Section 124.15. Pharmaceutical services.

 

(1)   Definitions. In this section:

(a) "Automated dispensing system" means a mechanical system that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing or distribution of medications, and which collects, controls, and maintains all transaction information.

(am) "Drug room" means the room in a hospital that does not have a pharmacy, in which prescription drugs are stored and from which they are distributed.

(b) "Pharmacist" means a person licensed in Wisconsin under ch. 450 , Stats. , as a pharmacist.

(c) "Pharmacy" means any place in which prescription drugs, as defined in s. 450.01 (20) , Stats., are compounded or dispensed, and which is licensed under s. 450.06 , Stats.

(2)   Service. The hospital shall have a pharmacy directed by a pharmacist or a drug room under competent supervision. The pharmacy or drug room shall be administered in accordance with accepted professional practices.

(3)   Administration.

(a) Pharmacist accountability. The pharmacist shall be responsible to the chief executive officer for developing, supervising and coordinating all the activities of the pharmacy.

(b) Licensed pharmacy. In a hospital with a pharmacy, except for emergency orders, a pharmacist shall review the practitioner's order, a direct copy of the order or another type of verifiable order before the initial dose of a medication is dispensed. When a pharmacist is not on the premises, the medication order shall be reviewed by the pharmacist by the end of the next day.

(c) Drug room. If the hospital has only a drug room, prescription medications shall be dispensed by a qualified pharmacist elsewhere and only storing and distributing shall be done in the hospital. In this case:

1. An on-site review of the medication administration system shall be conducted at least monthly by a consultant pharmacist;

2. A consulting pharmacist shall assist in the development of the correct procedures and rules for storage and distribution of drugs, and shall visit the hospital on a regularly scheduled basis; and

3. A consulting pharmacist shall participate in reviewing at least a sample of current medication orders on a periodic basis.

(d) Availability. All hospitals shall have a pharmacist on call and available for consultation at all times.

(4)   Facilities.

(a) Storage and equipment. Drugs shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation and security. In a pharmacy, current reference materials and equipment shall be provided for the compounding and dispensing of drugs. Hospitals utilizing automated dispensing systems must meet the requirements under s. Phar 7.09 .

(b) Control.

1. Drugs shall be issued to floor units in accordance with approved policies and procedures.

2. Drug stocks and all medication areas shall be routinely reviewed by the pharmacist. All floor stocks shall be properly controlled.

3. Special locked storage space shall be provided to meet the legal requirements for storage of alcohol and prescription drugs, including controlled substances.

(5)   Personnel.

(a) Staff. The pharmacist shall be assisted by a sufficient number of pharmacists and nonpharmacists as required by the scope of the operations. All work performed by non-registered pharmacy personnel shall be directed, supervised and inspected by a pharmacist.

(b) Categories. The pharmacy, depending upon the size and scope of its operations, shall be staffed by the necessary categories of personnel. Categories of personnel may include director of pharmacy, one or more assistant directors, staff pharmacists, clinical pharmacy specialists, pharmacy trainees and supportive personnel.

(c) Emergency services. Provision shall be made for pharmaceutical services to be available in the event of emergencies.

(d) Consulting pharmacist. If the hospital does not have a staff pharmacist, a consulting pharmacist shall have overall responsibility for control and distribution of drugs, and a designated licensed nurse or practitioner shall have responsibility for day-to-day operation of the drug room.

(6)   Records.

(a) General. Records shall be kept of the transactions of the pharmacy or drug room and correlated with other hospital records where indicated. These records shall be maintained as required by law.

(b) Accounting. The managing or consulting pharmacist shall establish and maintain, in cooperation with the business office, a satisfactory system of records and bookkeeping, in accordance with the policies of the hospital, for:

1. Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies; and

2. Charging patients for drugs and pharmaceutical supplies.

(c) Controlled substances. Dispensing, distribution and administration of controlled substances shall be documented by the pharmacist, licensed nurse or practitioner so that the disposition of any particular item may be readily traced. These records shall be prepared and maintained in accordance with ch. Phar 8 and other state and federal laws that may apply.

(d) Formulary. A current copy of the drug formulary developed under sub. (8) (b) shall be maintained in the hospital.

(7)   Policies.

(a) Responsibility. All hospitals shall have written policies relating to the selection, intrahospital distribution and handling, and safe administration of drugs. The medical staff shall develop and monitor the administration of these policies and procedures in cooperation with the pharmacist and with representatives of other disciplines in the hospital.

(b) Automatic medication orders. The medical staff shall establish a written policy for the automatic cancellation of all medication orders when a patient undergoes surgery. Automatic drug orders shall otherwise be determined by the medical staff and stated in medical staff rules.

(8)   Specifications.

(a) Responsibility for specifications. The pharmacist in charge of the pharmacy, with the advice of the medical staff, shall be responsible for the quality, quantity and sources of supply of all medications.

(b) Formulary. The medical staff, with the cooperation of the staff or consulting pharmacist and the hospital's administrative staff, shall develop a drug formulary for use in the hospital and shall review and update the formulary at regular intervals.

(c) Medication stock. The pharmacy or drug room shall be adequately supplied with medications approved in the formulary.

Cr. Register, January, 1988, No. 385 , eff. 2-1-88; corrections in (1) (c) made under s. 13.93 (2m) (b) 7., Stats., Register, August, 2000, No. 536 ; CR 04-040 : renum. (1) (a) to be (1) (am), cr. (1) (a), am. (4) (a) Register November 2004 No. 587 , eff. 12-1-04.