In This Issue:

MPA CEO Perspective

MPA News

• MPA Welcomes New Director of Government Affairs
• Fourth Edition Pharmacy Law Books Available for Purchase

National Association News

• Michigan Reception at APhA Meeting March 25

MPA Member Updates

• Renew Your MPA Membership Now
• MPA Career Center — Featured Job Opportunities
• Cabrini Clinic Volunteer Opportunities
• MPF 2023 Golf Classic — Save the Date

CE Events

• Upcoming CE Opportunities

Legislative and Regulatory News

• Eli Lilly Cuts Insulin Prices by 70 percent; Caps Out-of-Pocket Costs at $35 Per Month
• FDA Warns Consumers Not to Purchase or Use Delsam Pharma's Artificial Eye Ointment
• Michigan House Votes to Repeal 1931 Abortion Ban
• DEA Exempt List: Fioricet Scheduling

COVID-19 Updates

• Government Makes Changes to Paxlovid Sticker Method, Shelf Life
• FDA Authorizes First Over-the-Counter At-Home Test to Detect COVID-19, Flu

Professional Practice

• MDHHS Provider Relations Seeks Feedback

I want to thank everyone for making our Annual Convention & Exposition (ACE) such a success. Attendees, awardees, exhibitors, sponsors, speakers and staff all came together for an exemplary event!

We had 500-plus members and more than 700 total attendees at our first totally in-person ACE since 2020. Up to 15 continuing education hours were available, including two fantastic keynote presentations. For our Opening Keynote, I want to thank National Boards of Pharmacy Executive Director Al Carter and MPA Past President Charlie Mollien for an informative fireside chat on hot topics in pharmacy.

I’d also like to extend my gratitude to the panel of national pharmacy leaders in our second keynote, including MPA member and current interim CEO for the American Pharmacists Association, Ilisa Bernstein. That panel discussion on pharmacy advocacy at the national level could have gone on for another hour!

I also want to thank the 65 exhibitors and sponsors that supported our exposition. I heard some very fine comments about the quality of traffic they saw at their booths. That’s because ACE is the premier pharmacy event in Michigan!

Finally, congratulations to all of our award recipients. We're very proud to represent some of the finest pharmacists in the country!

Save the date now. ACE 2024 will be Feb. 23-25 at the Detroit Marriott Renaissance Center. See you there!

MPA Welcomes New Director of Government Affairs

The Michigan Pharmacists Association (MPA) is excited to announce the return of Dr. Eric Roath to the organization as its new director of government affairs.

Roath received his Doctor of Pharmacy degree from Ferris State University in 2012 and his Master of Business Administration from Texas A&M-Corpus Christi in 2017. He completed PGY1 community pharmacy residency with PGPA Pharmacy and Ferris State University. He also served as MPA’s first Executive Fellow in 2013 and is the immediate past-chair of the Government Affairs Committee.

Roath has practiced in a variety of settings in his 10-year career. He is a past recipient of the MPA Distinguished New Pharmacist Practitioner Award and a member of the MPA Hall of Honor. Roath currently resides in Lansing with his wife and three children.

If you would like to contact Dr. Roath, email eroath@michiganpharmacists.org or call (517) 377-0254.

Fourth Edition Pharmacy Law Books Available to Purchase

The fourth edition of MPA's "Pharmacy Law Simplified: A Practical Approach to Contemporary Practice" are 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.

You're Invited: Michigan Reception at the APhA Annual Meeting

The Michigan Reception during the American Pharmacists Association (APhA) Annual Meeting will take place Saturday, March 25, 2023. The APhA Annual Meeting takes place March 24-27 in Phoenix, Arizona. 

All Michigan attendees are welcome to attend as guests of the event in the Sheraton Phoenix Downtown, Ahwatukee B, from 5 to 7 p.m. Beer, wine and appetizers will be served. Hosts include the Michigan Pharmacists Association (MPA), Ferris State University College of Pharmacy, University of Michigan College of Pharmacy and Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences.

Renew Your Membership Now Before It's Too Late!

There are many benefits to renewing your membership with the Michigan Pharmacists Association (MPA) including:

• Direct access to experts that can answer law and practice questions
• Networking opportunities with pharmacy professionals, such as complimentary membership in our local county associations and practice sections
• Free and discounted CE opportunities such as the MPA Annual Convention and Exposition - the state’s largest pharmacy conference
• Being part of the collective voice advocating for the future of the profession
• MPA Career Connect, a free service for you and other pharmacy professionals looking for job opportunities
• Competitive home, auto and business insurance through MPA’s affiliated PSI Insurance Agency

MPA exists for and is effective because of its members. RENEW today to ensure that your benefits are secured and that MPA has the resources to move the mountains ahead for you, for the profession and for patients.

If you are not renewed by March 30, 2023, you will no longer be considered an MPA member and will not receive PRN. If you choose not to renew, this will be the third-to-last edition of PRN you receive.

Featured Job Opportunities

Staff Pharmacist | Harbor Town Pharmacy | Ontonagon, MI

Director of Pharmacy | PGPA LLC | Eaton Rapids, MI

Pharmacy Manager | Ascension St. John Hospital | Detroit, MI

Michigan Pharmacy Foundation Golf Classic

Golfers, sponsors and volunteers come together each summer to support the Michigan Pharmacy Foundation at its annual Golf Classic! In addition to a round of golf, attendees receive a continental breakfast, lunch at the turn and an awards ceremony.

Registration also includes access to the putting green and practice range, opportunity to participate in various contests and more! Information about registration, sponsorships and more can be found here.

Implicit Bias Training

4-6 p.m. virtual session

April 10



Pharmacy Technician Advanced Immunization Training Home Study



1-2:30 p.m. virtual session April 18

Pharmacy-Based

Immunization Training

4-6 p.m. March 22

Registration

closes March 17

Lilly Cuts Insulin Prices by 70 Percent and Caps Patient Insulin

Out-of-Pocket Costs at $35 Per Month or Less

On March 1, Eli Lilly and Company announced price reductions of 70 percent for its most commonly-prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month.

Lilly is reducing the list price of insulins by:

• Cutting the list price of its non-branded insulin, Insulin Lispro Injection 100 units/mL, to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog® vial in 1999.
• Cutting the list price of Humalog® (insulin lispro injection) 100 units/mL1, Lilly's most commonly prescribed insulin, and Humulin® (insulin human) injection 100 units/mL by 70%, effective in Q4 2023.
• Launching Rezvoglar^TM (insulin glargine-aglr) injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus® (insulin glargine) injection, for $92 per five pack of KwikPens®, a 78% discount to Lantus, effective April 1, 2023.

"While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," said David A. Ricks, Lilly's Chair and CEO. "The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap."

In addition to reducing the list price of its insulins, Lilly is making it easier for more people with diabetes to get Lilly insulins:  

• Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.
• People who don't have insurance can continue to go to InsulinAffordability.com and immediately download the Lilly Insulin Value Program savings card to receive Lilly insulins for $35 per month.

"We are driving for change in repricing older insulins, but we know that seven out of 10 Americans don't use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable," Ricks said. "For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won't stop until all people with diabetes are in control of their disease and can get the insulin they need."

In the coming weeks, Lilly will launch a nationwide public awareness campaign to help ensure all Lilly insulin users understand how to access the company's industry-leading affordability solutions. For more information, go to Lilly.com/insulin.

FDA Warns Consumers Not To Purchase or Use

Delsam Pharma's Artificial Eye Ointment

The U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. This warning is in addition to a previous warning to not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile.

Using contaminated ointment increases risk of eye infections that could result in blindness. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.

On Feb. 22, 2023, the FDA recommended Global Pharma recall Delsam Pharma’s Artificial Eye Ointment and the firm agreed to initiate a recall. The FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of pseudomonas aeruginosa bacteria. As of Feb. 7, 2023, the CDC identified 56 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection and permanent vision loss from eye infections.  

The FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program: 

• Complete and submit the report online, or; 
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Michigan House Votes To Repeal 1931 Abortion Ban

The Michigan Legislature, which first prohibited abortion in 1846, took steps Thursday in favor of legal abortion for the first time in its history when the House voted to repeal the 1931 ban on the procedure.

By voting to repeal Michigan's 1931 abortion law, which made some changes to the original 1846 prohibition, House Democrats say they are accomplishing what voters sent them to Lansing to do.

"It's a promise that was made to voters," said Rep. Laurie Pohutsky, D-Livonia, sponsor of the main bill. "It is something that was very clearly the will of the people, and it's been a priority. I'm glad that we were able to get it done and that we got it done within the first couple of months that we were here."

The House passed HB 4006 and HB 4032 on votes of 58 to 50 vote Wednesday.

HB 4006 repeals the section of Michigan law that subjects anyone who administers an abortion to a felony and HB 4032 accordingly amends the state's Code of Criminal Procedure.

Two Republicans, Rep. Thomas Kuhn, R-Troy, and Rep. Donni Steele, R-Orion Township, voted with all 56 Democrats.

Both Rep. Kuhn and Rep. Steele are freshman legislators and received Right to Life endorsements during the 2022 election cycle. Both representatives also are from purple areas of Oakland County. Prior to the election, Ms. Steele said she planned to be a lawmaker that would embrace the middle and would vote to represent her constituents.

Last November, voters passed Proposal 3, which changed the Michigan Constitution to protect legal access to abortion procedures. Repealing the 1931 law was a natural response to that vote, Democrats said.

The proposal passed in both Rep. Kuhn's and Rep. Steele's districts.

In a statement after the vote, Rep. Kuhn said he took an oath to uphold the Michigan Constitution, and the Michigan Constitution now guarantees the right to an abortion, he said, which supersedes his personal view.

Rep. Stephanie Young, D-Detroit, sponsor of the other bill in the package, said the legislation is about representing the will of the people.

"I could have stayed at home and rested on my own religious morals…but I signed up to be a representative of the people, and on this issue, the people have spoken. On this issue, we know what the will of the people happens to be. There's no guesswork."

Several Democratic lawmakers spoke in support of the bill, saying that it was essential to protecting women's reproductive rights.

"I'm not speaking in support of this bill because of a wife. I'm not speaking in support of this bill to support a sister or a daughter. I'm a gay man without a wife or children, but I have a stake in reproductive freedom," said Rep. Jason Morgan, D-Ann Arbor. "We all deserve the right to access the health care we need to protect ourselves, to plan for our futures, to take care of our families and to lead fulfilling lives in the state of Michigan. When women can't secure the health care they need, our society suffers, our economy suffers, our communities suffer and our families suffer."

Some Republicans raised concerns that removing the 1931 law will make it harder to prosecute botched abortions.

Now that the legislation has passed the House, it will be sent to the Senate. The Senate has its own bills addressing abortion, including SB 2, SB 37, SB 38, SB 39 and SB 93, which the Senate Judiciary Committee reported Wednesday.

Read more at gongwer.com (subscription may be required).

Gov. Whitmer Reminds Michiganders No-Cost Contraception

Is Covered by Most Insurance Plans

With reproductive rights once again at the forefront of national public health policy discussions, Michigan Gov. Gretchen Whitmer and the Michigan Department of Insurance and Financial Services (DIFS) Director Anita Fox are reminding Michiganders that most health plans are required to cover contraception and other related reproductive health services.

“As we await a decision in the Texas lawsuit that seeks to ban mifepristone, a safe and effective medication used for numerous health concerns, it has never been more important to ensure that reproductive health care, including contraception, is affordable and accessible,” Whitmer said. “At some point in her life, nearly every woman will rely on contraception to either treat a health condition or for family planning purposes, and I will work with anyone to keep Michiganders safe and help them plan their families on their own terms.”

“The Affordable Care Act requires most health plans to cover contraception and other related health care services when those medications and services are prescribed by a doctor, and the Texas lawsuit is not expected to change that requirement,” Fox said. More information about this requirement can be found by visiting the DIFS contraception website, or by calling DIFS at (877) 999-6442 from 8 a.m. to 5 p.m. Monday through Friday.

Contraception is widely used to treat medical conditions such as endometriosis and menstrual symptoms, as well as for family planning purposes for people who do not wish to become pregnant or for whom pregnancy may pose a medical risk. Under the Affordable Care Act (ACA), non-exempt health plans must provide, with no out-of-pocket cost, at least one type of each of the contraceptive methods currently approved by the Food and Drug Administration (FDA) as prescribed to women by a health care provider. Related health services, such as an office visit for a contraceptive shot, must also be covered.

Most health plans provide contraception without out-of-pocket costs, but there are certain circumstances where consumers may have to pay for these treatments, including:

• If they prefer a specific brand of contraceptive that is not currently covered by their insurer; 
• If they use a health care provider who is not in their plan’s network; 
• If their health insurance is provided by an exempt institution or company. 
• If their health plan is considered a “grandfathered” plan: generally, those sold before the ACA was enacted on March 23, 2010. Grandfathered plans are not required to provide coverage for contraception. 

For information about low- or no-cost reproductive health services provided by the State of Michigan, including under the state’s Medicaid program, visit the MDHHS’ Family Planning Program website.

DIFS can help consumers with health insurance questions and complaints. For more information visit Michigan.gov/HealthInsurance or call DIFS at (877) 999-6442 from 8 a.m. to 5 p.m. Monday through Friday.

The mission of the DIFS is to ensure access to safe and secure insurance and financial services fundamental for the opportunity, security, and success of Michigan residents, while fostering economic growth and sustainability in both industries. In addition, the Department provides consumer protection, outreach, and financial literacy and education services to Michigan residents. For more information, visit Michigan.gov/DIFS or follow the Department on Facebook, Twitter, or LinkedIn.

DEA Exempt List: Fioricet Scheduling

Butalbital is classified as an intermediate-acting barbiturate. Butalbital is a Schedule 3 controlled substance that falls under Administration Controlled Substances Code Number 2100, as it is a derivative of barbituric acid [21 CFR 1308.13(c)(3)]. In 1967, products such as Fioricet, which contained butalbital (50 mg) in combination with acetaminophen (300 mg) and caffeine (40 mg), qualified for the exception under the above criteria.

However, products such as Fiorinal, which contained butalbital (50 mg) in combination with aspirin (325 mg) and caffeine (40 mg), did not contain enough aspirin to meet the exception criteria and therefore did not qualify for the exception. As such, Fiorinal was a Schedule 3-controlled product, while Fioricet and similar butalbital combination products containing sufficient amounts of acetaminophen were automatically granted exempted prescription product status under the Bureau of Drug Abuse Control (BDAC) criteria once an application under 21 CFR 1308.31 was received. The rationale behind the difference between Fiorinal and Fioricet was that the acetaminophen quantity in Fioricet would deter the product's abuse due to the potential liver toxicity resulting from the ingestion of high doses of acetaminophen.

The DEA exempt list was last updated in August 2022. The Michigan Pharmacists Association (MPA) has noted that some Fioricet NDCs were not listed on the exempt list and has reached out to the Department of Licensing and Regulatory Affairs (LARA) to better advise membership. At this time, pharmacists are encouraged to verify NDCs of Fioricet in stock and treat those that are not on the DEA exempt list as controlled substances.

For example, KVK Tech manufacturer has a product (NDC 10702-0253-50) that is on the exempt list. However, Strides Pharma (NDC 64380-0157-01) is not on the DEA exempt list, therefore it needs to be handled as you would with a controlled substance. 

In addition, the DEA is looking to revoke the exemption list, which would make Fioricet a controlled substance.

MPA is following this closely and will keep the membership posted on the outcome. If you have any questions, please contact Farah Jalloul, MPA director of professional development, at Farah@MichiganPharmacists.org. 

 MDHHS Addendum To Rotarix Liquid Formulation

This is an addendum to the update that was sent Dec. 21, 2022 (FDA Licenses new Rotarix liquid formulation). The Michigan Department of Health and Human Services (MDHHS) has received additional information on the Rotarix presentations and administration. See package insert for preparation and administration directions.

Rotarix is supplied in two presentations, a vial and oral dosing applicator presentation, and an oral dosing applicator-only presentation.

• Vial and Oral Dosing Applicator Presentation (the original/retiring presentation): The vial contains the lyophilized vaccine component and the oral dosing applicator contains the diluent. The contents of the vial must be reconstituted with the diluent to form Rotarix prior to administration. 
• Oral Dosing Applicator-Only Presentation (the new presentation): The oral dosing applicator-only presentation contains Rotarix and does not require reconstitution or dilution before use.

Both the original lyophilized (requires reconstitution) and the new liquid rotavirus vaccine presentations will remain in use until the lyophilized formulation is used up or expires.

The Centers for Disease Control (CDC) and MDHHS do not endorse one rotavirus product over the other.

Government Makes Changes

To Paxlovid^TM Sticker Method, Shelf Life

End of Sticker Method for Reduced Dosing of Standard Paxlovid^TM

The federal government and Pfizer are concluding the use of affixing stickers for standard dose packs of Paxlovid^TM that have been modified for renal dosing. Moving forward, stickers to implement a reduced dose adjustment for Paxlovid^TM are no longer being provided and should not be used. There are no supply constraints on renal Paxlovid^TM

dose packs and providers are encouraged to order additional supply moving forward.

Shelf-Life Extension for Specific Lots of Paxlovid^TM

The FDA has recently announced the shelf-life extension for certain lots of Paxlovid^TM from 18 months up to a possible 24 months since the date of manufacture. Please verify existing inventory by reviewing the following link: Shelf-Life Extension for Specific Lots of Paxlovid.

Additional announcements for shelf-life extension for COVID-19 therapeutics can be found here, under COVID-19 Therapeutics Announcements. Expiration Dating Extension | FDA

On-Site Destruction of Expired or Unauthorized Product

For licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations, therapeutics can be destroyed on site only if the following apply:

• Guidelines are followed on what product can be destroyed

1. Only expired product or unauthorized product that can no longer be stored
2. No unexpired product that is currently authorized for use can be destroyed

• Sites are to follow established protocols for destruction and attest in HPOP to following all regulations
• Quantities of any product destroyed must be recorded in HPOP 

This process has been enabled in HPOP. Under ‘Therapeutic Inventory’ select the ‘Wastage’ tab, including ‘Add Wastage’. Prompts will allow for attestation of whether product was destroyed on site or returned directly to the manufacturer.

FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

On Feb. 24, the U.S. Food and Drug Administration issued an emergency-use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B — commonly known as the flu — and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 and Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.

“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly supports innovation in test development and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”

MDHHS Provider Relations Seeks Feedback

Do you often visit the Michigan Medicaid Provider Alerts webpage for tools and resources and don’t see what you want, or do you love what you see? The Michigan Department of Health and Human Services (MDHHS) Provider Relations wants to hear from you.

Please take this quick six-question survey to let MDHHS know how it can better serve Michigan providers (survey link).

For questions regarding Provider Training or this survey, please contact Provider Outreach and Education at ProviderOutreach@Michigan.gov.