Development of a sterile compounding training and competency program at a large academic medical center.

PURPOSE: This article is one of the 5 articles describing steps taken to enhance sterile compounding compliance at a large, multisite academic medical center. This article focuses on the development of a comprehensive personnel training and assessment program for sterile compounding. SUMMARY: Increased regulatory oversight and the release of new United States Pharmacopeia chapters motivated the reenvisioning of the medical center's sterile compounding personnel training and assessment program. The main challenges facing any entity undertaking sterile compounding include identification of compounding staff, development of policies and procedures, and baseline and ongoing training including observational competency assessments and record keeping. These challenges are exacerbated by high work volumes and variation in compounding practices encountered within a large multisite institution. Our organization developed a team of specialized pharmacists and pharmacy technicians to implement and enforce changes promoting the safe production and use of compounded sterile products and meet rising regulatory requirements. This team worked within various operational areas to customize purchased policies and procedures and group compounding staff based on training needs. The team performs ongoing personnel monitoring and training of new compounders in a shared training space. Challenges encountered and future considerations for program enhancement are described. CONCLUSION: Implementation of standards and enforcement of staff behaviors in a large academic medical center is perhaps best completed by a team of highly trained experts working in collaboration with supervisors and using a dedicated training and testing space, as evidenced by the success of the described program in overecoming past challenges.

A compounding compliance team at an academic medical center.

PURPOSE: Highly publicized safety issues arising from poor sterile compounding practices in facilities around the United States have garnered substantial attention in recent years. This attention has led to increased scrutiny of health systems by regulatory bodies, new regulatory requirements, and changes to existing regulations or their interpretation. Health systems are often resource constrained, and the added work resulting from this scrutiny challenges pharmacy departments in meeting regulatory requirements and United States Pharmacopeia chapter 797 standards for sterile compounding. This article describes the creation of a dedicated compounding compliance team (CCT) and the team's responsibilities in support of pharmacy operations in achieving compliance with those standards. SUMMARY: Visits to our organization by several regulatory bodies resulted in findings that required substantial work in order to achieve compliance with sterile compounding standards. Given the number and complexity of findings and the need for timely resolution, it was felt that specialized staff were needed to understand, evaluate, and correct identified deficiencies and help the already overburdened staff and leadership comply with existing standards. A CCT was formed, and work was simultaneously initiated on ensuring proper credentialing and training of all compounding staff, development of standard operating procedures, improvements in facilities, environmental monitoring, equipment certifications, practice auditing, and documentation. Key activities of the team included strategic planning, building relationships, communicating with stakeholders, self-education, and record keeping. Key partners included environmental services, facilities, and infection prevention and control personnel and departmental staff and leaders. CONCLUSION: The formation and collaborative work of a CCT at an academic medical center was successful in changing the culture of the organization and achieving compliance during visits from several regulatory agencies.

The impact of drug order complexity on prospective medication order review and verification time.

OBJECTIVE: To assess if the amount of time a pharmacist spends verifying medication orders increases as medication orders become more complex. MATERIALS AND METHODS: The study was conducted by observing pharmacist verification of adult medication orders in an academic medical center. Drug order complexity was prospectively defined and validated using a classification system derived from 3 factors: the degree of order variability, ISMP high-alert classification, and a pharmacist perception survey. Screen capture software was used to measure pharmacist order review time for each classification. The annualized volume of low complexity drug orders was used to calculate the potential time savings if these were verified using an alternate system that did not require pharmacist review. RESULTS: The primary study hypothesis was not achieved. Regression results did not show statistical significance for moderate (n = 30, 23.7 seconds, sd = 23.3) or high complexity (n = 30, 18.6 seconds, sd = 23.1) drugs relative to the low complexity drugs (n = 30, 8.0 seconds, sd = 14.4) nor for moderate vs high complexity; (ßmoderate vs low = 15.6, P = .113), (ßhigh vs low = 10.3, P = .235), (ßmoderate vs high = 5.3, P = .737). The sensitivity analysis showed statistical significance in the high vs low comparison (ßhigh vs low = 13.8, P = .017). DISCUSSION: This study showed that verifying pharmacists spent less time than projected to verify medication orders of different complexities, but the time did not correlate with the classifications used in our complexity scale. Several mitigating factors, including operational aspects associated with timing antimicrobial orders, likely influenced order verification time. These factors should be evaluated in future studies which seek to define drug order complexity and optimize pharmacist time spent in medication order verification. CONCLUSION: The findings suggest that there may be other factors involved in pharmacist decision-making that should be considered when categorizing drugs by perceived complexity.

Surface contamination of counting tools after mock dispensing of cyclophosphamide in a simulated outpatient pharmacy.

PURPOSE: The primary aim was to determine if dispensing of cyclophosphamide tablets resulted in accumulated residue on pharmacy counting tools during a simulated outpatient dispensing process. Secondary objectives included determining if cyclophosphamide contamination exceeded a defined threshold level of 1 ng/cm2 and if a larger number of prescriptions dispensed resulted in increased contamination. METHODS: Mock prescriptions of 40 cyclophosphamide 50 mg tablets were counted on clean trays in three scenarios using a simulated outpatient pharmacy after assaying five cleaned trays as controls. The three scenarios consisted of five simulated dispensings of one, three, or six prescriptions dispensed per scenario. Wipe samples of trays and spatulas were collected and assayed for all trays, including the five clean trays used as controls. Contamination was defined as an assayed cyclophosphamide level at or above 0.001 ng/cm2 and levels above 1 ng/cm2 were considered sufficient to cause risk of human uptake. Mean contamination for each scenario was calculated and compared using one-way analysis of variance. P-values of < 0.05 implied significance. RESULTS: Mean cyclophosphamide contamination on trays used to count one, three, and six cyclophosphamide prescriptions was 0.51 ± 0.10 (p=0.0003), 1.02 ± 0.10 (p < 0.0001), and 1.82 ± 0.10 ng/cm2 (p < 0.0001), respectively. Control trays did not show detectable cyclophosphamide contamination. Increasing the number of prescriptions dispensed from 1 to 3, 1 to 6, and 3 to 6 counts increased contamination by 0.51 ± 0.15 (p = 0.0140), 1.31 + 0.15 (p < 0.0001), and 0.80 ± 0.15 ng/cm2 (p = 0.0004), respectively. CONCLUSION: Dispensing one or more prescriptions of 40 cyclophosphamide 50 mg tablets contaminates pharmacy counting tools, and an increased number of prescriptions dispensed correlates with increased level of contamination. Counting out three or more prescriptions leads to trays having contamination that surpasses the threshold at which worker exposure may be increased. Pharmacies should consider devoting a separate tray to cyclophosphamide tablets, as cross-contamination could occur with other drugs and the efficacy of decontamination methods is unclear. Employee exposure could be minimized with the use of personal protective equipment, environmental controls, and cleaning trays between uses. Future investigation should assess the extent of drug powder dispersion, the effects of various cleaning methods, and the potential extent of contamination with different oral cytotoxic drugs.

Parenteral product error detection before and after implementation of intravenous workflow management technology.

OBJECTIVE: To assess the difference in pharmacy error detection rates when using a manual process compared to an intravenous workflow management system for the preparation of parenteral medications. METHODS: Baseline error data were collected by staff using a standard form over a four-day time period before intravenous workflow management system implementation and compared to 48 weeks of electronically collected data following implementation. The chi-square test was used for statistical comparisons. RESULTS: The ability to detect an error during the intravenous preparation process increased immediately following implementation, but this difference was not sustained and was not statistically different when the entire post-implementation time period was compared to the baseline sample. The most prevalent errors at baseline were wrong drug amount (36.4%) and wrong base solution (22.7%). Post-implementation product expiration (26.1%), wrong diluent or base (17.9%), and wrong drug amount (19.2%) were the most prevalent errors. Barcode scanning technology detected 60% of the errors during the post-implementation period. A decrease in error detection over time was observed post-implementation and was attributed to corrections and additions to the intravenous workflow management library and better prospective identification of potential errors by staff as they adjusted to the system. The use of serial imaging enabled pharmacists to detect errors prospectively, which may have previously been undetected using the traditional intravenous preparation process. CONCLUSION: The implementation of intravenous workflow management technology was unable to detect a statistically significant greater percentage of sterile product preparation errors compared with the baseline time period. Statistical significance was achieved during three of the first four months following implementation ( P < 0.05); however, this statistically significant increase was not maintained when the entire post-implementation sample was included.

Initial study of clinical pharmacy work prioritization tools.

PURPOSE: The development, implementation, and validity of clinical pharmacy work prioritization tools (CPWPTs) were analyzed. METHODS: Informatics pharmacists were contacted and asked to participate in 30-minute teleconference interviews, as they have primary responsibility for the technical configuration of CPWPTs. A total of 19 respondents participated in the survey. The qualitative data collected encompassed the thoughts and ideas of practicing informatics pharmacists who are knowledgeable about the design, configuration, management, and use of CPWPTs. In addition to capturing their thoughts and ideas with open-ended questions, demographic data were collected, as was information about the sites where respondents worked and the CPWPTs they used. RESULTS: Most of the CPWPTs were built into existing electronic health record platforms. There was considerable variation among the prioritization factors used at each site. The most commonly identified categories of prioritization factors were patient-specific factors, therapeutic classes of medications, and potential pharmacist interventions. All respondents reported that the prioritized tasks generated by their CPWPTs were examined for face validity. Of the 19 respondents, only 4 reported that the priorities generated by their CPWPT had been empirically validated in some way. Qualitative data analysis revealed that informatics pharmacists have 5 general perceptions about CPWPT factors, validation, and use in practice: (1) mirroring practice, (2) pharmacist consensus-based design, (3) complexity of logic, (4) tension between task-oriented and patient-centric approaches to practice, and (5) comfort from tracking tasks to completion. CONCLUSION: Early CPWPTs vary significantly in their prioritization factors. These tools partially reflect the scope of clinical pharmacy practice at the sites where they are used.

Surface contamination of hazardous drug pharmacy storage bins and pharmacy distributor shipping containers.

Purpose This study was conducted to determine whether there is contamination on exterior drug packaging using shipping totes from the distributor and carousel storage bins as surrogate markers of external packaging contamination. Methods A two-part study was conducted to measure the presence of 5-fluorouracil, ifosfamide, cyclophosphamide, docetaxel and paclitaxel using surrogate markers for external drug packaging. In Part I, 10 drug distributor shipping totes designated for transport of hazardous drugs provided a snapshot view of contamination from regular use and transit in and out of the pharmacy. An additional two totes designated for transport of non-hazardous drugs served as controls. In Part II, old carousel storage bins (i.e. those in use pre-study) were wiped for snapshot view of hazardous drug contamination on storage bins. New carousel storage bins were then put into use for storage of the five tested drugs and used for routine storage and inventory maintenance activities. Carousel bins were wiped at time intervals 0, 8, 16 and 52 weeks to measure surface contamination. Results Two of the 10 hazardous shipping totes were contaminated. Three of the five-old carousel bins were contaminated with cyclophosphamide. One of the old carousel bins was also contaminated with ifosfamide. There were no detectable levels of hazardous drugs on any of the new storage bins at time 0, 8 or 16 weeks. However, at the Week 52, there was a detectable level of 5-FU present in the 5-FU carousel bin. Conclusions Contamination of the surrogate markers suggests that external packaging for hazardous drugs is contaminated, either during the manufacturing process or during routine chain of custody activities. These results demonstrate that occupational exposure may occur due to contamination from shipping totes and storage bins, and that handling practices including use of personal protective equipment is warranted.

Comparison and alignment of an academic medical center's strategic goals with ASHP initiatives.

PURPOSE: An academic medical center's strategic goals were compared and aligned with the 2015 ASHP Health-System Pharmacy Initiative and the Pharmacy Practice Model Initiative (PPMI). METHODS: The department's pharmacy practice model steering committee identified potential solutions to narrow prioritized gaps using a modified nominal group technique and a multivoting dot technique. RESULTS: Five priority solutions were identified and assigned to work groups to develop business plans, which included admission medication history and reconciliation for high-risk patients and those with complex medication regimens, pharmacist provision of discharge counseling to high-risk patients and those with complex medication regimens, improved measurement and reporting of the impact of PPMI programs on patient outcomes, implementation of a departmentwide formalized peer review and evaluation process, and the greeting of every patient at some time during his or her visit by a pharmacy team member. Stakeholders evaluated the business plans based on feasibility, financial return on investment, and anticipated safety enhancements. The solution that received the highest priority ranking and was subsequently implemented was "improved measurement and reporting of the impact of PPMI programs on patient outcomes." CONCLUSION: A defined process was followed for identifying gaps among current practices at an academic medical center and the 2015 ASHP Health-System Pharmacy Initiative and the PPMI. A key priority to better document the impact of pharmacists on patient care was identified for our department by using a nominal group technique brainstorming process and a multivoting dot technique and creating standardized business plans for five potential priority projects.

Increased appropriateness of customized alert acknowledgement reasons for overridden medication alerts in a computerized provider order entry system.

OBJECTIVE: Computerized provider order entry systems commonly contain alerting mechanisms for patient allergies, incorrect doses, or drug-drug interactions when ordering medications. Providers have the option to override (bypass) these alerts and continue with the order unchanged. This study examines the effect of customizing medication alert override options on the appropriateness of override selection related to patient allergies, drug dosing, and drug-drug interactions when ordering medications in an electronic medical record. MATERIALS AND METHODS: In this prospective, randomized crossover study, providers were randomized into cohorts that required a reason for overriding a medication alert from a customized or non-customized list of override reasons and/or by free-text entry. The primary outcome was to compare override responses that appropriately correlate with the alert type between the customized and non-customized configurations. The appropriateness of a subset of free-text responses that represented an affirmative and active acknowledgement of the alert without further explanation was classified as "indeterminate." Results were analyzed in three different ways by classifying indeterminate answers as either appropriate, inappropriate, or excluded entirely. Secondary outcomes included the appropriateness of override reasons when comparing cohorts and individual providers, reason selection based on order within the override list, and the determination of the frequency of free-text use, nonsensical responses, and multiple selection responses. RESULTS: Twenty-two clinicians were randomized into 2 cohorts and a total of 1829 alerts with a required response were generated during the study period. The customized configuration had a higher rate of appropriateness when compared to the non-customized configuration regardless of how indeterminate responses were classified (p<0.001). When comparing cohorts, appropriateness was significantly higher in the customized configuration regardless of the classification of indeterminate responses (p<0.001) with one exception: when indeterminate responses were considered inappropriate for the cohort of providers that were first exposed to the non-customized list (p=0.103). Free-text use was higher in the customized configuration overall (p<0.001), and there was no difference in nonsensical response between configurations (p=0.39). CONCLUSION: There is a benefit realized by using a customized list for medication override reasons. Poor application design or configuration can negatively affect provider behavior when responding to important medication alerts.

Recommendations to improve the usability of drug-drug interaction clinical decision support alerts.

OBJECTIVE: To establish preferred strategies for presenting drug-drug interaction (DDI) clinical decision support alerts. MATERIALS AND METHODS: A DDI Clinical Decision Support Conference Series included a workgroup consisting of 24 clinical, usability, and informatics experts representing academia, health information technology (IT) vendors, healthcare organizations, and the Office of the National Coordinator for Health IT. Workgroup members met via web-based meetings 12 times from January 2013 to February 2014, and two in-person meetings to reach consensus on recommendations to improve decision support for DDIs. We addressed three key questions: (1) what, how, where, and when do we display DDI decision support? (2) should presentation of DDI decision support vary by clinicians? and (3) how should effectiveness of DDI decision support be measured? RESULTS: Our recommendations include the consistent use of terminology, visual cues, minimal text, formatting, content, and reporting standards to facilitate usability. All clinicians involved in the medication use process should be able to view DDI alerts and actions by other clinicians. Override rates are common but may not be a good measure of effectiveness. DISCUSSION: Seven core elements should be included with DDI decision support. DDI information should be presented to all clinicians. Finally, in their current form, override rates have limited capability to evaluate alert effectiveness. CONCLUSION: DDI clinical decision support alerts need major improvements. We provide recommendations for healthcare organizations and IT vendors to improve the clinician interface of DDI alerts, with the aim of reducing alert fatigue and improving patient safety.

Clinical decision support for atypical orders: detection and warning of atypical medication orders submitted to a computerized provider order entry system.

The specificity of medication-related alerts must be improved to overcome the pernicious effects of alert fatigue. A systematic comparison of new drug orders to historical orders could improve alert specificity and relevance. Using historical order data from a computerized provider order entry system, we alerted physicians to atypical orders during the prescribing of five medications: calcium, clopidogrel, heparin, magnesium, and potassium. The percentage of atypical orders placed for these five medications decreased during the 92 days the alerts were active when compared to the same period in the previous year (from 0.81% to 0.53%; p=0.015). Some atypical orders were appropriate. Fifty of the 68 atypical order alerts were over-ridden (74%). However, the over-ride rate is misleading because 28 of the atypical medication orders (41%) were changed. Atypical order alerts were relatively few, identified problems with frequencies as well as doses, and had a higher specificity than dose check alerts.

Development and validation of a survey instrument for assessing prescribers' perception of computerized drug-drug interaction alerts.

OBJECTIVE: To develop a theoretically informed and empirically validated survey instrument for assessing prescribers' perception of computerized drug-drug interaction (DDI) alerts. MATERIALS AND METHODS: The survey is grounded in the unified theory of acceptance and use of technology and an adapted accident causation model. Development of the instrument was also informed by a review of the extant literature on prescribers' attitude toward computerized medication safety alerts and common prescriber-provided reasons for overriding. To refine and validate the survey, we conducted a two-stage empirical validation study consisting of a pretest with a panel of domain experts followed by a field test among all eligible prescribers at our institution. RESULTS: The resulting survey instrument contains 28 questionnaire items assessing six theoretical dimensions: performance expectancy, effort expectancy, social influence, facilitating conditions, perceived fatigue, and perceived use behavior. Satisfactory results were obtained from the field validation; however, a few potential issues were also identified. We analyzed these issues accordingly and the results led to the final survey instrument as well as usage recommendations. DISCUSSION: High override rates of computerized medication safety alerts have been a prevalent problem. They are usually caused by, or manifested in, issues of poor end user acceptance. However, standardized research tools for assessing and understanding end users' perception are currently lacking, which inhibits knowledge accumulation and consequently forgoes improvement opportunities. The survey instrument presented in this paper may help fill this methodological gap. CONCLUSION: We developed and empirically validated a survey instrument that may be useful for future research on DDI alerts and other types of computerized medication safety alerts more generally.

Developing and implementing clinical decision support for use in a computerized prescriber-order-entry system.

PURPOSE: The development and implementation of clinical decision support (CDS) in a computerized prescriber-order-entry (CPOE) system in a large, tertiary care, academic health care system are described. SUMMARY: CDS is generally considered to be a key factor in promoting successful system adoption, patient safety, and positive patient outcomes for CPOE implementation. The impact of CDS depends on the methods used by the institution to implement CPOE using both passive and active system design features. At the University of Michigan Health System, interdisciplinary project teams were assembled to plan, build, and implement the CDS component of CPOE using several underlying fundamental principles to ensure the usability and safety of the system, including standardization of system configuration, workflow design, and prioritization of the number and types of interruptive alerts that would be deployed. Passive CDS rules were established for nomenclature, links to information, relevant results, and order sets. Active CDS rules were developed for noninterruptive alerts (patient list alert flags and form-called medical logic modules) and interruptive alerts, including alerts for allergies, dose checks, drug-drug interactions, drug-food interactions, and drug-disease interactions. The institution provided sufficient staffing and institutional governance to implement and sustain CDS. CONCLUSION: Through an interdisciplinary collaboration, an academic health care system planned, designed, and implemented institution-specific, CPOE-integrated CDS to improve clinical efficiency and facilitate the compliance with regulatory policies and guidelines.