Phar 7.095(6)(a)1. 1. Have written policies and procedures for system operation, safety, security, accuracy and access.
Phar 7.095(6)(a)2. 2. Implement an on-going quality assurance program that monitors performance that includes the number of prescriptions dispensed per month, number of medication errors documented, loss or diversion of inventory, and documentation of remedial training to prevent future errors.
Phar 7.095(6)(a)3. 3. Visit the remote dispensing site at least monthly to conduct controlled substance inventory, to ensure written policies and procedures are being followed, and to ensure that remote dispensing site personnel comply with all federal and state laws regulating the practice of pharmacy.
Phar 7.095(6)(a)4. 4. Retain documentation of the monthly inspection visits at the remote dispensing site for 2 years.
Phar 7.095(6)(b) (b) The managing pharmacist at the supervising pharmacy is responsible for all remote dispensing sites connected to the supervising pharmacy.
Phar 7.095(7) (7)Requirements for pharmacy technicians and interns. Pharmacy technicians and interns employed at a remote dispensing site shall satisfy all of the following requirements:
Phar 7.095(7)(a) (a) Be 18 years of age or older.
Phar 7.095(7)(b) (b) Be a high school graduate or have equivalent education.
Phar 7.095(7)(c) (c) Have completed 1500 hours of work as a technician within the 3 years prior to the date of employment at the remote dispensing site or completed a training program approved by the board.
Phar 7.095 History History: CR 09-099: cr. Register March 2010 No. 651, eff. 4-1-10.
Phar 7.10 Phar 7.10 Administration of drug products and devices other than vaccines.
Phar 7.10(1) (1) In this section, “course of study” means one or more classes, workshops, seminars, or continuing education programs.
Phar 7.10(2) (2)A pharmacist may administer a drug product, as defined in s. 450.01 (11), Stats., or device, as defined in s. 450.01 (6), Stats. After the pharmacist administers a prescribed drug product or device, the pharmacist, a person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., or the pharmacist's agent shall notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner.
Phar 7.10(3) (3)A pharmacist may not administer by injection a prescribed drug product or device unless the pharmacist has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board.
Phar 7.10(4) (4)A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., may not administer a prescribed drug product or device unless the person satisfies all of the following:
Phar 7.10(4)(a) (a) Successfully completes a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board.
Phar 7.10(4)(b) (b) Administers the prescribed drug product or device only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council of Pharmacy Education or the board.
Phar 7.10(4)(c) (c) After administering the prescribed drug product or device, notifies the prescribing practitioner or enters the information in a patient record system shared by the prescribing practitioner.
Phar 7.10(5) (5)The board may approve courses of study which meet criteria substantially equivalent to criteria used by the Accreditation Council for Pharmacy Education.
Phar 7.10(6) (6)A course of study and training in administration technique shall include all of the following topics:
Phar 7.10(6)(a) (a) Safe injection practices to prevent infections.
Phar 7.10(6)(b) (b) Anatomy.
Phar 7.10(6)(c) (c) Proper injection techniques.
Phar 7.10(6)(d) (d) The five rights of administration including right patient, right drug, right dose, right route, and right time.
Phar 7.10(6)(e) (e) Patient reassessment after administration including signs and symptoms of adverse drug reactions.
Phar 7.10(6)(f) (f) Best practices in documentation of the medication administration.
Phar 7.10(7) (7)This section does not apply to the administration of vaccines.
Phar 7.10 Note Note: To administer a vaccine a pharmacist must meet the requirements in s. 450.035, Stats.
Phar 7.10 History History: Cr. Register, December, 1999, No. 528, eff. 1-1-00; CR 14-023: am. (1) Register August 2014 No. 704, eff. 9-1-14; CR 16-079: r. and recr., Register August 2017 No. 740, eff. 9-1-17; correction in (2) made under s. 35.17, Stats., Register August 2017 No. 740.
Phar 7.12 Phar 7.12 Central fill pharmacy.
Phar 7.12(1)(1)In this section:
Phar 7.12(1)(a) (a) “Central fill pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription.
Phar 7.12(1)(b) (b) “Originating pharmacy" means a pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order.
Phar 7.12(2) (2)A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription order received by an originating pharmacy only pursuant to the following requirements:
Phar 7.12(2)(a) (a) The central fill pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law.
Phar 7.12(2)(b) (b) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number, for which it processes a request for the filling or refilling of a prescription order received by the originating pharmacy. The record shall be made available upon request for inspection by the board or its agent.
Phar 7.12(2)(c) (c) The central fill pharmacy and originating pharmacy maintain a written filling protocol delineating each pharmacy's assumption of responsibility for compliance with the prescription drug compounding and dispensing requirements of this chapter and ch. Phar 8.
Phar 7.12(2)(d) (d) The originating pharmacy shall remain responsible for compliance with the prescription drug compounding and dispensing requirements of this chapter and ch. Phar 8, and which are not assumed in writing by the central fill pharmacy pursuant to a written filling protocol.
Phar 7.12(2)(e) (e) The originating pharmacy shall at all times remain solely responsible to perform and comply with the requirements of s. Phar 7.01 (1) (e) and (em).
Phar 7.12(2)(f) (f) Unless the central fill pharmacy shares a common central processing unit with the originating pharmacy, it may not perform processing functions such as the medication profile record review of the patient, drug utilization review, refill authorizations, interventions and drug interactions.
Phar 7.12(2)(g) (g) The prescription label attached to the container shall contain the name and address of the originating pharmacy as the licensed facility from which the prescribed drug or device was dispensed for purposes of s. 450.11 (4) (a) 1., Stats. The date on which the prescription was dispensed for purposes of s. 450.11 (4) (a) 2., Stats., shall be the date on which the central fill pharmacy filled the prescription order.
Phar 7.12(2)(h) (h) The originating pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.
Phar 7.12(2)(i) (i) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill prescription orders for purposes of filing and recordkeeping as required by state and federal law.
Phar 7.12(2)(j) (j) In addition to meeting the other recordkeeping requirements required by state and federal law, the central fill pharmacy and originating pharmacy shall each maintain records to identify each of its pharmacists responsible for receiving and reviewing prescription orders and compounding and dispensing pursuant to a prescription order and track the prescription order during each step in the dispensing process.
Phar 7.12(2)(k) (k) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and insure compliance with this section.
Phar 7.12(2)(L) (L) The originating pharmacy shall provide the patient with the name and address of the central fill pharmacy and obtain consent as required by applicable state and federal law.
Phar 7.12 History History: CR 01-075: cr. Register November 2003 No. 575, eff. 12-1-03; CR 09-098: am. (2) (f) Register May 2010 No. 653, eff. 6-1-10.
Phar 7.20 Phar 7.20 Automated technology product verification.
Phar 7.20(1)(1)Definitions. In this section:
Phar 7.20(1)(a) (a) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.
Phar 7.20(1)(b) (b) “Supervising pharmacist” means the pharmacist licensed in this state who is responsible for the operations and outcomes of the product verification done by an automated technology.
Phar 7.20(2) (2)   Automated technology product verification qualifications. Product verification may be done only by an automated technology which meets all of the following:
Phar 7.20(2)(a) (a) Located within a licensed pharmacy.
Phar 7.20(2)(b) (b) Utilizes barcodes or another machine-readable technology to complete the product verification.
Phar 7.20(2)(c) (c) Validated by the following process:
Phar 7.20(2)(c)1. 1. The automated technology shall make a product verification for accuracy and correctness of a minimum of 2500 product verifications and achieve an accuracy rate of at least 99.8%.
Phar 7.20(2)(c)2. 2. A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.
Phar 7.20(2)(d) (d) Revalidated if the software is upgraded or any component of the automated technology responsible for the accuracy and correctness of the product verification is replaced or serviced outside of the manufacturer's standard maintenance recommendations.
Phar 7.20(3) (3)   Eligible product. The automated technology may do the product verification if the product meets all of the following:
Phar 7.20(3)(a) (a) Is dispensed in the original package from a manufacturer or if a licensed pharmacist has ensured that any repackaging results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and expiration or beyond use date.
Phar 7.20(3)(b) (b) Has a drug utilization review performed by a pharmacist prior to delivery.
Phar 7.20(3)(c) (c) Will be administered by an individual authorized to administer medications at the institution where the medication is administered.
Phar 7.20(4) (4)   Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the automated technology product verification which shall be made available to the board upon request.
Phar 7.20(5) (5)   Records.
Phar 7.20(5)(a)(a) Each pharmacy shall maintain for 5 years the following records:
Phar 7.20(5)(a)1. 1. All validation records of each automated technology that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
Phar 7.20(5)(a)2. 2. Documentation indicating acceptance of responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist and start and end dates of supervision.
Phar 7.20(5)(a)3. 3. Documentation of the completion of the manufacturer's recommended maintenance and quality assurance measures.
Phar 7.20(5)(a)4. 4. Documentation of the dates of all software upgrades.
Phar 7.20(5)(a)5. 5. Documentation of all service performed outside of the manufacturer's standard maintenance recommendations.
Phar 7.20(5)(b) (b) Records shall be made available to the board upon request.
Phar 7.20 History History: EmR1916: emerg. cr., eff. 10-3-19; CR 19-023: cr. Register February 2020 No. 770, eff. 3-1-20; correction in (2) (b) made under s. 35.17, Stats., Register February 2020 No. 770.
Phar 7.21 Phar 7.21 Delegate-check-delegate.
Phar 7.21(1)(1)Definitions. In this section:
Phar 7.21(1)(a) (a) “Delegate” means a person to whom the pharmacist has delegated the task of product verification.
Phar 7.21(1)(b) (b) “Delegate-check-delegate” means the process in which one delegate conducts the task of product verification of technical dispensing functions completed by an unlicensed individual. A delegate may not conduct product verification as part of the final check of their own product preparation.
Phar 7.21(1)(c) (c) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.
Phar 7.21(1)(d) (d) “Supervising pharmacist” means the pharmacist licensed in this state who is responsible for the operations and outcomes of product verification done by a delegate and ensuring for direct supervision of the delegate.
Phar 7.21(2) (2)   Delegate qualifications. A pharmacist may delegate the product verification of a prescription or chart order to a delegate who meets all of the following:
Phar 7.21(2)(a) (a) Is at least 18 years old.
Phar 7.21(2)(b) (b) Completed an accredited technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.
Phar 7.21(2)(c) (c) Completed a didactic and practical training curriculum approved by the supervising and managing pharmacist that includes training in all of the following:
Phar 7.21(2)(c)1. 1. Elements of correct product including all of the following:
Phar 7.21(2)(c)1.a. a. Drug name.
Phar 7.21(2)(c)1.b. b. Strength.
Phar 7.21(2)(c)1.c. c. Formulation.
Phar 7.21(2)(c)1.d. d. Expiration date.
Phar 7.21(2)(c)1.e. e. Beyond use date.
Phar 7.21(2)(c)2. 2. Common dispensing medication errors and concepts including all of the following:
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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.