Remote Data Entry

PURPOSE: This rule authorizes and establishes requirements for remote data entry sites. (1) Definitions. (A) “Remote Data Entry Sites”—A remote site located in a U.S. state or territory that is operated by a Missouri licensed pharmacy and used by a Missouri licensed or registered pharmacy technician or intern pharmacist to electronically perform non-dispensing data entry functions, including, but not limited to, obtaining, entering, validating, or processing patient information or data. (B) “Supervising Pharmacy”—A Missouri licensed pharmacy that is physically located in Missouri and responsible for operating a remote data entry site. (2) Licensing. (A) “Remote Data Entry Sites”—A permit is not required for a remote data entry site. The site shall be deemed part of and operating under the supervising pharmacy’s permit. The supervising pharmacy must maintain an address listing of all remote data entry sites in operation which must be made immediately available upon request of the board or the board’s authorized designee. (3) Remote data entry sites must be safely operated in compliance with applicable state and federal law. The supervising pharmacy is responsible for all pharmacy operations at the remote data entry site. No medication or medical device may be located at or dispensed from a remote data entry site. (A) Adequate security and supervision must be maintained at all times to prevent unauthorized access to the remote data entry site and equipment. Confidential records must be securely maintained to prevent unauthorized access to, and unauthorized storage/transfer of, confidential information. Any breach in the security of the remote data entry site equipment or confidential records must be documented and reported to the board in writing within seven (7) days of the breach. Paper patient or prescription records may not be generated, located, or maintained at a remote data entry site. (B) Except as otherwise provided by state and federal requirements, the remote data entry site and the supervising pharmacy must share a common database or prescription record-keeping system that allows real-time, online access to relevant patient profile information by both the supervising pharmacy and the remote site. The identity of the pharmacy technician or intern pharmacist responsible for remotely entering, validating, or modifying data at a remote data entry site must be electronically documented/recorded in the pharmacy’s records and maintained for a minimum of five (5) years. (C) Pharmacy technicians and intern pharmacists operating at a remote data entry site must be competent in the duties performed. At a minimum, technicians and intern pharmacists must have completed employer approved training in the activities performed remotely and must have an initial and, if applicable, annual documented assessment of competency. Documentation of the completed training and competency assessment must be maintained in the pharmacy’s records for a minimum of two (2) years and provided to the board or the board’s designee upon request. (D) A sufficient mechanism must be in place to allow communication between the supervising pharmacist and pharmacy technician or intern pharmacist when needed. A pharmacist must be available to respond to technician/intern pharmacist questions at all times a remote data entry site is in operation and must provide the personal assistance, direction, and approval required to verify and ensure delegated tasks are safely and properly performed. Non-dispensing data entry functions may not be performed by a pharmacy technician or intern pharmacist at a remote data entry site if the required real-time communication mechanism is not operating or available. (E) Remote data entry sites may be inspected by the board as authorized by law. Notification by the inspector will be provided to the supervising pharmacy a minimum of seventy-two (72) hours ahead of the scheduled inspection. The supervising pharmacy permit holder must arrange for a designated representative to be present that is not a resident of the location under inspection. (4) Policies and Procedures. The supervising pharmacy must establish written policies and procedures governing all aspects of operation of a remote data entry site that are reviewed annually by the pharmacist-in-charge. At a minimum, policies and procedures must include authorized technician and intern pharmacist activities, site security procedures and requirements, reporting security breaches, quality assurance review procedures, and staff education/training. The annual policy and procedure review date must be documented in the pharmacy’s records. AUTHORITY: sections 338.010, 338.035, and 338.140, RSMo Supp. 2021, and sections 338.013 and 338.280, RSMo 2016.* Original rule filed Feb. 7, 2020, effective Aug. 30, 2020. Emergency rule filed June 5, 2020, effective June 19, 2020, expired Sept. 1, 2020. Amended: Filed Nov. 2, 2021, effective May 30, 2022. *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019, 2021; 338.013, RSMo 1997, amended 2004, 2009; 338.035, RSMo 1990, amended 1993, 1995, 2007, 2020; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; and 338.280, RSMo 1951, amended 1971, 1981.