24 Del. Admin. Code §§ 2500-15.0
Current through Register Vol. 27, No. 12, June 1, 2024
Section 2500-15.0 - Automated Pharmacy Systems15.1 Purpose and Scope 15.1.1 The purpose of this regulation is to recognize the use of automated pharmacy systems in community, hospital/institutional, and long term care pharmacy settings.15.2 Definitions 15.2.1 "Automated Pharmacy Systems" include, but are not limited to, mechanical systems that perform operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medications, and which collect, control, and maintain all transaction information.15.2.2 Automated Pharmacy Systems under the jurisdiction of the Board of Pharmacy can be utilized in licensed pharmacies, remote locations, and licensed health care facilities when legally permissible. Automated Pharmacy Systems shall be used only in settings where there is an established program of pharmaceutical care that ensures medication orders are reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy practice.15.3 Approval 15.3.1 Any new Automated Pharmacy System must be presented to the Board for approval prior to installation in the State. The presentation shall focus on patient safety and shall include how the technology functions and its quality control features.15.3.2 The Board may approve the Automated Pharmacy System pending an inspection of the first installation within the State.15.3.3 The Board will maintain a list of currently approved automated systems including the make and model.15.3.4 To ensure that changes in automation technology are reflected the Board will be notified of any updates, a repeat presentation shall be made to the Board if there is a substantive change in the technology.15.3.5 A pharmacy wishing to install an Automated Pharmacy System previously approved by the Board will provide the Board shall prior written notice of the installation or substantive changes of automated pharmacy systems. This written notification shall be readily retrievable upon inspection. Such notice must include, but is not limited to: 15.3.5.1 The name and address of the pharmacy; and the location of the automated equipment;15.3.5.2 Anticipated go-live date;15.3.5.3 The identification of the responsible pharmacist;15.3.5.4 Written policies and procedures for system operations that address accessibility and quality assurance unless already on file with the Board.15.4 Duties and Responsibilities of the Permit Holder 15.4.1 The Permit Holder has the following responsibilities:15.4.1.1 Notifying the Board in writing prior to the installation or removal of an approved Automated Pharmacy System.15.4.1.2 Developing and implementing an ongoing quality assurance program that monitors performance of the Automated Pharmacy System.15.4.1.3 Developing written policies and procedures for accessibility and quality assurance.15.4.1.4 Maintaining documentation readily available at the location where the system is used of at least the following: 15.4.1.4.1 Board approved documentation.15.4.1.4.2 Name and address of the pharmacy and/or licensed health care facility where the automated pharmacy system is being used;15.4.1.4.3 Manufacturer's name and model;15.4.1.5.4 Policies and procedures for accessibility and quality assurance.15.5 Record Keeping Requirements15.5.1 Records and/or electronic data kept by Automated Pharmacy Systems shall meet the following requirements: 15.5.1.1 All events involving the filling/restocking, dispensing and maintenance of the Automated Pharmacy System must be recorded; and15.5.1.2 Records must be maintained by the pharmacy and must be readily available to the Board for a three(3) years and shall include: 15.5.1.2.1 Type of transaction including filling/restocking, dispensing and maintenance;15.5.1.2.2 Identification of the individual accessing the system;15.5.1.2.3 Name, strength, dosage form, and quantity of the drug removed or added;15.5.1.2.4 Name of the patient for whom the drug was ordered; and15.6 General Requirements 15.6.1 The pharmacist-in-charge or authorized designee shall be responsible for:15.6.1.1 Assigning, discontinuing, or changing access to the system.15.6.1.2 Ensuring that access to the medication complies with State and Federal regulations.15.6.1.3 Checking the Automated Pharmacy System for accurate dispensing of medications at appropriate periodic intervals.15.6.2 Community/Outpatient Pharmacy. A final check by the pharmacist is required after the medication is placed in the final container prior to dispensing.15.6.3 Hospital/Institution. Unit based or centralized dispensing requires the same level of supervision required in subsection 9.2.3 which states: pharmacy technicians may be utilized in assisting the pharmacist. These persons must be supervised by a registered pharmacist who is present within the hospital and is responsible for the activities of those persons".15.6.4 Long Term Care Pharmacy. The filling/restocking of automated pharmacy systems in long term care settings may be performed by a licensed pharmacist, physician, physician assistant, advanced practice nurse, and registered nurse who is authorized by their Act to handle such medications subject to accountability provisions of subsection 11.3.4.15.6.5 All containers of medications stored in Automated Pharmacy System shall be packaged and labeled in accordance with Federal and State laws and regulations.15.6.6 All aspects of handling controlled substances shall meet the requirements of all State and Federal laws and regulations.15.6.7 The Automated Pharmacy System shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the Automated Pharmacy System, all in accordance with existing State and Federal law.15.6.8 The Automated Pharmacy System shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing State and Federal law.24 Del. Admin. Code §§ 2500-15.0
13 DE Reg. 506 (10/01/09)
21 DE Reg. 989 (6/1/2018) (Final)