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Medication error reporting in rural critical access hospitals in the North Dakota Telepharmacy Project David M. Scott, Daniel L. Friesner, Ann M. Rathke, and Shelly Doherty-Johnsen

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edication “quality-related events” (QREs), which include medication errors and adverse drug events (ADEs), are a major concern for pharmacists. Each year, as many as 1.5 million individuals are harmed by ADEs,1 of which nearly 7000 result in death.2 The economic costs of ADEs are in excess of $3.5 billion per year.1 While precise accounts of ADE incidence rates are impossible to obtain due to the variety of empirical definitions and criteria used,3 studies within institutional settings generally estimate the incidence of ADEs at between 2% and 7%.4 Much of the literature on ADEs contends that their genesis lies in the process of providing pharmacy services rather than with individuals or participants in the health care process (e.g., physicians, pharmacists, nurses).5 For example, Bates and colleagues6 conducted a series of studies examining the impact of ADEs in a large urban hospital. In one of these inpatient studies, 56% of all ADEs occurred at the stage of ordering, 6% at the transcribing stage, and 4% and

Purpose. Results of a study of medication “quality-related events” (QREs) at critical access hospitals (CAHs) participating in a telepharmacy project are reported. Methods. Rates and types of medication QREs (i.e., all types of drug therapy problems requiring pharmacist intervention) were evaluated at 17 CAHs receiving telepharmacy services from a central orderentry site in the North Dakota Telepharmacy Project (NDTP). During the 17-month study, remote pharmacists used telepharmacy technology to review medication orders prepared at the CAH sites, identify and address QREs, and code clinical interventions. The collected data were analyzed via chisquare testing. Results. Cumulative monthly medication orders at the CAH study sites ranged from a low of 12,535 in the first month of the study to a high of 18,257. Monthly rates of visual medication verification and clinical

34% at the dispensing and administration stages, respectively. Two other inpatient studies estimated that half of medication errors occurred at the drug ordering stage7,8 and about half at the administration stage.9,10 Cina and colleagues11 found that nearly

David M. Scott, M.P.H., Ph.D., B.S.Pharm., is Professor; Daniel L. Friesner, Ph.D., is Professor and Associate Dean of Student Affairs and Faculty Development; and Ann M. Rathke, M.A., M.Ed., is Coordinator, North Dakota Telepharmacy Project, College of Pharmacy, Nursing, and Allied Sciences, North Dakota State University, Fargo. Shelley Doherty-Johnsen, B.S.Pharm., is Director, ePharmacist Direct, Catholic Health Initiatives, Fargo. Address correspondence to Dr. Scott ([email protected]).

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intervention ranged from 8.0% to 14.2% and from 1.3% to 3.1%, respectively. Overall, the most frequently identified QREs were transcription errors, which accounted for 2,389 interventions (43.3%); 2,078 interventions (37.7%) targeted prescribingrelated QREs. The most frequently cited intervention codes were for dosage adjustments (n = 547), deep venous thrombosis prophylaxis (n = 437), pharmacokinetic consultation (n = 268), renal dosing (n = 182), and the prevention of minor (n = 148) and major (n = 94) adverse drug events. Conclusion. The study results indicate that the NDTP telepharmacy model is effective in identifying and resolving QREs in CAHs. The use of the telepharmacy services increased over the study period, suggesting that CAH practitioners became more comfortable using the technology on a regular basis to enhance patient safety. Am J Health-Syst Pharm. 2014; 71:58-67

4% of drug orders had some sort of mistake, and while the pharmacy staff caught most of these mistakes, some undetected mistakes left the pharmacy. Of the undetected errors, 24% resulted in ADEs, of which one fourth posed the potential for serious

Supported by grant 4D1BTM 00051-03-03 from the Office for the Advancement of Telehealth, Health Resources and Services Administration, and a grant provided by the North Dakota Board of Pharmacy. The authors have declared no potential conflicts of interest. Copyright © 2014, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/14/0101-0058$06.00. DOI 10.2146/ajhp120533

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harm to patients and 1% were lifethreatening. Background At large hospitals, there is typically a sufficient number of pharmacy staff to implement and continually assess pharmacy services to minimize the frequency and impact of ADEs. Not surprisingly, most of the published research on ADEs has been conducted in large tertiary care centers.4-6,8-12 However, smaller hospitals, many of which are designated as critical access hospitals (CAHs), face a variety of unique challenges in minimizing the frequency and impact of ADEs. The designation CAH was created as a part of the 1997 Balanced Budget Act to preserve the financial viability of rural hospitals. To be designated as a CAH, the facility must be located in a rural area, provide a limited but well-defined set of services, and have no more than 25 inpatient beds.13 For a given payment code, CAHdesignated facilities are eligible to receive cost-based reimbursement, which exceeds payments to nonCAH facilities. In 2011, there were over 1300 CAHs, which represented nearly 30% of all U.S. community hospitals.14,15 Despite greater per-unit reimbursement, low patient volumes generally mean that CAHs have limited financial resources. This lack of resources is generally sufficient to prevent a CAH from earning Joint Commission accreditation, which would require well-defined qualityimprovement initiatives to minimize the incidence of ADEs.16,17 A lack of resources and location in a rural area also create challenges for facilities in hiring and maintaining sufficient pharmacy services staff to provide 24-hour pharmacist coverage. For example, a random sample of CAHs were surveyed about their qualityimprovement practices. Only 20% of respondents were Joint Commission accredited, nearly 80% dispensed most oral medications in unit dose

form, 76% had a pharmacist review medication orders within 24 hours, and 43% had a pharmacist onsite less than 20 hours per week.16 As a result, CAHs are more likely to have more variability in how pharmacy services are delivered, much less pharmacist participation in the delivery of those services (including medication review), and weaker protocols in place to prevent ADEs.16,17 Investigators in two studies concluded that limited pharmacist coverage has an adverse impact on the pharmacist’s ability to ensure medication safety.16,18 These conditions may also create a culture where the staff values the status quo and may not initially see the added value in enhanced medication safety protocols.19 A 2011 survey of U.S. hospitals suggested that these trends continue to exist.20 The results indicated that hospitals with fewer than 50 beds were less likely to require pharmacists to review and approve medication orders prior to delivery, more likely to outsource pharmacy services, and more likely to require registered nurses to prepare i.v. doses or manipulate oral doses. The challenges faced by CAHs are compounded by increasing pressure from the Joint Commission, the Centers for Medicare and Medicaid Services, and other regulatory and accrediting agencies for all hospitals to improve patient safety by instituting 24/7 (i.e., round-the-clock) pharmacist review of medication orders. Telepharmacy initiatives One approach that has been advocated as a way for small rural hospitals with limited pharmacist coverage to obtain additional pharmacist resources is through the use of telepharmacy. Telepharmacy involves the use of telecommunications technology to deliver health-related services, information, and education to medically underserved communities, a high percentage of which are rural. Telehealth initiatives (which include

telepharmacy) seek to improve access to care, lower the cost of delivery, and, ultimately, improve patient outcomes.21 The National Association of Boards of Pharmacy (NABP) defines telepharmacy as “the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance.”22 In recognition of the evolving role of telepharmacy, NABP has incorporated the practice of telepharmacy within and across state lines into the scope of pharmacy practice.23 A key feature of the North Dakota Telepharmacy Project (NDTP) is that the pharmacist remains the primary health care provider in the delivery of pharmacy services. 24-27 North Dakota was among the first states to adopt telepharmacy. In 2001, the North Dakota Board of Pharmacy, in conjunction with North Dakota State University (NDSU) and the North Dakota Pharmacists Association, drafted and approved temporary rules for the practice of telepharmacy in the state. In 2008, NDSU received a federal grant from the Health Resources and Services Administration to partner with Catholic Health Initiatives (CHI) to establish a central orderentry (COE) site in Fargo designed to deliver clinical pharmacy services via telepharmacy to CAHs choosing to contract for these services. The goal of the NDTP is to restore, retain, or establish pharmacy services in medically underserved rural communities in North Dakota. The telepharmacy rules developed by the state board of pharmacy addressed the major concerns of the state’s practicing pharmacists regarding the roles and interaction of pharmacists at the COE site and pharmacy technicians and nursing staff at the remote dispensing site. One concern was that the remotesite technicians and nursing staff would be asked to perform tasks beyond their qualifications.28 In a CAH setting, this concern is less pressing

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because nurses and other clinical staff already participate in the medication dispensing process regardless of qualifications. Adding central site services simply provides an extra layer of pharmacist oversight to ensure effective drug therapy and further reduce the incidence of ADEs. In these cases, staff “buy-in” at the CAH remote site is crucial to ensure that the CAH staff understands the benefits and costs of the technology (i.e., the extra oversight may be slightly more cumbersome, but it reduces the potential for ADEs). A number of recent studies have examined the impact of telepharmacy technology in a community pharmacy setting. The results of the studies have shown that the practice is financially viable,29 patient satisfaction with the technology is high,30 and rates of medication mistakes are comparable to those of traditional community pharmacies and the corresponding central site pharmacies.31,32 However, less is known about the impact of the technology in a CAH setting, especially the impact on the incidence of ADEs, and only a handful of studies have examined ADEs in this setting.17-19 The purpose of the study described here was to measure medication QREs in CAHs that use the NDTP technology. The investigators postulated that the telepharmacy sites dispense prescriptions in a manner that meets current practice standards and, hence, that telepharmacy dispensing and related QRE rates are consistent with those in traditional hospital pharmacies. As a corollary study objective, since the literature does not provide a plethora of information concerning the numbers and types of QREs, the distribution of such problems was quantified as a benchmark for future research. Lastly, because fostering organizational buy-in by CAH staff and staff familiarity with telepharmacy protocols takes time, we investigated the numbers and rates of drug therapy 60

problems, both overall and by major category, and their variation over the course of the project. Methods Definitions. The literature posits a number of definitions of potential and actual mistakes in the provision of pharmacy services. A well-known study by Bates et al.6 examined ADEs, which were defined as only those mistakes that reach the patient and have the potential to cause harm. Other researchers have used the broader term medication errors, which may include not only ADEs but other mistakes that may or may not cause the patient direct harm (e.g., typographical errors on the medication label).8-12 In the study described here, we used the term QREs, which includes any rationale for a pharmacist to intervene in a drug therapy process.31,32 Thus, QREs include situations that require a prescriber to clarify an order, as well as any errors that require remedial pharmacist action, including the resolution of ADEs. This definition facilitated an analysis that is consistent with the literature but required us to disaggregate our QRE measures into subcategories so that the resulting data could be compared with data from other studies that focused on ADEs or other more specifically defined types of drug therapy problems. Participating rural CAHs. Seventeen CAHs in North Dakota (n = 10) or northwestern Minnesota (n = 7) participated in the study. Twelve of the 17 rural hospitals are CHI affiliates. All 17 hospitals receive telepharmacy services from CHI’s COE site. Four of the 17 hospitals are Joint Commission–accredited facilities. A project standardization team established a QRE reporting system with the assistance of the Alliance for Patient Medication Safety, a federally listed patient safety organization. This article focuses on the rates and types of QREs that occurred at the CAHs over 17 months, from April

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2010 (the month the system was launched) through August 2011 (the month the study concluded). Characteristics of the CAHs, pharmacy staffing levels and hours of service, and details on the technical and managerial challenges of implementing the telepharmacy technology (including the QRE reporting system) are reported elsewhere.33 COE site operations. CHI is a national, nonprofit health system based in Denver, Colorado, that operates in 19 states and includes 75 hospitals, with 19 of them being CAHs. The CHI-operated COE site for the NDTP, known as ePharmacist Direct and located in Fargo, was initially staffed for 10 hours a day by two fulltime pharmacists and one part-time pharmacist; the staffing hours were subsequently extended to provide 24/7 coverage to the CAHs. The central site communicates with connected CAHs in real time via camera and computer. Staff pharmacists at the CHI hub site review and verify medication orders, observe medication preparation, perform remote order entry, monitor therapy for potential interactions, and consult with nurses, pharmacy technicians, physicians, and patients as needed.34 Identifying, defining, and resolving ADEs. Some CAHs served by ePharmacist Direct have electronic medication order-management systems, while others have paper-based systems. When an automated dispensing device is used, new medication orders are entered into an electronic patient profile; then the profiled medications can be removed by CAH nursing staff from the automated medication cabinet and administered to a patient. At CAHs not using automated dispensing devices, medications are prepared by nurses or pharmacy technicians and then photographed using a highresolution document-imaging camera for visual verification by the telepharmacist. When the COE site pharmacist identifies a QRE and

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commences an intervention, the intervention is determined to be of major importance or of less than major importance. For major interventions, the pharmacist communicates with the CAH staff via phone or audio–video link to specify the intervention and expedite the resolution of the problem; for other interventions, the pharmacist completes a Clinical Intervention Communication form, which is faxed to the CAH for documentation in the patient chart.35 COE site pharmacists are responsible for documenting QREs on at least a daily basis. Each CAH facility has a unique designation in a Microsoft Access–based system (Microsoft Corporation, Redmond, WA). COE staff members track the total number of orders as well as the total number of orders for which pharmacists perform visual order verification. Visual verifications that require pharmacist intervention are also recorded using a set of predefined intervention codes (appendix). These intervention codes can be aggregated into five general categories: administration, dispensing, transcription, prescribing, and all other. For simplicity, we focused initially on overall QRE metrics, subsequently examining the five general intervention categories and their components. Because the project was essentially a pilot study of a new clinical practice model, primary emphasis was given to describing major trends in QREs rather than extensive testing of specific hypotheses. Because all 17 CAHs did not contribute to the data set throughout the entire study (1 or 2 hospitals were added per month over the first 8–9 months, and use of the technology varies according to the staffing needs of each CAH), we focused on the rates of specific QREs and the frequencies of QREs within specific time periods during which CAH participation was constant in order to ensure comparability across CAHs and over time. A decision was

made to include the entire 17-month evaluation window rather than only the last 6–12 months (a period during which all 17 sites were able to report QREs) in order to comprehensively capture changes over time in the use of the system. Data analysis. The COE site reported QREs on at least a daily basis into the database system, and the data were downloaded and analyzed in Microsoft Excel (Microsoft Corporation). From the collected data, the investigators first determined the numbers and rates of QREs over the 17-month study period. For this period, QRE rates were calculated by dividing the total number of QREs by the total number of medication orders filled. Hypothesis tests were subsequently conducted to examine differences over time or across QRE categories. Given the discrete nature of the data (event counts and rates by month and QRE category), all hypothesis tests were operationalized using the chi-square test of homogeneity and a 5% significance level. The methods of data collection and analysis were approved by the NDSU institutional review board (IRB). Due to the aggregated data reporting required for IRB approval, it was infeasible to conduct more detailed statistical analyses, including (but not limited to) the construction of survival curves. Results Total drug orders, visual medication verifications, and clinical interventions. As shown in Table 1, the total monthly drug orders over the 17-month study period ranged from a low of 12,535 in the first month of the study (April 2010) to a high of 18,257 in May 2011. The total number of drug orders generally increased over the 17 months of the study (p < 0.05 for April through December 2010 only, January through August 2011 only, and the entire 17 months). Visual medication verifications ranged from a

low of 1,396 in April 2010 to a high of 2,032 in February 2011 (p < 0.05 for April through December 2010 only, January through August 2011 only, and the entire 17 months). Visual medication verifications as a percentage of total orders ranged from 8.0% in July 2011 to 14.2% in December 2010, indicating no statistically significant variation over time (p > 0.05 for all month-to-month comparisons. Also shown in Table 1 are data on total interventions, which ranged from a low of 175 in April 2010 to a high of 449 in August 2011 (p < 0.05 for all month-to-month comparisons). Clinical interventions as a percentage of total drug orders ranged from 1.3% in June 2010 to a high of 3.1% in September 2010. As with the visual medication verifications, there were no significant variations over time in the monthly percentages of total orders requiring an intervention (p > 0.05 for all month-to-month comparisons). Thus, while the cumulative use of the COE site’s services increased over time, there was a high degree of consistency from month to month in the percentage of those orders requiring verification and intervention. Clinical interventions by QRE category. Table 2 reports on the total number of clinical interventions and how they related to designated medication error categories over the course of the study. Overall, the mean number of interventions per month was 299.3 in 2010 and 353.0 in 2011. The highest number of errors was in the transcription category, followed closely by the prescribing, all other, administration, and dispensing categories. Averaged over multiple months, the highest error rates were in the transcription category (139.8 per month over nine months in 2010 and 141.4 per month over eight months in 2011), and the second highest rates were in the prescribing category (105.3 per month in 2010 and 141.3 per month in 2011). Aver-

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Table 1.

Cumulative Telepharmacy Drug Orders, Visual Verifications, and Clinical Interventions at the 17 CAH Study Sitesa Yr and Mo 2010 Apr May Jun Jul Aug Sep Oct Nov Dec Total c2 p 2011 Jan Feb Mar Apr May Jun Jul Aug Total c2 p Cumulative total (Apr 2010– Aug 2011) c2 p

Total Drug Orders

Visual Verifications

Clinical Interventions

n

12,535 14,824 14,371 13,992 14,744 13,126 14,159 14,569 13,837 126,157 331.957 0.999

1.40 1.57 1.28 1.78 2.58 2.69 3.05 2.52 2.32 2.14 0.015c >0.999

15,357 15,705 18,048 17,803 18,257 17,768 16,830 17,289 137,057 482.265

Medication error reporting in rural critical access hospitals in the North Dakota Telepharmacy Project.

Results of a study of medication "quality-related events" (QREs) at critical access hospitals (CAHs) participating in a telepharmacy project are repor...
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