Pharmacy Administration, Policy and Regulation Commons^™

Evaluating The Market Withdrawal Of Andexanet Alfa, Jordyn Linfield, Addisyn Cooper, Alexander Defranco, Emma Gerding, Jessica Kelley, Tyler Henney, Connor Dains, Brenna Hissong, Brittany Bates

Pharmacy and Wellness Review

The coagulation cascade comprises intrinsic, extrinsic, and common pathways that converge when thrombin converts fibrinogen (factor I) into fibrin, leading to fibrin mesh formation, stabilization of the platelet plug, and ultimately thrombus formation. Inhibition of the coagulation cascade can be achieved with a variety of anticoagulant medications, including direct oral anticoagulants (DOACs). The mechanism of action of DOACs is to inhibit either factor Xa or thrombin. Reversal of anticoagulation remains an important clinical consideration when managing patients on DOACs who experience serious bleeding events. Andexanet alfa is a recombinant, modified human factor Xa protein previously indicated for patients receiving rivaroxaban …

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

Fda Approval Of Zuranolone: A Breakthrough Treatment For Postpartum Depression, Connor Dains, Makayla Eversole, Kiley Devoll, Daniella Egbujor, Marisa Petrunich, Madilyn Paphanchith, Joshua Honaker, Samantha Mccord, Manoranjan D'Souza

Pharmacy and Wellness Review

Postpartum depression (PPD) is a serious medical condition that increases the risk of postpartum mortality and affects the ability of a postpartum individual to take care of their newborn. Until 2023, intravenously-administered brexanolone was the only Food and Drug Administration (FDA)-approved medication for PPD. Brexanolone’s route of administration poses significant barriers to accessibility and convenience. Other treatment options, such as psychotherapy and antidepressants, often require long-term commitment and may not provide rapid relief for severe symptoms. In August 2023, the FDA approved zuranolone as an oral medication for PPD, which enhances treatment accessibility and offers patients a more flexible, outpatient …

Pharmacists Provision Of Non-Dispensing Services In Health Professional Shortage Areas, Haley L. Kessinger, Emily R. Landis

ONU Student Research Colloquium

Background: Individuals living in primary care health professional shortage areas (PCHPSAs) experience health inequities. Community pharmacists are healthcare professionals with an opportunity to provide care to underserved populations. The objective of this study was to compare non-dispensing services provided by Ohio community pharmacists in PCHPSAs and non-PCHSPAs.

Methods: An electronic, IRB-approved 19-item survey was sent to all community pharmacists practicing in full PCHPSA counties and a random sample practicing in non-PCHPSA counties in Ohio (n=324). Questions assessed current provision of non-dispensing services as well as interest and barriers regarding such services.

Results: Seventy-three usable responses were received (23% response rate). …

Student Self-Developed Wellness Goals Before And During Covid, Han Pham, Dalen Foster

ONU Student Research Colloquium

Background: This study aims to investigate the change over time in student developed well-being related goals based on the definition of “The 8 dimensions of wellness”. It is expected that the changes experienced by students during the COVID 19 pandemic will impact the type of wellness goals students develop for themselves.

Method: All pharmacy students at ONU are required to complete an annual goal setting assignment as part of their co-curricular requirement each academic year. Personal goals were extracted from submissions from 2019 to 2021. The goals were classified into 8 categories (emotional, financial, intellectual, occupational, physical, social, spiritual, and …

Professional Leadership Development, Jena Schlabach, Meagan Brandt, Olivia Vanscoy, Kasie Bellmann, Jenelle Sobotka, Marianne F. Ivey

Pharmacy and Wellness Review

No abstract provided.

Sterile Compounding: Regulations Addressed After The Meningitis Outbreak Of 2012, Kelly M. Dye, Tara M. Tokar, Halle M. Orlinski, Heather Helsel, Marcia M. Worley

Pharmacy and Wellness Review

No abstract provided.

Common Questions And Answers Regarding Oarrs For Pharmacists, Brittany M. Dye, Victoria S. Pennington, Rachel J. Pucel, Lindsay A. Fleegle, Donald L. Sullivan

Pharmacy and Wellness Review

No abstract provided.

Decoding The Prescription, Kim Baucher, Jessica Langhals, Ross Robison, Kristen Finley Sobota

Pharmacy and Wellness Review

No abstract provided.

Understanding Drug Shortages As A Pharmacist, Heather Helsel, Thomas Otroba, Juliana Zschoche, Elizabeth Dodds-Ashley

Pharmacy and Wellness Review

No abstract provided.

Legislation Across The Nation And The Impact On Pharmacy Practice, Sabrina Hamman, Hannah Lamb, Jennifer Harklerode, Elizabeth Kramer, Steven Martin

Pharmacy and Wellness Review

Pharmacy legislation is constantly being updated, giving pharmacists a larger role in the health care field. In the past 20 years, pharmacists have seen expansions to legislation involving contraceptive authority, medical marijuana, vaccines and provider status. There is a greater pharmacist impact from legislation passed on the state level in comparison to the national level. As a result, pharmacists have different opportunities to provide new and advanced services to patients based on the state in which they are practicing. Comparing these various laws across the nation allows the profession to determine which sections of the law are problematic and which …

Changing Roles In Leadership For Today's Pharmacist - A Look Into The New Acpe Draft Leadership Standards, Maureen Moynihan, Sabrina Hamman, Rachel Muhlenkamp, Steven Martin, Jenelle Sobotka

Pharmacy and Wellness Review

With the advancement of the profession of pharmacy, the demand for pharmacist leadership continues to rise. In order for pharmacists to acquire the necessary leadership skills for the profession, there is a call for colleges of pharmacy to incorporate leadership development into their academic programs. The Accreditation Council for Pharmacy Education (ACPE) has released the new 2016 Standards and Guidance Documents for institutions to follow in order for their pharmacy students to graduate with leadership skills.

Achieving Provider Status For Pharmacists, Kasie Bellmann, Alexandra Dimit, Kelsey Weisenburger, Donald L. Sullivan

Pharmacy and Wellness Review

In order to receive payment for medical services through Medicare Part 8, health care professionals must be identified as "providers" under the Social Security Act. Pharmacists currently are not included in the list of providers and, therefore, cannot provide many services to patients. Through their extensive education and training, accessibility and immense trust in their profession, pharmacists are the ideal health care professionals to help expand the continuity of care of our nation's patients. On Jan. 1, 2014, Senate Bill 493 was passed into law recognizing pharmacists in the state of California as providers. With this new legislation, the pharmacists' …

Legislation Editorial, Kent Wilin, Kaitlin Horton, Maria Laikos

Pharmacy and Wellness Review

No abstract provided.

An Update On Acetaminophen Labeling Changes: A Pharmacist's Call To Action, Rebecca Airel, Kayla Durkin, Taylor Gauthier, Jamie Amero, Natalie A. Dipietro

Pharmacy and Wellness Review

Due to the number of acetaminophen overdoses each year, the Food and Drug Administration and the National Center for Prescription Drug Programs made changes and recommendations regarding the labeling of acetaminophen-containing products. It is important for pharmacists to understand these changes and to educate patients on the correct use of these products.

Rems: Risk Management Strategies, Current Issues, And The Pharmacist's Role, Kristen Thatcher, Megan Stojic

Pharmacy and Wellness Review

Risk Evaluation and Mitigation Strategies (REMS) are the most recent risk management initiative put forth by the Food and Drug Administration (FDA) that decreases the risk associated with certain medications. They may be mandatory by the FDA or can be produced voluntarily by the manufacturer in order for a drug associated with significant risk to be approved. REMS may include one or multiple elements, including a Medication Guide (MedGuide), Communication Plan, Elements to Assure Safe Use (ETASU), Implementation Plan, and Timetable for Submission of Assessments. Although REMS enhance patient care by reducing risk and maintaining patient safety, an unbalanced burden …