bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of Pharmacoeconomic Studies: Utilization of a Checklist
Authors: Sacristán José A. , Soto Javier , Galende Ines 
Published: January 2017

OBJECTIVE: To review the fundamental concepts used in clinical economic analysis and establish a simple model to systematically evaluate the quality of pharmacoeconomic studies. DATA SOURCES: A MEDLINE search was used to identify pertinent pharmacoeconomic literature, including reviews. STUDY SELECTION: Selected literature evaluating the methodology of health economics studies was used. CONCLUSIONS: The number of studies presenting a pharmacoeconomic evaluation has increased progressively; however, the quality of the studies has not improved in parallel. The existence of different types of pharmacoeconomic studies does not justify their arbitrary use and the achievement of valid conclusions must be based on sound knowledge of the concepts employed, as well as on use of the most adequate tool in each instance. By evaluating pharmacoeconomic studies systematically, the more common errors (i.e., in planning the study or interpreting the results) can be detected and thus prevented. The checklist we present has 12 sections, each of which includes several subsections. After evaluating the corresponding subsections, each section is labeled as “correct”, “acceptable”, “doubtful”, “incorrect”, or “not applicable.” From this qualitative evaluation, aspects that have been dealt with correctly and those needing improvement will become apparent. Also, the checklist permits the user to verify whether the results have been correctly obtained and, therefore, whether the conclusions are valid. The use of a checklist for evaluating pharmacoeconomic studies may be useful for researchers, journal editors, and the audience when performing, receiving, reading, or accepting a clinical economic study.
Challenge to Clinical Pharmacy Practice in Malaysia
Authors: Hassan Yahaya 
Published: January 2017

OBJECTIVE: To report on the current status and future trends of clinical pharmacy practice in Malaysia. DATA SOURCES: Published conference reports and journal articles. DATA EXTRACTION: Data on areas related to clinical pharmacy practice in Malaysian hospitals were gleaned from various publications. DATA SYNTHESIS: Malaysia is capable of implementing clinical pharmacy services in hospitals and perhaps also in the community setting. The important factors in clinically oriented pharmacy practice include improvement of the drug-control process, development of physical and human resources, clinical pharmacy skills, and the training of practicing pharmacists. A number of Malaysian pharmacists have already developed a unit-dose drug distribution system, patient counseling, therapeutic drug monitoring, drug information, and total parenteral nutrition services. CONCLUSIONS: The pharmacy profession in Malaysia has many challenges ahead and it is hoped that every practicing pharmacist will be highly committed to future professional needs so that clinical pharmacy practice in Malaysia becomes a reality.
Nsaid Use and Efficacy in the Emergency Department: Single Doses of Oral Ibuprofen versus Intramuscular Ketorolac
Authors: Wright Julie M. , Price Stephen D. , Watson William A. 
Published: January 2017

OBJECTIVE: To compare the clinical efficacy of single doses of intramuscular ketorolac and oral ibuprofen in the emergency department (ED) treatment of acute pain. DESIGN: A retrospective analysis of data collected during a prospective survey of pain management efficacy. The design was noninterventional, and therapy was selected by the treating physician independent of the trial. SETTING: Urban teaching hospital adult patient emergency department. PARTICIPANTS: A convenience sample of ED patients in acute pain. INTERVENTIONS: Patients received ibuprofen 800 mg po (n=95), or ketorolac 60 mg im (n=30) as a single dose. Therapy was selected by the treating physician and was not influenced by the study. RF.8ULTS: Data collected were a 100-mm visual analog pain scale at patient arrival and discharge, verbal description of pain relief, patient demographics, pain management data, and discharge diagnosis. Baseline pain intensity was higher in patients receiving ketorolac (77 mm median) than in those receiving ibuprofen (65 mm, p=0.02). Pain relief was similar (p=0.29) with either treatment when assessed by visual analog scale or patient definition of pain relief. CONCLUSIONS: A single dose of either nonsteroidal antiinflammatory drug produced similar pain relief in the general ED population during clinical treatment of pain. Ketorolac should not necessarily be considered a more effective analgesic than ibuprofen in these commonly used doses.
Chronic Hemodialysis Patients. Part I: Characterization and Drug-Related Problems
Authors: Kaplan Barbara , Mason Nancy A. , Shimp Leslie A. , Ascione Frank J. 
Published: January 2017

OBJECIVE: To describe medication use in hemodialysis patients and to characterize the potential drug-related problems that may occur in this population. DESIGN: All patients being dialyzed during the study period who were responsible for taking their own medications and who were able to provide an accurate medication history were included in this study. A pharmacist administered a structured medication history and drug therapy review protocol known as the Focused Drug Therapy Review Program to identify potential drug-related problems. This process was modified for a hemodialysis population. SETIING: Outpatient hemodialysis unit at a university-affiliated hospital. RESULTS: Thirty patients with endstage renal disease requiring hemodialysis were enrolled in the study. On average, 10 prescription and 2 prescribed nonprescription medications were used per patient. The incidence of potential adverse effects and medication allergies or intolerances averaged 5.5 and 2.2 per patient, respectively. Twenty patients (67 percent) reported missing an average of 3.4 (range I-II) doses of medication per month. A total of 216 potential drug-related problems (encompassing both prescribing choices and patient behaviors) were identifiedby the pharmacist; the categories of drug selection and medication compliance contained the greatest number of potential problems (24 and 23 percent, respectively). CONCLUSIONS: Hemodialysis patients use a large number of medications, which increases the risk for adverse reactions and other drug-related problems. The types of potential drug-related problems identified are amenable to pharmacist input. Thus, such patients should be targeted for clinical pharmacy intervention.
Chronic Hemodialysis Patients. Part II: Reducing Drug-Related Problems through Application of the Focused Drug Therapy Review Program
Authors: Kaplan Barbara , Shimp Leslie A. , Mason Nancy A. , Ascione Frank J. 
Published: January 2017

OBJECTIVE: To test the value and measure the impact of a model of pharmacy practice called the Focused Drug Therapy Review Program (FDTRP)in patients with endstage renal disease on hemodialysis. DESIGN: A modified version of FDTRP, adapted for a hemodialysis population, was assessed for its impact on prescriber behavior. The impact was measured by examining the percentage of pharmacist therapeutic recommendations accepted and implemented by the prescriber. SETTING: Thirty patients at a university hospital-based outpatient hemodialysis unit participated in the study. Twenty-four patients completed the study through the implementation evaluation. RESULTS: The pharmacist generated 114 therapeutic recommendations and 85 informative comments regarding drug therapy. The prescriber accepted 76 percent and implemented 70 percent of the therapeutic recommendations. The prescriber considered the informative comments to be helpful, even if the information was known previously. CONCLUSIONS: The FDTRP has been shown to be useful in the care of chronic hemodialysis patients. In addition, the pharmacist was able to provide clinically important recommendations in a closely monitored patient population.
Hypertension and Endstage Renal Disease
Authors: Brown Thomas E.R. , Carter Barry L. 
Published: January 2017

OBJECTIVE: To review current literature regarding the development of hypertensive renal disease, its epidemiology, and its pathophysiology. This review focuses on strategies to slow or halt the progression of endstage renal disease (ESRD) in hypertension, including the role of blood pressure control, different types of antihypertensive agents, early treatment, and dietary considerations. DATA SOURCES: Information was retrieved from searching the MEDLINE database for articles consisting of epidemiologic studies, clinical studies, and review articles pertaining to hypertension and ESRD. Information also was obtained from the US Renal Data System annual data reports. STUDY SELECTION: Emphasis was placed on clinical trials in the English language addressing issues in hypertension and ESRD. Clinical trials reporting relationships between blood pressure control and ESRD, as well as those comparing different antihypertensive agents, were evaluated. DATA EXTRACTION: The methodology and results from clinical trials were evaluated. Studies were assessed according to the measures of renal function used, baseline data collected, degree of blood pressure control, and antihypertensive therapy. DATA SYNTHESIS: Clinical trials including patients with essential hypertension, diabetes mellitus, and renal insufficiency of various etiologies were evaluated. The recommendations from these evaluations were based on study design and the types of populations used (i.e., blacks vs. whites, diabetics vs. nondiabetics). CONCLUSIONS: Blood pressure control is currently the most important strategy to slow or halt the progression of renal insufficiency in hypertensive individuals. Whether specific antihypertensives are renal protective is still controversial, but results from clinical trials are promising.
Treating Isolated Systolic Hypertension in the Elderly
Authors: Howard Patricia A. 
Published: January 2017

OBJECTIVE: To review the prevalence, pathophysiology, vascular risk, and treatment of isolated systolic hypertension (ISH) in the elderly. DATA SOURCE: A MEDLINE search of the English language literature was performed to identify pertinent literature. Key search terms were hypertension, systolic, and elderly. STUDY SELECTION: All studies available evaluating drug therapy for ISH or hypertension in the elderly as well as review articles discussing the prevalence, pathophysiology, and treatment of ISH were selected. SYNTHESIS: ISH occurs commonly in the elderly and is associated with increased risk for cardiovascular and cerebrovascular disease. Although the mechanism for ISH in the elderly is not completely understood, the primary factor is believed to be a reduction in arterial compliance. Results of the Systolic Hypertension in the Elderly Program demonstrated that control of ISH using a diuretic alone or in combination with a beta-blocker significantly reduced the incidence of strokes and cardiovascular events. In this trial, drug therapy was found to be safe and generally well tolerated by the elderly. Newer antihypertensive agents such as the calcium-channel blockers and angiotensin-converting enzyme (ACE) inhibitors have also been shown to effectively lower SBP in the elderly, but the effects on long-term morbidity and mortality are not yet known. CONCLUSIONS: ISH is an important risk factor for vascular disease in the elderly. Accurate diagnosis and effective drug treatment can result in significant reductions in the risk of cardiovascular and cerebrovascular events. Based on the available trial data, diuretics appear to be the drugs of first choice unless there are contraindications. If combination drug therapy is required, beta-blockers should be considered although their contribution to vascular risk reduction remains less clear. Additional studies are needed to determine the long-term benefits and risks of alternative antihypertensive agents such as calcium-channel blockers and ACE inhibitors.
Pharmacoeconomic Analysis of Cefmenoxime Dual Individualization in the Treatment of Nosocomial Pneumonia
Authors: Paladino Joseph A. , Fell Robert E. 
Published: January 2017

OBJECTIVE: To determine if dual individualization of cefmenoxime dosing is cost-effective. DESIGN: Retrospective, pharrnacoeconomic decisionanalysis of two consecutively conductedprospective clinical studies. PATIENTS: Patientswithdocumentedgram-negative nosocomial pneumoniawere evaluated. Thirty-three patients received cefmenoximeat standarddosing and 28 patients received doses according to dual individualization methodology. MAIN OUTCOME MEASURE: Antibiotic and infection-related costs were compared between groups. The number of hospital antibiotic days and costs incurred on those days were also evaluated. A decision model was constructed to characterize differences in treatment outcome. Probabilities with in the decision tree were derived from 61 evaluable patients. Cost-effectiveness and incremental cost-effectiveness ratios were calculated. Sensitivity analysis was performed by varying out come probabilities, antibiotic prices, and hospital room costs. RESULTS: Antibiotic and infection-related costs (mean ± SEM) were $848 ± 78 for standard cefmenoxime dosing and $1123 ± 128 for dual individualization (p<0.05). Total hospital costs were $10 660 ± 1432 or standard dosing and $11 700 ± 1900 for dual individualization (p>0.05). Median antibiotic length of stay (ALOS) was 15.2 and 12.7 days for standard and dual individualization methodologies, respectively (p>0.05). Incremental analysis of cost effectiveness indicated that a similar reduction in length of stay for 259 dual individualization patients would save $321 808 annually. CONCLUSIONS: Sensitivity analysis indicates that by reducing ALOS, dual individualization could be a cost-effective method of betalactam dosing for patients with pneumonia. A prospective study should be conducted to validate these findings.
Clinical Experience with Ketorolac in Children
Authors: Buck Marcia L. , Rudis Maria 
Published: January 2017

OBJECTIVE: To describe the use of parenteral ketorolac in a large population of children, focusing on dosing patterns, efficacy, and safety. DESIGN: Observational, prospective study conducted over a four-month period. SETTING: A 122-bed children's medical center located within an academic medical center hospital. PARTICIPANTS: Children receiving ketorolac during their hospitalization. MAIN OUTCOME PARAMETERS: Indications for treatment, dose, dosing interval, use of a loading dose, length of therapy, efficacy (subjective response and use of concomitant therapy), and adverse effects (bleeding, gastrointestinal ulceration or vomiting, and renal dysfunction). RESULTS: Of 112 children evaluated, 110 received ketorolac for analgesia, and 2 were given ketorolac as an antipyretic. The children ranged in age from 6 months to 19 years. Doses of 0.5 mg/kg q6h were used for most children (range 0.17–1.0). The average length of therapy was 3.4 days (range 1–12). The most frequent reason for discontinuing ketorolac therapy was a change to oral therapy. Therapy was discontinued because of a lack of efficacy in only 2 children. Adverse reactions were unusual, with only 2 patients having bleeding potentially associated with ketorolac use. CONCLUSIONS: Ketorolac appears to be a safe and effective therapy for children when given in appropriate doses for a limited duration.
Omnibus Budget Reconciliation Act of 1990 and Voluntarism: Logistic Regression Analysis of Pharmacist Responsibility
Authors: Hansen Robert W. , Ranelli Paul L. 
Published: January 2017

OBJECTIVE: To examine the relationship between pharmacists' willingness to assume further professional responsibilities, as measured by attitudes to the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) requirements, and their attitudes toward voluntarism as their responsibility to society and their level of interest in their jobs. DESIGN: A survey was distributed to a convenience sample of 443 pharmacists who were asked to indicate their responses on a number of items. SETTING: Surveys were distributed to participants in an annual pharmacy continuing education program. PARTICIPANTS: The response rate was 65 percent with completed surveys from 290 Florida pharmacists who were typically male (73 percent) and practicing in the community setting (39 percent) for over 25 years (33 percent). MAIN OUTCOMES: Questions were aimed at gathering the following information: (1) demographics; (2) attitudes concerning the benefits of the three OBRA '90 requirements: Patient counseling, prospective drug-use review (DUR), and information recording; (3) attitudes toward voluntarism; and (4) job interest. RESULTS: Pharmacists tended to agree that all three of the OBRA '90 mandates will be beneficial. Fifty-six percent favored the prospective DUR requirements, while 68 percent favored the patient counseling requirements and 66 percent favored the information-recording requirements. Logistic regression analysis showed that unit increases in scaled responses, indicating more favorable attitudes toward believing that voluntarism was one's responsibility, increased the odds of favoring counseling by 38.7 percent and information recording by 32.4 percent. A similar directional relationship was found for the DUR requirement. Job interest did not add to the predictive ability of the variables already in the models. CONCLUSIONS: This study suggests a possible association between pharmacists' attitudes toward social responsibility and their acceptance of expanded professional responsibility.
Pancreatitis during Intravenous Pentamidine Therapy in an AIDS Patient with Prior Exposure to Didanosine
Authors: Foisy Michelle M. , Slayter Kathryn L. , Hewitt Ross G. , Morse Gene D. 
Published: January 2017

OBJECTIVE: To report a case of an HIV-positive man who received sequential didanosine and pentamidine treatment and subsequently developed acute clinical pancreatitis. CASE SUMMARY: In June 1992 didanosine 200 mg po bid was initiated in a 30-year-old man with AIDS. After a 22-week course of didanosine, the patient was hospitalized and didanosine was discontinued on day 4. The patient then received 8 days of treatment for a presumed Pneumocystis carinii pneumonia (PCP) with pentamidine 4 mg/kg/d iv. As the patient responded clinically to therapy, he was discharged home to complete a 21-day course of pentamidine. On day 14 of therapy, the patient experienced nausea, vomiting, diarrhea, fatigue, and was hypotensive. The dosage of pentamidine was reduced by 50 percent. After receiving 18 doses of pentamidine, treatment was discontinued, as symptoms had worsened and serum amylase and lipase concentrations were elevated. The patient was hospitalized and the diagnosis of acute clinical pancreatitis was made. After a 21-day hospitalization, the patient was discharged home in fair condition on hyperalimentation. DISCUSSION: Potential causes of pancreatitis, including opportunistic infections, neoplasms, and drugs, are discussed. The most probable factors associated with pancreatitis in our patient are didanosine and pentamidine therapy. CONCLUSIONS: As our patient developed pancreatitis following sequential administration of didanosine and pentamidine, it would be prudent to monitor for signs and symptoms of pancreatitis in similar cases. In addition, didanosine should be discontinued during and for one week following treatment of PCP when pentamidine is used.
Anaphylactoid Reactions Associated with Ondansetron
Authors: Kossey Joyce L. , Kwok Karl K. 
Published: January 2017

OBJECTIVE: To describe two patients with anaphylactoid-type reactions to ondansetron. CASE SUMMARY: A 41-year-old man with grade III leiomyosarcoma of the right tibia was admitted to the hospital for his second dose of first-cycle neoadjuvant intraarterial cisplatin 60 mg/m2 therapy. He experienced an anaphylactoid reaction following intravenous ondansetron infusion that was confirmed on rechallenge. In a second case, premedication with intravenous ondansetron resulted in an anaphylactoid reaction in a 44-year-old woman with stage III ovarian cancer receiving her ninth course of cyclophosphamide and carboplatin. Both patients had received ondansetron previously with no adverse effects. DISCUSSION: Peer-reviewed journal articles and reports, obtained through a MEDLINE search, were reviewed. Information on the individual cases was obtained from the patients' medical records. Preservative changes in ondansetron infusion were examined as possible causes of the anaphylactoid reactions in our patients, but no conclusive data linking them were found. CONCLUSIONS: The efficacy and safety of ondansetron has led to the widespread use of this medication in the treatment of nausea and vomiting caused by cancer chemotherapy and radiation therapy. Practitioners should be made aware that acute severe anaphylactoid reactions could occur in patients who have previously received ondansetron with no adverse effects.
Flecainide Distribution, Transplacental Passage, and Accumulation in the Amniotic Fluid during the Third Trimester of Pregnancy
Authors: Bourget Philippe , Pons Jean-Claude , Delouis Christine , Fermont Laurent , Frydman René 
Published: January 2017

OBJECTIVE: To study the disposition of flecainide acetate and its transplacental passage (both into the fetus and in the amniotic fluid) during the third trimester of pregnancy. DATA SOURCES: Reference articles and books are identified in the text. A literature review is presented. CASE SUMMARY: Flecainide distribution, transplacental passage, and accumulation into the amniotic fluid were studied in a patient at term presenting with a fetal supraventricular tachycardia diagnosed at 33 4/7 weeks of gestation. The fetal tachycardia was accompanied by cardiac failure with placental anasarca and hydramnios. Flecainide 100 mg po bid was prescribed initially; by the time of delivery, the dosage had been decreased to 50 mg bid. At delivery day (39 5/7 weeks), the pharmacokinetics of total flecainide were studied at plateau. DATA SYNTHESIS: The concentrations of flecainide at birth in fetal and maternal blood and in amniotic fluid were 235.4, 241.2, and 6426.5 μg/L, respectively. Calculation of a fetomaternal blood accumulation ratio of 0.97 showed that, at this gestational age, flecainide penetrates the placental membrane easily without accumulation in fetal blood. In contrast, the concentration of flecainide in amniotic fluid was approximately 27-fold that measured in maternal peripheral blood. Our results suggest the following: (1) close to term, the metabolic clearance (fetal hepatic clearance) of flecainide offers a high yield and its excretion by the fetal kidney is efficient; (2) given that amniotic fluid is constantly swallowed, it seems that, in contrast to what is seen in adults (relative oral bioavailability ≥95 percent), the oral bioavailability of flecainide is possibly low in the fetus at term or close to term; under such circumstances, the drug would accumulate passively within the gestational sac; and (3) an alternative explanation is that the concentration in the fetus is, in part, the result of both transplacental crossing of the drug and reabsorption orally from the amniotic fluid. CONCLUSIONS: The regular therapeutic monitoring of flecainide is necessary and sufficient in the mother as the concentrations found appear to accurately reflect the degree of fetal accumulation. Because previous studies in infants and children have indicated few toxic adverse effects attributed to flecainide, it appears that the risk to a sucking infant of ingesting toxic amounts of flecainide in human breast milk is very low. Finally, the child of the patient described here has normal initial growth and development at the present time. The transplacental penetration of a drug can be considered, according to gestational age and the disorder being treated, as being of no consequence, dangerous, or desirable. Flecainide appears to fall into this last category.