NAC639.4998. Duties of pharmacist who establishes policies and procedures.

A pharmacist employed by or contracted with a surgical center for ambulatory patients pursuant to NAC 639.4996 shall:

     1. Visit the surgical center at least once each month to:

     (a) Evaluate the effectiveness of the policies and procedures established pursuant to NAC 639.4996; and

     (b) Confirm that the surgical center is complying with those policies and procedures, the provisions of this section and NAC 639.4996;

     2. Maintain documentation of each visit that the pharmacist makes pursuant to subsection 1;

     3. Conduct an audit at least once each month using a sufficient number of records of the surgical center, including, without limitation, records of patients and records relating to the purchasing, storing and dispensing of drugs and investigational drugs, which must be randomly selected, to determine whether:

     (a) The records indicate that the drugs and investigational drugs are dispensed in a safe and effective manner in accordance with accepted standards of practice and the specifications of the manufacturer;

     (b) Drugs and investigational drugs are diluted in accordance with accepted standards of practice or pursuant to the specifications of the manufacturer;

     (c) The records demonstrate:

          (1) That a discrepancy does not exist in the number of drugs and investigational drugs that are in vials designated by the manufacturer for a single use which are dispensed and the number of patients who receive such drugs and investigational drugs; and

          (2) That drugs, not including investigational drugs, which are in vials designated by the manufacturer for a single use and any remaining medication in those vials are discarded after use;

     (d) The records demonstrate that drugs, not including investigational drugs, which are in vials designated by the manufacturer for more than one use are discarded when the medication in the vials has expired or not more than 28 days after the initial breach of the vial;

     (e) The employees of the surgical center properly maintain accurate records relating to drugs and investigational drugs; and

     (f) The employees of the surgical center properly monitor and maintain the perpetual inventory required pursuant to paragraph (d) of subsection 1 of NAC 639.4996; and

     4. Submit a written report, including, without limitation, a written explanation, to the Board not later than 5 business days after the pharmacist determines that:

     (a) The surgical center is violating a state or federal law which affects the care and safety of a patient;

     (b) There is a discrepancy of 5 percent or more between the actual quantity of a controlled substance in the possession of the surgical center and the amount of the controlled substance that should be in the possession of the surgical center according to the records of the surgical center, including, without limitation:

          (1) Purchase orders and invoices for the controlled substance;

          (2) Records which indicate the removal of the controlled substance from the storage area;

          (3) Patient records;

          (4) Records which indicate the return of the controlled substance to the manufacturer;

          (5) Records which indicate that the controlled substance was destroyed; and

          (6) Any other record for the controlled substance;

     (c) The surgical center has intentionally or recklessly failed to create or maintain a record required by the policies and procedures established pursuant to NAC 639.4996;

     (d) The surgical center is administering a drug or an investigational drug in violation of accepted standards of practice or the specifications of the manufacturer; or

     (e) The surgical center is engaged in a practice which endangers the health, safety or welfare of a patient or employee of the surgical center.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)