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Phar 7.10 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.11 Phar 7.11 Pharmacy records.
Phar 7.11(1)(1)General. Pharmacy records shall be maintained for a minimum period of 5 years unless otherwise specified in state or federal law.
Phar 7.11(2) (2)Prescription records.
Phar 7.11(2)(a) (a) A computerized system may be used for maintaining a record, as required under this section, of prescription dispensing and transfers of prescription order information for the purposes of original or refill dispensing if the system is:
Phar 7.11(2)(a)1. 1. Capable of producing a printout of any prescription data which the user pharmacy is responsible for maintaining.
Phar 7.11(2)(a)2. 2. Equipped with an auxiliary procedure which, during periods of down-time, shall be used for documentation of prescription dispensing. The auxiliary procedure shall ensure that prescription refills are authorized by the original prescription order, that the maximum number of prescription refills has not been exceeded and that all of the appropriate data are retained for on-line entry as soon as the computer system is again available for use.
Phar 7.11(2)(b) (b) A record of all prescriptions dispensed shall be maintained for a minimum period of 5 years after the date of the last refill.
Phar 7.11(2)(c) (c) All systems used for maintaining a record of any prescription dispensing shall contain all items required in the medical profile record system.
Phar 7.11(2)(d) (d) A paper prescription for non-controlled substances may be scanned and stored electronically in the computer system under par. (a). For purposes of this chapter, the prescription becomes an electronic prescription.
Phar 7.11(3) (3)Medication profile record system.
Phar 7.11(3)(a) (a) An individual medication profile record system shall be maintained in all pharmacies for humans and non-humans for whom prescriptions, original or refill, are dispensed. The system shall be capable of permitting the retrieval of information.
Phar 7.11(3)(b) (b) The following minimum information shall be retrievable:
Phar 7.11(3)(b)1. 1. Patient's first and last name, or if not human, name of pet, species and last name of owner.
Phar 7.11(3)(b)2. 2. Address of the patient.
Phar 7.11(3)(b)3. 3. Birth date of the patient or, if not human, birth date of the owner.
Phar 7.11(3)(b)4. 4. Name of the drug product or device dispensed.
Phar 7.11(3)(b)5. 5. Strength of the drug product or device dispensed.
Phar 7.11(3)(b)6. 6. Form of the drug product or device dispensed.
Phar 7.11(3)(b)7. 7. Quantity of the drug product or device prescribed, dispensed and remaining.
Phar 7.11(3)(b)8. 8. Number of refills prescribed.
Phar 7.11(3)(b)9. 9. Directions for use.
Phar 7.11(3)(b)10. 10. Prescription order number.
Phar 7.11(3)(b)11. 11. Original date of issue.
Phar 7.11(3)(b)12. 12. Dates of dispensing.
Phar 7.11(3)(b)13. 13. Prescriber's first and last name.
Phar 7.11(3)(c) (c) 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 7.11(3)(d) (d) Medication profile records shall be maintained for a minimum period of 5 years following the date of the last dispensing.
Phar 7.11 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1), (3) (b) 3. made under s. 35.17, Stats., Register December 2020 No. 780.
Phar 7.12 Phar 7.12 Delegation by a physician. The pharmacist shall document the delegation by a physician under s. 450.033, Stats. The delegated act may not be started prior to the documentation. The documentation shall be maintained for a minimum of 5 years after the last delegated act under that delegation.
Phar 7.12 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction made under s. 35.17, Stats., Register December 2020 No. 780.
Phar 7.13 Phar 7.13 Administration of drug products and devices other than vaccines.
Phar 7.13(1)(1)In this section, “course of study” means one or more classes, workshops, seminars, or continuing education programs.
Phar 7.13(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 7.13(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 7.13(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 7.13(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 7.13(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 7.13(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 7.13(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 7.13(6) (6) A course of study and training in administration technique shall include all of the following topics:
Phar 7.13(6)(a) (a) Safe injection practices to prevent infections.
Phar 7.13(6)(b) (b) Anatomy.
Phar 7.13(6)(c) (c) Proper injection techniques.
Phar 7.13(6)(d) (d) The 5 rights of administration including right patient, right drug, right dose, right route, and right time.
Phar 7.13(6)(e) (e) Patient reassessment after administration including signs and symptoms of adverse drug reactions.
Phar 7.13(6)(f) (f) Best practices in documentation of the medication administration.
Phar 7.13(7) (7) This section does not apply to the administration of vaccines.
Phar 7.13 Note Note: To administer a vaccine a pharmacist must meet the requirements in s. 450.035, Stats.
Phar 7.13 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (6) (d) made under s. 35.17, Stats., Register December 2020 No. 780.
Phar 7.14 Phar 7.14 Delegate-check-delegate.
Phar 7.14(1)(1)Definitions. In this section:
Phar 7.14(1)(a) (a) “Delegate” means a person to whom the pharmacist has delegated the task of product verification.
Phar 7.14(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 7.14(1)(c) (c) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, as part of the final check and ensure the product has not reached its expiration or beyond use date.
Phar 7.14(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 7.14(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 7.14(2)(a) (a) Is at least 18 years old.
Phar 7.14(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 7.14(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 7.14(2)(c)1. 1. Elements of correct product including all of the following:
Phar 7.14(2)(c)1.a. a. Drug name.
Phar 7.14(2)(c)1.b. b. Strength.
Phar 7.14(2)(c)1.c. c. Formulation.
Phar 7.14(2)(c)1.d. d. Expiration date.
Phar 7.14(2)(c)1.e. e. Beyond use date.
Phar 7.14(2)(c)2. 2. Common dispensing medication errors and concepts including all of the following:
Phar 7.14(2)(c)2.a. a. Wrong medication.
Phar 7.14(2)(c)2.b. b. Wrong strength.
Phar 7.14(2)(c)2.c. c. Wrong formulation.
Phar 7.14(2)(c)2.d. d. Extra or insufficient quantity.
Phar 7.14(2)(c)2.e. e. Omitted medications if utilizing unit dose or compliance packaging.
Phar 7.14(2)(c)2.f. f. Expired medication.
Phar 7.14(2)(c)2.g. g. Look-alike or sound-alike errors.
Phar 7.14(2)(c)2.h. h. High-alert medications.
Phar 7.14(2)(c)3. 3. Eligible medications for delegate-check-delegate.
Phar 7.14(2)(c)4. 4. Organizational policies and procedures on reporting of medication errors.
Phar 7.14(2)(c)5. 5. Overview of the medication use process including all of the following:
Phar 7.14(2)(c)5.a. a. Procurement.
Phar 7.14(2)(c)5.b. b. Ordering.
Phar 7.14(2)(c)5.c. c. Dispensing.
Phar 7.14(2)(c)5.d. d. Administration.
Phar 7.14(2)(c)5.e. e. Monitoring.
Phar 7.14(2)(c)6. 6. A practical training designed to assess the competency of the delegate prior to starting the validation process. The practical training shall include simulation of at least 2 occurrences of each of the following:
Phar 7.14(2)(c)6.a. a. Wrong drug.
Phar 7.14(2)(c)6.b. b. Wrong strength.
Phar 7.14(2)(c)6.c. c. Wrong formulation.
Phar 7.14(2)(c)6.d. d. Omitted medication, if utilizing unit dose or compliance packaging.
Phar 7.14(2)(d) (d) Completed the following validation process:
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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.