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Minnesota News: Certification and Quality Assurance
Reprinted from the July 2007 Minnesota Board of Pharmacy Newsletter.
Pharmacists are reminded that there is a difference between certification and quality assurance, and that both are required per Minnesota Rules. Certification is the process by which one pharmacist or pharmacist-intern takes responsibility for ensuring that a prescription has been accurately filled and that a prospective drug utilization review has been completed. In certifying the completed prescription, the pharmacist or pharmacist-intern must:
A. check the original labeled container from which the medication was withdrawn;
B. check the labeling on the container in which the drug is to be dispensed;
C. check the contents of the container in which the drug is to be dispensed and the appearance of the total product;
D. review the patient’s medication profile for purposes of conducting a prospective drug review and checking the accuracy of the addition to the profile of the medication dispensed; and
E. initial the prescription or other permanently maintained record.
Pharmacists using automated medication management dispensing systems must develop written policies and procedures, which provide that all certification steps are performed and documented before the medication is distributed to the patient. These policies and procedures must be available for inspection by the Board.
The Board’s quality assurance rule requires pharmacies to have a procedure in place to ensure that prescription data is correctly entered into computers. A pharmacy must implement a written quality assurance plan that includes the pharmacist comparing the original written prescription or an image of the original written prescription, to the information entered into the computer, and documenting the completion and accuracy of this comparison with the date and initials of the pharmacist completing the task. This process must not occur prior to two hours after the prescription has been initially certified, unless it is completed by a second individual pharmacist as soon as possible after the initial certification has occurred. The process must be completed within 72 hours.
As an alternative, hospitals providing inpatient pharmacy services may elect instead to develop a plan to provide safeguards against errors being made and perpetuated due to inaccurate prescription data being entered into the pharmacy’s computer. This written quality assurance plan must be made available to the Board surveyors upon request.
