bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of Increased Copayments on the Discontinuation/Switching Rates of Nonformulary Medications
Authors: Nair Kavita V , Valuck Robert J , Allen Richard R , Lewis Sonya J
Published: September 2013

Background:

Patients with chronic diseases are particularly affected by prescription copayment increases, as they are faced with the decision to switch to formulary alternatives or pay more to stay on their current medication.

Objective:

To evaluate the impact of increased copayments as a result of a change in formulary status on the continuation rates of nonformulary medications in multitiered pharmacy benefit plans.

Methods:

A retrospective cohort study was conducted on patients with chronic diseases who were part of a health plan in the western US. Individuals were selected if they were taking a medication that was being removed from the health plan's formulary and, thus, experienced increases in their copayments for nonformulary medications (n = 1,244). The time periods before and after the increase in copayments were studied. Adjusting for demographics, chronic comorbidities, medication use, Medicare + Choice status, and percentage increase in copayment for nonformulary medications, Cox regressions were used to assess continuation rates for these drugs.

Results:

A clear relationship between increasing copayment differentials and continuation rates for nonformulary medications in the period after the copayment increases could not be established. In general, those who experienced higher copayment differentials (50–100%, 100–200%, >200%) were more likely to continue their nonformulary medication than were those who experienced copayment increases of 25–50% and >25%.

Conclusions:

Individuals confronted with increased copayments often switched their drugs to formulary alternatives. However, a clear relationship could not be established between increasing copayments and continuation behavior. Further research is needed to determine whether these switching behaviors result in inappropriate medication behaviors, such as complete discontinuation of drug therapy due to the increased costs.
New Treatment for Chronic Obstructive Pulmonary Disease: Tiotropium Bromide
Authors: Evans Emily W
Published: September 2013

Objective:

To review chronic obstructive pulmonary disease (COPD) and evaluate the role of tiotropium bromide in its treatment.

Data Sources:

MEDLINE was searched for articles published between 1990 and June 2004 that contained the terms tiotropium and chronic obstructive pulmonary disease.

Study Selection/Data Extraction:

Selected studies documented clinical outcomes related to the use of tiotropium bromide and included a complete description of methods and results. These studies were examined to determine the extent of the effect of tiotropium on clinical outcomes involved in COPD.

Data Synthesis:

Tiotropium bromide has a long duration of action and thus can be dosed just once daily. It was found to improve lung function, reduce symptoms, improve health status, and decrease exacerbations compared with both placebo and other bronchodilator medications.

Conclusions:

Tiotropium appears to be a valuable addition to the current therapies available for COPD.
A Case Study: Treatment of Refractory Schizoaffective Disorder with Aripiprazole
Authors: Soto Joseph A De , Kazi Aneela , Rivera Alejandro , Muhammad AB Wilson
Published: September 2013

Objective:

To report the use of aripiprazole in the treatment of refractory schizoaffective disorder.

Case Summary:

A 42-year-old African American male with a 10-year history of schizoaffective disorder decompensated while being treated with haloperidol decanoate 200 mg intramuscularly per month and valproic acid 500 mg twice daily. Upon admission, his Global Assessment of Function scale (GAF) score was 10 and his Mini-Mental State Examination (MMSE) score was 2. He was treated with an initial injection of haloperidol decanoate 100 mg and, thereafter, with haloperidol 5 mg orally twice a day. He remained refractory to haloperidol and, on day 14, chlorpromazine 150 mg/day was added. The patient continued to show no response. On day 20, oral aripiprazole 15 mg was substituted for haloperidol and chlorpromazine. Forty-eight hours later, the GAF score was 30 and the MMSE score was 18. Ninety-six hours after receiving aripiprazole, the GAF and MMSE scores were 40 and 26, respectively.

Discussion:

Aripiprazole has been approved for the treatment of schizophrenia and bipolar disorder; however, it has not been approved for treatment of schizoaffective disorder. Aripiprazole is a novel drug representing a new class of agents used for the treatment of psychosis. Aripiprazole is a partial agonist at the dopamine D2 and serotonin 5-HT1A receptors, but an antagonist at the serotonin 5-HT2A receptors.

Conclusions:

Aripiprazole may be useful in treatment of refractory schizoaffective disorder.
Exenatide: A Novel Therapeutic Approach for Type 2 Diabetes Mellitus
Authors: McCord Amie D
Published: September 2013

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy and safety studies, adverse effects, drug interactions, and dosage and administration of exenatide, a novel incretin mimetic agent recently approved for the treatment of type 2 diabetes mellitus.

Data Sources:

Information was obtained from MEDLINE searches of the English-language literature (1990–November 2004). Search terms included exenatide, synthetic exendin-4, exendin-4, AC2993, and GLP-1 agonist.

Study Selection and Data Extraction:

All available data were reviewed, including animal and human data disseminated as abstracts, clinical trials, review articles, and press releases.

Data Synthesis:

Exenatide is a novel therapeutic agent recently approved for the treatment of type 2 diabetes. The unique pharmacologic profile of exenatide offers a promising adjunctive treatment option for this patient population.

Conclusions:

While the long-term safety and efficacy of this agent are not well documented, the available data indicate the efficacy and safety of exenatide in combination with various oral antidiabetic agents in reducing postprandial glucose concentrations, glycosylated hemoglobin values, and potentially body weight without increasing the risk of hypoglycemia.
Factors Associated with Ribavirin-Induced Anemia
Authors: Friedenberg Frank K , Gollamudi Satya P , Chang Alan W , Guatam Manjushree , Schmutz Joan K , Skole Kevin S , Thomas Rebecca M , Black Martin
Published: September 2013

Background:

During treatment of hepatitis C, ribavirin-induced anemia (RIA) requires reduction of the ribavirin dose or initiation of erythropoietin in up to 20% of patients. RIA usually occurs in the first 8 weeks of treatment, and a decrease >3 g/dL or a nadir <10 g/dL is considered significant.

Objective:

To prospectively examine factors associated with RIA in a population of patients with hepatitis C.

Methods:

Consecutive patients with hepatitis C (hepatitis B virus and HIV negative) underwent treatment with pegylated interferon and weight-based ribavirin. Prospectively gathered data included demographics, alcohol consumption, and hepatitis C virus risk factors. Patients underwent laboratory studies at baseline and at intervals of 4–8 weeks after starting treatment.

Results:

One hundred eight patients were enrolled. Of these, 30 (27.8%) experienced a >3 g/dL fall in hemoglobin levels in the first 8 weeks; in 10 (33%) patients, the change occurred by week 4. The initial hemoglobin level was higher in those with a decrease compared with those without a fall (15.3 vs 14.1 g/dL; p < 0.001). In addition, for patients with a decrease, the iron saturation was higher (44.6% vs 30.1%; p = 0.002). Finally, those with fibrosis stage 6/6 (cirrhosis) had a greater percent fall in hemoglobin (27.0% vs 14.0%; p = 0.009) than those with less severe fibrosis. By logistic regression analysis, only iron saturation was associated with RIA (p = 0.002).

Conclusions:

In our patients, initial hemoglobin, serum iron, and fibrosis were associated with a potentially clinically important decrease in hemoglobin. In approximately one-third of the population, RIA occurred in the first 4 weeks of treatment. No patient had a severe complication.
Argatroban in Post-Cardiovascular Surgery Patient with Heparin-Induced Thrombocytopenia Requiring Hemodialysis and Continuous Hemofiltration
Authors: Lau Keith K , Escue Eric J , Ault Bettina H , Jones Deborah P , Storgion Stephanie A
Published: September 2013

Objective:

To describe the use of argatroban in a postoperative cardiovascular surgery patient with heparin-induced thrombocytopenia (HIT) requiring hemodialysis and continuous veno-veno hemofiltration (CVVH).

Case Summary:

A 23-year-old white woman with HIT developed acute renal failure after cardiovascular surgery. Argatroban was used as a substitute for heparin during hemodialysis and CVVH. Both activated partial thromboplastin time (aPTT) and activated clotting time (ACT) were used to guide the dosage of argatroban. The patient was successfully dialyzed without clotting of the circuit. The dosage required in our patient was much lower than the manufacturer's recommendation.

Discussion:

Argatroban is a selective thrombin inhibitor that does not cross-react with heparin-induced antibodies. It is metabolized by the liver, and dosage adjustment is recommended in patients with severe hepatic impairment. The correct dosage for patients with unstable hemodynamics is not known. Our patient had apparently normal hepatic function at the initiation of therapy, but the dosage of argatroban recommended by the manufacturer resulted in prolonged elevation of the aPTT and ACT with associated gastrointestinal bleeding. This may be due to hepatic congestion secondary to poor cardiac function and/or severe generalized edema.

Conclusions:

When argatroban is considered for therapy in place of heparin for CVVH, it needs to be used with extreme caution since the correct initial dosage in patients with mild hepatic impairment and unstable hemodynamics is unclear.
Understanding the Perceptions and Attitudes of Pharmacy Students on Administering Adult Vaccines
Authors: Akala Folasade O , Powers Mary F
Published: September 2013

Background:

Community pharmacy practice is changing to include pharmacist-administered immunization. As this change occurs, there is a need to understand pharmacy students' attitudes and interests regarding this new role.

Objective:

To examine the attitudes and interests of pharmacy students in administering immunizations and to use the information obtained to design and implement an immunization training program within an existing course in the PharmD curriculum at a college of pharmacy.

Methods:

A survey questionnaire was distributed to the first- and second-year PharmD students during the fall semester of the 2003–2004 academic year. Descriptive statistics, including mean and standard deviation, were used to report the data.

Results:

Two hundred nine surveys were distributed to first- and second-year students, and 172 were completed, yielding a response rate of 82%. Survey results showed that 76.7% of the students were aware that pharmacists can legally administer adult immunizations in Ohio, 94.2% think pharmacist-administered adult immunization is an important healthcare service, and 93.6% indicated they would be willing to administer adult immunizations after graduating.

Conclusions:

With the incorporation of an immunization training program into the curriculum, students can be well prepared and confident in administering adult immunizations. The immunization training program can also provide students with an opportunity to become involved in immunization as advocates or facilitators.
Treatment of Hypercholesterolemia in Pregnancy: Risks versus Benefits
Authors: Zaiken Kathy , Raval Kalindi D
Published: September 2013

Objective:

To identify treatment options for hypercholesterolemia in pregnant women.

Data Sources:

A search was conducted of MEDLINE (1966–March 2004), EMBASE (1980–March 2004), and International Pharmaceutical Abstracts (1970–March 2004). Key terms included fibric acid derivatives, plant stanol/sterols, niacin, ezetimibe, vitamin E, LDL-apheresis, and fish oil.

Study Selection and Data Extraction:

The articles evaluated described hypercholesterolemia during pregnancy and lipid therapy options.

Data Synthesis:

Elevated lipid levels in pregnant women may have a negative impact on the fetus. Case reports and clinical trials from 1966 to March 2004 were evaluated for information regarding the impact of various cholesterol-lowering agents on both the mother and fetus. These case reports and trials conclude that additional studies are needed to determine their overall safety in pregnant women.

Conclusions:

Lipid-lowering therapies have differing levels of safety and efficacy and are not well studied in pregnant women. Therefore, a diet low in cholesterol and fat is the recommended treatment for hypercholesterolemia during pregnancy.
Exploring the Professional Expertise of Pharmacy Technicians
Authors: Wilson Debbie L , Kimberlin Carole L , Brushwood David B
Published: September 2013

Objective:

To investigate whether the adapted model of professional expertise for pharmacy fits the opinions of pharmacists about pharmacy technicians, explore the qualities of professional expertise that pharmacists feel pharmacy technicians have, and generate ideas to encourage pharmacy technician professional expertise.

Methods:

An adapted model of professional expertise was used in this investigation of pharmacy technicians and included 4 constructs: Knowledge, Patient Assessment and Education, Reasoning and Judgment, and Virtues. Four one-on-one interviews and one focus group with 10 pharmacists were conducted. Content analysis was conducted of verbatim transcriptions of the interviews using a tree of codes that incorporated the concepts of the adapted model.

Results:

The model fit 179 (65%) of the 276 text units and included 43 concepts. The pharmacists employed narrations, stories, lists, and simple responses in the comments that the model fit.

Conclusions:

The adapted model of professional expertise for pharmacy aligned with the pharmacists' comments on pharmacy technicians. Pharmacists reported that pharmacy technicians possess many qualities of professional expertise. These qualities were used to make recommendations for encouraging pharmacy technician professional expertise.
Encephalopathy and Hyperammonemia Associated with Valproic Acid
Authors: Yee Jennie L , Wong David , Ormiston Thomas M
Published: September 2013

Objective:

To discuss the case of a patient who experienced an altered level of consciousness secondary to hyperammonemia associated with valproic acid who had normal drug concentrations and liver function tests.

Case Summary:

A 48-year-old man with a history of seizure disorder treated with valproic acid presented with an altered level of consciousness. An extensive workup revealed only an increased ammonia level. His medications were withheld. Within 24 hours, the ammonia level returned to normal and he was able to be aroused. His antiseizure medication was changed to gabapentin. All of his chronic medications, other than valproic acid, were restarted. The patient has had no further increases in ammonia levels or episodes of altered mental status.

Discussion:

Encephalopathy due to hyperammonemia is generally due to severe liver dysfunction. In our case, however, hyperammonemia occurred in a patient with normal liver function who was also taking valproic acid. An objective causality assessment revealed that the adverse drug event was probably related to valproic acid. A review of the literature indicates that the increased ammonia levels were probably secondary to the effect of valproic acid on the kidneys or the liver. Withdrawal of the offending agent resulted in normalization of ammonia levels and resolution of encephalopathy.

Conclusions:

With a widening of its clinical indications, the use of valproic acid has been increasing. Even though valproic acid concentrations may be therapeutic/nontoxic and liver function tests normal, practitioners are encouraged to check the ammonia level. Hyperammonemia, once recognized, is easily treated.
Cytochrome P450 Enzymes and Drug—Drug Interactions: An Update on the Superfamily
Authors: Lewis Jeffrey D , Bachmann Kenneth A
Published: September 2013

Objective:

To provide an update of the biological characteristics of cytochrome P450 (CYP) enzymes and appreciate the implications of such in the prediction and assessment of drug–drug interactions (DDIs).

Data Sources:

Searches of MEDLINE (1966–July 2005) and Web sites plus manual review of journals, conference proceedings, and reference textbooks were performed using the key search terms cytochrome P450 and drug–drug interaction.

Study Selection/Data Extraction:

All articles identified from the data sources were evaluated, and information deemed relevant was included for this review.

Data Synthesis:

During the past few years, significant strides have been made in our understanding of the biology of CYP enzymes and our ability to accurately assess and predict the occurrence of CYP enzyme–related pharmacokinetic DDIs. Once considered a single enzyme, the enzymes of the CYP superfamily are now recognized to exhibit highly variable substrate specificity and intriguing cooperativity with other enzymes and transporter proteins (eg, P-glycoprotein). Mechanisms of enzyme induction and inhibition have been further characterized, and the clinical implications of this knowledge require a more thorough understanding of the topic by healthcare practitioners.

Conclusions:

We offer a contemporary survey of the biology of CYP enzymes, including mechanisms of enzyme induction and inhibition, and encourage the incorporation of this knowledge into the assessment and prediction of DDIs in the clinical setting.
Keeping Score on Psychiatric Drug Effects: Is Mefloquine Safe for Malaria Chemoprophylaxis?
Authors: Willmore Catherine B , Ayesu Linda W
Published: September 2013

Background:

Armed servicemen or tourists visiting Asian and African continents bear the risk of contracting falciparum malaria. Chemoprophylaxis, for certain individuals, is recommended. All drugs marketed for prophylaxis of malarial infection have adverse effects. Notably, antimalarial drugs can impose neuropsychiatric harm. Mefloquine is a widely used malaria chemoprophylactic despite its association with neuropsychiatric symptoms including panic attacks, seizures, headaches, visual and auditory hallucinations, sleeplessness, paranoia, and psychosis.

Objective:

To emphasize caregiver counseling and ensure patient follow-up for nonimmune travelers to malaria indigenous regions when mefloquine chemoprophylaxis is scheduled.

Data Sources and Selection:

A literature search was conducted through May 1, 2004, for reports of psychologic or neurologic adverse effects following mefloquine therapy. After review of MEDLINE, EMBASE, and EMBR citations, pertinent articles were selected if they were thought to be of special interest to physicians and pharmacists handling mefloquine.

Data Synthesis:

Literature to date indicates a higher rate of drug-provoked neuropsychiatric adverse effects than that acknowledged by mefloquine's manufacturer, Hoffman LaRoche. There is also evidence supporting a greater incidence of adverse effects for specific groups. Neuropsychiatric adverse effects are more often reported by females, particularly low body-weight females. Individuals who ingest mefloquine while under stress appear more at risk for neuropsychiatric adverse effects.

Conclusions:

Professional consult and therapeutic follow-up for all patients receiving mefloquine chemoprophylaxis is warranted.
Compliance with the JNC 7 Guidelines and Blood Pressure Attainment in an Inner-City Tertiary Care Hospital
Authors: Plakogiannis Roda , Sakalis Elias G
Published: September 2013

Background:

Blood pressure control has demonstrated significant reductions in strokes and coronary events. Using an evidence-based approach, the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guidelines recommend health-promoting lifestyle modifications, antihypertensive agents, and target blood pressure for different patient care groups.

Objective:

To assess medication selection(s) and blood pressure goal attainment in a large inner-city, hospital-based, primary care clinic.

Methods:

A 6 month retrospective, randomized, observational study was conducted to evaluate hypertension management in Bellevue Hospital's adult primary care clinic. Age, sex, ethnicity, comorbidities, blood pressure measurement, and antihypertensive treatment were obtained from computerized medical records. Antihypertensive medication selection was compared with recommendations given by the JNC 7 guidelines. Blood pressure goal attainment sorted by ethnicity, comorbidities, and age was assessed and compared with the National Health and Nutrition Examination Survey (NHANES) data.

Results:

A total of 210 patients were evaluated for antihypertensive agent(s) selection. Overall, 72% of patients received antihypertensive agents recommended by the JNC 7 guidelines. More patients in our primary care clinic achieved their systolic blood pressure goal compared with NHANES data. However, hypertensive management at our clinic was below the national average in goal diastolic blood pressure achievement. Patients with frequent follow-up visits were more likely to achieve their goal blood pressure. The most common antihypertensive agents prescribed were β-blockers (40%), followed by angiotensin-converting enzyme inhibitors (35%) and diuretics (33%).

Conclusions:

Hypertensive management in the outpatient primary care clinic of our institution warrants improvement in blood pressure goal attainment. Frequent follow-up clinic visits were associated with higher attainment rates of JNC 7 blood pressure goals.
Lanthanum Carbonate Treatment of Hyperphosphatemia in End-Stage Renal Disease
Authors: Cheng Christine M
Published: September 2013

Objective:

To review the literature on the safety and efficacy of lanthanum carbonate for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD).

Data Sources:

Primary literature was obtained through a PubMed search (1966–September 2005) using the key terms Fosrenol and lanthanum carbonate. The FDA review, manufacturer-provided data, and published abstracts on lanthanum carbonate were also reviewed and evaluated.

Study Selection and Data Extraction:

Human studies in which lanthanum carbonate was compared with placebo or active control for the treatment of hyperphosphatemia secondary to renal disease were included. Dose-titration studies were excluded.

Data Synthesis:

Phosphate-lowering agents and dietary phosphate restriction are currently the first-line therapies for initial treatment of hyperphosphatemia associated with ESRD. Lanthanum carbonate is a highly effective non–aluminum, non–calcium-containing phosphate binder. It is the only FDA-approved phosphate binder that is available as an unflavored chewable tablet that may be taken without water.

Conclusions:

Clinical studies demonstrate that lanthanum carbonate is more effective than placebo but as or less effective than standard therapies in lowering serum phosphate to target levels. When compared with calcium salts, lanthanum carbonate had a lower incidence of hypercalcemia and a lower risk of patients developing bone disease. However, in clinical trials, patients receiving lanthanum carbonate had greater discontinuation rates, some due to adverse events. The long-term safety data (>5 y), including the potential for lanthanum accumulation in the bone with subsequent development of osteodystrophy, remain unknown.
Vildagliptin (LAF 237): A Dipeptidyl Peptidase IV Inhibitor for the Treatment of Type 2 Diabetes Mellitus
Authors: Cornell Susan
Published: September 2013

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy and safety studies, adverse effects, drug interactions, dosage, and administration of vildagliptin (LAF 237), a dipeptidyl peptidase IV (DPP-4) inhibitor in Phase III development for the treatment of type 2 diabetes mellitus.

Data Sources:

Information was obtained from MEDLINE searches of the English-language literature (1990–September 2005). Search terms included vildagliptin, LAF 237, DPP-IV inhibitor, DPP-4 inhibitor, and GLP-1 agonist.

Study Selection and Data Extraction:

Available literature reviewed included abstracts, clinical trials with human and animal data, and review articles.

Data Synthesis:

Vildagliptin is a potent and highly selective DPP-4 inhibitor. This novel treatment modality enhances the activity of incretin hormones through inhibition of the enzyme responsible for their degradation.

Conclusions:

Vildagliptin demonstrates good tolerability with minimal adverse effects and can effectively improve metabolic control of glucose through an array of mechanisms.
Combination of Methylphenidate, Venlafaxine, and Escitalopram Resulting in Serotonin Syndrome
Authors: Lizer Mitsi H , Masters Kelly P
Published: September 2013

Objective:

To report a case of possible serotonin syndrome resulting from the addition of methylphenidate and/or escitalopram to venlafaxine.

Case Summary:

A 23-year-old woman being treated for bipolar depression experienced suspected serotonin syndrome. During the course of hospitalization, several medication changes were implemented. Despite these treatment interventions, depressive symptoms persisted during combination therapy with venlafaxine, lamotrigine, and gabapentin. Clinical problems developed when escitalopram and methylphenidate were later added to the regimen within a 2 day period. Several hours after receiving the second dose of methylphenidate, the patient developed a fever, exhibited hallucinations, and began hyperventilating. She was managed with supportive measures with some response, but continued to be lethargic and dizzy. Physical examination revealed increased rigidity of the upper extremities and labile blood pressure. Serotonin syndrome was suspected and all medications were withheld; the patient was then transferred to the intensive care unit.

Discussion:

Prompt and accurate diagnosis of serotonin syndrome is difficult but requires the presence of serotonergic agents in addition to core symptoms that have been identified through years of clinical antidepressant use. Additionally, serotonin syndrome is often complicated by other drug-related disorders with overlapping symptoms. Separately and together, escitalopram, venlafaxine, and methylphenidate have the ability to increase serotonin levels. Utilizing the Naranjo probability scale, we determined the likelihood of both methylphenidate and escitalopram contributing to serotonin syndrome as possible. Review of the established criteria for diagnosing serotonin syndrome, the clinical presentation of the patient, and the time frame of symptom development in correlation with drug therapy changes suggests that this is a case of serotonin syndrome.

Conclusions:

We believe that this was most likely a case of serotonin syndrome, precipitated by the addition of methylphenidate and/or escitalopram to venlafaxine.
Smoking Cessation Therapy in Pregnancy
Authors: Smith Curtis L , Rivard Erin K , Edick Cathleen M
Published: September 2013

Objective:

To determine the safety and efficacy of pharmacologic therapy for smoking cessation in pregnancy by conducting a review of current literature, focusing on controlled clinical trials.

Data Sources:

A MEDLINE search (1966–May 2006) of English-language, human clinical trials was conducted. Key search terms included nicotine, nicotine replacement therapy, bupropion, smoking cessation, and pregnancy. In addition, relevant articles were cross-referenced to screen for additional information.

Study Selection/Data Extraction:

Studies were chosen for further review if they were randomized, controlled, long-term evaluations of the safety and/or efficacy of pharmacologic therapy for smoking cessation in pregnancy. A total of 5 trials met the criteria for review.

Data Synthesis:

Controlled clinical trials of smoking cessation therapy in pregnant women are limited. Three trials have examined the long-term use of nicotine replacement products. Neither of the 2 placebo-controlled trials found a statistically significant difference in abstinence rates between women receiving transdermal nicotine replacement therapy (NRT) and placebo. However, transdermal nicotine products appeared to be safe in this population. No long-term studies have evaluated use of other nicotine replacement products in pregnant women. Bupropion has demonstrated efficacy in smoking cessation in pregnancy, but the data are limited.

Conclusions:

Transdermal NRT appears to be safe in pregnant women, although its efficacy is unclear. Information on other NRT formulations in pregnancy is unavailable. Bupropion may be a nonnicotine alternative for smoking cessation in pregnancy, but data are currently incomplete. Further studies are needed to determine the ideal population for treatment, the timing of initiation, appropriate monitoring, and the optimal length of therapy.
Potential Contribution of Long-Term Rofecoxib in a Patient with Cardiogenic Syncope and Ischemic Stroke
Authors: Colucci Vincent J , Rivey Michael P
Published: September 2013

Objective:

To report a case of syncope followed by a cerebrovascular event in a patient receiving long-term therapy with rofecoxib.

Case Summary:

A 62-year-old man presented to a local rural hospital emergency department with loss of motor control in his left extremities. Neurologic workup confirmed a right hemispheric cerebrovascular accident. Carotid arteries were noncontributory, and cardiac workup was unrevealing except for thoracic aorta atherosclerosis. There was no history of hypertension, coronary artery disease, diabetes mellitus, left ventricular systolic dysfunction, or valvular stenotic disease. Cardiovascular risk factors included smoking and dyslipidemia with low high-density lipoprotein cholesterol and hypertriglyceridemia. Of importance was the patient's 4 year history of rofecoxib use, 25 mg daily for a chronic back injury.

Discussion:

Recently published reports suggest that rofecoxib can contribute significantly to increased cerebrovascular events by an approximately twofold elevation in relative risk. An adverse drug reaction assessment, using the Naranjo probability scale, indicated a possible relationship of rofecoxib to the events. Rofecoxib was discontinued.

Conclusions:

Recent evidence of additive cardiovascular risk conveyed by cyclooxygenase-2 inhibitors and the temporal relationship between rofecoxib use and cerebrovascular events suggests that rofecoxib may be a potentially contributing factor to the unfavorable outcomes in our patient.
Combining Bisphosphonates with Raloxifene to Treat Osteoporosis: A Review of the Evidence
Authors: Miller Brian M , Patel Sheel M , Sokos Denise R
Published: September 2013

Objective:

To evaluate published studies regarding the combination of a bisphosphonate and raloxifene in the treatment of osteoporosis.

Data Sources:

A MEDLINE search (1966–February 2006) was conducted using the search terms osteoporosis, alendronate, risedronate, ibandronate, raloxifene, bisphosphonate, treatment, and selective estrogen-receptor modulators.

Study Selection and Data Extraction:

Clinical trials examining the efficacy of bisphosphonate and raloxifene in the treatment of osteoporosis were reviewed. Two trials evaluated alendronate or clodronate plus raloxifene for the treatment of osteoporosis in postmenopausal women.

Data Synthesis:

The results demonstrated a significant increase in lumbar bone mineral density (BMD) and conflicting results in the femoral BMD. Fracture risk was not assessed in either study.

Conclusions:

Published trials assessed BMD rather than fracture risk and were limited by methodologic flaws. Due to insufficient clinical outcomes data, combining these antiresorptive treatments cannot be recommended.
Anaphylactic Shock to Oxaliplatin in the Adjuvant Context
Authors: Tze Christina Ng Van
Published: September 2013

Objective:

To report a case of anaphylactic shock in a patient receiving oxaliplatin treatment.

Case Summary:

A 60-year-old Chinese woman received adjuvant oxaliplatin in combination with fluorouracil and folinic acid for treatment of stage 3 colon cancer. Shortly after initiation of her 12th infusion, she developed anaphylactic shock. She has since fully recovered from the adverse drug event. She was not rechallenged with oxaliplatin.

Discussion:

Severe hypersensitivity reactions to oxaliplatin are rare. An objective causality assessment using the Naranjo probability scale revealed that an adverse drug reaction to oxaliplatin was highly probable. Based on the Common Terminology Criteria for Adverse Events version 3 for defining reaction severity, our patient had experienced a grade 4 reaction, or anaphylaxis.

Conclusions:

With more widespread use of oxaliplatin in the treatment of early stage as well as advanced disease, the potential for more instances of severe hypersensitivity reactions exists, although the percentage of grade 4 reactions will likely remain rare. The role of intradermal skin testing to predict oxaliplatin sensitivity and the implementation of oxaliplatin desensitization protocols in cases of severe hypersensitivity reactions to this drug in the adjuvant setting may be useful.
Sorafenib for the Treatment of Renal Cell Carcinoma
Authors: Hughes Caren L , Tan Winston W , Ferrone Marcus
Published: September 2013

Objective:

To summarize the pharmacology, development, and clinical application of sorafenib, a specific tyrosine kinase and vascular growth factor inhibitor, for the treatment of renal cell carcinoma (RCC).

Data Sources:

Clinical literature, including both primary studies and review articles, was obtained by searching MEDLINE (1966–May 2006), using the search terms BAY 43-9006, sorafenib, renal cell carcinoma, and tyrosine kinase inhibitor. Additional information was supplied by the manufacturer, Bayer HealthCare Pharmaceuticals.

Study Selection and Data Extraction:

Review articles, abstracts, and clinical studies related to sorafenib were analyzed. An evaluation of the research exploring sorafenib as a potential therapy for RCC was conducted. Relevant information was then selected and is reviewed in this article.

Data Synthesis:

Knowledge of the cellular abnormalities that can cause solid tumors has led to the development of medications that block these pathways. Sorafenib is an oral tyrosine kinase inhibitor that both blocks the Raf kinase pathway and inhibits vascular growth factors. Phase I and II trials have demonstrated that sorafenib has activity against RCC. Dermatologic reactions (rash, desquamation), fatigue, and hypertension have been the most commonly seen treatment-related adverse events. Sorafenib received FDA approval in December 2005 for treatment of advanced RCC.

Conclusions:

Sorafenib is a novel oral tyrosine kinase inhibitor effective in the treatment of RCC.
Educational Intervention to Reduce Frequency of Use of Restricted Abbreviations in a Community Health Center
Authors: Burkiewicz Jill S , Hassenplug Karen L
Published: September 2013

Background:

Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) patient safety goals recognize that misuse of many common medical abbreviations correlates directly with medication errors. An institution-specific educational intervention may facilitate appropriate use of abbreviations to improve communication.

Objective:

To estimate the frequency of use of JCAHO-restricted abbreviations in prescriptions received at an outpatient pharmacy and determine whether an educational intervention on proper abbreviations decreases the rate of use of restricted abbreviations.

Methods:

Prescription records from an outpatient pharmacy of an urban community health center were reviewed during a 3 week interval to determine the baseline rate of inappropriate abbreviation use. Following an educational intervention, prescription records were prospectively reviewed for a 3 week interval to compare the frequency of inappropriate abbreviation use.

Results:

Inappropriate abbreviation use occurred at a rate of 25.8% (214/829) in the preintervention group and 18.3% (169/922) in the postintervention group (p < 0.001). The most commonly misused abbreviation was QD, representing 98.5% and 98.2% of the misused abbreviations before and after the intervention, respectively. Compared with the preintervention period, the frequency of overall abbreviation misuse (25.8% vs 18.3%; p < 0.001) and use of QD (62.4% vs 50.9%; p = 0.001) were decreased after the educational intervention.

Conclusions:

There is a high frequency of use of the abbreviation QD within this institution. While a brief educational intervention decreased the frequency of inappropriate abbreviation use, the rate of abbreviation misuse remained unacceptably high. A system-wide educational effort and/or enforcement approach may be needed to target inappropriate abbreviation use.
Abatacept: A Novel Agent for Rheumatoid Arthritis
Authors: Sheth Neha U , Hilas Olga , Charneski Lisa
Published: September 2013

Objective:

To evaluate the role of abatacept in the treatment of rheumatoid arthritis (RA) with respect to its pharmacology, pharmacokinetics, clinical efficacy, and adverse effect profile.

Data Sources:

A MEDLINE search (1966–November 2006) was conducted for primary and secondary literature. Search terms included BL125118, CTLA4-Ig, abatacept, and rheumatoid arthritis.

Study Selection and Data Extraction:

All articles retrieved from the data sources were evaluated. The most relevant studies were selected and included in this review.

Data Synthesis:

Abatacept is the first in a new class of RA agents with a unique mechanism of action. It is a selective costimulation modulator that inhibits T cell activation and other inflammatory mediators. This agent has been studied as an adjunct in patients who are receiving disease-modifying antirheumatic drug therapy and in those who have failed tumor necrosis factor-alfa antagonist therapy. Clinical trials were evaluated for information on abatacept's indication, dosing, safety, and efficacy profile.

Conclusions:

Abatacept has been shown to reduce signs and symptoms of RA and improve the condition of patients with moderately to severely active RA.
Febuxostat: A Novel, Non-Purine Xanthine Oxidase Inhibitor
Authors: Kim Karissa Y , Wigle Patricia R
Published: September 2013

Objective:

To review the pharmacology and clinical data for febuxostat in the treatment of gout and hyperuricemia.

Data Sources:

Articles on febuxostat published in English between 1966 and November 2006 were identified through a MEDLINE search using the key words febuxostat, TEI-6720, TMX-67, gout, and hyperuricemia. Additional articles were identified through search of the publications' reference lists. Abstracts from the 2005 proceedings of the American College of Rheumatology, American College of Clinical Pharmacology, and American Society for Clinical Pharmacology and Therapeutics were also searched for febuxostat studies.

Study Selection and Data Extraction:

All published febuxostat trials in humans were selected for this review. Clinical, pharmacokinetic, and pharmacodynamic data were evaluated.

Data Synthesis:

Febuxostat is a non-purine, selective inhibitor of xanthine oxidase that has demonstrated efficacy in lowering serum uric acid levels in patients with hyperuricemia associated with gout. Compared with allopurinol 300 mg/day, febuxostat 80 or 120 mg/day was more effective in lowering serum uric acid levels to less than 6 mg/dL. Febuxostat appears to be safe, with the majority of treatment-related adverse events reported being transient and mild-to-moderate in severity. However, abnormal elevation of liver enzyme levels has been reported with its use. There have been no documented major drug interactions with febuxostat.

Conclusions:

Febuxostat is a novel, non-purine xanthine oxidase inhibitor undergoing review by the FDA. It represents a potential advancement in the treatment of hyperuricemia associated with gout.
A Comparison of Event Rates for Patients Receiving Sirolimus Drug-Eluting vs. Bare Metal Stents
Authors: Mullin Molly A , Brouse Sara D
Published: September 2013

Background:

Two types of stents are used to revascularize occluded coronary arteries. Bare metal stents prevent elastic recoil and negative remodeling of the vessel wall following balloon catheter stretch. Drug-eluting stents release medications that prevent the development of neointimal hyperplasia. Drug-eluting stents, however, have been purported to increase the risk of acute stent thrombosis, potentially placing patients at higher risk for major adverse cardiac events in the 12 months following stent implementation.

Objective:

To determine whether patients receiving a drug-eluting stent experienced a higher rate of major adverse cardiac events at one year after stent placement than did patients who received a bare metal stent, and to determine the impact of antiplatelet therapy on major adverse cardiac event rates.

Methods:

We conducted a retrospective chart review of patients receiving either a sirolimus-eluting or bare metal stent at the Veterans Affairs North Texas Health Care System between July and December 2003.

Results:

Sixty-eight patients were included in the study. There was one episode of acute stent thrombosis and no statistically significant difference in major adverse cardiac event rates at 1 year after stent placement between the groups. Clopidogrel therapy was originally prescribed for an average of 3.9 months in the drug-eluting stent group and 1 month in the bare metal stent group. The actual duration of clopidogrel therapy differed significantly from the original prescribed duration for both groups, mainly due to renewal of clopidogrel prescriptions by noncardiology practitioners.

Conclusions:

Patients who received a sirolimus-eluting stent did not experience an increase in major adverse cardiac events compared with patients receiving a bare metal stent.
PDA-Based Documentation of Medication Interventions in an Ambulatory Care Setting
Authors: Fit Kathy E , Burkiewicz Jill S , Sweeney Brooke L
Published: September 2013

Background:

Although personal digital assistant (PDA)-based documentation systems are available for documentation of clinical pharmacy services, none is specific to documentation of drug-related problems (DRPs) in the ambulatory care setting.

Objective:

To describe types of medication interventions performed by pharmacists in an urban ambulatory care clinic within a teaching hospital, determine predictors of preselected DRPs, and describe physician acceptance rates.

Methods:

Following development of a PDA-based documentation system, this 6 month prospective study documented interventions performed by a clinical pharmacy team. Descriptive statistics were employed to describe the type and frequency of interventions and physician acceptance rates. Multivariate logistic regression analysis was used to determine significant predictors for preselected DRPs.

Results:

Over a 6 month period, 965 interventions were documented. The patients' mean ± SD age was 61.8 ± 15.51 years, 72.3% of patients were female, and the mean number of medications was 7.1 ± 3.95 per intervention. The most common interventions were laboratory monitoring (56.2%), patient education (14.5%), and changes in drug therapy (12.4%). The use of antihypertensive agents was a predictor for the DRPs “dose too high” and “dose too low” (p = 0.001 and p = 0.003, respectively). Of the applicable interventions, 89.8% (246/274) were accepted by the physician.

Conclusions:

Pharmacists in this urban ambulatory care clinic offered a variety of recommendations that were well received by physicians.
Investigation of Consumer Choice of Community, Mail Order, or Internet Pharmacies
Authors: Holiday-Goodman Monica , Darley William K , Lively Buford T , Siganga Walter , Deshmukh-Estoll Harsha C
Published: September 2013

Background:

The 3 major options for purchase of medications by consumers are community pharmacy, mail order pharmacy, and Internet pharmacy. Certain consumer characteristics and motivating factors may be related to the type of pharmacy a person chooses to patronize.

Objective:

To describe and compare consumers who use Internet pharmacy versus those who choose community or mail order pharmacy and identify and compare the motivating factors for the use or lack of use of Internet versus community or mail order pharmacies.

Methods:

Two hundred seventy-eight residents of a major Midwest city were surveyed by mail questionnaire. A total of 91 responses were received, yielding a response rate of 32.7%. Descriptive statistics and Kendall's W coefficient of concordance were performed to analyze the respondents' answers.

Results:

Internet pharmacy patrons, compared with community pharmacy and mail order pharmacy patrons, were more likely to be male, younger, white, married, wealthier, and more educated. Respondents using Internet pharmacy listed quality and convenience as highly ranked factors in choosing a pharmacy, while respondents using community pharmacy listed quality and reliability and those using mail order pharmacy ranked reliability and convenience most highly.

Conclusions:

This study suggests that characteristics and motivating factors may differ for customers who choose Internet pharmacy instead of community or mail order pharmacy. As this study was exploratory in nature, additional studies are needed to draw more definitive conclusions.
Varenicline: A Novel Nicotinic Receptor Partial Agonist for Smoking Cessation
Authors: Kerr Jessica L , Timpe Erin M , Karpinski Julie P
Published: September 2013

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of varenicline, a selective partial nicotinic receptor agonist for smoking cessation.

Data Sources:

Primary literature and review articles were obtained via a MEDLINE search (1966–January 2007) using the key terms smoking cessation, nicotinic receptor, tobacco, and varenicline. Additional studies and abstracts were identified from the bibliographies of reviewed literature.

Study Selection and Data Extraction:

Available English-language literature, including abstracts, preclinical and clinical trials, and review articles were identified. Six randomized, placebo-controlled trials were evaluated to determine varenicline's efficacy for smoking cessation.

Data Synthesis:

Varenicline is a partial agonist selective for the α4β2 nicotinic receptor. Varenicline has been compared with placebo and sustained-release (SR) bupropion in randomized, double-blind, controlled trials. These trials found varenicline to have more successful 4 week continuous quit rates compared with both placebo and bupropion SR. One study reported a significantly increased continuous abstinence rate with varenicline versus bupropion SR; however, 2 other studies found no difference between varenicline and bupropion SR. To date, dose-dependent nausea is the most frequent adverse effect associated with varenicline; this may be limited with proper dosage titration.

Conclusions:

Increased cessation rates in comparison with placebo and, possibly, bupropion SR, as well as limited safety concerns, suggest that varenicline may have a role as another first-line therapy for smoking cessation.