Pharmacy and Pharmaceutical Sciences Commons^™

Signifor® Receives Fda Approvalfor The Management Of Cushing's Disease, Justin Steele, Ann Marie Ruhe, Andrew Skouby, Eric Stack, Sandra L. Hrometz

Pharmacy and Wellness Review

Cushing's disease is a disorder characterized by supraphysiologic levels of circulating cortisol due to excessive adrenocorticotropic hormone (ACTH) secretion. Most often hypersecretion of ACTH is due to a pituitary adenoma, where surgical resection of the tumor is considered first-line treatment for the disease. Alternatively, the FDA has recently approved the somatostatin analogue, Signifor® (pasireotide), for the management of Cushing's disease in patients for whom surgery is not an option. In clinical trials, pasireotide has shown a statistically significant reduction in urinary free cortisol levels, as well as significant improvements in quality of life. Based on current data, pasireotide appears to …

Ado-Trastuzumab Emtansine For Her2 Positive Breast Cancer, Kimberly Baucher, Taylor Beale, Maria Laikos, Eric Stack, Mary Ellen Hethcox

Pharmacy and Wellness Review

No abstract provided.

Novel Oral Anticoagulants: A Comparative Study Of The Clinical Potential For Dabigatran, Rivaroxaban, And Apixaban Versus Warfarin, Lindsay Mark, Joanne Tran, Zachary Jones, Jessica Beck, David Bright

Pharmacy and Wellness Review

Although Coumadin® (warfarin) has been the standard outpatient anticoagulant for long-term prevention of thrombosis for many decades, it presents with significant challenges for both patients and health care providers in optimizing standards of care including dietary and drug restrictions, regular monitoring of the patient's International Normalized Ratio (INR), and difficulty maintaining therapeutic levels. Despite its unmistakable effectiveness, there has been an interest from the medical community in developing potential alternative drug therapies. As a result, within the past three years the U.S. Food and Drug Administration (FDA) has approved the use of three new oral anticoagulant drugs (dabigatran, rivaroxaban, and …

Fda Approves New Tuberculosis Drug: Bedaquiline (Sirturo®), Megan Ruffner, Kent Wilin, Charles Hay, Zachary Crawford, Andrew Roecker

Pharmacy and Wellness Review

Tuberculosis (TB), caused by the acid-fast bacilli (AFB) Mycobacterium tuberculosis, is an infectious disease that continues to greatly impact morbidity and mortality worldwide; in 2011 it caused 1.4 million deaths. Some strains of the bacteria have become resistant to current treatment regimens, resulting in multidrug-resistant (MOR) and extensively drugresistant (XOR) TB. The emergence of these resistant strains of bacteria calls for new treatment regimens that can quickly and effectively eradicate the organism. The U.S. Food and Drug Administration (FDA) recently approved Sirturo® (bedaquiline) with the indication of MDR pulmonary TB. Bedaquiline introduces a novel mechanism of action via the inhibition …

Endometriosis: The Etiology And Recommended Treatment, Amanda Lovell, Kasie Bellmann, Kelsey Fink, Jessica Beck, Michelle Musser

Pharmacy and Wellness Review

Endometriosis is a gynecological condition that occurs in women between the ages of 15 and 49 years, in which endometrial cells grow outside the uterus. Normally, endometrial cells form the endometrium and respond to hormones throughout the menstrual cycle, but when endometrial cells are located outside the endometrium, painful bleeding and other side effects may occur. Treatment of endometriosis is usually symptomatic relief, including the use of oral contraceptives and other hormone replacement options, as well as non-steroidal anti-inflammatory drugs. To ensure that patients receive the appropriate treatment for this condition, pharmacists should be able to recognize the signs and …

Immunization Guidelines For Pregnant Women, Kelly Dye, Maria Laikos, Tristan Maiers, Eric Stack, Natalie Dipietro

Pharmacy and Wellness Review

There are many misconceptions among the general public regarding the administration of vaccinations during pregnancy. It is imperative for pharmacists to be current regarding guidelines and updates about recommended vaccines. Data from the Centers for Disease Control and Prevention (CDC) indicate that while some vaccines are highly recommended during pregnancy, others have limited safety data or are contraindicated. As new data emerges on the safety and efficacy of immunizations during pregnancy, pharmacists should continue to review the literature to stay up-to-date on vaccination recommendations. The CDC also has information available for pharmacists and other health care professionals regarding the use …

Truvada® Recommended By Fda Committee For Pre-Exposure Prophylaxis In High-Risk Hiv-Negative Individuals, Justin Steele, Emily Blum, Alison Steinbrunner, Lara Long, Andrew M. Roecker

Pharmacy and Wellness Review

Once-daily combination tenofofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has received Food and Drug Administration (FDA) approval for use in pre-exposure prophylaxis (PrEP) against Human Immunodeficiency Virus (HIV) infection in high-risk individuals. In clinical trials, FTC/TDF has been shown to reduce the risk of HIV acquisition by 62 percent in sexually active heterosexual men and women. Similarly, use of FTC/TDF demonstrated a 44 percent reduction in HIV infection within the men who have sex with men population.⁷ When used compliantly and in conjunction with safe sex practices, it appears that FTC/TDF can play an important role in reducing the …

Comparing The Glp-1 Receptor Agonists: Byetta®, Victoza® And Once-Weekly Bydureon™, Todd A. Tucker Jr., Sarah Turley, Kaila Bollinger, Jessica Beck, Sandra L. Hrometz

Pharmacy and Wellness Review

Type 2 diabetes mellitus (T2DM) has traditionally been managed with oral medications. However, in the last few years, subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonists have risen to fame. These agents serve as a reliable addition to current monotherapy. GLP-1 receptor agonists offer a significant reduction in hemoglobin AlC (HbAlc), fasting plasma glucose, and have the added benefit of weight loss. They work primarily by enhancing glucose-dependent insulin secretion while inhibiting glucagon secretion. The available GLP-1 agonists are Byetta® (exenatide), Victoza® (liraglutide), and Bydureon™ (exenatide extended-release). Studies suggest that they are similar in safety and efficacy, with the longer acting GLP-1 …

Sildenafil As An Appropriate Monotherapy Option In The Treatment Of Pulmonary Arterial Hypertension (Pah), Kaitlin Horton, Kent Wilin, Sarah Ginty, Lara Long, David Bright

Pharmacy and Wellness Review

Pulmonary arterial hypertension (PAH) is a debilitating disease characterized by constriction in the diameter of the pulmonary arterial lumen.1,2 This leads to increased pressure and stress on the right ventricle of the heart, which may lead to heart failure and death.2,3 Currently there are only a few treatment options for patients with PAH. Sildenafil, a phosphodiesterase type 5 (PDE-5) inhibitor, can be used to treat PAH. Sildenafil inhibits the degradation of cyclic guanosine monophosphate (cGMP). Increased cGMP concentration results in pulmonary vasculature relaxation. Current clinical trials have indicated that sildenafil can significantly improve many of the symptoms of PAH. The …

Overview Of Stevens-Johnson Syndrome And Toxic Epidermal Necrolysis, Christina Spinaris, Sarah Kradel, Tara Tokar, Zachary Crawford, Michael M. Milks

Pharmacy and Wellness Review

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immunologic reactions that typically present due to drug hypersensitivity. These reactions present with serious mucocutaneous manifestations that can lead to significant morbidity and mortality. The pathogeneses of SJS and TEN have yet to be clearly elucidated, but three potential immunologic mechanisms have been defined in literature: granulysin, Fas-FasL, and perforin and granzyme B. Medications have been immunologically linked as the primary causative agents of SJS/TEN. Corticosteroids, intravenous immunoglobulin administration (IVIG) and cyclosporine have been employed as treatments; however, none have resulted in consistent positive outcomes. Pharmacists have a significant role in …

The Impact Of Pharmacogenomics On Chemotherapeutic Drug Development And Use, Lara Long, Amy Pasternak, Ellen Hazelet, David Kisor

Pharmacy and Wellness Review

Cancer therapy is largely dependent on general treatment guidelines, and patients undergoing chemotherapy often experience treatment failure with standard drugs. The development of individualized drug therapy through pharmacogenomics has the potential to enhance chemotherapy regimen selection and improve patient outcomes. Antineoplastic agents such as cetuximab and trastuzumab are effective in treating cancers possessing specific genetic biomarker characteristics. Patients need to undergo genetic testing before these agents are administered to ensure appropriate use. Cetuximab has been shown to improve outcomes in metastatic colorectal cancers and head and neck squamous cell carcinomas positive for EGFR. Trastuzumab has shown benefit in human epidermal …

Beta-Blockers In Cardiovascular Therapy: A Review, Camelia C. Diaconu, Dragos R. Marcu, Ovidiu G. Bratu, Ana Maria A. Stanescu, Gina Gheorghe, Andreea A. Hlescu, Dan L. Mischianu, Maria Manea

Journal of Mind and Medical Sciences

The role of beta-adrenergic receptor antagonists in cardiovascular therapy has been the subject of various studies over time, these agents representing one of the oldest class of drugs used for the treatment of cardiovascular diseases. Although beta-blockers have been excluded from guidelines as the first-line therapy in essential hypertension, they remain the first choice in patients with heart failure, coronary artery disease, and atrial fibrillation. In this article, we review the major clinical evidence for the use of beta-blockers in cardiovascular diseases. Several trials have demonstrated that beta-blockers reduce mortality in patients with heart failure with a reduced ejection fraction. …

Changes In Body Mass Index And Atherosclerotic Disease Risk Score After Switching From Tenofovir Disoproxil Fumarate To Tenofovir Alafenamide., Jason J. Schafer, Kaitlin N. Sassa, Jaclyn R. O'Connor, Ayako Shimada, Scott W. Keith, Joseph A. Desimone

College of Pharmacy Faculty Papers

Background: Switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF)-containing antiretroviral therapy (ART) can improve renal function and bone mineral density in people with human immunodeficiency virus (PWH). The switch can also negatively influence cholesterol, but changes in body mass index (BMI) and atherosclerotic cardiovascular disease (ASCVD) risk are unknown.

Methods: This retrospective observational study evaluated BMI and ASCVD risk score changes in virologically suppressed PWH who switched from TDF to TAF without switching other ART regimen components. Adults on TDF for ≥1 year with 2 consecutive HIV ribonucleic acid values/mL before a TAF switch were included. Body weight, …

Joint Annual Wellness Visit Scheduling, Rob Chamberlin, Jennifer Bliss, Andrea Lai, Paula Dougherty, Deb Swett, Logan Merrithew, Pam Stevens, Scott Williams

MaineHealth Maine Medical Center

Problem/Impact Statement: The pharmacists in Scarborough & Westbrook Primary Care conduct Medicare Annual Wellness Visits (AWVs) with a physician. The pharmacist and physician see the patient individually. The practices achieved and sustained FY18 Joint AWV volume goals through a new process to reschedule physician-only AWVs to Joints AWVs with a pharmacist. This leads to reschedule rework and reduced time practice staff have for patient care.

Patients Living With Hiv Infection Are Less Likely To Receive The Correct Statin Intensity For Cardiovascular Disease Risk Reduction, Jason J. Schafer, Pharmd, Mph, Roshni Emmons, Pharmd, Bcps, Nick V. Hastain, Pharmd, Todd Miano, Pharmd, Phd

College of Pharmacy Posters

• Patients living with HIV (PLWH) are at high risk for atherosclerotic cardiovascular disease (ASCVD)
• Eligible PLWH should receive statins for ASCVD risk reduction according to current guidelines
• Studies suggest that statins are underprescribed in PLWH, but comparisons to uninfected patients and assessments of statin intensity have not occurred

Objective

To determine the influence of HIV infection on appropriate statin prescribing for ASCVD risk reduction

Long-Term Safety And Efficacy Of Subcutaneous Pasireotide In Patients With Cushing's Disease: Interim Results From A Long-Term Real-World Evidence Study., Luca Manetti, Timo Deutschbein, Jochen Schopohl, Kevin C J Yuen, Michael Roughton, Ulrike Kriemler-Krahn, Libuse Tauchmanova, Ricardo Maamari, Carla Giordano

Articles, Abstracts, and Reports

PURPOSE: Clinical trials have demonstrated the favorable efficacy/safety profile of pasireotide in patients with Cushing's disease (CD). We report interim long-term results of an ongoing real-world evidence study of subcutaneous pasireotide in patients with CD.

METHODS: Adults with CD receiving pasireotide, initiated before (prior-use) or at study entry (new-use), were monitored for ≤ 3 years during a multicenter observational study ( http://clinicaltrials.gov identifier NCT02310269). Primary objective was to assess long-term safety of pasireotide alone or with other CD therapies.

RESULTS: At the time of this interim analysis, 127 patients had received pasireotide (new-use, n = 31; prior-use, n = 96). …

Collaboration Between Rheumatology Clinic And Specialty Pharmacy To Positively Impact Patient Experience And Hospital Stewardship, Alaina Linafelter, Julia G. Harris, Robert Herr, Stephanie Quinn, Ashley M. Cooper

Posters

Biologic medications are commonly utilized to treat pediatric rheumatic diseases. Being high-cost, most third-party payers require dispensing through a specialty pharmacy. Children's Mercy Hospital Specialty Pharmacy (CMH SP) started acceting patients in March 2015.

The number of patients benefited by the superior service of CMH SP has risen steadily, leading to high patient satisfaction and financial benefits for the hospital.

Clinical Evaluators Take Your Mark, Jodi Polaha, Mckenzie Highsmith, William Lusenhop, Deepu George, Adrian Sandoval

ETSU Faculty Works

• Discuss two implementation outcomes (adoption and reach) and explain why they are important for clinicians to measure and report, with application to own work
• Name sources of data that are accessible to clinicians in health care settings, with consideration of own setting.
• Describe a range of dissemination strategies used to create impact, including new ideas for dissemination of own work.

Multiple Sclerosis Outcomes After Cancer Immunotherapy, Catherine R. Garcia, Rani Jayswal, Val R. Adams, Lowell B. Anthony, John L. Villano

Markey Cancer Center Faculty Publications

INTRODUCTION: Neurological immune-related adverse events are a rare but potentially deadly complication after immune checkpoint inhibitor (ICI) treatment. As multiple sclerosis (MS) is an immune-mediated disease, it is unknown how ICI treatment may affect outcomes.

METHODS: We analyzed the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database for pembrolizumab, atezolizumab, nivolumab, ipilimumab, avelumab, and durvalumab 2 years prior their FDA approval until December 31, 2017, to include all cases with confirmed diagnosis/relapse of MS. We also included cases reported in the literature and a patient from our institution.

RESULTS: We identified 14 cases of MS …

Pediatric Surgery Opioid Prescription Follow-Up, Gadison Quick, Nathaniel Aviles, Gabriel Melgarejo, Hunjung Choi, Elizabeth Edmundson

Posters

This quality improvement project is assisting general and orthopedic surgeons in gaining greater clarity when prescribing opioids for specific surgical procedures. Additional surgical services are being added to the project fall of 2019. Opioid prescribing patterns are, and will continue to be, key to all prescribing providers within our organization.

An Update On Gestational Diabetes, Jamie L. Amero, Jennifer L. Bauer, Sarah M. Webb, Ryan A. Fischer, Lindsey A. Hallman, Sandra L. Hrometz

Pharmacy and Wellness Review

Gestational diabetes is a concern for a large number of pregnant women due to the potential for long-term complications for both the mother and the fetus. With the increasing prevalence of obesity and diabetes in the general public, the number of pregnant women with undiagnosed type 2 diabetes mellitus has also increased. In order to adequately educate their patients, it is important for pharmacists to be aware of the general practices of treating gestational diabetes. This review will highlight recent updates to initial screening, the criteria for diagnosing gestational diabetes, and current management strategies.

Pediatric Poisoning: Overview, Treatment, And Prevention, Margaret Rowland, Taylor Gauthier, Kaitlin Sanders, Caitlin Swann, David Bright

Pharmacy and Wellness Review

Pediatric poisoning remains a common and preventable occurrence in the United States. Every year, prescription and over-the-counter medications account for a significant portion of documented poison exposures. Frequent causes of overdose in children include improper medication storage and caregiver or physician dosing error. As easily accessible medication experts, pharmacists have an opportunity to counsel patients in an effort to decrease these preventable poisoning cases. Because children frequently ingest products prescribed for adult use, pharmacist should relay safety considerations to all patients, regardless of age. This article provides a general review of toxicity concerns, discusses clinical implications of common medications resulting …

Will New Mrsa Guidelines Make A Difference In Clinical Outcomes? A Comparison Of United States And United Kingdom Guidelines And Outcomes, Kelly Fargo, Erica Schoenberger, Kristen Thatcher, Lindsey Hallman, Andrew Roecker, Tarek Mahfouz

Pharmacy and Wellness Review

As of February 2011, the Infectious Disease Society of America (IDSA) published the first guidelines assessing the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections. S. aureus is present in the environment and is also located on the skin's surface. MRSA can cause a variety of clinical syndromes presenting with different symptoms that vary with the type and stage of the infection. MRSA is also classified into community-acquired MRSA (CA-MRSA) and hospital-acquired (HA-MRSA), both of which possess different treatment options and strategies. Due to the complex treatment of MRSA, as well the concern over the development of resistance, suggested treatment guidelines …

Osteoarthritis: Natural Supplements For Joint Health, Katherine Salay, Kimberly Gathers, Lindsey Mcclish, Lisa Vranekovic, Kristen Seaman, Ryan W. Naseman

Pharmacy and Wellness Review

An estimated 46 million adults in the U.S. are affected by arthritis, with osteoarthritis (OA) being the most common. Due to the limited pharmacologic therapy available to treat this condition, many patients are turning to dietary supplements to relieve their symptoms. Some of the most popular supplements available for the treatment of OA are glucosamine, chrondroitin and methylsulfonylmethane (MSM), but many less studied products are also available. Due to limited evidence of efficacy, it is difficult to make a strong recommendation for any of these products; however, pharmacists must be able to educate the patients that choose to use these …

Use Of Gastric Bypass Surgery For The Treatment Of Type 2 Diabetes Mellitus, Kaitlin A. Sanders, Jenna L. Schaffner, Leslie M. Hart, Whitney N. Detillion, Anne Gentry

Pharmacy and Wellness Review

Over the past decade, the incidence of type 2 diabetes mellitus (T2DM) has increased significantly. Evidence has shown that a clear association exists between obesity and diabetes development. This association has inspired researchers to explore bariatric surgery as an option for diabetes management and possible disease reversal. Improvement of T2DM using Roux-En-Y gastric bypass (RYGB) is thought to result from from a combination of weight loss, decreased caloric intake, hormonal changes and rearrangement of the gastrointestinal anatomy. Positive outcomes resulting from the procedure include decreased mortality rates, normalization of HbA1c levels, decreased dependence on diabetic medications, and increased insulin sensitivity. …

An Update On Exenatide And Liraglutide For Type 2 Diabetes Mellitus, Sarah M. Webb, Lacey A. Shumate, Ashley M. Overy, Ashley E. Lehnert, Monica A. Weisenberger, David R. Bright, Whitney N. Detillion

Pharmacy and Wellness Review

No abstract provided.

A Review Of Rivaroxaban, An Oral Anticoagulant, Lindsey A. Hallman, Chad A. Rounds, Rebecca A. Carey, Nicole R. Hume, Ryan W. Naseman, Karen L. Kier

Pharmacy and Wellness Review

No abstract provided.

A New Horizon: Emergency Department Pharmacy Practice, Amanda C. Mcdavid

Pharmacy and Wellness Review

No abstract provided.

Implementation Of Trauma Service Guideline For The Use Of Phenobarbital In The Management Of The Non-Icu Trauma Patient At Risk Or Experiencing Severe Alcohol Withdrawal, Joseph Rappold, Julianne Ontengco, Stephen Tyzik, Suneela Nayak, Ruth Hanselman, Amy Sparks

Operations Transformation

The trauma service in a large academic tertiary medical center admits a large proportion of patients with the secondary diagnosis of alcohol use disorder. Given the successful use of phenobarbital in the critical care unit for withdrawal prophylaxis and treatment of acute withdrawal, a quality improvement project was established to create and implement guidelines for the non ICU patient.

A root cause analysis demonstrated several issues to include inconsistent clinical decision documentation. As a result, several countermeasures were initiated to address the various issues.

Post implementation of countermeasures, a decrease in the amount of severe alcohol withdrawal as well as …

Improving Recognition And Reporting Of Adverse Drug Reactions In The Nicu: A Quality Improvement Project., Betsy Cammack, Alexandra Oschman, Tamorah R. Lewis Md Phd

Manuscripts, Articles, Book Chapters and Other Papers

Adverse drug reactions (ADRs) are under-recognized and under-reported in the Neonatal Intensive Care Unit (NICU) population, with up to 95% of all ADRs not reported. Compared with non-elderly adults, pediatric patients are 3 times more likely to experience an ADR, with varying rates from 0.6% to 16.8%. The Children's Mercy NICU has an ADR rate of 0.29% (2015). This high rate presents an opportunity to increase recognition and reporting, and improve characterization of ADRs in the NICU.

Methods: The primary aim of this quality improvement project was for 70% of patients who received specified medications (indomethacin, dexmedetomidine, fentanyl, lorazepam, dexamethasone, …