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1.
Am J Pharm Educ ; 88(2): 100643, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38191094

ABSTRACT

Creating a welcoming and supportive environment for learners with disabilities needs to be a focus within pharmacy education. Including students with disabilities enhances program diversity and contributes to awareness and understanding of disability. Barriers to embracing disability include stigma toward disability, insufficient resource allocation, and misunderstanding of accommodations. Steps that need to be taken to embrace disability include evaluation of current programmatic culture, provision of education, and collaboration with external stakeholders. Schools/colleges of pharmacy must move toward a framework that embraces disability within our programs.


Subject(s)
Disabled Persons , Education, Pharmacy , Pharmaceutical Services , Pharmacy , Humans , Curriculum , Schools, Pharmacy
2.
Am J Pharm Educ ; 87(12): 100551, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37336326

ABSTRACT

OBJECTIVE: This study aimed to describe trends in social vulnerability (SV) among pharmacy students at a large public college of pharmacy, and to describe differences in SV by race and ethnicity using the Centers for Disease Control and Prevention Social Vulnerability Index (SVI). METHODS: The SVI was determined for each student admitted between Fall 2017 and Fall 2022 using the submitted permanent address for each student in a deidentified fashion. International students and students not from the 50 US states were excluded from the analysis. RESULTS: During the study period, 1427 pharmacy students met the study inclusion criteria and were included in the final analysis. Students from historically minoritized populations accounted for 53.4% (n = 763/1427) of students. The median SVI score for all students was 0.4091 (interquartile range [IQR]: 0.2091-0.6395), which is consistent with low/moderate SV risk. When considering SVI by race, students from historically minoritized populations had a higher median SVI (0.4807 [IQR: 0.2791-0.7071] vs 0.3562 [IQR: 0.1561-0.5523]), and were more likely to come from moderate/high SV regions compared with White students (odds ratio 2.00 [95% confidence interval: 1.609-2.486]). CONCLUSION: Among pharmacy students at a large public university, a substantial proportion of students had moderate/high SV risk, particularly those from historically minoritized backgrounds. Colleges and schools of pharmacy need to consider the unique needs of students from high SV backgrounds and provide intentional equity-based mitigation strategies to maximize the potential for student success for all.


Subject(s)
Education, Pharmacy , Students, Pharmacy , Humans , Universities , Social Vulnerability , Schools, Pharmacy
3.
Curr Pharm Teach Learn ; 15(4): 329-333, 2023 04.
Article in English | MEDLINE | ID: mdl-37105797

ABSTRACT

INTRODUCTION: There is a long-standing commitment in higher education to provide parallel experiences for students with disabilities, including those with hearing disabilities or impairments. The commitment remains the same in professional pharmacy school education, with the objective to train competent clinical pharmacy practitioners. COMMENTARY: Limited literature exists to provide schools and colleges of pharmacy (S/COP) with best practices when accommodating students who are deaf or hard of hearing (DHOH) in the didactic pharmacy curriculum. The authors will examine practices implemented at the COP to accommodate students with either a DHOH disability. IMPLICATIONS: Students who are DHOH in didactic pharmacy education require individualized assistance to help ensure success throughout the program. A collaborative approach between the student, disability resources, student affairs office, faculty, and staff help ensure accommodations are met and fosters a culture of inclusiveness.


Subject(s)
Hearing Loss , Pharmacy , Humans , Curriculum , Educational Status , Hearing
4.
Curr Pharm Teach Learn ; 14(8): 1060-1067, 2022 08.
Article in English | MEDLINE | ID: mdl-36055697

ABSTRACT

PROBLEM DESCRIPTION: To decrease delayed graduation and student dismissal, we developed a systematic process to identify and intervene with students with academic challenge across the first three years of the curriculum. QUALITY IMPROVEMENT METHODS: Four strategies were implemented to support student academic success: early identification of academic challenge, supplemental instruction, tutoring, and remediation. Outcomes were tracked through the number of students requiring remediation, academic performance during remediation, and changes in delayed graduation and academic dismissal. RESULTS OF CQI INQUIRY: The number of students requiring remediation has decreased each year since implementation in 2017 to 2020 (54, 36, 30, and 21, respectively). The rate of successful remediation has ranged from 72% to 87%. Strategies to support student success have resulted in decreased delayed graduation and academic dismissal. INTERPRETATION AND DISCUSSION: Commitment to academic success was a culmination of resources to support students, including the investment in an academic performance specialist and paid supplemental instructors. A focus on student success has led to awareness of additional strategies that may be employed to enhance the student support program. These include creating a culture of no shame for receiving academic support and mandating some activities for students who do not maintain a minimum threshold. CONCLUSIONS: A holistic approach to academically support students that included preventive and interventional strategies was successful in decreasing delayed graduation and academic dismissal.


Subject(s)
Academic Performance , Academic Success , Achievement , Curriculum , Humans , Students
5.
Curr Pharm Teach Learn ; 14(3): 304-309, 2022 03.
Article in English | MEDLINE | ID: mdl-35307089

ABSTRACT

INTRODUCTION: The purpose of this study was to compare student and faculty perceptions of strength of residency candidacy and to identify student preferences and perceptions that influence the process of being selected by a residency program beyond standard application materials. METHODS: A 31-item questionnaire was administered to third-year and fourth-year pharmacy students to collect information regarding factors deemed important for successful residency program candidacy. Global assessment of strength of residency candidacy was self-rated by students and a group of clinical faculty blinded to student responses. Interrater reliability for student-to-faculty and faculty-to-faculty perceptions of strength of residency candidacy was determined. RESULTS: Students generally reported good academic metrics and participation in a wide variety of scholarly activities deemed important in attaining a residency position. Students rated overall strength of residency candidacy as "above average" (n = 54, 37.2%), "average" (n = 60, 41.4%), and "below average" (n = 31, 21.3%), and self-perception increased with matriculation. Student self-assessment of strength of residency candidacy compared to faculty assessment showed poor agreement (mean [SD] kappa = 0.27 [0.08]). Faculty concordance in assessment of strength of residency candidacy was moderate (α = 0.55). CONCLUSIONS: Concordance in self-assessment of strength of residency candidacy of students compared to faculty was poor. In contrast, agreement among faculty was moderate with generally lower ratings compared to student self-rating, suggesting that students are overconfident in this regard. These findings support residency preparedness training in pharmacy curricula which should include formal assessment of strength of residency candidacy to identify gaps.


Subject(s)
Internship and Residency , Students, Pharmacy , Faculty , Humans , Reproducibility of Results , Self-Assessment
7.
Med Decis Making ; 37(7): 827-843, 2017 10.
Article in English | MEDLINE | ID: mdl-28384413

ABSTRACT

BACKGROUND: Corticosteroids used as immunosuppressants to prevent acute rejection (AR) and graft loss (GL) following kidney transplantation are associated with serious cardiovascular and other adverse events. Evidence from short-term randomized controlled trials suggests that many patients on a tacrolimus-based immunosuppressant regimen can withdraw from steroids without increased AR or GL risk. OBJECTIVES: To measure the long-term tradeoff between GL and adverse events for a heterogeneous-risk population and determine the optimal timing of steroid withdrawal. METHODS: A discrete event simulation was developed including, as events, AR, GL, myocardial infarction (MI), stroke, cytomegalovirus, and new onset diabetes mellitus (NODM), among others. Data from the United States Renal Data System were used to estimate event-specific parametric regressions, which accounted for steroid-sparing regimen (avoidance, early 7-d withdrawal, 6-mo withdrawal, 12-mo withdrawal, and maintenance) as well as patients' demographics, immunologic risks, and comorbidities. Regression-equation results were used to derive individual time-to-event Weibull distributions, used, in turn, to simulate the course of patients over 20 y. RESULTS: Patients on steroid avoidance or an early-withdrawal regimen were more likely to experience AR (45.9% to 55.0% v. 33.6%, P < 0.05) and GL (51.5% to 68.8% v. 37.8%, P < 0.05) compared to patients on steroid maintenance. Patients in 6-mo and 12-mo steroid withdrawal groups were less likely to experience MI (11.1% v. 13.3%, P < 0.05), NODM (30.7% to 34.4% v. 37.7%, P < 0.05), and cardiac death (29.9% to 30.5% v. 32.4%, P < 0.05), compared to steroid maintenance. CONCLUSIONS: Strategies of 6- and 12-mo steroid withdrawal post-kidney transplantation are expected to reduce the rates of adverse cardiovascular events and other outcomes with no worsening of AR or GL rates compared with steroid maintenance.


Subject(s)
Decision Support Systems, Clinical , Graft Rejection/complications , Immunosuppressive Agents/pharmacology , Kidney Transplantation/adverse effects , Steroids/pharmacology , Tacrolimus/pharmacology , Adolescent , Adult , Aged , Cardiovascular Diseases/complications , Cardiovascular Diseases/epidemiology , Computer Simulation , Databases, Factual , Female , Humans , Male , Middle Aged , Regression Analysis , United States/epidemiology , Young Adult
8.
Pharmacoepidemiol Drug Saf ; 25(9): 1042-51, 2016 09.
Article in English | MEDLINE | ID: mdl-27133913

ABSTRACT

PURPOSE: The aim of this study was to evaluate the practice pattern of off-label use of fluoroquinolones (FQs) in ambulatory settings and to identify the related risk factors. METHODS: The National Ambulatory Medical Care Surveys from 2006 through 2012 was used to identify subjects who received FQ off-label prescriptions. We defined off-label use as the use of FQs for indications other than those in the FDA-approved drug label. Descriptive statistics were calculated by using a series of weighted chi-squared statistics. Multivariate logistic regression was conducted to identify factors associated with off-label FQ drug use. RESULTS: There were 93 million ambulatory visits in which an FQ was prescribed, and 53.16% of these visits involved the prescribing of FQs in an off-label manner. The percentage of off-label prescriptions was the highest among individuals ≥80 years old (61.6%) and male patients (60.9%). The FQ drug prescribed most for an off-label indication in our study was ciprofloxacin (29.5% of the total visits). The multivariate analysis showed that age of ≥80 years and male patient was significantly associated with off-label use of FQs (adjusted odds ratio (OR) 3.66, 1.72-7.80 and OR 3.26, 2.32-4.56, respectively). Medicaid or private insurance versus Medicare were associated with significantly higher off-label prescribing of FQs (OR 2.53, 1.28-5.01 and 1.77, 1.03-3.03, respectively). CONCLUSION: The percentage of visits involving off-label FQs in US ambulatory settings is substantial. Efforts are needed consolidate and evaluate what high-quality scientific evidence is available and what is needed to support the safety and effectiveness of such off-label uses. Copyright © 2016 John Wiley & Sons, Ltd.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Fluoroquinolones/administration & dosage , Off-Label Use/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Ambulatory Care/statistics & numerical data , Female , Health Care Surveys , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Outpatients , Risk Factors , Sex Factors , United States , Young Adult
9.
J Am Pharm Assoc (2003) ; 55(3): 246-54, 2015.
Article in English | MEDLINE | ID: mdl-26003155

ABSTRACT

OBJECTIVES: To determine if a community pharmacy-based transition of care (TOC) program that included the full scope of medication therapy management (MTM) services (TransitionRx) decreased hospital readmissions, resolved medication-related problems, and increased patient satisfaction. DESIGN: Prospective, quasi-experimental study. SETTING: Nine Kroger Pharmacies located in Western Cincinnati. PATIENTS: Patients older than 18 years of age and discharged from two local hospitals with a diagnosis of congestive heart failure, chronic obstructive pulmonary disease, or pneumonia. Patients were recruited from two local hospitals and referred to the community pharmacy for MTM services with the pharmacist within 1 week of discharge. MAIN OUTCOME MEASURES: Pharmacists reconciled the patients' medications, identified drug therapy problems, recommended changes to therapy, and provided self-management education. At 30 days after discharge, research personnel conducted telephone surveys, using a previously validated survey instrument, to assess hospital readmissions and patient satisfaction. Pharmacist interventions and medication-related problems were documented. RESULTS: A total of 90 patients completed the study. Of these, 20% of patients in the usual care group were admitted to the hospital within 30 days compared with 6.9% of patients in the intervention group (P = 0.019). In the 30 patients who received MTM services from the pharmacist, 210 interventions were made. The overall mean patient satisfaction with the TOC process was not significantly different between patients who were seen by the pharmacist and those who were not seen by the pharmacist. CONCLUSION: Community pharmacies successfully collaborated with hospitals to develop a referral process for TOC interventions. Patients who received MTM services from the pharmacist experienced significantly fewer readmissions than patients who received usual care.


Subject(s)
Community Pharmacy Services/organization & administration , Continuity of Patient Care/organization & administration , Medication Therapy Management/organization & administration , Patient Readmission/statistics & numerical data , Aged , Female , Humans , Male , Middle Aged , Ohio , Program Evaluation
10.
Ann Pharmacother ; 48(12): 1570-9, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25280975

ABSTRACT

BACKGROUND: For patients with atrial fibrillation (AF), early treatment is essential to prevent serious complications such as stroke. Several randomized clinical trials have shown that rate-control may be as effective as rhythm-control medications, whereas the latter have serious side effects. Little evidence exists, however, about which class of rate-control medication-ß-blockers (BBs) or calcium channel blockers (CCBs)-may be superior. OBJECTIVE: The objective was to compare the long-term persistence on BBs versus CCBs in nonelderly adult patients with AF. METHODS: A longitudinal retrospective cohort study for patients 40 to 60 years old with newly diagnosed AF (identified by ICD-9 code 427.31) was performed using data from Ohio Medicaid physician, institutional, and pharmacy claims from January 2006 through June 2011. A Cox proportional hazard regression, with time to change out of rate-control therapy as the dependent variable, was estimated to compare persistence on (proxy for effectiveness of) rate-control medication across drug classes. A propensity-score analysis was used to control for selection bias. Additional covariates included age, development of heart failure, and medication adherence. RESULTS: Out of 1239 patients included in the cohort, 1016 received a BB; 223 received a CCB. Over time, patients on CCBs were significantly more likely to switch out of rate-control therapy (hazard ratio = 1.89; 95% CI = 1.14-3.09) than patients on BBs. CONCLUSIONS: Evidence suggests that nonelderly AF patients, when prescribed rate-control therapy, persist longer on BBs than CCBs. Because this is the first long-term study comparing the 2 drug classes in the nonelderly population, further research is suggested.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Atrial Fibrillation/drug therapy , Calcium Channel Blockers/therapeutic use , Adult , Atrial Fibrillation/physiopathology , Female , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Retrospective Studies
11.
Pharmacoepidemiol Drug Saf ; 23(5): 539-47, 2014 May.
Article in English | MEDLINE | ID: mdl-24619888

ABSTRACT

PURPOSE: Several clinical trials have shown that rhythm-control drugs have serious adverse events and no survival advantage over rate-control drugs in patients with atrial fibrillation. The objectives were to determine and explain the recent trends in outpatient prescribing of both drug classes. METHODS: Data were obtained over 10 years from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. Visits by patients with atrial fibrillation were identified by ICD-9 diagnosis code 427.31. Trend lines were estimated for drug prescribing and comorbidities. A multinomial logistic model was estimated to predict treatment on the basis of visit characteristics. RESULTS: The percentage of visits mentioning only a rate-control medication trended upward (p = 0.07) from 41.9% in 2001 to 47.3% in 2010; the percentage mentioning both rhythm-control and rate-control drugs also had an upward trend (p < 0.05) from 3.1% to 12.5%; finally, the percentage mentioning rhythm-control drugs alone remained steady (p = 0.37). Consistent with the increase (p = 0.10) in the percentage of visits mentioning hypertension, there was a statistically significant (p < 0.01) rise in the prescribing of ß-blockers from 20.5% to 43.4%. The odds that a patient aged 65 years or younger was prescribed a rhythm-control medication were significantly higher (p < 0.01) than those for a patient older than 65 years. The estimated odds that a diabetic patient was prescribed both rhythm-control and rate-control medications was only 0.269 (p < 0.05). CONCLUSIONS: This study documents change in the outpatient treatment of atrial fibrillation in the USA from 2001-2010. In clinical practice, there has been a growing reliance on rate-control medications.


Subject(s)
Ambulatory Care/trends , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Practice Patterns, Physicians'/trends , Age Factors , Aged , Aged, 80 and over , Anti-Arrhythmia Agents/adverse effects , Anti-Arrhythmia Agents/pharmacology , Health Care Surveys , Humans , Logistic Models , Male , Middle Aged , Outpatients , United States
12.
Patient Prefer Adherence ; 7: 301-7, 2013.
Article in English | MEDLINE | ID: mdl-23620661

ABSTRACT

OBJECTIVES: To measure the association of transplant patients' personality, depression, and quality of life with medication adherence in kidney and liver transplant recipients. METHODS: A cross-sectional study of liver and kidney transplant recipients greater than 1 year post-transplant was conducted. Patients' adherence with medications was assessed using the Immunosuppressive Therapy Adherence Scale. Personality and depression were assessed using the NEO Five-Factor Inventory Scale and Patient Health Questionnaire 9, respectively. Quality of life was assessed using the Short Form-36, and functional status was determined using the Karnofsky Performance Status Scale. RESULTS: A total of 86 kidney and 50 liver transplant patients completed the surveys. Logistic regression analysis demonstrated an association between depression and adherence with immunosuppressive medications in kidney transplant recipients. Kidney transplant patients who exhibited "low openness" scores were 91% more likely to be nonadherent. Kidney transplant patients' physical functional status was strongly associated with nonadherence, and for each point increase in functionality the patients' adherence increased by 4%. In the liver sample, age was associated with adherence. For every year increase in age, adherence increased by 7%. CONCLUSION: The presence of low openness as a personality trait, poor physical functional status, and depression were associated with adherence in the kidney transplant population. In the liver transplant population, younger age was associated with nonadherence.

13.
J Am Med Inform Assoc ; 20(2): 268-76, 2013.
Article in English | MEDLINE | ID: mdl-23048007

ABSTRACT

OBJECTIVE: To observe the effect of electronic medical record (EMR) system sophistication on preventive women's healthcare. MATERIALS AND METHODS: Providers in the National Ambulatory Medical Care Survey (NAMCS), 2007-8, were included if they had at least one visit by a woman at least 21 years old. Based on 16 questions from NAMCS, the level of a provider's EMR system sophistication was classified as non-existent, minimal, basic, or fully functional. A two-stage residual-inclusion method was used with ordered probit regression to model the level of EMR system sophistication, and outcome-specific Poisson regressions to predict the number of examinations or tests ordered or performed. RESULTS: Across the providers, 29.23%, 49.34%, 15.97%, and 5.46% had no, minimal, basic, and fully functional EMR systems, respectively. The breast examination rate was 20.27%, 34.96%, 37.21%, and 44.98% for providers without or with minimal, basic, and fully functional EMR systems, respectively. For breast examinations, pelvic examinations, Pap tests, chlamydia tests, cholesterol tests, mammograms, and bone mineral density (BMD) tests, an EMR system increased the number of these tests and examinations. Furthermore, the level of sophistication increased the number of breast examinations and Pap, chlamydia, cholesterol, and BMD tests. DISCUSSION: The use of advanced EMR systems in obstetrics and gynecology was limited. Given the positive results of this study, specialists in women's health should consider investing in more sophisticated systems. CONCLUSIONS: The presence of an EMR system has a positive impact on preventive women's healthcare; the more functions that the system has, the greater the number of examinations and tests given or prescribed.


Subject(s)
Guideline Adherence , Medical Records Systems, Computerized , Outcome Assessment, Health Care , Preventive Health Services/statistics & numerical data , Women's Health , Adult , Decision Making, Computer-Assisted , Female , Health Care Surveys , Health Education/statistics & numerical data , Humans , Mass Screening/statistics & numerical data , Poisson Distribution , Regression Analysis , Reminder Systems , United States
14.
Clin Ther ; 34(10): 2118-2131.e1, 2012 Oct.
Article in English | MEDLINE | ID: mdl-23031625

ABSTRACT

BACKGROUND: The incidence of invasive fungal infections (IFIs) has increased substantially in the recent past. Advances in medical technology, including broad-spectrum antibiotics, may increase the risk for fungal infections. Moreover, immunocompromised patients with cancer, HIV/AIDS, and/or transplants are susceptible to IFIs. Meanwhile, superficial fungal infections (SFIs) are common and can be difficult to cure. OBJECTIVE: To provide a historical perspective on a dynamic market with expensive medications, this study describes trends in the utilization of, spending on, and average per-prescription spending on outpatient antifungal medications individually, in classes (for IFIs or SFIs), and overall, by the US Medicaid programs from 1991 to 2009. METHODS: The publicly available Medicaid State Drug Utilization Data, maintained by the Centers for Medicare & Medicaid Services, were used. Annual prescription counts and reimbursement amounts were calculated for each of the antifungals reimbursed by Medicaid. Average per-prescription spending as a proxy for drug price was calculated by dividing reimbursement by the number of prescriptions. RESULTS: Overall utilization for Medicaid beneficiaries remained steady, with 4.56 million prescriptions in 1991 and 4.51 million in 2009. Expenditures rose from $93.87 million to $143.76 million (in current-year US$) over the same time period. The drop in the utilization of first-generation azoles over the last 5 years of the study period can be explained in part by the movement of dual-eligibles from Medicaid to Medicare Part D and in part to a rise in fungal infections better treated with second-generation azoles or echinocandins. Whereas the average per-prescription price for generic (oral) fluconazole was $8 in 2009, the price per prescription of branded (intravenous) voriconazole was $2178. CONCLUSIONS: Overall spending by Medicaid on outpatient antifungal medications increased more slowly than did the growth of the Medicaid programs from 1991 to 2009. However, the utilization of antifungal agents for IFIs increased almost 10-fold over this period, far outpacing the rise in the number of Medicaid beneficiaries.


Subject(s)
Antifungal Agents/therapeutic use , Drugs, Generic/therapeutic use , Medicaid/economics , Mycoses/drug therapy , Antifungal Agents/economics , Drug Costs/trends , Drugs, Generic/economics , Health Expenditures/trends , Humans , Medicaid/trends , Mycoses/epidemiology , Outpatients/statistics & numerical data , Retrospective Studies , United States/epidemiology
15.
Am J Pharm Educ ; 76(6): 115, 2012 Aug 10.
Article in English | MEDLINE | ID: mdl-22919091

ABSTRACT

OBJECTIVE: To implement and assess the effectiveness of a 2-course collaborative decision analysis project intended to help students understand the relevance of pharmacoeconomics to clinical pharmacy practice and provide them an opportunity to apply skills taught in pharmacoeconomics to a "real world" problem. DESIGN: Students were assigned a pair of drugs, 1 commonly used as standard therapy and 1 newly approved, and conducted a decision analysis. The results were then used in a mock pharmacy and therapeutics (P&T) committee meeting. ASSESSMENT: Ninety-eight of 106 (92%) students completed a 4-question survey instrument. Ninety-six percent of students agreed or somewhat agreed that the decision analysis project met the learning objectives. Students felt the shared assignment influenced their choice of formulary drug, augmented understanding of factors influencing decisions, broadened their thinking about drug costs, and was a good approximation of a "real world" application. CONCLUSION: An innovative joint-course assignment proved to be a successful technique for teaching decision analysis.


Subject(s)
Decision Support Techniques , Economics, Pharmaceutical , Education, Pharmacy/methods , Students, Pharmacy , Clinical Competence , Cooperative Behavior , Data Collection , Formularies as Topic , Humans , Pharmaceutical Services/organization & administration , Pharmacy and Therapeutics Committee/organization & administration
16.
Pediatr Transplant ; 16(3): 280-5, 2012 May.
Article in English | MEDLINE | ID: mdl-22372519

ABSTRACT

While it is known that sirolimus affects sex hormones in adult kidney transplant patients, there is a scarcity of data on its effects on sex hormone levels in adolescent kidney recipients. The objective of this study is to describe the impact of sirolimus on the sex hormones in this patient population. This is a retrospective review of male adolescent renal transplant patients transitioned to sirolimus. Baseline and subsequent annual testosterone levels were collected. Linear regression was undertaken to determine the predictors of testosterone levels. Four African Americans and 11 Caucasians, median age of 15 yr (11-18) in 2008, were included. Mean time post-transplant was 81 ± 37 months. Mean testosterone values were the following: 336 ± 135 ng/dL (n = 8) at baseline, 349 ± 130 ng/dL (n = 15) one yr later, and 360 ± 132 ng/dL (n = 13) two yr later (normal range for adult males: 350-970 ng/dL). Seven (47%) patients experienced a decrease in testosterone levels. Time on sirolimus was associated with decreased testosterone (r = 0.643, p = 0.010). Testosterone levels in pubertal male kidney transplant recipients on sirolimus may be suppressed, especially if they have been treated with sirolimus for several years. These data need to be confirmed in a larger study.


Subject(s)
Gonadal Steroid Hormones/metabolism , Immunosuppressive Agents/pharmacology , Kidney/metabolism , Sirolimus/pharmacology , Adolescent , Child , Follicle Stimulating Hormone/metabolism , Glomerular Filtration Rate , Humans , Kidney Transplantation/methods , Male , Prednisone/pharmacology , Regression Analysis , Retrospective Studies , Testosterone/blood
17.
Prog Transplant ; 20(4): 350-6, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21265288

ABSTRACT

CONTEXT: Tacrolimus is an immunosuppressant that undergoes therapeutic drug monitoring. The laboratory at our institution changed its immunoassay techniques from the fluorescence polarization immunoassay to the cloned enzyme donation immunoassay. OBJECTIVE: To evaluate the relationship between the 2 assays and to determine the impact of the change on clinical decision making. DESIGN: A retrospective study of patients admitted to the hospital during the assay transition period. Tacrolimus values for the 2 assays were collected for 4 weeks and compared. SETTING: An academic health center. PATIENTS: Liver transplant patients hospitalized from February 18, 2008, to March 18, 2008. MAIN OUTCOME MEASURE: The primary outcome was the agreement between the results of the 2 immunoassays. Secondary outcome was agreement of clinical decision making with established patient-specific therapeutic ranges or with a 30% difference in absolute values between the assays. RESULTS: Seventy-nine pairs of tacrolimus concentrations were collected from 21 liver transplant patients. The mean (SD) tacrolimus concentrations were 7.36 (4.21) microg/L for the fluorescence polarization immunoassay and 9.00 (5.30) microg/L for the cloned enzyme donation immunoassay (P = .03). A clinically different decision would have been made if the fluorescence polarization immunoassay value had not been reported 51% of the time. A Bland-Altman plot indicated no relationship between the assay results. CONCLUSION: A change in tacrolimus monitoring assay would have resulted in different clinical decisions 51% of the time. Awareness of changes in assay technology must be heightened to enhance clinical decision making and prevent potential impact on morbidity among liver transplant patients.


Subject(s)
Drug Monitoring/methods , Fluorescence Polarization Immunoassay/methods , Immunoenzyme Techniques/methods , Immunosuppressive Agents , Liver Transplantation/immunology , Tacrolimus , Analysis of Variance , Chromatography, Liquid , Decision Making , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/blood , Linear Models , Liver Transplantation/adverse effects , Mass Spectrometry , Middle Aged , Practice Patterns, Physicians' , Tacrolimus/administration & dosage , Tacrolimus/blood , Transplantation Immunology
19.
Clin Transplant ; 22(1): 113-9, 2008.
Article in English | MEDLINE | ID: mdl-18217912

ABSTRACT

UNLABELLED: Transplant patients are at increased risk of developing dyslipidemia, which contributes to coronary artery disease and cardiovascular events. The purpose of this study was to explore documented adverse effects of liver transplant recipients receiving lipid-lowering therapies. METHODS: A retrospective chart review of 69 liver transplant patients was conducted to evaluate the incidence of adverse effects, especially rhabdomyolysis and liver function abnormalities, in liver transplant patients treated with a lipid lowering agent (LLA). Data were collected from the time of initiation of LLA to 12 months later, looking at the type, dose, and duration of LLA, concurrent cytochrome P450 inhibitors, immunosuppression used, and laboratory parameters. RESULTS: For HMG-CoA reductase inhibitor therapy, simvistatin was used in five (7.8%) patients, pravastatin in 40 (62.5%), fluvastatin in one (1.6%), atorvastatin in five (7.8%), and lovastatin in three (4.7%). Gemfibrozil, a fibric acid derivative, was employed as monotherapy in 10 (15.6%) of patients. There were five patients who received combination therapy with a fibric acid derivative, four (80%) with gemfibrozil + pravastatin, and one (20%) with gemfibrozil + simvastatin. Six patients studied had adverse effects, five (7.2%) with myalgia and one (1.4%) with myopathy. LLA monotherapy with either pravastatin or atorvastatin was used in these patients. The five patients with myalgia were on concurrent therapy with cyclosporin, and the patient with myopathy was on concurrent cyclosporin + diltiazem therapy, both of which are P450 inhibitors. One out of 23 patients on a non-immunosuppressant P450 inhibitor developed adverse effects. No significant elevation of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase was noted in any patient. CONCLUSIONS: Overall, there was a general tolerability with a low incidence of adverse events, no incidence of severe complications, and no alterations in liver function tests in the study population with the use of LLA.


Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Liver Transplantation , Muscular Diseases/epidemiology , Cytochrome P-450 Enzyme Inhibitors , Dyslipidemias/prevention & control , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Liver Function Tests , Liver Transplantation/adverse effects , Myositis/epidemiology , Patient Education as Topic , Pravastatin/adverse effects , Pravastatin/therapeutic use , Retrospective Studies , Rhabdomyolysis/epidemiology
20.
Prog Transplant ; 17(2): 103-19; quiz 120, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17624133

ABSTRACT

PURPOSE: To provide current information on pharmacoeconomic outcomes in transplantation for the past 6 years. METHODS: An extensive literature search was undertaken using PubMed and other authenticated Internet sources. Key words used to elicit pertinent studies were "pharmacoeconomics," "transplantation," "cost-effectiveness," "cost-benefit," "cost-minimization" and "cost-utility" analyses. Studies included in the review contain updated pharmacoeconomic data generated during the past 6 years on economic, clinical, and humanistic outcomes. These data are used to describe and analyze the cost of drug therapy used in transplantation. RESULTS: Background information is included in the review to provide a context from which to evaluate new study material. Data extracted from the studies include significant findings and study limitations. Data were stratified into understanding pharmacoeconomic methods and their application to transplantation, maintenance and induction therapies, and management of and costs associated with adverse events and quality-of-life issues. CONCLUSIONS: Continued evolution of pharmacoeconomic analysis is needed so that optimal care can be provided in the most cost-effective manner. Pharmacoeconomic study, done rationally and logically, is an indispensable tool in determining optimal transplantation regimens.


Subject(s)
Drug Costs/statistics & numerical data , Economics, Pharmaceutical/organization & administration , Immunosuppressive Agents/economics , Organ Transplantation/economics , Cost of Illness , Cost-Benefit Analysis , Data Interpretation, Statistical , Decision Trees , Direct Service Costs/statistics & numerical data , Graft Rejection/economics , Health Expenditures/statistics & numerical data , Humans , Immunosuppressive Agents/adverse effects , Markov Chains , Models, Econometric , Morbidity , Organ Transplantation/psychology , Outcome Assessment, Health Care , Patient Compliance/psychology , Quality of Life , Regression Analysis , Research Design
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