Micaela Maeyaert, PharmD, BCPS, DPLA – Spirit Lake
Morgan Herring, PharmD, BCPS, FAPhA – West Des Moines
Brett Faine, PharmD, MS – Iowa City
Cory Garvin, PharmD – Wilton
HONORARY PRESIDENT
Marilyn Osterhaus, RPh – Maquoketa
PHARMACY TECHNICIAN
Connie Bentrott, CPhT – Ames
Kayla Batdorf – Drake University Rebecca Scribano – University of Iowa
The Journal of the Iowa Pharmacy Association is a peer-reviewed publication. Authors are encouraged to submit manuscripts to be considered for publication in the Journal. For author guidelines, see www.iarx.org/journal
“The Journal of the Iowa Pharmacy Association” (ISSN 1525-7894) publishes 3 issues per year: January/February/March/April issue; May/June/July/August issue; and September/October/November/ December issue by the Iowa Pharmacy Association, 2570 106th Street, Unit D, Urbandale, IA 50322. Periodicals postage paid at Des Moines, Iowa and additional mailing offices.
POSTMASTER: Send address changes to: The Journal of the Iowa Pharmacy Association, 2570 106th Street, Unit D, Urbandale, IA 50322. Published tri-annually, The Journal is distributed to members as a regular membership service paid for through allocation of membership dues. Subscription rates are $80 per year, single copies are $30. Printed by Mittera; Graphic design done by the Iowa Pharmacy Association.
IN EVERY ISSUE
LIVING IN THE GREY
Kate Gainer, PharmD
Executive Vice President & CEO, Iowa Pharmacy Association
There are pharmacists who prefer to have clear direction—black and white instructions—for how they practice pharmacy. I’ve pondered if our regulatory framework or training creates risk-aversion, or if payment models disincentivize permissionless innovation,1 or if people drawn to the pharmacy profession are naturally detail-orientated and less comfortable living in shades of grey. Pharmacists are trained to compound medications following a precise formula, we are trained to follow evidence-based guidelines for treatment recommendations, and our prescriptive authority is guided by statewide protocols or collaborative practice agreements.
The Iowa Pharmacy Association has always been a resource for Iowa pharmacists. Many questions relate to practice authorities and statutory or regulatory restrictions. Questions such as:
“Where in the Iowa Code does it say…?”
“Where in the Board of Pharmacy rules does it list…?”
“What exactly can I do (or can’t I do) pursuant to…?”
Answers to these questions come from bright-line legislation and rules. A bright-line rule is an objective rule that resolves legal questions in a straightforward, predictable manner. In the pharmacy profession, we’ve regulated ourselves with an abundance of bright-line statutes and rules.
Lists of which vaccines can be given, and to whom.
Lists of supplies that must be maintained.
Lists of duties that can or cannot be performed by a pharmacy technician, a certified pharmacy technician, a pharmacist-intern, a clerk, and even pharmacists.
Lists of specific education requirements, regardless of practice setting.
“Together as an association, IPA members will support one another, and we can all get a little more comfortable living in the grey.
Many pharmacists appreciate the straightforward, predictable manner of bright-line laws and rules. One problem with this framework is that you can’t legislate for every possible scenario, and when you try, there are unintended consequences.
The new Iowa Pharmacy Practice Act, which went into effect July 1, 2024, removes many bright-line sections of the code. Instead, the framework becomes a standard of care regulatory model, the same model used by other health profession licensing boards in our state.
To implement HF 555, the Iowa Board of Pharmacy will review and rewrite the entirety of its rule chapters beginning this fall. The first draft of this update reduces the number of BOP chapters from 43 down to 8. IPA will be thoroughly reviewing these rule revisions and submitting comments on behalf of our members and in line with IPA policy.
While some pharmacists are eager to practice pharmacy commensurate with their training and provide care for patients in their community, clinics, and institutions, other pharmacists are not yet comfortable with the removal of dozens of pages from Iowa Code 155A (Pharmacy Practice Act) and Iowa Administrative Code 657 (Board of Pharmacy rules).
With the absence of black-and-white law and rules that state explicitly what can or cannot be done in pharmacy practice, where will pharmacy professionals turn? IPA is ideally suited to provide guidance and resources to pharmacists to evaluate their practices within peer groups and shared resources.
Instead of questions asking for specific wording from a bright-line statute, these questions will evolve to navigate the grey. IPA is poised to help Iowa pharmacists understand the standard of care in their practice, their geography, and their level of training.
As the profession continues to evolve, the grey allows for greater flexibility, increased efficiency, and ultimately improved patient care. Together as an association, IPA members will support one another, and we can all get a little more comfortable living in the grey. ■
1. Adams, Alex J. “Toward Permissionless Innovation in Health Care.” Journal of the American Pharmacists Association, July 2015, www.japha.org/article/S1544-3191(15)30078-9/abstract.
COVER STORY:
A New Era: The Future of Pharmacy Practice Under a Standard of Care Regulatory Framework – Pages 6-11
BOARD ELECTION RESULTS
IPA congratulates the newly elected members of its Board of Trustees, who were installed at the 2024 IPA Annual Meeting, June 20-21 in Coralville, Iowa.
Jim Hoehns was installed as the association’s 146th President at the IPA Annual Meeting. Hoehns is a Clinical Associate Professor at the University of Iowa College of Pharmacy and Ambulatory Care Preceptor at Cedar Valley Primary Care. He was elected to the position last spring.
IPA thanks all candidates for their leadership in running and demonstrating their willingness to serve the profession in this capacity! ■
Ryan Jacobsen, PharmD, BCPS Vice Speaker of the House Iowa City
Betsie Frey, PharmD, BCPS Trustee At-Large Cedar Falls
Jim Hoehns, PharmD, BCPS, FCCP
President Cedar Falls
Kelly Kent, PharmD Trustee – Region #1 Williamsburg
Andy Stessman, PharmD Trustee At-Large West Des Moines
Wes Pilkington, PharmD President-Elect Waterloo
Helen Eddy, RPh, MBA Trustee – Region #3 Des Moines
Kelly Andersen, CPhT Pharmacy Technician Des Moines
A NEW ERA: THE FUTURE OF PHARMACY
PRACTICE
UNDER A STANDARD OF CARE REGULATORY FRAMEWORK
Authors:
Emmeline Paintsil, PharmD, MSLD, BCPS
Mikayla Harris, PharmD
Kate Gainer, PharmD
Seth
Brown, JD
Editor:
Allison Hale Luther
ABSTRACT
Acknowledgments:
Anthony Pudlo
Casey Ficek
Matt Eide
Kate Walton
Jennifer Adams
Andrew Funk
Pharmacy practice is undergoing a significant transformation with Iowa’s adoption of a standard of care regulatory framework. This paper explores the historical evolution and future trajectory of pharmacy practice within this new regulatory context, emphasizing enhanced patient care, professional autonomy, and innovation. The Iowa Pharmacy Association (IPA) has a legacy of advancing the profession through progressive legislation. The modernized Pharmacy Practice Act (HF 555), passed in 2024, makes Iowa the third state to adopt this framework, moving from prescriptive rules to a flexible, patient-centered approach. Key developments include removing outdated restrictions, adding therapeutic substitution, and establishing a standard of care framework. These changes support pharmacist prescriptive authority and advanced pharmacy services. This framework aligns pharmacy regulation with other healthcare disciplines, empowering pharmacists to deliver high-quality care. Continued collaboration between IPA, the Iowa Board of Pharmacy, and other stakeholders is crucial for successful implementation and evolution.
BACKGROUND
As stewards of the profession, pharmacists have a responsibility to create a future that supports the health of our communities. From the evolution of the BS Pharm to PharmD curriculum, to vaccinations provided by pharmacy technicians, and the provision of acute and chronic disease state management by pharmacists, the landscape of pharmacy is proactive and progressive. It meets the future demands of healthcare while ensuring the safety and well-being of patients.1 The Iowa Pharmacy Association has a rich legacy of leading and transforming the practice of pharmacy, whether through legislation or the collaborative development of innovative practice models and creative solutions, driven by a constant pursuit of progress and a brighter future.2
The landmark passage of the modernized Pharmacy Practice Act (HF 555) has positioned Iowa as the third state in the United States to adopt a standard of care regulatory framework, following Idaho and Alaska.3 Efforts spanning over six years through the IPA House of Delegates, collaboration with the Iowa Board of Pharmacy, virtual and in-person town hall meetings, and advocacy over two legislative sessions have culminated in the modernization of the Iowa Pharmacy Practice Act (Iowa Code 155A), which governs the profession of pharmacy.
The first Pharmacy Practice Act was established in 1880 and last revised in 1983-1987. The modernized Pharmacy Practice Act is the result of efforts from 2018-2024 and formally established a standard of care regulatory framework for the practice of pharmacy in Iowa. The changes today ensure that as the practice of pharmacy evolves, the regulatory landscape provides flexibility and broad authority without the need for continual legislative updates. With oversight from the Iowa Board of Pharmacy via rules (Iowa Administrative Code IAC), the modernization of the Pharmacy Practice Act enables pharmacy professionals to practice at the top of their training and expertise for the purpose of providing high-quality patient care.
Pharmacy of the future will be more technologically advanced, patientcentered, and integrated into the broader healthcare ecosystem. As we look to a future where the pharmacy profession takes on more clinical responsibilities while leveraging technology to handle routine tasks, ultimately leading to improved patient outcomes and more efficient healthcare delivery, our regulatory landscape must enable pharmacy professionals, including student pharmacists and young practitioners, to innovate and meet the demands of the future.4,5,6
History of Early Innovation in Iowa:7
1880: Iowa State Pharmaceutical Association organized by George Shafer, a young pharmacist from Fort Madison, successfully lobbied for the Iowa Pharmacy Law of 1880—the first Pharmacy Practice Act—establishing pharmacy as the state’s first legally recognized profession. He was elected as the first President of ISPA.
1882: Iowa College of Pharmacy established (now Drake University College of Pharmacy and Health Sciences).
1885: University of Iowa College of Pharmacy established.
1896: The Iowa State Pharmaceutical Association (ISPA) changed its name to the Iowa Pharmaceutical Association (IPhA).
Regulation of Pharmacy and Other Healthcare Professions
“Laws and regulations are intended to protect the public; however, overregulation of the profession can block initiatives focused on patient safety and public health.”7 Pharmacy laws, in comparison to those governing medicine and nursing, tend to be lengthier, impose more restrictions, are generally newer, and are amended more frequently. Specifically, pharmacy regulations contain 97.5% more words than those for nursing and 105.8% more words than those for medicine regarding professional practice standards.9 Pharmacists, uniquely, are accustomed to practicing under bright-line rules. A bright-line rule is an objective rule that resolves a legal issue in a straightforward, predictable
STANDARD OF CARE
manner. It is easy to administer and leaves little room for varying interpretation, providing a clear and consistent legal resolution with a lack of flexibility.10,11
Other healthcare disciplines (medicine, nursing, dentistry, veterinary) operate under a standard of care regulatory framework, designed to maintain high standards of patient care and professional conduct. At its core is peer review, a self-regulatory mechanism vital to upholding the standard of care. Peer review processes, conducted by ethics committees, hospital credentials committees, and other professional bodies, assess professional conduct and promote adherence to ethical standards. This system balances the autonomy of healthcare professionals in medical decision-making with accountability, adhering to fairness and objectivity to maintain trust and safeguard individual rights.
Prior to the modernization of the Iowa Pharmacy Practice Act, Iowa Code 155A stood out from other healthcare practice acts in Iowa due to its stringent regulations (bright-line regulations) on the drug supply chain, physical pharmacy locations, and individual licensees and registrants—pharmacists, certified technicians, interns, and pharmacy support persons.
Modernizing the Iowa Pharmacy Practice Act positions pharmacists to deliver clinical services across various practice settings, enhancing patient- and practice-specific decision-making. The goal is to be less prescriptive and allow for flexibility in pharmacy practice without requiring legislative changes each time practice advances. This update allows Iowans to fully benefit from the extensive training and education pharmacists receive.
What is Standard of Care & What Has Changed in Iowa?
Pharmacy Practice Under a Standard of Care Regulatory Model
General Principles:
Pharmacists can practice, and will be regulated, under a standard of care framework, and must consider:
1. Is the act expressly prohibited in statute, rules, or regulations?
2. Is the act consistent with their education, training, and experience (degree, credentials, certifications, continuing education, etc.)?
Standard of care is defined as the level of care and service that a reasonably competent and skilled health professional, with a similar background and in a similar setting, would have provided under similar circumstances. This is often considered within the context of actions that led to alleged malpractice.12 It is a benchmark used to measure the quality and appropriateness of the care provided by healthcare practitioners. The standard of care model allows for greater flexibility and increased efficiency and autonomy in practice.
3. Is the act within the accepted standard of care that would be provided in a similar setting by a reasonable and prudent licensee or registrant with similar education, training, and experience?
The regulatory model based on the “standard of care” is determined by the individual circumstances that present in practice rather than specific requirements codified in law, allowing for flexibility as practice guidelines change, technology changes, and new knowledge is identi-
Pharmacy Practice Under a Bright-Line Regulatory Model
Adams, Jennifer L. “Perspectives on Implementing Standard of Care Regulation.” 14 July 2022.
STANDARD OF CARE
fied. This model requires less regulatory modification to keep pace with change.
Standard of care is not to be confused with scope of practice or clinical ability. Scope of practice refers to the services that a qualified health care professional is deemed competent to perform and permitted to undertake according to the terms of their professional licensure. It encompasses the activities a health professional is allowed to engage in, as defined by state laws and regulations. This is what you may do.
Scope of practice is determined by the political process, leading to geographical differences. It applies uniformly to all professionals within a class (one-size-fits-all) and remains static, except for changes in the law.13 Specialized pharmacists, such as those certified in ambulatory care, may order and interpret laboratory tests to monitor and adjust medication therapy. Clinical pharmacists in areas like oncology or critical care may design and manage intricate medication regimens tailored to individual patient needs. Additionally, pharmacists with certifications in pharmacogenomics conduct genetic testing and provide counseling to guide medication selection and dosing based on a patient’s genetic profile.
Clinical ability refers to the true competence and ability of a health professional. It is determined by their education, training, career experience, and practice environment.14 This is what you can do. Clinical ability is unique to each professional, recognizing that everyone has different skills and expertise. It is dynamic, advancing with new education, technology, and practice. For pharmacists, clinical ability might include competencies such as: performing comprehensive medication reviews; providing immunizations; managing chronic disease states; offering patient education and counseling; conducting health screenings and diagnostic tests; implementing medication therapy management (MTM) services; or ordering and interpreting laboratory tests.
How Did We Get Here?
After two years of legislative advocacy by IPA, Iowa became the third state behind Idaho and Alaska to pass a standard of care regulatory framework for the practice of pharmacy.3
Catalyst for Change from Idaho, NABP, and APhA
The catalyst for regulatory change began in 2018 when the National Association of Boards of Pharmacy (NABP) formed the Task Force to Develop Regulations Based on Standards of Care, aimed at assisting states in crafting regulations grounded in “standards of care” instead of “prescriptive rule-based regulation.” The task force recommended that NABP encourage state boards of pharmacy to review and update outdated regulations, balancing patient safety with professional practice. They discussed “permissionless innovation,” citing Idaho’s approach, which allows pharmacists to perform any act not expressly prohibited by law, provided it aligns with their education, training, and meets the accepted standard of care. Additionally, the task force suggested NABP collaborate with states adopting standards of care-based regulations to monitor and share outcomes.15 In 2022, the American Pharmacists Association (APhA) House of Delegates adopted official policy on Standard of Care.16
Standard of Care Regulatory Model for State Pharmacy Practice Acts
1. APhA requests that state boards of pharmacy and legislative bodies regulate pharmacy practice using a standard of care regulatory model similar to other health professions’ regulatory models, thereby allowing pharmacists to practice at the level consistent with their individual education, training, experience, and practice setting.
2. To support implementation of a standard of care regulatory model, APhA reaffirms 2002 policy that encourages states to provide pharmacy boards with the following: (a) adequate resources; (b) independent authority, including autonomy from other agencies; and (c) assistance in meeting their mission to protect the public health and safety of consumers.
WHAT WAS REMOVED WHAT WAS ADDED WHAT STAYS THE SAME
• General principles to the Practice of Pharmacy — Standard of Care
• “Pharmacist” added to the definition of “Practitioner”
• Paves way for pharmacists to apply for individual CSA registrations
• Allows pharmacists to prescribe
• Therapeutic Substitution: Allows pharmacists to substitute therapeutically equivalent products
• Pharmacists may authorize refills pursuant to SOC
• Authority for the BOP and HHS to adopt statewide protocols
• Telepharamcy restrictions, including 10-mile radius requirement
• Requirement for in-state pharmacies to include a PIC (pharmacist in charge) on license registration
• Notification requirements to BOP
• Medication selection restrictions
• Statewide protocols and authority for pharmacist and pharmacy technician vaccine ordering and administering
On August 7, 2024, the Iowa Board of Pharmacy noticed for intended action eight (8) new regulatory chapters. These new rules are intended to implement HF 555 along with Governor Reynolds’ Executive Order 10. Iowa Board of Pharmacy chapters will be identified in Iowa Administrative Code (IAC) as follows: DIAL’s agency identification is 481 (Board of Pharmacy ID was previously 657). New chapters will be named 481 IAC chapters 550-569. The initial draft of new BOP chapters includes 481 IAC chapters 550-557, reserving 12 chapters for future use if needed.
3. APhA encourages NABP as well as state and national pharmacy associations to support and collaborate with state boards of pharmacy in adopting and implementing a standard of care regulatory model.
4. APhA and other pharmacy stakeholders should provide educational programs, information, and resources regarding the standard of care regulatory model and its impact on pharmacy practice.
IPA House of Delegates Adopts Policy to Form Joint Task Force Between IPA and BOP
In 2019, the IPA Policy Committee on Public Affairs submitted a report to the IPA Board of Trustees, detailing the 1983-1987 joint effort of IPA and the Iowa Board of Pharmacy to revise and modernize the Iowa Pharmacy Practice Act and if such an effort needed to be undertaken once again in response to the evolving practice of pharmacy.17 Keeping with the rich tradition of IPA’s House of Delegates, the association’s policy-making body reviewed internal history and external trends and adopted a future-focused policy to guide IPA. That same year, the IPA House of Delegates adopted 19-U2: REVISIONS TO THE IOWA PHARMACY PRACTICE ACT, a policy to create a task force in conjunction with the Iowa Board of Pharmacy. The IPA House of Delegates would later pass three policies from 2022-2023 to support the standard of care regulatory model and alignment of the pharmacy practice.
One Profession, One Voice – A Collaborative Effort Led by The Practice Act Task Force
The Practice Act Task Force (PATF), comprised of pharmacists and pharmacy technicians from a diverse array of practice backgrounds, was established and met for the first time during the fall of 2020, with their mission being to identify and discuss the need, essential components, and purpose for modernizing Iowa’s Pharmacy Practice Act to ensure the profession of pharmacy can meet the current and future needs of patients. The PATF navigated the COVID-19 pandemic and public health emergency while gathering input from Idaho on how they reached a standard of care framework and taking a deep look into the Practice Act. Over 120 pharmacists, student pharmacists, and pharmacy technicians participated in the five virtual and socially-distanced in-person town halls. Based on the discussion, a working draft of a new Practice Act was developed, and a new vision and goal were shaped.
Meetings on Bob Osterhaus’ Porch & Leadership Discussions
STANDARD OF CARE
2018-2019 IPA Policy Committee on Public Affairs
Angie Danielson, PharmD, Bettendorf – Chair
Dena Dillon, PharmD, Iowa City – Vice Chair
Morgan Herring, PharmD, BCPS, FAPhA, West Des Moines – Past Chair
Jim Hoehns, PharmD, BCPS, FCCP, Cedar Falls – Speaker of the House
Ashley Dohrn, BA, PharmD, CGP, Woodland Park, CO –Vice Speaker of the House
Samantha Campbell, Student Pharmacist, Drake University
Maia Determan, Student Pharmacist, Drake University
Olivia Welter, Student Pharmacist, Drake University
Trang Dang, Student Pharmacist, University of Iowa
Raemi Chavez, Student Pharmacist, University of Iowa
Bob O.’s porch has long been a venue for intellectualizing and strategizing on the future of the pharmacy profession, encouraging the intersection of personal, professional, and political ideas. In light of a significant shift in pharmacy history, IPA convened a Bob O.’s Porch Meeting in 2023 to discuss the future and needs under a new Pharmacy Practice Act. Sixteen pharmacy leaders gathered in Maquoketa to share insights and develop a strategic roadmap for advancing pharmacy practice toward a standard of care model. The meeting aimed to collect input and expertise from these leaders, identify opportunities and responsibilities for key stakeholders, and prepare Iowa to lead nationally in creating resources for professional standards of pharmacy practice.
Patty Kumbera from Kumbera Solutions facilitated the discussion, fostering a collaborative environment. Despite having an agenda, the meeting’s organic format encouraged rich, engaging discussions and innovative ideas not necessarily confined by structured topics. Attendees were fully engaged, contributing to deep discussions about the future of the profession. The outcome was a comprehensive strategy to support pharmacy professionals and ensure the profession’s readiness upon the passage of the new Practice Act, positioning Iowa as a leader in the field.
STANDARD OF CARE
Advocacy Across Two Sessions and What It Takes to Get a Significant Bill Across the Finish Line
On January 10, 2023, Governor Kim Reynolds issued Executive Order #10, which imposed a moratorium on new administrative rulemaking and required a comprehensive review of all existing rules by December 31, 2026. The order aimed to streamline Iowa’s regulatory framework by eliminating outdated, obsolete, or duplicative regulations, thereby reducing the overall regulatory burden. It also directed the Administrative Rules Coordinator to develop a standardized process for evaluating the cost-benefit of current rules and exploring less restrictive alternatives.18 The political environment to remove red-tape and regulatory inefficiency added synergy with a modernized Pharmacy Practice Act allowing for a standard of care regulatory framework.
Drafts of the Pharmacy Practice Act were shared with stakeholders, including the Iowa Board of Pharmacy, Iowa Medical Society, legislators, and the executive branch for feedback. These conversations were imperative to ensure alignment and address any concerns before introduction during the legislative session.
In 2023, IPA introduced HF 555, advancing the bill through the House of Representatives on a vote of 86-10 and unanimously through the Senate Health and Human Services Committee. The bill did not make it to a full Senate vote in 2023 due to concerns related to COVID-19 and access to ivermectin treatment options for patients as well as vaccine administration. IPA committed to educating lawmakers throughout the interim, discussing hesitancies and clarifying what the bill allowed for pharmacy professionals.
In 2024, the modernized Iowa Pharmacy Practice Act was reintroduced as HF 555. The Senate passed the bill unanimously with one amendment, sending it back to the Iowa House of Representatives. On Wednesday, April 4, HF 555 passed the House of Representatives on a vote of 87-9 and was signed into law on April 19, 2024, by Governor Kim Reynolds.
IPA Policies
19-U2 REVISIONS TO THE IOWA PHARMACY PRACTICE ACT
1. IPA supports the development of a joint task force with the Iowa Board of Pharmacy to evaluate the current Iowa Pharmacy Practice Act and the need for modernization.
2. IPA supports a thorough consensus building process among stakeholders within and outside of the profession of pharmacy prior to finalizing the recommendations from the joint task force.
22-U2 STANDARD OF CARE MODEL FOR PHARMACIST PRACTICE
1. IPA supports an Iowa Pharmacist Practice Act based on standard of care.
2. IPA supports a standard of care regulatory framework, consistent with other healthcare providers, to allow flexibility based on the individual circumstances that present in professional practice.
3. IPA supports educating and empowering pharmacy professionals to practice using a standard of care model.
23-U3 PHARMACIST PROFESSIONAL STANDARDS
1. IPA reaffirms 22-U2.
2. IPA supports stakeholder collaboration in the development of resources and professional standards for pharmacists practicing in a standard of care model.
3. IPA supports professional standards for pharmacists based on education, training, and experience for their practice setting.
23-R2 PHARMACIST PRESCRIPTIVE AUTHORITY
1. IPA supports pharmacist prescriptive authority commensurate with their training and education and in accordance with the standard of care.
2. IPA recognizes that pharmacist prescriptive authority improves access to healthcare services for all patients to achieve optimal outcomes.
Practice Act Task Force Members (2019-2021)
Brett Barker, PharmD, Nevada
Connie Connolly, RPh, BCACP, LeClaire
Susan Frey, RPh, Villisca
Brandon Gerleman, PharmD, RPh, Winterset
Jason Hansel, PharmD, Bettendorf
Micaela Maeyaert, PharmD, BCPS, DPLA, Spirit Lake
Erik Maki, PharmD, BCPS, Johnston
Lisa Mascardo, PharmD, MBA, FASHP, North Liberty
Emily Muehling, PharmD, BCPS, Urbandale
Diane Reist, BS, PharmD, RPh, Cedar Rapids
Cheri Schmit, RPh, Ames
Stevie Veach, PharmD, BCACP, Bellevue
Amy Wadstrom, RPh, Pleasant Hill
Amanda West, CPhT, Cedar Falls
What Comes Next?
The Iowa Board of Pharmacy continues to conduct its comprehensive rule review under Executive Order #10 (EO10). The Board released a tentative timeline for rulemaking pursuant to EO10 and incorporating SF 2370 requirements starting July 1, 2024. The Board expects to have rules adopted in February 2025, with an effective date in the spring of 2025. The rulemaking timeline can be found in the June-July LIRC newsletter.
IPA is focused on creating educational resources for members and collaborating with the Board of Pharmacy to implement this legislation. IPA is developing a comprehensive education and implementation plan to help members and non-members understand and apply the standard of care framework. This plan will include working through case studies, engaging in discussions with colleges, and considering MPJE requirements with the Board of Pharmacy. Additionally, the plan will address feedback from members, focusing on risk management, liability, audit concerns, billing practices, and business development. To further support pharmacy professionals practicing in Iowa, IPA will host a Standard of Care Symposium on February 22, 2025.
Practice Considerations
IPA recommends continuing to operate under the existing Iowa Administrative Code (Board of Pharmacy rules) while the landscape evolves.
✓ Use current operations as a foundation.
✓ Conduct an audit of your current business and cognitive services to identify areas needing updates.
✓ Ensure that standard operating procedures, policies, and processes are in place and up to date.
✓ Stay informed by subscribing to and regularly checking IPA’s Law and Information Resource Center (LIRC).
✓ Engage with IPA staff and leadership regularly for guidance and support.
✓ Bookmark IPA’s Standard of Care webpage (www.iarx.org/soc) for easy access to relevant resources.
✓ Submit your questions to IPA (ipa@iarx.org) to clarify uncertainties and stay ahead of changes.
Additionally, pharmacists can follow the Pharmacists’ Patient Care Process (PPCP), developed by the Joint Commission of Pharmacy Practitioners (JCPP). The PPCP is a structured method for pharmacists to deliver care across various services and practice settings. The Accreditation Council for Pharmacy Education (ACPE) mandates pharmacy schools to include the PPCP in their curricula. Consistent application of the PPCP allows for effective measurement of the outcomes and value of pharmacists’ services, ensuring standardized expectations for consumers, healthcare providers, and payers. This method is an evidence-based approach adaptable to various practice settings and supports consistency and quality in patient care.19
CONCLUSION
The adoption of the standard of care regulatory framework marks a pivotal moment for Iowa’s pharmacy profession. This framework aligns pharmacy regulation with other healthcare disciplines, empowering pharmacists to deliver high-quality, patient-centered care. The shift from rigid rules to a flexible, innovative approach enhances professional autonomy and patient outcomes. The ongoing collaboration between the Iowa Pharmacy Association, the Iowa Board of Pharmacy, and other stakeholders will be essential in ensuring the successful implementation and continued evolution of this regulatory model, positioning Iowa as a leader in modern pharmacy practice.
References:
1. Elenbaas, R. M., Worthen, D. B., & Webb, E. (2009). Clinical pharmacy in the United States. Lenexa, KS: American College of Clinical Pharmacy.
2. About Us. About IPA | Iowa Pharmacy Association. https://www.iarx.org/aboutus.
3. Cathers M. Iowa bill updates pharmacy practice act to standard of care framework. American Pharmacists Association. July 3, 2024. https://www.pharmacist.com/Pharmacy-News/
4. Van Antwerp G, Bhatt V, Myers G, Elsner N, Shah S. The pharmacist of the future. Deloitte Insights.
5. PAI 2030 Recommendations. ASHP.
6. DiPiro JT, Hoffman JM, Schweitzer P, et al. ASHP and ASHP Foundation Pharmacy Forecast 2024: Strategic Planning Guidance for Pharmacy Departments in Hospitals and Health Systems. Am J Health Syst Pharm. 2024;81(2):5-36. doi:10.1093/ajhp/zxad231
7. Anderson, L., (1991) “A Case of Thwarted Professionalization: Pharmacy and Temperance in Late Nineteenth-Century Iowa”, The Annals of Iowa 50(7), 751-771. doi: https://doi. org/10.17077/0003-4827.9508
8. Adams JL, O'Connor S, Seignemartin B, et al. Battling professional self-sabotage: Embracing standard of care as the future of pharmacy regulation. J Am Pharm Assoc (2003). 2023;63(6):1685-1688.e1. doi:10.1016/j.japh.2023.08.015
9. Adams AJ. Transitioning pharmacy to “standard of care” regulation: Analyzing how pharmacy regulates relative to medicine and nursing. Research in Social and Administrative Pharmacy. 2019;15(10):1230-1235.
10. Adams, Jennifer L. “Perspectives on Implementing Standard of Care Regulation.” 14 July 2022.
11. Bright-line rule. LII / Legal Information Institute. https://www.law.cornell.edu/wex/brightline_rule
12. Vanderpool D. (2021). The Standard of Care. Innovations in clinical neuroscience, 18(7-9), 50–51.
13. Downie S, Walsh J, Kirk-Brown A, Haines TP. How can scope of practice be described and conceptualised in medical and health professions? A systematic review for scoping and content analysis. Int J Health Plann Manage. 2023;38(5):1184-1211. doi:10.1002/hpm.3678
14. Adams AJ, Weaver KK. Pharmacists’ Patient Care Process: State “Scope of Practice” Priorities for Action. Annals of Pharmacotherapy. 2021;55(4):549-555. doi:10.1177/1060028020950193
15. Report of the Task Force to Develop Regulations Based on Standards of Care. National Association of Boards of Pharmacy. May 2018. https://nabp.pharmacy/wp-content/uploads/2018/12/Task-Force-to-Develop-Regulations-Based-on-Standards-of-Care-December-2018.pdf
16. Actions of the 2022 American Pharmacists Association House of Delegates San Antonio, Texas March 18 – 21, 2022. Journal of the American Pharmacists Association. 2022;62(4):941-943. doi.org/10.1016/j.japh.2022.05.007
17. IPA Policy Committee on Public Affairs. Iowa Pharmacy Association. March 7, 2019. https://iowapharmacyassociation.sharepoint.com/Shared%20Documents/shrdata/X. Past%20Employees/APudlo/Committees/Policy%20Committees/PUblic%20Affairs/2019/ Final%20Packet/Pub%20Cmte%20Packet1.pdf?CT=1721869576416&OR=ItemsView
18. State of Iowa Executive Department. “Executive Order 10.” State of Iowa | Governor Kim Reynolds, 10 Jan. 2023, governor.iowa.gov/media/182/download?inline=.
19. Burns A. 2018. What is the Pharmacists Patient Care Process and why is it important? Pharmacy Today. https://www.pharmacytoday.org/article/S1042-0991(18)30492-4/fulltext
In February, IPA welcomed 140 pharmacists and pharmacy technicians to the 2024 PharmaCE Expo in downtown Des Moines. Featured topics included blending Community Health Workers (CHWs) and pharmacy practice, AI and advanced technology in pharmacy, promoting health assessments for women, updates in the management of mental health conditions, and much more. Erik Dominguez, BA, MS, delivered this year’s keynote on the importance of speaking up in professional settings to advance your personal growth, organizational progress, and pharmacy innovation. 14 hours of continuing pharmacy education were available during this year’s two-day event.
As PharmaCE Expo numbers have declined in recent years, IPA is evolving to better meet our members’ needs. In 2025, IPA will host a one-day Standard of Care Symposium to educate pharmacists and technicians on Iowa’s modernized Pharmacy Practice Act (HF 555) and what it means for your pharmacy practice, offering 6 hours of continuing pharmacy education. Save the date for February 22, 2025 in West Des Moines! ■
L to R: Emmeline Paintsil, PharmD, MSLD, BCPS; Biz McChesney; Kimberly McMains, MHA
UNIVERSITY OF IOWA CLASS OF 2024
While they met four years ago as small squares on a Zoom call, the University of Iowa (UI) College of Pharmacy Class of 2024 concluded their educational journey during commencement at Iowa City’s Hancher Auditorium on May 9 in person, shoulder-to-shoulder, with no masks, and surrounded by friends, family, and faculty. The 100-member class began their first year of pharmacy school in the fall of 2020, as the COVID-19 pandemic raged.
“You persevered and we’re going to celebrate that today,” said Dean Donald Letendre, presiding over his final commencement as the College’s leader.
WORDS OF WISDOM
Lessons learned emerged as the ceremony’s theme. Class of 2024 President Savannah Anderson shared key insights she will carry with her.
“Never stop advocating for yourself and your patients; more people believe in you than you think; sometimes the most impactful thing you can do is listen; and when things get difficult, remember there are always people in your life that will support you,” she said.
“It has been a privilege to earn a doctorate degree at the University of Iowa while being supported by so many great friends, faculty, and mentors.”
This year’s guest speaker was well-known to graduates.
Susan Vos, Senior Director of Student Affairs at the American Association of Colleges of Pharmacy, spent
17 years as a UI College of Pharmacy faculty member and most recently also was Associate Dean of Student Affairs. The Class of 2024 had heard her lecture on pediatric pharmacy, leadership, and more prior to her departure last fall.
“You are one of the most resilient groups of students I have encountered, and I am grateful to be part of your special day,” said Vos. She went on to impart two life lessons she has learned.
“The first one: happiness is not a destination, it is a direction,” she said. Referencing a book by a Harvard ‘happiness professor,’ she noted three “macronutrients that are essential ingredients to build a life…aimed in the direction of happiness:
• Enjoyment: the people you love and the memories you make,
• Purpose: serving others – be good to one other person each day, and
• Satisfaction: that thrill from accomplishing a goal – when faced with struggles, ask yourself ‘what is a list of things I can do today that can make this better?’”
The second life lesson Vos referenced was to “look for the breadcrumbs and leave breadcrumbs for others.” Follow the professional path others have left for you and “look for opportunities to add value to someone else’s career.”
Additional commencement participants were UI President Barbara Wilson; Amber Goedken, Interim Associate Dean and Associate Professor; and Mary Ray, Associate Dean and Clinical Associate Professor. Wilson told graduates, “Wherever you go, think about wearing something with a Tiger Hawk on it. Someone is going to yell out to you, ‘Go Hawks!’”
Letendre closed the ceremony proclaiming that this is just the beginning for the Class of 2024. “You will be obligated to
Credit: University of Iowa College of Pharmacy, May 16, 2024
DRAKE UNIVERSITY CLASS OF 2024
draw upon all of your special knowledge and skills to ensure the health and safety of those for whom you have been entrusted to serve.”
The evening before commencement, a recognition event was held in the College’s lobby/auditorium for graduates and their families. Goedken announced individuals receiving dual degrees, certificates, recognition cords, and more, while Letendre presented the commencement speaker’s medallion to Vos. Iowa Pharmacy Association Executive Vice President & CEO Kate Gainer and Director of Professional Affairs Emmeline Paintsil were also in attendance and applauded the class on joining an important profession. ■
The College of Pharmacy and Health Sciences (CPHS) held the annual Professional Hooding and Commencement Ceremony for professional program students on Saturday, May 18th, 2024. The CPHS Bachelor of Science in Health Sciences undergraduate students participated in the University Undergraduate Commencement Ceremony held on Sunday, May 19th.
Receiving their degrees and doctoral hoods during the CPHS Hooding and Commencement Ceremony were:
• 49 Occupational Therapy Doctoral (OTD) students
• 76 Doctor of Pharmacy (PharmD) students
• 8 Master of Athletic Training (MAT) graduates
• 9 Master of Health Informatics and Analytics (MSHIA) graduates, and
• 3 Master of Clinical Psychopharmacology (MSCP) graduates.
In addition to the doctoral and master’s degrees, many of the graduating students also received additional degrees or designations.
The Hooding and Commencement Ceremony included reflections from three of the graduating class student government representatives. Olivia Freehill (OTD), Tessa Laska (MAT), and Meghan Ryan (PharmD) reflected on their experiences from the time they stepped foot on Drake’s campus to graduation and provided words of encouragement for the graduates as they start their careers. These students also led their classes through the Oath of an Occupational Therapist, the Oath of an Athletic Trainer, and the Oath of a Pharmacist.
Drake University Provost Sue Mattison conferred the degrees. Rick Knudson, PH’98, Pharmacy Consulting Director with Huron Consulting Group in New York and Chair of the College’s National Advisory Council, welcomed the graduates into the Drake CPHS alumni network.
Pharmacy graduate awards announced during the ceremony included:
Abby Riewer – Viatris Excellence in Pharmacy Award
Erin Maxwell – Wolters Kluwer Clinical Drug Information Award of Excellence in Clinical Communication
Kayla Olstinske – Russell Johnson Outstanding Community Practice Graduate Award
Peyton Braun – Merck Royal Society of Chemistry Certificate of Excellence, and Nirjan Bhattarai – Jerry L. Karbeling Memorial Leadership Award. ■
Credit: Drake University College of Pharmacy & Health Sciences, June 3, 2024
NEW DEANS AT BOTH IN-STATE COLLEGES OF PHARMACY
Both Drake University College of Pharmacy and Health Sciences and the University of Iowa College of Pharmacy recently conducted a Dean search.
On May 6, Drake University College of Pharmacy and Health Sciences announced its new dean as Dr. Erik Maki, PharmD, BCPS. Maki assumed his new role on July 1, 2024. Since 2005, Dr. Maki has been a professor at Drake, most recently serving as Chair of Pharmacy Practice, a role in which he oversees 19 faculty members and instructional, research, and service operations of the department. Maki has been instrumental in the launch of new programs, including a master’s in athletic training, healthcare informatics and psychopharmacology, as well as the Occupational Therapy Doctorate program.
On May 23, the University of Iowa College of Pharmacy announced that Dr. Jill M. Kolesar, PharmD, MS, BCPS, FCCP, would serve as the college’s next Dean, assuming her new role on July 15, 2024. Most recently, Dr. Kolesar served as a University Research Professor at the University of Kentucky College of Pharmacy and the Dr. Michael Karpf Endowed Chair in Precision Medicine. Kolesar has extensive experience in oncology drug development and precision medicine, authoring over 150 peer-reviewed research articles and receiving more than $15 million in research funding from national organizations.
IPA thanks Deans Chesnut and Letendre for their dedicated leadership and collaboration during their tenure as Deans!
DIAL NAMES NEW BOARD OF PHARMACY EXECUTIVE DIRECTOR
Iowa’s Department of Inspections, Appeals, and Licensing (DIAL) has named a new Executive Director of the Iowa Board of Pharmacy, Anne Schlepphorst. Schlepphorst serves as the Bureau Chief of Monitoring and Executive Director of the Board of Pharmacy and Board of Nursing. Schlepphorst previously worked for the Board of Medicine as a Health Professions Investigator and was promoted to Chief Health Professions Investigator.
Following Governor Reynolds’ state agency realignment initiative, the Board of Pharmacy Executive Director is no longer hired by the members serving on the Board of Pharmacy, rather by the agency. The role is restructured from previous Board of Pharmacy Executive Directors, as Schlepphorst oversees all DIAL staff in the Bureau of Monitoring, as well as the Boards of Nursing and Pharmacy.
IPA looks forward to continuing a strong relationship with the state’s Board of Pharmacy, staff and Executive Director.
GAINER CONCLUDES NASPA LEADERSHIP
IPA’s CEO, Kate Gainer, recently concluded her term on the Board of Directors of NASPA (National Alliance of State Pharmacy Associations). Gainer served as a Presidential Officer from 2021-2024 (President 2022-2023) and two terms as a Director from 2017-2021. During Gainer’s time on the board, NASPA hired its second Chief Executive Officer, Krystalyn Weaver, JD, PharmD, who began her role with NASPA in February of 2024. As President of NASPA, Gainer attended three Joint Commission of Pharmacy Practitioners meetings (JCPP) and presented on the role of state pharmacy associations in advancing legislative priorities. Iowa has a strong history of leadership at NASPA (previously named the National Council of State Pharmacy Association Executives, NCSPAE) with Gainer being the sixth president from Iowa.
PRACTICE ADVANCEMENT
CARDIOVASCULAR HEALTH GRANT
IPA’s new Cardiovascular Health Grant Initiative, launched in collaboration with the State of Iowa Department of Health and Human Services and funded by federal grants from the National Cardiovascular Health Program and the CDC, is entering its second year on August 1st, following the completion of its implementation planning phase. This initiative focuses on identifying and supporting high-risk cardiovascular disease (CVD) patients, particularly those with hypertension and high cholesterol. Feedback from members has been helpful in refining the work plan, emphasizing infrastructure development. Key objectives include leveraging health information systems, forming multidisciplinary teams to address social service needs, enhancing community-clinical partnerships, and training pharmacy technicians as community health workers. The initiative’s goals are divided into short-term, intermediate, and long-term categories, all aimed at improving cardiovascular health and reducing health disparities.
PAI 2030
Last year, the IPA Board of Trustees created a task force to support ASHP’s Practice Advancement Initiative 2030, aiming to advance pharmacy practice to meet healthcare demands. The task force has worked hard over the past year, holding forums, creating FAQ guides, and gathering data to improve patient care in Iowa. By June 2024, Iowa ranked second nationally in completing the organizational assessment tool, just behind Wisconsin.
The task force is now analyzing data to identify key areas for improvement and where IPA can provide support through resources, training, and workshops. Key areas of need and focus as identified from survey results across the state include medication reconciliation and pharmacy technician roles. The PAI 2030 Task Force continues to encourage the completion of the self-assessment tool and involvement of residents and student pharmacists in the process.
HEALTH COACH TRAINING PROGRAM
IPA and CEimpact have launched a new health coaching advanced training program for pharmacists, offering 8 hours of on-demand continuing education in Pharmacy Administration and a certificate upon completion. Funded by the COVID-19 Vaccine Equity Grant from the Iowa Department of Health and Human Services, the program equips pharmacists with expertise in health coaching, motivational interviewing, and sustainable business practices, such as billing for services.
This comprehensive training covers behavior change, communication techniques, and video case studies, enabling pharmacists to integrate health coaching into their practice. Participants will learn to build strong patient relationships, enhance care quality, and open new revenue streams. Whether you’re an established pharmacist or a recent graduate, this course provides the tools to make a significant impact on patient health. To learn more, visit www.ceimpact.com/healthcoach.
HHS nPEP WORK GROUP
IPA was invited by State Medical Director Robert Kruse, MD, MPH, FAAFP, to participate in an ad-hoc workgroup to address the barriers Iowans face when accessing post-exposure prophylaxis (PEP) for HIV prevention in response to non-occupational exposures to HIV. The workgroup, comprised of over 25 professionals from various healthcare disciplines and backgrounds, held its first meeting in April to inform
the development of response strategies, best practices, and other recommendations to support increasing the availability and accessibility of nPEP. Key focus areas of the workgroup include emergent prescribing and provider training; payer policy and patient assistance; and drug inventory and rapid access. Over the next year, the workgroup will continue to meet with plans to submit final recommendations to Iowa HHS by March of 2025.
At the kick-off meeting, the workgroup reviewed data from the 2019 Prevention Needs Assessment Report, which found that only 46% of survey respondents (n=572) were aware that nPEP could prevent HIV acquisition. There is a need for greater promotion of awareness, particularly among communities that bear the burden of the HIV epidemic in Iowa. Reported barriers to nPEP access included encountering providers who refused to prescribe the medications (11%), the inability to access prescribed medications through a local pharmacy due to inventory constraints (22%), and the prohibitive expense of the medications (44%).
With a large emphasis on the role of pharmacy, the workgroup includes IPA members from Hy-Vee, OneroRx, University of Iowa Health Care, and Walgreens Specialty Pharmacy, all engaging across the focus areas to identify solutions and decrease barriers to accessing care for Iowans in need.
BPS CONTINUING PROFESSIONAL DEVELOPMENT OFFERING
Maintain your BPS certification with IPA! Beginning in 2024, the Board of Pharmacy Specialties (BPS) requires board-certified pharmacists to complete annual continuing professional development (CPD) activities to maintain their certification. This new framework, designed based on pharmacist feedback, aims to provide flexible, contemporary, and low-cost options for staying current in specialty practice areas. The CPD process involves reflecting, planning, learning, and evaluating activities within the MyBPS portal, ensuring pharmacists maintain relevant competencies.
The updated recertification framework, including CPD, impacts board-certified pharmacists starting a new certification cycle in 2024, encompassing those newly certified or recertified in 2023. This framework will gradually extend to all board-certified pharmacists with new 7-year certification cycles. IPA supports pharmacists by offering various CPD opportunities through volunteer committees, events, and resources, helping members seamlessly integrate these activities into their professional practice. Get involved with IPA to stay compliant and advance your skills effectively. For more information, visit BPS’ website: bpsweb.org/faq and select “Continuing Professional Development.”
ADDRESSING MEMBER ISSUES: OPTUM
In 2023, IPA began routine meetings with Optum Rx to address the concerns of community independent pharmacies and advocate for its members. These quarterly discussions have focused on issues related to payment and reimbursement, as well as contract terms and pharmacy operating income. Urgent topics of discussion have included trends and data related to pharmacy closures in Iowa and reduced access to care for patients, notably in rural communities. By maintaining this regular dialogue, IPA aims to ensure that the voices of independent pharmacies are heard and that their financial and operational challenges are addressed. Share your concerns and challenges with the IPA staff at ipa@iarx.org
ACADEMIC DETAILING AND HARM REDUCTION IN COMMUNITY PHARMACIES
IPA continues the work of academic detailing and increasing patient access to harm reduction services. Supported by funding from the National Association of City and County Health Officials (NACCHO), IPA staff Emmeline Paintsil, Director of Professional Affairs, and Mikayla Harris, Executive Fellow, participated in a comprehensive two-day training session by the National Resource Center for Academic Detailing (NaRCAD). This specialized training equips detailers with essential skills to effectively share key messages, which were created and intentionally refined based on feedback from individuals with lived experience.
During academic detailing visits, pharmacists shared valuable insights and experiences from their communities. Following these visits, IPA provided several resources for pharmacists and pharmacy staff as well as patients seeking connection to care. These resources included access to the SkillFlix video series on harm reduction practices, which offers an excellent opportunity for professional development and continuing education credit. For more information, contact ipa@iarx.org.
IPA GOES LOCAL:
DINNER • NETWORKING • FREE CPE
Through a virtual reality simulation, participants of this year’s program will experience aspects of living with dementia from the perspective of patients and their caregivers. Explore the pharmacy team’s role in providing person-centered care that considers cultural, structural, medication-related, and disease-related factors to 1) meet the unique needs of each patient and their caregivers, and 2) address disparities in care for people with dementia.
DUBUQUE — August 29, 2024
BLACK HAWK/BREMER — September 12, 2024
SPENCER — October 10, 2024
IOWA CITY — November 7, 2024
Academic Detailing at Parkersburg Pharmacy
Community Pharmacists’ Attitudes, Beliefs, Knowledge, and Comfortability Regarding Naloxone in Iowa
Authors: Ben Miskle, PharmD
Clinical Assistant Professor, Department of Pharmacy Practice and Science, University of Iowa College of Pharmacy; Iowa City, IA
Jilene Haas
PharmD candidate, 2024, University of Iowa College of Pharmacy; Iowa City, IA
Hannah Ungurean
PharmD candidate, 2024, University of Iowa College of Pharmacy; Iowa City, IA
Kylie Juenger
PharmD candidate, 2024, University of Iowa College of Pharmacy; Iowa City, IA
Laura Knockel, PharmD, BCACP
Clinical Assistant Professor, Department of Pharmacy Practice and Science, University of Iowa College of Pharmacy; Iowa City, IA
Corresponding Author:
Ben Miskle, PharmD
180 S Grand Ave
Iowa City, IA 52242
Phone: 319-467-1065
Fax: 319-353-5646
benjamin-miskle@uiowa.edu
Conflict of Interest: The authors declare no relevant conflicts of interest or financial relationships.
Acknowledgements: The authors would like to thank Gracie Schnell and Fabiola Gallardo for their contributions to this project.
ABSTRACT
Background: The opioid epidemic is one of the most prominent public health issues in America. Naloxone is a life-saving reversal agent used in opioid overdoses, but barriers exist preventing its optimal distribution to patients. The purpose of this study was to evaluate how community pharmacists in Iowa perceive and dispense naloxone in order to identify potential barriers.
Methods: A 27-question survey was distributed via email to all members of the Iowa Pharmacy Association. The survey included six questions collecting demographic information, 19 Likert scale questions, and two free response questions intended to gather information on the respondents’ attitudes, beliefs, knowledge, and comfortability regarding naloxone therapy. Survey analysis was completed using descriptive statistics.
Results: Twenty-four pharmacists completed the survey. Most respondents (95.8%) agreed or strongly agreed that there should be more education to community pharmacy staff regarding naloxone. Three-quarters of respondents have noticed stigmas firsthand at the pharmacy, and 54.2% do not tend to talk with their patients about naloxone bias. All respondents have previously dispensed naloxone. Patient awareness was the largest barrier to dispensing naloxone.
Conclusions: The most common barriers to dispensing naloxone in community pharmacies in Iowa include the need for increased patient awareness and greater education to pharmacy staff, with particular focus on methods to openly and empathetically discuss naloxone stigma.
BACKGROUND
The drug overdose crisis has become one of the most concerning epidemics in modern American history. Currently, 75% of all drug overdose deaths involve opioids, which includes prescription opioids, heroin, and synthetic opioids (e.g., fentanyl).1 In 2021, more than 80,000 people nationwide were killed by drug overdoses involving opioids, a number which has increased tenfold over the last 25 years.1 Naloxone, an opioid antagonist that reverses the effects of opioids, is a life-saving medication that has been shown to decrease deaths from opioid overdose.2,3 Although naloxone has become more widely available in recent years, including FDA over-the-counter approval, barriers still remain which prevent its distribution to patients and communities who may benefit.4 As trusted and accessible healthcare professionals, pharmacists can play a critical role in ensuring patients receive naloxone.2
In recent years, multiple studies have been undertaken to identify barriers preventing the optimal distribution of naloxone by pharmacies to patients and caregivers. Studies of community pharmacists in multiple states have found that the majority of respondents were not comfortable dispensing naloxone.5,6 Similar barriers were present in pharmacies across multiple states, including lack of training and education, lack of routine identification of eligible patients, and the stigmatization of opioid and naloxone use.6-8 Consistently, it was found that the greater the pharmacists’ knowledge of naloxone and opioid overdose, the more willing they were to offer and dispense naloxone.5 In addition, education on naloxone facilitated changes in attitudes and perceptions regarding opioid misuse and thereby reduced stigma.8
Pharmacists in Iowa are authorized to dispense naloxone to individuals at risk of an opioid-related overdose or to persons who may be able to assist those individuals via multiple methods: a prescription written by their provider, through a collaborative practice agreement, use of the statewide standing order, via the statewide protocol, or recommending over-the-counter naloxone nasal spray. Even with multiple avenues by which to order and dispense naloxone, it is unknown whether commu-
nity pharmacists in Iowa face similar barriers found in other states preventing its optimal distribution. This study aimed to assess the attitudes, beliefs, knowledge, and comfortability surrounding naloxone therapy among community pharmacists in Iowa.
METHODS
A 27-question survey was developed using surveys from similarly conducted studies as a reference.5,7-9 It was designed to be completed in five minutes or less to respect the time of respondents and increase the likelihood of response. Responses were collected using REDCap. The survey was distributed via email by the Iowa Pharmacy Association (IPA) to all IPA members. The invitation to complete the survey was sent twice; results were collected over a three month period.
Demographic information including age, gender, years of experience in community pharmacy, current job position, population of town/city where employed, and type of pharmacy where employed was collected. The next 18 items assessed respondents’ attitudes, beliefs, knowledge, and comfortability regarding naloxone using a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). One yes or no question followed, which asked if the respondent had previously dispensed naloxone. Finally, the survey concluded with two open-ended questions regarding respondents’ views on barriers to dispensing naloxone as well as ideas for improved dispensing.
Only completed surveys were included in the analysis. Data were analyzed using descriptive statistics. Open-ended responses were grouped into similar themes and compared by frequency. This study was determined to not be human subjects research by the University of Iowa Investigational Review Board (IRB) and did not need IRB approval.
RESULTS
Demographics
At the end of the three month survey, there were 24 survey responses that fit inclusion criteria. Demographics are reported in Table 1. The majority of respondents were female (75%) and worked at a privately-owned pharmacy (62.5%). There was a wide range of age and years of experience in community pharmacy among respondents. In addition, there was a close split between employment in a city/town with a population of 50,001+ people (45.8%) and with less than 10,000 people (41.7%).
Education regarding naloxone
The vast majority of those surveyed (91.7%) have completed training on the use of naloxone to help prevent opioid overdose. Nearly all respondents felt that their knowledge surrounding opioid use disorder is sufficient (91.7%) and that they have been provided the resources and materials to safely educate others about naloxone (100%). Even so, 95.8% of respondents believed that there should be more education to community pharmacy staff regarding naloxone. A comprehensive list of Likert scale survey questions and responses are reported in Table 2.
Bias surrounding naloxone
The survey found that 75% of respondents have noticed naloxone stigmas firsthand at the pharmacy. Even so, over half of respondents (54.2%) do not tend to talk with their patients about naloxone bias. While most respondents felt that they can recognize the attitudes and behaviors associated with the stigma around naloxone, 25.0% disagreed with this statement.
NALOXONE IN IOWA
Comfortability level with naloxone
The survey found that 91.7% of respondents had no moral objections surrounding the use of naloxone. The vast majority of respondents (87.5%) felt confident in their ability to identify a patient who would need naloxone as well as in their ability to accurately and thoroughly explain how to use, store, and handle naloxone (91.7%).
Closing questions regarding naloxone
All 24 respondents had dispensed naloxone in the past and agreed pharmacists can be more engaged in screening patients for naloxone. Almost all respondents (95.8%) agreed that there is a need for naloxone to be dispensed more often in pharmacies and naloxone should be readily available at every pharmacy nationwide. In addition, 87.5% of respondents believed the state of Iowa should directly provide funding for naloxone education and dispensing.
Open-ended questions
The responses were categorized based on general idea(s) and are shown in Figures 1 and 2. Lack of patient awareness was the most common barrier to dispensing naloxone. Other commonly reported barriers included time, lack of public awareness, and stigma. Respondents believed that increased public awareness and additional patient education would have the largest positive impact on dispensing naloxone.
DISCUSSION
With multiple ways to provide naloxone to patients, community pharmacists in Iowa have the responsibility to identify patients who would benefit and provide appropriate counseling on naloxone’s purpose and use. Even with a small sample size, this study demonstrates that there are barriers preventing the optimal distribution of naloxone to patients at community pharmacies in Iowa, as seen in similar studies conducted in other states.5,7-9 Overall, the need for additional patient awareness of naloxone, further education of pharmacy staff, and the stigma surrounding naloxone were found to be the most pressing barriers to overcome.
Nearly all respondents felt that their knowledge surrounding opioid use disorder was sufficient and that they have been provided the resources and materials to safely educate others about naloxone. In addition, all respondents were familiar with how to dispense naloxone, specifically using the statewide standing order, and felt comfortable utilizing resources to educate a patient about naloxone use. Even with knowledge reported as sufficient, 95.8% of respondents felt there should be more education to community pharmacy staff regarding naloxone. While the respondents may feel comfortable with basic naloxone counseling points of how the medication works, further training on how to effectively educate patients about the importance of having the medication on hand is likely warranted.
As one of the most accessible members of the healthcare team, pharmacists have a unique opportunity to thoroughly educate patients about naloxone. Over half of respondents do not tend to talk with their patients about naloxone bias, even though 75% of respondents have noticed naloxone stigmas firsthand at their pharmacies. This communication gap is a crucial barrier that contributes to the lack of patient awareness. Patients need to understand why they are being prescribed naloxone to help remove the stigma associated with it. A study that implemented naloxone training programs for community pharmacies found that pharmacists were more comfortable and willing to discuss,
educate, and dispense naloxone to patients after having completed the training program.8 Based on this study’s findings, further education of Iowa pharmacists can lead to more open and supportive discussions with patients, increasing patient awareness and resulting in increased patient access to naloxone.
This study had several limitations. The survey was sent out by IPA, so it was only available to association members. Due to small sample size, results may not be a true representation of the view of community pharmacists across Iowa. Both non-response bias and participation bias may have influenced our findings. In addition, the survey was administered prior to FDA approval of over-the-counter naloxone. While this should increase patient access to naloxone, it provides another opportunity for community pharmacists to counsel patients on naloxone use. Future directions should measure the impact of the OTC approval on naloxone access in Iowa.
CONCLUSION
Through surveying community pharmacists in Iowa about their attitudes, beliefs, knowledge, and comfortability regarding naloxone, this study found that barriers exist which prevent its optimal dispensing. The most common barriers include the need for additional patient awareness and pharmacy staff education, with particular focus on methods to openly and empathetically discuss naloxone stigma. Through these improvements, pharmacies can help increase the distribution of naloxone into the community, benefiting all Iowans.
References:
1. Centers for Disease Control and Prevention. The Drug Overdose Epidemic: Behind the Numbers. www.cdc.gov/opioids/data/index.html (accessed 2023 Aug 31).
2. Centers for Disease Control and Prevention. Lifesaving Naloxone. www.cdc.gov/ stopoverdose/naloxone/index.html (accessed 2023 Aug 31).
4. FDA Approves First Over-the-Counter Naloxone Nasal Spray. U.S. Food & Drug Administration. Published March 29, 2023. Accessed December 21, 2023. https:// www.fda.gov/news-events/press-announcements/fda-approves-first-over-counternaloxone-nasal-spray
5. Rudolph SE, Branham AR, Rhodes LA, Hayes HH Jr, Moose JS, Marciniak MW. Identifying barriers to dispensing naloxone: A survey of community pharmacists in North Carolina. J Am Pharm Assoc (2003). 2018;58(4S):S55-S58.e3. doi:10.1016/j. japh.2018.04.025
6. Green TC, Donovan E, Klug B, et al. Revisiting pharmacy-based naloxone with pharmacists and naloxone consumers in 2 states: 2017 perspectives and evolving approaches. J Am Pharm Assoc (2003). 2020;60(5):740-749. doi:10.1016/j. japh.2020.03.005
7. Hanson KA, Smart MH, Mandava MR, et al. Pharmacists and Naloxone: Barriers to Dispensing and Effectiveness of an Educational Outreach Program. J Am Pharm Assoc (2003). 2023;63(2):608-613.e3. doi:10.1016/j.japh.2022.12.018
8. Santa HM, Amirova SG, Ventricelli DJ, et al. Preparing pharmacists to increase naloxone dispensing within community pharmacies under the Pennsylvania standing order. Am J Health Syst Pharm. 2021;78(4):327-335. doi:10.1093/ajhp/zxaa387
9. Sisson ML, McMahan KB, Chichester KR, Galbraith JW, Cropsey KL. Attitudes and availability: A comparison of naloxone dispensing across chain and independent pharmacies in rural and urban areas in Alabama. Int J Drug Policy. 2019;74:229-235. doi:10.1016/j.drugpo.2019.09.021
Table 1: Demographics of Survey Respondents
NALOXONE IN IOWA
Table 2: Survey Domains & Items with Responses
Education regarding naloxone
If the resources are provided to educate a patient about naloxone use, I would feel comfortable utilizing them.
I have been provided the resources and materials to safely educate others about naloxone.
I feel my knowledge surrounding opioid use disorder is sufficient.
I have completed training about naloxone therapy.
I am aware of the standing order protocol and have completed the required training for dispensing naloxone under the protocol.
I believe that there should be more education to community pharmacy staff regarding naloxone.
Bias
There are currently barriers besides stigma to the utilization of naloxone.
I tend to talk with my patient about naloxone bias.
I can recognize the attitudes and behaviors associated with the stigma around naloxone.
I have noticed naloxone stigmas firsthand at the pharmacy.
I feel I can make a difference in the community as to the stigma surrounding naloxone dispensing and use.
Comfortability level with naloxone
I am confident in my ability to accurately and thoroughly explain how to use, store, and handle naloxone.
I am confident in my ability to identify a patient who would need naloxone.
I have moral objections surrounding the use of naloxone.
Closing questions regarding naloxone
There is a need for more naloxone to be dispensed in pharmacies.
Pharmacists can be more engaged in screening patients for naloxone.
I believe that naloxone should be readily available at every pharmacy nationwide.
I believe the state of Iowa should directly provide funding for education and dispensing of naloxone.
I have dispensed naloxone in the past.
*SD, strongly disagree; D, disagree; A, agree; SA, strongly agree
ATTENTION PHARMACISTS:
With its fast pace and massive volume of medications, the pharmacy profession is ripe for claims and litigation. If you think your employer’s coverage will protect you in the event of an error (actual or alleged), complaint, or legal claim, consider the following:
GAP #1: Employer coverage is designed to protect the company first, pharmacists second. Nothing personal, it’s just a matter of dollars and cents.
GAP #2: Your employer’s coverage may only be effective at your place of employment. If you have a second job, volunteer, or give advice to a neighbor, you’ll be on your own.
GAP #3: If a court judgment exceeds your employer’s limits, you may be responsible for paying the difference. That could cost you tens of thousands of dollars.
GAP #4: Employer insurance may not help when a patient files a complaint to the Board of Pharmacy. This could put you at risk of a disciplinary action without proper representation.
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Assessment of Xanomeline in Mitigating Symptoms Associated with Schizophrenia: A Literature Review
Authors:
Zoe Dittmar, PharmD Candidate, Drake University CPHS (Corresponding Author)
915 NW Horizon Dr, Ankeny IA, 50023 515-974-9754
zoe.dittmar@drake.edu
Jana Kay Lacanlale, PharmD Candidate, Drake University CPHS
Maddie Lee, PharmD/MPA Candidate, Drake University CPHS
Charles Phillips, PharmD, PhD Professor, Drake University College of Pharmacy & Health Sciences
Conflict of Interest: The authors report no conflict of interests.
ABSTRACT
Background: Nonadherence and intolerable side effects are significant obstacles of standard antipsychotic regimens for SCZ. A gap in current SCZ treatment exists in addressing the negative symptoms and cognitive deficits patients experience. Emerging research is analyzing the use of a cholinergic agent in combination with an anticholinergic agent to decrease symptoms of SCZ while mitigating potential side effects. The purpose of this literature review is to analyze xanomeline with respect to its efficacy in treating cognitive deficits, positive symptoms, and negative symptoms of schizophrenia (SCZ), as well as evaluate the tolerability of xanomeline-trospium combination therapy regarding motor, muscarinic, and anticholinergic effects.
Methods: Randomized controlled trials and respective post-hoc analyses, focused on xanomeline-trospium use for SCZ, were collected via PubMed, the National Institute of Health (NIH) U.S. Library of Medicine – Clinical Trials, and Karuna Therapeutics Scientific & Medical Research databases. Outcomes of studies included efficacy in the reduction of positive symptoms, negative symptoms, and cognitive deficits while maintaining safety and tolerability.
Results: Five studies were identified in the review, including the EMERGENT-I study and several post hoc analyses of the EMERGENT-1 study. Results included improvement over placebo for cognitive deficits and positive and negative symptoms.
Conclusions: Current literature appears to support the use of xanomeline-trospium for treating the three primary symptom categories seen in SCZ. Phase 3 trials are being conducted to investigate the safety and efficacy profile of xanomeline-trospium.
BACKGROUND
Schizophrenia Overview
Schizophrenia (SCZ) is a psychiatric condition classified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-
5) as a psychotic disorder.1 Diagnosis of a psychotic disorder indicates abnormalities within at least one of the following areas: (1) delusions, (2) hallucinations, (3) disorganized thoughts, (4) disorganized motor behavior, or (5) negative symptoms.1 Diagnosis of SCZ requires at least two of the aforementioned abnormalities lasting at least one month, with at least one of the areas being (1), (2), or (3), and a significant decrease in level of functioning.1 To confirm a diagnosis, any combination of abnormalities must be present and disrupt daily function over six months.
SCZ affects 0.6-1.9% of the population in the United States.2 A greater incidence of SCZ, particularly in a three to two ratio, has been found between men and women.3 Men begin exhibiting symptoms around ages 18-25, while symptom onset for women peaks from mid-twenties to mid-thirties or after 40 years of age.4
Individuals with SCZ present with three primary symptom categories: positive symptoms, negative symptoms, and cognitive deficits.1 Positive symptoms add a layer of mental functioning otherwise unseen in patients without psychotic disorders. Negative symptoms are the removal of mental function that is typically present for someone without SCZ.1 Examples include a decrease in emotional expression, anhedonia, and avolition. Negative symptoms are often categorically combined with cognitive deficits. Deficits include but are not limited to, a decline in attention, decision-making, logical reasoning, and memory.
While the exact etiology of SCZ remains unknown, it is hypothesized that disproportionate dopamine within the mesolimbic pathway is responsible for positive symptoms of SCZ, while insufficient dopamine levels within the mesocortical pathway induce negative symptoms. However, it is proposed that insufficient levels of acetylcholine are responsible for cognitive deficits, mainly through decreased activation of M1 receptors.6 Other studies have investigated the role of M4 receptor stimulation within the cerebral cortex to improve negative symptoms and M4 inhibition to reduce the presence of positive symptoms.7
Treatments and Adherence
Medications for SCZ have existed since the 1950s.6 Chlorpromazine and haloperidol are examples of first-generation antipsychotic agents with specific D2 dopamine receptor antagonism.8 This medication subclass is the most prominent culprit for drug-induced movement disorders, including dystonia, akathisia, pseudoparkinsonism, and tardive dyskinesia. The degree to which an antipsychotic medication will lead to characteristic adverse events depends on the extent of D2 antagonism, dose used, and patient vulnerability.
The development of second-generation antipsychotics aimed to reduce drug-induced movement disorders through 5-HT2A receptor antagonism with lower affinity for D2 receptors.8 Notable examples of second-generation antipsychotics include clozapine, quetiapine, and aripiprazole. Compared to first-generation agents, second-generation antipsychotics are responsible for anticholinergic and metabolic side effects.8
Up to 33% of patients do not experience positive symptom relief despite antipsychotic treatment.5 In addition, nonadherence is the largest contributing factor for treatment resistance, affecting upwards of 50% of patients.9 Patient adherence is limited due to the intolerable side effects seen with antipsychotic medications.
Despite high rates of nonadherence, both generations of antipsychotics have proven effective in reducing positive symptoms of SCZ.5 However, there is no consistent benefit for negative symptoms and cognitive deficits.
Expanding treatment mechanisms based on emerging cholinergic dysfunction hypotheses surrounding SCZ pathophysiology require further investigation. In addition to enhancing symptom reduction, focus should also be placed on adverse effect tolerability, which, in theory, would have a high probability of increasing adherence for patients with SCZ.
Gaps in Current Treatments
Recent research has examined the use of cholinergic agents in treating all SCZ symptoms rather than targeting a singular symptom subset. Gomes and Grace cite previous studies that assessed xanomeline, a cholinergic agent, for reduction of cognitive deficits related to Alzheimer’s Disease. While xanomeline successfully demonstrated improved cognitive function in this population, severe cholinergic adverse effects resulted in therapy discontinuation.
Xanomeline demonstrates an affinity for the central M1 and M4 receptors, which decreases dopaminergic activity in the ventral tegmental area (VTA), ideally reducing positive symptoms.8 Additionally, it should increase extracellular dopamine levels in the prefrontal cortex (PFC), which may improve negative symptoms and cognitive deficits.8
In an attempt to counteract adverse events, a peripherally restricted anticholinergic agent, trospium, has been added to xanomeline and has become a focus of SCZ research. The effect of xanomeline on cholinergic receptors is diminished by trospium peripherally but still allows for reduction of SCZ associated symptoms.6 The combination of these agents introduces a novel treatment option for SCZ while mitigating cholinergic side effects.
Objective
The primary purpose of this literature review is to analyze xanomeline and xanomeline-trospium with respect to efficacy in treating positive symptoms, negative symptoms, and cognitive deficits of SCZ. A secondary outcome is to evaluate the tolerability of xanomeline-trospium combination therapy regarding motor, muscarinic, and anticholinergic effects.
METHODS
Study Selection
Database searches occurred from January 2023 to March 2023 via PubMed, National Institute of Health (NIH) U.S. Library of MedicineClinical Trials, and Karuna Therapeutics Scientific & Medical Research databases between three individual reviewers. Each reviewer worked independently to assess eligibility, analyze for potential bias, and extract appropriate data for each study, fitting inclusion and exclusion criteria. MeSH term search strategies used within the PubMed databases included the following: {"Muscarinic Agonists''[Mesh] OR "Cholinergic Agents"[Mesh]) AND "Cholinergic Antagonists"[Mesh] AND "Schizophrenia"[Mesh]} and {("xanomeline" [Supplementary Concept]) AND
EFFICACY OF XANOMELINE
"Schizophrenia"[Mesh]}. Filters were placed to limit results to human-only randomized controlled trials and respective post-hoc analyses written in English.
Only studies that included SCZ patients were included in this literature review. Duplicate results were manually removed. From the NIH U.S. Library of Medicine - Clinical Trials database, the search “Condition or Disease: Schizophrenia, Other terms: KarXT” was used in conjunction with filters specifying “completed study status” and “results.” References cited for each eligible study were manually analyzed for additional studies meeting criteria not found through database searches.
Measurement Scale Definitions
Frequently used scales to assess SCZ symptom severity include the Cogstate Brief Battery (CBB) exam, the Positive and Negative Syndrome Scale (PANSS), and Clinical Global Improvement-Severity (CGI-S) measures. The CBB focuses on the extent of cognitive impairment associated with schizophrenia (CIAS). The computerized exams within the CBB assess the domains of attention, processing speed, executive function, verbal learning, and working memory.10 The PANSS indicates severity of positive and negative symptoms of SCZ through a seven-point scale of 30 items, with higher scores indicating greater impairment.11 The CGI-S scale utilizes a seven-point assessment to examine the severity of illness relative to the investigator’s prior experience with patients of the same diagnosis.11
RESULTS
Following data collection, 305 studies were identified. Implementing inclusion and exclusion criteria with duplicate study removal resulted in five studies. Study exclusion was primarily due to unrelated primary outcome measurements (e.g., cost), inappropriate patient populations (e.g., Alzheimer’s Disease), and treatment interventions other than xanomeline (e.g., haloperidol, aripiprazole).
For the five studies, the following were assessed: use of xanomeline alone for positive and negative symptom reduction; use of xanomeline with trospium for positive and negative SCZ symptom reduction; use of xanomeline-trospium in reduction of CIAS; qualitative extent of SCZ symptom improvement with xanomeline-trospium; clinical effect onset for improvement in positive symptoms, negative symptoms and CIAS for xanomeline-trospium, and safety and tolerability of xanomeline-trospium.
Shekhar et al evaluated the effectiveness of xanomeline monotherapy in the treatment of SCZ through a four-week double blind, randomized controlled trial.12 This pilot study included 20 participants meeting DSM-IV criteria for either a SCZ or schizoaffective disorder diagnosis, demonstrated worsening SCZ symptoms, and were medication-free before beginning the study. Primary outcomes included individual scores on the Brief Psychiatric Rating Scale (BPRS), PANSS, and CGI-S scale. Additional outcomes included PANSS subscales and cognitive test score changes. Week one of the trial consisted of a single-blind placebo treatment for all participants. During week two, subjects were assigned to either placebo or xanomeline treatment. In the xanomeline treatment group, the starting dose was 25 mg three times daily with a maximum final dosage of 75 mg three times daily. Both groups were titrated to the maximum tolerated dose, and subjects remained on this dose for three weeks before being tapered off and discharged. Those treated with xanomeline scored significantly better on the BPRS and PANSS. By day 25 of treatment, those administered xanomeline had a mean change of 14 points on the BPRS and 24 points on the PANSS (p < 0.05) 12
EFFICACY OF XANOMELINE
For the cognitive battery tests, the treatment group showed statistically significant (p = 0.05) improvements in measures of verbal learning and short-term memory function (Table 1). However, the measures of attention and speed of information processing remained the same. Xanomeline monotherapy, compared to placebo, resulted in increased side effects, specifically gastrointestinal distress. These adverse effects did not cause discontinuation for any patients in the treatment group.12
The EMERGENT-1 trial was a double-blind, phase 2 trial conducted to evaluate the xanomeline-trospium combination regarding efficacy in treating SCZ.13 This five-week trial enrolled 182 patients ages 18-60 with a primary diagnosis of SCZ. Participants were randomly assigned to receive twice daily dosing of xanomeline-trospium or placebo. Xanomeline-trospium was titrated to 125 mg of xanomeline and 30 mg of trospium per dose. The primary outcome was a change in PANSS scores. Other measures included PANSS subscores and the CGI-S scale. Table 2 outlines the least squares mean (LSM) changes between placebo and treatment groups on various measures from baseline to week five. The difference in total score was -11.6 with a 95% CI. Differences in the positive and negative symptom subscores were -3.2 and -2.3, respectively. Overall, the treatment of xanomeline-trospium resulted in statistically significant reductions (p < 0.001) in the total PANSS score and both the positive and negative symptom subscores. Researchers also compared the percentage of patients with a response according to a CGI-S score of 1 or 2 at week five.14 However, no significant difference existed between the two groups as 6% of patients in the treatment group showed a response compared to 1% of the placebo group (p = 0.15). Fifty-four percent of patients treated with xanomeline-trospium reported gastrointestinal adverse events, but these did not result in treatment discontinuation. Somnolence, restlessness, weight gain, and extrapyramidal symptoms were observed with no statistically significant difference between the groups.
In a post-hoc analysis of the EMERGENT-1 trial, further assessment of patient responses by Weiden et al categorized improvements in PANSS scores.14 Response rate categories were defined as PANSS score improvement of ≥ 20%, ≥ 30%, ≥ 40%, and ≥ 50% from baseline to the weeks two, four, or five endpoints. With a modified intention to treat (mITT) population of 83 patients administered xanomeline-trospium and 87 patients assigned placebo, the treatment group saw consistent, significant improvement in PANSS scores compared to placebo. Table 3 details the results of categorical response rates with respect to the timely endpoints. Only two groups (≥ 40% and ≥ 50% at week two) showed no significant difference in PANSS score. By the week five endpoint, an improvement of at least 20% was reached in 59.0% of the xanomeline-trospium group. This data supports that six out of ten patients saw at least 20% improvement in PANSS score after five weeks of treatment (NNT = 3). Results also indicated that one in seven patients met a response of greater than or equal to 50% by the same endpoint (NNT = 11).
In the same study, Weiden et al converted the 3-factor PANSS used in EMERGENT-1 to a Marder 5-factor analysis PANSS.14 This broadened the analysis to assess disorganized thought, uncontrolled hostility, and anxiety/depression in addition to positive and negative symptoms. Results showed a significant improvement in the LSM change in the Marder 5-factor PANSS score for disorganized thought (p = 0.003) and depression/anxiety (p = 0.0085) when comparing the groups by week two and onwards. A significant decrease in the LSM change for the uncontrolled hostility Marder 5-factor PANSS score was not seen until week four (p = 0.0007). By week five, the xanomeline-trospium to placebo LSM difference for disorganized thought, uncontrolled hostility,
and depression/anxiety improved in the xanomeline-trospium group: -2.13, CI 95% [-3.27, -1.00] (p = 0.0003); -1.52, CI 95% [-2.49, -0.56] (p = 0.0022); and -2.12, CI 95% [-3.11, -1.13] (p < 0.0001), respectively. Patients treated with xanomeline-trospium revealed positive symptom improvement at week five versus placebo, indicated by a LSM difference of -3.10, 95% CI [-4.62, -1.59] (p < 0.0001). An assessment of negative symptom incidence also showed improvement for the xanomeline-trospium group, evidenced by a LSM difference of -2.53, 95% CI [-3.85, -1.22] (p = 0.0002).14
Comparison of the treatment versus placebo group at week 5 demonstrated improvement in positive symptoms through a significant decrease in LSM difference in Marder 5-factors PANSS: -3.10, 95% CI [-4.62, -1.59] (p < 0.0001) 14 Negative symptoms exhibited clinical improvement at week 5 with a LSM difference of -2.53, 95% CI [-3.85, -1.22] (p = 0.0002).15
In another post-hoc analysis of the EMERGENT-1 trial, effectiveness of xanomeline-trospium in reducing CIAS was analyzed in patients with or without clinically meaningful CIAS at baseline.15 Patients who showed excessive intraindividual variability (IIV) were excluded to limit CBB scores reflective of non-compliance or invalid data, leaving 117 patients to assess. Classification of subgroups was identified based on each individual’s CIAS at baseline using a CBB composite Z-score cutoff of -1 SD relative to the normative mean. Of the 117 patients, 54 received xanomeline-trospium, and 63 received placebo. Xanomeline-trospium showed statistically significant improvement in cognition in the impaired subgroup relative to both baseline and compared to placebo. The placebo group showed no meaningful change in cognitive performance relative to baseline. Before removal of IIV outliers, there was a numerical improvement of CIAS from baseline to week five, but the change was not statistically significant (p = 0.16) in CBB scores.15 Following IIV outlier removal, a statistically significant (p = 0.04) treatment effect was shown relative to CBB composite scores.15
An additional post hoc analysis of the EMERGENT-1 study assessed the safety and tolerability of xanomeline-trospium.16 Several assessments were performed to gauge xanomeline-trospium safety, including adverse event monitoring, weight, non-fasting clinical laboratory values, vital signs, and somnolence. Adverse events examined include those associated with muscarinic receptor agonism or antagonism. These most common adverse events affected ≥ 2% of patients who received xanomeline-trospium and were seen at a two-fold higher incidence versus placebo.16 Both pro-cholinergic and anticholinergic events were reported and included nausea (16.9% vs. 4.4%), vomiting (9.0% vs. 4.4%), constipation (16.9% vs. 3.3%), and dry mouth (9.0% vs. 1.1%).16 Although xanomeline-trospium treated patients experienced higher adverse event rates, they were considered mild in severity and not categorized as incapacitating or negatively impacting activities of daily life. Rates of sedation were 7.9% in the xanomeline-trospium group and 6.7% in the placebo group.16 Similar to the pro- and anticholinergic adverse events, the severity of sedation was rated as mild or moderate in the treatment group. No patients from either group discontinued due to pro-cholinergic or anticholinergic adverse events. Vital signs did not show significant or clinically meaningful changes between treatment initiation and day 35 for any patient in either group.16 Similarly, there were no significant or clinically meaningful differences from baseline to week 5 for either group regarding cholesterol, blood glucose, or triglyceride concentrations.16
DISCUSSION
The literature examined showed promise for xanomeline being an effective treatment for SCZ in improving both positive and negative symptoms as well as CIAS. It is important to note that the study by Shekhar et al. included a small sample and outdated DSM-IV criteria and outcome measures. However, as an original pilot study assessing xanomeline monotherapy for treating SCZ, its general findings persist. The measures used at the time of the study were employed correctly and have since been defined to effectively assess symptoms and diagnostic criteria for SCZ.
Subsequent literature that evaluated the use of xanomeline-trospium combination therapy also supported its ability to treat the various symptoms associated with SCZ. The consistent improvement in SCZ symptoms measured through PANSS, BPRS, CGI-S scale, and CBB following administration of xanomeline-trospium validates its efficacy in SCZ treatment.
In SCZ, the relatively low NNT maintains xanomeline-trospium’s status as both a statistically and clinically significant option for symptom reduction compared to placebo. Due to the severe impact of SCZ on quality of life, consistent PANSS improvement, even within the lowest categorical range, can markedly improve quality of life when compared to baseline. Although not tested in treatment resistance, patients who have not responded to current SCZ treatments may benefit from this combination, given the incidence of improvement is relatively high for sample populations. The novel mechanism of action combined with the consistent reduction of SCZ symptoms potentially reveals a more significant impact of cholinergic activity than previously believed.
The tolerability of xanomeline-trospium may surpass current treatment options as studies show minimal pro-cholinergic and anticholinergic side effects. Those treated with xanomeline-trospium did not experience adverse events severe enough to prompt discontinuation, which may suggest fewer movement disorders and metabolic effects.
The measurement of PANSS outcomes alludes to a slight delay in treatment effects for xanomeline-trospium use in treating positive and negative symptoms and CIAS. Only one study could categorically assess symptom improvement in a manner aside from percentage change from baseline for respective syndrome scales.14 The ability to do so provides a clear distinction between the extent of improvement at specific treatment points. Current SCZ treatments can provide immediate effects or be maintenance therapy. Consideration of xanomeline-trospium as a maintenance therapy for SCZ needs to account for potential acute psychotic episodes prior to the onset of clinical efficacy. Currently, xanomeline-trospium lacks an established starting regimen or adjunctive agents for symptom control during this latency period.
The use of the Marder 5-factor PANSS is a significant strength of the Weiden et al study as it has a stronger ability to differentiate between varying domains of cognitive symptoms. It is important to recognize cognitive symptoms scored in the Marder factors can be influenced by positive and negative symptoms of SCZ. For example, a patient’s score for uncontrolled hostility may fluctuate depending on the severity or type of hallucinations or delusions being experienced. Nevertheless, improvement of all PANSS subdomain scores of at least 20% shown as early as week two holds promise for subsequent xanomeline-trospium studies.
EFFICACY OF XANOMELINE
One of the most notable limitations of the reviewed studies was the relative generalizability of results. The studies excluded patients with SCZ and comorbid psychiatric conditions. Given the overlap between pathophysiological mechanisms of psychiatric conditions, a diagnosis of SCZalone is not representative of the general population of patients with SCZ and caution is necessary when applying the results of xanomeline-trospium to patients with comorbid conditions. Similarly, several studies were post-hoc analyses based on the EMERGENT-1 trial, thus the potential for multiple-used subject bias exists.
This review is also unable to compare xanomeline-trospium efficacy to current antipsychotic regimens as the studies included have no active control arm. Current literature comparing xanomeline-trospium with the standard of care does not exist. Additionally, xanomeline-trospium has been examined as monotherapy compared to placebo, but its utility as an adjunctive agent is unknown. Of note, the EMERGENT-1 trial measured outcomes at the 5-week checkpoint only, so response maintenance through extended treatment regimens could not be evaluated. Studies assessing improvement in 5-factor PANSS scores at earlier week checkpoints may clarify the true time to therapeutic effect and assessments of 5-factor PANSS scores at later checkpoints may reveal trends in treatment effect sustainability over time.
There is a possibility that not all literature related to the topic was retrieved and thus is subject to author limitations. Broadly using databases and reviewing cited research in all retrieved studies minimizes this threat. At the completion of this review, data from the EMERGENT-2 and EMERGENT-3 trials were not yet available. Additionally, the EMERGENT-4, EMERGENT-5, ARISE, and KAR-013 trials are actively ongoing and thus cannot be evaluated for this review.
Further studies are needed to replicate and expand upon findings from the EMERGENT-1 study to characterize xanomeline-trospium potential in SCZ.15 At the time of this literature review, trospium was the only peripherally restricted anticholinergic being used in combination with xanomeline to treat SCZ. Balancing pro-cholinergic versus anticholinergic adverse events for patients treated with xanomeline-trospium remains an important question for phase 3 trials.
CONCLUSION
Antipsychotic medications have proven efficacious in treating the positive symptoms of SCZ; gaps in effective therapy exist for treating negative symptoms and CIAS. Xanomeline-trospium exhibits the potential for reducing all three components of the disease state and may benefit those unable to endure current antipsychotic treatments. This combination shows promise as a treatment for those experiencing intolerable side effects with standard SCZ treatments. Phase 3 trials are being conducted to assess the long-term efficacy and tolerability of xanomeline-trospium.
References:
1. American Psychiatric Association. Schizophrenia spectrum and other psychotic disorders. DSM-5. 2013; 5:132-166
2. Patel KR, Cherian J, Gohil K, Atkinson D. Schizophrenia: overview and treatment options. P T. 2014;39(9):638-645.
3. Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. 2016;388(10039):86-97. doi:10.1016/S0140-6736(15)01121-6
4. Holder SD, Wayhs A. Schizophrenia. Am Fam Physician. 2014;90(11):775-782.
EFFICACY OF XANOMELINE
5. Kahn RS, Sommer IE, Murray RM, et al. Schizophrenia. Nat Rev Dis Primers. 2015;1:15067. Published 2015 Nov 12. doi:10.1038/nrdp.2015.67
6. Gomes FV, Grace AA. Beyond dopamine receptor antagonism: new targets for schizophrenia treatment and prevention. Int J Mol Sci. 2021;22(9):4467. Published 2021 Apr 25. doi:10.3390/ijms22094467
7. Dean B, Scarr E. Muscarinic M1 and M4 receptors: Hypothesis driven drug development for schizophrenia. Psychiatry Res. 2020;288:112989. doi:10.1016/j. psychres.2020.112989
8. McCutcheon RA, Abi-Dargham A, Howes OD. Schizophrenia, dopamine and the striatum: from biology to symptoms. Trends Neurosci. 2019;42(3):205-220. doi:10.1016/j.tins.2018.12.004
9. Velligan DI, Sajatovic M, Hatch A, Kramata P, Docherty JP. Why do psychiatric patients stop antipsychotic medication? A systematic review of reasons for nonadherence to medication in patients with serious mental illness. Patient Prefer Adherence. 2017;11:449-468. Published 2017 Mar 3. doi:10.2147/PPA.S124658
10. Maruff P, Thomas E, Cysique L, et al. Validity of the CogState brief battery: relationship to standardized tests and sensitivity to cognitive impairment in mild traumatic brain injury, schizophrenia, and AIDS dementia complex. Arch Clin Neuropsychol. 2009;24(2):165-178. doi:10.1093/arclin/acp010
11. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276. doi:10.1093/schbul/13.2.261
12. Shekhar A, Potter WZ, Lightfoot J, et al. Selective muscarinic receptor agonist xanomeline as a novel treatment approach for schizophrenia. Am J Psychiatry. 2008;165(8):1033-1039. doi:10.1176/appi.ajp.2008.06091591
13. Brannan SK, Sawchak S, Miller AC, Lieberman JA, Paul SM, Breier A. Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia. N Engl J Med. 2021;384(8):717-726. doi:10.1056/NEJMoa2017015
14. Weiden PJ, Breier A, Kavanagh S, Miller AC, Brannan SK, Paul SM. Antipsychotic efficacy of KarXT (Xanomeline-Trospium): post hoc analysis of positive and negative syndrome scale categorical response rates, time course of response, and symptom domains of response in a phase 2 study. J Clin Psychiatry. 2022;83(3):21m14316. Published 2022 May 11. doi:10.4088/JCP.21m14316
15. Sauder C, Allen LA, Baker E, Miller AC, Paul SM, Brannan SK. Effectiveness of KarXT (xanomeline-trospium) for cognitive impairment in schizophrenia: post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study. Transl Psychiatry. 2022;12(1):491. Published 2022 Nov 21. doi:10.1038/s41398-022-02254-9
16. Correll CU, Angelov AS, Miller AC, Weiden PJ, Brannan SK. Safety and tolerability of KarXT (xanomeline-trospium) in a phase 2, randomized, double-blind, placebo-controlled study in patients with schizophrenia. Schizophrenia (Heidelb). 2022;8(1):109. Published 2022 Dec 3. doi:10.1038/s41537-022-00320-1
Table 1. Change in score on cognitive measures from baseline to post-treatment (Shekhar et al)
Table 2. LSM change from baseline in various measures (Brannan et al)
Table 3. Percentage of xanomeline-trospium treated patients meeting categorical improvement markers in PANSS score at a given endpoint as compared to placebo (Weiden et al)
HEALTHCARE HOT TOPICS
FDA APPROVES NEW CEPHALOSPORIN
ANTIBIOTIC FOR THREE DIFFERENT USES
Zevtera (ceftobiprole medocaril sodium for injection) is a cephalosporin antibiotic approved by the Food and Drug Administration (FDA) in April for various infections. It is indicated for adults with Staphylococcus aureus bloodstream infections (SAB), including right-sided infective endocarditis, adults with acute bacterial skin and skin structure infections (ABSSSI), and both adult and pediatric patients, aged three months to less than 18 years, with community-acquired bacterial pneumonia (CABP). Zevtera is available as a lyophilized powder in single-dose vials, containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole).
PATIENT SAFETY AND CYBERSECURITY:
THE IMPORTANCE OF BEING PROACTIVE
As healthcare organizations rely more on technology, the risk of cyber threats has increased, creating susceptibilities that can directly impact patient safety. Cyberattacks pose a threat to healthcare services, leading to delays in treatment and compromising patient care. If electronic health records are hacked, it can delay or change important medical treatments. Similarly, if medical devices are disabled, it can have immediate and serious effects on patient health.
To tackle these cybersecurity challenges, it’s crucial to implement strong security measures. Healthcare organizations should adopt foolproof security protocols, regularly train staff on cybersecurity best practices, and use advanced technologies to detect and respond to potential threats. These steps will help create a proactive defense against cyberattacks to reduce their impact on patient care. Regular training ensures staff are up to date on the latest threats, while advanced technology can help detect and respond to cyber incidents quickly.
AI IN PHARMACEUTICAL TECHNOLOGY AND DRUG DELIVERY DESIGN
The popularity and capabilities of artificial intelligence (AI) have skyrocketed in recent years. Pharmacists are now implementing AI in drug discovery to overcome limitations of traditional research methods, which can be expensive, slow, and prone to human error. Using techniques like machine learning and deep learning, AI is innovating various stages of drug development. These technologies help identify potential new drugs, analyze chemical structures, and consolidate largescale biological data, improving the efficiency and accuracy of drug discovery.
AI’s influence spans multiple phases of drug development, including target identification and drug design. It also helps find new uses for existing drugs and discover effective drug combinations. These advancements not only speed up the drug discovery process but also lower costs and increase the chances of success. The future of AI in drug discovery looks promising. Continuous advancements are expected to bring more
innovation and efficiency to the pharmaceutical industry. As AI continues to grow, it will undoubtably play a crucial role in developing new drugs and enhancing patient care.
LONG TERM ADHD MEDICATION USE AND INCREASED CARDIOVASCULAR RISK
A study published in JAMA Psychiatry addressed a growing concern regarding the potential cardiovascular risks associated with the longterm use of medications for Attention-Deficit/Hyperactivity Disorder (ADHD). A team of researchers in Sweden studied the association between ADHD medication use and the risk of cardiovascular diseases (CVD) among individuals aged 6 to 64 years. This case-control study identified individuals with ADHD diagnoses or medication dispensations between 2007 and 2020, along with CVD diagnoses. The study evaluated the cumulative duration of ADHD medication use over a 14year period and its relationship with incident CVD, while also exploring the impact of age, sex, and type of ADHD medication.
An association between long-term ADHD medication use and an increased risk of CVD was found, particularly hypertension and arterial disease. The risk increased with longer cumulative durations of medication use, with a significant increase within the first three years of treatment. Interestingly, the study found this association to be consistent across different age groups and sexes. The analysis also showed a correlation between specific medications, highlighting stimulants like methylphenidate and lisdexamfetamine as contributors to the heightened risk, while the association with atomoxetine was significant only in the initial year of use. These results highlighted the importance of considering potential cardiovascular risks when prescribing ADHD medications, especially with the increasing trend of long-term medication use, and the need for monitoring throughout the treatment course.
CDC H5N1 OUTBREAK UPDATE
The Center for Disease Control (CDC) is actively monitoring a widespread outbreak of avian influenza A (H5N1) virus in dairy cows and other animals across the United States. In collaboration with the USDA and FDA, they are focusing on a “One Health” approach, working at the local, state, and national levels to ensure optimal health outcomes and recognizing the interconnection between people, animals, plants, and their shared environment. Currently, the USDA reports over 150 confirmed cases in dairy cattle herds spread across thirteen states, with four human cases detected in the U.S. (Texas, Michigan, and Colorado) since April 1, 2024.
The CDC has monitored nearly 1,400 people exposed to infected animals, with at least 60 tested for flu-like symptoms. In addition to monitoring efforts, the CDC is stressing the importance of preventative measures, advising people to avoid close contact with sick animals and unpasteurized products from infected cows. While the threat to the public remains low, ongoing studies are vital to decrease the risk of further spread of the virus.
PUBLIC AFFAIRS
2024 LEGISLATIVE SESSION
The 2024 Iowa Legislative Session concluded in the early morning hours of Saturday, April 20th, after an overnight push Friday night to adjourn. Throughout the session, IPA registered on a total of 47 bills impacting the pharmacy profession and monitored many more internally.
Prior to session, IPA’s Legislative Committee proposed, and the Board of Trustees approved, three legislative priorities. An overview of IPA’s legislative priorities can be found below.
IPA PRIORITIES
Modernizing the Iowa Pharmacy Practice
Act
Passage of HF 555, IPA’s proposal to modernize Iowa’s Pharmacy Practice Act for the first time since 1986, highlighted the 2024 session. This bill implements a ‘standard of care’ regulatory model and removes burdensome restrictions on pharmacy practice. This change aligns practice with pharmacists’ full training and education for years to come. The bill adds pharmacists to the list of ‘practitioners,’ and includes independent refill authority and therapeutic substitution authority in accordance with the pharmacist’s standard of care.
Iowa becomes the third state to implement a standard of care framework behind Idaho and Alaska. This legislation places Iowa at the top of the country for least restrictive states to practice in. The bill went into effect on July 1, 2024. IPA now shifts attention to creating educational resources for members and collaborating with the Board of Pharmacy to implement the bill.
Protecting Iowa Medicaid Pharmacy Reimbursement
IPA secured funding for the cost of dispensing increase indicated in the 2022 Myers and Stauffer survey conducted by Iowa Medicaid. HF 2698 appropriates $500,000 to fund the pharmacy dispensing fee. This amount will be matched by the Centers for Medicare and Medicaid Services (CMS) to ensure Iowa pharmacies receive adequate payment.
Reforming Pharmacy Benefit Managers (PBMs)
Iowa Insurance Division PBM Legislation – In response to over 72,000 PBM complaints, the Iowa Insurance Division’s PBM transparency legislation (HF 2099/SF 2357) passed unanimously and was signed by Governor Reynolds on May 1st. The bill provides protections from practices uncovered through the complaint process, such as preventing PBMs from retaliating against a pharmacy for reporting complaints to regulators.
IPA PBM Legislation – IPA’s PBM reform proposal to increase PBM transparency, ensure pharmacy viability, and decrease prescription drug costs for patients and employers did not advance. Substantial opposition to HF 2401 from the big three PBMs, large insurers, and big business overcame support from within the chambers. IPA appreciates the tireless efforts of our legislative champions, including our bill sponsors Representative Shannon Lundgren and Senator Mike Klimesh, as well as House Speaker Pat Grassley, House Majority Leader Matt Windschitl, House Minority Leader Jennifer Konfrst, Representatives John Forbes, David Young, and Brian Best, and Senators Dan Dawson, Jason Schultz, Dawn Driscoll, Cherielynn Westrich, and Chris Cournoyer.
This fight is not over. IPA will regroup to refine our strategy and educate opponents of the bill in preparation for the 2025 Legislative Session. Please keep in contact with IPA if you expect to close your pharmacy; please continue submitting PBM complaints to the Iowa Insurance Division and CMS; and please maintain respectful communications with your elected officials.
OTHER NOTABLE ACTION
Boards and Commissions Bill Impacting the Board of Pharmacy Advances
The Governor’s priority to restructure Iowa’s state agencies, including the Board of Pharmacy, advanced and was signed into law on May 17th. The bill requires the ‘big four’ health boards (Pharmacy, Medicine, Nursing, and Dental) to share staff for inspections and investigations, removes the requirement that the health boards maintain oversight in evaluating candidates for Executive Director positions, and reduces the number of members on the Board of Pharmacy by one pharmacist and one public member. IPA submitted a public letter in response to the Boards and Commissions Committee’s recommendations and proposed amendments urging historical strengths of the Board to be retained.
Non-medical Switching Bill Passes
An IPA-supported bill prohibiting health plans from limiting coverage of a prescription drug for a covered person who is medically stable, as determined by medical professionals, was signed into law by the Governor on May 8th.
Pharmacists Respond to ‘Calls to Action’
IPA appreciates the time, effort, and quick responses by IPA members to the many action alerts issued to advance pharmacy’s priorities this session. Whether it was sending an email to your elected officials, signing on in support of PBM reform, or showing up at the capitol for Pharmacy Day on the Hill or PBM Advocacy Day, your voice made a difference.
Pharmacy’s greatest asset under the Gold Dome is its membership across the state in each district.
Thank you! ■
IO
WA P HARMA
CY A SSOCI AT IO N
PHARMACY DAY ON THE HILL
150 pharmacists and student pharmacists took part in face-to-face grassroots advocacy at the 2024 Pharmacy Day on the Hill on January 24 in Des Moines. Attendees shared the urgent need to modernize the Pharmacy Practice Act, protect Iowa Medicaid reimbursement, and prevent PBM abuses with their state legislators. Director Kelly Garcia of Iowa HHS delivered this year’s keynote. The Good Governance Award was presented to Representative Michael Bergan (District 63), and the Legislative Champion Award was presented to Michael (Mike) Andreski, RPh, PhD, of West Des Moines.
In addition, IPA held a special PBM Advocacy Day at the capitol on April 16, bringing pharmacy professionals from across the state together to advocate for IPA’s PBM reform legislation, HF 2401. IPA issued a sign-on letter in support of the bill, garnering the signatures of 330 individuals and 298 pharmacies in 95 of Iowa’s 99 counties. Pharmacists delivered this sign-on letter to their state Senators, demonstrating widespread support by pharmacists, patients, and healthcare stakeholders. ■
Good Governance Award
Rep. Michael Bergan
Legislative Champion Mike Andreski, RPh, PhD
Keynote: Director Kelly Garcia, Iowa HHS
IPA NAMES GEORGE APPLESETH AS 2024-2025 EXECUTIVE FELLOW
IPA welcomes its 2024-2025 Executive Fellow in Association Management, George Appleseth, PharmD, a recent graduate of the University of Iowa College of Pharmacy. As the IPA Executive Fellow, George will work to expand IPA’s clinical initiatives, attend state and national pharmacy meetings, gain exposure to all aspects of association work, and provide insight and assistance in advancing the association and profession.
George is IPA’s eighth Executive Fellow but first University of Iowa graduate. He officially started with IPA on June 17th.
““I’m grateful for the opportunity to begin this new chapter with IPA as the Executive Fellow! As a fourth-year student at the University of Iowa College of Pharmacy, the forward-thinking culture at IPA has been foundational in my professional and personal growth. I’ve witnessed first-hand how this organization propels our profession forward through involvement with the Legislative Advisory Board, IPA Policy Committee on Public Affairs, Bill Burke Student Leadership Conference, and other initiatives that advance pharmacy practice. I’ve always been proud to be an Iowan and look forward to serving the professional needs of our pharmacists, student pharmacists, and technicians in our great state through the execution of IPA’s strategic plan, advocacy events, and the numerous practice initiatives that are shaping the future of pharmacy.”
The IPA Executive Fellowship in Association Management was created to support the development of individuals interested in association management through training and experience in leadership, advocacy, professional affairs and problem-solving at IPA. Individuals who complete the fellowship will be well prepared for leadership positions in a variety of settings in the profession of pharmacy and healthcare. ■
NEWLY CERTIFIED IOWA PHARMACY TECHNICIANS
JANUARY 1–APRIL 1, 2024
Gabriella Allum
Anthony Asbille
Bailey Baccam
Charlotte Barnes
Hannah Behrends
Erica Benny
Jordan Bergeron
Amelia Berns
Christian Bowman
Madeline Brandfass
Rosanna Buchanan
Ella Bushman
Tabitha Chapman
Amado Chavez
James Chen
Sierra Clark
Grace Dalen
Lisa Daman
Sarah Decker
Ashton Donahoo
Cashmere Durant
Leonita Dzeladini
Congratulations to the following technicians!
Julie Embring
Beverly Ernzen
Aiden Evans
Megan Fishel
Kai Fox
Brittini Garrett
Marian Gorrell
Emma Hagemann
Kai Hahn
Gracie Hanneman
Liz Harknett
Madison Hirsch
Courtney Hook
Brenda Hyke
Brynn Johnson
Melisa Jusic
Cameron Kalin
Kevin Khemraj
Emma Kimmel
Kyla Klima
Tess Kraft
Chelsea Landau
Alexis Ledezma
April Lemaster
Beatrice Lewis
Shania Lindner
Chase Lyons
Erica Mallory
Christine Maske
Genevieve McCamant
Jack McMullen
Emad Morkos
Mya Moss
Rae Murray
Saranya Muthukumarasamy
Joel Nachazel
Rebecca Netherton
Samara Neubauer
Madison Norton
Heli Patel
Hayden Pauls
Megan Peiffer
Payton Petersen
Clay Pickrel
Alivia Poock
Emma Rector
Maren Redlinger
Ashley Rempt
Benjamin Reynolds
Cade Rose
Celeste Ruggle
Stormee Shaffer
Kayleigh Simon
Julisa Suazo
Amanda Swenson
Ashlynn Tjossem
Christ Tran
Malayna Tritle-Guger
Aliyah Walker
Taya Waseskuk
Brianna Williams
Rebecca Willrich
Klara Wilson
Sarah Zirkle
2023-2024 SCHOLARSHIPS
Each year, the IPA Foundation provides scholarships to student pharmacists at Drake University and the University of Iowa. The Foundation works with each college to determine recipients that exude the values of the Foundation and the best of the profession. Congratulations to the following scholarship recipients for the 2023-2024 academic year!
DRAKE UNIVERSITY
IPAF Eggleston-Granberg Scholarships
Ali Goldensoph (P4)
James Nichols (P4)
IPAF Mike & Terry Pursel Scholarship
Paula Ornelas (P3)
IPAF Russell E. Johnson Jr. & Lucille Johnson Scholarship
Kaitlyn Thomas (P3)
IPAF General Scholarships
Jana Kay Lacanlale (P4)
Anna Holden (P3)
Isaac Ramos (P4)
Caesar Yeaman (P4)
THE UNIVERSITY OF IOWA
IPAF Eggleston-Granberg Scholarships
Eric Macak (P3)
Davis Rieckenberg (P3)
IPAF General Scholarships
Kisara Thompson (P3)
Kylie Juenger (P4)
October 11, 2024
Sunnyside Golf & Country Club Waterloo, Iowa 9:30 AM Shotgun Start
Join us as we bring together pharmacists, student pharmacists, alumni, and friends for a fun-filled day at the golf course with a purpose. All proceeds benefit the IPA Foundation’s support of student pharmacists at Drake University and the University of Iowa.
New this year! TWO levels of competition offered: Eggleston Groups will play a standard best shot tournament (competitive bracket).
Granberg Groups will play a best shot tournament, adding the option to String It Out on Par 5 holes.
IPA IN ACTION
NEW IPA FINANCE COMMITTEE
IPA’s newly established Finance Committee consists of 7 members and is appointed by the President to oversee and review the association’s financial matters, operating budget, investment policy, and additional policies as needed. The IPA Treasurer serves as the Finance Committee Chair. Committee members may include current and former Board members who will serve a two-year term (coinciding with Board term if applicable).
2024 Committee Members
Kristin Meyer – Chair
Cory Garvin
John Hamiel
Rob Nichols
Wes Pilkington
OPEN HOUSE AT NEW HEADQUARTERS
In April, IPA hosted an open house and welcome reception at its new headquarters at 2570 106th Street in Urbandale. Over 20 members enjoyed refreshments while touring the new space and connecting with IPA staff.
The IPA team is fully moved in and adjusted to the new space, now implementing new tools and technologies to match the innovative environment. IPA staff utilize Asana’s project management system to increase efficiency and align day-to-day tasks with longitudinal goals set forth by the association’s strategic plan. In addition, IPA acquired new technology for the conference room, allowing intelligent video conferencing with a 360-degree Owl camera.
For those who were unable to attend the open house, our doors are always open. IPA is your professional home – We would love to have you stop by!
IPA MEMBER FORUMS
IPA’s virtual Member Forums are designed to address the specific needs of various pharmacy practice areas. These forums facilitate valuable connections among pharmacy professionals across the state and ensure members remain informed about the latest developments in pharmacy.
In January, the Long Term Care Pharmacy Forum focused on changes to infection control post-COVID-19. Attendees engaged in breakout discussions, sharing experiences and insights on collaborating with patient advocates and quality improvement initiatives. February’s Payment for Pharmacy Services Forum provided updates on new billing codes for point-of-care testing from Iowa Medicaid. Participants also learned about the latest advancements in pharmacogenomic testing reimbursement and strategies for overcoming payer credentialing challenges.
As specialty pharmacy continues to rapidly expand, April’s Specialty Pharmacy Forum featured updates on immunology and autoimmune disorder therapies. Attendees discussed strategies to keep pace with the evolving landscape of specialty pharmacy to maintain quality patient care. May’s Health-System Leadership Forum rounded out the 20232024 season. Participants shared successes and challenges with imple-
menting practice advancement initiatives. Dr. Eric Maroyka of ASHP presented tools to help health-systems identify areas for improvement to focus their efforts. The forum also included discussion on the latest 340B legislation updates.
IPA’s 2024-2025 Member Forum calendar has been set! Save the dates of our upcoming forums:
Industry/Managed Care Forum
September 25, 2024, 12:00-1:00 PM
Pharmacy Technician Forum
November 5, 2024, 7:00-8:00 PM
Independent & Community Pharmacy Practice Forum
December 5, 2024, 12:00-1:00 PM
Long Term Care Pharmacy Forum
January 24, 2025, 12:00-1:00 PM
Specialty Pharmacy Forum
February 20, 2025, 12:00-1:00 PM
Payment for Pharmacy Services Forum
April 9, 2025, 12:00-1:00 PM
Health-System Leadership Forum
May 8, 2025, 12:00-1:00 PM
IPA GOES LOCAL
IPA has hosted four Goes Local events so far in 2024, with four more planned throughout the summer and fall. This year’s CE program explores the pharmacy team’s role in providing whole-person care for people living with dementia, considering the unique needs of each patient and their caregivers. The program features a virtual reality simulation so participants can see and hear the world through the eyes and ears of their patients with dementia.
Established in partnership with Iowa’s regional pharmacy associations, each IPA Goes Local event offers one hour of educational programming, dinner, and networking with pharmacy colleagues. IPA saw great attendance in Des Moines, Mason City, Council Bluffs, and the Quad Cities, and we hope to see even more at our upcoming events!
Dubuque – August 29, 2024
Black Hawk/Bremer – September 12, 2024
Spencer – October 10, 2024
Iowa City – November 7, 2024
Mistakes happen. Risky processes become normalized and your operations can shift slightly with staffing changes, new products, and new procedures.
The APMS Patient Safety Organization (PSO) provides Pharmacy Quality Commitment+ (PQC+) Compounding, a confidential, highly secure, continuous quality improvement program. Track and analyze how, when, and where the risk in your workflow occurs so you can reduce Rx corrections and operational costs.
Our program includes:
A web-based reporting portal to collect patient safety events
Tools to chart, graph, and analyze data
Expert advice, tips, and safe practices
Resources to help you meet accreditation and quality improvement requirements Support to build a just culture of safety
QA Continuing Education and training opportunities
Patient Safety Organizations (PSOs) provide a safe space for members to conduct patient safety work. When you partner with our PSO for your Quality Improvement activities, the collection of quality assurance data and patient safety work is in a protected environment.
We are passionate about medication safety in community pharmacy and are here to walk you through the entire process.
Our customer service team has years of experience in pharmacy and is excited to help.
MEMBERS SECTION
IPA ADOPTS NEW CODES OF CONDUCT
In April, the Board of Trustees adopted Codes of Conduct for the IPA membership and attendees of IPA events. These guiding documents put longstanding IPA values in writing, specifically outlining the association’s expectations in upholding the highest standards of professional and personal conduct.
The Membership Code of Conduct reflects IPA’s commitment to treating all members with honesty, integrity, accountability, equity, and respect. It is the expectation that all IPA members, officers, staff, partners, and guests uphold and respect the IPA Code of Conduct, Constitution and Bylaws.
The Event Code of Conduct demonstrates IPA’s commitment to providing a safe, productive, and welcoming environment for all meeting participants, including, but not limited to, attendees, speakers, exhibitors, and staff. IPA has zero tolerance for any form of discrimination or harassment.
You can find both of these documents on IPA’s website under Governing Documents: www.iarx.org/governingdocs
IPA MEMBER RANDY MCDONOUGH INSTALLED AS APhA PRESIDENT-ELECT
In March, IPA member Randy McDonough, PharmD, MS, BCGP, BCPS, FAPhA, of Iowa City was installed as President-Elect of the American Pharmacists Association (APhA) at APhA’s 2024 Annual Meeting & Exposition in Orlando. Randy is the Chief Executive Officer and Co-Owner of Towncrest Pharmacy Corporation. He will succeed current President Alex C. Varkey next March at the 2025 APhA Annual Meeting in Nashville.
MEMBER MILESTONES
Jay Currie, PharmD, FCCP, FAPhA, is retiring after 40 years at the University of Iowa College of Pharmacy, most recently serving as a Clinical Professor and Department Chair for Pharmacy Practice and Science (PPS).
Susan Shields, RPh, Director of Pharmacy at the Iowa Department of Corrections, has been named a Top Supervisor for the Iowa Department of Corrections in 2024.
Laura Knockel, PharmD, BCACP, Clinical Associate Professor at the University of Iowa College of Pharmacy, recieved a Teaching in Highter Education Conference Award from the University of Iowa Council on Teaching.
Renae Chesnut, BS Pharm, EdD, MBA, Professor of Pharmacy Practice and former Dean at Drake University CPHS, received the 2024 Richard Morrow Transformational Leadership Award, recognizing a faculty member whose transformational work has gone above and beyond.
Michelle Fravel, PharmD, BCPS, FCCP, has been promoted to Clinical Professor of Pharmacy Practice and Science at the University of Iowa College of Pharmacy.
Eliza Dy-Boarman, PharmD, BCPS, Assistant Dean for Clinical Affairs at Drake University CPHS, received the 2024 Hartig Distinguished Professor Award, recognizing a pharmacy faculty member who has distinguished him or herself in teaching, scholarship, service, or practice.
IPA President Jim Hoehns, PharmD, BCPS, FCCP, has been promoted to Clinical Professor of Pharmacy Practice and Science at the University of Iowa College of Pharmacy.
Michael Nelson, BS Pharm, PhD, Assistant Dean of Student Affairs at Drake University CPHS, received the 2024 C. Boyd Granberg Professional Leadership Award, recognizing a faculty member who is committed to professional organizational leadership.
Stewart Peterson, PharmD, was promoted to Adjunct Associate Professor of Pharmacy Practice and Science at the University of Iowa College of Pharmacy.
Jamie Pitlick, PharmD, BCPS, Professor of Pharmacy Practice at Drake University CPHS, was named Faculty Preceptor of the Year.
IN MEMORIAM
James (Jim) Van Winkle passed away suddenly on June 15, 2024. Jim was a passionate pharmacist and Hawkeye. He was an active member of the Iowa Pharmacy Association, serving on the Legislative Advisory Committee, and will be dearly missed.
ENGAGED Pharmacists
Logan Schmalfeldt
Saida Tasseff
Vasilios Vagenas
Jennifer Clayton
Lacey Ferguson
Mindy Fults
Natalie Gadbois-Mincks
Julie Haefner
Taylo Naberhaus
Carroll Nelson
Tarah Penning
Leah Schneider
CONNECTED Pharmacists
Rebecca Gatzke
Kendall Kolk
Zachary Mulford
Pharmacy Technicians
Brianna Bengtson
Val Bovy
Sandra Bryant
Michelle Lawton
Makayla Nelson
Julie Nichols
Sydney Sanchez
Cassandra Taylor Bryana Westcott
Business Partners
Wells Hometown Drug Keosauqua
Associate Members
Mandy Banyas, Pace Analytical
Joe Dunham, OneroRx
Katie Kenan, Novo Nordisk
Linda Nunes, Dexcom
Tiffany Yerxa, Vertex
EVENTS
Onnen Company has been serving our customers’ needs since 1964. Fourth generation owned and operated, we offer endless industry knowledge through dedicated sales reps, management and owners with well over 100 years combined experience. We have a knowledgeable, unparalleled, and dedicated customer service staff to help you through the order process. Thank you for trusting us to continue to serve your prescription packaging and pharmacy supply needs.
20
06
Issues & Events That Have Shaped Iowa Pharmacy (Or Are Fun to Remember!)
JANUARY:
• Medicare Part D prescription drug benefit goes into effect as of January 1, establishing drug benefit coverage and cost sharing for eligible enrollees.
MARCH:
• The Combat Methamphetamine Epidemic Act of 2005 is signed into law by President George W. Bush.
• IPA begins sending monthly electronic newsletters via email in place of traditional mail.
APRIL:
• The Combat Methamphetamine Epidemic Act of 2005 goes into effect, requiring all products containing ephedrine, pseudoephedrine or phenylpropanolamine to be sold behind-the-counter or with a prescription, as well as enacting quantity limits and purchase tracking.
• Chantix (varenicline) is approved by the FDA for smoking cessation.
MAY:
• Zostavax, the first shingles vaccine, is approved in the U.S. for adults over age 50.
• The Community Pharmacy Foundation (CPF) launches the CPF Focus 2006 initiative, a one-year collaborative practice pilot study in Iowa that pays pharmacists for managing medications of eligible patients at high risk of therapy problems.
JUNE:
• Gardasil HPV vaccine is approved in the U.S. for adolescents to protect against HPV infection and lower the risk of developing cervical cancer.
• IPA establishes Karbeling Leadership Award to honor the late Jerry Karbeling.
AUGUST:
• FDA approves first OTC emergency contraceptive in the U.S. for adults aged 18 and older.
OCTOBER:
• IPA collaborates with Iowa Governor Tom Vilsack to initiate the first-annual Iowa Pharmacy Week to increase the public’s awareness of services provided by pharmacists in Iowa.
• The Iowa Board of Pharmacy and Iowa Board of Medical Examiners adopt collaborative practice rules that allow physicians and hospital pharmacy and therapeutics (P&T) committees to delegate authorized pharmacists to perform drug therapy management pursuant to written protocols.
NOVEMBER:
• The American Public Health Association publishes a policy statement supporting the expansion of pharmacist’s roles beyond traditional dispensing functions and into more patient-oriented functions, recognizing pharmacists as an accessible and valuable resource for improving public health.
The Iowa Pharmacy Association Foundation is committed to the preservation of the rich heritage of pharmacy practice in Iowa. By honoring and remembering the past, we are reminded of the strong tradition we have to build upon for a prosperous future for the profession.
