1. (a) The purpose of this section is to provide standards for remote or off-site order entry in retail pharmacies within Arkansas licensed by the Arkansas State Board of Pharmacy (“the board”).

2. (b) Definitions. As used in this part:

   1. (1) “Drug regimen review” means an evaluation of prescription drug orders and patient profile records for:

      1. (A) Known allergies;
      2. (B) Rational therapy-contraindications;
      3. (C) Reasonable dose and route of administration;
      4. (D) Reasonable directions for use;
      5. (E) Duplication of therapy;
      6. (F) Drug-drug interactions;
      7. (G) Drug-food interactions;
      8. (H) Adverse drug reactions; and
      9. (I) Proper utilization, including overutilization or underutilization;

   2. (2) “Off-site order entry” does not include the dispensing of a prescription drug order but includes any of the following:

      1. (A) Receiving, interpreting, or clarifying prescription drug orders;
      2. (B) Data entering and transferring of prescription drug order information;
      3. (C) Performing drug regimen review;
      4. (D) Reconciling third-party insurance claims;
      5. (E) Obtaining refill and substitution authorizations;
      6. (F) Interpreting clinical data for prior authorization for dispensing;
      7. (G) Performing therapeutic interventions; and
      8. (H) Providing drug information concerning a patient’s prescription; and
   3. (3) “Off-site order entry pharmacy” means a retail pharmacy that is licensed by the board to process legend and controlled substance prescriptions that remotely accesses another pharmacy’s electronic database from outside the pharmacy in order to process prescription drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records.

3. (c)

   1. (1) The board may approve a request for off-site order entry where the retail pharmacy can demonstrate that the procedure will result in an improvement in patient care by increasing the amount of time for pharmacist involvement in the process of medication review for safety and efficacy prior to the administration of the medication to the patient.
   2. (2) Off-site order entry shall be prohibited out of state for prescriptions dispensed in the State of Arkansas.

4. (d)

   1. (1) The pharmacist-in-charge or the permit holder of the retail pharmacy shall submit a written request for off-site order entry a minimum of thirty (30) days prior to the board meeting at which the pharmacist seeks board approval.

   2. (2)

      1. (A) The request shall be accompanied by a policy and procedure manual for off-site order entry that shall be:

5. (i) Maintained at all pharmacies involved in off-site order entry; and

   1. (ii) Available for inspection.

      1. (B) Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy’s operations.

      2. (C) The manual shall:

         1. (i) Outline the responsibilities of each of the pharmacies;
         2. (ii) Include a list of the names, addresses, and telephone numbers of the pharmacies involved in off-site prescription order entry; and
         3. (iii) Include policies and procedures for:
6. (a) (a) Patient confidentiality and full compliance with HIPAA requirements; and

7. (b) (b) Maintenance of appropriate records to identify the:

   1. (1) (1) Name or names, initials, or identification code or codes, and specific activity or activities of each pharmacist or pharmacy technician who performed any processing; and

   2. (2) (2) The store it was processed in;

      1. (iv) Specify that only a pharmacist or pharmacy technician holding a current Arkansas license or registration in good standing shall enter orders at a remote or off-site entry location that is a duly licensed pharmacy;

         1. (v) Comply with federal and state laws and rules; and
         2. (vi) Include procedures for annually reviewing the written policies and procedures for needed modification with documentation of such review.

8. (e) General requirements.

   1. (1) A pharmacy may utilize the services of an off-site order entry pharmacy provided the pharmacies:

      1. (A) Share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a nondispensing function and have the same owner; or
      2. (B) Entered into a written contract or agreement that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and rules.

   2. (2) An off-site order entry pharmacy shall comply with the provisions contained in 17 CAR § 160-1206 and 17 CAR § 160-2009 to the extent applicable for the specific processing activity and this section, including:

      1. (A) Duties that must be performed by a pharmacist; and
      2. (B) Supervision requirements for pharmacy technicians.
   3. (3) Off-site order entry may only be performed by a retail pharmacy as appropriately licensed by the board.

9. (f) Notifications to patients. A pharmacy that outsources off-site prescription order entry to another pharmacy shall, prior to outsourcing their prescription:

   1. (1) Notify patients that prescription processing may be outsourced to another pharmacy; and

   2. (2)

      1. (A) Give the name of that pharmacy, or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may process the prescription, the patient shall be notified of this fact.

      2. (B) Such notification may be provided through:

         1. (i) A one-time written notice to the patient; or
         2. (ii) Use of a sign in the pharmacy.

10. (g) Records.

    1. (1) All pharmacies shall maintain appropriate records that identify, by prescription drug order, the name or names, initials, or identification code or codes of each pharmacist or pharmacy technician who performs a processing function for a prescription drug order.
    2. (2) Any record generated in this process, whether in a hard copy or electronic format, shall be maintained for a minimum period of two (2) years from the last date of entry.

    3. (3) Such records may be maintained:

       1. (A) Separately by each pharmacy and pharmacist; or
       2. (B) In a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout that lists the functions performed by each pharmacy and pharmacist.
11. (h) In the operation of the off-site order entry, patient confidentiality and full compliance with HIPAA requirements shall be observed at all times.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(6/30/2007)" "HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104–191.