of an individual who holds a license issued by<br>that board or regulatory agency;d.Local, state, and federal law enforcement or prosecutorial officials engaged in<br>the enforcement of laws relating to controlled substances who seek information<br>for the purpose of an investigation or prosecution of the drug-related activity or<br>probation compliance of an individual;e.The department of human services for purposes regarding the utilization of<br>controlled substances by a medicaid recipient;f.Workforce safety and insurance for purposes regarding the utilization of<br>controlled substances by a claimant;g.Judicial authorities under grand jury subpoena or court order or equivalent<br>judicial process for investigation of criminal violations of controlled substances<br>laws;h.Public or private entities for statistical, research, or educational purposes after<br>the information is de-identified with respect to any prescriber, dispenser, or<br>patient who received a prescription for a controlled substance; ori.A peer review committee which means any committee of a health care<br>organization, composed of health care providers, employees, administrators,<br>consultants, agents, or members of the health care organization's governing<br>body, which conducts professional peer review as defined in chapter 23-34.4.The board shall maintain a record of each person who requests information from the<br>central repository. The board may use the records to document and report statistics<br>and outcomes. The board may provide records of the requests for information to:Page No. 2a.A board or regulatory agency responsible for the licensing of individuals<br>authorized to prescribe or dispense controlled substances that is engaged in an<br>investigation of the individual who submitted the request for information from<br>the central repository; andb.Local, state, and federal law enforcement or prosecutorial officials engaged in<br>the enforcement of laws relating to controlled substances for the purpose of an<br>active investigation of an individual who requested information from the central<br>repository.19-03.5-04. Authority to contract. The board is authorized to contract with anotheragency of this state or with a private vendor to facilitate the effective operation of the prescription<br>drug monitoring program.Any contractor is bound to comply with the provisions regardingconfidentiality of prescription drug information in this chapter and is subject to termination or<br>sanction or both for unlawful acts.19-03.5-05. Immunity. Nothing in this chapter requires a prescriber or dispenser toobtain information about a patient from the central repository prior to prescribing or dispensing a<br>controlled substance. A prescriber, dispenser, or other health care practitioner may not be held<br>liable in damages to any person in any civil action on the basis that the prescriber, dispenser, or<br>other health care practitioner did or did not seek to obtain information from the central repository.<br>Unless there is shown a lack of good faith, the board, any other state agency, a prescriber,<br>dispenser, or any other individual in proper possession of information provided under this chapter<br>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; or4.The fact that such information was factually incorrect or was released by the board<br>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<br>determine if there is reason to believe:(1)A prescriber or dispenser may have engaged in an activity that may be a<br>basis for disciplinary action by the board or regulatory agency<br>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<br>described in subdivision a may have occurred, the board may notify the<br>appropriate law enforcement agency or the board or regulatory agency<br>responsible for the licensing of the prescriber or dispenser.The advisorycouncil described in section 19-03.5-07 shall recommend guidelines to the<br>board for reviewing data and making determinations with respect to the referral<br>of patients, prescribers, or dispensers to law enforcement or appropriate<br>regulatory authorities.2.A patient, dispenser, or prescriber may request that erroneous information contained<br>in the central repository be corrected or deleted. The board shall review the request<br>to determine if the information is erroneous with respect to the patient, prescriber, or<br>dispenser. The board shall correct any erroneous information the board discovers<br>due to the request for review by a patient, prescriber, or dispenser.Page No. 33.The board shall adopt a procedure to allow information contained in the central<br>repository to be shared with officials in other states acting for the purpose of<br>controlled substance monitoring and for requesting and receiving similar controlled<br>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<br>board regarding how to best use the program to improve patient care and foster the<br>goal of reducing misuse, abuse, and diversion of controlled substances; to<br>encourage cooperation and coordination among state, local, and federal agencies<br>and other states to reduce the misuse, abuse, and diversion of controlled<br>substances; and to provide advice and recommendations to the board regarding any<br>other matters as requested by the board. The advisory council may have access to<br>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; andh.Any other prescriber or dispenser determined by the board to be necessary to<br>meet a mandate of, or avoid a delay in implementing, an appropriations<br>measure. The number of additional members selected by the board must be<br>limited to the number necessary to meet the mandate or avoid the delay of an<br>appropriation.3.The advisory council shall make recommendations to the board regarding:a.Safeguards for the release of information to individuals who have access to the<br>information contained in the central repository;b.The confidentiality of program information and the integrity of the patient's<br>relationship with the patient's health care provider;c.Advancing the purposes of the program, including enhancement of the quality<br>of health care delivery in this state; andd.The continued benefits of maintaining the program in relationship to the cost<br>and other burdens to the state.4.The board may provide reimbursement of expenses and per diem to members of the<br>advisory council within the limits provided in state law.19-03.5-08. Extraterritorial application. The board may provide data in the centralrepository to a practitioner or controlled substances monitoring system in another state, if the<br>disclosure to a practitioner or the prescription drug monitoring program located in this state is<br>authorized by this chapter.Page No. 419-03.5-09. Authority to adopt rules. The board may adopt rules that set forth theprocedures 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<br>fails to submit prescription drug monitoring information to the board as required by<br>this chapter or who knowingly submits incorrect prescription information to the<br>board.2.A person, including a vendor, who uses or discloses prescription drug monitoring<br>information in violation of this chapter is subject to the penalty provided in section<br>12.1-13-01.Page No. 5Document Outlinechapter 19-03.5 prescription drug monitoring program]]>