In its landmark report of 2000, the Institute of Medicine pointed out that thousands of patients are harmed by medication errors annually.1 In the ambulatory setting, for example, between 1.5% and 4.0% of prescriptions are in error with potentially serious risk to patients.2-4 According to a 2005 FDA report, medication errors result in at least one death per day and 1.3 million injuries per year in the United States.5 Inpatients who are given wrong medications average an additional 12 days in length-of-stay.
Technology enablers have the potential to carry out repetitious and routine mechanical processes in both the ambulatory and inpatient pharmacy setting. Automated pharmacy processes feature much higher precision and lower error rates than can be achieved by humans, thereby reducing medication errors, improving quality, and freeing up the pharmacist for more productive clinical interactions with patients. Through the use of innovative technology solutions, pharmacists can increase their oversight of critical processes during prescription preparation and dispensing, while at the same time making more efficient use of their overall professional time.
One major class of technology enablers with the potential to reduce medication errors is health information technology, which was recently reviewed.6 Other major classes of technology solutions include robotics, bar coding and radio frequency identification (RFID), automated calculation of doses and dilutions, digital imaging, telepharmacy, and noninvasive verification of capsule contents using spatially offset Raman spectroscopy (SORS). Often, several of these technologies can be employed in combination to provide an optimal solution for a given application.
Efficiency Gains
Robotic solutions have the potential to yield major improvements in efficiency and quality. Robotic devices can perform repetitious mechanical procedures with greater precision and accuracy than a human operator and do not become distracted or fatigued. Commercial applications typically combine a robotic system with computerized algorithms for automated dosing and dilutions. These systems employ bar coding or RFID for positive identification of pharmaceutical agents and diluents. Digital images are taken at critical steps during pharmaceutical preparation and dispensing so that a pharmacist can validate the accuracy of the process from a workstation, including confirmation that the dose was made with the right amounts of the correct products and diluents. The robot then applies a patient-specific label with a bar code that can be used to ensure that the right patient receives the dose.
One potential application for a robotic system is the preparation of chemotherapy doses. With a robotic process, pharmacists and technicians have direct contact only with sealed bags and vials and do not physically have direct contact with the pharmaceutical agents, diluents, or uncapped sharps. This improves safety for staff, who are not directly exposed to the drugs, and for patients, who will receive the right drug at the right dose and right dilution. Due to the efficiency of the process, doses can be made just in time so that they will be freshly prepared when administered. Robotic systems can also prepare and dilute various other intravenous medications including antibiotics. Again, every dose is accurate, verified, individually labeled, and bar-coded. Other robotic systems can fill ambulatory prescriptions for oral medications (capsules and tablets). Some commercial systems can fill up to 150 prescriptions per hour, thereby automating the repetitive dispensing sequences that are commonly subject to human error.
A telepharmacy system has been described at the University of Kansas Hospital in which the chemotherapy preparation process in the pharmacy's sterile room is monitored by bar coding and a camera that documents key steps.7 The technician scans the bar code on the chemotherapy drug vial to establish a match in the patient's computerized record. Then, in the sterile prep room, the technician captures an electronic image of the vial label and filled syringe prior to injecting the dose into an IV bag. A clinical pharmacist at a remote location then verifies the identity of the drug, the dose on the pulled-back syringe, the label on the IV bag, and the patient's medication order. This telepharmacy process, an alternative to using a robot, features quality assurance steps that are expected to greatly reduce errors.
A Multifaceted Approach
Crane and Crane at Dartmouth proposed that a systems approach combined with an array of technology solutions would radically reduce medication errors in hospitals.8 Their proposed strategy included computerized decision support (including real-time medical informatics), electronic medical records, computerized physician order entry (CPOE), bar coding, automated dispensing machines, and robotics. In theory, this appears to be a comprehensive approach; however, it is necessary to test the concept in actual practice. In this regard, there are some studies in the literature focused on the evaluation of one or more of these technologies. Poon et al tested the efficacy of bar coding in reducing medication errors in the hospital setting.9 When the process was configured to scan every dose, the use of bar coding resulted in an 86% to 97% relative reduction in the incidence of potential adverse drug events. Reifsteck et al reported on an end-to-end automated medication management system developed at Presbyterian Healthcare Services in Albuquerque.10 This implementation featured automated pharmacy operations with bar-coded medication administration, tightly interwoven with CPOE and decision support. The technology solution resulted in a dramatically lowered mortality rate and medication error rate. Oswald and Caldwell studied filling and dispensing rates before and after implementation of an automated pharmacy carousel system at a university hospital.11 The implementation of the automated cabinets decreased medication filling errors. Teagarden et al studied the dispensing error rate in a high-volume highly automated mail-service pharmacy.12
Using the automated process, the dispensing error rate was 0.075%. Most errors were related to incomplete or incorrect directions on the final label and were associated with the initial stages of processing, such as order entry. No errors were introduced by the mechanical dispensing system in over 21,000 filled prescriptions. Hence, available data, although limited in scope, suggest that the proposal of Crane and Crane has potential merit.8 Further studies of a multicomponent system featuring the integration of software and automation are needed to thoroughly test the model.
A final technology of great future interest is the ability to noninvasively detect the ingredients in a capsule using a form of spectroscopy with a 250-mW laser at 827 nm.13 SORS was developed at the Rutherford Appleton Laboratory in the United Kingdom and might have potential in detecting counterfeit or contaminated pharmaceutical products. The technology could also be used in conjunction with a robotic system to definitively confirm the identity of agents that are in the process of being dispensed. It is expected that this technology could contribute greatly to reduction in medication errors.
Error Rates Close to Zero?
Given the magnitude of morbidity caused by adverse drug events, including medication errors, it is imperative that systematic approaches be taken to redesign the medication dispensing process to eliminate the potential for error. It is conceivable that the combined application of powerful computer software and pharmacy system automation, including robotics, can bring dispensing error rates down close to zero. With the introduction of monitoring methods such as telepharmacy and SORS, the potential exists to continuously monitor dispensed products for correct product and dose, which could further detect and eliminate errors. The reduction of error rates to near zero will likely require close integration between the computer software and pharmacy automation, with human interfaces that are designed to error-proof inputs to the system. Further outcomes studies using such systems are required to prove that the potential reduction in medication errors can actually be achieved in both inpatient and ambulatory settings.
REFERENCES
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www.fda.gov/cder/handbook/
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www.scriptpro.com/news/press-
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http://optics.org/cws/article/
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