Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received at or before the public hearing to be held on December 17, 2019 to be included in the record of rule-making proceedings. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Chapter 7 is repealed and recreated to read:
PHARMACY PRACTICE
Subchapter I — General
7.01 Definitions. In this chapter:
(1) “Managing pharmacist” means a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy, and who is personally in full and actual charge of the pharmacy and personnel.
(2) “NDC” means national drug code.
(3) “Repackaging for stock” means transferring a non-sterile drug product from the stock container in which it was distributed by the original manufacturer and placing it into a different stock container as a source for subsequent prescription dispensing without further manipulation of the drug.
(4) “Standing order” means an order transmitted electronically or in writing by a practitioner for a drug or device for multiple patients or for one or more groups of patients.
7.02 Prescription (1) Requirements. A prescription drug order shall include all of the following:
1. Date of issue.
2. First and last name and address of the practitioner.
3. Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.
4. Name, strength, form and quantity of the drug product or device.
5. Directions for use of the drug product or device.
6. Refills, if any.
8. If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school. 9. If prescription is issued under s. 255.07 (2), the name and address of the authorized entity or individual. 10. Practitioner’s written signature, or electronic or digital signature.
(2) Standing order. (a) A prescription pursuant to a standing order shall include all of the following:
1. Date of issue.
2. First and last name and address of the practitioner.
3. Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.
4. Name, strength, form and quantity of the drug product or device.
5. Directions for use of the drug product or device.
6. Refills, if any.
8. If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school. 9. If prescription is issued under s. 255.07 (2), the name and address of the authorized entity or individual. 10. Indicate the prescription is pursuant to a standing order.
(b) A copy of the standing order shall be retained under s. Phar 7.11 (1). (3) electronic prescription. (a) Except as provided in s. 89.068 (1) (c) 4., Stats., and as otherwise prohibited by law, prescription orders may be accepted and dispensed if they have been transmitted electronically from a practitioner or his or her designated agent to a pharmacy via computer modem or other similar electronic device. Prescription orders transmitted by facsimile machine are not considered electronic prescription orders; but rather, written prescription orders. (b) A pharmacist may dispense a prescription pursuant to a prescription order transmitted electronically, if the pharmacist assures the prescription order meets all of the following:
1. Was sent only to the pharmacy of the patient’s choice and only at the option of the patient, with no intervening person or third-party having access to the prescription order other than to forward it to the pharmacy.
2. Contains all other information that is required in a prescription order.
(c) The prescribing practitioner’s electronic signature, or other secure method of validation shall be provided with a prescription order electronically transmitted via computer modem or other similar electronic device.
(4) Verbal prescription. Verbal prescription orders may be received at a pharmacy via a telephone answering device or voice mail. The oral prescription shall be reduced to writing or entered into a computer system under s. Phar 7.11 (2) and the prescription record shall indicate the pharmacist responsible for the accuracy of the prescription information. (5) Alterations. Any alterations that modify the original intent of a prescription shall be documented including the identification of the pharmacist responsible for the alteration and the practitioner or practitioner’s delegate who authorized the alteration.
7.03 Drug utilization review. (1) A pharmacist shall complete a drug utilization review by reviewing the patient record prior to dispensing each prescription drug order for all of the following:
(a) Known allergies.
(b) Rational therapy.
(c) Contraindications.
(d) Reasonable dose, duration of use, and route of administration, considering the age, gender, and other patient factors.
(e) Reasonable directions for use.
(f) Potential or actual adverse drug reactions.
(g) Drug interactions with food, beverages, other drugs or medical conditions.
(h) Therapeutic duplication.
(i) Reasonable utilization and optimum therapeutic outcomes.
(j) Potential abuse or misuse.
(2) Upon recognizing a concern with any of the items in sub. (1) (a) to (j), the pharmacist shall take steps to mitigate or resolve the problem.
7.04 Transferring prescription order information. (1) General requirements. A transfer of prescription order information between pharmacies licensed in this state or another state, for the purpose of original or refill dispensing of non-controlled substances and refills of controlled substances, may occur if all of the following conditions are satisfied:
(a) The transfer of prescription order information is communicated in one of the following ways:
1. Oral communication between two pharmacists.
2. Electronically or by facsimile machine between the two pharmacies.
(b) A transfer of prescription information orally shall be reduced to writing or entered into a computer system under s. Phar 7.11 (2) and the prescription record shall indicate the pharmacist responsible for the accuracy of the prescription information. (2) Non-controlled substances. The transfer of prescription order information for non-controlled substances for the purposes of original or refill dispensing is permissible pursuant to the following requirements:
(a) The prescription record of the transferred prescription shall include the following information:
1. The word “VOID" is written on the face of the invalidated prescription order or recorded in a similar manner to “VOID" on a prescription order in a computer system meeting the requirements of s. Phar 7.11 (2) (a). 2. The name and address of the pharmacy to which it was transferred, the date and the first and last name of the pharmacist transferring the information are recorded on the invalidated prescription order or in a computer system meeting the requirements s. Phar 7.11 (2) (a). (b) Unless a computer system meeting the requirements in sub. (4) is used, the transferred prescription order information shall include the following:
1. The word “TRANSFER" on the face of the transferred prescription order or recorded in a similar manner in a computer system.
2. The first and last name and address of the patient, the first and last name and address of the prescribing practitioner.
3. Name, strength, form and quantity of the drug product or device prescribed and the directions for use.
4. The date of issuance of the original prescription order, the original prescription order number, the original number of refills authorized on the original prescription order and the date of original dispensing if the prescription order has previously been dispensed.
5. The number of valid refills or total quantity remaining and the date of the last refill.
6. The pharmacy’s name and address from which the prescription order information was transferred.
7. The first and last name of the pharmacist transferring and receiving the prescription order information.
(3) Controlled substances. The transfer of original prescription information for a controlled substance listed in Schedule III – IV shall meet the following requirements:
(a) The transfer of prescription order information is permissible only on a one-time basis. Pharmacies electronically sharing a computer system meeting the requirements of sub. (4) may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
(b) The transfer shall be communicated directly between 2 licensed pharmacists.
