Section 657.21.4. Automated data processing system.

An automated data processing system may be used, subject to the requirements contained in this rule, for the storage and retrieval of original and refill information for prescription orders.

       21.4(1) On-line retrieval of prescription information. Any computerized system shall provide on-line retrieval (via CRT display and hard-copy printout) of original prescription order information and refill history information. This shall include, but is not limited to, the following:

        a.           Original prescription number;

        b.           Date of issuance of the original prescription order by the practitioner;

        c.           Date and quantity of initial fill;

        d.           Date and quantity of each refill or partial fill, if applicable, and the total number of refills dispensed to date;

        e.           Full name and address of the patient;

        f.            Name, address, and, if a controlled substance, DEA registration number of the prescriber;

        g.           Name, strength, dosage form, quantity of the drug or device prescribed, and the total number of refills authorized by the prescribing practitioner; and

        h.           For each fill or refill, the identification code, name, or initials of the dispensing pharmacist.

       21.4(2) Printout of prescription fill data. Any computerized system shall have the capability of producing a printout of any prescription fill data the user pharmacy is responsible for maintaining or producing under state and federal laws, rules and regulations. This would include a refill-by-refill audit trail for any specified strength and dosage form of any prescription drug by brand or generic name or both. Records maintained or provided in electronic format shall be sortable by prescriber name, patient name, drug dispensed, and date filled. Any computerized system employed by a user pharmacy shall be capable of providing at the pharmacy a printout or electronic file of the records in a format that is readily understandable to the board or other authorized agents. A pharmacy may contract with an application service provider, or the pharmacy may maintain computer servers at a remote location, but all required records shall be readily retrievable at the pharmacy if requested by the board or other authorized agent. The printout or electronic record shall include the following:

        a.           Name of the prescribing practitioner;

        b.           Name and address of the patient;

        c.           Quantity dispensed on each fill;

        d.           Date of dispensing for each fill;

        e.           Name or identification code of the dispensing pharmacist; and

        f.            The number of the original prescription order.

       21.4(3) Auxiliary procedure for system downtime. In the event that a pharmacy utilizing a computerized system experiences system downtime, the pharmacy shall have an auxiliary procedure that will be used for documentation of fills and refills of prescription orders. This auxiliary procedure shall ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for online data entry when the computer system is again available for use. As soon as reasonably possible upon resuming use of the computerized system, entry of all appropriate data accumulated during the system downtime shall be completed.

       21.4(4) Prescription notations. When a pharmacist fills an electronic prescription that would require the pharmacist to make a notation on the prescription if the prescription were a written prescription, the pharmacist shall make the same notation electronically and shall retain the annotation electronically in the prescription record or in linked files.

       21.4(5) Records for electronic prescriptions for controlled substances. A pharmacy that processes electronic prescriptions for controlled substances shall use a pharmacy prescription application that complies with DEA requirements relating to electronic prescriptions and that has been certified compliant with DEA regulations. When a prescription is received electronically from a prescriber’s electronic prescription application into the pharmacy prescription application, the prescription and all required annotations shall be retained electronically.

[ARC 9912B, IAB 12/14/11, effective 1/18/12]