Malovrh Named Fellow of ASHP

Congratulations to MPA member Margaret (Peggy) Malovrh, who was recently named a Fellow of the American Society of Health-System Pharmacists (ASHP)!



Malovrh is the vice chair of the Michigan Pharmacy Foundation Board of Trustees. According to the ASHP, Fellow status reflects a “high standard of excellence and sustained commitment to health system practice.” To earn the designation, the new Fellows “successfully demonstrated their active involvement and leadership in ASHP, contributions to the total body of knowledge in the field, and commitment to educating practitioners and others.”

ASHP has recognized 1,045 Fellows since the program began in 1988.

The Michigan Society of Hematology and Oncology (MSHO) is hosting its annual Oncology Pharmacist Forum on May 5, 2023, at the Grand Traverse Resort in Acme. The target audience is oncology pharmacists, with a secondary audience of pharmacy technicians, residents and other pharmacy healthcare professionals. Topics will include site of care; social determinants of health and disparities in cancer care; and logistic challenges with novel bispecific products and more.

Registration is free for MSHO members who sign up before April 21; cost is $75 for non-members. Cost is $75 for MSHO members who register after April 21 and $150 for non-members. The deadline to register is April 28.

340B Day for Michigan May 3 at Crowne Plaza

May 3 is 340B Day for Michigan from 9:30 a.m. to 2 p.m. at the Crowne Plaza West in Lansing, 925 S. Creyts Road.

The 340B drug pricing program allows many hospitals and health care providers to stretch scarce resources and increases access to affordable care to the country’s most vulnerable residents. The 340B program is integral to the fabric of health care financing for covered entities and losing this support could significantly reduce savings while removing access to care for residents in need across the state. Understanding the administration of the program, program management and compliance is of the utmost importance for leveraging the full savings potential and furthering the goals of the 340B program: to support access to healthcare.

The subject-matter experts for this workshop will be presenting insights for hospitals to optimize the administration of the 340B program, including maximizing savings that enable hospitals to provide better care, improve patient outcomes and help the vulnerable patient populations gain access to the services they need.

PROGRAM OBJECTIVES

Upon completion of this program, participants will be able to:

• Outline major regulatory and legislative developments in 340B.
• Identify opportunities to expand the 340B program in a compliant manner.
• Learn best practices in optimizing your 340B program.

WHO SHOULD ATTEND?

Michigan Pharmacists Association pharmacists associated with health systems. This event is intended for 340B entity stakeholders and invitees only. This includes CFOs, finance team members and pharmacy leadership.

Contact Rob Wood (rwood@mha.org) to register for this event.

Free CE Event April 25

The Michigan Pharmacists Association (MPA) and the Michigan Society of Health-System Pharmacists (MSHP) are presenting a live, one-hour continuing education presentation from 2 to 3 p.m. April 25 on Zoom.

Lisa Dumkow, Pharm.D., BCIDP, will present "research in Pharmacy Residency Programs: Addressing Barriers on the Road to Publication." The target audience is students, pharmacy residents and pharmacists. Dumkow currently serves as the pharmacy residency research coordinator for Trinity Health Grand Rapids.

Learning Objectives

At the completion of this activity, the participant will be able to:

1. Identify research questions and study methods suited for publishable residency research projects
2. Outline an annual research timeline that includes steps for successful manuscript completion prior to the finalization of the residency year
3. Recognize and address barriers to publication of residency research projects

Free Webinar on Operationalizing RTU Vancomycin

for Injection May 5

From 1 to 1:20 p.m. Friday, May 5, Xellia Pharmaceuticals is sponsoring a free webinar discussing a case study on successfully operationalizing RTU Vancomycin for injection.

Given drug shortages and staffing challenges, adopting ready-to-use products can reduce compounding risks and simplify distribution. VANCO READY® Vancomycin Injection, USP, is a premix, room temperature stable formulation. VANCO READY® has a boxed warning and is not for use during first and second trimester of pregnancy. Cody Parsons will discuss the operationalization of RTU vancomycin, outlining important patient considerations, storage requirements, EHR adaptation, and workflow simplifications. For full prescribing and safety information please visit vancoready.com.

SDoH: The More You Know

By Julie Schmidt, Pharm.D., BCPS; cardiology clinical pharmacist, Bronson Methodist Hospital, Kalamazoo; director, MSHP

In 1989, a series of public service announcements titled “The More You Know” began broadcasting on NBC-owned networks in the United States. These PSAs were aimed at educating individuals on different topics to increase awareness and understanding. 

I feel like this same phrase can be applied to health care workers when it comes to social determinants of health (SDoH). While SDoH has been a hot topic the past few years, the overarching concepts have been around long before that. Healthy People 2030 – the Department of Health and Human Services’ 10-year plan for addressing the nation’s “most critical public health priorities and challenges” – lists SDoH as one of its priority areas. Healthy People defines SDoH as “the conditions in the environments where people are born, live, learn, work, play, worship and age that affect a wide range of health, functioning and quality-of-life outcomes and risks.”  

Healthy People groups SDoH into five domains each with specific goals and objectives:

1. Economic Stability: Help people earn steady incomes that allow them to meet their health needs. One in 10 people in the United States lives in poverty and many cannot afford healthy foods or health care. Steady employment contributes to lower poverty rates. People who have certain health conditions, such as arthritis, may also be limited in their work abilities. One of the objectives in this domain is to reduce the proportion of those diagnosed with arthritis which limits their ability to work.
2. Education Access and Quality: Increase educational opportunities and help children and adolescents do well in school. Higher levels of education lead to healthier and longer lives. In addition, children from low-income families, those with disabilities, or children who experience social discrimination are more likely to struggle with certain school subjects such as reading and math. In the long-run this can lead to lower graduation rates, lower paying jobs and higher likelihood of health problems.
3. Health Care Access and Quality: Increase access to comprehensive, high-quality health care services. In the United States, approximately one in 10 people do not have health insurance. People without health care insurance are less likely to have a primary care provider, which can lead to less rates of preventative care, such as cancer screenings. Some people also live too far away from a health care provider. Increasing remote services can help this problem. One of the objectives under this domain is to reduce the proportion of people who cannot get prescription medications when they need them. As pharmacists, most of us are (or should be) naturally invested in this objective. We know how important it is to be able to obtain prescription medications and that being unable to obtain them can lead to treatable diseases getting worse. One of the avenues to address this is determining financial barriers and increasing insurance coverage.
4. Neighborhood and Built Environment: Create neighborhoods and environments that promote health and safety. The neighborhoods people live in can majorly impact their health. Every neighborhood has different rates of violence, air pollution and unsafe drinking water. People may also be exposed to different substances at work or in their homes, such as secondhand smoke.
5. Social and Community Context: Increase social and community support. Relationships and interactions with family, friends and community can have major health impacts. Positive and supportive relationships can improve health and well-being.

As a pharmacist, I believe the more we know, the more we can positively impact our patients. I encourage you to expand your SDoH knowledge by reading more on Healthy People 2030, or by researching how SDoH impact your specific patient populations. Gaining a better understanding and meeting our patients where they are will certainly lead to better healthcare.

References

1. Office of Disease Prevention and Health Promotion. “Healthy People 2030.” https://health.gov/healthypeople/priority-areas/social-determinants-health

- EDUCATIONAL AFFAIRS -

Michigan Pharmacists Association

Annual Convention and Exposition Recap

By Katie Axford, Pharm.D., MPH, BCPS; associate professor,

Ferris State University College of Pharmacy

The Michigan Pharmacists Association (MPA) Annual Convention and Exposition (ACE) was held Feb. 24-26 at the Detroit Marriott at the Renaissance Center. After a virtual conference in 2021 and a hybrid experience in 2022, it was exciting to return to a fully in-person format! MPA staff worked tirelessly to provide more than 40 hours of live continuing education programming along with opportunities to engage with exhibitors, network with fellow pharmacy professionals, celebrate the accomplishments of colleagues and identify priorities for the association as we continue to move our profession forward.

The Michigan Society of Health-System Pharmacists (MSHP) sponsored two continuing education programs during the convention. On Friday morning, Jason Moore, CFP, EA, presented “Financial Freedom: How to Partake in Planning.” Pharmacists and pharmacy technicians were able to learn about financial planning, including basics of the industry, general financial planning strategies and ways to improve their long-term financial success. 

Saturday morning featured a panel of current pharmacy residents who shared “Clinical Pearls for Pharmacy” on topics relevant to their training focus. First, Lauren Quiroga, PGY2 investigational drugs and research resident at Michigan Medicine, provided insights on the role of pharmacy professionals in caring for the clinical trial participant. Hannah Ferrari, PGY2 ambulatory care resident at Henry Ford Hospital, presented emerging data on the use of zuranolone for the treatment of peripartum depression. Rounding out the session, Spencer Graczyk, PGY2 emergency medicine resident at Detroit Medical Center/Detroit Receiving Hospital and Wolfegang Moorhouse, PGY2 critical care resident at Trinity Health St. Joseph Mercy Oakland, teamed up to summarize the most recent evidence for the use of phenobarbital in severe alcohol withdrawal.

The MSHP Membership Committee and President Michelle Dehoorne also hosted the annual MSHP Student Luncheon on Saturday afternoon. A group of MSHP members joined student attendees to engage in conversations around social determinants of health (SDoH); the wellbeing and resilience of the pharmacy workforce; transitioning from a student to new practitioner, and other topics of interest. Thanks to Ryan Bickel, Marc Guzzardo, Jesse Hogue, Melvin Leonard and Selma Yamamoto for volunteering as table facilitators for this event!

In addition to these MSHP-sponsored sessions, several other MSHP members stepped up to provide valuable educational programming at the ACE. Presenters included (in alphabetical order):

• Susan DeVuyst-Miller
• Candice Garwood
• Michael Klepser
• Melissa Lipari
• Alison Lobkovich
• Insaf Mohammad
• Mary Beth O’Connell
• Anne Ottney
• Benjamin Pontefract
• Claire Saadeh
• Brittany Stewart
• Kevin Szyskowski
• Emily Thomas
• Vishnuprabha Vogel
• Paul Walker

Thanks to all the members and staff who contributed to another successful convention!

Be sure to mark your calendar for more opportunities for live continuing education at the MSHP Annual Meeting on Oct. 27, 2023, in Lansing.

- MEMBERSHIP UPDATE -

The Value of Membership

By Denise Propes, CPhT, Michigan Medicine

Pharmacy organizational membership provides great opportunities for pharmacy technicians to engage in their profession. These groups can provide continuing education (CE), networking opportunities, job and career opportunities and professional development. They also invite engagement and provide a united voice that can identify the problems within the profession and, more importantly, an environment of sharing that brings creative solutions to the problems technicians face. There are various pharmacy organizations at the national, state and community level that invite technician participation.

I recently did a LinkedIn survey of pharmacy technicians and found that under half of those that responded (approximately 500), were members of a pharmacy organization. I also had many respondents asking how they could find pharmacy organizations in their community.

Based on my survey, and my own observations:

• Technicians are not aware of how and where to get involved and do not see the benefits of organizational membership.
• Pharmacy and pharmacy technician organizations are not visible to techs and perhaps need to provide more value to engage more technicians.

Many techs look at organizational membership as a CE product and the other values of organizational membership may not be as visible. However, membership can mean so much more than CE. The Michigan Society of Health-System Pharmacists (MSHP), the Michigan Pharmacists Association (MPA) and its regional and local affiliates are in the best position to provide the greatest value to their members and lead the charge on encouraging and supporting technicians through organizational membership as well as making the Michigan Society of Pharmacy Technicians (MSPT) and MPA more visible to our communities. 

I have put together a list of benefits that provide value to all our members (not only technicians). Below are some of the benefits that are already being implemented, but members may not know of. This is just a start, but there are lots of great ideas everyone can contribute as well.

• CE at no extra cost (including opportunities for “live” CE).
• Networking opportunities to discuss and address the issues technicians face to create a united voice. 
• Job and career advice (examples: resume/CV writing services, MPA leadership academy) 
• Publishing and public speaking workshops (examples: how to create a professional poster or presentation skills)
• Community outreach and involvement (examples: vaccine clinics, handing out water at a community walk for a charitable organization or hosting a booth at high school career fair on why pharmacy technician is a great career path).
• Free membership to pharmacy students and pharmacy technician students.
• Group discounts to attend national pharmacy conventions and MPA Leadership Academy.
• Discounts on advanced pharmacy technician certifications.

However, membership goes both ways. Pharmacy organizations are made up of mainly volunteer members giving their time and energy to promote their profession and provide a great organizational experience for their colleagues. In order to have a voice in changes and improvements to our profession, technicians need to become more involved. There are all kinds of committees, advisory boards and forums that are looking for technician involvement. Technician representation and leadership in pharmacy organizations is the best way to support and promote our profession for the future.



There are so many new and exciting opportunities coming our way, and organizations like MPA and MSHP can help us cross these bridges by providing great value for membership and a united voice in support of technicians. I am honored to be active member in these groups as they help us move our profession forward. Please reach out to me if you have questions or want to know more about how rewarding organizational membership and involvement can be. 

- RESIDENT'S CORNER -

Simplifying the Prescott Method for Acetaminophen Overdose

By Philip DiMondo, Pharm.D., BCPS

Acetaminophen (Tylenol^®) overdose is one of the most common toxic exposures treated in the United States.¹ More than 60 million Americans consume acetaminophen on a weekly basis.¹ The ability to purchase it over-the-counter and its presence in most common cold products leads to patients arriving in emergency rooms with unintentional overdoses – as well as intentional overdoses.¹ N-Acetylcysteine (NAC) has remained the antidote of choice in the treatment of acetaminophen toxicity due to its ability to replenish glutathione stores and prevent NAPQI accumulation and the associated hepatotoxicity following massive ingestions.¹

However, the historically-used intravenous (IV) NAC administration protocols – commonly referred to as the Prescott or three-bag method – requires unnecessarily complicated steps that can perpetuate gaps in IV NAC administration to the patient, which can lead to liver injury. In response to calculation dosing errors, NAC administration gaps and lack of sufficient IV NAC for massive ingestions (defined as greater than 30 grams of acetaminophen), Poison Control has begun recommending a more streamlined approach to dosing IV NAC using a simplified, two-bag method to hospitals in Michigan.

A streamlined, two-bag method is essential to prevent liver injury as a result of delayed and/or inconsistent NAC administration. Acetaminophen-induced cell death is often only thought of as CYP-mediated generation of NAPQI. However, throughout the 1990s and into the early 2000s, scientists learned the importance of mitochondrial injury and how the oxidative stress amplifies liver injury much more quickly – stressing the importance of receiving NAC as quick and consistently up-front as possible to ensure positive patient outcomes.² The traditional three-dose Prescott method not only presents health care workers with added steps, but it can also increase the likelihood of dosing errors and time to delivery due to three separate bags needing to be separately dosed, compounded and delivered per patient. 

Another downfall of the Prescott method and associated nomogram was that it was only studied to treat acute ingestions around 16 grams of acetaminophen; it does not adequately prevent liver injury in patients who ingest quantities more than 16 grams or chronic large ingestions.³ The Prescott method delivers drugs at a rate of approximately 7.5 milligrams per kilogram/hour (mg/kg/hr), or 300 milligrams per kilogram over 21 hours, while the two-bag method implements a higher overall NAC dose by giving a 150 milligrams per kilogram dose over one hour followed by a condensed, continuous infusion of 15 mg/kg/hr until hepatotoxicity resolution. 

“What is the most appropriate dose of N-acetylcysteine after massive acetaminophen overdose?” (Hendrickson et al., 2019) supports these modifications. He found that there is a 1 to 1 molar ratio between NAC and NAPQI, therefore ingestions more than 16 grams would need greater amounts of NAC.⁴ He studied several higher NAC rates (12.5 mg/kg/hr, 18.75 mg/kg/hr and 25 mg/kg/hr) and concluded that doubling the usual rate (12.5 mg/kg/hr) is increasingly accepted, well tolerated and safe for patients recovering from massive acetaminophen ingestions; though tripling and quadrupling the rate remains more controversial.⁴

Institutions across America, not just in Michigan, are beginning to implement more streamlined IV NAC treatment. “Evaluation of a Simplified N-Acetylcysteine Dosing Regimen for the Treatment of Acetaminophen Toxicity” utilized a simplified dosing regimen with a 150 milligrams per kilogram loading dose administered over 1 hour, followed by an infusion of 14 mg/kg/hr for 20 hours. It found that all 70 patients achieved resolution of toxicity and that their single-bag protocol was effective and well tolerated.⁵ 

“Simplification of the standard three-bag intravenous acetylcysteine regimen for paracetamol poisoning results in a lower incidence of adverse drug reactions” found that not only was the two-bag method effective at treating the acetaminophen overdose, but the incidence of non-allergic anaphylactoid reactions (NAARs) were significantly reduced by combining the first two bags of the traditional three-bag regimen and infusing these over four hours at 50 mg/kg/hr (10 percent versus 4.3 percent).⁶

In conclusion, the streamlined approach to treating acetaminophen overdose with a two-bag method can reduce the work burden on pharmacy and nursing. It also can improve patient outcomes by decreasing the chance of dosing errors, reducing preparation time, expediting NAC administration to the patient, and reducing the chances of patients experiencing a NAAR. More health systems in Michigan should consider implementing this new and improved NAC regimen for acetaminophen overdose. 

References

1. Agrawal S, Khazaeni B. Acetaminophen Toxicity. [Updated 2022 Aug 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441917/

2. Ramachandran A, Jaeschke H. Acetaminophen hepatotoxicity: A mitochondrial perspective. Adv Pharmacol. 2019;85:195-219. doi:10.1016/bs.apha.2019.01.007

3. Farkas, Josh. “Acetaminophen Toxicity.” EMCrit Project, 2021 November. https://emcrit.org/ibcc/acetaminophen/#acetylcysteine.

4. Hendrickson RG. “What is the most appropriate dose of N-acetylcysteine after massive acetaminophen overdose?”. Clin Toxicol (Phila). 2019;57(8):686-691. doi:10.1080/15563650.2019.1579914

5. Johnson MT, McCammon CA, Mullins ME, Halcomb SE. “Evaluation of a Simplified N-Acetylcysteine Dosing Regimen for the Treatment of Acetaminophen Toxicity”. Annals of Pharmacotherapy. 2011;45(6):713-720. doi:10.1345/aph.1P613

6. Wong A, Graudins A. “Simplification of the standard three-bag intravenous acetylcysteine regimen for paracetamol poisoning results in a lower incidence of adverse drug reactions”. Clin Toxicol (Phila). 2016;54(2):115-119. doi:10.3109/15563650.2015.1115055

- AMBULATORY CARE -

Billing for Ambulatory Care Pharmacy Services:

A Review and Update 

By Insaf Mohammad, Pharm.D., BCACP and Jodie Elder, Pharm.D.

Within the last few years, several additional billing opportunities for ambulatory pharmacy services have been identified and utilized. The Michigan Society of Health-System Pharmacists’ (MSHP) Ambulatory Care Survival Guide provides an overview of billing practices and codes to guide pharmacists in building a billing model that is tailored to innovative practice models. 

Prior to expanding billing for health care services, ambulatory care pharmacists must take into account a few considerations: the practice setting, the payer and the service provided.¹ Hospital-based clinics are financially tied to a hospital, whereas physician-based clinics are owned by a physician group. Community pharmacies are another practice setting where billing can occur, typically with medication therapy management (MTM) billing opportunities. 

While there are opportunities for pharmacists to bill under certain Medicare Part D plans for specific services, pharmacists do not have recognized provider status by Medicare Part B, so they cannot directly bill under Medicare Part B. Rather, they must bill under a recognized provider’s National Provider Identification (NPI) number. This is typically referred to as “incident to billing” and carries requirements for supervision and documentation. 

For Medicaid patients, there are limited opportunities for pharmacists to bill for clinical services. For commercial payers, there are service contracts for MTM or chronic disease services, but these may vary by payer, location and health-system. Pharmacist services can be provided either face-to-face or non-face-to-face. Often, these services are delegated to the pharmacist via a collaborative practice agreement.²

Billing Opportunities

Table 1 highlights many available billing options, including the codes, practice setting and anticipated payment for 2023 from Medicare. Pharmacists can check the reimbursement for a particular code via the Medicare Physician Fee Schedule.

Face-to-Face Billing Opportunities

Billing codes for face-to-face, incident-to-physician billing include evaluation and management (E&M) billing codes 99211-99215, with the code selected being based on the complexity of the visit and time spent with the patient. However, pharmacists are limited to billing 99211 regardless of time spent or complexity of the visit. 

In a hospital-based clinic, both 99211 and G0463 (the facility fee) may be submitted. In a physician-based clinic, only 99211 is billed for government payors such as Medicaid, Medicare, and TriCare. For both hospital and physician-based clinics, the commercial payers are only billed 99211, while G0463 does not apply. Other face-to-face billing opportunities reimbursed by Medicare include Transitional Care Management, Chronic Care Management (for non-face-to-face care coordination efforts), Annual Wellness Visits and Diabetes Self-Management Training (Table 1).

It is important to note that some billing codes only require general supervision (under provider direction, but the billing provider does not need to be onsite or immediately available). Other billing codes require direct supervision (provider must be present in the same building and immediately available while the service is delivered). 

Table 1: Overview of Billing Opportunities

Telehealth Billing Opportunities

In response to the COVID-19 pandemic, the Coronavirus Preparedness and Response Supplemental Appropriations Act became law on March 6, 2020.³ This legislation allowed CMS to expand access to care and telehealth billing codes. While the use of telehealth codes was originally planned to be used temporarily, the Consolidated Appropriations Act of 2023 extended telehealth flexibilities through Dec. 31, 2024. Table 2 provides an overview of telehealth billing codes.⁴

Table 2: Telehealth Billing Opportunities

Other Billing Opportunities

Billing opportunities for anticoagulation management and continuous glucose monitoring are outlined below.

Anticoagulation (warfarin) management: 93793, non-face-to-face management for INR interpretation and patient instructions ($11.71, hospital and physician-based clinics)

Continuous glucose monitoring (CGM) CPT codes:⁵

• 95249: Personal CGM start-up and training ($62.10, hospital and physician-based clinics), once per lifetime of CGM device, face-to-face
• 95250: Professional CGM device placement ($146.81, hospital and physician-based clinics)
• 95251: CGM interpretation ($35.40, hospital and physician-based clinics), telehealth allowed, Limitations exist for pharmacist billing

Conclusion

Billing opportunities for ambulatory care pharmacists have expanded in recent years and vary based on practice setting and type of service provided. While challenges exist across different practice sites based on health-system regulations, billing department barriers, or legal compliance, pharmacists should partner with their stakeholders and health-systems to identify opportunities to overcome such barriers. Often, this means working with billing and compliance at their institution and consulting with peer organizations to determine how to best move forward with generating revenue for services provided.

References

1. Kliethermes M. Billing Boot Camp I. APhA 2016 Annual Meeting.

2. CDC. Advancing Team-Based Care Through CPAs: A Resource and Implementation Guide […]. 2017.

3. Telehealth policy changes after the COVID-19 PHE. Telehealth.HHS.gov. 2023.

4. Mohammad I, et al. J Am Coll Clin Pharm. 2020;3(6):1129-1137

5. AACE Guide to CGM. https://pro.aace.com/cgm/toolkit/billing-codes.

- REGIONAL UPDATE -

Southeastern Michigan Society

of Health-System Pharmacists Update

By Jessica Jones, Pharm.D., BCPS, BCCCP

The Southeastern Michigan Society of Health-System Pharmacists (SMSHP) had a strong finish to 2022! I had the pleasure of presenting our final continuing education (CE) session in November on a topic near and dear to my heart – ICU delirium and post-ICU syndrome – and also being installed as the incoming president-elect for 2023. The newly inducted SMSHP board had a successful and productive leadership and planning retreat in December.  

In 2023, the board is exploring opportunities to expand networking, service and other offerings to our membership beyond CE programming. We are excited to start 2023 with all events in-person and are also seeking the optimal approach to integrating more flexibility into our events through both virtual and in-person options.

We’ve had a strong start to our CE programming this year. On Jan. 11, we had the pleasure of learning about B-cell maturation antigen (BCMA)-directed therapy in the management of relapsed/refractory multiple myeloma from Brittany Lines, Pharm.D., BCOP, at the Gazebo Banquet Center in Warren. Feb. 8 saw a great discussion on pharmacy economics – billing, reimbursement and practice models – from Insaf Mohammad, Pharm.D., BCACP, at Burton Manor in Livonia. We heard Nicole Stone, Pharm.D., present “The Nursing Perspective: Pain Assessment and Medication Administration” on March 8 at the Silver Gardens in Southfield.

Additionally, four board members were proud to represent SMSHP at the MPA annual House of Delegates Session on Feb. 26. Farzad Daneshvar, Pharm.D., BCPS; Dmitriy Martirosov, Pharm.D., BCIDP; Shelbye Herbin, Pharm.D., BCPS, BCIDP, and I enjoyed contributing to the discussion with our fellow delegates in partner organizations and voting to support initiatives that continue to advance the profession of pharmacy forward in the state of Michigan.

If you are a member who would like to get more involved, please reach out to SMSHP President Rox Gatia, or let us know via our website, smshp.org.

- STUDENT FOCUS -

Pharmacological Approaches for the Treatment of Obesity  

By Andy Kalka and Lauren Buchowski, 2023 Pharm.D. candidates, Ferris State University

Obesity is defined as abnormal or excessive fat accumulation that can present a significant risk to a person's overall health. Typically classified by body mass index (BMI), an individual is obese when they reach a BMI of 30 or higher. Recent data from the Centers for Disease Control and Prevention (CDC) suggests that more than 2 in 5 adults and 1 in 5 children in the United States struggle with obesity.^1,2 Obesity is considered a national health crisis with a devastating economic burden of $173 billion annually.¹ 

Due to the significant impact obesity has on the United States, a large portion of individuals are seeking pharmacologic options as an adjunct to lifestyle modifications for the treatment of obesity. Currently, there are five FDA-approved options for chronic weight management. These options include orlistat (Xenical, Alli), naltrexone-bupropion (Contrave), phentermine-topiramate (Qsymia), liraglutide (Saxenda), and semaglutide (Wegovy). Out of these options, glucagon-like peptide-1 receptor agonists (GLP-1s) Wegovy and Saxenda are associated with the highest efficacy (TABLE 1). Other GLP-1s are available, but are only FDA-approved for the treatment of type 2 diabetes.

A new agent, tirzepatide (Mounjaro) was recently approved for the treatment of type 2 diabetes mellitus and is in clinical trials for weight loss due to its expected weight loss potential.

Despite the efficacy of weight loss medications, several barriers exist that limit patient access. Although Medicaid plans in Michigan cover weight loss medications with a prior authorization, Medicare plans exclude this drug class entirely. Commercial insurance plans vary in coverage, with most requiring a prior authorization, in which the insurance company requires additional level of review and documentation to ensure the medication is medically necessary. It is often the case that certain insurance plans require specific forms to be submitted, making the process more confusing for both patients and prescribers. Supply chain issues and manufacturer back orders have also served as tremendous barriers to patients receiving these medications.

While off-label prescribing of GLP-1s for weight loss is an option, federal and commercial insurance companies may reject coverage without a diagnosis of type 2 diabetes. Adverse effects may also limit prescribing and increase patient hesitancy of starting a GLP-1. The most common adverse effects include gastrointestinal side effects such as nausea, vomiting and diarrhea, which are expected to lessen over time. 

Community pharmacists can play a role in educating patients on how to properly use GLP-1s and how to best manage any side effects. There is no recommended duration of use for these medications; most patients will be on these medications indefinitely. Weight regain is common following medication discontinuation.¹¹

Overall, obesity is considered a global crisis with a significant economic impact. Advancements in pharmacologic approaches for managing obesity have revolutionized treatment; however, there are several factors that need to be considered when prescribing these medications. As pharmacists, we can help patients navigate the existing barriers to obtaining their medication.

References

1. Centers for Disease Control and Prevention. Adult obesity facts. Available at: https://www.cdc.gov/obesity/data/adult.html. Accessed March 1, 2023.

2. Centers for Disease Control and Prevention. Childhood obesity facts. Available at: https://www.cdc.gov/obesity/data/childhood.html. Accessed March 1, 2023.

3. Sjöström L, Rissanen A, Andersen T, et al. Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. The Lancet. 1998;352(9123):167-172. 

4. Greenway FL, Fujioka K, Plodkowski RA, et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595-605.  

5. Apovian CM, Aronne L, Rubino D, et al. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity. 2013;21(5):935-943. 

6. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring). 2012;20(2):330-342. 

7. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomized, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2011 Apr 30;377(9776):1494]. Lancet. 2011;377(9774):1341-1352. 

8. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373(1):11-22.  

9. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989-1002. 

10. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. 

11. Wilding JPH, Batterham RL, Davies M., et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab.2022;24:1553-1564.

12. Lexi-Drugs. Lexicomp app. UpToDate, Inc. 2023.

OFFICERS

PRESIDENT | Michelle Dehoorne | (313) 343-6381 | Ascension, Detroit

PRESIDENT-ELECT | Kyle Schmidt | (616) 685-6675 | Mercy Health St. Mary's, Grand Rapids

IMMEDIATE PAST PRESIDENT | Shawna Kraft | (734) 232-6667 | Michigan Medicine, Ann Arbor

TREASURER | Marc Guzzardo | (810) 606-6095 | Ascension, Detroit

EXECUTIVE VICE PRESIDENT | Edward Szandzik | (313) 587-6279 | Detroit

DIRECTORS

Stacy Brousseau | (269) 341-7407 | Bronson Methodist Hospital, Kalamazoo

Diana Kostoff | (313) 725-7925 | Henry Ford, Detroit

Nada Farhat | nmhammou@med.umich.edu | Michigan Medicine, Ann Arbor

Julie Schmidt | (989) 450-6695 | Bronson Methodist Hospital, Kalamazoo

REGIONAL SOCIETY REPRESENTATIVES 

CENTRAL | Tim Ekola | (734) 845-3418 | VA Ann Arbor Healthcare System

NORTHERN | Miranda Maitland | mirandapmaitland@gmail.com | My Michigan Medical Center, Sault Ste. Marie

SOUTHEASTERN | Jessica Jones | (313) 982-5737 | Beaumont Health, Detroit

WESTERN | Shelby Kelsh | shelbyKelsh@ferris.edu | Ferris State University, Big Rapids

MANAGING EDITOR | Ryan Weiss | (517) 377-0232 | Michigan Pharmacists Association, Lansing