Patient-centered Pharmacist Care in the Hemodialysis Unit: a quasi-experimental interrupted time series study.

BACKGROUND: Nonadherence to medications by patients requiring hemodialysis (HD) leads to unfavorable clinical outcomes. Limited data exist to demonstrate the effect of incorporating patient-centered interventions using concepts of medication therapy management and motivational interview by pharmacists on pharmacoadherence in patients requiring HD. Therefore, we assessed the impact of patient-centered pharmacist care on pharmacoadherence and its outcomes in patients requiring HD. METHODS: Adult patients who had received outpatient HD for at least 3 months were enrolled. The study was conducted from October 2016 to April 2017. Pharmacists interviewed the patients at month 1, 2, 4 and 6, and the intervention (comprehensive review) occurred at months 3 and 5. The primary outcome was the change in pharmacoadherence as assessed by pre-HD serum phosphate levels and the differences in the number of medications between patient' self-report and medications records at the electronic healthcare records (EHRs). The secondary outcomes included changes in systolic blood pressure (SBP), glycosylated hemoglobin levels, serum low-density lipoprotein (LDL) levels, and the prevalence and types of medication-related problems (MRPs). RESULTS: Seventy-two patients were enrolled. Their median age was 59 (interquartile range: 47-67.5) years, and 53% were men. Pre- and post-intervention pharmacoadherence, as indicated by serum phosphate levels and the differences in the number of medications between patient' self-report and the medication records at the EHRs, did not significantly differ (p = 0.682 and 0.348, respectively). Mean SBP and mean LDL did not significantly change post-intervention. The median number of MRPs declined between Months 3 and 5 (p = 0.002): the prevalence of MRPs at Month 3 was 44.9% (95 confidence interval [CI]: 40.4-49.3) and decreased to 29.8% (95 CI: 25.6-34.3) at Month 5. Drug use without indication was the most frequent MRP (23.9%). CONCLUSIONS: Patient-centered pharmacist care did not result in significant changes in pharmacoadherence. However, its clinical utility as a tool to identify and mitigate MRPs in patients requiring HD is indisputable. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03576404 (retrospectively registered on July 3rd, 2018).

The vulnerabilities of computerized physician order entry systems: a qualitative study.

OBJECTIVE: To test the vulnerabilities of a wide range of computerized physician order entry (CPOE) systems to different types of medication errors, and develop a more comprehensive qualitative understanding of how their design could be improved. MATERIALS AND METHODS: The authors reviewed a random sample of 63,040 medication error reports from the US Pharmacopeia (USP) MEDMARX reporting system where CPOE systems were considered a "contributing factor" to errors and flagged test scenarios that could be tested in current CPOE systems. Testers entered these orders in 13 commercial and homegrown CPOE systems across 16 different sites in the United States and Canada, using both usual practice and where-needed workarounds. Overarching themes relevant to interface design and usability/workflow issues were identified. RESULTS: CPOE systems often failed to detect and prevent important medication errors. Generation of electronic alert warnings varied widely between systems, and depended on a number of factors, including how the order information was entered. Alerts were often confusing, with unrelated warnings appearing on the same screen as those more relevant to the current erroneous entry. Dangerous drug-drug interaction warnings were displayed only after the order was placed rather than at the time of ordering. Testers illustrated various workarounds that allowed them to enter these erroneous orders. DISCUSSION AND CONCLUSION: The authors found high variability in ordering approaches between different CPOE systems, with major deficiencies identified in some systems. It is important that developers reflect on these findings and build in safeguards to ensure safer prescribing for patients.

Ambulatory Computerized Prescribing and Preventable Adverse Drug Events.

BACKGROUND: Adverse drug events (ADEs) represent a significant cause of injury in the ambulatory care setting. Computerized physician order entry reduces rates of serious medication errors that can lead to ADEs in the inpatient setting, but few studies have evaluated whether computerized prescribing in the ambulatory setting reduces preventable ADE rates in ambulatory care. OBJECTIVE: To determine the rates of preventable ADEs before and after the implementation of computerized prescribing with basic clinical decision support for ordering medications. DESIGN: Before-after study of ADE rates in practices implementing computer order entry. PARTICIPANTS: Adult patients seeking care in primary care practices at academic medical centers in Boston, Massachusetts (n = 41,819), and Indianapolis, Indiana (n = 9128). MAIN MEASURES: We attempted to standardize the medication-related decision support knowledge base provided at the 2 sites, although the electronic records and presentation layers used at the 2 sites differed. The primary outcome was preventable ADEs identified based on structured results or symptoms defined by extracting symptom concepts from provider notes; potential ADEs were a secondary outcome. RESULTS: Computerized prescribing did not significantly change the rate of preventable ADEs at either site. Compared with Boston practices, the rate of potential ADEs was more than seven-fold greater at Indianapolis (6.4/10,000 patient-months vs. 49.5/10,000 patient-months, P < 0.001). Computerized prescribing was associated with a 56% decrease in the potential ADE rate at Indianapolis (49.5 to 21.9/10,000 patient-months, P < 0.001) but a 104% increase at Boston (6.4 to 13.0/10,000 patient-months, P < 0.001). Preventable ADEs that occurred after computerized prescribing was implemented were due to patient education issues, physicians ignoring feedback from CDSS, and incomplete computerized knowledge base was incomplete (34%, 33%, and 33% in Indianapolis and 44%, 28%, and 28% in Boston). CONCLUSIONS: The implementation of computerized prescribing in the ambulatory setting was not associated with any change in preventable ADEs but was associated with a decrease in potential ADEs at Indianapolis but an increase at Boston, although the absolute rate of ADEs was much lower in Boston.

Venous thromboembolism in hospitalized patients with active cancer.

Venous thromboembolism (VTE) is a common complication of cancer and chemotherapy. We evaluated the baseline clinical characteristics, thromboprophylaxis patterns, frequency and timing of VTE, and clinical outcomes in 1000 adult hospitalized patients with active cancer. Overall, symptomatic VTE occurred in 5.4% of hospitalized patients with cancer. The VTE occurred in 2.3% of patients with cancer during hospitalization and in 3.4% between hospital discharge and day 90. Few (13.9%) hospitalized patients with cancer received extended duration pharmacological prophylaxis after hospital discharge. Cancer was the most frequent known cause of death in both the groups. In conclusion, VTE was common in hospitalized patients with cancer, especially after discharge. Inhospital death and death between discharge and day 90 were frequent in hospitalized patients with cancer who developed VTE.

Hospital costs of acute pulmonary embolism.

OBJECTIVE: Pulmonary embolism places a heavy economic burden on health care systems, but the components of hospital cost have not been elucidated. We evaluated hospitalized patients with the primary diagnosis of pulmonary embolism. Our goal was to determine the total and component costs associated with their hospital care. METHODS: We included patients hospitalized at Brigham and Women's Hospital from September 2003 to May 2010. Patient demographics, characteristics, comorbidities, interventions, and treatments were obtained from the electronic medical record. Costs were obtained using the hospital's accounting software and categorized into the areas providing direct patient supplies or care. RESULTS: We identified 991 hospitalized patients with acute pulmonary embolism. In-hospital mortality was 4.2%, and 90-day mortality after hospital discharge was 13.8%. The median length of hospital stay was 3 days, and the mean length of hospital stay was 4 days. The mean total hospitalization cost per patient was $8764. Nursing costs, which included room and board, were $5102. Pharmacy ($966) and radiology ($963) costs were similar. Pharmacy costs ($966) were dominated by the use of low-molecular-weight heparin ($232). Radiology costs ($963) were dominated by the use of diagnostic imaging examinations ($672). During the observation period, an average of 160 patients with pulmonary embolism were admitted each year, requiring an annual hospital expense ranging from $884,814 to $1,866,489. CONCLUSIONS: Pulmonary embolism has a high case fatality rate and remains an expensive illness to diagnose and treat. Nursing costs comprise the largest component of costs.

Deaths reported from the accidental intrathecal administration of bortezomib.

Medication errors due to the inadvertent intrathecal administration of vincristine and other antineoplastic agents continue to occur despite the development of preventative strategies. Three fatalities due to bortezomib being accidentally given intrathecally instead of by the intended intravenous route have recently been reported by the European Medicines Agency. The most effective method for preventing accidental intrathecal administration is to eliminate the syringe as a means of administrating neurotoxic agents and prepare them in a small volume minibag. However due to a lack of stability data for bortezomib in a minibag and the increasing use of bortezomib via the subcutaneous route necessitates the continued preparation of bortezomib in a syringe. A number of recommendations aimed at preventing the possibility of accidental intrathecal administration of bortezomib are made. These need to be incorporated into standard practice internationally and pharmacists must take the lead to ensure this occurs as a matter of urgency.

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.

Ambulatory prescribing errors among community-based providers in two states.

OBJECTIVE: Little is known about the frequency and types of prescribing errors in the ambulatory setting among community-based, primary care providers. Therefore, the rates and types of prescribing errors were assessed among community-based, primary care providers in two states. MATERIAL AND METHODS: A non-randomized cross-sectional study was conducted of 48 providers in New York and 30 providers in Massachusetts, all of whom used paper prescriptions, from September 2005 to November 2006. Using standardized methodology, prescriptions and medical records were reviewed to identify errors. RESULTS: 9385 prescriptions were analyzed from 5955 patients. The overall prescribing error rate, excluding illegibility errors, was 36.7 per 100 prescriptions (95% CI 30.7 to 44.0) and did not vary significantly between providers from each state (p=0.39). One or more non-illegibility errors were found in 28% of prescriptions. Rates of illegibility errors were very high (175.0 per 100 prescriptions, 95% CI 169.1 to 181.3). Inappropriate abbreviation and direction errors also occurred frequently (13.4 and 4.2 errors per 100 prescriptions, respectively). Reviewers determined that the vast majority of errors could have been eliminated through the use of e-prescribing with clinical decision support. DISCUSSION: Prescribing errors appear to occur at very high rates among community-based primary care providers, especially when compared with studies of academic-affiliated providers that have found nearly threefold lower error rates. Illegibility errors are particularly problematical. CONCLUSIONS: Further characterizing prescribing errors of community-based providers may inform strategies to improve ambulatory medication safety, especially e-prescribing. TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov, NCT00225576.

Venous thromboembolism prophylaxis for medical service-mostly cancer-patients at hospital discharge.

OBJECTIVE: Many hospitalized Medical Service patients remain at high risk for venous thromboembolism (VTE) after hospital discharge. Our aim was to compare the effect of the use or omission of extended pharmacologic VTE prophylaxis after hospital discharge among Medical Service patients on the incidence of symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) over the ensuing 3 months. METHODS: In this case-control study, we identified a case population of 461 patients for whom parenteral pharmacological VTE prophylaxis was prescribed to continue after discharge and matched them according to age, sex, and VTE risk score to a control group of 922 patients for whom VTE prophylaxis was not continued after discharge. RESULTS: The primary endpoint of symptomatic DVT or PE at 90 days occurred in 5.0% of patients receiving extended prophylaxis compared with 4.3% of patients who received no prophylaxis after discharge (P=.58). Fewer patients were alive at 90 days in patients receiving extended pharmacologic VTE prophylaxis, compared with those who received no prophylaxis after discharge (56.8% vs 68.4%, P <.001). Major bleeding, defined as those events requiring blood transfusion, medical, or surgical intervention, occurred more frequently in patients receiving extended VTE prophylaxis after discharge than in those patients who received no prophylaxis after discharge (3.9% vs 1.9%, P=.03). CONCLUSION: Extended pharmacologic thromboprophylaxis in high-risk Medical Service patients did not reduce symptomatic DVT and PE in the ensuing 90 days after hospital discharge. There was a higher incidence of all-cause death and major bleeding episodes in patients receiving extended prophylaxis. Our observations do not support the routine use of extended VTE prophylaxis in Medical Service patients. Further research is needed to identify patients who may benefit from extended pharmacologic VTE prophylaxis and those who may have too great a bleeding risk.

Electronic drug interaction alerts in ambulatory care: the value and acceptance of high-value alerts in US medical practices as assessed by an expert clinical panel.

BACKGROUND: Computerized physician order entry systems are known to improve patient safety in acute-care hospitals. However, as clinicians frequently override drug interaction and allergy alerts, their value in ambulatory care remains uncertain. OBJECTIVE: The purpose of the study was to examine whether ambulatory care clinicians were more likely to accept drug-drug interaction alerts that an expert panel judged to be of high clinical value. STUDY DESIGN: We convened an expert panel to examine drug-drug interaction alerts generated by 2872 clinicians in Massachusetts, Pennsylvania and New Jersey who used a common electronic prescribing system between 1 January 2006 and 30 September 2006. We selected 120 representative drug interaction alerts from the most commonly encountered class-class interactions. MEASUREMENTS: The expert panel rated each alert based on the following categories: (i) strength of the scientific evidence; (ii) probability that the interaction would result in an adverse drug event (ADE); (iii) severity of typical and most serious ADEs; (iv) the likelihood that a clinician could act on the information; and (v) the overall value of the alert to the average primary care clinician. We then used multivariate regression techniques to examine the relationship between the alert acceptance rate and the expert panel's mean rating of each category. RESULTS: The decision of clinicians to accept drug interaction alerts increased (relative to a baseline alert acceptance rate of 8.8%) by 2.7% (95% CI 0.4, 5.1) for interactions that panelists judged would result in an ADE, by 2.3% (95% CI 0.9, 3.7) when primary care providers (PCPs) lacked prior knowledge about the information presented in the alert, and by 3.3% (95% CI 0.9, 5.8) when the PCP could readily act on the information provided in the alert. CONCLUSION: The value of electronic drug interaction alerts is influenced heavily by clinicians' judgements about the clinical value of the alert. Expert judgement should be taken into account when developing electronic decision support.

'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured.

Identification and measurement of adverse medical events is central to patient safety, forming a foundation for accountability, prioritizing problems to work on, generating ideas for safer care, and testing which interventions work. We compared three methods to detect adverse events in hospitalized patients, using the same patient sample set from three leading hospitals. We found that the adverse event detection methods commonly used to track patient safety in the United States today-voluntary reporting and the Agency for Healthcare Research and Quality's Patient Safety Indicators-fared very poorly compared to other methods and missed 90 percent of the adverse events. The Institute for Healthcare Improvement's Global Trigger Tool found at least ten times more confirmed, serious events than these other methods. Overall, adverse events occurred in one-third of hospital admissions. Reliance on voluntary reporting and the Patient Safety Indicators could produce misleading conclusions about the current safety of care in the US health care system and misdirect efforts to improve patient safety.

Impact of implementing alerts about medication black-box warnings in electronic health records.

BACKGROUND: The Food and Drug Administration issues black-box warnings (BBWs) regarding medications with serious risks, yet physician adherence to the warnings is low. METHODS: We evaluated the impact of delivering BBW-based alerts about drug-drug, drug-disease, and drug-laboratory interactions for prescription medications in outpatients in an electronic health record with clinical decision support. We compared the frequency of non-adherence to all BBWs about drug-drug, drug-disease, and drug-laboratory interactions for 30 drugs/drug classes, and by individual drugs/drug groups with BBWs between the pre- and post-intervention periods. We used multivariate analysis to identify independent risk factors for non-adherence to BBWs. RESULTS: There was a slightly higher frequency of non-adherence to BBWs after the intervention (4.8% vs. 5.1%, p=0.045). In multivariate analyses, after adjustment for patient and provider characteristics and site of care, medications prescribed during the pre-intervention period were less likely to violate BBWs compared to those prescribed during the post-intervention period (OR 0.67, 95% CI, 0.47-0.96). However, black-box warning violations did decrease after the intervention for BBWs about drug-drug interactions (6.1% vs. 1.8%, p<0.0001) and drug-pregnancy interactions (5.1% vs. 3.6%, p=0.01). CONCLUSIONS: Ambulatory care computerized order entry with prescribing alerts about BBWs did not improve clinicians' overall adherence to BBWs, though it did improve adherence for specific clinically important subcategories.

Addition of electronic prescription transmission to computerized prescriber order entry: Effect on dispensing errors in community pharmacies.

PURPOSE: The addition of electronic prescription transmission to computerized prescriber order entry (CPOE) and its effect on dispensing errors in community pharmacies were evaluated. METHODS: A controlled, before-and-after trial to measure the effect of electronic prescribing on dispensing errors in two control clinics and one e-prescribing clinic already using CPOE was conducted between January and November 2006. Prescriptions documented within the CPOE system were reconciled with dispensed prescription information from participating pharmacy chains via a national pharmacy information exchange network. Dispensing errors were defined as discrepancies between the prescriber's written orders and the dispensed prescription information. Prescriptions filled at nonparticipating pharmacies were not analyzed. RESULTS: A total of 11,447 prescriptions were written in the control clinics, and 29,575 were written in the e-prescribing clinic. During the intervention period, 2,179 (22%) of 9,905 intervention clinic prescriptions were electronically transmitted, including 621 (28%) available for analysis. There was no significant difference in the dispensing-error rates between the baseline and intervention periods for the control clinics. Similarly, the dispensing-error rates did not differ significantly for the e-prescribing clinic between the baseline and intervention periods for prescriptions that were not electronically transmitted. The e-prescribing clinic's dispensing-error rate for electronically transmitted prescriptions during the intervention was significantly lower than its baseline dispensing-error rate (p = 0.03). CONCLUSION: Electronic transmission of prescription data from physicians' offices to a pharmacy nearly halved the risk of dispensing errors compared with generating the prescription with outpatient CPOE and printing it and giving it to the patient.

Outpatient adverse drug events identified by screening electronic health records.

OBJECTIVES: Relatively little is known about rates of outpatient adverse drug events (ADEs), and most health systems do not routinely identify them. We developed a computerized ADE measurement process and used it to detect ADEs from electronic health records and then categorized them according to type, preventability, and severity. METHODS: The rules used represent combinations of variables including coded medication names, laboratory results, diagnoses, and specific items such as symptoms from free text clinician notes, all obtained from electronic health records. Rules targeted various diagnostic and laboratory abnormalities potentially caused by a broad range of outpatient medications commonly used in primary care. The rules were run on 4 months of data on primary care patients seen in the outpatient setting in 2 large health systems; possible incidents were identified by chart review and validated as ADEs by clinician reviewers, then rated by severity and preventability. RESULTS: The rates of ADEs were 75 ADEs/1000 person-years and 198/1000 person-years at the 2 sites, respectively. The overall rate was 138 ADEs/1000 person-years across the 2 sites. Eleven percent of ADEs were preventable, with a rate of 15 preventable ADEs/1000 person-years across sites. Approximately one-fourth of ADEs were serious or life threatening at both sites. The highest yield rules for identifying preventable ADEs included rules based on drug classes and symptoms, and drug-laboratory rules. CONCLUSIONS: Adverse drug events occurred frequently in routine outpatient care, and many were serious and preventable. Computerized monitoring represents an efficacious approach for identifying ambulatory ADEs, although it needs additional refinement. In addition, site-specific variations need further exploration.

An empirical model to estimate the potential impact of medication safety alerts on patient safety, health care utilization, and cost in ambulatory care.

BACKGROUND: Because ambulatory care clinicians override as many as 91% of drug interaction alerts, the potential benefit of electronic prescribing (e-prescribing) with decision support is uncertain. METHODS: We studied 279 476 alerted prescriptions written by 2321 Massachusetts ambulatory care clinicians using a single commercial e-prescribing system from January 1 through June 30, 2006. An expert panel reviewed a sample of common drug interaction alerts, estimating the likelihood and severity of adverse drug events (ADEs) associated with each alert, the likely injury to the patient, and the health care utilization required to address each ADE. We estimated the cost savings due to e-prescribing by using third-party-payer and publicly available information. RESULTS: Based on the expert panel's estimates, electronic drug alerts likely prevented 402 (interquartile range [IQR], 133-846) ADEs in 2006, including 49 (14-130) potentially serious, 125 (34-307) significant, and 228 (85-409) minor ADEs. Accepted alerts may have prevented a death in 3 (IQR, 2-13) cases, permanent disability in 14 (3-18), and temporary disability in 31 (10-97). Alerts potentially resulted in 39 (IQR, 14-100) fewer hospitalizations, 34 (6-74) fewer emergency department visits, and 267 (105-541) fewer office visits, for a cost savings of 402,619 USD (IQR, 141,012-1,012,386 USD). Based on the panel's estimates, 331 alerts were required to prevent 1 ADE, and a few alerts (10%) likely accounted for 60% of ADEs and 78% of cost savings. CONCLUSIONS: Electronic prescribing alerts in ambulatory care may prevent a substantial number of injuries and reduce health care costs in Massachusetts. Because a few alerts account for most of the benefit, e-prescribing systems should suppress low-value alerts.

Rating recommendations for consumers about patient safety: sense, common sense, or nonsense?

BACKGROUND: Although many organizations offer advice about the consumer's role in improving patient safety, little is known about these recommendations. METHODS: The Internet and medical literature were searched to identify patient safety recommendations for consumers. Recommendations were classified by type and tabulated by frequency. Nine investigators rated each recommendation for the quality of supporting empirical evidence, magnitude of benefit, and likely patient adherence. For a consumer perspective, 22 relatives of the investigators who were also mothers rated each recommendation. RESULTS: Twenty-six organizations identified 160 distinct recommendations; 115 (72%) addressed medication safety, 37 (23%) advised patients about preparation for hospitalization or surgery, and 18 (11%) offered general advice. Organizations most frequently advised patients to make a list of their medications (92% of organizations), to ask questions about their health and treatment (81%), to enlist an advocate (77%), and to learn about possible medication side effects (77%). Investigators assigned high scores to 11 of the 25 most frequently cited recommendations and to 4 of the 25 least common recommendations. There was little association between the frequency with which recommendations were promulgated and investigators' ratings (r = 0.27, p < .001). Investigators' scores correlated with those of the mothers (r = 0.71, p < .001). DISCUSSION: Contrary to expectation, there was little overlap among the 160 recommendations offered by the 26 organizations. Health care organizations offer many patient safety recommendations of limited value. These organizations should offer a concise and coherent set of recommendations on the basis of evidence, magnitude of benefit, and likely adherence.