Class N: Health Care Facility Automated Dispensing Systems

PURPOSE: This rule establishes licensing standards and requirements for the use of Class N automated dispensing systems (Health Care Facility). (1) Definitions. (A) “Class N: Automated dispensing system” (ADS)—An automated system located within a licensed health care facility used to dispense medication for resident patients of the facility pursuant to a patient-specific prescription or a medication order as defined by Chapter 338, RSMo, or a prescription drug order as defined by 20 CSR 2220-2.140. An automated dispensing system does not include an automated system used for compounding medication, a Class O automated dispensing system, or an automated filling system governed by 20 CSR 2220-2.950. (B) “Electronic verification system”—An electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system process used to verify and ensure medication has been properly stocked, restocked, loaded, filled, dispensed, or labeled. (C) “Licensed health care facility”—A health care facility licensed by or operated by the state of Missouri, or otherwise authorized by the state, to administer health care to resident patients in the ordinary course of business or professional practice. (D) “Med pak”—A patient med pak as defined by 20 CSR 2220-2.145. (2) Licensing. Applicants for a Class N (ADS) permit classifica tion must file an application on a form approved by the board with the applicable fee, and submit proof that the proposed Class N ADS location qualifies as a licensed health care facility, as defined by this rule. (A) A Class N ADS permit will be issued for the health care facility address designated on the application, and may be used to operate all Class N ADSs located at the board approved address. A Class N ADS must be located indoors at the permitted health care facility address and may not be located outside of the health care facility. (B) The appropriate pharmacy permit classification is required for any pharmacy activities under the board’s jurisdiction that occur at the Class N ADS site other than dispensing from an automated dispensing system. Class N ADS pharmacies must comply with all requirements applicable to any additional pharmacy permit classifications held by the pharmacy, including but not limited to all applicable security and staff supervision requirements. A Class J pharmacy permit is required for shared service activities, as provided in 20 CSR 2220-2.650. (C) A Class N ADS permit is not required for automated dispensing systems used solely to provide medication for immediate administration by health care facility staff to resident patients in an emergency situation, as allowed by law or the health care facility’s licensing agency. (3) System requirements. A Class N ADS must be maintained in good working order and in a clean and sanitary manner. If applicable, a Class N ADS must be cleaned and disinfected on a regular basis using appropriate materials and agents. (A) A Class N ADS must be validated by a properly qualified board licensee or appropriately supervised board registrant designated by the pharmacy to ensure the system is functioning properly prior to first use and prior to restarting the system after an unanticipated system shutdown or interruption. Additional validation must occur if any modification to the automated dispensing system occurs that changes or alters the dispensing or electronic verification process. (B) Medication must be stored and maintained in a thermostatically controlled area within temperature and AND INSURANCE humidity requirements as provided in the Food and Drug Administration approved drug product labeling or the United States Pharmacopeia (USP). (C) At a minimum, temperatures in drug storage areas of the ADS must be recorded and reviewed daily. Alternatively, a continuous temperature monitoring system may be used if the system maintains ongoing documentation of temperature recordings that promptly alerts pharmacy staff when temperatures are outside of the required range and provides the amount of variance. (D) An ongoing and documented quality assurance program must be established to monitor the performance of the automated dispensing system. The quality assurance program must include procedures for handling and reporting dispensing errors, system malfunctions, and other compliance concerns. (E) A pharmacist must reconcile a sample size of medication dispensed/removed from a Class N ADS on a quarterly basis to verify authorization for dispensing. The required sample size must be identified in the pharmacy’s policies and procedures. Proof of compliance with this subsection and the review date(s) must be maintained and documented in the pharmacy’s records. (4) Standards of operation. A Class N ADS must be safely and properly operated at all times in compliance with applicable state and federal laws, including but not limited to all applicable controlled substance laws. (A) A Class N ADS may only be used in settings that ensure prescriptions and medication/drug orders are reviewed by a pharmacist. Only staff of the licensed health care facility may remove or obtain medications from a Class N ADS for patient use. Patients may not obtain medication directly from the automated dispensing system. (B) Medication may only be dispensed by a Class N ADS pursuant to a valid prescription or medication/drug order. A prospective drug utilization review must be conducted for initial and changed prescriptions and medication/drug orders, as required by 20 CSR 2220-2.195. Policies and procedures must be in place for reviewing medication dispensing for compliance with this subsection, including but not limited to policies and procedures for terminating discontinued prescriptions and medication/drug orders and as needed prescriptions and medication/drug orders to prevent unauthorized dispensing. (C) A pharmacist must control all operations of the ADS and approve the release of the initial dose, except in cases of emergency dispensing for immediate administration to a patient as authorized by law. Subsequent doses from an approved prescription or medication/drug order may be removed from the ADS by health care staff in accordance with the pharmacy’s policies and procedures, provided a pharmacist must approve the release of subsequent dose(s) if any change in the prescription or medication/drug order occurs. Subsequent doses of patient-specific labeled prescriptions must comply with subsection (4)(D) of this rule. (D) For ADSs that dispense a patient-specific labeled prescription or medication/drug order, pharmacist verification of the final drug product and label may be satisfied if— 1. A pharmacist reviews and verifies the prescription or medication/drug order and the patient information used to initiate the dispensing process prior to dispensing; 2. The entire dispensing process is fully automated from the time the process is initiated until a completed, sealed, and properly labeled medication container is produced that is ready for dispensing. Required labels must be affixed to the container prior to release of the medication from the automated dispensing system. No manual manipulation of the prescription container or label may occur after the medication is released; and 3. An electronic verification system is used to ensure the correct label has been affixed and the correct medication and medication strength, dosage form, and quantity have been dispensed. (E) Labeled prescription containers provided to patients must be labeled in accordance with applicable statutory and regulatory requirements, and must contain the name, address, and telephone number of the Class N ADS permit holder. Med paks dispensed by a Class N ADS must comply with all applicable provisions of 20 CSR 2220-2.145, regardless if given to the patient. (F) In addition to 20 CSR 2220-2.080 and other prescription record-keeping requirements, the following information must be documented and readily retrievable for all prescriptions and medication/drug orders removed from the system: 1. The patient’s name or other unique identifier; 2. The date and time the medication is removed; 3. The medication, dosage strength, and quantity removed; and 4. The identity or other unique identifier of the authorized health care staff member removing the medication. (5) Supervision. A Class N ADS must be supervised by a Missourilicensed pharmacist who is readily accessible physically or electronically to monitor system activities and respond to inquiries or requests (e.g., on call). Electronic technology must allow the pharmacist to adequately monitor and supervise Class N ADS operations. The pharmacist supervision required by this section may not be delegated to an intern pharmacist. (A) If applicable, a two- (2-) way audio communication system must be in place to allow pharmacy technicians or intern pharmacists present at the Class N ADS pharmacy to effectively communicate with the supervising pharmacist. The Class N ADS may not be operated if the electronic or communication technology required by this section is unavailable or not in working order unless a pharmacist is on-site. (6) Stocking/restocking. Medication must be securely stocked, loaded, and reloaded in a Class N ADS in a manner that protects against theft and diversion, and in compliance with (A) Only board licensees or registrants may stock, load, or restock a Class N ADS, as authorized by the pharmacy’s policies and procedures. (B) A pharmacist must physically verify that medication has been properly stocked, restocked, and loaded into a Class N ADS. Alternatively, an electronic verification system may be used to verify that medication or medication containers have been properly stocked, restocked, and loaded into the device, if no manual intervention with the medication or medication container after the electronic verification occurs other than health care staff retrieving medication or medication being removed by authorized pharmacy staff for return/destruction. (C) If authorized by a pharmacist, intern pharmacists, or pharmacy technicians may stock, restock, or load manufacturer unit of use packages and repacked containers previously verified by a pharmacist into a Class N ADS without a pharmacist present or additional pharmacist verification if an electronic verification system is used to verify the manufacturer unit of use packages and repacked containers have been correctly stocked, restocked, or loaded. No manual intervention with the manufacturer unit of use package or repacked container may occur after the electronic verification required by this subsection, other than removing the manufacturer unit of use package or repacked containers by authorized health care facility staff for dispensing or return/destruction. (D) Return-to-stock medication may be returned and reused as authorized by 20 CSR 2220-3.040 or 20 CSR 2220-2.145 governing multi-med dispensing. No medication shall be returned directly to the Class N ADS for reissue or reuse by a person not licensed or registered by the Board of Pharmacy. (E) The following documentation must be maintained and readily retrievable: 1. The name, strength, and quantity of the medication stocked, loaded, restocked, or removed from the ADS system; 2. The date and time medication is stocked, loaded, restocked, or removed from the ADS system; 3. The identity of individuals stocking, loading, restocking, or removing medication in the ADS system; and 4. The identity of the pharmacist responsible for verifying the contents of any repacked containers stocked, restocked, or loaded into the ADS system, if applicable. (7) Security. Adequate security and supervision must be maintained at all times to prevent medication theft and diversion and unauthorized access to or use of the Class N ADS. A Class N ADS must also comply with all security provisions of 20 CSR 2220-2.010. Confidential records and Class N data must be securely maintained to prevent unauthorized access to, and unauthorized storage/transfer of, confidential information. (A) A Class N ADS must be securely placed, locked, and maintained inside the physical building of the licensed health care facility in a manner that prevents theft, diversion, and unauthorized access or medication removal. (B) A Class N ADS must have an alarm mechanism that promptly alerts a designated member of the pharmacy’s staff in the event of a security breach or unauthorized access to the system. (C) Authorized access to the Class N ADS must be defined in the pharmacy’s policies and procedures. The permit holder must be able to stop or change access to the Class N ADS as deemed necessary or appropriate. (D) A perpetual inventory must be maintained for each Class N ADS that stocks controlled substances that is reconciled by pharmacy staff on a monthly basis. (E) Class N ADS permit holders must maintain current poli cies and procedures for handling and investigating confirmed or suspected security breaches and medication losses or diversion, including but not limited to an escalation policy/ procedure for addressing inventory discrepancies and policies/ procedures for terminating system operations in the event of a security breach, inventory discrepancy, suspected loss/diver sion, or unauthorized access to or loss of patient confidential information. (F) Security breaches of the Class N ADS must be immediately investigated. Use/operation of the Class N ADS must immediately cease until the security breach has been rectified and proper security is restored. Any security breach of the Class N ADS must be documented and reported to the board in writing within three (3) business days of discovery. (G) Any confirmed or suspected medication diversion/theft must be immediately investigated. Medication diversion/theft must be reported to the board in writing within three (3) business days of discovery. (8) Policies and procedures. Class N ADS permit holders must maintain current and accurate written policies and procedures governing all aspects of Class N ADS activities, including but not limited to— (A) Staff education and training; (B) Maintaining the Class N ADS and the accompanying electronic verification process in good working order; (C) Maintaining and protecting system data and confidential information; (D) Granting, restricting, or terminating Class N ADS system access; (E) Filling, stocking, restocking, and loading the Class N ADS; (F) Removing expired, adulterated, misbranded, or recalled medication; (G) Temperature monitoring and documentation; (H) Prescription processing, verification, and recordkeeping, including handling/termination of discontinued prescriptions and medication/drug orders and as-needed prescriptions and medication/drug orders to prevent unauthorized dispensing; (I) Patient counseling, if applicable; (J) Ensuring cleanliness and sanitary operation of the device and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages; (K) Emergency response procedures, including but not limited to addressing power outages and terminating system operations; (L) Monitoring medication inventory to prevent diversion, theft, or loss, including an escalation policy/procedure for addressing inventory discrepancies; (M) Security requirements, including policies/procedures for authorizing Class N ADS system access and terminating Class N ADS system operations in the event of a security breach; (N) Handling and investigating inventory discrepancies, suspected loss/diversion, or unauthorized access to or loss of patient confidential information; (O) Receiving, handling, documenting, and investigating alarm notifications/alerts in the event of a security breach or unauthorized access to the Class N ADS, as referenced in section (7); (P) Conducting routine and preventive system validation and maintenance; (Q) Quality assurance; (R) Handling, investigation, and reporting dispensing errors; (S) Recordkeeping; and (T) Data retention and retrieval. (9) Records. (A) Class N permit holders must maintain readily retrievable records of all Class N ADS transactions, including but not limited to all prescriptions and medication/drug orders processed and/ or dispensed by the Class N ADS and records of all medication stocked in or removed from the Class N ADS. (B) Prescriptions and medication/drug orders dispensed from a Class N ADS must be separately identifiable in the pharmacy’s prescription records and individually retrievable from other prescriptions and medication/drug orders dispensed by the pharmacy. This requirement also applies to any Class J pharmacy dispensing prescriptions or medication/drug orders via a Class N ADS. (C) Except as otherwise provided by this rule or other applica ble law, all records required by this rule must be maintained a minimum of two (2) years and readily retrievable on request of the board or a board-authorized designee. Records maintained at a pharmacy must be produced immediately or within two (2) hours of a request from the board or the board’s authorized designee, or by making a computer terminal available to the inspector for immediate use to review the records requested. AND INSURANCE Records not maintained at a pharmacy must be produced within three (3) business days of a board request. AUTHORITY: sections 338.140, 338.210, and 338.220, RSMo Supp. 2023, and section 338.280, RSMo 2016.* This rule originally filed as 4 CSR 220-2.900. Original rule filed Nov. 1, 2000, effective June 30, 2001. Amended: Filed Feb. 18, 2003, effective Sept. 30, 2003. Moved to 20 CSR 2220-2.900, effective Aug. 28, 2006. Amended: Filed Aug. 21, 2006, effective April 30, 2007. Amended: Filed Sept. 6, 2023, effective March 30, 2024. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.210, RSMo 1951, amended 2001, 2011, 2020; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014, 2020; and 338.280, RSMo 1951, amended 1971, 1981.