Phar 7.055(2)(b)2. 2. The name and address of the patient, the name and address of the prescribing practitioner, and the name and quantity and dosage form of the drug product or device prescribed and the directions for use.
Phar 7.055(2)(b)3. 3. The date of issuance of the original prescription order.
Phar 7.055(2)(b)4. 4. The original number of refills authorized on the original prescription order.
Phar 7.055(2)(b)5. 5. The date of original dispensing if the prescription order has previously been dispensed.
Phar 7.055(2)(b)6. 6. The number of valid refills remaining and the date of the last refill.
Phar 7.055(2)(b)7. 7. The pharmacy's name, address, and the prescription order number from which the prescription order information was transferred.
Phar 7.055(2)(b)8. 8. The name of the pharmacist making the transfer.
Phar 7.055(2)(b)9. 9. The name, address and telephone number of the pharmacy from which the original prescription order was transferred if different than subd. 7.
Phar 7.055(3) (3)Controlled substances. The transfer of prescription order information for controlled substances for the purposes of refill dispensing is permissible pursuant to the following requirements:
Phar 7.055(3)(a) (a) The transfer of prescription order information is permissible only on a one time basis unless a computer system meeting the requirements of sub. (4) is used.
Phar 7.055(3)(b) (b) If a computer system meeting the requirements of sub. (4) is used, a transfer of prescription order information for the purposes of refill dispensing is limited to the number of authorized refills.
Phar 7.055(3)(c) (c) Unless a computer system meeting the requirements of sub. (4) is used, the pharmacist making the transfer shall record in writing the following information:
Phar 7.055(3)(c)1. 1. The word “VOID" is written on the face of the invalidated prescription order.
Phar 7.055(3)(c)2. 2. The name, address and DEA registration number of the pharmacy to which it was transferred, the name of the pharmacist receiving the prescription order and the date and the name of the pharmacist transferring the information are recorded on the reverse side of the invalidated prescription order.
Phar 7.055(3)(d) (d) Unless a computer system meeting the requirements of sub. (4) is used, the pharmacist receiving the transferred prescription order information shall record in writing the following information:
Phar 7.055(3)(d)1. 1. The word “TRANSFER" on the face of the transferred prescription order.
Phar 7.055(3)(d)2. 2. The name and address of the patient, the name, address and DEA number of the prescribing practitioner, and the name and quantity and dosage form of the drug product or device prescribed and the directions for use.
Phar 7.055(3)(d)3. 3. The date of issuance of the original prescription order.
Phar 7.055(3)(d)4. 4. The original number of refills authorized on the original prescription order.
Phar 7.055(3)(d)5. 5. The date of original dispensing.
Phar 7.055(3)(d)6. 6. The number of valid refills remaining and the dates and locations of previous refills, if applicable.
Phar 7.055(3)(d)7. 7. The name, address, telephone number, DEA registration number and prescription order number of the pharmacy from which the prescription order information was transferred if different from the pharmacy from which the prescription order was originally dispensed.
Phar 7.055(3)(d)8. 8. The name of the pharmacist making the transfer.
Phar 7.055(3)(d)9. 9. The name, address, telephone number, DEA registration number and prescription order number of the pharmacy from which the prescription order was originally dispensed.
Phar 7.055(4) (4)Use of computer system. A computer system used for transferring prescription order information shall, in addition to meeting the requirements of s. Phar 7.05 (1) (a) and (b), contain a common central processing unit electronically sharing a real-time, on-line database to which both the transferring and receiving pharmacy have access.
Phar 7.055 History History: CR 05-078: cr. Register January 2006 No. 601, eff. 2-1-06.
Phar 7.055 Note Note: See the table of Appellate Court Citations for Wisconsin appellate cases citing s. Phar 7.055.
Phar 7.065 Phar 7.065 Answering machines in pharmacies. Oral prescription orders may be received at a pharmacy via a telephone answering device and dispensed by the pharmacist if the voice of the physician or physician's agent is known to the pharmacist, and provided other requirements of reducing the prescription order to writing, labeling and filing are met.
Phar 7.065 History History: Cr. Register, December, 1998, No. 516, eff. 1-1-99.
Phar 7.07 Phar 7.07 Medication profile record system.
Phar 7.07(1)(1)An individual medication profile record system shall be maintained in all pharmacies for persons for whom prescriptions, original or renewal, are dispensed for outpatient use. The system shall be capable of permitting the retrieval of information. The system need not be limited to individual medication profile records.
Phar 7.07(2) (2)The following minimum information shall be retrievable:
Phar 7.07(2)(a) (a) Patient name, or other identifying information.
Phar 7.07(2)(b) (b) Address of the patient.
Phar 7.07(2)(c) (c) Birth date of the patient if obtainable.
Phar 7.07(2)(d) (d) Name of the drug product dispensed.
Phar 7.07(2)(e) (e) Strength of the drug product dispensed.
Phar 7.07(2)(f) (f) Dosage form of the drug product dispensed.
Phar 7.07(2)(g) (g) Quantity of the drug product dispensed.
Phar 7.07(2)(h) (h) Directions for use.
Phar 7.07(2)(i) (i) Retrieval designation assigned to the prescription order.
Phar 7.07(2)(j) (j) Date of all instances of dispensing, for original and renewal prescriptions.
Phar 7.07(2)(k) (k) Practitioner identification.
Phar 7.07 Note Note: This subsection incorporates renewal dispensing information required by federal law (21 CFR 1306.22) and state law (s. 450.11 (5), Stats.).
Phar 7.07(3) (3)The pharmacist shall be responsible for attempting to ascertain and record any patient allergies, adverse drug reactions, drug idiosyncrasies, and any chronic conditions which may affect drug therapy as communicated by the patient or agent of the patient. If none, this should be indicated.
Phar 7.07(4) (4)At the time a prescription order is reviewed by the pharmacist for dispensing, the pharmacist shall review the medication profile record of the patient for the previously dispensed medication history and shall determine whether the prescription order presented should be dispensed.
Phar 7.07(5) (5)Medication profile records, if used as the only documentation of renewal dispensing, shall be maintained for a period of not less than 5 years following the date of the last entry. If the profile records are not used as the only documentation of renewal dispensing they shall be maintained for a period of not less than 1 year from the date of the last entry.
Phar 7.07 History History: Cr. Register, January, 1989, No. 397, eff. 2-1-89; renum. from Phar 7.08, Register, August, 1991, No. 428, eff. 9-1-91; am. (1), Register, December, 1998, No. 516, eff. 1-1-99.
Phar 7.08 Phar 7.08 Prescription orders transmitted electronically.
Phar 7.08(1)(1)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.
Phar 7.08(2) (2)A pharmacist may dispense a prescription pursuant to a prescription order transmitted electronically, if the pharmacist assures the prescription order does all of the following:
Phar 7.08(2)(a) (a) 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.
Phar 7.08(2)(b) (b) Identifies the individual sender's name and telephone number for oral confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission.
Phar 7.08(2)(c) (c) Is designated “electronically transmitted prescription", or with similar words or abbreviations to that effect.
Phar 7.08(2)(d) (d) Contains all other information that is required in a prescription order.
Phar 7.08(3) (3)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.
Phar 7.08(4) (4)Any visual or electronic document received in connection with an electronically transmitted prescription order shall be accessible only within the professional service area of the pharmacy to protect patient confidentiality and assure security.
Phar 7.08(5) (5)A pharmacist who receives a prescription order electronically shall ensure the security, integrity and confidentiality of the prescription order and any information contained in the order. To maintain the confidentiality of patient records, the electronic system shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. Once the prescription has been dispensed, any alterations in prescription order drug data shall be documented including the identification of the pharmacist responsible for the alteration.
Phar 7.08(6) (6)Access to the electronic mail system for the receipt of prescription orders electronically may only be acquired by use of a password or passwords, known only to individuals authorized to access the system.
Phar 7.08(7) (7)A pharmacist may not use any electronic device to circumvent his or her responsibilities with regard to documenting, authenticating and verifying prescription orders or in order to circumvent other pharmacy laws.
Phar 7.08 History History: Cr. Register, November, 1999, No. 527, eff. 12-1-99; correction in (1) made under s. 13.92 (4) (b) 7., Stats., Register February 2017 No. 734.
Phar 7.09 Phar 7.09 Automated dispensing systems.
Phar 7.09(1)(1)In this section:
Phar 7.09(1)(a) (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.
Phar 7.09(1)(b) (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.
Phar 7.09(2) (2)An automated dispensing system may be used in a community pharmacy, as provided in this section.
Phar 7.09(3) (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.
Phar 7.09(4) (4)The managing pharmacist of a community pharmacy or an institutional pharmacy is responsible for all of the following:
Phar 7.09(4)(a) (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).
Phar 7.09(4)(b) (b) Implementing an ongoing quality assurance program that monitors performance of the automated dispensing system, which is evidenced by written policies and procedures.
Phar 7.09(4)(c) (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:
Phar 7.09(4)(c)1. 1. Name and address of the pharmacy.
Phar 7.09(4)(c)2. 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.
Phar 7.09(4)(c)3. 3. Identification of the managing pharmacist.
Phar 7.09(4)(d) (d) Assigning, discontinuing or changing personnel access to the system.
Phar 7.09(4)(e) (e) Assuring that access to the medications comply with state and federal laws.
Phar 7.09(4)(f) (f) Assuring that the automated dispensing system is stocked accurately and in accordance with established written policies and procedures.
Phar 7.09(5) (5)An automated dispensing system shall comply with the following provisions:
Phar 7.09(5)(a) (a) A pharmacy shall maintain on-site the following documentation relating to an automated dispensing system:
Phar 7.09(5)(a)1. 1. Name and address of the pharmacy or inpatient health care facility where the system is being used.
Phar 7.09(5)(a)2. 2. The system manufacturer's name, model and serial number.
Phar 7.09(5)(a)3. 3. Description of how the system is used.
Phar 7.09(5)(a)4. 4. Written quality assurance procedures to determine continued appropriate use of the system.
Phar 7.09(5)(a)5. 5. Except as required pursuant to par. (b), written policies and procedures for system operation, safety, security, accuracy, access and malfunction.
Phar 7.09(5)(b) (b) All written policies and procedures shall be maintained in the pharmacy responsible for the automated dispensing system.
Phar 7.09(5)(c) (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.
Phar 7.09(5)(d) (d) Records and data kept by the automated dispensing system shall meet the following requirements:
Phar 7.09(5)(d)1. 1. All events involving the contents of the automated dispensing systems must be recorded electronically.
Phar 7.09(5)(d)2. 2. Records shall be maintained by the pharmacy and be available to the board. Records shall include:
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.