Publications

BACKGROUND: Multiple complications can arise secondary to poor control of glucose, blood pressure, and cholesterol in a patient with diabetes.

OBJECTIVE: To evaluate the effect of a pharmacist-physician collaboration on attainment of diabetes-related measures of control.

METHODS: This was a prospective, multicenter, cohort study. Patients were enrolled from 7 practice sites throughout Tennessee if they had been diagnosed with type 2 diabetes, were aged 18 years or older with a life expectancy greater than 1 year, and were English speaking. Pregnant women were excluded. Patients were followed for 12 months following enrollment by informed consent. The pharmacist-physician collaboration method was established prior to study initiation. Primary outcomes included hemoglobin A1c (A1C), number of patients with A1C less than 7%, and percentage of patients with A1C greater than 9%.

RESULTS: Of the 206 patients enrolled, the mean age was 59.73 years, and most were male (59.71%) and white (66.02%). The A1C was reduced by an average of 1.16% (p < 0.0001). The proportion of patients with A1C less than 7% increased from 12.75% at baseline to 36.76% at study conclusion (p = 0.0002). The proportion of patients with A1C greater than 9% decreased from 34.15% to 16.50%, (p < 0.0001).

CONCLUSIONS: Pharmacist-physician collaborative management at multiple practice locations and types of setting (eg, private, academic, Veterans Affairs medical center) has a positive impact on glycemic control and diabetes-related health maintenance. This was accomplished without increasing the total number of antihyperglycemic agents prescribed and without an increase in patient-reported episodes of hypoglycemia.

OBJECTIVES: Promoting appropriate antibiotic use has the potential to decrease healthcare costs by reducing unnecessary prescriptions and the incidence of resistant infections. However, little is known about where antibiotic costs are incurred in the US healthcare system. We evaluated antibiotic expenditures by healthcare setting and antibiotic class in the USA.

METHODS: Systemic antibiotic expenditures in 2009 were extracted from the IMS Health(©) National Sales Perspectives database. These data represent a statistically valid projection of all medication purchases in the USA from 1 January 2009 to 31 December 2009.

RESULTS: Antibiotic expenditures totalled $10.7 billion. The majority (61.5%) of expenditures were associated with the outpatient setting, especially from community pharmacies. Inpatient and long-term care settings accounted for 33.6% and 4.9% of expenditures, respectively. The class of antibiotics that accounted for the most antibiotic expenditure overall was the quinolones, followed by the penicillins.

CONCLUSIONS: Over $10.7 billion was spent in 2009 on antibiotic therapy in the USA. Differences were observed in antibiotic expenditures by healthcare setting, with the majority in the outpatient setting, 87% of which was in community pharmacies.

BACKGROUND: For the past 30 years, clinical trials have been increasingly conducted in developing countries. These trials allow results to be generalizable to similar populations, offer access to treatment for patients in need, and examine diseases with differing patterns than developed countries. However, the characteristics of antineoplastic clinical trials and recent trends in study location in developing countries are unknown.

OBJECTIVE: The primary objective was to evaluate the location, study phase, results, funding source, and ethics board approval of randomized double-blind controlled clinical trials evaluating antineoplastic agents by geographic location.

SETTING: This is a retrospective evaluation of studies indexed in the PubMed/Medline database published in 2007-2011.

METHODS: Clinical trials were identified with the search terms "drug therapy", "antineoplastic agents" and "double blind method" and limited to English language, human, and randomized controlled trial.

MAIN OUTCOME MEASURE: We assessed frequencies of characteristics of antineoplastic clinical trials.

RESULTS: A total of 116 trials evaluating antineoplastic drug therapy were identified. The highest frequency of clinical trials were published in 2009 (27.6 %), followed by 2011 (23.3 %), 2010 (20.7 %), 2007 (14.6 %), and 2008 (13.8 %). According to geographic region, 33.8 % were conducted in North America, followed by Europe (31.5 %) and Asia (16.2 %). Based on economic status, the majority (77.8 %) of clinical trial locations were in developed countries and 22.2 % were in developing countries. No significant difference was found between study locations in developed countries and developing countries from 2007 to 2011. When comparing studies conducted in developing and developed countries, there was no difference in the year published, study phase, results, funding source, or investigational review board approval and informed consent. Studies conducted in developed countries were significantly more likely to be single country studies (p = 0.02) and published in a journal with an impact factor greater than 10 (p = 0.013) when compared to studies conducted in developing countries.

CONCLUSIONS: Based on economic status, there was no significant location change of antineoplastic clinical trials from 2007 to 2011. Clinical trials conducted in developing countries were more often multi-country studies and published in journals with lower impact factors.

PURPOSE: The frequencies and corresponding susceptibilities of bacteria isolated from patients in the emergency department (ED) were compared with those from hospitalized patients.

METHODS: A microbiology laboratory report of all positive bacterial cultures obtained in the ED, regardless of the source (e.g., blood, urine, sputum), was obtained. In the case of duplicate cultures, only the first isolate cultured from a single patient was included. Colonization-site cultures (e.g., nasal swabs) and culture reports identified by the laboratory as contaminant organisms were excluded from the evaluation. Antimicrobial susceptibility results were then compiled into a standardized ED-specific antibiogram. Antimicrobial susceptibilities for each pathogen in the ED antibiogram were compared with those in the hospitalwide antibiogram. If there was a difference of ≥5% between the susceptibility of a single antimicrobial agent, chi-square tests were conducted, and unadjusted odds ratios were calculated. Pathogens with fewer than 30 isolates were excluded from the susceptibility comparison.

RESULTS: A total of 3140 cultures were evaluated (1417 from the ED, 1723 from the hospital). The frequencies of pathogens isolated in the ED and hospitalwide were similar, with the exception of Escherichia coli, which were more commonly isolated in ED patients, and Enterococcus species and Pseudomonas aeruginosa, which were more common in hospitalized patients. Significant differences in susceptibility profiles were identified for Staphylococcus aureus, coagulase-negative Staphylococcus, Enterococcus faecalis, E. coli, Klebsiella pneumoniae, and P. aeruginosa.

CONCLUSION: Significant differences in the frequencies of bacteria isolated and corresponding susceptibilities were found in cultures obtained in ED patients compared with those obtained in hospitalized patients.

BACKGROUND: Some medicines regulatory authorities are encouraging research in pediatrics. However, children are a vulnerable population, and previous studies have suggested that research is increasingly being conducted outside of developed countries.

OBJECTIVE: The purpose of this study is to determine the location of trials in the pediatric population with human immunodeficiency virus (HIV).

SETTING: Not applicable.

METHODS: Clinical trials registered in the largest international clinical trials registry (clinicaltrials.gov) evaluating antiretrovirals in pediatric HIV infected patients were included. Data were collected on the location, funding, study purpose, design, initiation date, age of subjects, and medication classes tested.

MAIN OUTCOME MEASURES: We assessed frequencies of characteristics of pediatric HIV trials registered in the clinicaltrials.gov database.

RESULTS: Overall, 288 studies were included in the analysis. Most trials were conducted in ages 12-17 years (83 %), followed by studies in those <6 years (25 %) and 6-11 years (21 %). The location of most trials included at least one site in developed countries (83 %). The number of trials completed exclusively in developing countries increased from 1989 to 2011.

CONCLUSIONS: The majority of pediatric antiretroviral trials registered in clinicaltrials.gov were conducted in adolescent subjects in developed countries. The number of pediatric HIV studies in developing countries increased while studies conducted in developed countries decreased similar to trends of HIV.

A 52-year-old African American female presented with severe left thigh pain of unknown etiology. She had a past medical history of generalized seizure disorder treated with phenytoin for 7 years without incident. During admission a nurse witnessed a seizure, and consequently loading and maintenance doses of phenytoin were administered to obtain a therapeutic serum concentration. The patient had a history of noncompliance with multiple subtherapeutic phenytoin levels. Subsequently, unifocal blue discolored spots appeared, progressing to a bullous component that was positive for skin sloughing. Drug-induced fixed drug eruption was diagnosed and attributed to phenytoin. Clinicians should be cognizant of drug-induced fixed drug eruption in patients just initiated and those receiving long-term treatment with phenytoin. The administration rate of phenytoin may be associated with the development of fixed drug eruption.

BACKGROUND: Only 23% of patients are meeting all goals for cardiovascular complications of diabetes.

OBJECTIVE: The purpose of our study is to evaluate the effect of a pharmacist-physician collaboration on attainment of cardiovascular-related goals in patients with type 2 diabetes.

METHODS: This prospective, multicenter cohort enrolled patients from 7 practice sites that were members of the University of Tennessee Pharmacist Practice Based Research Network (UT Pharm Net). Patients were included if they were diagnosed with type 2 diabetes, at least 18 years of age and English speaking. Pregnant patients were excluded. Patients were followed for 12 months after enrollment. Primary cardiovascular outcomes included reduction in systolic blood pressure, diastolic blood pressure, and low-density lipoprotein (LDL) as well as the proportion of patients achieving a blood pressure goal of <130/80 mm Hg and proportion of patients achieving an LDL goal of <100 mg/dL.

RESULTS: For the 206 patients enrolled, the average age was 59.7 years; the majority were male (59.7%) and white (66%). When compared with baseline, the postintervention mean systolic (P < .0001), diastolic blood pressure (P = .0003), and LDL (P < .0001) decreased significantly. The proportion of patients achieving a blood pressure of <130/80 mm Hg increased 21.8% (P < .0001), and the proportion of patients achieving an LDL of <100 mg/dL increased 12% (P = .0023).

CONCLUSIONS: The results of our study indicate that collaborative management has a positive impact on decreasing cardiovascular risk and assists patients in attaining national goals for blood pressure and cholesterol.

PURPOSE: The results of a survey assessing Medicare Part D enrollment, the use of pharmacotherapies for chronic diseases, and other medication-use issues in a population of elderly military veterans are presented.

METHODS: Medicare-eligible (i.e., ≥65 years of age) patients with documented recent service use at a single Veterans Affairs (VA) medical center were targeted for a mail survey. Women were oversampled (20%) to ensure an adequate sample size; the sample was weighted to adjust for this oversampling. Usable survey data were received from 458 survey respondents.

RESULTS: Nearly all respondents (93.2%) reported having one or more chronic conditions; of those, 93.3% reported regular use of multiple drug therapies, and 30.1% reported using medications prescribed by both VA and non-VA providers for the same chronic condition. About half of the survey respondents reported at least one office visit with a non-VA physician during the previous year, and 55.8% reported obtaining medications from non-VA pharmacies. More than half (54.1%) of the respondents reported non-VA medication coverage, with 21.2% indicating they were enrolled in Medicare Part D. Among the respondents who reported obtaining medications from non-VA pharmacies, substantial proportions reported discussing those medications with VA physicians never (38.4%) or infrequently (15.7%).

CONCLUSION: Although large proportions of Medicare-eligible veterans take multiple medications and use non-VA health care services and pharmacies, many do not discuss medications obtained outside the VA system with VA physicians, suggesting that increased efforts to enhance provider-patient communication and medication reconciliation across VA and non-VA systems of care may be warranted.

OBJECTIVE: The objective of the study was to assess the adherence to hormonal contraception (pill, patch, ring, or injectable) among women veterans and examine the relationships between race/ethnicity and the months of contraceptive supply dispensed with contraceptive adherence.

STUDY DESIGN: We conducted a retrospective analysis of the Department of Veterans Affairs (VA) national databases to examine the adherence to hormonal contraception over 12 months among women aged 18-45 years who had hormonal contraceptive coverage during the first week of fiscal year 2008. We examined several adherence indicators including gaps between refills and months of contraceptive coverage. Descriptive statistics and multivariable models were used to examine the associations between race/ethnicity and contraceptive supply dispensed with adherence.

RESULTS: Our cohort included 6946 women: 47% were white, 6% were Hispanic, 22% were black, and 25% were other race or had missing race information. Most women (83%) received a 3 month supply of contraception at each fill. More than 64% of women had at least 1 gap in coverage of 7 days or longer. Only 22% of women received a full 12 months of contraception without any gaps (perfect adherence). Compared with whites, Hispanics were significantly more likely to experience gaps (64% vs 70%; P = .02), and Hispanics and blacks received fewer months of contraceptive coverage (9.3 vs 8.9 and 9.0, P < .001). Compared with women receiving 3 month supplies, those receiving 1 month supplies had a higher likelihood of a gap (63% vs 72%, P < .001), fewer months of coverage (9.3 vs 6.9, P < .001), and a lower likelihood of perfect adherence (22% vs 11%, P < .001).

CONCLUSION: Adherence to hormonal contraception among women veterans is poor. Efforts to improve contraceptive adherence and lower risk of unintended pregnancy are needed; dispensing more months of supply for hormonal contraception may be a promising strategy.