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Electronic Prescription Accountability

HRS div. 1, tit. 19, ch. 329, pt. VIII
in effect

HRS §329-101 Reporting of dispensation of controlled substances; electronic prescription accountability system; requirements; penalty

329-101. Reporting of dispensation of controlled substances; electronic prescription accountability system; requirements; penalty (a) A controlled substance electronic prescription accountability system shall be established within six months of June 18, 1996. (b) The designated state agency shall determine those schedules of controlled substances, classes of controlled substances, and specific controlled substances that are purportedly being misused and abused in the State. As part of the controlled substance registration process, all practitioners, except veterinarians, and pharmacies shall be registered with the department to utilize the electronic prescription accountability system. No identified controlled substances may be dispensed unless information relevant to the dispensation of the substance is reported electronically or by means indicated by the designated state agency to the central repository established under section 329-102, in accordance with rules adopted by the department. (c) The information required by this section shall be transmitted: on an electronic device that is compatible with the receiving device of the central repository; or by computer diskette, magnetic tape, or pharmacy universal claim form that meets the specifications provided in the rules of the designated state agency. The information to be transmitted under subsection (b) shall include at least the following for each dispensation: (1) The patient's name; (2) The patient's identification number; (3) The patient's date of birth; (4) The patient's address; (5) The eight-digit national drug code number of the substance dispensed; (6) The date the prescription was issued; (7) The date of dispensation; (8) The quantity and number of refills authorized; (9) The practitioner's Drug Enforcement Administration registration number; (10) The pharmacy's National Association of Boards of Pharmacy number and location; and (11) The practitioner's practice specialty and subspecialties, as determined by the applicable licensure boards. (d) Under the system: (1) Information shall be reported in numerical format, not less than once every seven days, on the filling of prescriptions for designated controlled substances and the dispensing of drug samples by a licensed practitioner; and (2) Each dispenser shall maintain a record of such filled prescriptions, including all information described in subsection (c), for a period of five years. Each dispenser shall keep these records available for inspection and copying by the designated state agency. (e) The system shall provide for the use of a central repository in accordance with section 329-102. The operation of the system shall be overseen by the designated state agency. The system shall include provisions to protect the confidentiality of information in the system, in accordance with section 329-104. (f) Intentional or knowing failure to transmit any information as required by this section, including a request by the designated state agency for data corrections, shall be a misdemeanor, may incur administrative fines, and shall result in the immediate suspension of that pharmacy or practitioner's ability to dispense controlled substances in the State until authorized by the administrator. [L 1996, c 268, pt of §2; am L 1997, c 280, §6; am L 1999, c 252, §13; am L 2001, c 203, §8; am L 2008, c 186, §7; am L 2010, c 123, §7; am L 2011, c 73, §4; am L 2016, c 55, §3 and c 218, §16]

HRS §329-102 Central repository

329-102. Central repository (a) Except as provided in subsection (b), the transmittal of information under this section shall be made: through an electronic transmitting device that is compatible with the receiving device of the central repository; or by computer diskette, magnetic tape, or other appropriate electronic means that meets the specifications provided by rules of the designated state agency. (b) The administrator may exempt individual dispensing entities from the electronic information reporting requirements of subsection (a) if: (1) The imposition of the requirement would result in financial hardship for a particular pharmacy; and (2) The pharmacy agrees to provide the information to the designated state agency through use of a pharmacy universal claim form. (c) The administrator, in consultation with the state pharmacist membership organizations and applicable licensure boards, shall develop policies that account for the transmission of data fields in section 329-101 that include unintentional data errors. Data errors collected by the designated state agency shall be presumed to be accidental in nature, unless a pattern of transmission errors occurs as determined by the agency. (d) The system shall provide for the maintenance of information collected in a central repository that meets the following requirements: (1) The central repository shall be a data processing system maintained by, or under contract with, the designated state agency. The system shall be capable of aggregating and displaying the collected information in formats required by the designated state agency, including reports showing controlled substances by the: (A) Practitioner's name, practice specialty and subspecialties, and identifying number or numbers as specified by the designated state agency, including the practitioner's Drug Enforcement Administration registration number; (B) Pharmacy's name, National Association of Boards of Pharmacy number, and registration number; (C) Patient's name, identification number, and date of birth; and (D) Eight-digit national drug code number, frequency of use, quantity, number of refills, and whether new or refill prescription; (2) The central repository shall provide the designated state agency with continual, twenty-four hour per day, on-line access to information; (3) The central repository shall secure the information against access by unauthorized persons and shall be subject to review and oversight by the administrator or the administrator's designee, to ensure the security of the information and the system; (4) If the central repository is not operated by the designated state agency, the vendor-repository: (A) Shall provide information in response to the designated state agency's inquiries within twenty-four hours and shall provide routine reports on a regular schedule to be specified by the designated state agency; and (B) Shall not withhold access to the collected information for any reason other than failure of the designated state agency to pay agreed fees and charges for the use of the central repository; and (5) If the relationship between the designated state agency and the vendor-repository is terminated, the vendor-repository shall provide to the designated state agency within thirty days all collected information, the database maintained by the vendor-repository, and such software as is needed to access the information and the database. (e) The administrator shall select the most overall cost-effective and efficient computerization system, and automatic data processing services and equipment, to ensure the successful implementation of the system. The administrator may enter into a contract with a vendor to implement the central repository. The repository may include an existing system, such as the State's medicaid management information system, or other existing computerization systems and automated data processing services available to the designated state agency. (f) All prescriptions for controlled substances in schedules II through V and other substances of concern designated by the designated state agency that are processed by an out-of-state pharmacy shall conform to reporting and registration requirements adopted by the State, and to any additional rules the department adopts. [L 1996, c 268, pt of §2; am L 2008, c 186, §8; am L 2011, c 73, §5]

HRS §329-103 Designated state agency

329-103. Designated state agency The designated state agency shall: (1) Oversee and administer the collection of information under the system; (2) Control access to the information in the system; and (3) Produce exception reports as defined in section 329-1. [L 1996, c 268, pt of §2]

HRS §329-104 Confidentiality of information; disclosure of information

329-104. Confidentiality of information; disclosure of information (a) The information collected under this part shall not be available to the public or used for any commercial purpose. Ownership of all data collected shall reside with the State. (b) Responsibility for limiting access to information in the system is vested in the administrator. Access to the information collected at the central repository pursuant to this part shall be confidential, and access to the information shall be limited to personnel of the designated state agency. (c) This section shall not prevent the disclosure, at the discretion of the administrator, of investigative information to: (1) Law enforcement officers, investigative agents of federal, state, or county law enforcement or regulatory agencies, United States attorneys, county prosecuting attorneys, or the attorney general; provided that the administrator has reasonable grounds to believe that the disclosure of any information collected under this part is in furtherance of an ongoing criminal or regulatory investigation or prosecution; (2) Registrants authorized under chapters 448, 453, and 463E who are registered to administer, prescribe, or dispense controlled substances and their practitioner delegate; provided that the information disclosed relates only to the registrant's own patient; (3) Pharmacists or pharmacist delegates, employed by a pharmacy registered under section 329-32, who request prescription information about a customer relating to a violation or possible violation of this chapter; (4) Other state-authorized governmental prescription-monitoring programs; (5) The chief medical examiner or licensed physician designee who requests information and certifies the request is for the purpose of investigating the death of an individual; (6) Qualified personnel for the purpose of bona fide research or education; provided that data elements that would reasonably identify a specific recipient, prescriber, or dispenser shall be deleted or redacted from the information prior to disclosure; provided further that release of the information may be made only pursuant to a written agreement between qualified personnel and the administrator in order to ensure compliance with this subsection; (7) Other entities or individuals authorized by the administrator to assist the program with projects that enhance the electronic prescription accountability system; (8) Authorized employees of the State of Hawaii department of health alcohol and drug abuse division and the emergency medical services and injury prevention system branch; and (9) The United States Department of Defense health agency prescription monitoring program. Information disclosed to a registrant, pharmacist, or authorized government agency under this section shall be transmitted by a secure means determined by the designated agency. (d) No person shall knowingly disclose or attempt to disclose, or use or attempt to use, information in the system in violation of this section. Any person who violates this section is guilty of a class C felony. (e) The designated state agency shall purge or cause to be purged from the central repository system, no later than five years after the date a patient's prescription data are made available to the designated state agency, the identification number of the patient, unless the information is part of an active investigation. [L 1996, c 268, pt of §2; am L 1999, c 145, §1; am L 2001, c 162, §1; am L 2006, c 69, §6; am L 2009, c 11, §42; am L 2010, c 123, §8; am L 2016, c 218, §17; am L 2019, c 230, §1]
Source: Hawaii State Legislature (capitol.hawaii.gov), via Internet Archive capturesURL: http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0329/HRS_0329-.htmFetched: 11/10/2026

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