Development and validation of a complexity score to rank hospitalized patients at risk for preventable adverse drug events.

PURPOSE: The development of risk models for 16 preventable adverse drug events (pADEs) and their aggregation into the final complexity score (C-score) are described. METHODS: Using data from 2 tertiary care facilities, logistic regression models were constructed for the first 5 hospital days that admissions were at risk for each of 16 pADEs. The best model for each pADE was validated in 100 bootstrap samples. The C-score was then aggregated and predicted individual pADE risk as the probability to develop at least 1 pADE. Using the 100 bootstrap samples for each pADE, 100 C-scores for validation were generated. RESULTS: We utilized electronic health records (EHR) data from 65,518 admissions to UF Health Shands and 18,269 admissions to UF Health Jacksonville to develop risk models for 16 pADEs. Most models had very strong discriminant validity (C-statistic > 0.8), with the highest predicted decile representing about half of manifest pADEs. Among admissions in the highest C-score decile, about two thirds experienced at least 1 pADE (C-statistic, 0.838; 95% confidence interval, 0.838-0.839). C-score precision, defined as the percentage of patients consistently (i.e., at least 95 of 100 samples) ranked in the 90th percentile, was 80-84%. CONCLUSION: The C-score was developed and validated for the identification of hospitalized patients at highest risk for pADEs. Aggregation of individual prediction models into a single score reduced its predictive power for most pADEs, compared with the individual risk models, but concentrated in the highest C-score decile a patient group more than two thirds of whom experienced at least 1 pADE.

Identifying and characterizing preventable adverse drug events for prioritizing pharmacist intervention in hospitals.

PURPOSE: The approach and results for identifying and characterizing preventable adverse drug events (pADEs) that are key targets for pharmacist medication therapy management (MTM) are summarized. METHODS: This study was part of a larger effort aimed at developing an electronic health record-based prediction model (the complexity score, or C-score) that ranks hospitalized patients according to their risk for pADEs. An environmental scan of published epidemiologic pADE studies and national patient safety priority areas was conducted. The final list of candidate pADEs was then disseminated to ASHP members and a national technical expert panel (TEP) to evaluate the importance, prevalence, severity, preventability, and measurability of these pADEs. Polychoric correlation tests were performed to evaluate and quantify associations between importance and any of the constructs' mean rankings for each individual pADE. RESULTS: The environmental scan yielded a total of 21 candidate pADEs, including drug-induced acute kidney injury, falls, respiratory depression, altered mental status, hemorrhage, hepatic failure, hypoglycemia, seizures, hypotension and bradycardia, ileus, blood dyscrasias, severe electrolyte imbalances, prolonged hyperglycemia, uncontrolled hypertension, uncontrolled arrhythmia, stress ulcers, hospital-acquired infections, uncontrolled hospital-acquired or community-acquired infection, uncontrolled pain, and venous thromboembolism. The survey confirmed all pADEs were important. Ranking of overall importance was mainly driven by perceived pADE severity and, to a lesser extent, by preventability and prevalence ratings. CONCLUSION: A literature review and survey of ASHP and TEP members were used to compile a list of important hospital-acquired pADEs for incorporation into a model for prioritizing patients for MTM services.

Development of a Medication Safety and Quality Survey for Small Rural Hospitals.

PURPOSE: We summarize the development and initial implementation of a survey tool to assess medication safety in small rural hospitals. SUMMARY: As part of an ongoing rural hospital medication safety improvement program, we developed a survey tool in all 13 critical access hospitals (CAHs) in Florida. The survey was compiled from existing medication safety assessments and standards, clinical practice guidelines, and published literature. Survey items were selected based on considerations regarding practicality and relevance to the CAH setting.The final survey instrument included 134 items representing 17 medication safety domains. Overall hospital scores ranged from 41% to 95%, with a median of 59%. Most hospitals showed large variation in scores across domains, with 5 hospitals having at least 1 domain with scores less than 10%. Highest scores across all facilities were seen for safety procedures concerning high-alert or look-alike medications and the assembly of emergency carts. The lowest median scores included availability and consistent use of standardized order sets and the effective implementation of medication safety committees. Most hospitals used the survey results to identify and prioritize quality improvement activities. CONCLUSIONS: The survey can be used to conduct a short medication safety assessment specific to a limited number of areas and services in CAHs. It showed good ability to discriminate medication safety levels across participating sites and highlighted opportunities for improvement. It may need modification if case mix or services differ in other states or if the status quo of medication safety in CAHs or related standards advance. The described process of survey development might be helpful to support such modifications.

Activated partial thromboplastin time versus antifactor Xa heparin assay in monitoring unfractionated heparin by continuous intravenous infusion.

BACKGROUND: Unfractionated heparin (UFH) has been used clinically for 5 decades. Despite being a cornerstone of anticoagulation, UFH is limited by its unpredictable pharmacokinetic profile, which makes close laboratory monitoring necessary. The most common methods for monitoring UFH are the activated partial thromboplastin time (aPTT) and antifactor Xa heparin assay (anti-Xa HA), but both present challenges, and the optimal method to monitor UFH remains unclear. OBJECTIVE: To compare the performance of the aPTT with the anti-Xa HA for efficiency and safety of monitoring intravenous UFH infusions. METHODS: This was a single-center, retrospective, observational cohort study conducted in an 852-bed academic medical center. RESULTS: One hundred patients receiving intravenous UFH for a variety of indications were enrolled in the study; 50 were assigned to each group. The mean (SD) time to achieve therapeutic anticoagulation was significantly less in the anti-Xa HA group compared with the aPTT group (28 [16] vs 48 [26] hours, p < 0.001). In addition, a greater percentage of anti-Xa HA patients compared to aPTT patients achieved therapeutic anticoagulation at 24 hours (OR 3.5; 95% CI 1.5 to 8.7) and 48 hours (OR 10.9; 95% CI 3.3 to 44.2). Patients in the anti-Xa HA group also had more test values within the therapeutic range (66% vs 42%, p < 0.0001). A significant difference was seen between the 2 groups in the number of aPTT or anti-Xa HA tests performed per 24 hours (p < 0.0001) and number of infusion rate changes per 24 hours (p < 0.01), both favoring the anti-Xa HA group. CONCLUSIONS: Monitoring intravenous UFH infusions with the anti-Xa HA, compared to the aPTT, achieves therapeutic anticoagulation more rapidly, maintains the values within the goal range for a longer time, and requires fewer adjustments in dosage and repeated tests.

Planning for pharmacy health information technology in critical access hospitals.

PURPOSE: A plan for the implementation of medication-related health information technology (HIT) in 12 critical access hospitals (CAHs) to improve safety and reduce medication errors is described. SUMMARY: Interviews were conducted to assess the status of HIT in 12 CAHs, including HIT needs and desires and barriers to HIT adoption. Two conferences were held as part of the planning process. It was determined that pharmacy HIT (pHIT) should be implemented in three phases in the CAHs. In phase 1, it was found that the first HIT needed by the CAHs was pharmacy information management systems (PIMS), the cornerstone for the implementation of other HITs. Criteria were developed for the appropriate selection of PIMS for the CAHs. Phase 2 revealed that automated dispensing cabinets (ADCs) should be the next HIT implementation. ADCs are effective in the reduction of medication errors in the dispensing stage. Phase 3 dealt with the implementation of smart infusion pumps. Smart infusion pumps contain a standard data set that includes parameters for infusion fluids and a clinical decision-support system, and they keep a record of rule violations. Barriers to HIT implementation included funding, staff resistance to change, staff adaptation to HIT and workflow changes, time constraints on small sta., facility and building barriers, and lack of information technology support. CONCLUSION: Planning conferences and interviews with hospital representatives helped to identify the HIT needs of 12 CAHs. The planning process resulted in a three-phase plan for pHIT implementation, which will include PIMS, ADCs, and smart infusion pumps.

Medication safety infrastructure in critical-access hospitals in Florida.

PURPOSE: The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. METHODS: Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. RESULTS: The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. CONCLUSION: Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

Causes of hyperglycemia and hypoglycemia in adult inpatients.

PURPOSE: The underlying causes of hyperglycemia and hypoglycemia in adult medical and surgical inpatients were studied. METHODS: Hyperglycemic and hypoglycemic events occurring in adult medical and surgical patients admitted between February and July 2003 to a tertiary care hospital were identified prospectively from automated daily printouts of abnormal blood glucose levels generated by the hospital laboratory. Information on the causes of a random sample of events was ascertained within 24 hours through chart review and provider and patient interviews. Narratives were presented to an expert committee to assess the causes of each event and preventability. RESULTS: Eighteen of 24 hypoglycemic events and 26 of 26 hyperglycemic episodes were considered preventable. Failure to adjust antidiabetic drugs in response to decreases in oral intake and unexpected deviation from normal hospital routine were the most common factors contributing to hypoglycemia. Hyperglycemia was most often associated with an unwillingness of providers to take responsibility for diabetes management and the exclusive use of sliding-scale insulin regimens. CONCLUSION: Hyperglycemia and hypoglycemia in medical and surgical inpatients were mostly related to inadequate prescribing, monitoring, and communication practices.

Nature and causes of clinically significant medication errors in a tertiary care hospital.

PURPOSE: Medication errors identified through solicited error reports in general medicine and specialty units of a major tertiary care teaching hospital were studied to identify prevalent patterns and causes. METHODS: Medication error reports by a multidisciplinary team of eight clinicians at adult medical and surgical, hematology and oncology, bone marrow transplantation, and medical and cardiac intensive care units were collected prospectively over a three-month period. The reports were validated in terms of clinical significance, causality, and true presence of an error by two independent reviewers. Cluster analysis of valid reports (reports accepted by both reviewers) was used to identify prominent error patterns. RESULTS: Of 321 medication error reports, 240 were included in the analysis. Of these, 95 represented manifested errors and the rest near misses (not manifested [94] or averted [51]). Most manifested errors involved uncontrolled infections associated with prescribed underdoses of antiinfectives (23%), renal failure associated with prescribed overdoses of antiinfectives (4%), central-nervous-system drug intoxication following prescribed overdoses (4%), or uncontrolled pain associated with prescribed underdoses (4%). Most errors were initiated during prescribing (72%) and were associated with deficits in pharmacotherapy knowledge (39%) or with failure to consider critical patient information (18%). Errors initiated during dispensing and administration were mostly associated with performance deficits (e.g., accidental slips and lapses). CONCLUSION: A limited number of prevalent medication-error patterns described more than half of all reported errors in a hospital and suggested excellent areas for quality improvement. Error causes varied with the node of the medication-use process where they arose and suggested the need for tailored interventions to improve clinicians' performance.

Resource use and cost of care for patients hospitalised with community acquired pneumonia: impact of adherence to infectious diseases society of america guidelines.

OBJECTIVE: The objective of this study was to compare the inpatient resource use and cost of care for patients hospitalised with community-acquired pneumonia (CAP) who were treated with preferred antibacterial therapy according to the 1998 Infectious Diseases Society of America (IDSA) guidelines with those who were not treated with preferred therapy. METHODS: A multicentre, observational study was conducted in Florida between 1999 and 2000. Hospitalised adult patients (aged > or = 18 years) started on antibacterial therapy for suspected or confirmed CAP were enrolled in the study. Data collected included patient demographic characteristics, pneumonia risk class, resource use (pharmacy, laboratory, radiology, respiratory services, hospital room and board) and economic data. Risk classification according to Fine et al.'s criteria was determined for each patient. Patient's antibacterial therapy was classified as being preferred or non-preferred according to the 1998 IDSA guidelines. Resource utilisation and cost of care were compared between these two groups. RESULTS: Ninety-nine patients were enrolled in the study. The average age was 60.6 years +/- 20.5 years. The percentage of patients in each risk class (according to Fine et al.) were 11.1% in class I, 39.4% in class II, 29.3% in class III, 16.2% in class IV and 4% in class V. The mean cost of hospitalisation per admission (excluding physician cost) was US 3,490 dollars +/- US 3,058 dollars (median US 2,430 dollars) with hospital room/board accounting for the largest percentage (83.7%), followed by laboratory (8.1%), antibacterial (4.6%), radiology (2.6%) and respiratory (0.9%) cost centres [year 2000 values]. The majority of patients (75.8%) received preferred antibacterials according to the IDSA guidelines. The group treated with preferred antibacterials had a shorter mean length of hospital stay (4.5 vs 6.8 days, p = 0.002), a lower total cost of hospitalisation (mean US 3,009 dollars +/- US 2,682 dollars vs US 4,992 dollars +/- US 3,686 dollars; median US 2,047 dollars vs US 3,805 dollars, p = 0.021) and lower antibacterial costs (mean US 117 dollars +/- US 79 dollars vs US 301 dollars +/- US 409 dollars; median US 97 dollars vs US 171 dollars, p = 0.038) compared with patients who did not receive preferred therapy. CONCLUSION: Implementation of protocols according to IDSA guidelines may result in cost savings to institutions wishing to reduce the economic burden associated with treating hospitalised patients for CAP.

Nature of preventable adverse drug events in hospitals: a literature review.

A literature review was conducted to identify the drug classes, types of errors, and types of adverse outcomes related to preventable adverse drug events (pADEs). Studies were identified by keyword search of MEDLINE and International Pharmaceutical Abstracts and by a manual search. The search was limited to peer-reviewed literature reporting pADEs in hospitalized patients and the frequencies of at least one pADE characteristic. The frequencies of pADEs and their characteristics were summarized using median and range. Ten studies published between 1994 and 2001 were included in the review. The reported median frequency of pADEs was 1.8% (range, 1.3-7.8%), and the median preventability rate of ADEs in the hospitals was 35.2% (range, 18.7-73.2%). Cardiovascular drugs were implicated for 17.9% of pADEs (range, 4.3-28.1%). Most pADEs occurred in the prescribing stage of the medication-use process and were dose related. Inappropriate prescribing decisions and patient monitoring were the most frequently identified causes of pADEs. The most common adverse outcomes were allergic reactions, hepatic or renal problems, cardiovascular problems, hematologic problems and bleeding, and central nervous system problems. Frequently reported examples of pADEs included antihypertensive overdose associated with bradycardia or hypotension, antiinfectives prescribed despite a history of allergy, warfarin overdose and inappropriate monitoring resulting in hemorrhage, and opioid overdose or underdose associated with respiratory depression or poor pain control, respectively. Despite the heterogeneity of pADEs, the results of this literature review suggest that a few types of drugs, errors, and adverse outcomes constitute a substantial proportion of pADEs. Targeting these high-priority areas could significantly reduce the overall frequency of pADEs.

Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports.

The ability of a hospital's adverse drug reaction (ADR) database to identify common and repeated patterns of preventable adverse drug events (ADEs) was analyzed. ADR reports collected from 1994 through 2000 were extracted from a teaching hospital's ADR database. Reports were assessed concurrently in accordance with seven previously published explicit criteria for preventability. Only cases considered clinically significant were included in this analysis. Events that occurred in the ambulatory care setting were excluded. Preventable ADEs were categorized by drug or drug class, type of medication error, and the subsequent adverse outcome. Novel in this analysis was the linking of these three descriptors. Of the 2571 ADR reports assessed, 415 ADEs were deemed preventable. Of the preventable ADEs, 98 were not analyzed because they occurred in the ambulatory care setting, leaving 317 preventable ADEs in 275 inpatients (mean age +/- S.D., 48.5 +/- 23.9 years) for analysis. Although 93 drugs were associated with these ADEs, only 10 drugs accounted for more than 60% of the events. Analysis and categorization by type of error and outcome suggested that three high-priority preventable ADEs accounted for 50% of all reports: (1) overdoses of anticoagulants or insufficient monitoring and adjustments (according to laboratory test values) were associated with hemorrhagic events, (2) overdosing or failure to adjust for drug-drug interactions of opiate agonists was associated with somnolence and respiratory depression, and (3) inappropriate dosing or insufficient monitoring of insulins was associated with hypoglycemia. Analysis of a hospital ADR database identified prevalent and preventable clinically significant ADEs.