§ 27.204. Automated medication systems.
(a) This section establishes standards applicable to licensed pharmacies that utilize automated medication systems which may be used to store, package, dispense or distribute prescriptions.
(b) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that:
(1) The pharmacist manager, or the pharmacist under contract with a long-term care facility responsible for the dispensing of medications if an automated medication system is utilized at a location which does not have a pharmacy onsite, is responsible for the supervision of the operation of the system.
(2) The automated medication system has been tested and validated by the pharmacy and found to dispense accurately prior to the implementation of the system. The pharmacy shall make the results of the testing available to the Board upon request.
(3) The pharmacy shall make the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the system.
(4) The automated medication system must electronically record the activity of each pharmacist, technician or other authorized personnel with the time, date and initials or other identifier so that a clear, readily retrievable audit trail is established. A pharmacist will be held responsible for transactions performed by that pharmacist or under the supervision of that pharmacist.
(c) The pharmacist manager or the pharmacist under contract with a long-term care facility responsible for the delivery of medications shall be responsible for the following:
(1) Reviewing and approving all policies and procedures for system operation, safety, security, accuracy, access and patient confidentiality.
(2) Ensuring that medications in the automated medication system are inspected, at least monthly, for expiration date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least monthly, for security and accountability.
(3) Assigning, discontinuing or changing personnel access to the automated medication system.
(4) Ensuring that the automated medication system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.
(5) Ensuring compliance with the applicable provisions of State and Federal law.
(d) When an automated medication system is used to fill prescriptions or medication orders, it shall be operated according to written policies and procedures of operation created or adopted by the pharmacy. The policies and procedures of operation must:
(1) Include a table of contents.
(2) Include a description of all procedures of operation.
(3) Set forth methods that ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least 2 years after the change is made. Each change shall be signed or initialed by the registered pharmacist manager and include the date on which the registered pharmacist manager approved the change.
(4) Set forth methods that ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made.
(5) Set forth methods that ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records.
(6) Set forth methods that ensure that access to the automated medication system for stocking and removal of medications is limited to licensed pharmacists or the pharmacist’s designee acting under the supervision of a licensed pharmacist. An accountability record which documents all transactions relative to stocking and removing medications from the automated medication system must be maintained.
(7) Identify the circumstances under which medications may be removed from the automated medication system by a licensed medical practitioner for distribution to a patient without prior order review by a licensed pharmacist.
(e) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall, at least annually, review its written policies and procedures of operation and revise them, if necessary.
(f) A copy of the written policies and procedures of operation adopted under this section shall be retained at the pharmacy and at the long-term care facility where the automated medication system is utilized. Upon request, the pharmacy shall provide to the Board a copy of the written policies and procedures of operation for inspection and review.
(g) The pharmacist manager shall be responsible for ensuring that, prior to performing any services in connection with an automated medication system, all licensed practitioners and supportive personnel are trained in the pharmacy’s standard operating procedures with regard to automated medication systems set forth in the written policies and procedures. The training shall be documented and available for inspection.
(h) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall create and operate according to a written program for quality assurance of the automated medication system which:
(1) Requires monitoring of the automated medication system.
(2) Establishes mechanisms and procedures to test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system.
(3) Requires the pharmacy to maintain all documentation relating to the written program for quality assurance for at least 2 years. Upon reasonable notice from the Board, the pharmacy shall provide information to the Board regarding the quality assurance program for automated medication systems.
(i) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall maintain a written plan for recovery from a disaster that interrupts the ability of the pharmacy to provide services. The written plan for recovery must include:
(1) Planning and preparation for a disaster.
(2) Procedures for response to a disaster.
(3) Procedures for the maintenance and testing of the written plan for recovery.
(j) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall maintain a written program for preventative maintenance of the system. Documentation of completion of all maintenance shall be kept on file in the pharmacy for at least 2 years.
Source The provisions of this § 27.204 adopted May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518.
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