Phar 7.20 Automated technology product verification (1) Definitions. In this section product verification means doing a check of the accuracy and correctness of the drug product and label requirements.
(2) Automated technology product verification qualifications. Automated technology may perform the product verification of a prescription which meets all of the following:
(a) Located within the licensed pharmacy.
(b) Utilizes barcodes or machine readable technology to complete the product verification.
(c) The automated technology shall be validated by the following process:
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%
2. A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.
(d) The automated technology shall be revalidated if the software is upgraded or any component of the automated technology responsible for the accuracy of the product verification is replaced or serviced outside of the manufacturer’s standard maintenance recommendations.
(3) Supervising pharmacist responsibilities. A supervising pharmacist, licensed in this state, shall be identified for each technology to be accountable for the operations and outcomes of the product verification checks. The supervising pharmacist is responsible for the product verification made by the automated technology.
(4) Eligible medications. The automated technology may do the product verification if the medications meet all of the following:
(a) Contained in a final package from a manufacturer or if packaged in the pharmacy a licensed pharmacist has ensured that the packaging process results in a final package that is labeled with the correct drug name, dose, strength, form, control or lot number, and beyond use date.
(b) A pharmacist performs the drug utilization review under Phar 7.03
(c) Administered by an individual authorized to administer medications at the institution where the medication is administered.
(5) 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.
(6) Records. (a) Each pharmacy shall maintain for 5 years the following records:
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.
2. Names of the supervising pharmacist including the start and end date of supervision responsibilities.
3. Documentation of managing pharmacist and supervising pharmacist of responsibilities.
4. Documentation of the completion of the manufacturer’s recommended maintenance and quality assurance measures.
5. Documentation of the dates of all software upgrades.
6. Documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.
(b) Records shall be made available to the board upon request.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ---------------------------------------------------------------------------------------------------------------------
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