bluuebunny/crossref_metadata_2025 huggingface dataset:
Should Gabapentin Be Dose Adjusted: What are the Clinical Consequences?
Authors: Gonyeau Michael J , Rooney Christina A
Published: September 2013

Objective:

To review the clinical necessity of renal dose adjustment of gabapentin.

Data Sources:

Medical literature (1966–February 2006, week 2) was accessed through MEDLINE, EMBASE, Pre-MEDLINE, International Pharmaceutical Abstracts, and the manufacturer's package insert. Search terms included gabapentin, side effects/adverse effects, overdose, toxicity, and renal impairment. Literature references were consulted for relevant information.

Study Selection and Data Extraction:

All studies from the data sources that were published in English were evaluated. Case reports, case series, and clinical trials with primarily adult populations were included in the review to determine the clinical necessity of dosage adjustment, including morbidity and mortality associated with dose adjustment failure. Case reports of gabapentin overdose were evaluated for clinically significant outcomes. All reports were examined for clinical relevance and adequate information to address the issue of major clinical consequences of failure to dose adjust gabapentin in specific patient populations, including renally impaired and elderly patients.

Data Synthesis:

The package insert suggests dose adjustment of gabapentin in patients with decreased renal function, yet published information regarding clinical consequences of gabapentin in patients is limited. Although gabapentin possesses a favorable safety profile and is generally well tolerated, there have been cases reporting serious adverse effects. While clinical studies and the majority of case reports demonstrate minimal adverse effects, there is some concern that select patients may experience serious outcomes if the drug is not dose adjusted.

Conclusions:

The recommendation for dosage adjustment is suitably based upon the pharmacokinetic properties of gabapentin, yet healthcare practitioners should determine the need for gabapentin dosage adjustment in specific patients. There should be continued emphasis on recommending renal dose adjustments, with the most concern applied to the elderly and patients with significant renal impairment/end-stage renal disease.
A Qualitative Review of Recent Economic Evaluations of Escitalopram
Authors: Sadri Hamid , Mittmann Nicole
Published: September 2013

Objective:

To review published pharmacoeconomic evaluations of escitalopram.

Data Sources:

MEDLINE, EMBASE, Health Star, and Ovid Journals databases were searched using escitalopram, cost, cost-effectiveness, and economics as search terms. All articles and abstracts published from January 2003 to April 2006 were reviewed and cross-referenced for possible exclusions or duplications. Searches were not limited to English-language publications.

Study Selection and Data Extraction:

One prospective economic study and 10 studies using decision analytical models assessing the cost-effectiveness of escitalopram compared with citalopram and/or venlafaxine were identified and reviewed.

Data Synthesis:

Pharmacoeconomic studies using country-specific currency economic analysis from Europe and Canada have been conducted assessing the cost-effectiveness of escitalopram in major depression. Several studies have shown escitalopram to be more cost-effective compared with citalopram, with cost savings identified in societal and healthcare system perspectives. However, the cost-effectiveness of escitalopram was less significant when compared with venlafaxine.

Conclusions:

Economic studies suggest that escitalopram is cost-effective compared with citalopram in treatment of major depression, but has marginal advantage compared with venlafaxine.
Interleukin-1 in Rheumatoid Arthritis: Its Inhibition by IL-1Ra and Anakinra
Authors: Ghivizzani Steven C , Gouze Elvire , Watson Rachael S , Saran Jeetpaul , Kay Jesse D , Bush Marsha L , Levings Padraic P , Gouze Jean-Noel
Published: September 2013

Objective:

To review the biology of interleukin-1 (IL-1) in the pathogenesis of rheumatoid arthritis (RA), as well as the biology of its natural inhibitor, IL receptor antagonist (IL-1Ra), and the clinical efficacy and safety of the recombinant form, anakinra.

Data Sources:

A MEDLINE search (1966–January 2007) of English-language articles was conducted using the key words anakinra, arthritis, clinical trial, interleukin-1 receptor antagonist, and Kineret.

Study Selection and Data Extraction:

Over 79 research articles and literature reviews were used to compile a discussion of the biology of IL-1 and IL-1Ra. Ten of these articles were selected to discuss the clinical safety and efficacy of anakinra.

Data Synthesis:

In RA, IL-1 primarily acts locally to mediate erosion of cartilage and bone. IL-1Ra serves to modulate its activity through competitive inhibition of cellular receptors. Administration of anakinra to animals with experimental arthritis reduced inflammation and joint damage. In clinical trials, anakinra was reasonably well tolerated; however, injection site reactions were frequent and there was a slight increased risk of serious infection. Alone or in combination with methotrexate, anakinra significantly reduced the symptoms and clinical signs of RA at the American College of Rheumatology 20% response level. However, no additive benefit was observed following coadministration with etanercept, a soluble tumor necrosis factor antagonist, and anakinra had no beneficial effect in patients that failed treatment with etanercept.

Conclusions:

Laboratory studies have indicated that IL-1 is primarily responsible for cartilage destruction and bone erosion in RA. The selective inhibition of IL-1 through administration of anakinra may offer symptomatic relief of RA in some patients.
Retrospective Evaluation of Prescription Frequency in Heart Failure
Authors: Ryzner Kristi L , Burkiewicz Jill S
Published: September 2013

Background:

Current clinical guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) recommend that all patients with heart failure, in the absence of absolute contraindications, be treated with both a β-blocker and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB). Despite guideline recommendations and strong evidence of mortality benefit, studies of practice patterns show suboptimal use of such drugs.

Objective:

To determine the frequency of ACE inhibitor or ARB and β-blocker combination therapy in patients diagnosed with heart failure.

Methods:

Medical records of patients diagnosed with heart failure through ICD-9 codes at an urban community health center were reviewed over a one year period to determine the frequency of use of β-blockers, ACE inhibitors, and ARBs. Data were classified according to patient characteristics and comorbid conditions.

Results:

Combination therapy with both a β-blocker and ACE inhibitor or ARB was used in 61.1% (107/175) of patients. Overall, 65.7% (115/175) of patients had no relative contraindications to therapy and were more likely to be prescribed combination therapy than those with contraindications (72.2% vs 40.0%; p < 0.001). Patients with relative contraindications to β-blocker therapy (chronic obstructive pulmonary disease, asthma) were less likely to be on combination therapy than patients without such contraindications (51.0% vs 81.0%; p < 0.001).

Conclusions:

Although a majority of patients were taking both a β-blocker and either an ACE inhibitor or ARB, a large number of patients were not prescribed appropriate ACC/AHA–recommended therapy. Interventions within health systems should be explored as a means to bridge this gap to improve patient outcomes and ensure quality of care.
Time Required by Pharmacy Technicians to Reconstitute New versus Old Piperacillin/Tazobactam Formulations
Authors: Sahni Jasmine K , Kuti Joseph L , Nicolau David P
Published: September 2013

Background:

Piperacillin/tazobactam, an intravenous broad-spectrum antibiotic commonly used in the hospital setting, has recently been reformulated with edetate disodium dehydrate (EDTA) and sodium citrate due to new guidelines on particulate standards. This reformulation is now compatible with lactated Ringer's solution and certain aminoglycosides.

Objective:

To determine the time required for pharmacy technicians to reconstitute the reformulated piperacillin/tazobactam solution compared with the original and European (Vial X) formulations.

Methods:

This study was conducted in an intravenous preparation room using a time–motion design. Each of 5 pharmacy technicians, who were blinded to the formulation, repeated the reconstitution process 6 times for a total of 30 observations of each strength within each formulation. Each piperacillin/tazobactam vial was reconstituted individually. Labor costs were calculated using the 2005 US hourly wage for pharmacy technicians.

Results:

Reconstitution times did not differ between formulations for the 3.375 g vial (mean ± SE, 4.15 ± 0.26 min for original vs 4.92 ± 0.58 min for EDTA formulations; p = 0.112). However, formulations containing EDTA went into solution more rapidly at the 4.5 g strength (4.41 ± 0.33 min vs 6.79 ± 0.61 min; p < 0.001) and did not differ from the Vial X formulation (4.12 ± 0.23 min; p = 0.781). The large 40.5 g pharmacy bulk vial was tested only with the EDTA formulation, which required 5.58 ± 0.41 minutes to reconstitute.

Conclusions:

Based on these timings, the labor costs associated with reconstituting a single vial of each strength is approximately $1 per vial, regardless of which formulation is used. Reformulated piperacillin/tazobactam containing EDTA and sodium citrate will go into solution at least as quickly as the original formulation.
Consumer Comprehension of OTC Medication Labels and the Scope for Improvement in Font Size
Authors: Murty Sharanya , Sansgiry Sujit S
Published: September 2013

Background:

On March 17, 1999, the FDA mandated a new standardized format called “Drug Facts” and a minimum font size of 6 points for the labeling of over-the-counter (OTC) medications. Yet, some text legibility studies report consumer preference for font sizes of at least 10 points. The possibility therefore exists that the minimum font size mandated by the FDA might be too small for certain consumers to read.

Objective:

To compare the effectiveness of 3 labeling formats—old, new, and simulated labels (SLs)—using the OTC medication Label Evaluation Process Model (LEPM).

Methods:

A within-subjects experimental design was used. SLs designed for this study contained similar information as the new labels plus a larger font size. English-speaking consumers viewed these label formats and completed a questionnaire that requested consumer demographic information and measured their responses on 5 domains of the LEPM: ease of use, product knowledge, attitude toward product label, product evaluation, and purchase intention. These 5 domains were the dependent variables for this study. The independent variable was the label format. Data were analyzed using the SAS 9.1 software. A multivariate analysis of variance (ANOVA) followed by a univariate ANOVA determined the effect of label format on the dependent variables.

Results:

Each label format differed significantly from the others in terms of ease of use, attitude, product evaluation, and purchase intention, with the highest mean scores reported for SLs. SLs were the only label format that significantly improved consumers' product knowledge.

Conclusions:

Although the new standardized OTC labels are an improvement from the old unstandardized label format, there is a need for further improvement in OTC medication labeling, especially regarding the font size on these labels.
What Women Want to Know: An Assessment of Online Questions Asked by Women Using an Ask-the-Pharmacist Service
Authors: Jariangprasert Chad S , El-Ibiary Shareen Y , Tsourounis Candy , Assemi Mitra
Published: September 2013

Background:

Almost three-quarters of American adults use the Internet. Eighty percent of these adults use online health information resources. Ask-the-Pharmacist (ATP) services provide individualized clinical information to online consumers.

Objective:

To characterize the content of online queries submitted by or on behalf of women to an ATP service.

Methods:

A retrospective review was conducted of online queries submitted to the Blue Shield of California ATP service between 2003 and 2004. Questions were characterized and analyzed using Analysis ToolPak package and SPSS software (version 12).

Results:

A total of 1,056 submitted queries were analyzed. The mean age of female consumers was 45.6 years (range 18–88). Thirty-three percent inquired about drug adverse effects; of these, 19% reported experiencing acute adverse reactions. Drug efficacy or indications were the subject of 26% of queries. The most common drug-related queries were about antidepressants (8.6%) and contraceptives (8.2%), with a majority interested in the adverse effects of these drug classes. Over-the-counter products accounted for 4.9% of the queries. Contraception and dermatology were the most frequent indications listed for women aged 18–35 years; for women over the age of 50 years, menopause was the most frequent indication.

Conclusions:

The questions asked regarding the health of female consumers reflect the fact that consumers need more information to make treatment decisions. Women want to know the differences in drug efficacy and adverse effects among different medications. Healthcare providers should be aware of these issues to better anticipate women's healthcare needs. In addition, this information may help health plans to develop specific materials targeted toward these issues.
Persistence with Medications in Glaucoma Management, Hypertension, and Dyslipidemia
Authors: Velentgas Priscilla , Sheffield Reinee , Nordstrom Beth L , Johnson Eric , Do Thy , Mentor Sherry M , Seeger John D
Published: September 2013

Objective:

To summarize pharmacy database studies of persistence with ocular hypotensives and review the literature of adherence with 2 additional classes of medication—antihypertensives and antihyperlipidemics—comparing methods used to analyze adherence in the 3 treatment areas.

Data Sources:

A search of MEDLINE (1990–2004) was conducted, using search terms designed to identify English-language articles describing adherence or persistence with any of the 3 drug classes of interest.

Study Selection and Data Extraction:

All articles identified through MEDLINE were reviewed and screened for use of an automated pharmacy database as an information source, quantitative results provided, and follow-up duration of at least 90 days. Details of methods used to estimate adherence or persistence and estimates of persistence with ocular hypotensive therapy, antihypertensives, and lipid-lowering agents were extracted.

Data Synthesis:

All studies describing the use of ocular hypotensives, and the majority of studies in the other treatment areas, identified inception cohorts of drug initiators. Use of survival analysis techniques to analyze adherence to medication therapy was less common in the hypertension and hyperlipidemia treatment adherence literature than in literature about glaucoma. In the treatment of hypertension, use of angiotensin II receptor antagonists or angiotensin-converting enzyme inhibitors was associated with higher levels of adherence. Statins in treatment of hyperlipidemia and topical prostaglandins as ocular hypotensive medications were also associated with higher levels of adherence.

Conclusions:

Findings regarding the relative superiority of specific drug classes were consistent within each therapeutic area, with less consistency in identifying other predictors of adherence. Increased use of survival analysis in future studies of persistence might improve comparability of results across studies.
Oral Bioavailability of Candesartan Cilexetil Suspension
Authors: Teng Renli , Hansson Anna-Carin , Börjesson Inger
Published: September 2013

Background:

Candesartan cilexetil is a prodrug that is converted to candesartan during absorption from the gastrointestinal tract. Candesartan is a potent, orally active, specific angiotensin II type 1 receptor antagonist that has become a well-accepted treatment for hypertension. Pediatric patients often require alternative dosage forms, as candesartan cilexetil is not yet commercially available as a liquid formulation.

Objective:

To determine the relative bioavailability of candesartan by comparing a candesartan cilexetil tablet (reference formulation) with an oral candesartan cilexetil suspension (test formulation).

Methods:

In an open-label, randomized, 2 period, 2 treatment crossover study, 24 healthy volunteers were given a 32 mg candesartan cilexetil tablet and a 32 mg candesartan cilexetil suspension with a 7 day washout period between treatments.

Results:

Pharmacokinetic analyses showed that the mean relative bioavailability of the candesartan cilexetil commercial 32 mg tablet compared with the suspension of 32 mg candesartan cilexetil was 93%. The 90% CIs of the plasma AUC for the tablet versus suspension (0.861 and 0.998, respectively) were well within the bioequivalence criteria of 80–125%. Administration of candesartan cilexetil suspension was associated with a 17% increase in the maximum plasma concentration (Cmax) relative to the tablet administration (643 vs 523 nM/L, respectively). The 90% CIs on the ratio of mean Cmax for the tablet and suspension were 0.738 and 0.914, respectively. Mean time to peak plasma concentrations (tmax) after suspension administration was 3.1 hours, whereas the tablet resulted in a mean tmax of 3.9 hours. No significant differences in elimination half-life were observed between the 2 formulations. Both formulations were well tolerated, and no serious adverse events were reported.

Conclusions:

These results demonstrate that administration of candesartan cilexetil suspension achieves an extent of absorption and tolerability that is comparable with those of orally administered candesartan cilexetil tablets.
Role of Proton Pump Inhibitors in Calcium Absorption, Bone Resorption, and Risk of Hip Fracture
Authors: Tahir Rabia , Patel Priti N
Published: September 2013

Objective:

To review the influence of proton pump inhibitors (PPIs) on calcium absorption, bone remodeling, and fracture risk.

Data Sources:

A search via MEDLINE (1966–April 2007) was performed using the search terms proton pump inhibitors, omeprazole, calcium absorption, calcium malabsorption, bone resorption, and fracture risk.

Study Selection and Data Extraction:

English-language literature, including abstracts, preclinical and clinical trials, and review articles, were identified from the data sources and reviewed.

Data Synthesis:

Data on the effect of PPIs on calcium absorption are conflicting; however, the majority of data indicate that PPIs decrease intestinal calcium absorption, which could negatively affect bone strength. In particular, calcium carbonate may be more difficult to absorb in an environment with elevated pH due to PPI use. Data on the role of PPIs in osteoclast function are also conflicting, with one human study indicating decreased bone resorption due to inhibition of osteoclast function and another human study indicating no association between PPIs and osteoclast function. The risk of fracture with PPI use was evaluated in 2 studies, and both studies found an increased risk of fracture of 14–44% after PPI use.

Conclusions:

PPI use may increase a patient's risk of fracture. Additional studies are needed before causality can be established.
Barriers to Community Pharmacists' Provision of Diabetes Care Services in Iowa
Authors: Plake Kimberly S , Chesnut Renae J , Odorzynski Melissa
Published: September 2013

Background:

Pharmacists are in a unique position to provide valuable patient care services to patients with diabetes. Even though many pharmacists have developed their diabetes care knowledge base and obtained credentials, they do not provide diabetes care on a regular basis, suggesting the existence of barriers to care other than knowledge and skills.

Objective:

To determine the barriers limiting the provision of diabetes care services in community pharmacy settings.

Methods:

Community pharmacists (N = 1,337) in Iowa were surveyed regarding (1) the types of diabetes care services provided, (2) reimbursement for services provided, (3) educational needs, (4) perceived barriers to providing diabetes services, and (5) demographics. A 46 item questionnaire was developed and mailed to participants with an addressed, stamped envelope. Nonrespondents were contacted by email or phone and asked to complete the questionnaire. Respondents' perceived barriers to diabetes care were compared based on their demographic characteristics.

Results:

Response rate to the questionnaire was 59.2%. Approximately 30% of respondents provided at least one diabetes care service. Of those respondents, 98% offered blood glucose meter training to their patients, and 64.7% offered patient education on diabetes topics. Issues pertaining to reimbursement, workload, and available time were the most limiting barriers to providing diabetes care services to their patients. Previously documented barriers such as patient attitudes, cultural/language barriers, store layout and patient privacy, and inadequate resources and start-up funds were not considered to be limiting by the respondents in this study.

Conclusions:

Provision of diabetes care services is higher than reported in earlier studies. While some barriers may no longer be as limiting as they were in the past decade, inadequate reimbursement, large workload, and lack of time continue to persist as the primary barriers cited by pharmacists who are charged with providing diabetes care.
Poor Central Nervous System Penetration of Tigecycline in a Patient with Sepsis and Ventriculitis Caused by Multidrug-Resistant Klebsiella Pneumoniae
Authors: Chen Julie L , Orsini Jose , Killu Claude
Published: September 2013

Objective:

To report the use of tigecycline in a case of ventriculitis and concurrent bacteremia.

Case Summary:

A 57-year-old African American male with a ruptured brain aneurysm was admitted to the intensive care unit after surgical intervention and external ventricular drainage placement. His hospital course was complicated by myocardial infarction, ventilator-associated pneumonia, ventriculitis, and sepsis, with multidrug-resistant (MDR) Klebsiella pneumoniae isolated from multiple sites, including blood and cerebral spinal fluid (CSF). The patient was treated with high doses of intravenous tigecycline and gentamicin along with intrathecal gentamicin. This combination eradicated infections outside the central nervous system (CNS) within 48 hours, but it took approximately 8 days for the CSF culture to become negative. Timed serum and CSF fluid samples were collected to determine CSF penetration of tigecycline on day 12 of therapy. CSF concentrations obtained 30 minutes after the dose and at the end of the dosing interval remained below the detectable limit of 0.05 μg/mL.

Discussion:

Although CSF tigecycline concentrations may not represent actual CNS tissue concentrations at the site of infection, the low CSF concentrations observed in our case may be responsible for the slow CSF clearance of infection. It was not clear whether gentamicin therapy alone, administered both intravenously and intrathecally, would have achieved the same outcome and cleared the infection from the CNS in this patient.

Conclusions:

Until additional clinical data are available, tigecycline should not be used for the management of MDR infections associated with the CNS.
A Pilot Study Comparing Two Methods for Warfarin Management in Hospitalized Patients
Authors: Ford M Michelle , Stewart David W
Published: September 2013

Background:

The potential for medication errors in a hospital setting has led to a change from daily order writing to scheduled dosing. It has also been hypothesized that scheduled dosing may decrease the pharmacists' workload in a community teaching hospital.

Objective:

To evaluate the impact that scheduled warfarin dosing would have on patient safety for a pharmacist-run anticoagulation service.

Methods:

Two methods for managing warfarin in a pharmacist-run anticoagulation service were compared. A retrospective chart review was conducted on a random sample of 80 inpatients who received warfarin either from January 2006 through December 2006 (control/daily dosing group) or from January 2007 through March 2007 (scheduled dosing group). Patients not managed by pharmacists or with a target international normalized ratio (INR) range other than 2 to 3 were excluded.

Results:

A total of 35 patients met inclusion criteria; 20 patients were in the daily order (control) group and 15 were in the scheduled dosing group. A total of 7 doses were omitted in the daily dosing group, compared with none in the scheduled dosing group. Of the 7, 4 were omissions in administration and 3 were order omissions. In the control group, the dose was changed 47 times (36%) compared with 23 times (28%) in the scheduled dosing group. In the daily dosing group, 28 (22%) INRs were within the therapeutic range and 97 (78%) were in the nontherapeutic range. In the scheduled dosing group, 24 (25%) INRs were within the therapeutic range and 72 (75%) were in the nontherapeutic range.

Conclusions:

Scheduled dosing eliminated omission-type medication errors and was more efficient than daily dosing. The process change decreased pharmacist workload without having a negative impact on patient care.
Preadmission Predictors of Graduating Grade Point Average in a Professional Pharmacy Program
Authors: Wiest Donald B , Chumney Elinor CG , Nappi Jean M
Published: September 2013

Background:

College of pharmacy admissions committees face an important task in selecting students who will excel as practitioners. This task becomes more cumbersome as the number of applicants continues to increase. Established criteria as predictors of academic success in a pharmacy program would be valuable tools in the student admissions process.

Objective:

To determine which preadmission variables (eg, Pharmacy College Admission Test [PCAT] score, undergraduate grade point average [GPA], applicant interview scores) best predicted academic success for 3 consecutive college of pharmacy graduating classes.

Methods:

This investigation was a blinded, retrospective record review of 141 pharmacy students from the graduating classes of 2002, 2003, and 2004 at the Medical University of South Carolina. Linear regression analysis was used to model academic success (ie, graduating GPA) as predicted by demographics and preadmission performance indicators.

Results:

Undergraduate GPA, PCAT score, and applicant interview scores were all highly significant predictors of graduating GPA. Factors found to be not significantly related to graduating GPA were student Scholastic Assessment Test scores, education level, sex, age, and letters of reference.

Conclusions:

The composite PCAT, prepharmacy GPA, and applicant interview scores were significant predictors of graduation from a professional pharmacy program.
Rash and Liver Dysfunction Related to Lamotrigine Therapy
Authors: Serwetman Lea RC , Krikorian Susan A , Javedan Houman
Published: September 2013

Objective:

To report a case of rash and liver dysfunction associated with lamotrigine treatment.

Case Summary:

An 81-year-old woman with a history of bipolar disorder presented to the emergency department with complaints of fever, chills, nausea, and headache. Two weeks prior to presentation, liver enzymes were normal. Lamotrigine 50 mg/day and sustained-release bupropion 200 mg/day were started after discontinuation of citalopram. The patient had previous exposure to bupropion and documented rash with exposure to penicillin and sulfa. On admission, laboratory tests revealed slightly elevated liver enzymes and slightly low serum albumin. All medications were continued. On hospital day 3, a diffuse maculopapular rash developed on the patient's chest, abdomen, neck, and upper extremities, which was pruritic and warm to the touch. Both lamotrigine and bupropion were discontinued. Liver enzymes increased to more than 3 times the upper limit of normal, and serum albumin decreased. Liver function tests improved on day 6, and the rash resolved.

Discussion:

Predictive risk factors associated with lamotrigine-induced rash and liver dysfunction include rapid dose titration, previously reported rash with other medications, age, and concurrent interacting medications. More serious adverse effects, such as Stevens–Johnson syndrome and fulminant hepatic failure, have also been associated with lamotrigine treatment. If rash appears at any time during treatment, lamotrigine must be discontinued. According to the Naranjo probability scale, an association between lamotrigine and rash and liver dysfunction could be considered probable in this case.

Conclusions:

A faster than recommended dose titration may lead to lamotrigine-induced adverse effects such as rash and liver dysfunction in patients with risk factors.
Effects of Preoperative Abciximab and Eptifibatide on Bleeding Indices in Coronary Artery Bypass Graft Patients
Authors: Stewart David W , Kincaid Edward H , Kon Neal D , Reichert Marc G
Published: September 2013

Background:

Glycoprotein (GP) IIb/IIIa antagonists are used routinely for the treatment of acute coronary syndrome and to prevent thromboses during percutaneous coronary interventions. It is not uncommon for patients who initially require a GP IIb/IIIa inhibitor to eventually receive a surgical intervention.

Objective:

To compare the difference in bleeding indices in patients who undergo coronary artery bypass grafting (CABG) after receiving either eptifibatide or abciximab.

Methods:

A retrospective chart review was completed on all adults who received abciximab or eptifibatide within 24 hours prior to undergoing CABG. Patients were excluded if they had received a dose of warfarin within 96 hours prior to the procedure or if they had an incomplete medical record, an off-pump procedure, a known hypercoagulable disorder, or hemophilia. A total of 54 patients were included and preoperative data, including doses of anticoagulant and antiplatelet agents, were recorded. Intraoperative and postoperative data collected for analysis included hemoglobin level, chest tube output, and the amount of blood products transfused for 24 hours postprocedure.

Results:

There was a statistically significant difference between the eptifibatide and abciximab groups in the amount of fresh frozen plasma (mean ± SD, 21 ± 31 vs 187 ± 125 mL, respectively; p < 0.05) and platelets (212 ± 81 vs 433 ± 118 mL, respectively; p < 0.01) transfused during the intraoperative period. However, when the total amount of blood products transfused intraoperatively (769 ± 243 vs 1395 ± 316 mL, respectively; p = 0.47) was evaluated, no significant difference was detected. Likewise, markers for bleeding that were collected during the 24-hour postoperative window (immediate and 24-h postoperative hemoglobin and total 24-h chest tube output) were not significantly different.

Conclusions:

Although there is an increased risk of bleeding when abciximab or eptifibatide is administered prior to CABG, no significant difference in the total amount of blood products used was detected between the 2 agents in this study.
Dietary Vitamin K in Oral Anticoagulation Patients: Clinician Practices and Knowledge in Outpatient Settings
Authors: Dennis Vincent C , Ripley Toni L , Planas Lourdes G , Beach Paige
Published: September 2013

Background:

Dietary vitamin K is a recognized variable associated with oral anticoagulant therapy. However, current practices of dietary education and instruction regarding vitamin K, as well as factors influencing related decision-making, are unknown. Research has examined healthcare providers' ability to identify a meal containing vitamin K, but the ability to classify portions of specific vegetables according to vitamin K content has not been evaluated.

Objective:

To characterize dietary evaluation and instructional methods provided to patients receiving warfarin therapy, assess factors influencing instructional methods, and evaluate clinician knowledge of vitamin K content for specific vegetable portions.

Methods:

A cross-sectional online survey of US healthcare providers involved with management of outpatient oral anticoagulation therapy was conducted.

Results:

One hundred twenty-two responses were received. Seventy-four percent of respondents collected initial dietary history from all patients and 52% asked all patients for dietary history at follow-up visits. Taking a verbal dietary history from all patients was significantly associated with larger clinic size and managing patients in person. Eighty-two percent of respondents reported providing dietary vitamin K education to all patients. Low patient literacy was a common factor influencing instruction to avoid foods high in vitamin K. Overall mean score reflecting the ability to classify vegetable portions by vitamin K content was 64.6 ± 10.9%.

Conclusions:

Acquisition of dietary history by anticoagulation providers is not always completed at initial and follow-up patient visits. Provision of patient education at initial visits is relatively high. Patient factors such as low literacy may influence a clinician's decision to provide a specific method of dietary instruction, including avoidance of foods high in vitamin K. Clinicians are least likely to correctly identify vegetable portions containing vitamin K in the range of 10–99 μg and should consider portion size when assessing dietary history.
Medications for Extensively Drug-Resistant Tuberculosis: Back to the Future?
Authors: Ashby Charles R , Jodlowski Tomasz Z , Sym Donna
Published: September 2013

Objective:

To reexamine the existing medications for the potential treatment of extensively drug-resistant tuberculosis (XDR-TB), based on susceptibility data, and to identify potential future medications from the literature.

Data Sources:

Relevant information was identified through a search of MEDLINE (1966–November 2007), PubMed (1955–November 2007), American Search Premier (1975–November 2007), International Pharmaceutical Abstracts (1960–November 2007), Science Citation Index Expanded (1996–November 2007), Cochrane Databases (publications archived until November 2007), and various tertiary sources as listed in the references, using the terms extensively drug-resistant tuberculosis (XDR-TB), ethambutol, pyrazinamide, para-aminosalicylic acid, cycloserine, linezolid, diarylquinoline, nitroimidazopyran, fluoroquinolones, β-lactams, new treatments, and ethionamide alone or in combination regimens.

Study Selection and Data Extraction:

After identification of the relevant information, the data presented in this article were selected based on clinical relevance and value of information.

Data Synthesis:

Based on susceptibility data, pyrazinamide, ethambutol, para-aminosalicylic acid, cycloserine, and ethionamide may be used for the treatment of tuberculosis. However, due to the emergence of XDR-TB, many of these agents are no longer successful treatment regimens. We have found limited data supporting potential future use of β-lactams, clarithromycin, and linezolid in resistant TB infections. TMC207, nitroimidazopyran, and SQ109 compounds may also prove to be viable options in the near future for treatment of tuberculosis, especially in cases with resistance to mainstay medications.

Conclusions:

Extensively resistant tuberculosis appears to be a potentially catastrophic disease if allowed to spread. Due to its resistance profile, very few potentially effective agents are available, calling attention to this growing problem.
Pharmacy and Public Policy: Evolution of the Legal and Regulatory Framework for Generic Interchange
Authors: Fink Joseph L
Published: September 2013

The past 40 years have seen a movement in the profession of pharmacy to modify the strictures on professional judgment and professional service to patients emanating from antisubstitution laws, both statutes and regulations, at the state level of government. The shift of responsibility for preparing final dosage forms more and more from the community pharmacist to the pharmaceutical industry led the brand name pharmaceutical manufacturers to form an organization to seek enactment of restrictions on the ability of pharmacists to select the brand of medication to be dispensed. Beginning in 1970, the American Pharmaceutical Association sought to change these laws, and through that decade, coalitions were formed with a variety of groups to effect the modifications. A variety of public policy issues were presented for consideration as part of this movement, with the states adopting a variety of approaches, with all jurisdictions eventually restoring to pharmacists the ability to make professional judgments in the area of drug product selection. This initiative within the profession was a highlight of the past century and may have built the confidence of pharmacists to seek other modifications in public policy related to the legal and regulatory framework within which they practice.

This article was adapted from a presentation before the American Society for Pharmacy Law 31st/American Pharmaceutical Association 153rd Annual Meeting, San Francisco, CA, March 18, 2006.
Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
Authors: Gilchrist Neil A
Published: September 2013

Objective:

To review the pharmacology, pharmacokinetics, efficacy, and safety of ambrisentan, a selective endothelin type A (ETA) receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).

Data Sources:

Articles were identified through a search of the MEDLINE (1950–November 2007) database for English-language articles containing the key words ambrisentan, pulmonary arterial hypertension, pulmonary hypertension, endothelin antagonist, and endothelin type A receptor. References from publications identified in this search were reviewed for relevant information. Unpublished data received from the manufacturer were also included in this review.

Study Selection and Data Extraction:

All articles identified from the data search were reviewed for relevant information. Applicable information was included in this review.

Data Synthesis:

Ambrisentan is the first oral nonsulfonamide ETA receptor antagonist approved by the FDA for use in patients with PAH who have World Health Organization class II or III symptoms. To date, the use of ambrisentan in the treatment of PAH has been evaluated by only 1 published Phase 2 clinical trial and 3 unpublished Phase 3 clinical trials. Ambrisentan therapy during clinical trials resulted in a significant improvement in exercise capacity and hemodynamic parameters. Metabolism occurs by hepatic glucuronidation, with elimination primarily through nonrenal pathways. A half-life of 15 hours allows for once-daily dosing. The most common adverse effect reported during clinical trials was peripheral edema. Hepatotoxicity occurred very infrequently, with affected patients requiring only a dose reduction to resolve an episode of elevated aminotransferases.

Conclusions:

Ambrisentan appears to be a promising treatment option for patients affected by PAH, given its improved drug–drug interaction and hepatotoxicity profile compared with other endothelin antagonists. Future studies are needed to determine the role of ambrisentan in the treatment of PAH and the selection of optimal endothelin antagonism.
Oxcarbazepine for Treatment of Posttraumatic Stress Disorder and Alcohol Dependence: A Case Series
Authors: Melvin Kelly E , Martin Peter R
Published: September 2013

Objective:

To report 2 cases that examine the use of oxcarbazepine as treatment for individuals with posttraumatic stress disorder (PTSD) and comorbid alcohol dependence.

Case Summaries:

A 59-year-old male with a past psychiatric history significant for PTSD and alcohol dependence underwent alcohol detoxification and was subsequently prescribed oxcarbazepine 300 mg twice daily, which was titrated to 600 mg twice daily prior to discharge. He experienced significant reduction in PTSD symptoms including anxiety, nightmares, flashbacks, racing thoughts, and avoidance behaviors. Over time, he also experienced a reduction in alcohol cravings and decreased daily alcohol intake. A 62-year-old male with a past psychiatric history of PTSD and alcohol dependence was treated in the outpatient clinic. He experienced almost complete resolution of PTSD symptoms and any craving for alcohol within 4 months of starting oxcarbazepine treatment, which was initiated at 150 mg twice daily and increased to 600 mg/day during that time.

Discussion:

Both patients appeared to receive excellent symptomatic relief from their PTSD symptoms. Recurring symptoms, including nightmares and flashbacks, seemed to be particularly responsive to the treatment. Additionally, in both cases, it is possible that oxcarbazepine had a secondary beneficial effect by decreasing alcohol cravings, although this was not formally measured.

Conclusions:

Our experience with these patients suggests that oxcarbazepine could be an effective treatment for the symptoms of PTSD and may decrease alcohol cravings and consumption in patients with co-occurring alcohol dependence. Controlled studies examining the effectiveness of oxcarbazepine for treatment of patients with PTSD, including those with complicating alcohol dependence, are warranted.
The Role for Anticoagulation with Warfarin in Patients with Systolic Heart Failure and Normal Sinus Rhythm
Authors: Marino Elizabeth A , Perez Mirza E
Published: September 2013

Objective:

To evaluate the role of anticoagulation with warfarin in patients with systolic heart failure (HF) and normal sinus rhythm (NSR).

Data Sources:

Literature was accessed through MEDLINE (1950–December 2007) and the American College of Cardiology Annual Scientific Session (2004) using the terms heart failure, warfarin, and anticoagulation.

Study Selection and Data Extraction:

All articles in English identified via the searches were evaluated. We excluded trials that evaluated the use of anticoagulation in patients with atrial fibrillation (AF) or valvular disorders.

Data Synthesis:

Patients with systolic HF are considered to be in a prothrombotic state. Studies have demonstrated a decreased incidence of thromboembolic events with anticoagulation therapy in patients with HF and concomitant AF, valvular dysfunction, or hypercoagulable disorders, but there are limited data supporting the role of anticoagulation in patients with HF and NSR. There are 3 prospective clinical trials and 1 ongoing trial designed to assess the efficacy of warfarin in patients with HF and NSR. These trials compare warfarin with antiplatelet therapy or no antithrombotic therapy. Warfarin did not show a benefit in the primary clinical composite outcome of death, myocardial infarction, or stroke, but was associated with more adverse events. However, these trials were underpowered to detect a difference between treatment arms.

Conclusions:

There is no objective evidence to support the need for anticoagulation with warfarin in patients with systolic HF and NSR. Additional large randomized, controlled trials need to be completed to determine the efficacy and safety of anticoagulation with warfarin in such patients.
Documentation of Student Pharmacists' Interventions from Medication Histories in a Primary Care Setting
Authors: Fit Kathy E
Published: September 2013

Background:

Medication safety is a major concern in primary care. Documented interventions by clinical pharmacists have shown positive clinical outcomes. In addition, it has been shown that student pharmacists have positive outcomes when participating in their advanced pharmacy practice experiences (APPEs). Most of this documentation has taken place in hospital settings. No data are available regarding interventions performed when APPE students record medication histories prior to a primary care provider (PCP) appointment.

Objective:

To describe the number and types of interventions made by APPE students in recording medication histories and to describe PCP acceptance rates.

Methods:

This prospective study documented the interventions from medication histories by 2 APPE students. With faculty supervision, the students recorded medication histories and vital signs prior to patient appointments with their PCPs. This was done approximately 1.5 days/week. Recommendations to the PCP were made verbally prior to the patient examination. Type of recommendation made, patient demographics, and PCP acceptance were documented. Descriptive statistics were employed.

Results:

Over 6 weeks, 109 interventions were documented. The mean ± SD patient age was 61.8 ± 14.94 years. The most common interventions documented were laboratory monitoring (22.0%), drug information (17.4%), and patient education (14.7%). Of the applicable interventions, 69% (49/71) were accepted by the PCP.

Conclusions:

APPE students in this clinic provided a variety of recommendations following completion of medication histories. A majority of the interventions were accepted. Such data demonstrate the benefit of including APPE students in patient care.
Ranirestat: A Selective Aldose Reductase Inhibitor for Diabetic Sensorimotor Polyneuropathy
Authors: Vo Ty , Marcus Kristine B
Published: September 2013

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of ranirestat, an oral aldose reductase inhibitor with a unique chemical structure, as treatment of diabetic sensorimotor polyneuropathy in patients with diabetes mellitus.

Data Sources:

Primary literature and review articles were identified by searching MEDLINE (1950–June 2008), EMBASE (1991–June 2008), International Pharmaceutical Abstracts (1970–June 2008), and Google Scholar using the key terms ranirestat, AS-3201, SX-3030, aldose reductase inhibitors, diabetes mellitus, and peripheral neuropathy. Additional articles were identified from the bibliographies of the obtained literature.

Study Selection and Data Extraction:

Reviewed literature was restricted to available English-language articles. Preclinical and clinical trials were reviewed. One Phase 2 clinical trial and its extension study were identified. No data have yet been reported from Phase 3 trials that were conducted between 2004 and 2006.

Data Synthesis:

Ranirestat is a selective and reversible inhibitor of aldose reductase. Nerve damage is reduced by inhibiting this key enzyme in the polyol pathway, thus preventing the accumulation of sorbitol and fructose. Ranirestat has been compared with placebo in randomized, double-blind, controlled trials. Improvement in nerve function, sensation, and clinical grading scale were noted. Ranirestat was reported to be well tolerated.

Conclusions:

Ranirestat may offer a clinical advantage over current treatment modalities as the first agent to address one factor in the underlying cause of diabetic sensorimotor polyneuropathy. Further studies should be done on safety, efficacy, tolerability, and quality of life to determine how successful this agent will be in the treatment of diabetic sensorimotor polyneuropathy.

ACPE Universal Program Numbers:

407-000-08-056-H01-P (Pharmacists); 407-000-08-056-H01-T (Technicians)