Andrea S. Franks

Acute Pancreatitis Associated with Liraglutide

Objective: To report what is, to our knowledge, the first postmarketing case of acute pancreatitis associated with liraglutide Case Summary: A 60-year-old female with type 2 diabetes presented with a 16-hour history of mid-epigastric pain 3 weeks after treatment was changed from exenatide 10 μg twice daily, which she had taken for 4 years, to liraglutide 1.8 mg daily. Her serum lipase level was elevated (478 units/L) at admission, and other laboratory values were within normal limits. Liraglutide was discontinued at admission. Standard therapy for pancreatitis resulted in symptom resolution and a significant decrease in serum lipase (131 units/L) by hospital day 4; she was discharged on hospital day 5. Discussion: Based on the Naranjo scale, this case represents a probable adverse drug reaction. Eight cases of pancreatitis were observed in liraglutide-treated patients in premarketing clinical trials. Extensive literature describing exenatide-related pancreatitis and premarketing reports of liraglutide-related pancreatitis, along with the temporal relationship between the initiation of liraglutide and the onset of this patients symptoms, suggest that the episode of pancreatitis was induced by liraglutide. Conclusions: Liraglutide should be used cautiously in patients with a history of pancreatitis, and clinicians should have a high index of suspicion for this rare, but potentially serious, adverse effect.

Team-Based Learning in US Colleges and Schools of Pharmacy

Objective. To characterize the use of team-based learning (TBL) in US colleges and schools of pharmacy, including factors that may affect implementation and perceptions of faculty members regarding the impact of TBL on educational outcomes. Methods. Respondents identified factors that inhibit or enable TBL use and its impact on student learning. Results were stratified by type of institution (public/private), class size, and TBL experience. Results. Sixty-nine of 100 faculty members (69%) representing 43 (86%) institutions responded. Major factors considered to enable TBL implementation included a single campus and student and administration buy-in. Inhibiting factors included distant campuses, faculty resistance, and lack of training. Compared with traditional lectures, TBL is perceived to enhance student engagement, improve students’ preparation for class, and promote achievement of course outcomes. In addition, TBL is perceived to be more effective than lectures at fostering learning in all 6 domains of Bloom’s Taxonomy. Conclusions. Despite potential implementation challenges, faculty members perceive that TBL improves student engagement and learning.

Best Practices for Implementing Team-Based Learning in Pharmacy Education

Colleges and schools of pharmacy are incorporating more team-based learning (TBL) into their curriculum. Published resources are available to assist instructors with implementing TBL and describing it in the health professions literature. The 7 core elements include: team formation, readiness assurance, immediate feedback, sequencing of in-class problem solving, the 4 “S” structure for developing team application exercises (significant problem, same problem, specific answer choice, simultaneous reporting), incentive structure, and peer evaluation. This paper summarizes best practices related to implementation of TBL in pharmacy education, including courses taught using teaching teams.

Pancreatitis: A Potential Complication of Liraglutide?

OBJECTIVE: To review the evidence surrounding a potential association between liraglutide and pancreatitis. DATA SOURCES: A literature search was conducted in MEDLINE (1948-July 12, 2012) and EMBASE (1974-week 27, 2012) using the search terms pancreatitis, liraglutide, and glucagon-like peptide 1/adverse effects. Reference citations from identified publications were reviewed. The manufacturer was contacted and regulatory documents from the Food and Drug Administration website were reviewed for unpublished data related to cases of pancreatitis associated with liraglutide use. STUDY SELECTION AND DATA EXTRACTION: All identified sources that were published in English were considered for inclusion. DATA SYNTHESIS: Eleven cases of pancreatitis have been reported in patients taking liraglutide. Seven were from the LEAD (Liraglutide Effect and Action in Diabetes) studies, 1 was reported in the extension of a clinical trial, and 1 was in an unpublished obesity trial. Two were published postmarketing case reports. Nine of the cases reported were diagnosed as acute pancreatitis, while 2 were classified as chronic pancreatitis. The mean age of the patients was 57.5 years and mean body mass index was 33.92 kg/m2. Six of the 11 cases occurred in male patients. Nine of the patients were white and 1 was African American. In 7 of the cases, onset occurred at liraglutide doses at or above 1.8 mg daily. Common comorbidities included history of pancreatitis, cholelithiasis, and diabetes. One case was fatal. CONCLUSIONS: Pancreatitis is a potential complication with liraglutide therapy. Liraglutide should be used cautiously in patients at risk of pancreatitis (eg, alcohol abuse, history of pancreatitis, cholelithiasis).

A critical appraisal of and recommendations for faculty development.

The 2009-2010 American Association of Colleges of Pharmacy (AACP) Council of Faculties Faculty Affairs Committee reviewed published literature assessing the scope and outcomes of faculty development for tenure and promotion. Relevant articles were identified via a PubMed search, review of pharmacy education journals, and identification of position papers from major healthcare professions academic organizations. While programs intended to enhance faculty development were described by some healthcare professions, relatively little specific to pharmacy has been published and none of the healthcare professions have adequately evaluated the impact of various faculty-development programs on associated outcomes. The paucity of published information strongly suggests a lack of outcomes-oriented faculty-development programs in colleges and schools of pharmacy. Substantial steps are required toward the development and scholarly evaluation of faculty-development programs. As these programs are developed and assessed, evaluations must encompass all faculty subgroups, including tenure- and nontenure track faculty members, volunteer faculty members, women, and underrepresented minorities. This paper proposes AACP, college and school, and department-level recommendations intended to ensure faculty success in achieving tenure and promotion.

Pharmacist-Physician Collaboration for Diabetes Care: The Diabetes Initiative Program:

BACKGROUND: Multiple complications can arise secondary to poor control of glucose, blood pressure, and cholesterol in a patient with diabetes. OBJECTIVE: To evaluate the effect of a pharmacist-physician collaboration on attainment of diabetes-related measures of control. METHODS: This was a prospective, multicenter, cohort study. Patients were enrolled from 7 practice sites throughout Tennessee if they had been diagnosed with type 2 diabetes, were aged 18 years or older with a life expectancy greater than 1 year, and were English speaking. Pregnant women were excluded. Patients were followed for 12 months following enrollment by informed consent. The pharmacist-physician collaboration method was established prior to study initiation. Primary outcomes included hemoglobin A1c (A1C), number of patients with A1C less than 7%, and percentage of patients with A1C greater than 9%. RESULTS: Of the 206 patients enrolled, the mean age was 59.73 years, and most were male (59.71%) and white (66.02%). The A1C was reduced by an average of 1.16% (p < 0.0001). The proportion of patients with A1C less than 7% increased from 12.75% at baseline to 36.76% at study conclusion (p = 0.0002). The proportion of patients with A1C greater than 9% decreased from 34.15% to 16.50%, (p < 0.0001). CONCLUSIONS: Pharmacist-physician collaborative management at multiple practice locations and types of setting (eg, private, academic, Veterans Affairs medical center) has a positive impact on glycemic control and diabetes-related health maintenance. This was accomplished without increasing the total number of antihyperglycemic agents prescribed and without an increase in patient-reported episodes of hypoglycemia.

Spironolactone for Hirsutism in Polycystic Ovary Syndrome

OBJECTIVE: To evaluate the level of evidence for treatment of hirsutism associated with polycystic ovary syndrome (PCOS) with spironolactone. DATA SOURCES: Studies and reports were located in MEDLINE (1966–January 2005%), EMBASE, and International Pharmaceutical Abstracts through the second week of January 2005. DATA SYNTHESIS: Hirsutism is a common clinical problem and is often associated with PCOS. Research has been performed to assess the efficacy of spironolactone therapy in patients with hirsute characteristics. Five studies that evaluated the effectiveness of spironolactone for hirsutism in PCOS were identified and reviewed. CONCLUSIONS: The effects of multiple treatment options on the subjective and objective measures of hirsutism have displayed varying results. The outcomes reported to date have shown a positive trend toward using spironolactone in women with PCOS and hirsutism.

Faculty and student perceptions of effective study strategies and materials.

Objectives. To evaluate faculty members’ and students’ perceptions of study strategies and materials. Methods. Focus groups were conducted with course directors and first- and second-year students to generate ideas relating to use of course materials, technology, class attendance, and study strategies for mastering class concepts. Results. Students and faculty members differed in their opinions about the utility of textbooks and supplemental resources. The main learning method recommended by students and faculty members was repeated review of course material. Students recommended viewing classroom lectures again online, if possible. Course directors reported believing that class attendance is important, but students based their opinions regarding the importance of attendance on their perceptions of lecture and handout quality. Results did not differ by campus or by student group (first-year vs. second-year students). Conclusions. Students and faculty members have differing opinions on the process that could influence learning and course design. Faculty members should understand the strategies students are using to learn course material and consider additional or alternative course design and delivery techniques based on student feedback.

Safety of Concomitant Tamoxifen and Warfarin

Objective: To review the literature regarding the potential interaction between tamoxifen and warfarin. Data Sources: A search of MEDLINE from 1948 to August 20, 2009, was performed using the search terms tamoxifen, warfarin, drug interactions, and cytochrome P450 2C9. EMBASE was searched (1980–week 33, 2009), using the search terms tamoxifen and warfarin, for articles limited to use in humans and published in English, then further narrowed to drug interactions. Bibliographic review was conducted but did not reveal any additional references. Study Selection and Data Extraction: All sources evaluated were published in English and included original case reports, letters, and medical record or database reviews that described an interaction between warfarin and tamoxifen. Data Synthesis: Since tamoxifen therapy and cancer increase the risk of venous thromboembolism, warfarin may be prescribed to these patients. However, product information, primary literature, and tertiary literature describe concomitant use of tamoxifen and warfarin as a contraindication since this may increase the level of anticoagulation and the risk of bleeding complications. Although the exact mechanism of the interaction is unknown, one theory is that tamoxifen inhibits CYP2C9, which metabolizes the S-isomer of warfarin. Five publications were identified including 2 letters, 2 individual case reports, and 2 retrospective reviews (1 of the case reports was included in a medical record review). Collectively, these articles described a total of 31 patients taking warfarin and tamoxifen concomitantly, with 8 patients experiencing bleeding complications. Conclusions: Although concomitant use of warfarin and tamoxifen is deemed a contraindication, evidence regarding this potential interaction is limited. Therefore, safety of concomitant use of tamoxifen and warfarin may be similar to that of other drugs that interact with warfarin, requiring consistent and careful monitoring. However, more evidence is needed to warrant the routine use of this combination.

Weight Gain Mitigation with Topiramate in Mood Disorders

OBJECTIVE To review the evidence of weight loss with use of topiramate in patients with mood disorders. DATA SOURCES Literature search included MEDLINE (1966—December 2003), International Pharmaceutical Abstracts (1970–December 2003), and EMBASE (1980—December 2003). Search terms included topiramate, weight loss, adverse effect, mood disorders, bipolar disorder. DATA SYNTHESIS Weight gain is a common adverse effect of many agents used to treat mood disorders. Topiramate has been evaluated in the management of some mood disorders, and weight loss may be a beneficial side effect in these patients. Case reports, letters to the editor, prospective investigations, and retrospective observational studies were reviewed to identify evidence of weight loss with topiramate use in patients with mood disorders. CONCLUSIONS Current evidence suggests an association between topiramate and weight loss. Based on the limited data, controlled studies need to be conducted to define the role of topiramate in patients with mood disorders who would also benefit from weight reduction.