Consultant pharmacists in a facility are involved in the following areas of pharmaceutical care that include drug storage, distribution, and utilization in that facility:

1. (1) Supervision of services.

   1. (A)

      1. (i) The consultant pharmacist or pharmacists shall develop, coordinate, and supervise all pharmaceutical services.
      2. (ii) The consultant pharmacist for the facility must ensure that pharmacist consultation is available on a twenty-four-hours-per-day, seven-days-per-week basis.
      3. (iii) Consultant pharmacists shall devote a sufficient number of hours based upon the needs of the facility during regularly scheduled visits to carry out these responsibilities.
   2. (B) Consultant pharmacists shall assist the facility in developing procedures to ensure the provision of emergency drugs, and shall report to the Arkansas State Board of Pharmacy any pharmacy refusing to provide medication for the pharmacy’s regular patients in the facility on a twenty-four-hours-per-day, seven-days-per-week basis.
   3. (C) The consultant pharmacist or pharmacists shall provide written consultation on compliance with federal and state laws governing legend drugs, including controlled substances.

   4. (D) The consultant pharmacist or pharmacists shall:

      1. (i) Be knowledgeable of all laws and rules pertaining to the facility; and
      2. (ii) Communicate with the state agencies involved with enforcement and regulation of the facility.

   5. (E) The consultant pharmacist or pharmacists shall spend sufficient time to:

      1. (i) Evaluate discontinued or other unused medication for destruction or donation;
      2. (ii) Check entries in a bound, numbered controlled drugs book;

      3. (iii) Process unused medication for donation as provided in:

         1. (a) (a) Arkansas Code § 17-92-1101 et seq.; and
         2. (b) (b) 17 CAR § 160-1706; and
      4. (iv) Make general observations at the nursing stations.

   6. (F) Records shall indicate the day the consultant pharmacist or pharmacists visited the home and a brief statement of:

      1. (i) Purpose;
      2. (ii) Finding; and
      3. (iii) Actions;

2. (2) Control and accountability of all legend drugs, including controlled substances.

   1. (A) The consultant pharmacist:

      1. (i) Develops written procedures for control and accountability of all drugs and biologicals throughout the facility; and
      2. (ii) Supervises the implementation of these procedures.

   2. (B)

      1. (i) Only approved drugs and biologicals are used in the facility and shall be dispensed in compliance with federal and state laws.
      2. (ii) Records of receipt and disposition of all controlled drugs shall be maintained in sufficient detail to enable an accurate reconciliation.

      3. (iii) The consultant pharmacist shall determine that:

         1. (a) (a) Drug records are in order; and
         2. (b) (b) An account of all controlled drugs is maintained and reconciled.

   3. (C) The consultant pharmacist or pharmacists shall establish procedures to ensure that:

      1. (i) All legend drugs and controlled substances must be stored in a secured location and appropriately locked;
      2. (ii) Proper records of receipt and administration of controlled drugs must be maintained for review by the consultant pharmacist;

      3. (iii) Noncontrolled legend drugs.

         1. (a) (a) Drugs to be destroyed shall be handled in accordance with state and federal requirements.
         2. (b) (b) Drugs to be donated. The consultant pharmacist shall cause all drugs that are designated for donation to charitable clinics licensed by the board under 17 CAR § 160-1304 and Arkansas Code § 17-92-1101 et seq., to be processed in accordance with 17 CAR § 160-1706; and
      4. (iv) Controlled drugs shall be handled in accordance with state and federal requirements;

3. (3) Patient drug regimen review.

   1. (A) The primary duty of the consultant pharmacist or pharmacists to the patients’ concerns is to apply his or her expertise on drugs to the patient’s specific situation.
   2. (B) State and federal rules shall be the minimum standards for an adequate drug regimen review.

   3. (C) Additionally, the consultant pharmacist shall routinely review each patient’s medical records and:

      1. (i) Ascertain that patient history and drug utilization is being properly recorded;
      2. (ii) Review drug usage, including O.T.C. and prescriptions;
      3. (iii) Review patient compliance with drug regimen;
      4. (iv) Review drug allergies or sensitivities;

      5. (v) Determine whether the patient is predisposed to side effects due to:

         1. (a) (a) Disease;
         2. (b) (b) Illness; or
      6. (c) (c) Age;
      7. (vi) Determine whether potential exists for significant drug interaction;
      8. (vii) Develop procedures to monitor patients’ records for signs that indicate abuse or misuse of drugs by the patient or individuals;

      9. (viii) Make recommendations regarding drug therapy to:

         1. (a) (a) The physician;
         2. (b) (b) The nurse; or
      10. (c) (c) Other persons involved in the patient’s care;
      11. (ix) Communicate to the facility procedures that ensure adequate pharmacy services are available for emergencies that might develop in the facility for a specific patient; and

      12. (x) Promote pharmacists’ ability and knowledge to:

          1. (a) (a) All persons involved in patient care; and
          2. (b) (b) Offer assistance in solving specific problems relating to a patient drug regimen.

   4. (D) A consultant pharmacist or pharmacists shall quarterly in ICF/IID and assisted living (level II) facilities and monthly in nursing homes:

      1. (i) Review each patient’s medication record; and
      2. (ii) Consult with and provide a written report of findings to the director of nursing or the patient’s physician;

4. (4) Labeling of drugs and biologicals and proper storage.

   1. (A) All legend drugs, including controlled substances, on the premises of a nursing home, except for the emergency kit maintained pursuant to 17 CAR § 160-1804 and 17 CAR § 160-1805, shall:

      1. (i) Be stored under lock pursuant to Department of Health rules; and
      2. (ii) Always be in a properly labeled container as dispensed upon a prescription by the pharmacy of the patient’s choice.

   2. (B) It is the duty of the consultant pharmacist or pharmacists to ascertain that:

      1. (i) Medications are:

         1. (a) (a) Properly labeled;
         2. (b) (b) Properly stored; and
      2. (c) (c) Refrigerated when needed;
      3. (ii) Expiration dates are routinely checked; and
      4. (iii) Appropriate accessory and cautionary instructions are on all medications when required; and

5. (5) Quality assurance and patient assessment committee.

   1. (A) A consultant pharmacist or pharmacists shall be a member of the quality assurance and patient assessment committee or its equivalent and make official reports to this committee as often as needed to ensure quality pharmaceutical care.

   2. (B) The consultant pharmacist shall ensure that there are written policies and procedures for safe and effective drug:

      1. (i) Therapy;
      2. (ii) Distribution;
      3. (iii) Control; and
      4. (iv) Use.

   3. (C) The policies and procedures shall include and are not limited to:

      1. (i) Stop order policies or other methods to ensure appropriateness of continued drug therapy;
      2. (ii) Maintaining the contents of the emergency kit in compliance with 17 CAR § 160-1805; and
      3. (iii) Policies for the safe procurement, storage, distribution, and use of drugs and biologicals.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(10/9/80, Amended 2/17/82, 6/25/83, 10/12/93, 02/11/2003, 6/23/05, 7/10/2009, 8/1/2018, and 2/14/2022)" "O.T.C." means over-the-counter. "ICF/IID" means intermediate care facility for individuals with intellectual disabilities.