Ixekizumab: A Review of Its Use for the Management of Moderate to Severe Plaque Psoriasis.

OBJECTIVE: To review the efficacy, safety, and place in therapy of ixekizumab for the treatment of moderate to severe plaque psoriasis. DATA SOURCES: PubMed (1966 to July 2018) and clinicaltrials.gov were searched using the terms ixekizumab, LY2439821, interleukin-17, and psoriasis. STUDY SELECTION AND DATA EXTRACTION: Human studies published in peer-reviewed medical journals in English were used. DATA SYNTHESIS: The efficacy and safety of ixekizumab has been primarily reported by 4 phase III trials (UNCOVER-1, UNCOVER-2, UNCOVER-3, and UNCOVER-J) and multiple post hoc analyses. The average proportions of patients achieving a 75%, 90%, and 100% reduction in their Psoriasis Area and Severity Index (PASI) were 89%, 70%, and 38%, respectively, after 12 weeks of therapy. PASI75 was maintained for up to 3 years in 80.5% of participants. Ixekizumab was statistically significantly more effective than ustekinumab, with 76.5%, compared with 59%, of patients achieving PASI90 in 52 weeks. The most common adverse events include nasopharyngitis (14.1%), upper respiratory tract infections (7.9%), and injection-site reactions (6.8%), which are similar to that for other biological agents. The risk of inflammatory bowel disease may be increased with ixekizumab. Relevance to Patient Care and Clinical Practice: This review summarizes and evaluates clinical data regarding the efficacy and safety of ixekizumab and discusses relevant differences compared with other biological agents used for the management of chronic plaque psoriasis. CONCLUSIONS: Ixekizumab is a highly efficacious and well-tolerated treatment option for patients with moderate to severe plaque psoriasis.

Memantine for the prevention of primary headache disorders.

OBJECTIVE: To describe the current data evaluating the efficacy and safety of memantine for the prevention of primary headache disorders. DATA SOURCES: A literature search using MEDLINE (1966-July 2014) and EMBASE (1973-July 2014) was conducted using the search terms memantine, headache, migraine, glutamate, and NMDA. References of identified articles were reviewed for additional, relevant citations. STUDY SELECTION AND DATA EXTRACTION: All English-language articles dealing with the use of memantine for prevention of primary headache disorders were included. DATA SYNTHESIS: Data from several retrospective reports and 2 prospective clinical trials suggest that memantine may be a useful treatment option for the prevention of primary headache disorders. The majority of available literature focuses specifically on chronic migraine prevention in refractory patients who had failed multiple previous prophylactic therapies. In these patients, 10 to 20 mg of memantine daily reduced the frequency and intensity of migraine headaches and was generally well tolerated, with few adverse events. Data regarding the efficacy of memantine for other primary headache disorders such as chronic tension type and cluster headaches are limited. CONCLUSION: Although further studies evaluating the efficacy of memantine for prevention of primary headache disorders are warranted, memantine may be a reasonable option, used either as monotherapy or adjunctive therapy, in the refractory chronic migraine prophylaxis setting.

Graduating student pharmacists' perspectives on e-professionalism and social media: qualitative findings.

OBJECTIVE To characterize students' views and opinions of professionalism on popular social media sites and compare responses about social media behavior among students in different groups. DESIGN Cross-sectional survey. SETTING Four colleges of pharmacy in midwestern United States. PARTICIPANTS 516 graduating student pharmacists. INTERVENTIONS Online survey with open-ended questions. MAIN OUTCOME MEASURES Qualitative analysis of responses and themes. RESULTS A total of 212 student pharmacists completed surveys (41% response rate). Mean (± SD) age was 25.2 ± 4.6 years, and 72% of respondents were women. Major overarching themes identified in the qualitative analysis were separation of personal and professional lives, how accountability for actions should vary by severity, and the extent of representation of the students' character on social media. CONCLUSION Identified themes provided important insights into the ways in which student pharmacists view social media and use this widely accessible means of personal communication.

Pharmacist perception and use of UpToDate®.

A cross-sectional survey of a convenience sample of 1,199 pharmacists was conducted to describe pharmacists' use and perception of UpToDate®. Of 472 (39%) respondents, 217 (46%) reported using UpToDate. Most respondents who used or had heard of UpToDate indicated willingness to change a treatment plan based on UpToDate recommendations (77%). Many believed that UpToDate is updated weekly (31%) or monthly (49%) and that all articles undergo external peer review (51%). In conclusion, the majority of respondents reported that they would adjust drug therapy based on UpToDate recommendations; however, many pharmacists may hold misconceptions regarding the updating and peer-review processes.

Development and Assessment of a Rubric for Evaluating Teaching Portfolios Developed by Teaching and Learning Curriculum (TLC) Program Participants.

OBJECTIVE: To describe the validation and reliability assessment of a rubric designed to assess the participants' teaching portfolios and identify teaching excellence among teaching and learning curriculum (TLC) program participants. METHODS: Following focus groups with program leadership at a single TLC program, an initial rubric was developed, consisting of criteria mapped to 5 domains, to be rated on a 4-point scale. The rubric was then redistributed to the TLC program leadership and external stakeholders for evaluation of face and content validity. The rubric was piloted using teaching portfolios from 3 cycles of the program. Cronbach αwas used to measure internal consistency and a 2-way random-effects model was used to assess the inter-rater reliability. RESULTS: A total of 18 portfolios were independently evaluated by 4 raters. The overall mean Cronbach α for internal consistency was 0.90 and ranged from 0.65 to 0.84 by domain. The overall mean intraclass correlation coefficient for inter-rater reliability was 0.95 and ranged from 0.57 to 0.91 by domain. CONCLUSION: The rubric evaluates characteristics of teaching portfolios important to internal and external stakeholders and had good to excellent internal consistency and inter-rater reliability. It can be adapted and applied by TLC programs to identify teaching excellence.

Concomitant use of ipratropium and tiotropium in chronic obstructive pulmonary disease.

OBJECTIVE: To describe the current data evaluating the efficacy and safety of ipratropium used in combination with tiotropium in patients with chronic obstructive pulmonary disease. DATA SOURCES: A literature search using MEDLINE (1966-August 2012) and EMBASE (1973-August 2012) was conducted using the search terms ipratropium, tiotropium, combination drug therapy, and chronic obstructive pulmonary disease. References of identified articles were reviewed for additional relevant citations. STUDY SELECTION AND DATA EXTRACTION: All English-language articles regarding the concomitant use of ipratropium and tiotropium were reviewed. DATA SYNTHESIS: Two prospective randomized controlled trials have demonstrated increases in bronchodilation with ipratropium when added to maintenance tiotropium therapy, suggesting potential benefits during short-term, combined use. One study reported significantly higher peak forced expiratory volume in 1 second (FEV(1)) responses with both ipratropium (230 mL) and fenoterol (315 mL) compared to placebo (178 mL) when added to maintenance tiotropium. The peak response with fenoterol was significantly higher than with ipratropium (FEV(1) difference = 84 mL). Another study reported a mean difference in FEV(1) of 81 mL (95% CI 27 to 136) with albuterol versus placebo and a mean difference in FEV(1) of 68 mL (95% CI 3 to 132) with ipratropium versus placebo. The difference between albuterol and ipratropium when added to maintenance tiotropium was not significant. One large observational study reported a significantly higher risk of acute urinary retention in individuals receiving combination therapy with a short- and long-acting anticholinergic agent compared to those receiving monotherapy (OR 1.84; 95% CI 1.25 to 2.71). Individuals at highest risk were men and those with evidence of benign prostatic hypertrophy. CONCLUSIONS: While ipratropium may provide spirometric improvements in lung function for patients receiving tiotropium maintenance therapy, the clinical significance of these improvements has not been documented and the risk of anticholinergic adverse effects is increased with combination therapy. Further studies evaluating the safety and efficacy of concomitant ipratropium and tiotropium are warranted before combination use can be recommended for select patients.

Factors associated with reported preventable adverse drug events: a retrospective, case-control study.

BACKGROUND: It has been reported that error occurs at some point during the medication use process in approximately 6% of medication doses administered in the inpatient setting. An estimated 1-10% of medication errors lead to patient harm; however, factors affecting the risk of harm from a medication error are undefined in the literature. OBJECTIVE: To identify independent factors affecting the risk of reported preventable adverse drug events (ADEs) (ie, medication errors contributing to patient harm) compared to medication errors that did not contribute to patient harm in a diverse patient population. METHODS: This was a retrospective, case-control study conducted at 3 hospitals within a large health system. Medication error reports from July 1, 2009, through June 30, 2010, were assessed. All reported medication errors determined to have contributed to patient harm were matched 1:1 with a medication error that did not contribute to harm. Data collected through review of the incident report and medical record included patient, provider, medication, and other related factors. Multivariable logistic regression was used to determine the relationship of potential factors to patient harm. RESULTS: Of 4321 medication errors reported at study sites, 182 (4%) contributed to patient harm. Factors associated with increased independent risk of harm were 30-day readmission, time of day 0300-0659, and Institute for Safe Medication Practices (ISMP) high-alert medications. Factors associated with decreased independent risk of harm were multiple medication errors, occurrence during February or April, dispensing errors, and pharmacist review of medication order. CONCLUSIONS: Health systems should develop programs to promote safe, conscientious use of ISMP high-alert medications, promote pharmacist review, control the use of cabinet overrides, and direct provider attention toward recently admitted patients. Efforts should be made to determine factors associated with risk of harm at local levels.

Nitroglycerin ointment for the prevention of postmenopausal osteoporosis.

OBJECTIVE: To determine whether clinical trial data support the use of nitroglycerin for prevention of postmenopausal osteoporosis. DATA SOURCES: A literature search using MEDLINE (1966-September 2011) and EMBASE (1973-September 2011) was conducted using the search terms nitroglycerin, bone mineral density, fracture, and osteoporosis. References of identified articles were reviewed for additional citations. STUDY SELECTION AND DATA EXTRACTION: All English-language articles related to the use of nitroglycerin ointment in postmenopausal women were reviewed. DATA SYNTHESIS: Four observational studies reported significant improvements in bone mineral density of postmenopausal women with the use of nitrates. One pilot study and 2 prospective, randomized, placebo-controlled clinical trials reported conflicting results regarding the efficacy of nitroglycerin ointment. CONCLUSIONS: Clinical data do not support use of nitroglycerin for this indication; its potential is limited at this time by inconclusive efficacy and a high incidence of headache. Further well-designed clinical trials demonstrating efficacy and safety of nitroglycerin ointment for prevention of postmenopausal osteoporosis are needed before this medication can be recommended for routine use.

Pharmacy students' intrinsic motivation to participate in electronic peer review of journal article critique assignments.

BACKGROUND AND PURPOSE: Journal article critiques are frequently used to teach literature evaluation to pharmacy students. Peer review is one method to improve students' competency regarding journal article critiques. The objective of this manuscript is to describe implementation of electronic peer review of journal article critique drafts and explore students' intrinsic motivation to participate in the peer-review process. Influence of students' motivation to participate in peer review on their self-competence regarding journal article critiques was also explored. EDUCATIONAL ACTIVITY AND SETTING: Second-year pharmacy students participated in three in-class, electronic, anonymous peer-review sessions for written journal article critique drafts. Students were invited to complete a 16-item survey instrument based on self-determination theory. Modified Intrinsic Motivation Inventory and Perceived Competence Scales assessed student interest in and perceived value of the peer-review sessions and their self-competence regarding journal article critiques. FINDINGS: The survey response rate was 99% (146/148). Based on a Likert scale of 1 (not at all true) to 7 (very true), students demonstrated moderate interest in the peer-review sessions (M = 3.86), viewed them as valuable (M = 5.25), and had a moderate level of self-competence regarding journal article critiques (M = 3.74). Additionally, interest and perceived value of the peer-review sessions significantly influenced self-competence in completing journal article critiques. SUMMARY: An anonymous, electronic peer-review system provides an efficient method for in-class peer review of draft assignments. Implementing strategies to increase student interest in peer review may increase their motivation for participation and ultimately improve self-competence regarding literature evaluation.

Reporting quality of survey research articles published in the pharmacy literature.

BACKGROUND: Survey research methodology is commonly used in the pharmacy literature and standards have been set forth for quality reporting. A systematic review to assess the reporting quality of survey research has only been completed for general medical literature. OBJECTIVES: The objective of this study is to examine the quality of survey research reporting published in the pharmacy literature and identify reporting areas researchers can focus on for increased transparency in survey research methodology. METHODS: A cross-sectional study of survey research articles published in seven key pharmacy journals in 2016 was conducted using a published 30-item checklist instrument designed for the reporting quality surveys. Each article was evaluated by two independent study investigators and assigned a final score out of 30. RESULTS: Out of 197 articles assessed for eligibility, 105 (53%) used survey research as the primary methodology and were included in the study. The average reporting score was 18.2±3.0 (range 10-25) out of 30, with the highest average scores reported for PharmacoEconomics (22.5), JMCP (20.4) and RSAP (19.8). Checklist items related to the quality of reporting survey research methodology with the highest compliance included: original reference cited for use of existing tools (100%), description of survey population and sample frame (90%); and reporting response rate (90%). Checklist items with low reporting included: psychometric properties for existing tools (14%); reliability and validity for new instruments (11%); analysis of nonresponse bias (8%); definition of complete versus partial responses (8%); methods of handling missing data (19%); and information about how non-respondents differ from respondents (14%). CONCLUSIONS: Survey research published in the pharmacy literature scored moderately on a published instrument designed for systematic appraisal of survey research reporting quality. Several areas for continued improvement exist for survey research reporting quality in the pharmacy literature.

The Current Landscape of College-Sponsored Postgraduate Teaching and Learning Curriculum Programs.

Objective. To describe the landscape of teaching and learning curriculum (TLC) programs sponsored by US schools and colleges of pharmacy and evaluate their adoption of best practice recommendations. Methods. A 28-item electronic survey instrument was developed based on best practice recommendations published by the American Association of Colleges of Pharmacy (AACP), American Society of Health-System Pharmacists (ASHP), and American College of Clinical Pharmacy (ACCP) for the conduct of TLC programs. The survey instrument was electronically distributed to 137 accredited colleges and schools of pharmacy in the United States. Results. Eighty-eight institutions responded, resulting in a response rate of 64%. Sixty-one TLC programs were included in the final analysis. Seventy-five percent of TLC programs reported using best practice recommendations; however, 10% of respondents indicated they were not aware of the published recommendations. Inconsistencies among programs were noted in required teaching experiences, participant evaluation, and ongoing programmatic assessment. Conclusion. Most institutions offering TLC programs are aware of published best practice guidelines and have adopted a majority of the published best practices. However, considerable variability exists across the country. Development of a formal external validation process for TLC programs is necessary to ensure consistent quality.

Selecting an appropriate medication for treating neuropathic pain in patients with diabetes: a study using the U.K. and Germany Mediplus databases.

OBJECTIVE: To evaluate the appropriateness of prescribing select neuropathic pain medications to diabetes patients based on the potential for drug-drug interactions with medications diabetes patients were prescribed continuously for > or =3 months (chronic use). METHODS: Medical records of patients with a diagnosis of diabetes or use of antidiabetic medications between January 1, 2002 and September 30, 2005 in the U.K. and Germany Mediplus databases were obtained. PATIENTS: Medication use profiles were evaluated between April 2004 and September 2005. The metabolic pathways associated with medications that were prescribed chronically to at least 10% of study patients were compared with the metabolic pathways of neuropathic pain medications to identify potential drug-drug interactions. RESULTS: A total of 40,448 patients in the U.K. (63.6 +/- 16.6 years, 51% male) and 31,930 patients in Germany (68.9 +/- 12.7 years, 46% male) were identified. Frequently prescribed medications in the U.K. included aspirin (33.7%), metformin (32.7%), simvastatin (25.5%), atorvastatin (19.4%), atenolol (18.1%), and in Germany hydrochlorothiazide (35.8%), aspirin (25.2%), metformin (21.6%), metoprolol (20.3%), and simvastatin (18.3%). Several neuropathic pain medications have potential for drug-drug interactions with medications prescribed to diabetes patients. Examples include (neuropathic pain medications vs. diabetes medications): duloxetine, paroxetine, and methadone (CYP2D6 inhibitors) and oxycodone HCL, hydrocodone (CYP2D6 substrates) vs. metoprolol and bisoprolol (CYP2D6 substrates); and carbamazepine (CYP3A4 inducer) vs. simvastatin, and atorvastatin (CYP3A4 substrates). CONCLUSIONS/INTERPRETATION: Our findings underscore the need for medical vigilance when selecting medications for treating neuropathic pain in diabetes patients.

Prazosin treatment of nightmares related to posttraumatic stress disorder.

OBJECTIVE: To describe current data evaluating the use of prazosin in adults with posttraumatic stress disorder (PTSD) who are experiencing nightmares. DATA SOURCES: A literature search using MEDLINE (1966-March 2007) and the Published International Literature on Traumatic Stress database (1982-March 2007) was conducted using the search terms alpha-antagonist, alpha-blocker, prazosin, and posttraumatic stress disorder. References of identified articles were reviewed for additional citations. STUDY SELECTION AND DATA EXTRACTION: All English-language articles regarding the use of prazosin in adults with nightmares related to PTSD were reviewed. DATA SYNTHESIS: PTSD is a psychiatric disorder that develops in some people after exposure to trauma. Sleep disturbances occur in up to 70% of patients with PTSD. Several neurotransmitters have been implicated in the pathophysiology of sleep disturbances in PTSD. Adrenergic agents that inhibit norepinephrine, such as prazosin, may decrease the arousal produced by norepinephrine in response to a stressor. Four open-label studies, 1 retrospective chart review, and 2 placebo-controlled trials reporting the use of prazosin for nightmares related to PTSD were reviewed. All studies included a small number of patients (4-59) and evaluated prazosin dosages ranging from 1 to 20 mg/day. Despite various limitations, all of the studies showed significant improvements in the sleep-related symptoms of PTSD following the addition of prazosin therapy, based on the Clinician Administered PTSD Scale recurrent distressing dreams item and the Clinical Global Impression of Change scale. CONCLUSIONS: Prazosin appears to be a promising and fairly well tolerated agent for the management of PTSD-related nightmares and sleep disturbances. Further well designed trials are warranted to establish its place in therapy.

Evidence-based review of the black-box warning for droperidol.

PURPOSE: Data collected from the Food and Drug Administration (FDA) under the Freedom of Information Act are presented to help clinicians understand the data prompting the black-box warning for droperidol and to make educated decisions regarding the use of droperidol and alternative agents. SUMMARY: A written request was submitted to FDA to provide a report of any and all reports of cardiovascular adverse events related to droperidol that were part of the decision to add a black-box warning to the label of droperidol. The report listed 277 cases of adverse effects associated with droperidol since its introduction to the market in 1970. Many of the reports were duplicates, leaving a total of 65 individual cases. Of these cases, only 2 described adverse effects possibly caused by droperidol in dosages commonly used in the United States. In addition to these reports, the results of two European studies prompted FDA to make the decision for the black-box warning. Both studies used droperidol doses 50-100 times higher than those used in the United States. CONCLUSION: Studies show that there is a dose-dependent increase in the rate of adverse cardiovascular events when droperidol is used either alone or in combination with other medications that cause Q-T interval prolongation. At this time, there does not appear to be significant evidence to suggest that serotonin type 3-receptor (5-HT(3)) antagonists are safer than droperidol with regard to Q-T interval prolongation. More studies are needed to determine the safety and efficacy of droperidol when used in doses of 0.625-1.25 mg compared with the 5-HT(3) antagonists.

Student perceptions of digital badges in a drug information and literature evaluation course.

BACKGROUND AND PURPOSE: The purpose of this article is to describe student perceptions of implementation of digital badges in a drug information and literature evaluation course. EDUCATIONAL ACTIVITY AND SETTING: Two digital badges were developed as voluntary learning opportunities. Student perceptions were obtained through pre- and post-survey instruments consisting of selected questions from the Motivated Strategies for Learning Questionnaire. FINDINGS: The response rate was 69% (106/153). At baseline, 53% of respondents agreed that digital badges could help them better understand course material. More students agreed they would share earned digital badges on LinkedIn (68%) than Facebook (19%). Most students who earned digital badges agreed that badges helped increase their confidence in course material (73%), focus on specific learning objectives (55%), look deeper into course competencies (64%), and were a useful adjunct to the traditional teaching method (82%). DISCUSSION AND SUMMARY: Digital badges were perceived by students as a positive adjunct to learning and may provide a novel mechanism for development of an electronic skills-based portfolio.

Teaching Certificate Program Participants' Perceptions of Mentor-Mentee Relationships.

Objective. To assess teaching certificate program (TCP) participants' perceptions of mentor-mentee relationships. Methods. A 15-item survey instrument was administered to all 2014-2015 participants of the Indiana Pharmacy Teaching Certificate (IPTeC) program. Results. One hundred percent of IPTeC program participants (83/83) responded to the survey. The majority of participants indicated that having a professional mentor was either very important (52%) or important (47%) to their professional development and preferred to choose their own professional mentor (53%). Mentor characteristics rated as highly important by mentees included having similar clinical practice interests (82%), having similar research interests (66%), and being available to meet face-to-face (90%). Age, race, and gender of the mentor were not rated by mentees as important. Conclusion. Teaching certificate program participants place high importance on having a professional mentor. Mentorship of pharmacists completing TCPs should be a priority for current pharmacy faculty members so adequate guidance is available to future pharmacy educators.

Redesign of a statewide teaching certificate program for pharmacy residents.

OBJECTIVES: To identify and assess changes made to the Indiana Pharmacy Resident Teaching Certificate program over 10 years to adapt to the growing number and changing needs of pharmacy educators in the next generation. DESIGN: In 2011, all resident program participants and directors were sent an electronic survey instrument designed to assess the perceived value of each program component. ASSESSMENT: Since 2003, the number of program participants has tripled, and the program has expanded to include additional core requirements and continuing education. Participants generally agreed that the speakers, seminar topics, seminar video recordings, and seminar offerings during the fall semester were program strengths. The program redesign included availability of online registration; a 2-day conference format; retention of those seminars perceived to be most important, according to survey results; implementation of a registration fee; electronic teaching portfolio submission; and establishment of teaching mentors. CONCLUSION: With the growing number of residents and residency programs, pharmacy teaching certificate programs must accommodate more participants while continuing to provide quality instruction, faculty mentorship, and opportunities for classroom presentations and student precepting. The Indiana Pharmacy Resident Teaching Certificate program has successfully evolved over the last 10 years to meet these challenges by implementing successful programmatic changes in response to residency program director and past program participant feedback.