Women Versus Men: Is There Equal Benefit and Safety from Statins?

Coronary heart disease (CHD) is the leading cause of death in the United States. CHD risk differs between genders, with coronary events lagging behind ten years for women in comparison to men. Low-density lipoprotein cholesterol lowering with statin therapy is a major target for cardiovascular risk reduction. The benefit of statin therapy has been well established in men, for both primary and secondary prevention. However, the same has not been shown for women. While studies have demonstrated benefit in women for secondary prevention, their role in primary prevention of cardiovascular disease remains controversial. Data released over the past several years regarding statin efficacy and safety in men and women has been inconsistent, given that these studies had small sample sizes with numerous study limitations. A recent large scale meta-analysis of both primary and secondary statin prevention trials with sex-specific outcomes demonstrated a similar benefit in both men and women. Statins demonstrated a decrease in cardiovascular events and all-cause mortality in both sexes. In regards to statin safety, additional trials investigating the difference in adverse events of statins in men versus women, particularly new onset of diabetes, myalgias, and liver dysfunction, are warranted. Increased awareness and monitoring of female patients for myalgias and hyperglycemia should be considered as a precaution. Overall, women need to be better represented in prospective clinical trials powered to evaluate gender-specific differences in statin safety and efficacy in the management of cardiovascular disease.

The Influence of Intersectionality on Professional Identity Formation among Underrepresented Pharmacy Students.

OBJECTIVE: The objective of this study is to explore professional identity formation (PIF) among student pharmacists from underrepresented groups (URGs). METHODS: In this qualitative study, 15 student pharmacists from the University of Georgia and Midwestern University Colleges of Pharmacy were recruited for interviews to explore the influence of intersectionality of race, ethnicity, and gender on PIF. Interview data were analyzed using constructivist grounded theory to identify themes and then further analyzed using Crenshaw's theory of intersectionality, namely structural, political, and representational intersectionality. RESULTS: Intersectionality of identities created situations where participants expressed advantages belonging to certain social categories, while simultaneously being disadvantaged belonging to other social categories. This awareness led to strategies to overcome these collective obstacles for themselves and their communities. Participants then described ways to shift perceptions of how society depicts pharmacists and the pharmacy profession. The results depict these processes and how intersectionality influences PIF for URG student pharmacists. CONCLUSION: The sociocultural aspects of race, ethnicity, and gender influence the PIF of student pharmacists who belong to URGs. Intersectionality helps us better understand the ways in which inequality compounds itself, and this results in URG student pharmacists creating opportunities for belongingness and representation. Resultantly, URGs create opportunities for inclusivity and representation. To continue to facilitate this it is essential for educators and university systems to promote ways to foster and incorporate PIF in student pharmacists.

Implementation of a Student Pharmacist-Led Program to Enhance Health Access in an Arab-American Community Head: Health Program in an Arab-American Community.

Objectives: Immigration of Arabs to the United States has increased in recent years due to political instability and need for improved access to healthcare. Cardiovascular disease, diabetes, and obesity disproportionally affect Arab Americans. Student pharmacists are well positioned to increase health awareness by providing health screening services and education classes to the Arab immigrant community. This report will describe the development of a student-run Arab American Health Awareness Program (AAHAP) that provides culturally-sensitive community screening services targeting common health disparities seen among Arab-Americans. Design: Data were collected on the number of patient cardiometabolic screenings, referrals for medical care, and health classes which were performed over the course of 2 years. The practice setting included community centers, faith-based centers, and grocery stores in the Chicago area participating in the AAHAP. Results: Over the course of two years, eight cardiometabolic screenings and four community health classes were provided to the Arab-American community. Over 100 student pharmacists provided screenings to 929 patients through AAHAP. Twenty percent (n=193) of all patients screened were referred for further medical care. A total of 77% patients were within goal for blood pressure, 82.3% for blood glucose, and 39.4% for BMI. Patients with a known history of hypertension (n=83) or diabetes (n=64) were more likely to have uncontrolled blood pressure (45% vs 11%, p<0.05) or blood glucose (39% vs 14%, p<0.05) compared to patients without a history of these chronic conditions. Conclusion: Student pharmacists can be drivers for health access through community health programs for ethnically minoritized populations. Development of a health awareness program focused on known health disparities in Arab Americans has provided student pharmacists with opportunities to deliver culturally-sensitive care and medical referral services to an underserved community.

Taking Action Towards Equity, Diversity, and Inclusion in the Pharmacy Curriculum and Continuing Professional Development.

Increased awareness of social injustices and inequities highlight the relevance and importance of diversity, equity, inclusion, and accessibility (DEIA) in health care. Former and recent graduates of pharmacy schools remain deficient in their knowledge of DEIA topics such as unconscious bias, which can directly influence health outcomes in an undesirable manner. Particular DEIA areas that are pertinent to pharmacy practice include: race, gender, sexual orientation, gender identity, ability status, religion, socioeconomic status, and political beliefs. The American Association of Colleges of Pharmacy (AACP) affirmed its commitment to DEIA as a priority. However, existing gaps in knowledge of pharmacy graduates in this area have the potential to contribute to health disparities and inequities, which are significant public health issues. We call on academic pharmacy institutions and professional pharmacy organizations to elevate DEIA topics and to designate them as essential to both addressing health equity and improving care for underserved populations. We also implore licensing boards to require continuing education related to DEIA as a foundational step to closing the knowledge gap for pharmacists in this area.

Student Stress Management and Wellness Programs among Colleges of Pharmacy.

OBJECTIVE: To describe the programmatic stress-related interventions that colleges of pharmacy are providing for their students. METHODS: A paper-based questionnaire was distributed to 80 college teams who attended two consecutive offerings of the American Association of Colleges of Pharmacy institute focused on promoting student well-being. The five-part questionnaire consisted of: 1) tracking and assessment of perceived student stress levels, 2) the types and formats of stress-coping interventions that are offered, 3) the measured impacts of any stress-coping interventions, 4) the level of faculty/staff training and involvement in student stress remediation, and 5) institutional demographics. RESULTS: Of the 40 college teams responding to the survey there were similar numbers of private (44%) and public (56%) institutions. More than half (57.5%) reported measuring student stress levels. The most common interventions offered were counseling (95%), academic advising (82%), physical exercise support (77%), and relationship building activities (70%). Topics offered in the curriculum were most often related to handling substance abuse (50%), time-management (45%), and finances (40%). A majority (79.5%) of schools reported they do not offer formal training on student stress and mental health to faculty and staff and do not formally assess the impact of stress and coping interventions. CONCLUSION: Colleges of pharmacy are addressing student stress and well-being, yet variability exists in terms of assessment, interventions, and didactic offerings. Multiple barriers to improvement remain and mediating barriers and determining assessments for coping and interventions may be next steps for Colleges of Pharmacy.

Treatment of systolic heart failure in the elderly: an evidence-based review.

OBJECTIVE: To review relevant literature supporting the use of ß-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), diuretics, digoxin, aldosterone antagonists, and vasodilators in the management of heart failure in an elderly patient population aged ≥65 years. DATA SOURCES: PubMed, EMBASE, and MEDLINE searches (January 1960-April 2010) were utilized to identify primary literature using the key terms heart failure, treatment, and elderly. Additionally, reference citations from publications identified were utilized, as well as the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines for the Diagnosis and Management of Chronic Heart Failure in the Adult. STUDY SELECTION AND DATA EXTRACTION: Primary and tertiary literature, including subgroup analyses, published in English and relating to the use of pharmacotherapy in the treatment of systolic heart failure in the elderly was reviewed. DATA SYNTHESIS: The aging of the US population is creating a higher prevalence of systolic heart failure in the elderly. Most clinical trials have established the mortality and morbidity benefit of pharmacotherapy in heart failure in nonelderly patients; however, the current ACC/AHA guidelines do not clearly delineate this benefit in persons ≥65 years of age. CONCLUSIONS: Clinical trial data, based on limited numbers of individuals aged ≥65 years, suggest that use of ß-blockers, ACE inhibitors, ARBs, aldosterone antagonists, and vasodilators (hydralazine/nitrates) have similar mortality benefit to that observed in younger patients. As supported in the ACC/AHA guidelines, these agents should be prescribed with clinical judgment to all elderly patients, with close monitoring for adverse events. Future clinical trials with greater inclusion of patients ≥65 years will help to elucidate the magnitude of benefits of optimal pharmacotherapy on mortality and morbidity rates in this population.

Aspirin dosing for the prevention and treatment of ischemic stroke: an indication-specific review of the literature.

OBJECTIVE: To evaluate the efficacy of aspirin for the treatment and prevention of ischemic stroke and identify the minimum dose proven to be effective for each indication. DATA SOURCES: PubMed and MEDLINE searches (up to January 2010) were performed to identify primary literature, using search terms including aspirin, stroke prevention, acute ischemic stroke, acetylsalicylic acid, atrial fibrillation, myocardial infarction, and carotid endarterectomy. Additionally, reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: Articles published in English were evaluated and relevant primary literature evaluating the efficacy of aspirin in the prevention of stroke was included in this review. DATA SYNTHESIS: Antiplatelet therapy is the benchmark for the prevention of ischemic stroke. Aspirin has been proven to prevent ischemic stroke in a variety of settings. Despite the frequency at which aspirin continues to be prescribed in patients at risk of ischemic stroke, there remains confusion in clinical practice as to what minimum dose is required in various at-risk patients. A thorough review of the primary literature suggests that low-dose (50-81 mg daily) aspirin is insufficient for some indications. Acute ischemic stroke treatment requires 160-325 mg, while atrial fibrillation and carotid arterial disease require daily doses of 325 and 81-325 mg, respectively. CONCLUSIONS: Available evidence suggests that aspirin dosing must be individualized according to indication. Recommendations provided by national guidelines at times recommend lower doses of aspirin than have been proven effective. Higher doses are indicated for stroke prevention in atrial fibrillation (325 mg) and acute ischemic stroke patients (160-325 mg). Aspirin has not yet been proven effective for primary prevention of strokes in men, and a minimum dose for these patients cannot be determined from the available data.

Barriers to Implementing an Insulin Order Form In a Non-ICU Medical Unit.

OBJECTIVE: We sought to evaluate barriers to the implementation of a standardized subcutaneous (SQ) insulin order form in a non-ICU medical unit. RESEARCH DESIGN AND METHODS: An insulin task force comprising physicians, nurses, dietitians, and pharmacists developed and implemented an SQ insulin order form in a community-based teaching hospital. A prospective observational study was conducted to identify difficulties in adopting the form and to delineate requirements for staff education. The main outcome measure was utilization of the form. RESULTS: The development of a standardized SQ insulin order set for the medical inpatient unit was intended to include a more physiological approach to the control of hyperglycemia. During an eight-week pilot period, only 9% of physician orders included basal, bolus, and correctional-dose (BBC) components of the order form. Because of a limited patient size and low utilization of the order form, it is difficult to determine whether use of the form succeeded in decreasing the occurrence of hyperglycemia. Experience gained from the initial implementation indicates that teaching personnel how to use the form and how to combine long-acting and short-acting insulins to prevent or control hyperglycemia are necessary for the form to gain acceptance. CONCLUSION: The extent to which the medical staff used the SQ insulin order form was modest. Clinician acceptance and education about hyperglycemia early on are essential for the successful adoption of a standardized tool into clinical practice.

Promoting cultural sensitivity with the ethical and professional use of social media during global pharmacy experiences.

INTRODUCTION: While the use of social media and blogging is an attractive and rapidly growing method to disseminate student reflections and information, the use of digital online methods of learning also require professional and ethical accountability. This commentary describes two approaches to using a checklist to promote the culturally sensitive, professional, and ethical use of social media platforms when students are expected to share their global pharmacy experiential experiences. COMMENTARY: Social media sites and online blogs have the potential to enhance student experiences and promote intercultural competence of participants due to their ease of use and familiarity. If social media applications are used by students as a means of gaining self-awareness of cultural differences or promotion of cultural knowledge and attitudes, a framework for how to approach this process methodically should be employed by educators. E-professionalism criteria, such as self-evaluation of implicit biases, appropriateness of visual images, and timing of online posting can be used to set expectations as part of pre-departure training and to ensure ethical dissemination of online student reflections. IMPLICATIONS: Pharmacy educators can assist students during global experiences abroad by improving their cultural competence when sharing reflections online. To ensure postings are culturally sensitive, ethical, and professional, consideration should be given to the deliberate use of a checklist that can assist with ensuring appropriateness of content and student reflections as part of a formal educational experience.

Report of the 2019-2020 AACP Student Affairs Standing Committee.

The 2019-2020 Student Affairs Standing Committee addressed charges related to professional identity formation (PIF) in order to set direction and propose action steps consistent with Priority #3.4 of the AACP Strategic Plan, which states "Academic-practice partnerships and pharmacist-involved practice models that lead to the progress of Interprofessional Practice (IPP) are evident and promoted at all colleges and schools of pharmacy." To this end, the committee was charged to 1) outline key elements of PIF, 2) explore the relationship between formal curricular learning activities and co- or extra-curricular activities in supporting PIF, 3) determine the degree to which there is evidence that strong PIF is embedded in student pharmacists' educational experience, and 4) define strategies and draft an action plan for AACP's role in advancing efforts of schools to establish strong PIF in pharmacy graduates. This report describes work of the committee in exploring PIF and provides resources and background information relative to the charges. The committee offers several suggestions and recommendations for both immediate and long-term action by AACP and members to achieve goals related to integrating PIF into pharmacy education. The committee proposes a policy statement relative to the committee charges. Furthermore, the report calls upon the profession to develop a unified identity and incorporate support for PIF into pharmacy education, training, and practice.

Impact of Food and Drug Administration hepatotoxicity warning on prescribing and monitoring of dronedarone in a tertiary teaching hospital.

OBJECTIVES: The purpose of this study was to determine the impact of a Food and Drug Administration (FDA) hepatotoxicity warning on 14 January 2011 on the prescribing practices and hepatic monitoring of patients receiving dronedarone. METHODS: Patients who received dronedarone 1 year before and after the FDA warning were retrospectively evaluated for the appropriateness of dronedarone prescribing, hepatic injury evaluation and medication discontinuation rates in a tertiary medical centre. KEY FINDINGS: Ninety-one patients (66.4%) were prescribed dronedarone prior to the FDA warning, compared with 46 patients (33.6%) after the warning. The frequency of liver function testing (72.5% versus 76.1%) and discontinuation rates (42.9% versus 50%) were similar before and after the FDA warning. CONCLUSIONS: There was no significant change in dronedarone prescribing practice, monitoring of hepatic function or discontinuation rates following an FDA hepatotoxicity warning.

Vorapaxar for reduction of thrombotic cardiovascular events in myocardial infarction and peripheral artery disease.

PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, dosage and administration, cost, and place in therapy of vorapaxar in the secondary prevention of atherosclerotic events are reviewed. SUMMARY: Vorapaxar is a highly selective, reversible antagonist of protease-activated receptor-1 expressed on platelets. Vorapaxar competitively inhibits thrombin from activating the receptor, thereby decreasing platelet aggregation. Vorapaxar is rapidly absorbed and distributed, with peak plasma levels being reached within 60-90 minutes. Vorapaxar's effective half-life is three to four days and its terminal elimination half-life is eight days. Vorapaxar sulfate 2.5 mg (equivalent to 2.08 mg of vorapaxar) orally daily without a loading dose was clinically effective for the secondary prevention of ischemic events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD) without a history of stroke. Phase II and III trials of vorapaxar given with aspirin or a thienopyridine or both demonstrated a reduction in the primary endpoint of cardiovascular death, MI, and stroke in patients with a history of MI or coronary artery disease and PAD. Patients with a history of stroke were found to have an increased rate of intracranial hemorrhage (ICH), which led to a boxed warning placed on vorapaxar's labeling to warn of the increased risk for bleeding in patients with a history of stroke. CONCLUSION: Vorapaxar is a novel antiplatelet agent that has demonstrated efficacy in reducing atherosclerotic events in patients with a history of MI or PAD without a history of stroke, transient ischemic attack, or ICH when taken in combination with aspirin and clopidogrel.

Journal clubs during advanced pharmacy practice experiences to teach literature-evaluation skills.

OBJECTIVE: To determine pharmacy students' attitudes and academic performance related to journal club during 2 advanced pharmacy practice experiences (APPEs). DESIGN: Fourth-year pharmacy students were required to complete 3 journal club assignments during drug information and internal medicine APPEs. ASSESSMENT: A majority (91.3%) of the 105 students who responded to a 21-item survey instrument indicated that journal club assignments during the drug-information APPE were valuable to their understanding of research design and statistics. Students who completed the drug-information APPE before the internal medicine APPE scored higher on their understanding of the strengths and weaknesses and the clinical relevance of studies and had a higher learning slope (p = 0.01) than did students who completed the internal medicine APPE first. CONCLUSION: Incorporating journal clubs into APPEs is an effective means of teaching literature-evaluation skills to pharmacy students.

Tadalafil: a long-acting phosphodiesterase-5 inhibitor for the treatment of pulmonary arterial hypertension.

BACKGROUND: Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor that was approved by the US Food and Drug Administration (FDA) in 2009 for the treatment of pulmonary arterial hypertension (PAH). OBJECTIVE: The purpose of this review is to evaluate the pharmacology, pharmacokinetic properties, clinical efficacy, adverse effects, drug interactions, and dosage and administration of tadalafil in patients with PAH. METHODS: A literature search of MEDLINE and International Pharmaceutical Abstracts (1960 through September 5, 2010) was conducted with the search terms tadalafil, pulmonary arterial hypertension, and phosphodiesterase-5 inhibitor. Data found from orignial research and case series published in English were screened for relevancy to pharmacology, pharmacokinetics, clinical efficacy and safety, and tolerability. Relevant articles from the bibliographies of the identified published articles were also obtained. Unpublished data and posters were obtained from the manufacturer of tadalafil and the FDA Web site. RESULTS: By selectively inhibiting PDE-5, tadalafil causes nitric oxide-mediated vasodilation in the pulmonary vasculature. Tadalafil has a greater affinity (10,000-fold) for PDE-5 compared with the other PDE inhibitors and has a t(½) of 17.5 hours. In a controlled clinical study in patients with PAH, patients receiving tadalafil in a total daily dose of 40 mg had significant improvements in their 6-minute walk distance (33 m from baseline) and time to clinical worsening compared with those receiving placebo (both, P < 0.05). Tadalafil had adverse effects similar to placebo, with headache being the most commonly reported (42%). CONCLUSIONS: In the small number of studies available, tadalafil was effective and well tolerated when used to treat patients with PAH. Compared with placebo, tadalafil was associated with significant improvements in exercise capacity and reduced time to clinical worsening (68% relative risk reduction; P = 0.038). There is limited evidence comparing tadalafil with sildenafil and vardenafil, and the studies are limited by short treatment durations.

Iloperidone: A new drug for the treatment of schizophrenia.

PURPOSE: The pharmacology, pharmacokinetics, pharmacogenomics, clinical efficacy, and safety and tolerability profile of iloperidone for the treatment of schizophrenia are reviewed. SUMMARY: Iloperidone is an atypical antipsychotic that recently received marketing approval from the Food and Drug Administration for the acute treatment of schizophrenia. Iloperidone is a pure antagonist and the first antipsychotic to have pharmacogenomic studies indicate predictive response based on six identified polymorphisms. Pharmacokinetic studies have determined that iloperidone is well absorbed orally, with a bioavailability of 96%. Phase II and III clinical trials have shown iloperidone to improve symptoms of schizophrenia, based on the Positive and Negative Symptom Scale, Brief Psychiatric Rating Scale, and Clinical Global Impressions-Severity scores (p < 0.05). Iloperidone has established tolerability at recommended dosages of up to 24 mg daily; however, the dosage must be slowly increased over seven days, and twice-daily administration is required to avoid orthostatic hypotension. The most common adverse effects associated with iloperidone were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight gain. Safety studies have also found that iloperidone increases the risk of Q-Tc interval prolongation, similar to that seen with ziprasidone. Minimal changes in glucose and lipid abnormalities were seen in short-term (4- and 6-week) and long-term (52-week) studies, indicating a low chance of metabolic disturbance with iloperidone. CONCLUSION: Iloperidone may be a viable and safe option for the treatment of schizophrenia in adult patients, especially for patients who cannot tolerate other antipsychotic agents. However, iloperidone lacks a clear benefit over other antipsychotic agents.