Ala. Admin. Code r. 420-5-7-.16

Current through Register Vol. 43, No. 1, October 31, 2024

Section 420-5-7-.16 - Pharmaceutical Services

(1) The hospital shall have pharmaceutical services that meet the needs of the patients. The institution shall have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff in conjunction with pharmacy department is responsible for developing and approving policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical service.

(2) Pharmacy management and administration. The pharmacy or drug storage area shall be administered in accordance with accepted professional principles.

(a) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

(b) The pharmaceutical service shall have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

(c) Current and accurate records shall be kept of the receipt and disposition of all scheduled drugs.

(3) Delivery of services. In order to provide patient safety, drugs and biologicals shall be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state law.

(a) All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with state and federal laws.

(b) All drugs and biologicals shall be kept in a secure area, and locked when appropriate.

(c) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be kept locked within a secure area.

(d) Only authorized personnel may have access to locked areas.

(e) Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use.

(f) When a pharmacist is not available, drugs and biologicals shall be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with federal and state law.

(g) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a reasonable time that is predetermined by the medical staff.

(h) Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician and, if appropriate, to the hospital-wide quality assurance program.

(i) Abuses and losses of controlled substances shall be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.

(j) Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration shall be available to the professional staff.

(k) A formulary system shall be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

Ala. Admin. Code r. 420-5-7-.16

Filed September 1, 1982. Amended: Filed May 20, 1992. Repealed and New Rule: Filed November 18, 1994; effective December 23, 1994. Repealed and New Rule: Filed August 24, 2012; effective September 28, 2012.

Rule .11 was renumbered to .16 as per certification filed August 24, 2012; effective September 28, 2012.

Author: W.T. Geary, Jr., M.D., Carter Sims

Statutory Authority:Code of Ala. 1975, §§ 22-21-20, et seq.