R432-100-25. Pharmacy Services

  (1) The pharmacy of a hospital currently accredited and conforming to the standards of JCAHO shall be determined to be in compliance with these rules.

  (a) If a hospital is not accredited by JCAHO, then the pharmacy of such hospital shall comply with rules in this section.

  (b) The pharmacy department and service shall be directed by a licensed pharmacist.

  (i) Competent personnel shall be employed in keeping with the size and activity of the department and service. If the hospital uses only a drug room and the size of the hospital does not warrant a full-time pharmacist, a consultant pharmacist may be employed.

  (ii) The pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy.

  (iii) Provision shall be made for access to emergency pharmaceutical services.

  (iv) The pharmacist shall be trained in the specific functions and scope of the hospital pharmacy.

  (2) Facilities shall be provided for the safe storage, preparation, safeguarding, and dispensing of drugs.

  (a) All floor-stocks shall be kept in secure areas in the patient care units.

  (b) Double-locked storage shall be provided for controlled substances. Electronically controlled storage of narcotics may be permitted if automated dispensing technology is utilized by the hospital.

  (c) Medications stored at room temperatures shall be maintained within 59 and 80 degrees F.

  (d) Refrigerated medications shall be maintained within 36 and 46 degrees F.

  (e) A current toxicology reference, and other references as needed for effective pharmacy operation and professional information shall be available.

  (3) Records shall be kept of the transactions of the pharmacy and medication storage unit and coordinated with other hospital records.

  (a) There shall be a recorded and signed floor-stock controlled substance count once per shift or the facility must use automated dispensing technology in accordance with R156-17b-605.

  (b) Hospitals that utilize automated dispensing technology must implement a system for accounting of controlled substances dispensed by the automated dispensing system.

  (c) The record shall list the name of the patient receiving the controlled substance, the date, type of substance, dosage, and signature of the person administering the substance.

  (4) Written policies and procedures that pertain to the intra-hospital drug distribution system and the safe administration of drugs shall be developed by the director of the pharmaceutical department or service in concert with the medical staff.

  (a) Drugs that are provided to floor units shall be administered in accordance with hospital policies and procedures.

  (b) The medical staff in conjunction with the pharmacist shall establish standard stop orders for all medications not specifically prescribed as to time or number of doses.

  (c) The pharmacist shall have full responsibility for dispensing of all drugs.

  (d) There shall be a policy stating who may have access to the pharmacy or drug room when the pharmacist is not available.

  (e) There shall be a documentation system for the accounting and replacement of drugs, including narcotics, to the emergency department.

  (f) Medication errors and adverse drug reactions shall be reported immediately in accordance with written procedures including notification of the practitioner who ordered the drug.