1. (a) The State Board of Health shall create the Prescription Drug Monitoring Program upon the Department of Health’s procuring adequate funding to establish the program.

2. (b) Requirements to submit information for dispensation of controlled substance:

   1. (1) Each dispenser shall submit to the department information regarding each Schedule II, III, IV, or V controlled substance dispensed;

   2. (2)

      1. (A) A dispenser located outside Arkansas and licensed and registered by the Arkansas State Board of Pharmacy shall submit to the department information regarding each Schedule II, III, IV, or V controlled substance prescription dispensed to an ultimate user whose address is within Arkansas.
      2. (B) A federal dispenser located in the State of Arkansas or located outside Arkansas may submit to the department information regarding each Schedule II, III, IV, or V controlled substance dispensation to an ultimate user whose address is within Arkansas; and
   3. (3) The State Board of Health shall create a controlled substances database for the Prescription Drug Monitoring Program.

3. (c) Each dispenser required to report under subsection (b) of this section shall submit to the department by electronic means, or other methods approved by the Prescription Drug Monitoring Program, information that shall include without limitation the following:

   1. (1) The dispenser's identification number;
   2. (2) The date the prescription was filled;
   3. (3) The prescription number;
   4. (4) Whether the prescription is new or is a refill;
   5. (5) The National Drug Code number for the controlled substance that is dispensed;
   6. (6) The quantity of the controlled substance dispensed;
   7. (7) The number of days' supply dispensed;
   8. (8) The number of refills ordered;

   9. (9)

      1. (A) A patient identifier.
      2. (B) A patient identifier shall not be a social security number or a driver's license number;
   10. (10) The patient's name;
   11. (11) The patient's address;
   12. (12) The patient's date of birth;
   13. (13) The patient's gender;
   14. (14) The prescriber's identification number;
   15. (15) The date the prescription was issued by the prescriber; and
   16. (16) The source of the payment for the prescription.

4. (d) If the prescription dispensed is for an animal patient, the prescription shall be reported as follows:

   1. (1) The prescription shall be identified as an animal/veterinary patient;
   2. (2) The owner of the animal/veterinary patient shall be reported to the department by first name, last name, and date of birth; and
   3. (3) The animal/veterinary patient shall be reported.

5. (e) Review of prescription drug monitoring information prior to prescribing or dispensing.

   1. (1) Except as required in subdivision (e)(2) of this section, practitioners are encouraged to access or check the information in the controlled substance database created under this section before prescribing, dispensing, providing medication reconciliation, or administering medications.

   2. (2) Mandatory review of prescription drug monitoring information prior to prescribing or dispensing.

      1. (A) A prescriber shall check the information in the Prescription Drug Monitoring Program when prescribing:

6. (i) An opioid from Schedule II or Schedule III for every time prescribing the medication to a patient; and

   1. (ii) A benzodiazepine medication for the first time prescribing the medication to a patient.

      1. (B) A licensing board that licenses practitioners who have the authority to prescribe shall adopt rules requiring the practitioners to check the information in the Prescription Drug Monitoring Program as described in subdivision (e)(2)(A) of this section.

      2. (C) This subdivision (e)(2) does not apply to:

         1. (i) A practitioner administering a controlled substance:
7. (a) (a) Immediately before or during surgery;

8. (b) (b) During recovery from a surgery while in a healthcare facility;

   1. (c) (c) In a healthcare facility; or

      1. (d) (d) Necessary to treat a patient in an emergency situation at the scene of an emergency, in a licensed ground ambulance or air ambulance, or in the intensive care unit of a licensed hospital;

         1. (ii) A practitioner prescribing or administering a controlled substance to:
9. (a) (a) A palliative care or hospice patient; or

10. (b) (b) A resident in a licensed nursing home facility; or

    1. (iii) Situations in which the Prescription Drug Monitoring Program is not accessible due to technological or electrical failure.

       1. (D) The State Board of Health may amend, by rule, the exemptions listed in subdivision (e)(2)(C) of this section upon a recommendation from the Secretary of the Department of Health and a showing that the exemption or lack or exemption:

          1. (i) Is unnecessarily burdensome; or
          2. (ii) Has created a hardship.
    2. (3) A licensed oncologist shall check the Prescription Drug Monitoring Program when prescribing to a patient on an initial malignant episodic diagnosis and every three (3) months following the diagnosis while continuing treatment.
11. (f) This section does not prohibit licensing boards from requiring practitioners to access or check the information in the controlled substance database as a part of a review of the practitioner's professional practice.

12. (g) Standard for submitting prescription drug information.

    1. (1) Each dispenser shall submit the required information in accordance with the Standard for Prescription Monitoring Programs of the American Society for Automation in Pharmacy (ASAP) Version 4 Release 2 September 2011, incorporated by reference, or other format approved by the Prescription Drug Monitoring Program.
    2. (2) Data shall be submitted via CD-ROM, a secure File Transfer Protocol (FTP), Virtual Private Network (VPN), https, or other methods approved by the Prescription Drug Monitoring Program.

    3. (3)

       1. (A) A dispenser shall report the controlled substance dispensing information records required under Arkansas Code §§ 20-7-601 – 20-7-615 and this part no later than the next business day after the date of dispensing.
       2. (B) Veterinarians shall report dispensing information every thirty (30) days.
       3. (C) If controlled substances were not dispensed for the reporting period, the dispenser shall submit a zero report in accordance with ASAP Version 4 Release 2 September 2011, or other format approved by the Prescription Drug Monitoring Program.

    4. (4)

       1. (A) The department or the department’s contractor shall notify a dispenser of an error in data reporting.
       2. (B) Upon receiving notification of an error in data reporting, the dispenser shall take appropriate measures to correct the error and transmit the corrected data to the department or the department’s contractor within fourteen (14) days of being notified of the error.

    5. (5)

       1. (A) If a dispenser does not dispense controlled substances, the dispenser may request a reporting exemption waiver from the Prescription Drug Monitoring Program.
       2. (B) The waiver shall be renewed annually.

       3. (C) If a dispenser with a reporting exemption waiver begins to dispense controlled substances in the state, the dispenser shall:

          1. (i) Notify the Prescription Drug Monitoring Program to relinquish the waiver on file prior to dispensing any controlled substances in the state; and
          2. (ii) Begin reporting dispensations to the Prescription Drug Monitoring Program.

13. (h) The department’s process for patients to address errors, inconsistencies, and other matters in their record as maintained under this section, including in cases of breach of privacy and security shall comply with Sections 261 through 264 of the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104 – 191 (the Administrative Simplification provisions) and regulations 45 C.F.R. pts. 160 and 164 (the HIPAA Security and Privacy Rule) and the Health Information Technology for Economic and Clinical Health Act, as enacted by the American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5, pursuant to Title XIII of Division A and Title IV of Division B.

    1. (i)
    2. (1) The department shall limit access to only those employees whose access is reasonably necessary to carry out this section.
    3. (2) However, a prescriber may delegate access to the controlled substance database to persons under his or her supervision or employment.

14. (j) A certified law enforcement prescription drug diversion investigator shall provide to the department the following information in order to be granted access to the Prescription Drug Monitoring Program:

    1. (1) The identification credentials assigned by the department;
    2. (2) The case number of the investigation submitted on the investigator’s law enforcement agency letterhead;
    3. (3) The badge number of the investigator; and
    4. (4) A copy of the investigator’s certification from the Arkansas Commission of Law Enforcement Standards and Training course in prescription drug diversion.

15. (k) Annual reports by qualified law enforcement agency.

    1. (1) A qualified law enforcement agency shall submit to the department an annual report of the data accessed by all certified law enforcement prescription drug diversion investigators in the qualified law enforcement agency, including without limitation:

       1. (A) Written verification that the inquiries were part of a lawful prescription drug diversion investigation as provided to the department through the case number of the investigation; and
       2. (B) The disposition of the investigation.

    2. (2) The department shall:

       1. (A) Create a verification form for use under subdivision (k)(1) of this section; and
       2. (B) Make the verification form available annually to the qualified law enforcement agency.

    3. (3) Submission of verification form.

       1. (A) The verification form under subdivision (k)(1) of this section shall be submitted to the department within thirty (30) days of receipt of the form by the qualified law enforcement agency.
       2. (B) Failure to submit a verification form under subdivision (k)(3)(A) of this section shall result in the immediate suspension of the access to the database by the qualified law enforcement agency and its certified law enforcement prescription drug diversion investigators until a determination is made by the department to allow continued access.

Codification Notes: “CD-ROM” means compact disc read-only memory. "https" means hypertext transfer protocol secure.