Section 7.09. Automated dispensing systems.

 

(1)  In this section:

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

(b) "Inpatient health care facility" means any hospital, nursing home, county home, county mental hospital, or tuberculosis sanitorium, but does not include community-based residential facilities.

(2)  An automated dispensing system may be used in a community pharmacy, as provided in this section.

(3)  An automated dispensing system may be used as provided in this section by an institutional pharmacy serving an inpatient health care facility, that has an established program of receiving prescription orders, and dispensing and returning prescription medications consistent with accepted inpatient institutional drug distribution systems. An automated dispensing system used by an institutional pharmacy shall only be located in that institutional pharmacy or within the inpatient health care facility.

(4)  The managing pharmacist of a community pharmacy or an institutional pharmacy is responsible for all of the following:

(a) Assuring that the automated dispensing system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed and complying with the recordkeeping and security safeguards pursuant to sub. (5) .

(b) Implementing an ongoing quality assurance program that monitors performance of the automated dispensing system, which is evidenced by written policies and procedures.

(c) Providing the board with prior written notice of the installation or removal of an automated dispensing system. The notice provided shall include, but is not limited to the:

1. Name and address of the pharmacy.

2. Initial location of the automated dispensing system. The automated dispensing system may thereafter be relocated within the pharmacy or inpatient health care facility without providing subsequent notification to the board.

3. Identification of the managing pharmacist.

(d) Assigning, discontinuing or changing personnel access to the system.

(e) Assuring that access to the medications comply with state and federal laws.

(f) Assuring that the automated dispensing system is stocked accurately and in accordance with established written policies and procedures.

(5)  An automated dispensing system shall comply with the following provisions:

(a) A pharmacy shall maintain on-site the following documentation relating to an automated dispensing system:

1. Name and address of the pharmacy or inpatient health care facility where the system is being used.

2. The system manufacturer's name, model and serial number.

3. Description of how the system is used.

4. Written quality assurance procedures to determine continued appropriate use of the system.

5. Except as required pursuant to par. (b) , written policies and procedures for system operation, safety, security, accuracy, access and malfunction.

(b) All written policies and procedures shall be maintained in the pharmacy responsible for the automated dispensing system.

(c) An automated dispensing system shall have adequate security systems and procedures, evidenced by written policies and procedures to prevent unauthorized access to maintain patient confidentiality and to comply with federal and state laws.

(d) Records and data kept by the automated dispensing system shall meet the following requirements:

1. All events involving the contents of the automated dispensing systems must be recorded electronically.

2. Records shall be maintained by the pharmacy and be available to the board. Records shall include:

a. The time and location of the system accessed.

b. Identification of the individual accessing the system.

c. Type of transaction.

d. Name, strength, dosage form and quantity of the drug accessed.

e. Name of the patient for whom the drug was ordered.

f. Such additional information as the managing pharmacist may deem necessary.

(e) The stocking of all medications in the automated dispensing system shall be accomplished by qualified personnel under no less than the general supervision of a licensed pharmacist; except that when an automated dispensing system is located within a pharmacy the supervision must be direct.

(f) A record of medications stocked into an automated dispensing system shall be maintained for 5 years and shall include identification of the person stocking and pharmacist checking for accuracy.

(g) All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with state and federal law.

(h) All aspects of handling controlled substances shall meet the requirements of all state and federal law.

(i) The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, in accordance with state and federal law.

(j) The automated dispensing system shall provide a mechanism for securing and accounting for medication returned to the system and accounting for wasted medications in accordance with state and federal law.

Cr. Register, October, 2000, No. 538 , eff. 11-1-00.