Section R4-23-658. Drug Distribution and Control

A.      General. The Director of Pharmacy or pharmacist-in-charge shall in consultation with the medical staff, develop, imple- ment, review, and revise in the same manner described in R4- 23-653(A) and comply with written policies and procedures for the effective operation of a drug distribution system that optimizes patient safety.

B.       Responsibility. The Director of Pharmacy is responsible for the safe and efficient procurement, dispensing, distribution, administration, and control of drugs, including the following:

1.        In consultation with the appropriate department personnel and medical staff committee, develop a medication for- mulary for the hospital;

2.        Proper handling, distribution, and recordkeeping of investigational drugs; and

3.        Regular inspections of drug storage and preparation areas within the hospital.

C.      Physician orders. A Director of Pharmacy or pharmacist-in- charge shall ensure that:

1.        Drugs are dispensed from the hospital pharmacy only upon a written order, direct copy or facsimile of a written order, or verbal order of an authorized medical practi- tioner; and

2.        A pharmacist reviews the original, direct or facsimile copy, or verbal order before an initial dose of medication is administered, except as specified in R4-23-653(E)(1).

D.      Labeling. A Director of Pharmacy or pharmacist-in-charge shall ensure that all drugs distributed or dispensed by a hospi- tal pharmacy are packaged in appropriate containers and labeled as follows:

1.        For use inside the hospital.

a.         Labels for all single unit packages contain at a mini- mum, the following information:

i.         Drug name, strength, and dosage form;

ii.        Lot number and beyond-use-date; and

iii.      Appropriate auxiliary labels;

b.        Labels for repackaged preparations contain at a min- imum the following information:

i.         Drug name, strength, and dosage form;

ii.        Lot number and beyond-use-date;

iii.      Appropriate auxiliary labels; and

iv.       Mechanism to identify pharmacist accountable for repackaging;

c.         Labels for all intravenous admixture preparations contain at a minimum the following information:

i.         Patient’s name and location;

ii.        Name and quantity of the basic parenteral solu- tion;

iii.      Name and amount of drug added;

iv.       Date of preparation;

v.        Beyond-use-date and time;

vi.       Guidelines for administration;

vii.     Appropriate  auxiliary  label  or  precautionary statement; and

viii.    Initials of pharmacist responsible for admixture preparation; and

2.        For use outside the hospital. Any drug dispensed to a patient by a hospital pharmacy that is intended for self- administration outside of the hospital is labeled as speci- fied in A.R.S. §§ 32-1963.01(C) and 32-1968(D) and

A.A.C. R4-23-402.

E.       Controlled substance accountability. A Director of Pharmacy or pharmacist-in-charge shall ensure that effective policies and procedures are developed, implemented, reviewed,  and revised in the same manner described in R4-23-653(A) and complied with regarding the use, accountability, and record- keeping of controlled substances in the hospital, including the use of locked storage areas when controlled substances are stored in patient care areas.

F.       Emergency services dispensing. If a hospital permits dispens- ing of drugs from the emergency services department when the pharmacy is unable to provide this service, the Director of Pharmacy, in consultation with the appropriate department personnel and medical staff committee shall develop, imple- ment, review, and revise in the same manner described in R4- 23-653(A) and comply with written policies and procedures for dispensing drugs for outpatient use from the hospital’s emergency services department. The policies and procedures shall include the following requirements:

1.        Drugs are dispensed only to patients who have been admitted to the emergency services department;

2.        Drugs are dispensed only by an authorized medical prac- titioner, not a designee or agent;

3.        The nature and type of drugs available for dispensing are designed to meet the immediate needs of the patients treated within the hospital;

4.        Drugs are dispensed only in quantities sufficient to meet patient needs until outpatient pharmacy services are available;

5.        Drugs are prepackaged by a pharmacist or a pharmacy intern, graduate intern, pharmacy  technician, or phar- macy technician trainee under the supervision of a phar- macist in suitable containers and appropriately prelabeled with the drug name, strength, dosage form, quantity, man- ufacturer, lot number, beyond-use-date, and any appropri- ate auxiliary labels;

6.        Upon dispensing, the authorized medical practitioner completes the label on the prescription container that complies with the requirements of R4-23-658(D); and

7.        The hospital pharmacy maintains a dispensing log, hard- copy prescription, or electronic record, approved by the Board or its designee and includes the patient name and address, drug name, strength, dosage form, quantity, directions for use, medical practitioner’s signature or identification code, and DEA registration number, if applicable.

Historical Note

Former Rules 6.7610, 6.7620, and 6.7710; Amended

effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Correction to subsection (I)(5) (“unnecessary” changed to “necessary”) (Supp. 91-1). Amended effective November 1, 1993 (Supp. 93-4). Amended by final

rulemaking at 8 A.A.R. 4902, effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). Amended by

final rulemaking at 12 A.A.R. 3032, effective October 1,

2006 (Supp. 06-3).