Provider Decisions and Patient Outcomes After Premature Metformin Discontinuation.

The purpose of this study was to evaluate the effects of alternative antihyperglycemic therapy after discontinuation of metformin due to documented declining renal function. This retrospective, single-site study evaluated patients who had metformin discontinued between 1 January 1999 and 30 September 2013. Medical records were evaluated for documented adverse events, subsequent glycemic control, and costs associated with the alternative therapy. Patients served as their own controls. A total of 179 patients met study entry criteria, and their peak A1C was significantly higher within the year after metformin discontinuation (P <0.001). After the provider added new medications to control patients' blood glucose, their A1C by the end of the first year after discontinuing metformin was similar to their A1C while taking metformin. Significant weight gain accompanied the use of the medications added to replace metformin, with an average increase of 3.81 kg (P <0.001). Additionally, after discontinuing metformin, more patients experienced hypoglycemia with the addition of other medications to control their blood glucose (P <0.001). As expected, the cost of therapy was significantly higher (P <0.0001) after metformin was discontinued because metformin was generically available, whereas the replacement medications frequently were not. Providers should consider the expanded recommendations for the use of metformin in patients with mild to moderate stable renal dysfunction to help such patients avoid weight gain, hypoglycemia, loss of blood glucose control, and increased costs.

Assessment and revision of clinical pharmacy practice internet web sites.

BACKGROUND: Health care professionals, trainees, and patients use the Internet extensively. Editable Web sites may contain inaccurate, incomplete, and/or outdated information that may mislead the public's perception of the topic. OBJECTIVE: To evaluate the editable, online descriptions of clinical pharmacy and pharmacist and attempt to improve their accuracy. METHODS: The authors identified key areas within clinical pharmacy to evaluate for accuracy and appropriateness on the Internet. Current descriptions that were reviewed on public domain Web sites included: (1) clinical pharmacy and the clinical pharmacist, (2) pharmacy education, (3) clinical pharmacy and development and provision for reimbursement, (4) clinical pharmacists and advanced specialty certifications/training opportunities, (5) pharmacists and advocacy, and (6) clinical pharmacists and interdisciplinary/interprofessional content. The authors assessed each content area to determine accuracy and prioritized the need for updating, when applicable, to achieve consistency in descriptions and relevancy. The authors found that Wikipedia, a public domain that allows users to update, was consistently the most common Web site produced in search results. RESULTS: The authors' evaluation resulted in the creation or revision of 14 Wikipedia Web pages. However, rejection of 3 proposed newly created Web pages affected the authors' ability to address identified content areas with deficiencies and/or inaccuracies. CONCLUSIONS: Through assessing and updating editable Web sites, the authors strengthened the online representation of clinical pharmacy in a clear, cohesive, and accurate manner. However, ongoing assessments of the Internet are continually needed to ensure accuracy and appropriateness.

The Role of Consumerism in Pharmacy Education.

The notion of consumerism and that students are customers of pharmacy colleges was explored by proponents and opponents of the idea. First, a working definition of a "customer" in pharmacy education is pondered with respect to the roles and responsibilities of students and schools/colleges of pharmacy. Second, the pros and cons of "student-centered" education are considered in the light of students and their families being consumers of the educational experience. Third, the duality of student-centered education is discussed including student engagement/disengagement in their learning, professional/unprofessional behaviors, and shared/individual responsibilities. Lastly, learning and teaching environment dynamics are discerned when higher education becomes more student-centric and how that may affect the overall outcome of the student and the goals of pharmacy educational programs.

Review of Best Practices for Diversity, Equity, and Inclusion Committees Within Colleges of Pharmacy.

Objective. To provide a review of best practices for diversity, equity, and inclusion (DEI) committees at United States colleges of pharmacy.Findings. In colleges of pharmacy, DEI committees can play a crucial role in promoting a culture change to ensure pharmacy graduates are equipped to provide equitable and representative care for the patients they serve. There is limited literature available on DEI committee composition, roles, and responsibilities, and their place within a college of pharmacy's organizational structure. A commitment to DEI should be part of the college's strategic plan and embedded and supported at all levels of the college and university to ensure success of DEI-related strategic initiatives. For a DEI committee to be effective, its composition should be intentional to include change agents, campus leaders, and members who are passionate and knowledgeable to execute the DEI goals. For sustainable change, involvement of the entire learning community and an organizational culture change is also important. Thus, DEI committees need to establish active bidirectional collaborations and communication with all key committees, offices, community leaders, and alumni to implement diversity goals.Summary. The DEI committee's established place in the organizational structure of the college is essential to ensure fair and appropriate representation of the community it serves. A clearly defined DEI committee with committee composition, roles, responsibilities, and its association with all constituents of the college and community can help achieve its intended strategic goals.

Impact of COVID-19 on Pharmacy Education and Practice: Strategies to Boost Advocacy and Unity among Health Care Organizations.

The global COVID-19 pandemic impacted pharmacy education and changed the pharmacists' scope of practice at the federal and state levels. Based on the Amended Public Readiness and Emergency Preparedness Act, pharmacists were authorized to provide essential services, including testing, treatments, and immunizations at various practice settings. Specifically, the United States Food and Drug Administration issued emergency use authorization for several medications, vaccines, and medical devices. The pandemic also affected the regulatory landscape for pharmacists, pharmacy education, access to care, and delivery of pharmacy services in-person and through telehealth. The pandemic's specific impact on pharmacy education heightened awareness of the well-being of the Academy. This commentary will highlight the impact of COVID-19 on both pharmacy education and practice. It will also provide strategies that educators, researchers, and practitioners can take into future research and action to help promote advocacy and unity among pharmacy organizations.

Efficacy and benefits of mock residency interviews.

INTRODUCTION: Obtaining a residency has become more competitive as more pharmacy students seek postgraduate training. This is likely due to pharmacist positions increasing in clinical settings. To be fully prepared, students seeking residency positions should be trained for the interview process by their pharmacy school. METHODS: Mock residency interviews (MRI) were conducted at the Texas Tech University Health Sciences Center School of Pharmacy which included components of typical residency interviews. The primary outcome compared residency match rates for MRI participants vs. non-participants. Secondary outcomes evaluated student preparedness, student and faculty feedback, and satisfaction/benefit of the event along with comparison of school vs. national match rate and assessment of those matching compared to grade point average (GPA). RESULTS: Match rates were similar between MRI participants vs. non-participants (75% vs. 73%) with significant difference in Phase I match rates between MRI participants vs. non-participants (75% vs. 51%, P = .007). MRI was significantly associated with Phase I matching in the multivariable analysis (odds ratio (OR) = 2.81, 95% CI 1.27-6.22). The overall school's match rate exceeded the national two out of three years in the quality improvement project period. GPA was the only other factor independently associated with Phase I matching (OR = 1.15, 95% CI 1.01-1.32). Students and faculty consistently reported positive feedback following participation. CONCLUSIONS: MRI are valuable and are making a difference as indicated by improved Phase I match rates for those that participated. Students and faculty reported an increase in preparedness and overall satisfaction after attending MRI.

Advancing Pharmacy Education and Workforce Development Amid the COVID-19 Pandemic: Report of the 2020-2021 AACP Academic Affairs Committee.

EXECUTIVE SUMMARY The 2020-2021 Academic Affairs Committee was charged to (1) Read all six reports from the 2019-20 AACP standing committees to identify elements of these reports that are relevant to your committee's work this year; (2) Determine what changes made in colleges and schools of pharmacy during the COVID-19 pandemic should be continued to advance pharmacy education; (3) Develop a realistic model for colleges and schools of pharmacy to share resources to meet the curricular needs of member schools; (4) Create strategies by which colleges and schools of pharmacy can meet current and future workforce development needs particularly in light of the changes in healthcare delivery as a result of the COVID-19 pandemic; (5) Identify salient activities for the Center To Accelerate Pharmacy Practice Transformation and Academic Innovation (CTAP) for consideration by the AACP Strategic Planning Committee and AACP staff. This report provides an overview of changes made in schools and colleges of pharmacy implemented in response to the COVID-19 pandemic that may be continued to advance pharmacy education; a realistic model for colleges and schools of pharmacy to share resources to meet the curricular needs of member schools; and strategies by which schools and colleges of pharmacy can meet current and future workforce development needs, particularly in light of the changes in healthcare delivery as a result of the COVID-19 pandemic. The committee is proposing one policy statement for consideration by the 2021 AACP House of Delegates, four suggestions for consideration by schools and colleges of pharmacy (including two endorsements for suggestions from the 2020-21 Argus Commission), and one recommendation for consideration by AACP for CTAP to implement and oversee.

Third-line agent selection for patients with type 2 diabetes mellitus uncontrolled with sulfonylureas and metformin.

Patients with type 2 diabetes mellitus often begin treatment by taking oral agents, usually metformin or a sulfonylurea, and then progress to the combination of these two agents. Most patients often require three or more agents or a change to an insulin regimen. However, no guidelines are available to aid the clinician in the decision-making process for selecting the third agent. Many options are available for additional therapy, including thiazolidinediones, intermediate- and long-acting insulins, exenatide, and dipeptidyl peptidase-4 inhibitors. Although the American Diabetes Association recommends metformin as first-line therapy, it does not give exact specifications for second- and third-line agents but only summarizes clinical data and options about each therapeutic drug class. Guidelines from the American College of Endocrinology and American Association of Clinical Endocrinologists recommend several options depending on the patient's hemoglobin A(1c) level. Therefore, a standard of care cannot be provided; rather, clinicians must evaluate each patient to ascertain that patient's optimum therapy. In doing so, clinicians need to be familiar with the efficacy, safety, and cost of each agent.

An Evidence-Based Review of Statin Use in Patients With Nonalcoholic Fatty Liver Disease.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a common complication in patients with metabolic syndrome. The role of statin therapy specifically for the treatment of NAFLD remains unknown. The aim of this review is to discuss outcomes of recent articles analyzing statin therapy in patients with NAFLD. FINDINGS: A total of 12 trials met the inclusion criteria. Statins were not found to increase the prevalence of NAFLD once confounding variables were considered. Statins were also found to be beneficial in treating dyslipidemia and improving liver function. Histological liver outcomes in patients with NAFLD were controversial. One trial found a reduction in the incidence of hepatocellular carcinoma associated with the use of statins. CONCLUSIONS: Overall, therapy with statins appears to be safe for use in patients with NAFLD. Several trials have validated the use of statins for the treatment of dyslipidemia; however, it remains unknown as to whether statins should be used to specifically treat NAFLD.

Assessment of a didactic ambulatory care pharmacy elective on student perceptions and subsequent performance in an ambulatory care advanced pharmacy practice experience.

INTRODUCTION: This study assessed student perception in treating chronic disease states before and after taking an ambulatory care didactic elective and the impact on performance within a fourth-year ambulatory care advanced pharmacy practice experience (APPE). METHODS: Assessment of student perceptions was evaluated in students taking the Fall 2016 and Spring 2017 elective offering by completing an 11-item electronic survey prior to the first lecture of the course and after the last lecture of the course. A retrospective assessment of student performance in the APPE compared students that had taken the elective to those that had not over a two-and-one-half year period. Data collected included the students' final APPE experiential and required examination grade. RESULTS: In all but one survey question, student perceptions significantly improved upon completion of the elective. Student ambulatory care APPE final experiential grades were higher in students who had taken the elective compared to those that had not (90.3% vs. 88.9%, respectively, p = 0.04) as were APPE examination scores (78.0% vs. 74.0%, respectively, p = 0.01). DISCUSSION AND CONCLUSIONS: Student perception in key ambulatory care concepts, disease states, and drug knowledge improved after taking the ambulatory care elective. Student ambulatory care APPE performance was also mildly improved as a result of taking the elective compared to those who did not take the course. This is the first study to evaluate subsequent performance in an APPE as a result of taking an elective ambulatory care course and can serve as a template for other research in elective assessment.

Utilizing Clinical Pharmacy Specialists to Address Access to Care Barriers in the Veteran Population for the Management of Diabetes.

OBJECTIVE: To show that clinical pharmacy specialists (CPSs) can be utilized in remote facilities to provide appropriate diabetes outcomes along with potential cost savings. METHODS: A retrospective cohort chart review conducted at the Veterans Affairs North Texas Healthcare System (VANTHCS) evaluated outcomes in patients with type 2 diabetes mellitus referred to CPSs at Fort Worth Outpatient Clinic (FWOPC) or the endocrinologist-managed specialty clinic at the Dallas VA Medical Center (DVAMC). The primary outcome was percentage of patients reaching hemoglobin A1c (HbA1c) goal of <8%. Secondary outcomes were percentage of patients reaching HbA1c <7%, time to reach HbA1c goals of <8% and <7%, and cost savings. RESULTS: There was no statistically significant difference in the number of patients reaching HbA1c goal <8% in the FWOPC (65.3%) compared to the DVAMC (55.8%). Secondary end points comparing FWOPC and DVAMC found no difference in patients reaching HbA1c <7% (20.8% vs 19.2%) and time to reach HbA1c goal of <8% (4.5 vs 6 months) and <7% (8.5 vs 7.5 months). Cost-saving analysis demonstrated a composite of US$350 292 could be saved by the VANTHCS facility if patients continued to be referred to CPS. CONCLUSION: CPSs can be utilized in diabetes management to provide similar health outcomes as the endocrinologist-managed clinic and to potentially allow for facility cost savings.

Implications of rosiglitazone and pioglitazone on cardiovascular risk in patients with type 2 diabetes mellitus.

Clinical data suggest that thiazolidinediones--specifically, rosiglitazone and pioglitazone--may improve cardiovascular risk factors through multiple mechanisms. Low insulin sensitivity has been described as an independent risk factor for coronary artery disease and cerebrovascular disease. Patients with insulin resistance often have several known risk factors, such as obesity, dyslipidemia, and hypertension. Other emerging risk factors may be prevalent in patients with insulin resistance, such as hyperinsulinemia, elevated C-reactive protein, elevated plasminogen activator inhibitor levels, and small, dense, low-density lipoproteins. The only available drug class that primarily targets insulin resistance is the thiazolidinediones. These drugs have shown efficacy in affecting surrogate markers of cardiovascular risk in patients with diabetes mellitus. Alterations in these risk factors are likely due to their effects on improving insulin sensitivity and/or glycemic control. Trials to assess whether thiazolidinediones actually reduce cardiovascular outcomes are continuing.

Recommendations for Aligning PGY2 Pharmacy Residency Training and Pharmacy Specialist Board Certification.

With the increased focus and anticipated growth in specialty training and certification within the profession of pharmacy, it is important for the profession to step back and evaluate the manner in which its adopted education and certification systems interface. As a result of specialty practice development, significant growth is occurring in both postgraduate year two (PGY2) pharmacy residency programs and individuals seeking certification by the Board of Pharmacy Specialties. As the profession continues to evolve its specialty training and credentialing systems, it is important to consider the inherent relationship between these systems. This paper considers the current landscape of specialty training and certification, including issues related to the quality of PGY2 training, consistent application of standards across and within PGY2 programs, credentialing of preceptors and program directors, and alignment of training with specialty certification examination content domains. We outline recommendations across three areas: (1) creating consistency between specialty training and certification, (2) aligning qualifications of PGY2 residency program directors and preceptors with the designated specialty area, and (3) assessing program quality in the context of the expectations of specialists established by the profession. The goal of this paper is to stimulate professional dialogue on these issues. Establishing both formal and informal connections between specialty training and certification can serve as the foundation for a rational approach to professional development and the credentialing that will be recognized by stakeholders outside the pharmacy profession. Establishing these connections will also support and advance the profession's mission of meeting the medication needs of patients.

Dulaglutide: an evidence-based review of its potential in the treatment of type 2 diabetes.

INTRODUCTION: As the prevalence of type 2 diabetes mellitus (T2DM) is anticipated to continue to rise worldwide, so too are the treatment options also continuing to expand. Current guidelines recommend individualized treatment plans which allow for provider choice and diversity of pharmacotherapeutic regimens. The glucagon-like peptide-1 receptor agonist (GLP-1 RA) class is rapidly expanding, with dulaglutide (Trulicity™) as a once-weekly agent recently approved. AIMS: This article examines the evidence currently available on the efficacy and safety of dulaglutide for use in T2DM. EVIDENCE REVIEW: Dulaglutide has been shown to have similar efficacy and safety to other newer GLP-1 RAs, and better glycemic control than placebo. It lowers glycated hemoglobin (A1c), fasting and postprandial glucose levels, and promotes weight loss when used as first-, second-, or third-line therapy. It has also been shown to improve ß-cell function and provide cardiovascular benefits, such as lower blood pressure and improved lipid levels. Dulaglutide also has a low risk for hypoglycemia and a similar adverse effect profile to other GLP-1 RAs in the class, with transient gastrointestinal problems and potential risk for pancreatitis. PLACE IN THERAPY: While long-term data on safety and efficacy are forthcoming, dulaglutide is positioned to be placed at the same level as other GLP-1 RAs in the class: as second-line therapy in addition to diet and exercise in those patients who cannot achieve glycemic control on monotherapy metformin. It may also be useful as first-line therapy instead of metformin. CONCLUSION: Dulaglutide is a once-weekly GLP-1 RA approved for the treatment of T2DM that has shown similar efficacy to other agents in this class.

Sodium-glucose co-transporter 2 inhibitors: evidence and place in therapy.

Type 2 diabetes effects millions of people yet remains difficult to treat with oral pharmacotherapy. Metformin is the first line recommended therapy, and current guidelines suggest individualized therapy for second line selection. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are the newest class of agents in treating type 2 diabetes via an insulin independent mechanism to lower blood glucose. Currently marketed agents, including canagliflozin, dapagliflozin, empagliflozin, and luseogliflozin, reduce hemoglobin A1c (HbA1c) ~0.8-1%, reduce fasting and post prandial glucose, and have little hypoglycemia associated with them when added to therapies including metformin, a sulfonylurea, pioglitazone, or insulin. Patients receiving SGLT-2 inhibitors have reduced weight and blood pressure, but are more susceptible to urinary tract infections and genital mycotic infections. This review summarizes current literature regarding the SGLT-2 inhibitors.

Statins in the treatment of asthma.

PURPOSE: Current evidence on statin agents as potential alternatives or adjuncts to corticosteroid therapy for asthma is reviewed. SUMMARY: Research showing antiinflammatory and antioxidant effects of statins in animal models suggested that the cholesterol-lowering drugs might be useful in mitigating the adverse effects of long-term corticosteroid therapy in patients with asthma, but studies in humans have yielded mixed results. Two small placebo-controlled clinical trials indicated that statins were not effective in combating asthmatic inflammatory processes, and trials of statins as adjunctive therapy have indicated minimal steroid-sparing benefits. In two studies involving a total of more than 1000 current and former smokers with asthma, statin use correlated with reduced acute asthma exacerbations and a slower decline of lung function in some patients. A large population-based study (n = 3965) found that statin therapy was associated with a significantly reduced risk of hospitalization for asthma after an average follow-up period of about 4.5 years; a smaller U.S. retrospective cohort study indicated a significantly lower 1-year rate of asthma-related emergency room visits among patients receiving statins relative to those not using statins (9.08% versus 4.18%). Much of the research on statins and asthma has not controlled for confounding influences such as patient comorbidities and concomitant medication use. CONCLUSION: Clinical trials have shown that statin therapy is not superior to and does not enhance the beneficial effects of inhaled corticosteroids for the treatment of asthma. Some evidence suggests that statins may help preserve lung function in cigarette smokers with obstructive pulmonary disease and reduce hospitalizations in asthmatic smokers and nonsmokers.

Race as a factor for intensification of diabetes medications.

PURPOSE: The purpose of this study was to investigate if patients of nonwhite race are less likely to receive insulin therapy for treatment of poorly controlled diabetes than patients of white race. METHODS: A retrospective review was performed of patients with an A1C >10%. The primary objective was to determine any difference in the initiation of insulin between white and nonwhite patients. Secondary outcomes measured the impact of clinic type and provider specialty on the initiation of insulin therapy. Exclusion criteria included those patients with type 1 diabetes mellitus, those who were previously receiving insulin, and those without an outpatient clinic visit within 14 days of an A1C >10%. RESULTS: A total of 277 patients were included. Of these patients, 132 (47.7%) were white, followed by 95 (34.2%) black non-Hispanic patients and 30 (10.8%) Hispanic/Latino patients. No difference was found in receipt of insulin therapy for nonwhite patients as compared to white patients (12.5 vs 21.4, P = .117). Neither clinic type nor provider specialty impacted initiation of insulin therapy. No changes to medication regimen were made at 35% of clinic visits. CONCLUSIONS: Failure to intensify diabetic medications was common in this outpatient setting. There were no disparities in the receipt of insulin therapy between white and nonwhite patients.

An update in incretin-based therapy: a focus on glucagon-like peptide-1 receptor agonists.

The glucagon-like peptide-1 receptor agonists, exenatide and liraglutide, offer a unique mechanism in the treatment of type 2 diabetes mellitus (T2DM) as part of the incretin system. Their mechanism of action is to increase insulin secretion, decrease glucagon release, reduce food intake, and slow gastric emptying. They target postprandial blood glucose values and have some effect on fasting levels as well. In addition, they promote weight loss and may help to preserve ß-cell function, both major problems in T2DM patients. Changes in hemoglobin A1c are similar to those produced by other T2DM agents, including thiazolidinediones, low-dose metformin, and sulfonylureas, and better than those caused by α-reductase inhibitors and dipeptidyl peptidase-4 inhibitors. These agents have been safely studied in combination with metformin, sulfonylureas, meglitinides, thiazolidinediones, and insulin therapy. Overall, data are limited for head-to-head comparisons, but it appears that liraglutide may have better efficacy and tolerability compared with exenatide; however, more studies are needed. They are overall well tolerated, with the main adverse events being similar to those with metformin (gastrointestinal intolerances that are transient and dose dependent). However, patients must be monitored for pancreatitis as a rare but possible side effect. For T2DM patients willing to use an injectable agent, exenatide and liraglutide offer another therapeutic option to control hyperglycemia with the potential for weight loss and may be combined with other agents safely.

An update in incretin-based therapy: a focus on dipeptidyl peptidase--4 inhibitors.

Dipeptidyl peptidase -4 inhibitors represent a novel way to augment the incretin system and one of the newest class of medications in the treatment of type 2 diabetes mellitus. Their mechanism of action is to decrease the inactivation of glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide, both of which are involved in maintaining euglycemia subsequent to carbohydrate intake. Currently investigated agents include sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin. Each agent has been shown to provide significant improvements in glycemic control compared to placebo. They are effective when added to other oral diabetes agents and in the cases of sitagliptin, vildagliptin, and alogliptin in addition to insulin. These agents may not provide as significant improvement in glucose concentrations as some other medications including metformin, thiazolidinediones, or glucagon-like peptide 1 agonists. The lack of head to head clinical data comparing the various dipeptidyl peptidase 4 inhibitors does not allow for specific recommendations if one agent is more effective or safer than another within the class. Their side effect profile suggests they are very well tolerated and have few drug interactions. For patients with mildly elevated glucose concentrations, they are therapeutic options in both drug-naive patients as well as those not optimally controlled on other diabetes medications.

Ranolazine for the treatment of refractory angina in a veterans population.

BACKGROUND: Pivotal ranolazine trials did not require optimization of conventional medical therapy including coronary revascularization and antianginal drug therapy prior to ranolazine use. This case series describes the use of ranolazine for the treatment of chronic stable angina refractory to maximal medical treatment in a veterans population. RESULTS: A total of 18 patients with a median age of 66 years were identified. All patients had prior percutaneous coronary intervention and/or coronary artery bypass graft surgery; 83% had three-vessel coronary artery disease, with left main disease present in 39% of patients. Prior to initiating ranolazine, antianginal use consisted of beta blockers (94%), long-acting nitrates (83%) and calcium channel blockers (61%). Median blood pressure (116.2/61.8 mmHg) and pulse (65 beats per min) were controlled. Median preranolazine angina episodes and sublingual nitroglycerin (SLNTG) doses per week were 14 and 10, respectively, with a Canadian Cardiovascular Society (CCS) angina grade of III-IV in 67% of patients. After initiation of ranolazine, median angina episodes per week and SLNTG doses used per week decreased to 0.7 and 0, respectively, with CCS grade of III-IV declining to 17%. Of the 18 subjects enrolled, 44% had complete resolution of angina episodes. CONCLUSION: The addition of ranolazine to maximally tolerated conventional antianginal drug therapy post coronary revascularization was associated with decreases in angina episodes and SLNTG utilization and improvement in CCS angina grades. Ranolazine may provide an effective treatment option for revascularized patients with refractory angina.