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 Wednesday, July 5, 2000 to be included in the record of rule-making proceedings.
Analysis Prepared by the Dept. of Regulation and Licensing
Statutes authorizing promulgation: ss. 15.08 (5) (b) and 227.11 (2)
Statute interpreted: s. 450.02 (3) (a) and (e)
Rules of the Pharmacy Examining Board identify in s. Phar 7.01 (1) (e) that prescription drugs may be delivered by an agent of the pharmacist to a patient's residence where the delivery is accompanied by appropriate directions and an offer that consultation is available by contacting the pharmacist. The rule amendment proposed will expand the patient's options for choice in designating a location of delivery.
Section Phar 7.01 (1) (e) is amended to expand the exception for delivery of prescription drugs and will allow the patient to designate other locations for delivery in addition to the patient's residence. In the case of delivery to a location other than the patient's residence, the requirement to offer consultation is expanded to apply to any other location designated by the patient.
Text of Rule
SECTION 1. Phar 7.01 (1) (e) is amended to read:
Phar 7.01 (1) (e) Give the patient or agent appropriate consultation relative to the prescription except that prescriptions may be delivered by an agent of the pharmacist to a patient's residence or other locations designated by the patient if the delivery is accompanied by appropriate directions and an indication that consultation is available by contacting the pharmacist. The consultation requirement applies to original and renewal prescription orders and, except when prescriptions are delivered to a patient's residence or other location designated by the patient, is not satisfied by only offering to provide consultation.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: These rules would increase agency costs due to printing and postage costs for mailings for approximately 6,000 pharmacists. A copy of the rules and a cover letter would need to be mailed and associated with this mailing would be approximately $15,000. This cost to print and mail each rule is estimated at $2.50 multiplied by 6,000. This is a one-time cost.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s. 227.114 (1) (a), Stats.
Copies of Rule and Contact Information
Copies of this proposed rule are available without cost upon request to:
Pamela Haack
Telephone (608) 266-0495
Dept. of Regulation and Licensing
Office of Administrative Rules
1400 East Washington Ave., Room 171
P.O. Box 8935
Madison, WI 53708
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), 450.02 (2), (3) (a) and (d) and 450.11 (3), 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 7.015, relating to delegation of duties by a pharmacist.
Hearing Information
The hearing will be held as follows:
Date and Time Location
June 14, 2000 Room 179A
Wednesday 1400 East Washington Ave.
9:15 a.m. MADISON, WI
Written Comments
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 Wednesday, July 5, 2000 to be included in the record of rule-making proceedings.
Analysis Prepared by the Dept. of Regulation and Licensing
Statutes authorizing promulgation: ss. 15.08 (5) (b), 227.11 (2), 450.02 (2), (3) (a) and (d) and 450.11 (3)
Statute interpreted: s. 450.02 (3) (a), (b), (d) and (e)
Rules of the Pharmacy Examining Board identify in s. Phar 7.01 that non-pharmacist employees may be assigned duties by a pharmacist relating to receiving prescriptions, preparing and dispensing drugs. The rules proposed will more specifically define the responsibilities of a pharmacist who delegates duties and describe the types of duties related to compounding and delivering drugs that may be delegated.
Section Phar 7.015 is created to define a pharmacy technician as a non-pharmacist or non-pharmacist intern, who is under the immediate and direct supervision of the pharmacist. The functions of the pharmacy technician are technical and nonjudgmental. The technical dispensing functions which may be delegated to a pharmacy technician are listed, as well as those dispensing functions which may not be delegated to a pharmacy technician. The delegation of approved dispensing functions to a pharmacy technician by the pharmacist does not relieve the pharmacist of responsibility for the proper filling of the prescription order.
Text of Rule
SECTION 1. Phar 7.015 is created to read:
Phar 7.015 Pharmacy technicians. (1) As used in this section, “pharmacy technician" means a non-pharmacist or non-pharmacist intern who, under the immediate and direct supervision of the pharmacist, assists the pharmacist in the technical and nonjudgmental functions related to the practice of pharmacy in the processing of prescription orders and inventory management. “Pharmacy technician" does not include ancillary persons which include, but are not limited to, clerks, secretaries, cashiers or delivery persons, who may be present in the pharmacy.
(2) A pharmacist may delegate technical dispensing functions to a pharmacy technician, but only if the pharmacist is on site where delegated functions are performed. Technical dispensing functions include:
(a) Accepting written or electronic prescription orders of the prescribing practitioner or from the prescribing practitioner's agent.
(b) Accepting original oral prescription orders from the prescribing practitioner or prescribing practitioner's agent, if the conversation is recorded and listened to and verified by the pharmacist prior to dispensing.
(c) Requesting authorization for a refill from the prescribing practitioner.
(d) Accepting oral authorization for a refill from the prescribing practitioner or prescribing practitioner's agent, provided there are no changes to the original prescription order.
(e) Accepting a request from a patient to refill a prescription.
(f) Obtaining and entering patient or prescription data into the patient information system.
(g) Preparing a prescription label.
(h) Retrieving medication from stock, counting or measuring medication, and placing the medication in its final container.
(i) Reconstituting prefabricated dosage forms.
(j) Compounding pharmaceuticals pursuant to written policies and procedures.
(k) Affixing a prescription label to its final container.
(L) Placing ancillary information on the prescription label.
(m) Possessing drug orders to suppliers for pharmaceuticals, receiving and checking orders.
(n) Prepackaging and labeling drugs for dispensing by a pharmacist.
(o) Preparing unit dose carts for final review by a pharmacist.
(p) Retrieving and transporting stock medication to and from approved areas.
(q) Other technical functions that do not require the professional judgment of a pharmacist.
(3) A pharmacy technician shall not do any of the following:
(a) Provide the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order.
(b) Perform any of the following tasks:
1. Participate in final drug utilization reviews.
2. Make independent therapeutic alternate drug selections.
3. Participate in final drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.
4. Perform any act necessary to be a managing pharmacist.
5. Administer any prescribed drug products, devices or vaccines.
(c) Provide patient counseling, consultation, or patient specific judgment such as interpreting or applying information, including advice relating to therapeutic values, potential hazards and uses.
(4) The pharmacist shall provide the final verification for the accuracy, validity, completeness, and appropriateness of the patient's prescription prior to the delivery of the prescription to the patient or the patient's representative.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: These rules would increase agency costs due to printing and postage costs for mailings for approximately 6,000 pharmacists. A copy of the rules and a cover letter would need to be mailed and associated with this mailing would be approximately $15,000. This cost to print and mail each rule is estimated at $2.50 multiplied by 6,000. This is a one-time cost.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on small businesses, as defined in s. 227.114 (1) (a), Stats.
Copies of Rule and Contact Information
Copies of this proposed rule are available without cost upon request to:
Pamela Haack
Telephone (608) 266-0495
