Class of 2008 Abstract / Objectives: To determine the active drug content and weight uniformity for half tablets of commonly split medications as a means to outline the safety and efficacy of tablet splitting. Methods: This analytical study was performed using the following six medications: warfarin, simvastatin, metoprolol succinate, metoprolol tartrate, citalopram, and lisinopril. Whole tablets (n=15) and half tablets (n= 30) were analyzed for drug content using high pressure liquid chromatography as compared to established standard curves. Weight uniformity was assessed using half tablet weights as compared to one half of the average whole tablet weight. Results: Percent deviation from the expected drug content for all drugs analyzed ranged from 81%- 126%. All drugs produced tablet halves falling outside of the range of 90%-110% for active drug content: warfarin (1), simvastatin (3), metoprolol succinate (10), metoprolol tartrate (4), citalopram (5), and lisinopril (10). Percent relative standard deviation for drug content was less than 6% for all drugs analyzed. Weight uniformity, defined as 85%-115% of the expected weight, was found for all drugs analyzed with the exception of lisinopril, with one half tablet at 122% of the expected weight. Statistical significance for the data was not determined. Conclusions: Half tablet drug content uniformity was not concluded for the medications/ manufacturers studied. To determine true safety and efficacy of tablet splitting, additional research must be performed assessing clinical endpoints using patient-split tablets. Furthermore, USP methods for assessing drug content uniformity must be developed for half tablets, as a means to determine which medications are safe to split.

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This thesis examines three main themes; depression, suicidality, and non-fatal overdose involving pharmaceutical and over-the-counter (OTC) medications. At any given time depression affects approximately one in every twenty adults in Australia. People with depression are at elevated risk of attempted and completed suicide compared to those without. Medication overdose is a frequently chosen method of suicidal behaviour, and accounts for one in ten suicide deaths and close to nine out of ten non-fatal episodes of suicidal behaviour for which hospital treatment is sought. The study reported here had six primary aims; (i) to quantify medication overdose presentations over a 12-month period to the Emergency Department (ED) of a major metropolitan public hospital in Melbourne, Australia, (ii) to describe the medication overdose patient group, including comparison with two other relevant types of presentation, illicit drug overdose, and actual or potential self-harm by means other than overdose, (iii) to explore the relationship between depression, suicidal ideation and medication overdose, (iv) to identify the medications typically used in overdose and their means of acquisition, (v) to explore patient experiences of emergency care following a medication overdose, and (vi) to comment on the feasibility of introducing a brief intervention within the ED with the intention of addressing the issue of medication overdose. Three data sources were employed: computerised ED records, interviews with a sub-sample of patients attending the ED following a medication overdose, and observation of ED processes in relation to these cases. / One of the most important findings of the study was the large contribution made by benzodiazepine medications to the overall medication overdose statistics. When considered in conjunction with the patient interview data, it appeared that many patients included in the study were prescribed benzodiazepines in a manner that contradicts current national prescribing guidelines. The problem of medication overdose could be partially addressed by working with doctors to ensure the appropriateness of their prescribing practices, to encourage them to more closely monitor the treatment progress of at-risk patients, and to increase awareness of other evidence-based forms of treatment for depression and anxiety.

Submitted by Maria Creuza Silva (mariakreuza@yahoo.com.br) on 2014-07-16T19:15:47Z No. of bitstreams: 1 Tese Claudio Leão. 2011.pdf: 1126510 bytes, checksum: dada43746a68d91919e3a1c1bf80fd10 (MD5) / Approved for entry into archive by Maria Creuza Silva (mariakreuza@yahoo.com.br) on 2014-07-16T20:33:36Z (GMT) No. of bitstreams: 1 Tese Claudio Leão. 2011.pdf: 1126510 bytes, checksum: dada43746a68d91919e3a1c1bf80fd10 (MD5) / Made available in DSpace on 2014-07-16T20:33:36Z (GMT). No. of bitstreams: 1 Tese Claudio Leão. 2011.pdf: 1126510 bytes, checksum: dada43746a68d91919e3a1c1bf80fd10 (MD5) / Os gastos em saúde têm sido uma preocupação dos governos que justificaria a produção pública de medicamentos, ao menos daqueles considerados essenciais pela Organização Mundial da Saúde. Nessa perspectiva, o propósito dessa tese é analisar a estrutura de governança da produção pública de medicamentos e o papel dos laboratórios oficiais nessa produção. A hipótese que orienta a tese é a de que a produção pública de medicamentos atual é uma estrutura de governança inadequada para ampliar o acesso da população brasileira a esse bem. A análise dos casos estudados mostrou que o contexto em que a estrutura de produção pública brasileira se insere evoluiu rapidamente e esta não se adaptou a esse novo contexto. Os arranjos institucionais de compras públicas, planejamento da produção, mix de produtos, contratos de trabalho, acesso e transferência de tecnologia são entraves à produção pública eficiente. As Parcerias Público-Privadas (PPP) como solução híbrida de opção entre o público e o privado, elegendo uma cooperação entre as duas esferas, em que pese o seu ponto positivo de coordenar as políticas de saúde e econômicas. Esse modelo ainda têm vários problemas em aberto sobre a capacidade desse arranjo institucional no futuro ser a melhor solução para ampliação do acesso a medicamentos no Brasil. / Health expenditures has been a concern of the government that would justify public production of drugs, at least those considered essential by the World Health Organization. In this sense, the purpose of this thesis is to analyze the governance structure of public production of drugs and the role of official laboratories in this production. The hypothesis that guides the thesis is that public production of drugs is a current governance structure inadequate to improve access of the population to that well. The analysis of the cases studies showed that the context in which the structure of brazilian’s public production is insert rapidly evolved and this has not adapted to this new context. The institutional arrangements for procurement, production planning, product mix, labor contracts, access and transfer of technology are obstacles to efficient public production. The Public-Private Partnerships (PPPs) as a hybrid solution of choice between public and private, electing cooperation between the two spheres, despite their positive coordinate health policies and economic. This model still has several problems about the capacity of this institutional arrangement in the future be the best solution for increasing access to medicines in Brazil.

Falls are caused by many factors in older patients. Medications have been shown to be a risk factor for falls, and studies have shown that patients taking more than five total medications may have a two-fold increased risk of impaired balance. A more recent model suggests only medications with sedating and anticholinergic properties contribute significantly to physical impairment. The authors of this paper helped to develop a multidisciplinary clinic to evaluate the risk of falls in at-risk patients. We present the case of a woman on multiple medications that increased her risk of falling. Of note, this patient was taking a total of 14 prescription medications, seven of which were considered sedating. Based on a comprehensive medication evaluation, six specific changes were recommended to improve this patient's medication regimen and reduce her risk of falling.

BACKGROUND: High-cost healthcare users (HCUs) are patients who use disproportionate healthcare resources compared to their peers. A better understanding of their co-morbidity status, medication use, and healthcare utilization is needed to improve health interventions and policies. OBJECTIVES: We aimed to: (1) synthesize what is known about HCUs and interventions for managing them, (2) characterize how HCUs differ from non-HCUs, and (3) explore the impact of medications and whether prescribing quality contributes to differences in healthcare costs and HCU status development. METHODS: We synthesized what is known about HCUs and used the GRADE framework to evaluate the evidence for interventions designed to improve their health. We conducted retrospective population-based matched cohort and case-control studies of incident older adult HCUs using health administrative data. We examined prescribing and medication costs over the non-HCU to HCU transition period and compared them to non-HCUs. We conducted logistic regression to evaluate associations between HCU status development and the use of high-cost drugs and potentially inappropriate medications. RESULTS: HCU interventions to date have shown inconsistent effects on clinical outcomes and healthcare costs and the overall quality of evidence supporting their efficacy is low. Compared to non-HCUs, HCUs have higher rates of polypharmacy, hospitalization, and mortality. Medications are the highest healthcare cost category in the pre-HCU year and these costs rise nearly 1.7-fold in the HCU year. High-cost drug use increases significantly during the HCU transition period and 3.6% achieve HCU status based on drug costs alone. Use of several potentially inappropriate medications and high-cost drugs significantly increase the odds of HCU development. CONCLUSIONS: Medications can contribute to high-cost healthcare directly through drug costs alone or indirectly through adverse effects on health. Medication optimization interventions and policies to reduce inappropriate medication use and ensure cost-effective medication use are needed to manage high-cost healthcare and prevent HCU development. / Thesis / Doctor of Philosophy (PhD) / High-cost healthcare users (HCUs) are patients who use disproportionate healthcare resources compared to their peers. More research is needed to better understand HCUs to design interventions to improve their health outcomes and costs. In this thesis, we evaluated what previous studies have discovered about HCUs and we used Ontario’s health system data to explore whether the quality of prescribing and medication use in older adults influences their risk of becoming a HCU. We found that current interventions for HCUs have had inconsistent effects on improving health outcomes and costs. We also found two medication-related factors contributing to the risk of becoming an older adult HCU: (1) use of very expensive medications, and (2) use of potentially inappropriate medications where the risk of harm may outweigh potential benefits. Interventions and health policies to optimize the appropriate and cost-effective use of medications are needed to manage high-cost healthcare and prevent HCU development.

Yes / Introduction: Many older people live with both multiple long‐term conditions and frailty; thus, they manage complex medicines regimens and are at heightened risk of the consequences of medicines errors. Research to enhance how people manage medicines has focused on adherence to regimens rather than on the wider skills necessary to safely manage medicines, and the older population living with frailty and managing multiple medicines at home has been under‐explored. This study, therefore, examines in depth how older people with mild to moderate frailty manage their polypharmacy regimens at home. Methods: Between June 2021 and February 2022, 32 patients aged 65 years or older with mild or moderate frailty and taking five or more medicines were recruited from 10 medical practices in the North of England, United Kingdom, and the CARE 75+ research cohort. Semi‐structured interviews were conducted face to face, by telephone or online. The interviews were recorded, transcribed verbatim and analysed using reflexive thematic analysis. Findings: Five themes were developed: (1) Managing many medicines is a skilled job I didn't apply for; (2) Medicines keep me going, but what happened to my life?; (3) Managing medicines in an unclear system; (4) Support with medicines that makes my work easier; and (5) My medicines are familiar to me—there is nothing else I need (or want) to know. While navigating fragmented care, patients were expected to fit new medicines routines into their lives and keep on top of their medicines supply. Sometimes, they felt let down by a system that created new obstacles instead of supporting their complex daily work. Conclusion: Frail older patients, who are at heightened risk of the impact of medicines errors, are expected to perform complex work to safely self‐manage multiple medicines at home. Such a workload needs to be acknowledged, and more needs to be done to prepare people in order to avoid harm from medicines. Patient and Public Involvement: An older person managing multiple medicines at home was a core member of the research team. An advisory group of older patients and family members advised the study and was involved in the first stages of data analysis. This influenced how data were coded and themes shaped. / National Institute for Health and Care Research (NIHR). Grant Number: NIHR201056. National Institute for Health and Care Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre.

Adherence to combination antiretroviral therapy is important for achieving optimal HIV-related outcomes. Epidemiologic data indicate that persons with mental disorders are disproportionately affected by HIV/AIDS, which is concerning since having a mental disorder has been associated with poor adherence to medications for treatment of chronic disease states. The purpose of this study was to examine the relationship between the presence of mental disorders and adherence to combination antiretroviral therapy. Additionally, this study examined the relationship between adherence to psychotropic medications and adherence to antiretroviral therapy. Study data were collected from the Texas Medicaid Vendor Drug Program database and Texas Medicaid enrollment files. Adherence to and persistence with antiretroviral therapy, as well as adherence to psychotropic medications when applicable, were evaluated over a 12-month period in 1,321 patients starting a new combination antiretroviral regimen. The presence of a mental disorder was defined based on prescription claims for psychotropic medications. Proportion of days covered was used to calculate adherence, while persistence was defined as the number of days persistent with all antiretrovirals in the index regimen. Logistic regression was used to evaluate the relationship between psychotropic medication use and adherence to antiretroviral therapy (90% cut-off), as well as the relationship between adherence to psychotropic medications (80% cut-off) and adherence to antiretroviral therapy. The relationship between antiretroviral persistence and psychotropic medication use was evaluated using multiple linear regression. Factorial ANOVA was used to evaluate the interactions between race/ethnicity, gender, and psychotropic medication use in their effects on adherence to and persistence with antiretroviral therapy. No significant relationship was found between the presence of a mental disorder and adherence to or persistence with combination antiretroviral therapy in this study. However, the limitations of using psychotropic medication use as a proxy for mental disorders may have affected the results. Adherence to psychotropic medications overall (n = 501; OR = 3.37, 95% CI: 1.86 – 6.10; p < 0.001) and specifically to antidepressants (n = 443; OR = 4.23, 95% CI: 2.31 – 7.75; p < 0.001) was significantly associated with adherence to antiretroviral therapy, indicating a possible relationship between effective treatment for mental disorders and combination antiretroviral therapy adherence. While additional research is needed to clarify this relationship, these data support the need for an integrated approach to treatment of mental disorders and HIV/AIDS. / text

Purpose: The purpose of this study was to determine the influence of out-of-pocket prescription and healthcare costs on adherence to guideline recommended statins, angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARB), and beta-blockers (BB) used for secondary prevention of coronary heart disease and the associations of adherence with cardiovascular mortality in community-dwelling Medicare beneficiaries ≥ 65 years. Methods: Data from the 2004, 2005, and 2006 Medicare Current Beneficiary Survey (MCBS) was utilized to conduct a retrospective, cross-sectional (i.e., multiple cohort) study. Dependent variables of interest included adherence to statins, ACE/ARBs or BBs, and all-cause mortality, with out-of-pocket (OOP) costs, and adherence to these medications the primary independent variables of interest in these models. Adherence was analyzed as a binary variable with ≥ 80 percent annual adherence the threshold utilized in primary analyses. Total OOP prescription costs for all medications and total OOP healthcare costs borne by the beneficiary were reported. Complex survey design-specified logistic regression with sampling weights was the main statistical analysis used. Sensitivity analyses on adherence thresholds and subgroups were additionally conducted. Results: A significant positive relationship between total OOP prescription costs and statin adherence was identified across observation years in the primary models. Similar relationships were noted for ACE/ARBs and BB in 2004, and ACE/ARBs in 2005. No significant association between adherence and total OOP healthcare costs was indicated in the primary models. Mortality could not be used as a clinical outcome of interest due to limitations with the data. Thus, acute coronary syndrome (ACS) events were used as the clinical outcome. At the ≥ 80 percent threshold, no significant reductions in ACS events were reported. However, various sensitivity analyses did suggest significant reductions in ACS events with ACE/ARBs. Additionally, significantly higher risk of ACS was noted when BB adherence thresholds were reduced to ≥ 60 percent. Conclusions: OOP prescription costs are a significant factor influencing adherence to these medications used for secondary prevention of CAD/MI in Medicare beneficiaries. Continuing to monitor how these costs impact adherence and ultimately outcomes will be critical, particularly given policy changes such as Medicare Part-D.

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.