Class of 2009 Abstract / OBJECTIVES: To determine the likelihood of pharmacists in England of reporting adverse drug reactions (ADR), whether they are aware of the reporting processes, and what they believe the reasons for not reporting may be. METHODS: A survey containing five different scenarios of ADRs was distributed to licensed, community pharmacists around Surrey, England. The responses were analyzed using rates and chi-square. RESULTS: A total of 47 surveys were returned to the researcher. Of those, 72% of the participants were likely to report the adverse drug reaction in the scenarios provided. In addition, 87.5% of the pharmacists were familiar with the reporting procedures in place in the United Kingdom. A total of 51.9% were not able to distinguish between a major and minor adverse reaction. Finally, with a X2 value of 0.070, there was not a significant difference between males and females and the likelihood of reporting these errors (p=0.79). Similarly, there was no significant difference between the likelihood of reporting an event involving a pediatric patient vs. an adult patient with a X2 value of 0.275 (p=0.599). CONCLUSIONS: Most pharmacists were aware of the procedures involved in reporting ADRs in the United Kingdom and were likely to report these ADRs. Additionally, the most common reason predicted for not reporting was due to the lack of time pharmacists have to report these events. Regardless of gender, male and female pharmacists were equally likely to report ADRs.

Class of 2005 Abstract / Objectives: The purpose of this retrospective investigation is to compare the quantity, importance, and associated cost implications of drug-related problems identified (and ultimately resolved) through order entry/verification versus other clinical activities of a decentralized critical care pharmacist. Methods: The data from this study was collected by one decentralized pharmacist assigned to a surgical intensive care unit. A standard form was used to document all interventions during the period of this observation. For the purposes of this retrospective evaluation the following data will be extracted from the existing database: amount of time spent performing various clinical activities, how drug-related problems were identified (e.g., order entry verification versus chart reviews), the time it took to identify and resolve drug-related problems, a general description of interventions, the importance of the intervention, and the estimated economic impact associated with interventions. Results: In only a 41⁄2 month period, 111 patients would have likely experienced an adverse drug event had the ICU pharmacist not intervened. This equals a cost avoidance to the institution of anywhere from $200,000 to $280,000 for as little on average of 15-30 minutes of the pharmacist time. Implications: As previous studies have shown, the presence of a pharmacist in an ICU is crucial to lowering the incidence of adverse drug events. Our results have proven the interventions pharmacist make during team rounding and chart review are not only cost effective, but substantially improve patient care.

The purpose of this dissertation was to use the theory of planned behavior (TPB) to predict Texas pharmacists’ intention to report serious adverse drug effects (ADEs) to the Food and Drug Administration (FDA). The study explored the utility of the TPB model constructs (attitude [A], subjective norm [SN], perceived behavioral control [PBC]), as well as past reporting behavior (PRB), and perceived moral obligation (PMO) to predict pharmacists’ intention to report serious ADEs to the FDA. The study also determined if the pharmacists’ A, SN and PBC were related to practice characteristics and demographic factors. A survey was developed based on two focus group interviews, pretested and mailed to 1,500 Texas practicing pharmacists. An overall response rate of 26.4 percent was obtained (n = 377 pharmacists). Overall, pharmacists intended to report serious ADEs, had a favorable attitude towards reporting, were somewhat influenced by social norms regarding reporting and perceived themselves to have some control over reporting serious ADEs to the FDA. For direct measures, A and SN were significant predictors of intention to report serious ADEs, but PBC was not. The TPB constructs together accounted for 34.0 percent of the variance in intention to report serious ADEs to the FDA. Using indirect measures, A, SN and PBC were significant predictors of intention and together accounted for 28.8 percent of the variance in intention to report serious ADEs. PRB and PMO improved the explanatory power of the regression models (direct and indirect measures) over and above the TPB constructs. Unlike most other practice characteristics and demographic factors examined, knowledge was significantly related with the TPB constructs. In summary, A, SN, PBC (indirect measures), PRB, and PMO influence the formation of pharmacists’ intention to report serious ADEs. The TPB has utility in predicting ADE reporting behavior. Pharmacy educators should explore pharmacists’ attitudes, beliefs, and expectations of important others in designing educational programs. Strategies to help pharmacists report more serious ADEs should focus on altering their perception of social pressure towards reporting and addressing the barriers towards ADE reporting (e.g., lack of knowledge). / text

Class of 2009 Abstract / OBJECTIVES: To compare possible differences in the proportion of serious potential ADEs associated with high-risk medications that were avoided by the use of AID technology in adult and pediatric ICU patients and to investigate the proportion of serious ADEs associated with high-risk medications as identified by root cause analyses (RCA) that occurred before and after AID implementation. METHODS: Study Site: This retrospective study was conducted at a tertiary care, academic medical center in Tucson Arizona. Design: This was a two-part retrospective study involving data obtained from an AID database and root-cause analyses. Information on high-risk medications obtained from the AID database was used to compare the proportion of serious ADEs avoided by the use of AID technology in adult and pediatric patients. Information on high-risk medications (administered by continuous infusion) obtained from root-cause analyses was used to compare the proportion of serious ADEs that occurred during the 5-year period before and the 5-year period after AID implementation. RESULTS: A total of 261 infusions (225 in the adult and 36 in the pediatric) generated an alert where the final outcome resulted in a reprogramming event when the limit was exceeded by 2.5 times or greater. The pediatric population was 1.68 time (95% CI=1.18 to 2.38) more likely to require a reprogramming event than the adult acute care population for all high-risk medications combined. Significantly more reprogramming events occurred in the pediatric patients with potassium (RR=2.77, 95 CI=1.15 to 6.68) and insulin (RR=2.73, 95% CI=1.15 to 6.45) infusions. Overrides accounted for 80% of the total reprogramming and override events when the maximum limit was exceeded by 10 times or more. There were significantly more overrides in the pediatric compared to the adult population for the high-risk medications (RR=1.82, 95% CI=1.32 to 2.53), however, there were significantly fewer overrides in the pediatric versus adult patients on fentanyl (RR=0.34, 95% CI=0.17 to 0.70). CONCLUSIONS: We found that medication errors involving high-risk medications with the potential to cause ADEs can occur frequently during the administration phase of drug delivery. While smart AIDs cannot intercept all errors, it did show that it was able to intercept certain errors, especially key=pad entry errors. We also determined that when an alert was generated involving our high-risk medications, clinicians were more apt to reprogram the AID when the alert occurred in our pediatric population. While smart pumps have shown great improvement and allow for safer drug delivery, more research is needed in this area before the ability of these smart AIDs to improve drug administration safety can be shown.

Master of Science / Department of Clinical Sciences / Gregory F. Grauer / Prostaglandins play many important roles in the kidney including regulation of renal blood flow, glomerular filtration, renin release, and sodium excretion. Upon activation of the renin angiotensin aldosterone system (RAAS), prostaglandin upregulation becomes critical to offset the vasoconstrictive effects of norephinephrine, angiotensin II, and vasopressin. Nonsteroidal anti-inflammatory drugs (NSAIDs) produce both their beneficial and detrimental effects through inhibition of the cyclooxygenase enzyme and subsequent interference with prostaglandin production. Healthy canine kidneys express both COX-1 and COX-2, although basal COX-2 expression in dogs is significantly higher than in other species. Nonsteroidal anti-inflammatory drugs that spare COX-1 have exhibited less gastrointestinal toxicity, but no NSAID has been proven safe for the kidney. The kidney is the organ with the second highest reports of adverse drug events, which is usually manifested as functional changes. However, structural changes including renal papillary necrosis, can occasionally be observed. Dogs with chronic kidney disease could be expected to be at increased risk for NSAID-related adverse drug effects. As nephrons and renal reserve are lost in chronic kidney disease, the canine kidney becomes more dependent on COX-2 for production of prostaglandins. Inasmuch as the prevalence of both CKD and OA increases with age, it is expected that many dogs being treated with NSAIDs for OA will have loss of renal reserve and/or early stage CKD. If administration of an NSAID is required for long term treatment of osteoarthritis, frequent monitoring of blood pressure and renal parameters, as well as hepatic enzymes are recommended.

京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第18676号 / 医博第3948号 / 新制||医||1007(附属図書館) / 31609 / 京都大学大学院医学研究科医学専攻 / (主査)教授 中山 健夫, 教授 川上 浩司, 教授 柳田 素子 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM

京都大学 / 0048 / 新制・論文博士 / 博士(医学) / 乙第13192号 / 論医博第2156号 / 新制||医||1030(附属図書館) / (主査)教授 中山 健夫, 教授 松村 由美, 教授 川村 孝 / 学位規則第4条第2項該当 / Doctor of Medical Science / Kyoto University / DFAM

This was the first study to quantitatively test the use of SEIPS (Systems Engineering Initiative for Patient Safety) model to identify factors influencing a medication safety outcome. By using a SEIPS model, our study developed a comprehensive approach to identifying potential factors influencing adverse drug events (ADEs). The SEIPS work system is composed of five components which include person, organization, technologies and tools, tasks, and environment. SEIPS model successfully explained the work system factors influencing ADEs and falls in nursing homes (NHs). The second important contribution of our study is that it used the CMS (Centers for Medicare and Medicaid Services) ADE Trigger Tool not only to detect actual ADEs, but also to identify specific potential ADEs in NHs. This study had five objectives: 1) calculate actual ADE incidence rate (number of incidents per 100 residents per month) in NHs using the ADE trigger tool, 2) measure potential ADE incidence rate based on abnormal lab data, vital signs and non-harmful falls, 3) identify the classes of medications most likely to cause ADEs, 4) evaluate the relationships between work system characteristics and the incidence of ADEs, and 5) assess the relationships between work system characteristics and resident fall incidents. This study was an observational quantitative study. It included two quantitative methods: retrospective resident medical chart extraction and survey four types of healthcare practitioners. The staff surveys included four categories of NH practitioners at each facility to ensure comprehensive assessment of the work system: Director of nursing (DON), registered nurse (RN), certified nurse assistant (CNA) and consultant pharmacist. The surveys included questions about the facility conditions, environment, technology, task, and staff/practitioners. Both methods were conducted within the same facilities and during the same period. The study was conducted in 11 NHs in nine cities in Iowa. Data collection was conducted over fall 2016 and spring 2017. Binary logistic regression with Generalized Estimated Equation (GEE) was used to measure the association between the ADE incidence (Yes/No) and characteristics of residents and facilities. The secondary outcome was the incidence of falls. We reviewed 755 medical charts and conducted 44 staff surveys. The rate of ADEs was 6.13 incidents per 100 residents per month. Approximately (64.1%) of the ADEs were preventable. More than half of the ADEs were fall-related (51.1%) and half of those harmful falls were due to hypotension. We considered all the harmful falls as ADEs in residents with one or more psychotropic, antihypertensive, opioid and/or anti-diabetic medications, which can cause fall. The most common ADEs included medication (opioid)-induced constipation (24.6%), psychotropic induced confusion, dizziness or drowsiness (6.5%), antibiotic-induced Clostridium difficile diarrhea (4.2%), anticoagulant induced bleeding (3.9%) and antidiabetic induced hypoglycemia (3.2%). The most common fall-related ADEs were bruise (9.7%) and abrasion or laceration (9.4%). Psychotropic medications (74.9%), antidepressants (61.3%), antihypertensive agents (58.7%), and opioids (51.9%) were the most common medications associated with ADEs. The rate of potential ADEs was 48.6 per 100 residents per month. The rate of falls was 23.38 per 100 residents per month. The regression analysis revealed significant associations between the ADEs and opioid analgesics, psychotropic medications, warfarin, skilled care, consultant pharmacist accessibility, nurse-physician collaboration, CNA skills in taking vital signs, number of physician visits to the facility, nurse workload and the use of electronic health records. On the other hand, the regression analysis showed non-significant relationships between ADEs and cardiac arrhythmia (AFib), DON years in the facility and distracting noise during medication administration. The six significant facility characteristics represent five concepts of the SEIPS model: organization, task, environment, person and technology. In the fall regression analysis, twelve of the resident and the facility SEIPS variables had significant relationships with the incidence of resident falls. The significant variables represent four concepts of the SEIPS model: organization, task, environment, and person. Longer DON years in the facility and more nurse time per resident per day were associated with lower number of fall incidents. The CNA skills in taking vital signs have significant negative association with both ADEs and falls. Finally, the variable “CNAs work fast” and the nurse workload also have positive association with the incidence of falls

Concern beliefs in medicines are patients' anxieties about the harmful effects of a specific prescribed medication. Three papers examined the importance of concern beliefs in medicine, specifically its relationship to patient outcomes such as self-reported adverse drug events (ADEs) and symptom attribution, and the factors that might drive a change in concern beliefs over time. For the first and second paper, a cross-sectional internet survey of Medicare enrollees who were English speakers, 65 years and older and enrolled in the Medicare Part D program was done. In the third paper, a longitudinal internet survey of the same sample was done before Medicare Part D in 2005 and after Medicare Part D in 2007, and adults 40 years and older with physical limitations were interviewed using telephone. Multiple logistic regressions showed that having stronger concern beliefs in medicine and more symptoms was related to self-reported ADE, rather than using an inappropriate medicine or the number of inappropriate medicines used. Using independent sample t-tests, concern beliefs in medicine were found to be unrelated to symptom attribution for any causal reason, irrespective of whether there was patient-clinician agreement on attribution. Multiple linear regressions showed that concern beliefs changed over time for some older adults and having an ADE in the past year was related to this change. Among adults with physical limitations, though concern beliefs changed for some individuals; only one factor included in this study, changes in number of medicines, was related to this change. Establishing the importance of concern beliefs in medicines as a socio-psychological variable to consider in medication use outcomes will enhance the understanding of clinical researchers and practitioners concerning the mechanism of ADEs and symptom reporting.

Adverse drug events (ADE) cause many deaths annually in addition to affecting the quality of life of many others. The descriptive mixed methods approach, specifically exploratory case study and experimental design that guided this research utilized the survey and focus group methods to evaluate perceptions about robotic technology (RT) to reduce the rate of ADEs in U.S. nursing homes (NH). There is a lack of scholarly research into whether a conceptual approach rooted in RT can be implemented to assist with drug administrations in NHs. The purpose of this study was twofold. The first purpose was to evaluate the causes of ADEs specifically related to tablets, capsules, and pills. The second purpose was to evaluate the perceptions of nurses and administrators relative to the use of RT to assist in reducing ADEs. In the quantitative part, the sample means from 102 surveys from nurses and administrators were evaluated with the t test and the paired t test; while in the qualitative part, survey results, reported errors, and focus group data was assessed collectively. The research results did not indicate any new causes of ADEs and showed that the participants had a favorable perception of RT. Based on the results of this research, RT may be tailored in such a way that it can significantly reduce ADE occurrences for citizens in U.S. NHs.