A Mixed-Methods Analysis of Medication Safety Incidents Reported in Neonatal and Children's Intensive Care.

BACKGROUND: Critically ill neonates and paediatric patients may be at a greater risk of medication-related safety incidents than those in other clinical areas. OBJECTIVE: This study aimed to examine the nature of, and contributory factors associated with, medication-related safety incidents reported in neonatal and paediatric intensive care units (ICUs). METHODS: We carried out a mixed-methods analysis of anonymised medication safety incidents reported to the National Reporting and Learning System that involved children (aged ≤ 18 years) admitted to ICUs across England and Wales over a 9-year period (2010-2018). Data were analysed descriptively, and free-text descriptions of harmful incidents were examined to explore potential contributory factors associated with incidents. RESULTS: In total, 25,567 eligible medication-related incident reports were examined. Incidents commonly occurred during the medicines administration (n = 13,668 [53.5%]) and prescribing stages (n = 7412 [29%]). The most commonly implicated error types were drug omission (n = 4812 [18.8%]) and dosing errors (n = 4475 [17.5%]). Neonates were commonly involved in reported incidents (n = 12,235 [47.9%]). Anti-infectives (n = 6483 [25.4%]) were the medications most commonly associated with incidents and commonly involved neonates. Incidents that were reported to have caused patient harm accounted for 12.2% (n = 3129) and commonly involved neonates (n = 1570/3129 [50.2%]). Common contributing factors to harmful incidents included staff-related factors (68.7%), such as failure to follow protocols or errors in documentation, which were often associated with working conditions, inadequate guidelines, and design of systems and protocols. CONCLUSIONS: Neonates were commonly involved in medication-related incidents reported in children's intensive care settings. Improvements in staffing and workload, design of systems and processes, and the use of anti-infective medications may reduce this risk.

Framework for Pharmacy Services Quality Improvement-A Bridge to Cross the Quality Chasm.

OBJECTIVE: To review the literature on the subject of quality improvement principles and methods applied to pharmacy services and to describe a framework for current and future efforts in pharmacy services quality improvement and effective drug therapy management. BACKGROUND: The Academy of Managed Care Pharmacy produced the Catalog of Pharmacy Quality Indicators in 1997, followed by the Summary of National Pharmacy Quality Measures in February 1999. In April 2002, AMCP introduced Pharmacy's Framework for Drug Therapy Management in the 21st Century. The Framework documents include a self-assessment tool that details more than 250 specific "components" that describe tasks, behaviors, skills, functions, duties, and responsibilities that contribute to meeting customer expectations for effective drug therapy management. FINDINGS: There are many opportunities for quality improvement in clinical, service, and cost outcomes related to drug therapy management. These may include patient safety; incidence of medical errors; adverse drug events; patient adherence to therapy; attainment of target goals of blood pressure, glucose, and lipid levels; risk reduction for adverse cardiac events and osteoporotic-related fractures; patient satisfaction; risk of hospitalization or mortality; and cost of care. Health care practitioners can measure improvements in health care quality in several ways including (a) a better patient outcome at the same cost, (b) the same patient outcome at lower cost, (c) a better patient outcome at lower cost, or (d) a significantly better patient outcome at moderately higher cost. Measurement makes effective management possible. A framework of component factors (e.g., tasks) is necessary to facilitate changes in the key processes and critical factors that will help individual practitioners and health care systems meet customer expectations in regard to drug therapy, thus improving these outcomes. CONCLUSIONS: Quality improvement in health care services in the United States will be made in incremental changes that rely on a structure-process-outcome model. The structure is provided by evidence created from controlled randomized trials and other studies of care and system outcomes that are based on the scientific method. The process portion is created by the application of evidence in the form of clinical practice guidelines, clinical practice models, and self-assessment tools such as Pharmacy's Framework for Drug Therapy Management. Incremental changes in structure and process will result in the desirable outcome of meeting customer needs for more effective drug therapy and disease management. DISCLOSURES: Authors Richard N. Fry and Steven G. Avey are employed by the Foundation for Managed Care Pharmacy, a nonprofit charitable trust that serves as the educational and philanthropic arm of the Academy of Managed Care Pharmacy; author Frederic R. Curtiss performed the majority of work associated with this manuscript prior to becoming editor-in-chief of the Journal of Managed Care Pharmacy. This manuscript underwent blinded peer review and was subject to the same standards as every article published in JMCP.

Impact of medication therapy management on pharmacotherapy safety in an intensive care unit.

Background Drug-related problems are mostly preventable or predictable circumstances that may impact on health outcomes. Clinical pharmacy activities such as medication therapy management can identify and solve these problems, with potential to improve medication safety and effectiveness. Objective To evaluate ability of medication therapy management service to detect drug-related problems and prevent adverse drug events. This study also aimed to assess the risk factors for drugrelated problem occurrence. Setting Medical intensive care unit of a public tertiary hospital in Brazil. Methods Patients were evaluated by a clinical pharmacist, who provided medication therapy management service. Detected drug-related problems were categorized according to the Pharmaceutical Care Network Europe methodology and analyzed in multinomial regression to identify risk factors. Main outcome measure Potential risk factors for drug-related problem occurrence. Results The proposed medication therapy management service allowed detection of 170 drug-related problems that had potential to reach patients causing harm and other 50 unavoidable adverse events. Drug-related problems identified were more often associated with antibacterial use, caused by improper combinations or inadequate drug dosage. These problems required interventions that were accepted by the multidisciplinary team, resulting in more than 85% adherence and total problem solving. Main risk factors identified were previous diagnosis of kidney injury (OR = 8.38), use of midazolam (OR = 7.96), furosemide (OR = 5.87) and vancomycin (OR = 4.82). Conclusion Medication therapy management proved to be an effective method not only for drug-related problem detection, but also for adverse drug event prevention, contributing to improve patient safety.

Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology.

Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a 'reviewer form' has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6-14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete 'ready-to-use' tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.

Period prevalence and reporting rate of medication errors among nurses in Iran: A systematic review and meta-analysis.

AIMS: To estimate the 1-year period prevalence of medication errors and the reporting rate to nurse managers among nurses working in hospitals in Iran. BACKGROUND: Medication errors are one of the main factors affecting the quality of hospital services and reducing patient safety in health care systems. METHOD: A literature search from Iranian and international scientific databases was developed to find relevant studies. Meta-regression was used to identify which characteristics may have a confounding effect on the pooled prevalence estimates. RESULTS: Based on the final 22 studies with 3556 samples, the overall estimated 1-year period prevalence of medication errors and its reporting rate to nurse managers among nurses were 53% (95% confidence interval, 41%-60%) and 36% (95% confidence interval, 23%-50%), respectively. The meta-regression analyses indicated that the sex (female/male) ratio was a statistically significant predictor of the prevalence of medication errors (p < .05), but not of the prevalence of reporting medication errors to nurse managers. CONCLUSION: The period prevalence of medication errors among nurses working in hospitals was high in Iran, whereas its reporting rate to nurse managers was low. IMPLICATIONS FOR NURSING MANAGEMENT: Continuous training programmes are required to reduce and prevent medication errors among nursing staff and to improve the reporting rate to nurse managers in in Iran.

Design and application of a medication assessment tool for secondary prevention of stroke.

Background Optimisation of drug therapy is essential in the care of older persons and may be facilitated by application of medication assessment tools (MATs). Objective To design, psychometrically evaluate and apply an innovative MAT for secondary prevention of ischaemic stroke with particular relevance to older persons. Method Review criteria were selected from clinical practice guidelines and MAT-CVA was developed, validated and tested for reliability and feasibility. MAT-CVA was applied to 150 patients with a diagnosis of ischaemic stroke or transient ischaemic attack admitted to a rehabilitation hospital. Results MAT-CVA consists of 17 criteria sectioned into antithrombotic, lipid lowering, antihypertensive and glycaemic therapy. Content validity was demonstrated for all criteria. Reliability was confirmed with kappa values of 0.80 for both inter- and intraobserver agreements. Mean application time for the two observers was 5.55 and 6.56 min. Adherence to applicable criteria was 55% and justified non-adherence was 22.3%. Non-adherence was predominantly evident for prescription of anticoagulation in concurrent atrial fibrillation (36.4%), thiazide diuretics ± angiotensin converting enzyme inhibitors for hypertension (26.8%) and dipyridamole at the recommended dose (24.0%). Conclusion Application of MAT-CVA indicated good overall adherence and identified gaps in clinical performance which may be targeted to enhance drug therapy optimisation.

Meaningful use of health information technology and declines in in-hospital adverse drug events.

OBJECTIVE: Nationwide initiatives have promoted greater adoption of health information technology as a means to reduce adverse drug events (ADEs). Hospital adoption of electronic health records with Meaningful Use (MU) capabilities expected to improve medication safety has grown rapidly. However, evidence that MU capabilities are associated with declines in in-hospital ADEs is lacking. METHODS: Data came from the 2010-2013 Medicare Patient Safety Monitoring System and the 2008-2013 Healthcare Information and Management Systems Society (HIMSS) Analytics Database. Two-level random intercept logistic regression was used to estimate the association of MU capabilities and occurrence of ADEs, adjusting for patient characteristics, hospital characteristics, and year of observation. RESULTS: Rates of in-hospital ADEs declined by 19% from 2010 to 2013. Adoption of MU capabilities was associated with 11% lower odds of an ADE (95% confidence interval [CI], 0.84-0.96). Interoperability capability was associated with 19% lower odds of an ADE (95% CI, 0.67- 0.98). Adoption of MU capabilities explained 22% of the observed reduction in ADEs, or 67,000 fewer ADEs averted by MU. DISCUSSION: Concurrent with the rapid uptake of MU and interoperability, occurrence of in-hospital ADEs declined significantly from 2010 to 2013. MU capabilities and interoperability were associated with lower occurrence of ADEs, but the effects did not vary by experience with MU. About one-fifth of the decline in ADEs from 2010 to 2013 was attributable to MU capabilities. CONCLUSION: Findings support the contention that adoption of MU capabilities and interoperability spurred by the Health Information Technology for Economic and Clinical Health Act contributed in part to the recent decline in ADEs.

Prescribing error at hospital discharge: a retrospective review of medication information in an Irish hospital.

BACKGROUND: Prescribing error may result in adverse clinical outcomes leading to increased patient morbidity, mortality and increased economic burden. Many errors occur during transitional care as patients move between different stages and settings of care. AIM: To conduct a review of medication information and identify prescribing error among an adult population in an urban hospital. METHODS: Retrospective review of medication information was conducted. Part 1: an audit of discharge prescriptions which assessed: legibility, compliance with legal requirements, therapeutic errors (strength, dose and frequency) and drug interactions. Part 2: A review of all sources of medication information (namely pre-admission medication list, drug Kardex, discharge prescription, discharge letter) for 15 inpatients to identify unintentional prescription discrepancies, defined as: "undocumented and/or unjustified medication alteration" throughout the hospital stay. RESULTS: Part 1: of the 5910 prescribed items; 53 (0.9%) were deemed illegible. Of the controlled drug prescriptions 11.1% (n = 167) met all the legal requirements. Therapeutic errors occurred in 41% of prescriptions (n = 479) More than 1 in 5 patients (21.9%) received a prescription containing a drug interaction. Part 2: 175 discrepancies were identified across all sources of medication information; of which 78 were deemed unintentional. Of these: 10.2% (n = 8) occurred at the point of admission, whereby 76.9% (n = 60) occurred at the point of discharge. CONCLUSIONS: The study identified the time of discharge as a point at which prescribing errors are likely to occur. This has implications for patient safety and provider work load in both primary and secondary care.

Medicines management.

Medication errors are the second most reported incident type in the NHS. Other concerns around medicines management include poor medicines security, theft and poor administration practice.

Are older Western Australians exposed to potentially inappropriate medications according to the Beers Criteria? A 13-year prevalence study.

AIM: To examine time trends and factors associated with exposure to potentially inappropriate medications (PIMs) by the Beers Criteria. METHODS: PIM consumption days accumulated from the pharmaceutical claims of 251 305 Western Australians aged ≥65 years (1993-2005) and person follow-up times produced counts/rates. Logistic/Poisson regression generated odds/rate ratios. RESULTS: A total of 187 616 participants (74.7%) took ≥1 PIM (1993-2005), the cohort consuming 109 415 PIM daily doses/1000 person-years. Annual exposure decreased from 45-47% to 40%, and annual consumption rate declined from 117 836 to 90 364 daily doses/1000 person-years. Temazepam had the highest exposures (>17 000 daily doses/1000 person-years). Number of medications taken (OR 35.03; 95% CI 34.37-35.71 for ≥10 vs. 0-2 drugs), annual drug intake (2.08; 2.04-2.12 for highest vs. lowest quartile), and high-level residential aged care (1.96; 1.91-2.01) were most predictive of PIM exposure. CONCLUSIONS: PIM exposure remains high in older Western Australians. Our findings identify patients most at risk and medications to consider on Australia-specific PIM lists.

The statistical validity of nursing home survey findings.

OBJECTIVES: The Medicare nursing home survey is a high-stakes process whose findings greatly affect nursing homes, their current and potential residents, and the communities they serve. Therefore, survey findings must achieve high validity. This study looked at the validity of one key assessment made during a nursing home survey: the observation of the rate of errors in administration of medications to residents (med-pass). DESIGN: Statistical analysis of the case under study and of alternative hypothetical cases. SETTING: A skilled nursing home affiliated with a local medical school. PARTICIPANTS: The nursing home administrators and the medical director. INTERVENTION: Observational study. MEASUREMENTS: The probability that state nursing home surveyors make a Type I or Type II error in observing med-pass error rates, based on the current case and on a series of postulated med-pass error rates. RESULTS: In the common situation such as our case, where med-pass errors occur at slightly above a 5% rate after 50 observations, and therefore trigger a citation, the chance that the true rate remains above 5% after a large number of observations is just above 50%. If the true med-pass error rate were as high as 10%, and the survey team wished to achieve 75% accuracy in determining that a citation was appropriate, they would have to make more than 200 med-pass observations. In the more common situation where med pass errors are closer to 5%, the team would have to observe more than 2000 med-passes to achieve even a modest 75% accuracy in their determinations. CONCLUSION: In settings where error rates are low, large numbers of observations of an activity must be made to reach acceptable validity of estimates for the true rates of errors. In observing key nursing home functions with current methodology, the State Medicare nursing home survey process does not adhere to well-known principles of valid error determination. Alternate approaches in survey methodology are discussed.

Patterns in nursing home medication errors: disproportionality analysis as a novel method to identify quality improvement opportunities.

PURPOSE: To explore the use of disproportionality analysis of medication error data as a novel method to identify relationships that might not be obvious through traditional analyses. This approach can supplement descriptive data and target quality improvement efforts. METHODS: Data came from the Medication Error Quality Initiative (MEQI) individual event reporting system. Participants were North Carolina nursing homes who submitted incident reports to the Web-based MEQI data repository during the 2006 and 2007 reporting years. Data from 206 nursing homes were summarized descriptively and then disproportionality analysis was applied. Associations between medication type and possible causes at the state level were explored. A single nursing home was selected to illustrate how the method might inform quality improvement at the facility level. Disproportionality analysis of drug errors in this home was compared with benchmarking. RESULTS: Statewide, 59 drug-cause pairs met the disproportionality signal and 11 occurred in 10 or more reports. Among these, warfarin was co-reported with communication errors; esomeprazole, risperidone, and nitrofurantoin were disproportionately associated with transcription error; and oxycodone and morphine were disproportionately reported with name confusion. Facility-level analyses illustrate how descriptive frequencies and disproportionality analysis are complementary, but also identify different safety targets. CONCLUSIONS: Exploratory analysis tools can help identify medication error types that occur at disproportionate rates. Candidate associations might be used to target patient safety work, although further evaluation is needed to determine the value of this information.

Potentially inappropriate medication use and healthcare expenditures in the US community-dwelling elderly.

BACKGROUND: Potentially inappropriate medication (PIM) use is a major source of drug-related problems in the elderly. Few studies have quantified the effect of PIM use on total healthcare expenditures in the United States. OBJECTIVES: : We sought to determine the relationship between PIM use and healthcare expenditure and to estimate the annual incremental healthcare expenditures related to PIM use in the community-dwelling elderly population in the United States in 2001. METHODS: This was a retrospective cohort study. Participants were age 65 years or older who had no PIM use in rounds 1 and 2 of the 2000-2001 Medical Expenditure Panel Survey, a nationally representative survey of the US noninstitutionalized population. On the basis of the 2002 Beers criteria, PIM users were identified as those who had been prescribed at least one PIM during specified time periods in the study. Propensity scores were used to match PIM users and nonusers in the analysis examining differences in total healthcare expenditures. RESULTS: PIM utilization is a significant predictor for higher healthcare expenditures (P < 0.05). A conservative estimate of the incremental healthcare expenditures related to PIM use in the community-dwelling elderly population would be $7.2 billion (95% confidence interval, $3.4 billion-$15.7 billion) in the United States in 2001. CONCLUSIONS: PIM use is a major patient safety concern that results in increased healthcare expenditures. This study emphasizes the need for continued provider education to inform prescribers of the potential risks of using certain medications in the elderly and to improve prescribing practices.

Inappropriate medication use and health outcomes in the elderly.

Inappropriate medication use is a major problem for the elderly. Although increasing attention has been paid to inappropriate prescription medication use, most previous research has been limited to the investigation of prevalence and trends. Few studies provide the empirical evidence for the adverse effect of inappropriate medication use on health outcomes at the national level. This study is the first attempt to assess the relationship between inappropriate prescription use and health status for the elderly in the United States. Based on the 1996 Medical Expenditure Panel Survey, inappropriate medication use in a national representative elderly population was first identified using Beers criteria. A survey type of ordered probit model was then estimated to quantify the effect of inappropriate drug use on patient self-perceived health status measured using a five-point scale (poor, fair, good, very good, and excellent). After controlling for a set of possible confounding factors, it was found that individuals using inappropriate medications in Round 1 were more likely than those not using inappropriate medications to report poorer health status in Round 2. Other risk factors for poor health status include a higher number of prescriptions, being black, having low education, and having one or more chronic diseases. This study provides strong evidence of a significant adverse effect of inappropriate medication use on patient health status. These findings lend partial support to the use of Beers criteria in assessing the quality of prescribing and the appropriateness of medication use in the elderly population.

Learning from prescribing errors.

The importance of learning from medical error has recently received increasing emphasis. This paper focuses on prescribing errors and argues that, while learning from prescribing errors is a laudable goal, there are currently barriers that can prevent this occurring. Learning from errors can take place on an individual level, at a team level, and across an organisation. Barriers to learning from prescribing errors include the non-discovery of many prescribing errors, lack of feedback to the prescriber when errors are discovered by other healthcare professionals, and a culture that does not encourage reflection on errors together with why they occurred and how they can be prevented. Changes are needed in both systems and culture to provide an environment in which lessons can be learnt from errors and put into practice.