Idaho Admin. Code r. 16.03.14.330

Current through September 2, 2024

Section 16.03.14.330 - PHARMACY SERVICE

The hospital shall provide an organized pharmaceutical service that is administered in accordance with accepted professional principles and appropriate federal, state, and local laws.

01.Organization and Supervision. Pharmacy services shall be under the overall direction of a pharmacist who is licensed in Idaho and is responsible for developing, coordinating, and supervising all pharmaceutical services in the hospital.

a. The director of the pharmaceutical service, whether a full, part-time or a consultant member of the staff, shall be responsible to the chief executive officer or his designee.

b. The pharmacist shall be responsible for the supervision of the hospital drug storage area in which drugs are stored and from which drugs are distributed.

c. If trained pharmacy assistants, pharmacy students, or pharmacy interns are employed, they shall work under the direct supervision of a pharmacist.

d. If the director of the pharmaceutical service is part-time, sufficient time shall be provided by the pharmacist to fulfill the responsibilities of the director of pharmaceutical services.

e. The director of the pharmaceutical service shall be responsible for maintaining records of the transactions of the pharmacy as required by law and as necessary to maintain adequate control and accountability of all drugs. This includes a system of control and records for the requisitioning and dispensing of drugs and supplies to nursing units and to other department/services of the hospital, as well as records of all prescription drugs dispensed to the patient.

f. The pharmacist shall periodically check drugs and drug records in all locations in the hospital where drugs are stored, including but not limited to nursing stations, emergency rooms, outpatient departments, operating suites.

02.Staffing. The pharmaceutical service shall be staffed by a sufficient number of qualified personnel in keeping with the size and scope of services offered by the hospital.

a. The services of a pharmacist shall be sufficient to meet the needs of the patients and to ensure that the established medication distribution system is functioning according to hospital policy.

b. A pharmacist shall be available on premises or on call at all times.

03.Scope of Services. The scope of pharmaceutical service shall be consistent with the needs of the patients and include a program for the control and accountability of drug products throughout the hospital. A pharmacy and therapeutics committee or its equivalent composed of members of the medical staff, the director of pharmaceutical services, the director of nursing services, hospital administration and other health disciplines as necessary, shall develop written policies and procedures for drug selection, preparation, dispensing, distribution, administration, control, and safe and effective use. Refer to Subsections 250.03 and 250.04.

04.Policies and Procedures. Written policies and procedures shall be developed by the pharmacy and therapeutics committee or its equivalent to govern the pharmaceutical services provided by the hospital.

a. Policies and procedures shall be reviewed revised and amended as necessary, and dated to indicate the time of last review.

b. Written policies and procedures that are essential for patient safety, and for the control and accountability of drugs, shall be in accordance with acceptable professional practices and applicable federal, state and local laws.

c. Policies and procedures shall include, but are not limited to the following:

i. There shall be a drug recall procedure that can be readily implemented; and

ii. All medications not specifically prescribed as to time or number of doses shall be controlled by automatic stop orders or other methods; and

iii. Drugs shall be dispensed and administered only upon written or verbal order of a member of the medical staff authorized to prescribe. Verbal orders for drugs shall be given only to those health care practitioners empowered to accept orders under Idaho law and written hospital policies and procedures. Verbal or telephone orders shall be signed or otherwise authenticated in a timely manner by the prescriber in accordance with the hospital's policy. The person accepting the verbal or telephone orders shall meet the procedures set forth in Subsection 250.09; and

iv. If patients bring their own drugs into the hospital, these drugs shall not be administered unless they are identified by the pharmacist and a physician's order is written to administer these specific drugs. If the drug(s) that the patient brought to the hospital is (are) not to be used while he is hospitalized, it (they) shall be packaged, sealed, stored, and returned to the patient at the time of discharge; and

v. Self-administration of medications by patients shall not be permitted unless specifically ordered by the physician; and

vi. Investigational drugs shall be used only under the supervision of the principal investigator and after approval for use by the pharmacy and therapeutics committee; and

vii. Acts of drug compounding, packaging, labeling, and dispensing, shall be restricted to the pharmacist or to his designee under supervision; and

viii. The labeling of drugs and biologicals shall be based on currently accepted professional principles, applicable federal, state, and local laws, and include the appropriate accessory and cautionary instructions, as well as the expiration date when applicable. Only the pharmacist or authorized pharmacy personnel under the supervision of the pharmacist shall make labeling changes; and

ix. Discontinued drugs, outdated drugs, or containers with worn, illegible, or missing labels shall be returned to the pharmacy for proper disposition; and

x. Only approved drugs and biologicals shall be used. (See definition.) A list or formulary of approved drugs shall be maintained in the hospital.

05.Space, Equipment, and Facilities. Space, equipment and supplies provided for the professional and administrative functions of the pharmaceutical service shall be appropriate to ensure patient safety through proper storage, compounding, and dispensing of drugs.

a. The organized pharmaceutical service of the hospital shall have the necessary equipment and physical facilities for compounding and dispensing drugs, and where indicated, radiopharmaceuticals and parenteral preparations.

b. There shall be special storage areas throughout the hospital for photosensitive and thermolabile products, and for controlled substances requiring special security.

c. Up-to-date pharmaceutical reference materials shall be provided to furnish the medical and nursing staffs with current information concerning drugs.

06.Safe Handling of Drugs. In addition to the rules listed below, written policies and procedures that govern the safe dispensing and administration of drugs shall be developed by the pharmacy and therapeutics committee with the cooperation and the approval of the medical staff.

a. The pharmacist shall review the prescriber's original order or a direct copy thereof; and

b. The pharmacist shall develop a procedure for the safe mixture of parenteral products; and

c. All medications shall be administered by trained personnel in accordance with accepted professional practices and any laws and regulations governing such acts; and

d. Each dose of medication administered shall be properly recorded as soon as administered in the patient's medication record that is a separate and distinct part of the patient's medical record; and

e. Drug reactions and medication errors shall be reported to the attending physician and pharmacist in accordance with hospital policy.

07.Inservice/Continuing Education. The pharmacist shall provide inservice/continuing education for medical and nursing staff at least once quarterly.

08.Security. The pharmacist is responsible for the drug storage security elements of the designated areas. Access to the pharmacy shall be gained only by him and by individuals designated by him. All prescribed medications shall be under lock and schedule II drugs shall be double-locked.

09.Unit Dose Drug Distribution. Unit dose procedures, if employed, shall be practiced in accordance with accepted standards of labeling, quality control, and accountability.

Idaho Admin. Code r. 16.03.14.330

Effective March 17, 2022