Biomedical subjects

Abraham G Hartzema

Publications and source records attributed to Abraham G Hartzema.

14 recordsLinked to original sources

PubMed2006

Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs.

BACKGROUND: Despite growing numbers of pharmacogenetics studies, little pharmacogenetics-based prescribing information is available to practitioners. It is possible that the lack of prescribing data for commonly used drugs is due to a paucity of evidence-based pharmacogenetics literature for these agents. OBJECTIVE: To investigate the relationship between pharmacogenetics prescribing data in drug package inserts (PIs) and pharmacogenetics research literature for agents represented in the top 200 prescribed drugs for 2003. METHODS: A PubMed search (to August 7, 2004) was performed to identify pharmacogenetics studies relevant to the top 200 drugs. These data were compared with PIs for drugs in the top 200 list that contained pharmacogenetics prescribing information. RESULTS: Pharmacogenetics data in the literature were available for 71.3% of the top 200 drugs. The gene involved coded for a drug-metabolizing enzyme in 34.5% of the literature sampled. The remaining 65.5% of the pharmacogenetics studies contained information largely related to genetic variability in target proteins and drug transporters. Three drugs with PIs containing pharmacogenetics prescribing information deemed to be useful to guide therapy were in the top 200 list (celecoxib, fluoxetine, pantoprazole). There was no consensus on the strength of association between genetic variability and drug response for these agents. CONCLUSIONS: The lack of specific pharmacogenetics-based prescribing information in PIs for commonly used drugs does not seem to be related to a paucity of pharmacogenetics data in the research literature. Rather, other factors including, but not limited to, the uncertain clinical relevance of genetic associations may make practical prescribing recommendations difficult.

Drug Prescriptions↗

PubMed2006

Medication safety infrastructure in critical-access hospitals in Florida.

PURPOSE: The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. METHODS: Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. RESULTS: The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. CONCLUSION: Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

Drug Compounding↗

PubMed2006

Effectiveness of nesiritide on dialysis or all-cause mortality in patients undergoing cardiothoracic surgery.

BACKGROUND: Natriuretic peptides have been shown to have favorable renal effects. However, recent evidence suggests potential renal side effects in patients with congestive heart failure. HYPOTHESIS: This study examined the effect of nesiritide (human B-type natriuretic peptide) on hemodialysis or death in patients undergoing cardiothoracic surgery. METHODS: This retrospective cohort study included patients (n = 940) undergoing nontransplant adult cardiothoracic surgery between July 2001 and February 2004. Patients receiving nesiritide within 3 days after and not before surgery (n = 151) were compared with those not given nesiritide (n = 789) for incidence of hemodialysis or in-hospital death by Day 21 (HD/death). Patients with preexisting dialysis and intraoperative deaths were excluded. Forward inclusion multiple logistic regression was used based on published risk factors for HD/death. RESULTS: Of 940 patients (318 coronary artery bypass graft, 348 valve, and 274 thoracic aorta), 36 required dialysis and 60 patients died (HD/death; n = 77). Adjusted for significant confounders (gender, age, procedure, intra-aortic balloon, baseline serum creatinine mg/dl [SCr], 1 day % SCr increase), nesiritide showed a statistically nonsignificant HD/death reduction (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.29-1.17; p = 0.129) in the group as a whole. When stratified by baseline SCr, a significant benefit was noted in patients with SCr > 1.0 (OR, 0.35; 95% CI 0.14-0.87; p = 0.024), while no significant effect was found in patients with SCr < 1.0 (OR, 1.55; 95% CI 0.48-5.07, p = 0.465). CONCLUSIONS: Nesiritide appears promising in reducing the risk of dialysis or death in patients with SCr > 1.0 undergoing cardiothoracic surgery; however, no effect was noted with SCr < 1.0. This study provides strong rationale for a randomized trial.

Acute Kidney Injury↗

PubMed2006

The effects of prophylactic iron given in prenatal supplements on iron status and birth outcomes: a randomized controlled trial.

OBJECTIVE: The hypothesis that daily use of a prenatal supplement with iron from enrollment to third trimester to initially iron-replete, nonanemic pregnant women would reduce third-trimester anemia and improve birth outcomes was tested. STUDY DESIGN: Eight hundred sixty-seven women in Raleigh, North Carolina, who were at < 20 weeks of gestation were enrolled; 429 of these women had hemoglobin levels of > or = 110 g/L and ferritin levels of > or = 40 microg/L and were assigned randomly to receive prenatal supplements with 30 mg of iron as ferrous sulfate (n = 218 women) or 0 mg of iron (n = 211 women) until 26 to 29 weeks of gestation. Intent-to-treat analysis was used for the outcomes of third-trimester iron status, birth weight, preterm birth, and small-for-gestational age. RESULTS: Mean birth weight was higher by 108 g (P = .03), and the incidence of preterm delivery was lower (8% vs 14%; P = .05) in the 30-mg group compared with the control group, respectively. Iron supplementation did not affect the prevalence of small-for-gestational age infants or third-trimester iron status. CONCLUSION: Prophylactic iron supplementation that is begun early in pregnancy among low income women in the United States may have benefits beyond the reduction of iron deficiency anemia during pregnancy.

Adolescent↗

PubMed2006

Correction for errors in measuring adherence to prenatal multivitamin/mineral supplement use among low-income women.

Adherence to prenatal multivitamin/mineral supplement use is often measured by self-reports or pill counts. Although both measures were shown to overestimate adherence, measurement error is rarely considered. In this study, we examined measurement error in adherence to prenatal supplement use among pregnant women and demonstrated a calibration method to adjust for error. In a validation subsample (n=51) from a larger clinical study of supplementation, adherence was assessed by self-reports, pill counts, and a Medication Event Monitoring System (MEMS) bottle cap that recorded the date and time of each opening of the pill bottle. Mean adherence in the validation sample as measured by the MEMS (the gold standard) was 68%; thus, adherence measured by self-report (77%) and pill count (84%) reflected overestimation. The Pearson correlation coefficients of self-reports and pill counts to MEMS were 0.35 and 0.62, respectively. When adherence was defined as taking >or=75% of the pills prescribed, sensitivity and specificity were greater for pill counts (93 and 52%, respectively) than for self-reports (88 and 44%). The regression coefficient for pill count adherence from a linear regression on MEMS adherence was applied to pill counts from a larger sample (n=244). The adjustment significantly lowered the estimate of adherence from 74 to 64% (P<0.001) in this larger sample. In conclusion, our data show that both self-reports and pill counts overestimate adherence and that linear regression in comparison to an external standard such as MEMS can be used to correct for measurement error in adherence.

Adolescent↗

PubMed2006

Pharmacoeconomic modeling of nesiritide versus dobutamine for decompensated heart failure.

STUDY OBJECTIVE: To model the cost-effectiveness of nesiritide compared with dobutamine in patients with decompensated heart failure. DESIGN: Cost-effectiveness analysis. MEASUREMENTS AND MAIN RESULTS: A decision tree model was derived from randomized clinical trial data and data from a previously published economic study. Four cost-effectiveness analyses were performed: analysis 1 -- full probabilistic analysis, repeatedly sampled probabilities for 6-month mortality and hospital readmission from distributions based on 95% confidence intervals (CIs); analysis 2 -- best-case nesiritide analysis, used the limiting values of the 95% CI favorable to nesiritide; analysis 3 -- best-case dobutamine analysis, used the limiting values of the 95% CI favorable to dobutamine; and analysis 4 -- replicated the previously published cost-effectiveness study and served as a methodologic control. Fifty-one consecutive Monte Carlo simulations for cohorts of 1000 hypothetical patients were performed for each analysis. Incremental cost, incremental effectiveness, and incremental cost-effectiveness ratios (ICERs) were calculated for nesiritide versus dobutamine. Analysis 1 showed a mean ICER of 767 US dollars/life-year gained for nesiritide versus dobutamine (incremental cost 251 US dollars +/- 290 US dollars, incremental effectiveness 0.33 +/- 0.22 yr). The 95% confidence region surrounding this point estimate spanned all four quadrants of the incremental cost-effectiveness scatterplot, suggesting inconclusive results. Nesiritide was the dominant treatment strategy in analysis 2 (incremental cost -734 US dollars+/- 106 US dollars, incremental effectiveness 1.19 +/- 0.07 yrs), whereas dobutamine was dominant in analysis 3 (incremental cost 1242 +/- 73 US dollars, incremental effectiveness -0.57 +/- 0.05 yr). Analysis 4 was comparable to the previously published cost-effectiveness analysis (incremental cost -77 +/- 87 US dollars, incremental effectiveness 0.48 +/- 0.05 yr). CONCLUSIONS: Based on available randomized clinical trial data, nesiritide did not exhibit robust economic superiority over dobutamine. When incorporating the uncertainty (i.e., 95% CIs) in clinical effectiveness as reported in available clinical trial data into the economic analysis, either nesiritide or dobutamine may be the dominant treatment (i.e., more effective at lower cost) for the studied population. Economic analyses of nesiritide and any comparator must account for uncertainty in estimates of cost as well as in clinical effectiveness.

Cardiotonic Agents↗

PubMed2005

The roles of teaching hospitals, insurance status, and race/ethnicity in receipt of adjuvant therapy for regional-stage breast cancer in Florida.

OBJECTIVES: We examined the roles of teaching hospitals, insurance status, and race/ ethnicity in women's receipt of adjuvant therapy for regional-stage breast cancer. METHODS: Data were taken from the Florida Cancer Data System for cases diagnosed from July 1997 to December 2000. We evaluated the impact of health insurance status and hospital type on use of adjuvant therapy (after adjustment for age, race/ethnicity, and marital status). Interaction terms for hospital type, insurance status, and race/ethnicity were entered in each model. RESULTS: Teaching facilities diagnosed 12.5% of the cases; however, they cared for a disproportionate percentage (21.3%) of uninsured and Medicaid-insured women. Among women who received adjuvant chemotherapy only, those diagnosed in teaching hospitals were more likely than those diagnosed in nonteaching hospitals to receive therapy regardless of insurance status or race/ethnicity. Among women who received chemotherapy with or without hormonal therapy, Hispanics were more likely than White non-Hispanic women to receive therapy, whereas women with private insurance or Medicare were less likely than uninsured and Medicaid-insured women to receive this type of therapy. CONCLUSIONS: Teaching facilities play an important role in the diagnosis and treatment of regional-stage breast cancer among Hispanics, uninsured women, and women insured by Medicaid.

Adult↗

PubMed2005

Pharmacy-specific quality indicators for asthma therapy.

BACKGROUND: Lack of appropriate drug therapy in asthma patients is a recognized quality problem leading to preventable emergency room visits, hospitalizations, or death. While indicators measuring pharmacotherapy quality on the level of prescribers and third party payers are widely used, no such indicators exist for pharmacies. OBJECTIVE: This study aimed to (1) develop quality indicators for asthma care applicable to retail pharmacies, (2) estimate the prevalence of inappropriate asthma drug therapy, and (3) explore variation in the quality of care across pharmacies. METHODS: We present a descriptive analysis of automated patient-specific dispensing data from February 1, 2000 to January 31, 2001 of beta-agonists and anti-inflammatory agents with a Food and Drug Administration-approved indication for asthma. Two quality indicators of potentially inappropriate drug therapy were applied: (1) the proportion of patients who obtained more than a 360-day supply (assuming maximum acceptable daily dose) of short-term beta-agonists (SABA) including all inhaler types, inhaler solutions, and syrups during the 12-month study and (2) the proportion of patients with 2 consecutive early refills of defined SABAs. Indicator values with 95% confidence intervals are reported for each pharmacy. RESULTS: Pharmacies had an average of 328 (range 169-534) patients who received SABAs. An average of 11 patients per pharmacy (3.4% of all patients who received SABAs) met the indicator 1 definition. The second indicator identified 8.2% (27) patients per pharmacy as short-term SABA overusers (range 3.9-11.9%). Of these, 48% did not receive any anti-inflammatory agents during the time frame when SABA overuse occurred. CONCLUSION: Application of drug therapy quality indicators at the level of individual pharmacies using dispensing data is feasible and identifies opportunities for quality improvement. Indicator 2 is most appropriate for daily practice, because it allows for timely identification of potentially uncontrolled patients, and offers a balance between indicator sensitivity and positive predictive value.

Adrenergic beta-Agonists↗

PubMed2005

Pill count adherence to prenatal multivitamin/mineral supplement use among low-income women.

In the United States, the prevalence of third trimester anemia among low-income pregnant women is 29% and has not improved since the 1980s. Although low adherence has been linked to the ineffectiveness of iron supplementation programs, data regarding adherence to supplementation in low-income women are currently lacking. Hence this study was conducted to better understand the factors associated with adherence to the use of iron-containing prenatal multivitamin/mineral supplements among low-income pregnant women. Adherence to supplement use was assessed by pill counts among 244 pregnant women of 867 women who were initially randomized to receive 1 of 3 prenatal supplements. All women received care at a public prenatal clinic. Maternal characteristics associated with adherence were identified using predictive modeling. Women took 74% of supplements as prescribed. Adherence was higher among non-Hispanic white women than among non-Hispanic black women (79% vs. 72%, P </= 0.01). Interactions of ethnicity with age group, smoking status, and prior supplement use were significant. Multivariate regression analysis stratified by ethnicity revealed that among the white women education beyond high school, unmarried status, nulligravidity, and smoking were positively associated with adherence. In contrast, among the black women, supplement use 3 mo prior to current pregnancy and no loss of appetite were positively associated with adherence. Further research investigating the influence of cultural factors is necessary to better understand adherence to supplement use and the differences in adherence among ethnic groups.

Adolescent↗

PubMed2004

Intranasal vaccine for prevention of influenza in children.

The current strategy for combating the yearly toll of influenza is to protect the highest-risk individuals through annual immunization. Despite its effectiveness, the inactivated influenza vaccine is underused, and no substantial decrease in influenza-related morbidity and mortality has occurred during the past two decades. Increasing recognition of (1) the high rate of influenza and the substantial morbidity it causes in otherwise healthy children and (2) the dominant role of children in community transmission of the influenza virus has led to the proposal for routine immunization of healthy children. This strategy would both reduce the medical burden of influenza in children and limit the spread of the disease. FluMist, because of its ease of administration, tolerability, and safety, is well suited for mass immunization. The success of such an immunization policy will, however, be predicated on addressing organizational and logistical challenges. Pharmacists will be key in developing the educational foundation and organizational framework for such expanded coverage.

Administration, Intranasal↗

PubMed2004

Disability measures in stroke: relationship among the Barthel Index, the Functional Independence Measure, and the Modified Rankin Scale.

BACKGROUND AND PURPOSE: Residual disability after stroke presents a major economic and humanistic burden. To quantify disability in patients, activities of daily living (ADL; Barthel Index [BI], and motor component of Functional Independence Measure [M-FIM]) and categorical disability measures (Modified Rankin Scale [MRS]) are used. The purpose of this study is to examine the predicting ability of ADL measures to global disability scale. METHODS: Kansas City Stroke Study data were used for the present study. Correlation coefficient, Kruskal-Wallis test, and polytomous logistic regression analysis were applied to examine the relationship between the ADL measure and global disability scale. Model fit statistics were examined to verify logistic regression appropriateness. A categorization scheme, which minimized the false-positive response rate, was selected as the optimal categorizing system. RESULTS: The 3 measures were highly correlated. Both BI and M-FIM differentiated disability better in lower than higher disability. In logistic regression, BI differentiated 4 disability levels; M-FIM differentiated 3 levels in MRS. However, on the basis of results of the Kruskal-Wallis and multiple comparison tests, we suspect that M-FIM may have the potential to predict MRS categories better with a different model. CONCLUSIONS: The proposed categorization scheme can serve as a translation between measures. However, because of the ceiling effect of BI and M-FIM, the translation could not be completed for all 6 levels of MRS. No apparent variation over time in the categorization scheme was observed. Further research needs to be conducted to develop better prediction models explaining the relationship between M-FIM and MRS.

Activities of Daily Living↗

PubMed2003

Labor costs associated with incontinence in long-term care facilities.

OBJECTIVES: To understand the labor resource consumption in caring activities of long-term care residents with versus without urinary incontinence (UI) and the variation in consumption patterns across shifts and facility types. METHODS: This prospective study was conducted in three phases. Phase I of the study developed a taxonomy of the caring activities involved in the care of the incontinent patient and of the control group patient. In Phase II, the frequency of these activities was assessed. Phase III extrapolated the cost impacts of incontinence. The sample consisted of 37 long-term care facilities in the vicinity of Winston-Salem, North Carolina, along with a supplemental sample of 12 facilities in the vicinity of Chapel Hill, North Carolina. The study examined the costs of labor, supplies, and services. To our knowledge, this is the first study to apply microcosting approaches to UI. RESULTS: All things being equal, the incremental labor costs (per shift) were 3.31 dollars (in 2002 dollars) for patients with occasional UI and 5.16 dollars for patients with frequent UI. Combining patients with frequent UI (more than 70% of all UI patients) and occasional UI, the weighted average incremental costs per shift were 4.52 dollars. CONCLUSIONS: With incremental labor costs of 4.52 dollars per patient per shift, UI costs an additional 13.57 dollars to treat per day, or 4957 dollars annually. Our findings can be used to capture the "averted costs" in long-term care facilities from curing UI.

Aged↗

PubMed2002

Attitudinal factors among adult prescription recipients associated with choice of where to be vaccinated.

The objective of this article was to evaluate adult prescription recipients' choices among vaccine providers. The study setting was a cluster sample from 24 community pharmacies based on prescription records that suggested need for pneumococcal and influenza vaccines. Vaccination status, choice of vaccine provider, and opinions regarding vaccine providers were retrospectively surveyed by mail in spring 1999. Overall, 52% of survey recipients responded; 89% of respondents reported returning to the same type of vaccine provider in consecutive years. Two key factors affected choice of provider: convenience and provider experience. Convenience was a stronger factor for people younger than 65 taking chronic medications and those not vaccinated in the previous year. Most adult recipients of influenza vaccine returned to sites where they were vaccinated the previous year. Convenience was a major factor in vaccination decisions of adult prescription recipients.

Adult↗

PubMed2002

Patients' views of priority setting for new medicines. A qualitative study of patients with rheumatoid arthritis.

OBJECTIVE: To identify rheumatoid arthritis patients' perceptions about what should govern priority setting for the new class of high-cost anti-rheumatics, the TNF inhibitors. METHODS: Qualitative study employing semi-structured interviews of 22 patients diagnosed with rheumatoid arthritis at three hospitals in the region of Stockholm, Sweden. The interviews were conducted from December 1999 to March 2000. RESULTS: Patients suggest that a basis for priority setting should be need, including priority to persons with severe and/or early disease, and to those not responding to other anti-rheumatics. Some patients believe that age and productivity have to be taken into account in priority setting, while others oppose this view. Some patients want the individual physician to carry out priority setting, while others consider this too arbitrary. Respondents often suggest criteria unfavourable to themselves. Alongside suggestions for priority setting criteria, there is also a notion that, ideally, priority setting should not have to take place at all. CONCLUSIONS: Patients' views of priority setting are not necessarily influenced by the patients' individual needs and may contribute to the development of priority guidelines. Knowledge of the patients' perceptions of priority setting for a specific treatment might also support patient-provider discussions on priority setting.

Adult↗