In This Issue:

MPA CEO Perspective

MPA News

• Malovrh Recognized as Fellow of ASHP
• New Students Welcomed at MPA
• 340B Day for Michigan May 3
• Law Books Available for Purchase

MPA Member Updates

• MPF 2023 Golf Classic — Register Today

National Association News

• APhA Journal Seeks Papers for Gender and Sexual Healthcare Issue

CE Events

• Upcoming CE Opportunities

Upcoming Events

• Pink Book Registration Now Open

Legislative and Regulatory News

• Whitmer: Medication Abortion Still Legal Despite Federal Judge's Ruling
• APhA Stands by FDA Approval of Mifepristone
• Whitmer Strikes 1931 Abortion Ban
• InflaRx COVID-19 Monoclonal Antibody Gets FDA's Emergency-Use Authorization
• LARA Issues Reminder on Required Inventory for Controlled Substances

COVID-19 Updates

• MDHHS Issues Proposed Medicaid Policy

Professional Practice

• Drug-Resistant Eye Bacteria Can Spread Person to Person
• Pfizer RSV Vaccine Effective in Infants When Given to Pregnant Mothers

Things are heating up legislatively in Michigan and Washington, D.C. MPA continues to be your voice for both, but you can be engaged legislatively as well.

In Michigan, MPA is pursuing immunization bills (HB 4316 and SB 219), birth control prescribing legislation and white bagging, among others. We also have met with legislators and their staffs to ensure appropriations language regarding pharmacy dispensing fees is included in the 2023 budget boilerplate language. House Bill 4276 also seeks to codify the methodology by which pharmacy reimbursements are determined (as dictated by CMS) in the Social Welfare Act. Watch your email for updates from MPA, including requests for you to act. We have special software that allows you to send letters to your legislators with a click of a mouse – stay tuned!

If your interests are more focused on national legislation, then you need to attend the NCPA Congressional Fly-in April 26-27, 2023, in Alexandria, Virginia. It’s the first time since 2019 that NCPA has held the event due to COVID-19 and subsequent visitation restrictions on Capitol Hill. This is an opportunity to meet with federal lawmakers face-to-face to discuss issues important to the practice of pharmacy, such as PBM transparency and patient access to pharmacist care. Register online through the NCPA website. If you are planning to attend the fly-in, please notify Eric Roath, MPA director of government affairs, at eroath@michiganpharmacists.org. A tentative schedule of events for the fly-in can be found here.

I hope to see you in our nation’s capital!

Malovrh Recognized as Fellow of ASHP

Congratulations to Peggy Malovrh, who was recently named a Fellow of the American Society of Health-System Pharmacists (ASHP)! Malovrh is the clinical supervisor and residency program director at Sparrow Hospital in Lansing. She received her Bachelor of Science degree in 1980 and her Doctor of Pharmacy degree in 1993 from Ferris State University College of Pharmacy.

She is a preceptor for student pharmacists from the University of Michigan, Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences and FSU.

Peggy is currently serving as a delegate to the Michigan Pharmacists Association (MPA) House of Delegates and previously served on the MPA Executive Board. She is a past president of the Capital Area Pharmacists Association and the Michigan Society of Health-System Pharmacists (MSHP), along with being a member of the ASHP since 1981 and the American College of Clinical Pharmacy since 1998.

Peggy is board-certified in pharmacotherapy, is a Fellow of MPA and has been an MPA member for 42 years. She was recently elected to her second term as a Michigan Pharmacy Foundation (MPF) trustee and currently serves as MPF’s vice chair.

MPA Welcomes Students for April

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 healthcare providers to stretch scarce resources and increases access to affordable care for the country’s most vulnerable residents. The 340B program is integral to healthcare financing for covered entities. 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 present 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.

Fourth Edition Pharmacy Law Books Available to Purchase

The fourth edition of Michigan Pharmacists Association's "Pharmacy Law Simplified: A Practical Approach to Contemporary Practice" is now available for purchase!

"Michigan Pharmacy Law Simplified" is intended to be informative and provides additional guidance to pharmacy professionals in relation to pharmacy practice in the state of Michigan. The book compiles state and federal laws and rules relevant to the practice of pharmacy, avoiding legal jargon.

To get your hands on a copy, visit the MPA store, fill out the Online Store Order Form and email it to MPA@MichiganPharmacists.org.

Michigan Pharmacy Foundation Golf Classic

Register Below!

MPA Career Center

Featured Job Opportunities

Staff Pharmacist | Harbor Town Pharmacy | Ontonagon, MI

Pharmacist | Northland Foods | Kingsley, MI

Pharmacy Technician Advanced Immunization Training Home Study



Live sessions April 18 and May 16;

Home self-study must be completed before your live session date

Research in Pharmacy Residency Programs: Addressing Barriers on the Road to Publication

2-3 p.m. live virtual session April 25

Implicit Bias Training

4-6 p.m. live virtual session June 15

MPJE Pharmacy Law Review 2023

9 a.m.-noon live virtual session May 20

APhA Pharmacy-Based Immunization Training

9-11 a.m. live virtual session July 19

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.

MSHO has reserved a block of rooms at the Grand Traverse Resort for a special rate of $169, plus taxes and fees for hotel guestrooms, and $209 plus taxes and fees for tower guestrooms. Details for securing a room will be sent with your confirmation when you register. If you do not receive a confirmation, please contact Linda Raveau at lraveau@msho.org, or (248) 385-5464. 

The room block deal ends April 13, so register today!

Pink Book Registration Now Open

Registration for the Pink Book Conference is now open. This live, two-day course is intended for state, county and regional immunization programs. Two speakers from the Centers for Disease Control (CDC) will provide an overview of vaccination principles, general best practices, immunization strategies and specific information about vaccine-preventable diseases and the vaccines that prevent them. 

The conference will be held June 13-14, 2023, at the Lansing Center. Registration and a light continental breakfast begin at 7:30 a.m. A light lunch will also be served. There is no charge for this event. 

Due to limited space, registration for this event will close at 450 participants and a waiting list will begin.

Contact Connie DeMars at demars@anr.msu.edu with any questions, or if you sign up for the event and cannot attend. This will allow an individual from the waiting list to attend instead.

APhA Journal Seeks Papers for Gender

and Sexual Healthcare Issue

The "Journal of the American Pharmacists Association" (JAPhA) is soliciting papers regarding gender and sexual health for an upcoming theme issue in January 2024. The due date for submission is July 15, 2023. The journal seeks a broad range of contributors, and submissions from any practice setting are welcome.

The following topics are of particular interest for this theme issue:  

• Comprehensive reproductive health care and justice 
• Gender-affirming care and how health care professionals provide care for patients 
• Sexually transmitted infections including treatment 
• Role of health care professionals in providing comprehensive reproductive health care services 
• Gender dysphoria, including its effects on mental health
• Period products and ways to increase access 
• Women’s and men’s health

Authors are invited to submit manuscripts in the categories of research, research notes, advances in pharmacy practice, reviews or commentaries. 

For manuscript preparation and submission guidelines, please see the author guidelines at japha.org. 

Please contact the journal with any questions (japha@aphanet.org).

Whitmer: Medication Abortion Still Legal

Despite Federal Judge's Ruling

Gov. Gretchen Whitmer said medication abortion is still legal in Michigan despite the ruling from a federal judge in Texas that suspended approval of the drug mifepristone.

“Today, an extreme federal judge in Texas who is out-of-step with the majority of Michiganders and Americans has attempted to ban mifepristone, one of the most common abortion medications that have been approved by the FDA, prescribed and safely used for decades," Whitmer said in an April 7 statement. “Mifepristone gives people the freedom to choose when or how to start a family. If today’s ruling takes effect, over 64 million Americans, including millions of Michiganders, may effectively be prevented from accessing the drug. Despite this ruling, I want to be clear: abortion, including medication abortion, remains safe and legal in the state of Michigan."

U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, ordered a hold on federal approval of mifepristone, which had been approved by the FDA since September 2000. Another ruling by U.S. District Judge Thomas O. Rice, an appointee of former President Barack Obama, issued at competing ruling essentially stating the opposite, leaving the drug's status in limbo.

APhA Stands by FDA Approval of Mifepristone

The American Pharmacists Association (APhA) said in a statement that it stands by the Food and Drug Administration's (FDA) approval of mifepristone following a ruling by a Texas federal judge that suspended its approval.

"APhA and our nation's pharmacists stand behind the FDA review and approval process that relies on evidence-based expert review to establish the safety and efficacy of marketed drugs," said Ilisa Bernstein, Pharm.D., J.D., FAPhA, interim executive vice president and CEO of APhA. "The FDA gold standard for approval has been in place for nearly 120 years and is the basis for pharmacists' trust and confidence in the medicines they recommend and dispense to patients. The Texas decision does not change this gold standard."

APhA mentioned they are currently reviewing the decision. However, this "only adds more confusion and complexity to an already complicated state and federal legal and regulatory landscape for pharmacists and patients related to mifepristone."

Whitmer Strikes 1931 Abortion Ban from Michigan Law

A near-century-old abortion ban that fueled one of the largest ballot drives in Michigan history was repealed April 5 by Gov. Gretchen Whitmer, just months after voters enshrined abortion rights in the state’s constitution.

“Today, we’re going to take action to make sure that our statutes and our laws reflect our values and our constitution,” Whitmer said at a bill signing outside of Detroit.

The 1931 abortion ban made it a four-year felony to assist in an abortion. Roe v. Wade had made the law null and void until the landmark decision was overturned in June by the U.S. Supreme Court.

Last month, the Michigan House and Senate — each with a two-seat Democratic majority — voted to send a repeal of the abortion ban to the governor. A majority of Republicans opposed the bill, speaking out ahead of the vote on the legality of abortion as a whole.

InflaRx COVID-19 Monoclonal Antibody Gets

FDA's Emergency-use Authorization

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for the monoclonal antibody vilobelimab (Gohibic — InflaRx NV) to treat hospitalized COVID-19 patients when administered within 48 hours of undergoing artificial life support.

The injection targets a portion of the immune system that is believed to affect inflammation that triggers disease progression in COVID-19 patients. A late-stage trial found that patients treated with vilobelimab had a reduced risk of death by day 28 and day 60 of treatment compared with a placebo.

InflaRx is currently in talks with FDA about applying for full approval for vilobelimab for this COVID-19 indication. According to the FDA, the recommended dosage is 800 milligrams administered through intravenous infusion after dilution, injected up to six times during treatment. 

LARA Issues Reminder on Required Inventory

for Controlled Substances

The Michigan Department of Licensing and Regulatory Affairs (LARA) has issued a reminder that MCL 333.7321(2) of the Michigan Public Health Code requires licensees who manufacture, distribute, prescribe or dispense controlled substances to inventory all schedule 2-5 controlled substances on an annual basis. 

The inventory must be conducted each year between April 1 and June 30 and retained for at least two years by the licensee. A 2017 amendment to this law eliminated the requirement to submit the results of the inventory to LARA each year. The statute still requires the inventory to be made available for inspection upon request by LARA. Do not submit your inventory to LARA unless requested.

Those with questions regarding this notification, please contact the MAPS Support Staff who oversee this process, by email at BPL-MAPS@michigan.gov. If you are looking to purchase an inventory list, complete an order form and submit to MPA! For any questions, contact Farah Jalloul, Director of Professional Development at Farah@MichiganPharmacists.org.

MDHHS Issues Medicaid Policy Bulletin on End of Federal PHE

The U.S. Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service Act, to expire at the end of the day on May 11, 2023.

During the federal COVID-19 PHE, many changes were made to Michigan Medicaid program policies to ease rules for providers and prevent Medicaid beneficiaries from losing healthcare coverage. Michigan has begun unwinding certain policies enacted during the PHE as the authority for these policies expires. The purpose of the MMP 23-27 bulletin is to notify providers of several of these unwind actions. 

Drug-Resistant Bacteria Tied to Eye Drops

Can Spread Person to Person

The Centers for Disease Control (CDC) reports that drug-resistant pseudomonas aeruginosa found in contaminated eye drops from India has spread from person to person in a long-term care facility in Connecticut, suggesting the strain could gain a foothold in the nation's healthcare sites.

To date, EzriCare artificial tears have been linked to three deaths, eight cases of blindness and numerous infections, leading to a recall earlier this year. The U. S. Food and Drug Administration (FDA) has halted imports of the over-the-counter product. According to CDC, the bacteria showed signs of spreading in the Connecticut facility among asymptomatic patients, which can occur when patients touch items contaminated with a pathogen, or when healthcare workers transmit infectious microorganisms.

David van Duin, an infectious disease specialist at the University of North Carolina School of Medicine, says resistant pseudomonas can be difficult to eliminate, both in moist areas, such as sink drains and water faucets, and from patients who develop bloodstream infections. Maroya Walters, lead investigator for CDC's antimicrobial resistance team, says cases associated with the eye drops have mostly been contained because of a product recall and an increase in media reports.

The FDA also announced the recall of Delsam Pharma's Artificial Eye ointment, which was made in the same factory as the EzriCare eyedrops, due to potential contamination. CDC has asked physicians to cooperate with public health labs in identifying the genetic fingerprint of difficult-to-treat pseudomonas infections in the eye and body. The strain had not been previously identified in the United States, according to infectious disease specialists. Read More (Paid Subscription May Be Required)

Pfizer RSV Vaccine Effective in Infants

When Given to Pregnant Mothers

According to a recent report, an experimental vaccine developed by Pfizer has shown promising results in preventing severe cases of RSV in infants when given to pregnant mothers.

The vaccine was found to be 82 percent effective in preventing severe cases of RSV in infants when given to pregnant mothers in the second half of their pregnancy. RSV is a common respiratory virus that can become severe in infants and seniors and cases of the virus saw a worrying spike in the U.S. in late 2022. 

The rise in cases last year put a strain on children's hospitals as they dealt with a surge of young patients that were suffering from more severe cases of the illness. The success of the experimental vaccine offers hope for preventing severe cases of RSV in infants. 

While the shot was successful in preventing severe cases of the illness, it did not reach its goal of more effectively preventing non-severe cases of the virus. Nevertheless, the Pfizer vaccine would be the first maternal vaccine available for the virus and the Food and Drug Administration is set to decide on its commercial use by August.