W H I T E P A P E R O N
The White Paper on Automation in Pharmacy represents the culmination of over two years' work by the Automation in Pharmacy Initiative, a coalition of pharmacy associations, members of state boards of pharmacy, and representatives from the pharmacy automation industry.
INTRODUCTION Advances in technology are changing the world, and the pharmacy profession stands to benefit greatly from the proliferation of technological innovation. Nowhere is this more apparent than in the availability and use of medication dispensing technologies to accelerate the transition of pharmacists from the traditional, product-focused dispensing role to that of patient-focused service provider. To make this transition, pharmacists must be knowledgeable about automated technologies and active in determining the best ways to manage and integrate this technology into a pharmaceutical care practice. Real and perceived barriers, both within and outside the pharmacy profession, must be addressed and resolved in order to ensure the safe and appropriate use of automated dispensing technology. The purpose of this document is to educate pharmacists, regulators, legislators, and policy makers on issues involving automation in pharmacy. It is intended to assist in understanding how automated drug distribution technology may affect the quality and efficiency of the delivery of drug products. It is also intended to advise the vendors and regulators of such technology on the needs and concerns of the users. This document is the product of the Automation in Pharmacy Initiative, which was established to identify and address regulatory and legislative issues surrounding automation in pharmacy across all practice sites. Members of the Automation in Pharmacy Initiative include the Academy of Managed Care Pharmacy (AMCP), American Pharmaceutical Association (APhA), American Society of Consultant Pharmacists (ASCP), American Society of Health-System Pharmacists (ASHP), National Association of Chain Drug Stores (NACDS), National Community Pharmacists Association (NCPA), and the Pharmaceutical Care Management Association (PCMA). The Initiative was undertaken in cooperation with the National Association of Boards of Pharmacy (NABP) and representatives from the automation industry. The Automation in Pharmacy Initiative addresses automation in all pharmacy practice sites; its scope is limited to automated equipment, such as that used for storage, packaging, dispensing, or distribution of medications, and that which collects, controls, and maintains transaction information. The Automation in Pharmacy Initiative did not address automated I.V. compounders, drug delivery systems such as infusion pumps, or issues surrounding electronic data transfer. The Automation in Pharmacy Initiative identified a set of strategies for addressing barriers to the use of automation in pharmacy. One such strategy was the commissioning of this White Paper on automation in pharmacy to educate pharmacists, regulators, legislators, and policy makers. For the purposes of this document, automated pharmacy systems (APS) 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 that collect, control, and maintain all transaction information. Data-processing technologies, although incorporated as integral components of most of these systems, are not considered per se in this document. Additional definitions are included in the Glossary.
CONCEPT OF AUTOMATED SYSTEMS A "system" is defined as "an aggregate of two or more physical components and a set of procedures by means of which they function together for a stated purpose." Today, automation of a system means that the machines used to perform work are controlled by a computer. It is essential, therefore, that the computer know and respond to the purpose for which the system is established. Automated systems are desirable because they are capable of achieving efficiency and accuracy far superior to that achievable in any other way. The main challenge for users is the complexity of automated systems resulting from computerized controls. This complexity makes it exceedingly difficult to diagnose, much less anticipate and understand, the various types of system failures. Automated systems must be implemented for the purpose they were designed for and monitored by a human being who has a full understanding of the purpose of the system. Patient care systems should be organized for the purpose of achieving outcomes defined in terms of patient health, quality of life, efficiency, and cost. There must be someone responsible for each major process of the system to monitor that part of the system and assure that the ultimate purpose is being served. The person held responsible for each major process should have control of that process. For automated pharmacy systems, the person best prepared for this responsibility is the pharmacist who, as the drug use expert, best understands the purpose of these systems and their limitations. Many pharmacists will need additional training to operate, control, and monitor automated pharmacy systems and evaluate the system's performance in achieving pharmaceutical care outcomes. Pharmacists, as well as other health professionals working with automated systems, will need to be so trained in the future.
POTENTIAL BENEFITS OF AUTOMATED PHARMACY SYSTEMS The potential benefits of automated pharmacy systems are substantial, and the widespread adoption of the technology attests to the fact that these benefits are realized in many practice settings. Automated systems can outperform humans in tasks that require tedious repetition, tiresome movement, intense concentration, immense memory retention, and meticulous record keeping. This describes many of the tasks in the drug distribution process. Automated pharmacy systems simply replace many labor-intensive tasks, thereby saving pharmacist, technician, and nursing time. Automation is an enabler for the re-engineering of pharmacy practice and frees pharmacists for the practice of pharmaceutical care. Automated pharmacy systems can reduce medication errors, improve documentation, increase authorized access to both medications and information, and enhance security. Turnover of personnel and on-the-job stress may be reduced when pharmacists are freed from "count and pour" dispensing for more rewarding, patient-centered tasks. These benefits can be summarized in terms of increased productivity, accuracy, and drug use control, and in improved patient care.
PHARMACY MANPOWER With more than 190,000 licensed practitioners, pharmacists stand behind nurses (2,033,032) and physicians (601,060) as the third largest health professions workforce.1 A number of forces are causing a shift in pharmacist activities away from dispensing or technical functions and toward cognitive services and activities; the greatest is the increased use of pharmacy technicians and automation. In a 1994 article on pharmacy manpower, Knapp estimated that by the year 2000, as many as 60,000 pharmacist positions devoted to drug distribution and dispensing can be freed up for pharmaceutical care activities by automation and technicians.2 Knapp observed that trends favorable to the employment of those pharmacists freed by automation include the recent emphasis on primary care. Accessibility and geographic distribution are very strong positive attributes for pharmacists interested in primary care roles. The accessibility of pharmacists and the appropriateness of their training for making a real contribution to primary care must be recognized and understood. Pharmacists and pharmacies are well-distributed in medically under-served inner-city and rural areas. The tendency for other health professionals to congregate in urban areas has created health manpower shortages in rural areas, a void that pharmacists can fill. Two-thirds of pharmacists practice in community pharmacies, which are probably the most accessible health care facilities in terms of numbers of outlets, ease of access (no appointment required), and hours of operation. The trend toward capitation could prove to be the strongest boost for primary care pharmacy because pharmacists play an important role in disease prevention, wellness, and self-treatment of minor ailments, which can reduce utilization of other health care resources, such as nurse call-in services, physician office visits, urgent care or emergency room visits, and hospitalization.2 Pharmacist-conducted clinics for chronic diseases, such as asthma or diabetes, or therapies, such as anticoagulation, are a promising site for professional expansion. Training and retraining of pharmacists is key to their continued professional growth and development. Changing their focus from output (the prescription) to the outcome of drug therapy will require pharmacists to clinically evaluate, interpret, and make recommendations for changes in therapy. Improving pharmacistsÕ skills will require a concerted effort by pharmacy schools, professional organizations, and health care institutions and other employers to develop and fund creative training programs that provide learning in a structured format, so that working pharmacists can upgrade their knowledge and skills with minimal disruption of their practices. It does seem certain that the technical prescription preparation role of the pharmacist may become obsolete as a result of dispensing automation, but in its place the pharmacist will be free to refocus on the broader responsibilities of pharmaceutical care. For the foreseeable future, humans tend to excel where perception, abstraction, emotion, unpredictability, contextual meaning, creativity, and judgment are required. Technology does a poor job when these attributes are required.3
ROLE OF THE PHARMACIST IN DRUG USE CONTROL Pharmacists contribute to positive medication outcomes by assuring that each patient receives safe, appropriate, and effective drug therapy through the provision of pharmaceutical care, which is the responsible provision of drug therapy for the purpose of achieving defined therapeutic outcomes that improve a patient's quality of life while minimizing patient risk.4 The provision of pharmaceutical care extends the pharmacist's responsibility beyond the delivery of the drug product to include the outcomes of drug therapy. Within the broad concept of pharmaceutical care, the public must be assured that pharmacists will retain their crucial role in the medication use process-specifically the pharmacist's review and evaluation of all prescriptions or medication orders before dispensing or administration, and control of the distribution of every dose dispensed or administered to every individual patient-even as the dispensing process becomes increasingly automated. Although control of medication distribution will be increasingly exercised through automated systems, the ultimate responsibility for these systems must remain with the pharmacist, the drug use expert who best understands the purpose of these systems and their limitations. The exercise of control over an automated pharmacy system will require that the pharmacist implement standards developed by the profession for the performance of the system, and provide a mechanism for identifying deviations from those standards and a responsive system for taking action to correct any deviations when they occur. Thus, in each of the automated pharmacy systems evolving, the focus of the pharmacist should be on the control system-its performance standards and contribution to the achievement of pharmaceutical care outcomes. Pharmacists must obtain the needed education and training in order to effectively implement and monitor these control systems. As the use of automation increases, the complexity of drug distribution systems will be such that the pharmacist will no longer be able to comprehend all aspects of these systems, nor should the pharmacist be expected to do so. The crucial new skills for the pharmacist will encompass:
DESCRIPTION OF CURRENT SYSTEMS Automated pharmacy systems are already in widespread use throughout pharmacy practice. Their primary use today is for the functions of counting, packaging, and labeling dosage forms for pharmacists and other health professionals to dispense and/or administer to patients while electronically documenting the process. This section contains general descriptions of some of the automated pharmacy systems currently in use today. Automated pharmacy systems may be centralized, pharmacy-based devices, or decentralized devices on nursing units, in long-term care facilities, and in other health care facilities. There are currently two types of pharmacy-based automated pharmacy systems: systems that repackage medications from bulk, and robotic systems that utilize "overwrapping" of unit-dose medications. Decentralized automated pharmacy systems store and dispense drugs and supplies in locations outside the pharmacy, and may be interfaced to a central pharmacy computer to maintain centralized control over the drug storage and distribution processes. Some devices are used to dispense multiple-dose packages, while others dispense unit-doses. Some systems package the doses, while other devices dispense only prepackaged medications. Community pharmacies have used technology to improve the efficiency of the drug distribution process since the 1970s; the first such systems simply counted tablets. Today, automated pharmacy systems are available that automate the entire dispensing process. There are automated medication dispensing devices that serve different segments of the community pharmacy market based on prescription volume. Prescription processing begins when an order is input into the pharmacy computer system and sent to the automated pharmacy system computer, which then initiates printing of barcoded labels and receipts, selecting the prescription bottle, labeling of the container, filling, and capping. A video image of the drug inside the bottle is obtained before capping. When the bottle-specific bar code is scanned by the pharmacist, the video image is placed next to a pharmacy-specific reference image for that medication to allow for a final check by the pharmacist. The technology allows for pricing of the prescription, adjusting the inventory, and documenting the transaction. Mail service pharmacies use "assembly line" automated drug distribution systems to dispense prescriptions, which are checked by a pharmacist and mailed with patient information directly to the patient. Mail service pharmacy has taken advantage of the economies of scale offered by automation, and is attractive for serving some patients with chronic diseases who are taking maintenance medication and need to have the prescription delivered to their homes. Large, fully automated mail service pharmacies integrate the patient medication database with "assembly line" automated drug distribution systems to dispense thousands of prescriptions per day. In the Veterans Affairs (VA) system, consolidated mail outpatient pharmacies (CMOPs) located across the country use automation to fill 8,000 to 10,000 prescriptions in a ten-hour day. This has freed pharmacists to spend more time on direct patient care.5 Medication orders are entered into patient databases at the local VA medical center and are electronically transmitted to the CMOP, where they are automatically processed. All items to be dispensed to one patient are placed in a barcoded tote bin. A technician scans the tote's bar code and a computer screen indicates which items are needed. The tote is placed on a conveyor belt, where prepackaged items, loaded into racks mounted over the conveyor belt, are automatically dispensed onto an area of the belt that the computer has designated for the individual order. The items are then transported to a chute and deposited into the appropriate tote. The tote travels to the final dispensing area, where machines automatically dispense oral solids into plastic vials. The automated bottle filler scans the tote to determine what medication is to be dispensed. A label containing both patient and medication information is printed and applied to the vial, and the vial is filled and capped. Before releasing the vial, the computer verifies the tablet count, cap integrity, and label placement. When the order is complete, a pharmacist checks the items and sends the tote to technicians who prepare the medications for mailing.5 Hospitals and institutional long-term care pharmacies employ various centralized automated pharmacy systems, which are integrated with the pharmacy information system, for repackaging and labeling of solid oral medications. These automated pharmacy systems count, package, and label medication in patient-, date-, and time-specific single unit-dose, multidose, or patient "med pak" packaging (all medications for a particular administration time are packaged together). Bulk medications are identified by humans and manually loaded into an individual, medication-specific canister that is calibrated according to the size and shape of the specific drug product, and that will only fit into its assigned location. Some systems incorporate barcode labeling on the canister, which can be scanned against the bulk medication supply to ensure accuracy. With information downloaded from the pharmacy information system, the automated pharmacy system packages medications in unit-dose packets, labels the packet with the required information, and dispenses the medications in the order in which they appear on the fill list. Integrated robotic systems that read barcoded overwrapped unit-dose packages are used to fill patient medication cassettes, and have the ability to return unused medications to stock. These systems are not limited to oral solid medications; injectables, suppositories, and liquid unit-dose containers can all be handled. A new comprehensive and electronically sophisticated automated pharmacy system not only counts, packages, and labels patient-specific medications in unit-of-use envelopes at the time of medication administration, but also sorts the envelopes by patient in the order in which the medications are to be administered. It can be used centrally in the pharmacy or in decentralized patient care areas. Nursing unit-based, decentralized systems feature "ATM-like" dispensing cabinets, which offer secure, computer-controlled access to medications and related supplies. When linked with the pharmacy computer system, as soon as a pharmacy-verified order is activated, the nurse may request a dose from the automated pharmacy system. Mobile systems offer the ability to move the dispensing cabinets from bedside to bedside, and enter and review orders from a terminal mounted on the cabinet. An important optional feature permits barcode checking and the reading of the dose being administered at the patient's bedside. Today, integrated drug distribution systems are being planned to meet the needs of an entire community by providing seamless distribution to primary care clinics, hospitals, long-term care facilities, and private homes. Automated pharmacy systems are making it possible for large health care systems to provide just-in-time deliveries of doses to refill drug distribution machines in an area-wide system of health care delivery sites.
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