Impact of supplemental individual verbal defense on confidence, engagement, and performance in a team-based learning therapeutics course.

BACKGROUND AND PURPOSE: Team-based learning (TBL) has been successfully applied to multiple healthcare education disciplines. A primary tenet of TBL is the development of solutions leveraging the collective knowledge of a team rather than the individual competency of any one student. In an effort to enhance individual student accountability, an individual verbal defense (IVD) format was implemented in a multi-campus TBL-based pharmacotherapeutics course. The study sought to investigate the use of TBL-IVD embedded within a traditional TBL format on student engagement, teaching style preferences, and exam performance compared to a TBL-only format. EDUCATIONAL ACTIVITY AND SETTING: In this cross-sectional study, second-year pharmacy students enrolled in a pharmacotherapeutics course during fall 2019 completed an 11-item survey. The survey was designed to assess TBL-IVD on student engagement and teaching style preference. Free-response qualitative feedback was solicited to assess positive-negative themes related to the activity. Aggregate exam performance for community-acquired pneumonia (CAP) related content was compared to historical exam data to assess the impact on student performance. FINDINGS: The majority of students (72%, n = 54) preferred the TBL-IVD compared to a TBL-only format. Students reported higher engagement with TBL-IVD (84%, n = 63). Correct exam responses for CAP related content were higher in the TBL-IVD group (67% vs. 55%, P < .001). Positive themes included an increased opportunity to defend recommendations verbally and increased interaction with an on-campus faculty member. SUMMARY: The study demonstrates the addition of IVD can enhance student perceptions, confidence, and performance within a large, multi-campus, TBL-based pharmacotherapeutics course.

Gluten content of barium sulfate suspensions used for barium swallows in patients with celiac disease.

PURPOSE: To determine the availability and accuracy of information provided by hospitals, imaging centers, and manufacturers regarding gluten in barium sulfate suspensions. METHODS: A total of 105 facilities were contacted via telephone to determine the gluten content of the contrast media used in those facilities. Manufacturers were contacted and their Web sites reviewed to determine the gluten content of their barium products. RESULTS: Thirty-nine percent of the hospitals and 52% of the imaging centers were not aware of the gluten content of the contrast media they used. Twenty-nine-and-a-half percent of the respondents provided the correct gluten content. The manufacturers noted that 5 products were tested and confirmed gluten free, 1 product was not tested but described as gluten free, 1 product's gluten content depended upon its flavor, and 1 product was reported to contain gluten. DISCUSSION: Clinicians caring for patients with celiac disease or patients who choose to restrict their gluten consumption must ensure that the barium sulfate suspension ingested is gluten free. CONCLUSION: It can be difficult to determine the gluten content of barium sulfate, as a majority of radiology departments and imaging centers did not know whether the product they use is gluten free. Educating staff members and improving product labeling would benefit the quality of care provided to patients with celiac disease.

New therapeutic alternatives for the management of dyslipidemia.

Hypercholesterolemia affects over 34 million adults in the United States and is a major cause of coronary heart disease (CHD). Conventional therapies, such as statins, have demonstrated their ability to improve clinical end points and decrease morbidity and mortality in patients with CHD. Lomitapide (Juxtapid(®)), mipomersen (Kynamro(®)), and icosapent (Vascepa(®)) are 3 novel agents approved by the US Food and Drug Administration in the past 2 years, which offer new lipid-lowering treatment options with unique pharmacology.

Determining the gluten content of nonprescription drugs: information for patients with celiac disease.

OBJECTIVES: To determine whether the information on the gluten content of nonprescription drugs is readily available from the manufacturer/supplier, to identify how patients are directed on the product labeling to obtain answers to questions that they have about the nonprescription medication, and to determine the time needed to obtain information about the gluten content of the product when contacting manufacturers/suppliers. DESIGN: Descriptive, exploratory, nonexperimental study. SETTING: United States during July 2010. PARTICIPANTS: Manufacturers/suppliers of 41 nonprescription drug products. INTERVENTION: The packaging of the products was reviewed for information on gluten content. The manufacturer/supplier listed on each product's packaging was contacted using the phone number provided and questioned about the gluten content of the product. A uniform script was used for the telephone inquiry. The responses provided and the duration of the phone calls were documented. The manufacturer's websites also were reviewed for pertinent information. MAIN OUTCOME MEASURES: Gluten status of products, time spent on phone to determine gluten status, and availability of online information regarding gluten status. RESULTS: Information concerning the gluten content was not included on any of the products' packaging. The mean time required to receive a response was 6.2 minutes (median 5 minutes). A total of 15 products were reported to be gluten free; 13 products were not tested, but the manufacturer/supplier stated that they did not add gluten to the products; 9 products did not have any gluten added by the manufacturer/ supplier, but no guarantee was made that the raw ingredients were gluten free; 2 products contained gluten; and 2 products had no available gluten status information. Gluten information was found on product websites for a total of six products. Four of those six websites indicated gluten status that was different from the information provided via the telephone call with the manufacturer. CONCLUSION: Information concerning the gluten content of many nonprescription drugs is relatively easy for patients to obtain if the manufacturer/supplier is contacted. Although the time to obtain a response was quite short for many of the inquiries, it took a substantial amount of time to receive the requested information from some of the companies.

Effect of acetaminophen on international normalized ratio in patients receiving warfarin therapy.

Warfarin is known to have extensive interactions with many classes of drugs. The literature suggesting a relevant interaction between acetaminophen and warfarin is inconsistent. Considering the ubiquitous use of acetaminophen, a review of the effects on international normalized ratio (INR) in patients taking warfarin was necessary. Thus, we performed a search of the PubMed (1966-November 2010) and International Pharmaceutical Abstracts (1970-November 2010) databases to review the available literature addressing an acetaminophen-warfarin interaction and its possible mechanisms. A sample of case reports, in addition to all English-language studies were evaluated, and relevant references were examined for additional articles. Reports of nonwarfarin coumarin anticoagulants were excluded. Published documentation reporting an interaction between acetaminophen and warfarin is limited. Small prospective studies of various designs and case studies describe aberrant INR results in patients using acetaminophen while receiving warfarin. These INR elevations typically involved acetaminophen ingestion of at least 2 g/day for several consecutive days. In several small prospective studies, INR results were elevated to a statistically significant extent that would require a change in warfarin dosing and monitoring in clinical practice. The mechanism for this interaction remains to be elucidated yet is suggested to occur through alterations in hepatic metabolism. The use of moderate-to-high doses of acetaminophen while receiving warfarin results in supra-therapeutic INRs in some patients. The characteristics that may predispose a patient to this interaction are unclear, yet the widespread use of acetaminophen calls for enhanced clinician awareness and reinforcement of patient education about this interaction.

Disease modifying agents for multiple sclerosis.

OBJECTIVE: To summarize major clinical trials which evaluate the efficacy and safety data of approved disease modifying agents for the treatment of various types of multiple sclerosis. DATA SOURCES: A MEDLINE (1966 to August 2008) search of clinical trials using the terms multiple sclerosis, interferon, glatiramer, mitoxantrone and natalizumab was performed. A manual bibliographic search was also conducted. English-language articles identified from the searches were evaluated. New agents under investigation in phase 3 clinical trials were identified using www.clinicaltrials.gov. STUDY SELECTION #ENTITYSTARTX00026; DATA EXTRACTION: Relevant information was identified and selected based on clinical relevance and evidence-based strength. Prescribing information leaflets were used to provide usual dosage, contraindications, precautions, monitoring parameters and other relevant drug-specific information. DATA SYNTHESIS: Interferon beta products are more efficacious for the treatment of relapsing-remitting multiple sclerosis. Interferon beta 1-b also delayed the time to diagnosis of definite multiple sclerosis and reduced brain lesion burden in patients with clinical isolated syndrome. Glatiramer and natalizumab have both established efficacy in relapsing forms of multiple sclerosis; whereas mitoxantrone is more commonly used in patients with advanced disease. There are limited data the comparative efficacy among different disease modifying agents. New agents currently under investigation have showed promising results and may offer more treatment options in the future. CONCLUSIONS: MS is a complex and devastating disease with challenging treatment considerations and approaches. Interferon beta products continue to be the mainstay of therapy in many patients, however, other treatments are proving to be at least as effective in the management of various types of MS. Newer compounds are being developed and studied with much anticipation and promise for the clinical management of the disease.

Seasonal, avian, and novel H1N1 influenza: prevention and treatment modalities.

OBJECTIVE: To review the pathophysiology, pandemics/epidemics, transmissibility, clinical presentation, treatment, prevention/immunization, and resistance associated with seasonal, avian, and swine influenza. DATA SOURCES: Literature was obtained from MEDLINE (1966-October 2009) and International Pharmaceutical Abstracts (1971-October 2009) using the search terms influenza, seasonal influenza, avian influenza, swine influenza, H1N1, novel H1N1, H3N2, and H5N1. STUDY SELECTION AND DATA EXTRACTION: Available English-language articles were reviewed, along with information obtained from the Centers for Disease Control and Prevention, the Food and Drug Administration, and the World Health Organization. DATA SYNTHESIS: The influenza virus has caused disease in birds, swine, and humans for many centuries. Pandemics and epidemics have occurred throughout history and reports of new strains continue to emerge. Two major surface antigenic glycoproteins, hemagglutinin and neuraminidase, have various subtypes, resulting in numerous combinations of these proteins. For example, combinations occur when an influenza strain from a bird "mixes" with a strain from a human. This mixing occurs in a host, often in pigs, resulting in a new strain. This new strain can cause pandemics since people have no immunity to the new strain. An H1N1 subtype pandemic occurred in 1918, causing millions of deaths. Simultaneously, veterinary reports of "influenza" in pigs also emerged. It is postulated that humans infected pigs with this H1N1 virus. H1N1 reappeared in humans in 1976, and more recently in 2009. Other pandemics have occurred with H2N2 and H3N2 strains. In 1997, strain H5N1, which usually causes disease in fowl, was able to infect humans. CONCLUSIONS: Influenza subtypes continue to change, causing disease in animals and humans. Utilization of immunization and antiviral treatment options are available to prevent, treat, and contain the spread of this infection.

Withdrawal symptoms after discontinuation of transdermal scopolamine therapy: treatment with meclizine.

PURPOSE: The case of a patient who treated withdrawal symptoms from trans-dermal scopolamine with meclizine is reported. SUMMARY: A 30-year-old woman for whom transdermal scopolamine was prescribed to manage motion sickness during a vacation experienced severe withdrawal symptoms that began 24 hours after patch removal and lasted for several days. Other medications included an oral contraceptive and as-needed zolmitriptan for migraines. She used the scopolamine patches as prescribed, applying one patch behind the ear every 3 days. After 10 consecutive days of wearing the patch and experiencing no motion sickness, she began to develop dry mouth and uncomfortable, dry eyes, which prompted her to remove the patch. After 24 hours without the patch, she developed severe nausea that did not subside during a car ride. Due to the intractable nausea, she applied a new patch, which she wore for 3 consecutive days without recurrence of the nausea. Upon returning from the trip, she removed the last patch. Twelve hours after the last patch was removed, nausea recurred but was not related to motion. She felt better while lying down, but felt nauseated when standing or walking. After 3 days of this nausea, she began taking nonprescription meclizine 25 mg orally every 12 hours. The nausea subsided after two doses, and she was able to resume her normal activities. The nausea did not recur after discontinuation of the meclizine. She had used transdermal scopolamine eight years prior without any withdrawal symptoms. CONCLUSION: Withdrawal symptoms experienced after removal of a transdermal scopolamine patch were successfully treated with oral meclizine.

Telavancin: a novel lipoglycopeptide antibiotic.

OBJECTIVE: To review the pharmacology, antimicrobial activity, pharmacokinetics, clinical applications, and safety of telavancin, a new lipoglycopeptide antibiotic. DATA SOURCES: Literature was obtained from MEDLINE (1966-April 2009) and International Pharmaceutical Abstracts (1971-April 2009) using the search terms telavancin and TD-6424, and also from Theravance, Inc., and Astellas Pharma US, Inc. STUDY SELECTION AND DATA EXTRACTION: Available English-language articles were reviewed, as well as information obtained from Theravance, Inc., and Astellas Pharma US, Inc. DATA SYNTHESIS: Telavancin has rapid bactericidal activity against gram-positive aerobic and anaerobic bacteria through multiple mechanisms of action. In vitro and Phase 2 in vivo data support the efficacy of telavancin against antibiotic-resistant gram-positive organisms. On March 4, 2008, the Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the October 19, 2007, New Drug Application approvable letter for telavancin to be used as treatment for complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. QTc interval prolongation has been reported, although the clinical impact of this has not been determined. Drug interactions have not been identified as of yet. CONCLUSIONS: Telavancin is currently under review by the FDA for the treatment of cSSSIs caused by gram-positive bacteria. The completion of Phase 3 trials will determine whether telavancin will have a role in the treatment of other infections caused by resistant gram-positive bacteria.

Caring for patients with celiac disease: the role of the pharmacist.

OBJECTIVE: To review the epidemiology, pathophysiology, diagnosis, treatment, and complications of celiac disease, in order to provide guidance to pharmacists. DATA SOURCES: Published articles identified through Medline using search terms such as celiac disease, gluten sensitivity, and gluten enteropathy. Additional resources were identified from personal bibliographies collected by the authors and bibliographies from gathered articles. DATA SYNTHESIS: Celiac disease is an autoimmune disorder that is characterized by intolerance to gluten and affects approximately 3 million Americans. Although the most common manifestations of the disease are gastrointestinal, including diarrhea, steatorrhea, and weight loss, the disease is a multisystem disorder. Malabsorption is common, often leading to vitamin and mineral deficiencies and resulting in anemia and osteoporosis. Diagnosis is initiated through serology testing and confirmed by intestinal biopsy. The only treatment for celiac disease is strict, lifelong adherence to a gluten-free diet, which includes avoidance of foods, prescription and nonprescription pharmaceutical products, and cosmetics containing wheat, barley, and rye. Adherence to the gluten-free diet will promote intestinal healing and symptom relief and usually prevent complications of celiac disease. CONCLUSION: Pharmacists can play an important role by identifying patients who may have celiac disease, providing information for gluten-free foods and pharmaceutical products, and encouraging adherence to the gluten-free diet.

Eculizumab in paroxysmal nocturnal haemoglobinuria.

Eculizumab is a monoclonal antibody that binds with high affinity to the complement protein C5, preventing terminal complement-mediated intravascular haemolysis in patients with paroxysmal nocturnal haemoglobinuria (PNH). In three well designed clinical trials in patients with PNH, eculizumab blocked serum haemolytic activity and decreased transfusion rates. Pooled data from the three clinical trials demonstrated that eculizumab treatment decreased the overall thromboembolism rate in patients with PNH. Eculizumab carries a black box warning for the potential increased risk of meningococcal infections and requires patients to receive the meningococcal vaccine at least 2 weeks before starting treatment. Eculizumab is the first drug to be approved by the US FDA for the treatment of PNH and is a novel treatment that offers a new option for patients with PNH.

Varenicline: a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist approved for smoking cessation.

Tobacco smoking remains a significant health problem in the United States. It has been associated with staggering morbidity and mortality, specifically due to malignancies and cardiovascular disease. Smoking cessation can be difficult and frequently requires pharmacologic interventions in addition to nonpharmacologic measures. Previously available agents are nicotine replacement products and bupropion, which increased quit rates by about 2-fold compared with placebo. Varenicline is the first drug in a new class known as the selective alpha4beta2 nicotinic receptor partial agonists. In several randomized, double-blind, 52-week clinical trials involving healthy chronic smokers, varenicline demonstrated superiority to placebo and bupropion in terms of efficacy measures. Additionally, it improved tobacco withdrawal symptoms and reinforcing effects of smoking in relapsed patients. Patients should start therapy in combination with tobacco cessation counseling 1 week before quit date and continue the regimen for 12 weeks. The dose of varenicline should be titrated to minimize nausea. The recommended dosage is 0.5 mg once daily (QD) on days 1-3; titrate to 0.5 mg twice daily (BID) on days 4-7; and 1 mg BID starting on day 8. An additional 12-week maintenance therapy may be considered for those who achieve abstinence. The most common side effects are nausea (30%), insomnia (18%), headache (15%), abnormal dreams (13%), constipation (8%), and abdominal pain (7%). Overall, varenicline is a breakthrough in the management of tobacco addiction and has demonstrated good efficacy in motivated quitters. It also provides an option for smokers who cannot tolerate other pharmacologic interventions.

Rimonabant: a novel selective cannabinoid-1 receptor antagonist for treatment of obesity.

PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy, safety, drug interactions, and dosage and administration of rimonabant in the treatment of obesity and related metabolic factors are reviewed. SUMMARY: Discovery of the cannabinoid receptors has led to the development of rimonabant, a cannabinoid-1 (CB(1)) antagonist. Selective blockade of this receptor has been shown to lead to decreased appetite and food intake in animal models. Clinical studies have shown that rimonabant 20 mg once daily produces significant decreases in weight and waist circumference in obese human subjects and improves the lipid profile and glucose control. The frequency of metabolic syndrome also decreased significantly with rimonabant 20 mg daily. Limited data are available regarding the pharmacokinetics and pharmacodynamics of rimonabant. Preclinical data have demonstrated a long duration of action. As of yet, no drug-drug, drug-food, or drug-disease interactions have been identified with rimonabant. Adverse reactions occurred rarely, with nausea, dizziness, diarrhea, arthralgia, and back pain being the most common. Psychiatric disorders, including depression and anxiety, were the most common reasons for subjects to withdraw from rimonabant studies. Rimonabant has been shown to be safe for up to two years of treatment. Further research will clarify currently unknown areas, including pharmacokinetics, drug interactions, and the drug's role in standard therapy. CONCLUSION: Rimonabant, a selective CB(1) antagonist, is a novel treatment option for obese and overweight individuals. Significant weight loss, decrease in waist circumference, and improvements in lipid profile and glucose control have been shown in clinical trials of rimonabant.

Facial flushing associated with duloxetine use.

PURPOSE: A case of flushing associated with duloxetine use is presented. SUMMARY: A 43-year-old nonmenopausal woman was prescribed duloxetine 20 mg daily for migraine prophylaxis after the usual medications for treatment and prevention of migraines were used with little or no success. Magnetic resonance imaging and computed tomography ruled out structural causes of migraines. The patient took 20 mg daily for five days and then decided, on her own, to decrease the dosage after experiencing insomnia, a common adverse effect of duloxetine. She opened the 20-mg capsules and took half of the contents to "create" the 10-mg dose, placing the contents of the opened capsule directly onto her tongue. She did this for two weeks and found the migraines to be significantly reduced in number and intensity. At that time, she began to experience what she described as a hot flash and facial flushing. The flushing was not accompanied by itching and did not spread beyond the face. The flushing occurred one to two hours after administering the 10-mg dose and typically resolved the following day. One week later, the patient noticed that the vessels in her face were more prominent. Concomitant therapies included pindolol for hypertension and duloxetine and botulinum toxin type A injections for migraines. The patient weaned herself off duloxetine. Facial flushing continued for one week after discontinuation of the drug. At a one-month follow-up visit, she stated that the flushing had resolved and not occurred since the original episodes. CONCLUSION: A patient treated with duloxetine developed facial flushing, possibly caused by inappropriate administration of the drug.

Methylene blue for management of Ifosfamide-induced encephalopathy.

OBJECTIVE: To evaluate the use of methylene blue for the treatment of ifosfamide-induced encephalopathy. DATA SOURCES: MEDLINE (1966-August 2005) and International Pharmaceutical Abstracts (1971-August 2005) were searched using the terms methylene blue, ifosfamide, encephalopathy, and neurotoxicity. DATA SYNTHESIS: Several case reports and one retrospective chart review described the use of methylene blue for ifosfamide-induced encephalopathy, but no controlled clinical trials were found. Methylene blue appeared to aid in the resolution of encephalopathic symptoms as rapidly as within 10 minutes of administration in some patients, but it had modest efficacy in most patients. Symptoms in patients who did not receive methylene blue resolved in the same time frame; this indicates that ifosfamide-induced encephalopathy may resolve without treatment. CONCLUSIONS: Available data from case reports indicate that methylene blue is an option in the treatment of ifosfamide-induced encephalopathy, especially in patients with severe symptoms of toxicity. However, the lack of controlled clinical trials and the possibility of spontaneous resolution of encephalopathy make the usefulness of methylene blue unclear.