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ARTICLE |
a Center for Pediatric Quality, Women and Children's Hospital of Buffalo, Buffalo, New York
b Departments of Pediatrics
d Otolaryngology, School of Medicine and Biomedical Sciences
c School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, New York
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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OBJECTIVE. The purpose of this study was to reduce the risk of harm to children resulting from prescribing errors.
METHODS. We sequentially implemented patient safety initiatives over a 1-year time frame at a pediatric tertiary care academic facility. The initiatives included an educational Web site with competency examination, distribution of a personal digital assistant-based standardized dosing reference, a zero-tolerance policy for incomplete or incorrect medication orders, prescriber performance feedback, and presentation of outcome data at citywide grand rounds. A total of 8718 orders were collected and analyzed to assess the impact of these initiatives.
RESULTS. The absolute risk reduction from prescribing errors was 38 per 100 orders, with a relative risk reduction of 49%. Web-based education with point-of-care drug references and a zero-tolerance policy for incomplete or incorrect orders were most effective in decreasing potential adverse drug events. Documentation of appropriate weight-based dosing and indication for therapy increased by 24% and 42%, respectively.
CONCLUSIONS. Process-improvement initiatives focusing on prescriber education and behavior modification can reduce the risk of harm to pediatric patients from prescribing errors.
Key Words: patient safety • medication errors • adverse events • risk reduction • pediatric
Abbreviations: ADE—adverse drug event • CPOE—computerized physician order entry • FFF—forced-format form • WCHOB—Women and Children's Hospital of Buffalo • pADE—potential adverse drug event • CHECKS—Children's Hospital Ensuring Comfort and Kids Safety • PDA—personal digital assistant • ICD-9—International Classification of Diseases, Ninth Revision
Medication management is a complex, multifaceted system, which is prone to error during any one of the steps within the process. The act of prescribing medications has been shown to be a significant source of such error. Prescribing errors occur far upstream in the process, and as such, their effects can be perpetuated, and sometimes even exacerbated, in subsequent steps. Some errors result in adverse drug events (ADEs), which cause harm to patients and increase health care costs.1–14
Prescribing errors are of particular concern in the pediatric population for which dosing based on weight or body surface area must be precise.14–23 Children, particularly young infants, have unique physiology and an immature ability to metabolize drugs. These factors place them at greater risk for ADEs.
Medication prescribing involves both cognitive and technical components. Process-improvement initiatives must, therefore, focus on education in the safe and correct use of medications, as well as behavior modification to ensure clear communication of the prescription itself. Computerized physician order entry (CPOE) has been offered as a tool to help effectuate safe and correct prescribing practices. Studies have shown that CPOE can reduce prescribing errors, potential ADEs, and actual ADEs.24–26 However, there is also literature to suggest that implementation of CPOE may increase harm to patients in some settings.27,28
Less than 10% of hospitals in the United States have CPOE systems completely available.29 CPOE systems are expensive, and successful implementation requires changes in the culture and processes of a hospital, a task requiring enormous investments in time, labor, and resources. For many institutions, these factors are prohibitive for adopting such systems in the near future. Alternative methodologies to promote safe prescribing practices must, therefore, be sought and investigated.
The purpose of this study was to assess the impact of a series of process-improvement and educational initiatives aimed at reducing prescribing errors. These initiatives were built on the foundation of a previously established forced-format form (FFF) for medication orders, a precursor to CPOE.30 The FFF promotes good prescribing habits by requiring documentation of the cognitive aspects of therapeutic decision-making, including indication for therapy, and standardizing prescribing mechanics. Impact was assessed in terms of reduction of risk for ADEs from prescribing over a 1-year time period.
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METHODS |
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12000 admissions.
Operational Definitions
An "original order" was defined as a medication order written de novo by a prescriber, to be differentiated from an order rewritten by the prescriber after having been returned by the pharmacy. A "start order" refers to an order to initiate therapy, as opposed to an order to renew or discontinue therapy. All of the medication orders described in this article refer to original start orders unless otherwise specified.
A "complete order" was defined as containing all of the following elements appropriate for that order: medication name, weight-based dosing (eg, milligrams per kilogram per day), dose, route, interval, and indication for therapy. An order was considered correct if all of the components were consistent with standard pediatric dosing guidelines. Prescribers were required to document "max dose" or "adult dose" for weight-based dosing that reached or exceeded maximum or adult recommendations.
A "potential ADE" (pADE) was defined as any medication order that was not wholly complete and correct. In other words, any medication order with missing or incorrect information was considered a pADE.
Process-Improvement Initiatives
Sequential patient safety initiatives were implemented at WCHOB over the course of a 1-year period from June 2003 through June 2004 (Table 1). After each initiative, pediatric medication orders were collected from the medical and surgical units, the PICU, and the NICU and then analyzed to assess the effect. The 6 initiatives (and the baseline) are described below, including the number of orders analyzed for each.
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New Housestaff Orientation
Through a collaboration with the State University of New York at Buffalo Graduate Medical Dental Consortium, a Web-based pediatric patient safety educational program called the Children's Hospital Ensuring Comfort and Kids Safety (CHECKS) Web site was incorporated into new housestaff orientation. The CHECKS Web site contains a tutorial designed to teach clinicians general principles of patient safety with specific attention to pediatrics. A case scenario is then used to test the user's skills in writing 4 pediatric medication orders. The Web site directs the user to correct any mistakes made until all 4 of the orders are complete and correct. Once this is accomplished, the user, as well as the hospital patient safety officer, receives notification that he/she has successfully completed the program and is certified to write pediatric medication orders at our facility. An electronic record was kept of all of the users who successfully complete the Web site. All of the incoming residents, regardless of specialty or level of training, were required to complete this training as a prerequisite for beginning their clinical duties. The inclusion of all of the housestaff presumed that most would rotate through the WCHOB at some point in their training, and all might potentially care for a child in an emergent setting. After the new housestaff completed the Web site and were credentialed to write orders, another 1-week sample of medication orders was collected in early July 2003 (n = 976).
Clinical Staff Education and Implementation of Standardized Electronic Dosing Reference
In October 2003, an institution-wide campaign was launched to have all of the clinical staff, including physicians, registered nurses, and pharmacists, complete the Web-based educational program. During this same time frame, a handheld electronic pediatric dosing reference (Pediatric Lexi-Drugs) was provided to all of the prescribers. For those prescribers who did not already possess a personal digital assistant (PDA), one was provided to them. Completion of the Web site was a requirement for the dosing reference and supplied PDAs. A 2-week sample of medication orders was collected after implementation (n = 1536).
Zero-Tolerance Policy
In November 2003, a zero-tolerance policy was implemented for incomplete or incorrect orders. Any medication order deemed by the nursing or pharmacy staff to be incomplete or incorrect was returned to the prescriber to be rewritten. Stickers with the phrase "please clarify and rewrite" were used to highlight these orders. A 2-week sample of medication orders was collected after this initiative (n = 1524).
Prescriber Feedback
In February 2004, all of the prescribers at our institution were provided with feedback. The 50 highest-volume prescribers were provided with individualized reports. All of the prescribers were given institution-wide performance averages. After the prescribers received the feedback, another 1-week sample of medication orders was collected and analyzed (n = 1908).
Academic Presentation
Institutional data were presented at citywide pediatric grand rounds in April 2004, after which a 1-week sample of medication orders was collected and analyzed (n = 1007).
Final Sample
In June 2004, a 1-week sample of medication orders was collected and analyzed (n = 996). This sample established the baseline for the new academic year, analogous to the July 2003 sample, with the departure of senior housestaff and the influx of new housestaff who completed the CHECKS Web site during their orientation.
Data Analysis
A relational database, referred to as Safe Prescriber Order Tracking (SPOT CHECKS), was designed to track order completeness and correctness. Data entry was performed by a registered nurse stationed within the inpatient pharmacy and supervised by a clinical pharmacist. Thirty-eight variables were assessed and evaluated per order reflecting both the cognitive aspects (ie, correctness) and the mechanics (ie, completeness). Questions regarding evaluation of an order were referred to a registered pharmacist. Data were analyzed, and statistics were computed using Microsoft Excel (Microsoft, Redmond, WA), SAS (SAS Institute, Cary, NC), and SPSS (SPSS Inc, Chicago, IL) software packages. Only original start orders for pediatric patients were included in the data sets for analysis.
Absolute risk reduction was calculated as the difference between the baseline and postintervention risks. Relative risk reduction was calculated as the absolute risk reduction divided by the baseline risk, converted to a percentage:
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2 tests. |
RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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As new patient safety initiatives were sequentially implemented, the number of pADEs trended downward. Table 2 shows the pADE rate and change in pADE rate after each intervention. Figure 1 depicts these results graphically.
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Subanalysis was performed for the 2 components not traditionally included in a medication order: weight-based dosing and the indication for therapy. At baseline, 50% of the medication orders for which weight-based dosing was appropriate contained the correct information. At the end of the study, 74% had the correct information documented (2 = 85.95; P < .001). Indication for therapy was documented on 40% of the medication orders at baseline. By the end of the study period, 82% of orders contained this information (2 = 229.66; P < .001).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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pADEs are, in effect, a measure of risk. An incomplete medication order requires assumptions to be made on the part of the nurse and/or pharmacist. These assumptions can be erroneous, thereby putting the patient at risk of harm. An order written without units could result in 5 mg being administered instead of 5 mcg. An order written without route of delivery could result in an oral solution being administered intravenously. Perhaps more alarming is incorrect information, which, if not detected and corrected, undoubtedly places the patient at risk of harm. By reducing the number of pADEs, the risk of actual ADEs may be reduced.
Years of attention have been invested in the issue of patient safety, yet accurate measurement of the prevalence of medical errors and incidence of actual adverse events remains elusive. Even the Institute of Medicine report To Err is Human1 described the scope of harm inflicted by medical errors using broad margins. Incident reporting, the traditional method of quantifying this data, is affected by too many factors to be reliable. Time constraints, cumbersome reporting tools, severity and visibility of the event, blameful versus blameless environments of reporting, fear of retribution by colleagues or sanctions by regulatory agencies, and the awareness of surveillance itself influencing the reporting behavior are just some examples of these factors. Without the ability to reliably measure ADEs, it will remain difficult to discern whether variations in ADE rates are true changes or merely artifact resulting from the influences described above.
Our group focused on risk reduction using a consistent, objective methodology independent of incident reports. Because pADEs would be expected to increase the risk of an error reaching the patient, reduction in the number of such potential events should result in the reduction of actual events. Quantifying the correlation between pADEs and actual ADEs is currently under study.
The statistically significant increase in pADEs seen after new housestaff orientation in 2004 would, at first glance, seem to suggest ineffectiveness of the initiative. However, this time frame represents data after an influx of new trainees and an egress of the senior housestaff, that is, a significant change in the prescriber population. A more relevant comparison is that between the baseline pADEs rates at the beginning of each academic year, which did show significant improvement.
Weight-based dosing is a key concept in safe pediatric prescribing. Therefore, we require its documentation on all of the medication orders at our institution and include it as a requisite part of a complete order. This safety practice is even more crucial in an academic institution where rotating housestaff with minimal to no pediatric experience may not know that, in children, "one dose does not fit all." Documenting the weight-based dose, as well as the actual dose, allows both nurses and pharmacists to more efficiently and effectively double-check safe dosing and intercept pADEs.
Indication for therapy is rapidly being recognized as essential for improving medication safety in the hospital setting. This information ensures that appropriate therapy is being provided for the appropriate clinical condition and serves as a safety-check mechanism for nurses and pharmacists. The following anecdote illustrates this point:
In the NICU, a physician wrote an order for aminophylline, citing "sepsis" as the indication for therapy. The order was transcribed and sent to the inpatient pharmacy. The pharmacist noted the apparent discrepancy between the medication ordered and its intended use and called the physician. The physician immediately recognized her error: she meant to write an order for amphotericin. The mistake was immediately corrected, and the patient received the proper therapy.
This patient clearly would have suffered significant morbidity, if not mortality, from the delay in necessary therapy. There was also the potential for the adverse effects from unnecessary therapy had the indication not been included in the order.
Although indication for therapy has not been routinely required on medication orders, the concept is already embedded in other clinical arenas. Diagnostic laboratories request indication in the form of an International Classification of Diseases, Ninth Revision (ICD-9) code before testing is performed. Imaging centers request an ICD-9 code before proceeding with radiologic studies. Ironically, indication has become mainstream for these processes, neither of which generally put patients at risk of harm, but has been only recently recognized for drug therapy that can and does put patients at risk every day.
Indication has benefits beyond those described for patient safety and appropriateness of therapy. We have linked the most common indications for therapy at our institution to the corresponding ICD-9 code. This will allow for tracking and assessment of drug use by clinical indication, providing outcomes data that can be used to establish best practices.
Finally, our organization learned a great deal from this series of initiatives about influencing physician behavior. As was shown in our "Results" section, the greatest single improvement, 37.7%, was experienced with the zero-tolerance policy. This underscores that neither technology nor education alone can produce as great a change in behavior as can the simple establishment of a legitimate safety-related policy of zero tolerance. Implementation, dissemination, and enforcement by a vigilant clinical team of practicing physicians, nurses, and pharmacists were paramount to the success of this initiative.
Our results should be interpreted cautiously. Selection bias was unlikely to have caused the apparent difference in pADE rates, because all of the medication orders from the medical, surgical, and intensive care units were collected over a minimum of 7 days for each time period. In addition, time frames were specifically selected to represent the effect of each initiative. Evaluator bias was addressed by having only 1 nurse clinician evaluate all of the orders using an objective set of criteria, optimizing internal validity. Orders in question were adjudicated by a registered pharmacist. Prescribers were not aware of the data collection, thereby eliminating surveillance bias.
Reducing the risk of ADEs requires a change in the culture of medication management. This daunting but surmountable task can be facilitated by sequential implementation of patient safety initiatives aimed at multiple operant factors. This ongoing process requires strong leadership in implementation, as well as vigilance in clinical education, dissemination of safer practices, and surveillance of outcomes.
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ACKNOWLEDGMENTS |
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We recognize Kristen Martin, chief administrator for the Center for Pediatric Quality and project manager for this study, for invaluable contributions.
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FOOTNOTES |
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Address correspondence to Michael S. Leonard, MD, MS, Women and Children's Hospital of Buffalo, 219 Bryant St, Buffalo, NY 14222. E-mail: mleonard{at}upa.chob.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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