Evaluation of student-perceived growth in entrustable professional activities after involvement in a transitions-of-care process within an adult medicine advanced pharmacy practice experience.

BACKGROUND AND PURPOSE: Involvement of pharmacists and trainees in care transitions reduces medication-related problems. Participation in the transitions-of-care (TOC) process may impact self-perceived growth of autonomy within selected entrustable professional activities (EPAs). EDUCATIONAL ACTIVITY AND SETTING: A student-driven TOC documentation process was implemented within an inpatient family medicine advanced pharmacy practice experience. During the month-long rotation, students rounded with an interdisciplinary care team. Responsibilities included ensuring accurate medication reconciliation at care transitions throughout hospitalization and prior to discharge as well as medication optimization during hospitalization. Another responsibility was completing a medication-specific TOC note in the clinic-based electronic health record at discharge for patients receiving primary care from the associated clinic. The note was available to the outpatient interdisciplinary care team during the hospital follow-up appointment. Student-perceived growth in autonomy within selected EPAs was determined through an online anonymous survey. FINDINGS: Ninety percent (n = 18) of eligible students completed the survey. For specific EPA statements (collecting information, establishing patient-centered goals and establishing a care plan, implementing a care plan, collaborating as an interdisciplinary team member, and ensuring immunization), student-perceived autonomy increased after involvement in this student-driven TOC process. During the study period, 215 notes were generated by student pharmacists and included interventions/recommendations within the following themes: evidence-based changes in therapy, patient counseling, and medication access. SUMMARY: The importance of pharmacist and pharmacy trainee involvement in the TOC process has been well-documented. Involving students in student-driven TOC documentation processes serves to facilitate student-perceived growth in autonomy within selected EPAs.

Student Performance on Graded Versus Ungraded Readiness Assurance Tests in a Team-Based Learning Elective.

Objective. Team-based learning is widely used in pharmacy education. In this context, students need to be incentivized to do preclass preparation, thus ensuring they are ready for team-based learning, via graded readiness assurance tests (RATs). The purpose of this study was to determine the effect of graded versus ungraded RATs on examination performance in an ambulatory care elective course for third-year student pharmacists.Methods. For the course offered in spring 2020 and 2021, a standard team-based learning framework was employed. In 2020 the RATs were graded and contributed to the overall course grade (graded RAT cohort), but in 2021 RAT grades did not contribute to the course grade (ungraded RAT cohort). For the ungraded RAT cohort, at the end of the course students completed an online anonymous survey regarding class preparation and perceived team accountability.Results. No significant difference was found between the graded RAT (n=47) and ungraded RAT cohorts (n=36) in the overall mean percentage score on individual RATs (76% vs 74%) and individual examinations (82% vs 80%). Most students (69%-91%) in the ungraded RAT cohort reported completing preclass preparation assignments. In the postcourse survey, 94% of students agreed or strongly agreed that RATs contributed to team members' learning, and 86% agreed or strongly agreed that they were proud of their ability to assist in the team's learning.Conclusion. Ungraded RATs did not significantly impact students' examination performance in an elective course. Removing the grading of this test, whereby grading promotes the performance approach to learning, may have shifted the students' motivation to the mastery approach in the context of preclass preparation. This challenges a widely held belief that grades are necessary incentives for preclass preparation within team-based learning.

The role of online learning in pharmacy education: A nationwide survey of student pharmacists.

INTRODUCTION: Student pharmacists have significant exposure to online learning methods in their pre-pharmacy educational experiences. With decreasing resources and faculty shortages in pharmacy education, online delivery of course content is an efficient way to deliver pharmacy curricula while optimizing classroom time for active learning strategies. The purpose of this study was to assess student preferences associated with the utility of online learning methods such as online platforms, social media, and handheld devices. METHODS: An anonymous, voluntary 43-question online survey was delivered to students at colleges and schools of pharmacy in the United States (US). Frequency statistics were used to establish prevalence of student preferences. RESULTS: Overall, 1873 students from 29 schools of pharmacy completed the survey. Of these students, 30% preferred a blended course structure (with online and classroom components) throughout the curriculum, as compared to 47% of students who preferred live lectures exclusively. Approximately 57% of students found smart phones very or extremely valuable for their academic success. Approximately 61% of students reported using their smart phones and 37% reported using their tablets "always" or "often" during the past year for academic activities; however, only 31% of students found paper textbooks very or extremely valuable for their academic success, with approximately 26% using them "always" or "often." CONCLUSIONS: US pharmacy students prefer a blend of traditional classroom and online learning methods. When updating and revising pharmacy curricula, colleges and schools of pharmacy should consider the inclusion of technology and online learning methodologies.

Safety outcomes of apixaban in patients with nonvalvular atrial fibrillation and severe renal impairment.

Apixaban is prescribed for stroke prevention in nonvalvular atrial fibrillation (NVAF) in patients with varying degrees of renal dysfunction. While pharmacokinetic data support apixaban in severe renal impairment, clinical safety outcomes data are limited. This retrospective cohort analysis was conducted to evaluate the safety of apixaban in patients with NVAF and renal impairment. A total of 340 patients with NVAF receiving apixaban 5 mg or 2.5 mg twice daily were included for analysis; 287 preserved renal function (pRF: CrCl ≥ 25 ml/min and SCr ≤ 2.5 mg/dl) and 53 impaired renal function (iRF: CrCl < 25 ml/min and/or SCr > 2.5 mg/dl). The primary endpoint was major bleeding in patients taking apixaban 5 mg. Secondary endpoints included major bleeding with apixaban 2.5 mg and minor bleeding in both groups. There was no difference in major bleeding events in the 5 mg pRF group (4.41%) versus iRF group (3.57%) (P = 0.66). Similar rates occurred between the 2.5 mg pRF and iRF groups. Minor bleeding events were similar regardless of renal function. The incidence of bleeding in the 5 mg group was 11.45% with pRF versus 10.71% with iRF (P = 0.6). In the 2.5 mg group, bleeding incidence was 10% with pRF versus 16% with iRF (P = 0.47). There were no observed differences in bleeding between groups with pRF or iRF, regardless of apixaban dose. Because patients with severe renal impairment were excluded from original trials, this study contributes clinical safety outcomes to the limited data for use of apixaban in this patient population.

Pharmacy resident teaching and learning curriculum program outcomes: Student performance and quality assessment.

INTRODUCTION: The purpose of this study was to assess: (1) student performance on topics taught by first and second year postgraduate pharmacy residents and (2) the quality of learning objectives and multiple choice questions prepared by pharmacy residents. METHODS: Using a retrospective cohort design, residents and students who taught or were enrolled, respectively, in the Medication Therapy Management course in years 2010 to 2012 were participants in this study. Student performance was assessed using scores earned on the individual readiness assurance tests (iRATs), team readiness assurance tests (tRATs), and course examinations. To assess the quality of the learning objectives and multiple choice questions written by pharmacy residents, criteria were established by the authors. Each learning objective and multiple choice question was then evaluated independently by two authors to determine if these criteria were met. RESULTS: Statistical differences were observed in student performance across all content areas among the three years for iRAT, tRAT, and course examination scores, with the exception of the heart failure course examination (p = 0.05; all other p-values < 0.05). A total of 20 (42%) learning objectives met all quality review criteria, while 73 (79%) of the multiple-choice questions met all quality review criteria. DISCUSSION AND CONCLUSIONS: Student performance varied significantly depending on the content, but the overall impact of resident instructors on student course performance was not educationally significant. Teaching and learning curriculum programs should focus on teaching residents to create quality learning objectives that help students focus on learning the most important course content.

Implementation and assessment of a pulmonary diseases elective course for third-year pharmacy students.

BACKGROUND: Given the significant public health burden of pulmonary diseases and the vital role pharmacists play in management across the continuum of care (and within transitions in care), an elective course for pharmacy students focused on pulmonary diseases was developed. EDUCATIONAL ACTIVITY: A month-long elective course for third-year pharmacy students consisting of 12 class sessions delivered in two-hour periods three times per week, was implemented. The course was delivered using the team-based learning (TBL) format in addition to hands-on skills and simulation sessions. Knowledge and skills assessments were administered before and after completion of the course. Student perceptions of self-confidence and ability regarding management of pulmonary diseases pre- and post-course and their perceptions of the course and TBL as a teaching strategy for this course were evaluated upon course completion. CRITICAL ANALYSIS: Nine students completed the course. Mean scores on knowledge and skills assessment significantly improved after completion of the course (54.5% pre-course vs. 79.3% post-course; p < 0.05% and 60.3% pre-course vs. 93.2% post-course; p < 0.05, respectively). Student perceptions of their ability to care for patients with pulmonary diseases significantly increased, compared to pre-assessments, in all areas taught in the course (p< 0.05). Additionally, students' confidence in managing specific disease states significantly improved in all areas (p < 0.05) except for spirometry (p = 0.06). Students' knowledge, skills, and confidence regarding management of common pulmonary disease states improved following this month-long elective course delivered using a combination of TBL activities and hands-on skills sessions.

Do Electronic Cigarettes Have a Role in Tobacco Cessation?

Tobacco use continues to be a major cause of morbidity and mortality. Even with behavioral and pharmacologic treatment, long-term tobacco cessation rates are low. Electronic nicotine delivery systems, commonly referred to as electronic cigarettes or e-cigarettes, are increasingly used for tobacco cessation. Because e-cigarettes are widely used in this setting, health care professionals need to know if they are safe and effective. The purpose of this article is to review literature regarding use of e-cigarettes as a tool for tobacco cessation in patients who are ready to quit, as well as those who are not ready to quit, along with some selected patient populations. The safety and clinical implications of e-cigarette use are also reviewed. Small, short-term studies assessing smokers' use of e-cigarettes suggest that e-cigarettes may be well tolerated and modestly effective in achieving abstinence. High-quality studies are lacking to support e-cigarettes use for cessation in patients with mental health issues. One small prospective cohort study concluded that patients with mental health issues reduced cigarette use with e-cigarette use. Although one study found that patients with cancer reported using e-cigarettes as a tobacco-cessation strategy, e-cigarettes were not effective in supporting abstinence 6 and 12 months later. Additional research is needed to evaluate the use of e-cigarettes for smoking cessation in patients with pulmonary diseases. No data exist to describe the efficacy of e-cigarettes for smoking cessation in pregnant women. Although study subjects report minimal adverse effects with e-cigarettes and the incidence of adverse effects decreases over time, long-term safety data are lacking. Health care providers should assess e-cigarette use in their patients as part of the tobacco cessation process.

Assessment of Clinical Pharmacy Interventions to Reduce Outpatient Use of High-Risk Medications in the Elderly.

BACKGROUND: Use of high-risk medications in the elderly (HRME) and drug-disease (Rx-DIS) interactions in the elderly, as defined by the Healthcare Effectiveness Data and Information Set (HEDIS) Measures, are significantly associated with mortality, hospital admission, and need for emergency care. No published studies to date evaluate interventions to reduce the use of HEDIS-defined HRME, although many studies have postulated a beneficial effect of such interventions. OBJECTIVE: To evaluate the effect of pharmacist interventions on use of HRME and Rx-DIS interactions in the outpatient elderly population. METHODS: This retrospective cohort study was conducted in a resident-based family medicine clinic. Patients aged ≥ 65 years were prospectively screened for the use of HRME and Rx-DIS interactions before their visits with their primary care providers. If HRME or Rx-DIS interactions were noted, the clinical pharmacist sent messages to the physicians through the electronic medical record, alerting them of the findings with suggestions of safer alternative agents, if applicable. The recommendation acceptance rate was assessed and then compared with a historical control from a similar time frame. The primary outcome was assessed with a chi square analysis. Secondary outcomes were assessed with descriptive statistics, chi square test, and Fisher's exact test. RESULTS: HRME and/or Rx-DIS interactions were changed 25.9% of the time in the pharmacist intervention group compared with only 2.0% of the time in the historical control group (P = 0.001). The most frequently changed medication classes included skeletal muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs. Over 85% of the medication changes were preserved at the end of the study period. There was no difference between groups in the number of patients with HRME or Rx-DIS interactions. CONCLUSIONS: Clinical pharmacy interventions result in significant reductions in use of HRME and Rx-DIS interactions in the outpatient elderly population. Using electronic communication allows pharmacists to provide meaningful interventions for numerous patients receiving care in a high-volume family medicine clinic setting. DISCLOSURES: There was no funding or sponsorship for this study. Rowe reports personal fees from The Medicines Company, outside the submitted work. The other authors have nothing to disclose. Study concept and design were contributed by Jeter, Chamberlin, and Weddle, with assistance from Rowe and Franks. Weddle and Renwick collected the data, and data interpretation was performed by Weddle and Rowe, with assistance from Franks. The manuscript was written by Weddle and Rowe and revised by Weddle and Franks, assisted by Chamberlin. The abstract for the completed study was presented at the American College of Clinical Pharmacy Global Conference, San Francisco, California, October 2015, and the Southeastern Residency Conference, Athens, Georgia, April 2015 (platform presentation). The research-in-progress abstract was presented at the Tennessee Society of Health System Pharmacists, Nashville, Tennessee, February 2015; the American Society of Health System Pharmacists Midyear Clinical Meeting, Anaheim, California, December 2014; and the University HealthSystem Consortium Pharmacy Council, Anaheim, California, December 2014.

Comparison of answer-until-correct and full-credit assessments in a team-based learning course.

OBJECTIVE: To assess the impact of awarding partial credit to team assessments on team performance and on quality of team interactions using an answer-until-correct method compared to traditional methods of grading (multiple-choice, full-credit). METHODS: Subjects were students from 3 different offerings of an ambulatory care elective course, taught using team-based learning. The control group (full-credit) consisted of those enrolled in the course when traditional methods of assessment were used (2 course offerings). The intervention group consisted of those enrolled in the course when answer-until-correct method was used for team assessments (1 course offering). Study outcomes included student performance on individual and team readiness assurance tests (iRATs and tRATs), individual and team final examinations, and student assessment of quality of team interactions using the Team Performance Scale. RESULTS: Eighty-four students enrolled in the courses were included in the analysis (full-credit, n=54; answer-until-correct, n=30). Students who used traditional methods of assessment performed better on iRATs (full-credit mean 88.7 (5.9), answer-until-correct mean 82.8 (10.7), p<0.001). Students who used answer-until-correct method of assessment performed better on the team final examination (full-credit mean 45.8 (1.5), answer-until-correct 47.8 (1.4), p<0.001). There was no significant difference in performance on tRATs and the individual final examination. Students who used the answer-until-correct method had higher quality of team interaction ratings (full-credit 97.1 (9.1), answer-until-correct 103.0 (7.8), p=0.004). CONCLUSION: Answer-until-correct assessment method compared to traditional, full-credit methods resulted in significantly lower scores for iRATs, similar scores on tRATs and individual final examinations, improved scores on team final examinations, and improved perceptions of the quality of team interactions.

Comparison of Patients Receiving Long-Term Metformin Therapy and Vitamin B12 Monitoring.

Background: Metformin may cause vitamin B12 deficiency that can present with symptoms of peripheral neuropathy. Lack of vitamin B12 serum concentration monitoring could result in vitamin B12 deficiency progression, worsening of symptoms, and unnecessary medication. Objectives: The purpose of this study was to (a) compare the influence of the rate of symptoms consistent with vitamin B12 deficiency on obtaining vitamin B12 serum concentrations in patients using metformin; (b) assess if vitamin B12 serum concentrations were ordered as a routine monitoring parameter. Methods: This retrospective case-control study evaluated patients receiving metformin. Patients in the case group had documented symptoms or diagnosis of peripheral neuropathy or macrocytic anemia, while those in the control group did not. The primary outcome was frequency of vitamin B12 serum concentration assessment. The secondary outcomes included frequency of vitamin B12 serum concentration assessment for patients presenting with symptoms or diagnosis of peripheral neuropathy or macrocytic anemia. Results: Analysis included 355 patients (116 cases, 239 controls). The cases were 5 times more likely to have a serum vitamin B12 serum concentrations drawn versus controls (odds ratio [OR] = 5.83, 95% confidence interval [CI] = 3.47-9.77, P < .001). Patients with a diagnosis of peripheral neuropathy or macrocytic anemia were 4 times more likely to have a serum vitamin B12 concentration drawn than those who did not (peripheral neuropathy: OR = 4.92, 95% CI = 2.95-8.21, P < .001; macrocytic anemia: OR = 5.41, 95% CI = 1.30-20.97, P = .007). Conclusions: Cases were more likely to have vitamin B12 serum concentrations assessed than patients without symptoms. The majority of patients taking metformin did not have routine vitamin B12 serum concentration assessments for medication adverse event monitoring.

Impact of pharmacists' interventions and simvastatin dose restrictions.

BACKGROUND: On June 8, 2011, the United States Food and Drug Administration (FDA) reported safety concerns regarding statin-related myopathies and advised further restrictions on simvastatin dosing. These restrictions reduced the maximum dose for specific patient characteristics, primarily certain concomitant medications. OBJECTIVE: The purpose of this study was to compare the effectiveness of 2 different pharmacist-conducted educational interventions on appropriate simvastatin use in the primary care setting. METHODS: This retrospective cohort analysis was conducted in 2 academic medical center clinics. Patients prescribed simvastatin before June 8, 2011, requiring dosage adjustment based on labeling changes were evaluated for study inclusion. The pharmacists' interventions included: 30-minute didactic session for prescribers or patient-specific recommendation communicated with the physician during the patient's follow-up visit. Primary outcomes were the number of patients prescribed FDA-recommended simvastatin doses after pharmacist intervention and the intervention's impact on low-density lipoprotein (LDL). RESULTS: Medical record review identified 1173 patients prescribed simvastatin prior to June 8, 2011; 126 patients qualified for study inclusion. After controlling for baseline characteristics, the likelihood of patients being prescribed an appropriate dose postintervention increased if they were in the patient-specific recommendation group (odds ratio [OR] = 10.59; 95% CI = 3.43-32.69; P < .0001). LDL change occurred at a similar rate between intervention groups (P = .652). CONCLUSION: Following FDA labeling changes for simvastatin, patient-specific recommendations made by pharmacists correlated with a greater likelihood of appropriate simvastatin dosing compared with a one-time didactic education session. Patient-specific recommendations positively affect prescribing habits and making steps to improve patient safety.

Hospital readmission and emergency department use based on prescribing patterns in patients with severely uncontrolled type 2 diabetes mellitus.

BACKGROUND: Patients with uncontrolled diabetes are more likely to be readmitted to the hospital. The study objective was to determine the risk of hospital admission or emergency department (ED) use in patients with severely uncontrolled type 2 diabetes mellitus based on whether their diabetes medication regimen was intensified at discharge. SUBJECTS AND METHODS: A retrospective cohort study of patients admitted to the medicine services at an academic medical center was conducted during a 9-month period. Medical records were reviewed to identify patients with type 2 diabetes mellitus and hemoglobin A1c >10% who were admitted for more than 24 h. Primary exclusion criteria included pregnancy, age >65 or <18 years, life expectancy of <12 months, hypoglycemia at admission, and new diagnosis of type 2 diabetes. Admission medication lists for patients were compared with discharge medications to determine whether the diabetes regimen was intensified. Patients whose regimen was intensified were then compared with patients whose regimen was not intensified for admissions and ED visits within 3 months after discharge. The primary end point was 90-day all-cause hospital and ED visits. RESULTS: Patients who had their regimens intensified had significantly fewer average all-cause hospital and ED visits at 90 days (0.41 vs. 0.85; P=0.044). Statistical differences were also found in 30-day all-cause visits, readmissions within 90 days, and hospital-free time. CONCLUSIONS: Patients whose home diabetes regimen was intensified at discharge were less likely to return to the hospital within 90 days compared with patients whose regimen was not intensified.

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.

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.

Enhancing team-based active learning through hands-on experience with nicotine replacement therapy.

OBJECTIVES: To enhance tobacco cessation active-learning in an ambulatory care elective course by adding hands-on experience with nicotine replacement therapy to a team-based learning (TBL) session. DESIGN: A hands-on experience that included students chewing a piece of nicotine gum was added to a TBL class session. Student pairs used a skills checklist to evaluate and give peer feedback on appropriate counseling and gum use. ASSESSMENT: Students' scores on a tobacco cessation examination were higher than those of students enrolled in the previous course in which TBL alone had been used. Based on pre- and post-experience survey responses, students' perceptions regarding their abilities to provide tobacco cessation counseling improved. Subjective student comments regarding the experience were positive. CONCLUSION: Participating in a TBL session that incorporated hands-on experience with nicotine gum in an ambulatory care elective course increased students' confidence in their ability to provide tobacco cessation counseling and provided a unique perspective on the product's characteristics.

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.

Clinical utility of the chronic obstructive pulmonary disease knowledge questionnaire.

BACKGROUND AND OBJECTIVES: Although typically symptomatic, chronic obstructive pulmonary disease (COPD) is undertreated as compared to many asymptomatic conditions such as hypertension. Unfortunately, many patients lack basic information about their major disease states, including COPD. The purpose of this study was to assess the clinical utility of the valid and reliable COPD Questionnaire (COPD-Q) in a sample of underserved patients carrying a diagnosis of COPD. METHODS: This prospective, descriptive study enrolled COPD patients at a family medicine residency teaching clinic. Patients were administered a telephone survey assessing COPD knowledge, demographic data, and health literacy. Data regarding COPD clinical outcomes were gathered through the electronic medical record. RESULTS: Average total COPD-Q score was 7.6 plus or minus 2.1 (total possible score=13). Total COPD-Q scores were significantly related to health literacy and educational attainment. CONCLUSIONS: The COPD-Q is a valid, reliable tool used to assess COPD knowledge in a setting that includes patients with limited health literacy. It is useful in identifying key knowledge deficits that will allow the clinician to offer focused, individualized patient education and counseling.

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/m(2). 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).