Electronic Prescription Records

PURPOSE: This rule establishes requirements for utilizing an electronic data-processing system in a pharmacy. (1) In lieu of a non-electronic (manual) record-keeping system, a pharmacy may elect to maintain an electronic data processing (EDP) record keeping-system. All information concerning the compounding, dispensing, or selling by a pharmacy of any drug, device, or poison pursuant to a lawful prescription which is entered into an EDP system at any pharmacy shall be entered only by a licensed pharmacist or by a technician or intern pharmacist under the direct supervision and review of a licensed pharmacist. Prior to dispensing, a pharmacist shall personally verify the accuracy of prescription data entered into the EDP for each original prescription. The EDP system shall comply with all applicable state and federal controlled substance laws and regulations. (2) EDP systems shall comply with the requirements of section 338.100, RSMo, and capable of storing and retrieving the following information concerning the original filling or refilling of any prescription: (A) A unique, sequential prescription label number; (B) If applicable, a unique readily retrievable identifier; (C) Date the prescription was prescribed; (D) The date the prescription was initially filled and the date of each refill; (E) Patient’s full name, or if an animal, the species and owner’s name; (F) Patient’s address or animal owner’s address when a prescription prescribes a controlled substance; (G) Prescriber’s full name; (H) Prescriber’s address and Drug Enforcement Administration (DEA) number when a prescription specifies a controlled substance; (I) Name, strength, and dosage of drug, device, or poison dispensed and any directions for use; (J) Quantity originally dispensed; (K) Quantity dispensed on each refill; (L) Identity of the pharmacist responsible for verifying the accuracy of prescription data prior to dispensing on each original prescription; (M) Identity of the pharmacist responsible for reviewing the final product prior to dispensing on each original and refill prescription, if different from the pharmacist verifying prescription data; (N) The number of authorized refills and quantity remaining; (O) Whether generic substitution has been authorized by the prescriber; (P) The manner in which the prescription was received by the pharmacy (e.g., written, telephone, electronic, or faxed); and (Q) Any other change or alteration made in the original prescription based on contact with the prescriber to show a clear audit trail including, but not limited to, a change in quantity, directions, number of refills, or authority to substitute a drug. (3) The information specified in section (2) shall be required and recorded in the EDP system prior to dispensing by a pharmacist or pharmacy. (4) Except as otherwise provided by 20 CSR 2220-2.083, prescription hard copies must be maintained and filed by either the sequential prescription label number or by a unique readily retrievable identifier. For verbal, telephone, or electronic prescriptions, a hard copy representation of the prescription shall be made and filed which contains all of the information in section (2). Prescription hard copies must be retrievable at the time of inspection, except as otherwise provided by 20 CSR 2220-2.010(1)(J). For purposes of this subsection an “electronic prescription” is defined as provided in 20 CSR 2220-2.085. (5) If additional refills are authorized and added to a prescription, a notation indicating the method and source of the authorization must be a part of the EDP record or hard copy, in that case the expiration date of the original prescription shall remain the same. (6) Any hospital pharmacy using an EDP system licensed by the board, as described in section (1), for outpatient prescriptions, employee prescriptions, and take-home prescriptions shall conform to all sections of this rule. (7) Any EDP system must be capable of producing the record required by this rule and said records shall be readily retrievable online. Readily retrievable is defined as providing EDP records immediately or within two (2) hours of a request by an inspector or by making a computer terminal available to the inspector for immediate use. (8) An auxiliary record-keeping system shall be established for the documentation of refills if the EDP system is inoperative for any reason. The auxiliary system shall ensure that all refills are authorized by the original prescription or prescriber. When this EDP system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period shall be entered into the EDP system within seven (7) working days. However, nothing in this section precludes the pharmacist from using his/her professional judgment for the benefit of a patient’s health and safety. (9) If a prescription is transferred from a pharmacy using an EDP system, a notation or deactivation must be made on the transferred record to preclude any further dispensing. If the same prescription is transferred back into the original pharmacy, it shall be treated as a new record, showing the original date written and expiration date. (10) Prior to or simultaneously with the purging of any EDP system, the permit holder shall make certain that a record of all prescription activity being erased exists in readable form, either on paper, microfiche, or electronic media storage. A pharmacy that desires to discard hard copy prescriptions that are more than three (3) years old must maintain all prescription information on microfiche or electronic media. Any process utilizing microfiche must ensure that all data is available and in readable form. Any pharmacy opting for the utilization of microfiche records must also maintain a microfiche reader so that records may be reviewed on-site by pharmacy personnel or board inspectors. Electronic media storage is defined as any medium such as a computer, floppy disk or diskette, compact disk (CD), or other electronic device that can reproduce all prescription information as required by section 338.100, RSMo, and this rule and is retrievable within three (3) working days. (11) If coded information exists in the electronic EDP, the board inspector may request the definitions of the codes from the pharmacist on duty for immediate review. (12) The EDP system shall be able to provide a listing of drug utilization by date for any drug for a minimum of the preceding twenty-four- (24-) month period that includes the specific drug product, patient name, or practitioner. If requested to do so, the pharmacy shall have three (3) working days to provide the report. (13) The provisions of this rule do not preempt any federal laws or regulations. If any part of this rule is declared invalid by a court of law, that declaration shall not affect the other parts of the rule. (14) Licensees shall also comply with all state and federal controlled substance record keeping requirements, including, any required daily log books or printouts. AUTHORITY: sections 338.100 and 338.280, RSMo 2016, and section 338.140, RSMo Supp. 2019.* This rule originally filed as 4 CSR 220-2.080. Original rule filed March 8, 1984, effective Aug. 11, 1984. Amended: Filed Nov. 4, 1985, effective Feb. 24, 1986. Rescinded and readopted: Filed Dec. 5, 1988, effective March 11, 1989. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Amended: Filed Nov. 1, 2000, effective June 30, 2001. Moved to 20 CSR 2220-2.080, effective Aug. 28, 2006. Amended: Filed Jan. 10, 2013, effective Aug. 30, 2013. Amended: Filed May 13, 2019, effective Nov. 30, 2019. *Original authority: 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010, 2016; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; and 338.280, RSMo 1951, amended 1971, 1981.