Agency Procedure for Promulgation
Public hearings are required and will be held on January 19, February 8, and February 10, 2000.
The organizational unit responsible for the promulgation of the proposed rule is the DWD Unemployment Insurance Division.
Contact Information
Elaine Pridgen
Telephone: (608) 267-9403
Email: pridgel@dwd. state.wi.us
Workforce Development
Rule Submittal Date
On December 13, 1999, the Department of Workforce Development submitted a proposed rule to the Legislative Council Rules Clearinghouse.
Analysis
Statutory authority: ss. 66.293 and 103.49, Stats.
The proposed rule-making order affects chs. DWD 290 and 294, relating to prevailing wage rates.
Agency Procedure for Promulgation
A public hearing is required and will be held on Monday, January 24, 2000. The organizational unit responsible for the promulgation of the proposed rule is the DWD Equal Rights Division.
Contact Information
Elaine Pridgen
Telephone: (608) 267-9403
Email: pridgel@dwd. state.wi.us
N o t i c e S e c t i o n
Notice of Hearing
Pharmacy Examining Board
Notice is hereby given that pursuant to authority vested in the Pharmacy Examining Board in ss. 15.08 (5) (b), 227.11 (2) and 450.02 (3) (a), (b), (d) and (e), Stats., and interpreting s. 450.02 (3) (a), (b), (d) and (e), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to create s. Phar 7.09, relating to the automated dispensing of prescription drugs.
Hearing Information
January 12, 2000 1400 E. Washington Ave.
Wednesday Room 179A
9:30 A.M. Madison, Wisconsin
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Administrative Rules, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received by January 21, 2000 to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing
Statutes authorizing promulgation: ss. 15.08 (5) (b), 227.11 (2) and 450.02 (3) (a), (b), (d) and (e)
Statute interpreted: s. 450.02 (3) (a), (b), (d) and (e)
The objective of these rules is to establish minimum requirements for pharmacies and inpatient health care facilities that use automated systems, similar to vending machines, to store, package and dispense patient medications.
Technologies are available that mechanically dispense patient medications pursuant to prescription or medical orders. These systems also collect, control and maintain transactional information such as the identity of the individual accessing the system, the name, strength, dosage form and quantity of the drug accessed and the name of the patient for whom the drug is prescribed or ordered. This technology results in efficiencies over labor intensive pharmaceutical acts such as manually filling medication containers and labeling the containers. Such cost saving devices should be permitted in those settings in which there are adequate measures taken to assure the accuracy, accountability, security and patient confidentiality when the devices are utilized.
Accordingly, rules need to be developed defining minimum standards for assuring these systems are working properly by accurately dispensing patient medications; that only authorized and qualified personnel have access to them; that required records are maintained; and that procedures are in place to assure the security of the system and patient confidentiality.
Text Of Rule
SECTION 1. Phar 7.09 is created to read:
Phar 7.09 Automated dispensing systems. (1) In this section:
(a) “Automated dispensing system" means, but is not limited to, mechanical systems 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 sanitarium, but does not include community-based residential facilities.
(2) Automated dispensing systems may be utilized in licensed pharmacies, and inpatient health care facilities where legally permissible.
(3) Automated dispensing systems may only be used in inpatient health care facilities, where there is an established program of pharmaceutical care that ensures medication orders are reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy practice.
(4) The managing pharmacist shall be responsible for:
(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 while maintaining appropriate recordkeeping and security safeguards.
(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. Location of the automated equipment.
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) Documentation as to type of equipment, serial numbers, content, policies and procedures, and location shall be maintained on-site in the pharmacy. The documentation may include, but is not limited to, the following:
1. Name and address of the pharmacy or inpatient health care facility where the automated dispensing service is being used.
2. Manufacturer's name and model.
3. Description of how the device is used.
4. Quality assurance procedures to determine continued appropriate use of the automated device.
5. Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access and malfunction.
(b) All policies and procedures shall be maintained in the pharmacy responsible for the system and, if the system is not located within the facility where the pharmacy is located, at the location where the system is being used.
(c) An automated dispensing system shall have adequate security systems and procedures, evidenced by written policies and procedures to:
1. Prevent unauthorized access to comply with federal and state laws.
2. Maintain patient confidentiality.
(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. Identity of 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) Access to and limits on access to the automated dispensing system shall be defined by policy and procedures and must comply with state and federal laws.
(f) 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.
(g) A record of medications stocked into an automated dispensing system shall be maintained and shall include identification of the person stocking and checking for accuracy.
(h) All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with federal and state law.
(i) All aspects of handling controlled substances shall meet the requirements of all state and federal law.
(j) The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, all in accordance with existing state and federal laws.
(k) The automated dispensing system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal laws.
