Task Force on Automation Members Present: Carl D. Lyons, Chair (OK); Wendall F. Gaston (NE); W. Richard Marshman (PA); A. Jeffrey Newell (RI); Richard Waxman (IN). Others Present: Donna M. Horn, Executive Committee Liaison; Janice Feinberg, American Society of Consultant Pharmacists; Carmen A. Catizone, NABP Executive Director/Secretary; NABP Staff: Melissa Madigan, Barbara Nepi, Janice Teplitz. Absent: Timothey L. Tucker (TN) Introduction: The Task Force on Automation met January 3, 1997, at NABP headquarters in Park Ridge, Illinois. The Task Force on Automation TFA) was established by the NABP Executive Committee in response to Recommendation #7 of the 1995-1996 Committee on Law Enforcement/legislation, which read: The Committee on Law Enforcement/Legislation recommends that the Executive Committee appoint a Task Force to prepare model regulations addressing automated pharmacy systems. Review of the Task Force Charge: Task Force members reviewed their charge, proposing no changes, it remained as follows: 1. Investigate the subject of automation in pharmacy; and 2. Draft enabling, not restrictive, language addressing automation in pharmacy for incorporation into the NABP Model State Pharmacy Act and Model Rules, and to do so with appropriate input from interested pharmacy organizations. TFA Recommendation #1 The Task Force on Automation recommends to the Committee on Law Enforcement/Legislation (Committee that the following language be adopted for incorporation into the NABP Model State Pharmacy Act and Model Rules (Model Act). Article I Title, Purpose, and Definitions Section 105. Definitions. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net
(b) Automated Pharmacy Systems include, but are not limited to, mechanical systems that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collects, controls, and maintains all transaction information. [NOTE: The above new definition (b) would be inserted in Section 105 with sequential relettering of all subsequent definitions.] Model Rules for Pharmaceutical Care Section 2. Personnel. A. Duties and Responsibilities of the Pharmacist-in-Charge (2) The Pharmacist-in-Charge has the following responsibilities: (e) Assuring that the Automated Pharmacy System is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping and security safeguards. (f) Implementing an ongoing quality assurance program that monitors performance of the Automated Pharmacy System, which is evidenced by written policies and procedures developed by the pharmacy. [NOTE: The above new Sections (e) and (f) would be inserted in Section 2 with sequential relettering of all subsequent sections.] (m) Providing the Board with prior written notice of the installation or removal of Automated Pharmacy Systems. Such notice must include, but is not limited to: Section 3. Pharmacy Practice. (i) the name and address of the pharmacy; (ii) the location of the automated equipment; and (iii) the identification of the responsible pharmacist. L. Automated Pharmacy Systems Automated Pharmacy Systems can be utilized in licensed pharmacies, remote locations under the jurisdiction of the board of pharmacy, and licensed health care facilities where legally permissible and shall comply with the following provisions. (1) Documentation as to type of equipment, serial numbers, content, policies and procedures, and location shall be maintained on-site in the pharmacy for review by the board of pharmacy. Such documentation may include, but is not limited to: (a) Name and address of the pharmacy and/or licensed health care facility where the Automated Pharmacy System(s) is being used; (b) Manufacturer s name and model; (c) Description of how the device is used; (d) Quality assurance procedures to determine continued appropriate use of the automated device; and (e) Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, and malfunction. (2) Automated Pharmacy Systems should be used only in settings where there is an established program of pharmaceutical care that ensures medication orders are reviewed NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 2
by a pharmacist in accordance with established policies and procedures and good pharmacy practice. (3) All policies and procedures must be maintained in the pharmacy responsible for the system and, if the system is not located within the facility where the pharmacy is located, at the location where the system is being used. (4) Automated Pharmacy Systems shall have adequate security systems and procedures, evidenced by written policies and procedures, to: (a) prevent unauthorized access and to comply with federal and state reulations; and (b) maintain patient confidentiality. (5) Records and/or electronic data kept by Automated Pharmacy Systems shall meet the following requirements. (a) All events involving the contents of the Automated Pharmacy System must be recorded electronically. (b) Records must be maintained by the pharmacy and must be readily available to the board. Such records shall include: (i) identity of system accessed; (ii) identification of the individual accessing the system; (iii) type of transaction; (iv) name, strength, dosage, form, and quantity of the drug accessed; (v) (vi) name of the patient for whom the drug was ordered; and such additional information as the pharmacist-in-charge may deem necessary. (6) Access to and limits on access (e.g., security levels) to the Automated Pharmacy System must be defined by policy and procedures and must comply with state and federal regulations. (7) The pharmacist-in-charge shall be responsible for: (a) Assigning, discontinuing, or changing access to the system. (b) Ensuring that the Automated Pharmacy System is filled/stocked accurately and in accordance with established, written policies and procedures that ensure accuracy. (8) The filing/stocking of all medicals in the Automated Pharmacy System shall be accomplished by qualified personnel under the supervision of a licensed pharmacist. (9) A record of medications filled/stocked into an Automated Pharmacy System shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy. (10) All containers of medications stored in the Automated Pharmacy System shall be packaged and labeled in accordance with federal and state laws and regulations. (11) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations. (12) 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. (13) 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. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 3
[NOTE: The above new Section 3L would be inserted in Section 3 with sequential relettering of all subsequent sections.] Comments Section 3L(2). Each state should determine whether or not the dispensing of a first dose or an emergency dose may take place without prior order review by a pharmacist but with appropriate security and patient medication management controls in place. Section 3L(3). The use of Automated Pharmacy Systems requires written policies and procedures in place prior to installation to ensure safety, accuracy, security, and patient confidentiality and to define access and limits to access to equipment and medications. Section 3L(6). This section anticipates that decisions regarding which health care professionals may access the Automated Pharmacy System and the level of access allowed (e.g., access to medications, access to patient profiles for viewing only, access to patient profiles for modification) will be left up to the individual(s) responsible for the Automated Pharmacy System; however, states may decide to take on this responsibility and define those who may have access to the system and the levels of access allowed. Section 3L(9). This section anticipates that states will allow non-pharmacist personnel to fill/stock Automated Pharmacy Systems under a pharmacist s supervision; however, the state may decide to only allow a pharmacist to perform this function. Should the state allow non-pharmacist personnel to perform this function, it should define the level of pharmacist supervision necessary e.g., immediate, direct, general). Additionally, each state should decide whether the person checking the accuracy of the work of the person who is filling/stocking must be a pharmacist. Section 3L(12). The state may require that each licensed pharmacy or facility have in place written policies and procedures to address situations in which medications removed form the system remain unused and must be secured and accounted for. Section 3L(13). The state may require that each licensed pharmacy or facility have in place written policies and procedures to address situation in which medications removed from the system are wasted and must be secured and accounted for. Background: Task Force members discussed Automated Pharmacy Systems and expressed concern that many systems have already been placed into use without board involvement. It was agreed that there was a need for boards to regulate such system implementation and usage. Task Force members further agreed that model regulations addressing this subject should be developed and that these model regulations must affect outcomes, not processes, while being flexible enough to adapt to future technologies. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 4
For assistance in the development of such regulations, the Task Force reviewed model language addressing Automated Pharmacy Systems prepared by the Automation in Pharmacy Initiative (API), a coalition of national pharmacy associations, representatives from the automation industry, and pharmacy practitioners, established to identify and address regulatory and legislative issues surrounding automation in pharmacy across all practice sites. Task force members noted that API coalition participants drafted the model language following a year-long review that included an overview of current and proposed regulations concerning automation in pharmacy, the identification of areas of particular concern to boards of pharmacy, and considerable input from a wide spectrum of pharmacy organizations, including the Academy of Managed Care Pharmacy, the American Pharmaceutical Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the Pharmaceutical Care Management Association. Finding the model language drafted by API to be well-organized and thorough, the Task Force agreed to utilize it as a basis for the development of model language to be incorporated into the NABP Model Act. The Task Force insisted, however, that the following principles be observed: model regulations must be worded in such a manner so as to be flexible enough for boards to adapt to their own needs; such regulations must not conflict with or duplicate regulations already found within the Model Act; and the language must not be limiting in scope. Task Force members also insisted that the regulations include certain concepts; for example, that much of the documentation for Automated Pharmacy Systems be kept on-site and not be submitted to the board, that control of the system remain with the pharmacy department and/or the pharmacist-in-charge, and that electronic storage of documentation, data, and records be allowed rather than requiring paper copies of all records. Finally, the Task Force reviewed the following subjects and agreed that specific model language was sufficient or because those subject areas would be more appropriately addressed within individual pharmacy or facility policies and procedures. Inventory/Inspection Floor Stock Malfunction Storage Conditions Drug Recalls Electronic Transmission of Data TFA Recommendation #2 The Task Force on Automation recommends the following Sample Pharmacy Automation Policy and Procedure Outline be incorporated into the Model Act (perhaps within an appropriate Comments section) to assist the reader in the development of pharmacy automation policy and procedures. Pharmacy Automation Policy and Procedure Outline Sample I. Access NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 5
A. System Entry B. Access Codes C. System Access Privileges D. Changing Access Privileges E. Termination of user F. Temporary Access Codes G. Password Assignment II. Controlled Substances A. Chain of Custody B. Discrepancy Resolution III. Data A. Removal of Medications and/or Pharmaceutical Supplies B. Medication Access IV. Definitions V. Dispensing/Distribution VI. Downtime Procedures (see Malfunction) VII. VIII. Emergency Procedures Information Security/Confidentiality A. Patient Information B. Medication Information C. Transaction Files D. Information update Plan E. Patient Update Plan F. Information Access IX. Inspection X. Installation Requirements XI. Maintenance A. Service and Repair Protocols XII. Medication Administration A. Medication and Patient Validation B. Administration Verification XIII. Medication Security A. Security Management and Control B. Medication Loading and Storage C. Medication Loading Records D. Medication Containers E. Cross Contamination F. Lot Number Control G. Inventory H. Utilization Review I. Research XIV. Malfunction A. Troubleshooting B. Power Failure XV. Quality Assurance/Quality Improvement A. Documentation and Verification of Proper Loading and Refilling of Device B. Proof of Delivery NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 6
C. Removal of Drugs for Administration, Return, or Waste D. Chain of Custody of Controlled Substances (Institutions) E. Recording, Resolving, and Reporting of Discrepancies F. Periodic Audits to Assure Compliance with Policies and Procedures XVI. Reports A. System Maintenance B. Administrative Functions C. Inventory D. Error E. Discrepancies F. Activity G. Problem XVII. Medication Inventory A. Management XVIII. Staff Education and Training XIX. System Set-up Background: The Task Force members agreed this sample Pharmacy Automation Policy and Procedure Outline would be helpful for board members, compliance officers, and practitioners who are not familiar with the issues surrounding Automated Pharmacy Systems, and for those persons in the process of implementing such systems within their practice. TFA Recommendation #3 The Task Force on Automation recommends the NABP Executive Committee work with the appropriate federal agencies and officials to remove statutory and regulatory language that requires paper-based recordkeeping for the drug dispensing process. Once such language has been removed at the federal level, the Task Force recommends that NABP encourage the boards of pharmacy to enable electronic recordkeeping procedures in their state practice acts. Background: Several Task Force members expressed concern about the increased documentation, data, and record maintenance being required of pharmacy practitioners obey federal and sate authorities, and the fact that many regulations require paper-based maintenance of such records. Recognizing that paper-based recordkeeping is space-consuming, resource-depleting, and expensive, members questioned the need for such requirements. They noted that current technology allows for accurate and easily accessible storage of such items in an electronic form. The Task Force agreed to encourage federal and state officials to end requirements for paper-based recordkeeping and to allow the use of electronic data storage. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 7