William W. Churchill

Effect of bar-code technology on the safety of medication administration.

BACKGROUND Serious medication errors are common in hospitals and often occur during order transcription or administration of medication. To help prevent such errors, technology has been developed to verify medications by incorporating bar-code verification technology within an electronic medication-administration system (bar-code eMAR). METHODS We conducted a before-and-after, quasi-experimental study in an academic medical center that was implementing the bar-code eMAR. We assessed rates of errors in order transcription and medication administration on units before and after implementation of the bar-code eMAR. Errors that involved early or late administration of medications were classified as timing errors and all others as nontiming errors. Two clinicians reviewed the errors to determine their potential to harm patients and classified those that could be harmful as potential adverse drug events. RESULTS We observed 14,041 medication administrations and reviewed 3082 order transcriptions. Observers noted 776 nontiming errors in medication administration on units that did not use the bar-code eMAR (an 11.5% error rate) versus 495 such errors on units that did use it (a 6.8% error rate)--a 41.4% relative reduction in errors (P<0.001). The rate of potential adverse drug events (other than those associated with timing errors) fell from 3.1% without the use of the bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction (P<0.001). The rate of timing errors in medication administration fell by 27.3% (P<0.001), but the rate of potential adverse drug events associated with timing errors did not change significantly. Transcription errors occurred at a rate of 6.1% on units that did not use the bar-code eMAR but were completely eliminated on units that did use it. CONCLUSIONS Use of the bar-code eMAR substantially reduced the rate of errors in order transcription and in medication administration as well as potential adverse drug events, although it did not eliminate such errors. Our data show that the bar-code eMAR is an important intervention to improve medication safety. (ClinicalTrials.gov number, NCT00243373.)

Medication Dispensing Errors and Potential Adverse Drug Events before and after Implementing Bar Code Technology in the Pharmacy

Context Bar code technology could help reduce medication dispensing errors in the pharmacy. Contribution The authors observed hospital pharmacy technicians as they dispensed medications before and after the installation of a storage and retrieval system that used bar code technology to label medications. After implementation of the bar codebased system, dispensing errors were much less frequent if the system required scanning of all dispensed doses. Some errors actually increased if the system did not require scanning every dose. Cautions Bar code technology was only one part of an entirely redesigned medication storage and dispensing system. Implications Properly implemented, medication storage and dispensing systems that use bar code technology may help to reduce medication dispensing errors. The Editors Medication errors in hospitals are common (1, 2), and dispensing errors made in the pharmacy contribute considerably to these errors (3). Overall, dispensing error rates are relatively low, but because of the high volume of medications dispensed, more than 100 undetected dispensing errors may occur in a busy hospital pharmacy every day (4). Because only about one third of these dispensing errors are intercepted by nurses before medication administration (3), many errors reach hospitalized patients (5). Therefore, dispensing errors are an important target for patient safety interventions. Bar code technology has been touted as a promising strategy to prevent medication errors (6, 7). In industries outside of health care, bar code technology has been widely adopted because of its ease of use and high degree of reliability. In the context of pharmacy dispensing, if all medications in the pharmacy had a bar code that is scanned to ensure that the correct medication in its correct dose and formulation is being dispensed, dispensing errors may be substantially reduced. On the basis of the theoretical benefits for patient safety, the U.S. Food and Drug Administration (FDA) has mandated bar codes for all medications used in hospitals by April 2006 (8), and many institutions are beginning to adopt this technology to increase the accuracy of the dispensing and administration processes. Despite enthusiasm for this technology, few published studies have evaluated the effect of bar code technology on dispensing errors (9, 10). Previous work has also demonstrated that the implementation of health information technology (HIT) may result in unintended consequences and new types of errors (1113). Therefore, the decision to adopt this technology must be informed by a careful evaluation of its efficacy and limitations. To that end, we evaluated a recent implementation of bar code technology in a large hospital pharmacy to measure the changes in the rates of dispensing errors (see Glossary) and potential adverse drug events (ADEs) (see Glossary). Methods Study Site and Study Period We performed a before-and-after evaluation study over a 20-month period in a 735-bed tertiary care academic medical center, where approximately 5.9 million doses of medications were dispensed per year from the central inpatient pharmacy. Between February and August 2003 (prebar code implementation period), we measured the baseline rates of dispensing errors and potential ADEs. In November and December 2003, the hospital pharmacy converted to a bar codeassisted dispensing process. After the conversion, we remeasured the rates of dispensing errors and potential ADEs between May and September 2004 (postbar code implementation period). Observations in both periods were conducted on weekdays during the day shift, when most medications are dispensed. Dispensing Processes during Pre and PostBar Code Implementation Periods The Figure depicts an overview of the medication use process during the 2 observation periods. In both observation periods, the dispensing process involves 3 major steps that are commonly used in approximately 76% of U.S. hospitals (14) (Table 1 and Figure). In the first step, medications delivered to the pharmacy are stocked in the pharmacy inventory. The second step, known as filling, requires a pharmacy technician to retrieve the appropriate medications from the pharmacy inventory. The third step, known as verification, requires a staff pharmacist to verify the accuracy of the medications filled by the technician before delivery to patient care areas. If the staff pharmacist detects a dispensing error, the medication is returned for refilling. While the stocking and filling steps changed extensively with bar code technology implementation, the pharmacists visual inspection step remained functionally unchanged in the postbar code implementation period. In both periods, medications dispensed from the pharmacy would be delivered to either patient-specific medication drawers or semi-automated medication cabinets (Sure-Med, Omnicell, Mountain View, California) on the patient care units. Figure. Overview of the pharmacy dispensing process. *Sure-Med, Omnicell, Mountain View, California. CPOE = computerized physician order entry; MD = physician. Table 1. Description of the Dispensing Processes Studied in the PreBar Code and PostBar Code Implementation Periods In the prebar code implementation period, we studied 3 major dispensing processes: 1) Sure-Med fill, 2) first-dose fill, and 3) cart fill. Each medication dose (see Glossary) was dispensed by only 1 of these processes (Table 1). In the prebar code period, medications were stocked manually onto shelves and the filling step for all 3 processes was performed manually, with the pharmacy technician relying solely on visual inspection to pick the appropriate medication from the several storage areas in the pharmacy inventory. During the bar code conversion process, the study pharmacy built a dedicated repackaging center, which affixed a bar code onto every dose of medication (for example, each individual pill, vial, or ampoule) if the manufacturer had not applied a bar code. In the postbar code period, the prebar code dispensing processes were reorganized into 3 new dispensing processes: 1) carousel fill, 2) alternate zone fill, and 3) 2-day fill (Table 1). Each medication dose was dispensed by only 1 of these processes. For the 3 new dispensing processes, the pharmacy used a different configuration of bar codescanning technology to leverage a combination of internally developed and vendor-supplied software and hardware. Carousel Fill Process The carousel fill process dispensed the compact and nonrefrigeration-requiring forms of commonly used medications for the semi-automated medication cabinets (Sure-Med). These cabinets stored frequently used medications in medication-specific drawers, from which nurses dispensed doses for all patients on a particular unit. The Sure-Med fill process previously dispensed these medications. The new carousel fill process was so named because it used a newly purchased, bar codebased, high-volume storage and retrieval system called the carousel, which also monitored the supply levels in the Sure-Med cabinets to ensure an adequate supply of frequently used medications on each unit. When medications were stocked into the carousel, pharmacy staff scanned 1 dose per batch to ensure that the correct medications were placed in the appropriate compartment. When a pharmacy technician retrieved medications during the filling step, the machine directed the technician to the appropriate storage compartment within the carousel. The technician visually inspected the retrieved medication and scanned the bar code on it to ensure that he or she had retrieved the correct medication. In most cases, the carousel machine would instruct the technician to retrieve several doses of the same medication (a medication batch [see Glossary]) at a time to replenish the supplies for a particular cabinet. In these cases, only 1 dose was scanned. We will use Stock&Retrieve(+) Scan(+) as shorthand to characterize this process (see Glossary). Alternate Zone Process The alternate zone process dispensed commonly used medications that could not be accommodated in the carousel machine because of their size or need for refrigeration. Medications for this process were stocked onto shelves manually. When pharmacy technicians filled medications for this process, they manually retrieved the medications from the shelves, visually inspected them, and scanned their bar codes. Similar to the carousel fill process, if several doses of the same medication were being dispensed, only 1 dose was scanned. We will use Stock&Retrieve() Scan(+) as shorthand to characterize this process (see Glossary). Two-Day Fill Process The 2-day fill process handled less commonly used medications that the first-dose fill and cart fill processes previously dispensed to the patient-specific drawers on patient care units. Medications were stocked manually onto shelves and were retrieved by hand during the filling step. The technician in this process would typically retrieve several doses of the same medication at a time so that the patient-specific drawer in the patient care area would carry a 2-day supply. However, unlike the procedure in the carousel or alternate zone fill process, all doses retrieved in the 2-day fill process had to be scanned. We will use Stock&Retrieve() Scan(++) as shorthand to characterize this process (see Glossary). We excluded one dispensing process, controlled substance fill, which accounted for approximately 16% of daytime, weekday dispensing in the pharmacy, from the study because of limited research personnel and its lower baseline dispensing error rate (4). Measurement of Dispensing Error and Potential ADE Rates The primary outcomes of our study were the rates of target dispensing errors (see Glossary) and target potential ADEs (see Glossary). We used identical methods that were approved by the institutional review board at the study institution to measure the rates of dispensing errors in the prebar

How Many Hospital Pharmacy Medication Dispensing Errors Go Undetected

BACKGROUND Hospital pharmacies dispense large numbers of medication doses for hospitalized patients. A study was conducted at an academic tertiary care hospital to characterize the incidence and severity of medication dispensing errors in a hospital pharmacy. METHODS Direct observation of dispensing processes was undertaken to determine presence of errors with review by a physician panel to determine severity. RESULTS A total of 140,755 medication doses filled by pharmacy technicians were observed during a seven-month period, and 3.6% (5075) contalned errors. The hospital pharmacist detected only 79% of these errors during routine verification; thus, 0.75% of doses filled would have left the phannacy with undetected errors. Overall, 23.5% of undetected errors were potential adverse drug events (ADEs), of which 28% were serious and 0.8% were life threatening. The most common potential ADEs were incorrect medications (36%), incorrect strength (35%), and incorrect dosage form (21%). DISCUSSION Given the volume of medications dispensed, even a low rate of drug distribution process translates into a large number of errors with potential to harm patients. Pharmacy distribution systems require further process redesign to achieve the highest possible level of safety and reliability.

Overcoming Barriers to the Implementation of a Pharmacy Bar Code Scanning System for Medication Dispensing: A Case Study

Technology has great potential to reduce medication errors in hospitals. This case report describes barriers to, and facilitators of, the implementation of a pharmacy bar code scanning system to reduce medication dispensing errors at a large academic medical center. Ten pharmacy staff were interviewed about their experiences during the implementation. Interview notes were iteratively reviewed to identify common themes. The authors identified three main barriers to pharmacy bar code scanning system implementation: process (training requirements and process flow issues), technology (hardware, software, and the role of vendors), and resistance (communication issues, changing roles, and negative perceptions about technology). The authors also identified strategies to overcome these barriers. Adequate training, continuous improvement, and adaptation of workflow to address ones own needs mitigated process barriers. Ongoing vendor involvement, acknowledgment of technology limitations, and attempts to address them were crucial in overcoming technology barriers. Staff resistance was addressed through clear communication, identifying champions, emphasizing new information provided by the system, and facilitating collaboration.

Impact of Robotic Antineoplastic Preparation on Safety, Workflow, and Costs

PURPOSE Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. METHODS We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time. RESULTS Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P = .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P = .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P < .001). Mean drug preparation time increased by 47% when using the robot (P = .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P < .001). CONCLUSION Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations.

ASHP Statement on bar-code-enabled medication administration technology

The American Society of Health-System Pharmacists (ASHP) encourages health systems to adopt bar-code-enabled medication administration (BCMA) technology to improve patient safety and the accuracy of medication administration and documentation. To support the goal of having all medications electronically verified before they are administered, BCMA systems should be used in all areas of health systems in which medications are used. Pharmacists must be involved in the interdisciplinary planning, development, implementation, and management of BCMA systems and must ultimately be responsible for developing and maintaining the infrastructure required to ensure BCMA success. Health systems deploying BCMA programs must provide the funding and staffing necessary to permit pharmacists to fulfill this role. ASHP urges the Food and Drug Administration (FDA) and other regulatory agencies, standard-setting bodies, contracting entities, health systems, and others to mandate that pharmaceutical manufacturers use symbologies that are readily deciphered by commonly used scanning equipment to code for the National Drug Code (NDC), lot number, and expiration date on all unit dose, unit-of-use, and injectable drug packaging. Pharmaceutical manufacturers should also provide all medications used in health systems in unit dose packages. FDA, pharmaceutical manufacturers and packagers, and the manufacturers of BCMA systems should collaborate to minimize or eliminate the causes of false rejection of valid medication doses. Certain characteristics of the current NDC identification system contribute to the burden of implementing BCMA systems, and ASHP urges stakeholders to participate in efforts to develop a system that more reliably identifies the unique drug (or combination of drugs), strength, dosage form, and route of administration. Although bar-coding systems are currently a widely used point-of-care technology, ASHP recognizes that other types of machine-readable coding (e.g., radio-frequency identification) may evolve. ASHP supports the use of new technologies that are as effective as or improve upon existing systems and believes the principles outlined in this statement apply to such systems. ASHP urges further research on such systems as well as research that will definitively determine the extent to which BCMA systems reduce preventable medication errors and provide a financial return on investment for health systems.

Bariatric Surgery Pharmacy Consultation Service

Bariatric surgical patients often need changes in formulation and dosages of their medications. The literature contains minimal information regarding pharmaceutical care and consultation services for the bariatric surgery patient. Complex medication regimens and safety concerns initiated a collaborative effort between surgeons and pharmacists to manage more effectively bariatric patients perioperatively. The consultation service included patient identification, pharmacy referral, pharmacist consultation with the patient, communication of recommendations with surgeons, follow-up, and documentation. There were 124 consultations performed from February 2, 2009 to December 1, 2010 with an average of 7.7 medications optimized per patient. Every patient required a minimum of one adjustment to their regimen. The surgeons approved 98% of these recommendations. Of recommendations provided, the majority focused on changing the formulation of the medication in some manner. The collaborative effort between surgeons and pharmacists effected changes in medication transitioning perioperatively and resulted in improved pharmaceutical care for this patient population.

Implementation of a Hemostatic and Antithrombotic Stewardship program

Hemostatic and antithrombotic (HAT) agents are high risk, high cost products. They require close monitoring and dose titration to adequately treat or prevent thrombosis while avoiding bleeding events. Incorporating the principles of inpatient anticoagulation management service into a stewardship program not only improves outcomes and decreases cost, but also improves transitions of care, exposes gaps in therapy management, and leads to the development of institution specific protocols and guidelines. We implemented a HAT Stewardship to provide real time clinical surveillance and management of these agents in an effort to optimize appropriate use, decrease serious adverse events, and minimize costs. The stewardship is staffed daily by an interdisciplinary team comprised of a pharmacist, hematology attending, and medical director. The stewardship focuses on (1) management of heparin-induced thrombocytopenia (HIT), (2) management of patients with Hemophilia A/B with inhibitors and acquired Factor VIII deficiency due to inhibitors, (3) oversight of anticoagulation in patients on extracorporeal membrane oxygenation and (4) assistance with anticoagulation management for patients with mechanical cardiac assist devices. Through implementation of this service, we have been able to demonstrate improved patient care and a positive economic impact exceeding the cost of this program by almost sixfold. Other centers should consider instituting a HAT Stewardship to maximize patient outcomes and minimize adverse events.

An algorithmic computerised order entry approach to assist in the prescribing of new therapeutic agents: case study of activated protein C at an academic medical centre.

AbstractBackground: Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis remains a major cause of morbidity and mortality, especially in tertiary-care facilities. Recombinant human activated protein C reduces mortality in patients with severe sepsis, but trial data indicate that the benefit of the drug is confined to the more seriously ill patients, while the risk of bleeding complications can be considerable. The cost of the drug is approximately

A safe practice standard for barcode technology.

US6000–8000 per treated patient. Integration of this product into routine care has produced unique challenges concerning clinical decision making, safety and cost. Objectives: To describe one hospital’s multidisciplinary approach to the adoption of this new medication. Methods: Before activated protein C was approved for use, Brigham and Women’s Hospital (BWH) convened a working group to formulate clinical guidelines proactively. This new agent did not fit into an obvious therapeutic category but cut across multiple clinical disciplines requiring the involvement of several hospital departments in developing policy. As new data on efficacy emerged during the US FDA review of the drug, the working group had to devise a method for using the available information to assist clinical decision making while placing appropriate restrictions on the use of activated protein C. The goal was to make accurate information available to guide ordering physicians’ decision making interactively, 24 hours a day. Results: The committee developed a utilisation policy for activated protein C that provided guidance on patient selection, contraindications and risk stratification. Interactive computer-based order entry screens were developed to guide physicians through a complex set of clinical criteria to ensure appropriate evidence-based use. A careful review of contraindications is required as a second step. To risk stratify patients in accordance with the trial subset analyses and the FDA labelling guidelines, ordering physicians are guided in calculating an APACHE II (Acute Physiology and Chronic Health Evaluation) score for the patient. Physicians from several specialties are available for advice and consultation on patients with difficult or controversial conditions. Approximately two-thirds of completed orders passed the clinical algorithm; an additional 35% of patients did not meet the medication criteria but received the drug after the attending physician requested an override of the guidelines. Conclusion: The BWH approach to activated protein C used an innovative multidisciplinary approach and computer-assisted order entry to guide clinical use of a new agent with substantial clinical efficacy, risks and costs. This approach provides a model for strategies to deal with other new and complex medical technologies.