In This Issue:

MPA CEO Perspective

MPA News

• Register for ACE 2024
• MPF Accepting Applications for Scholarships
• It's Time to Renew Your Membership
• Coming Soon: Vote in MPA Elections

CE Events

• Register Now: MSHP Annual Meeting
• Upcoming MPA CE Offerings
• Try MPA's Home Studies
• MDHHS Fall 2023 Immunization Conferences – Register Today

Legislative and Regulatory News

• 10 U.S. Drugmakers Agree to Participate in Price Negotiations with Medicare
• FDA Approves Updated Novavax Shot as Another Option for COVID-19
• FDA Advisers Vote Against Experimental ALS Treatment

Professional Practice

• Pharmacies Face Staffing Shortages Entering Busy Season
• Educational Webinars: Pfizer RSV Vaccine
• MDHHS Additional 2023-2024 COVID-19 Vaccine Allocations

Great news! We made the announcement during Tuesday’s MPA Town Hall that registration is open for the MPA Annual Convention & Exposition Feb. 23-25, 2024 at the Detroit Marriott at the Renaissance Center in downtown Detroit. This will be the concluding year of a long-term contract with the “Ren-Cen,” so we’ll be taking ACE on the road beginning in 2025. So, what better time to celebrate the end of an era? Please mark your calendars today to attend and help us celebrate!

Speaking of celebrating, MPA will celebrate its 140th anniversary Nov. 14, 2023, and we want to commemorate the event by producing a video to air at ACE. You can assist by sending us photos, videos or even just a short video wishing MPA a Happy 140th Anniversary. We’ll edit everything together and show the finished product at ACE. You can send your photos/videos to MPA@MichiganPharmacists.org.

We’re planning another great ACE for you with terrific programming, including the Friday keynote speaker, APhA EVP/CEO Michael Hogue. Watch for our announcement regarding Saturday’s keynote speaker coming soon.

Don’t forget to spend time in our Annual Exposition as well. We’ll have another packed exposition floor with companies offering products and services to help you succeed in your practice setting. Please contact Bryan Freeman, MPA director of marketing and communications, for more information if you are interested in exhibiting or sponsorships.

Looking forward to seeing you in Detroit!

ACE 2024 Registration is Open!

It's time to start planning for ACE 2024! Registration opened Oct. 10, so reserve your spot now.

The signature event of MPA, the Annual Convention & Exposition (ACE), will take place Feb. 23-25, 2024, at the Renaissance Center in downtown Detroit. This will be MPA's last ACE in the Motor City for a while as we hit the road for Traverse City in 2025 and Lansing in 2026, 2027 and 2028, so don't miss out!

ACE is the premier continuing education event for pharmacists, pharmacy students and pharmacy technicians in Michigan. There will be something for everyone at ACE 2024.

Looking forward to seeing you all there!

MPF Accepting Applications for Scholarship Program

Deadline to Apply for Scholarships: Nov. 6

One way the Michigan Pharmacy Foundation (MPF) accomplishes its mission to “Foster the Future of Pharmacy” is to award future pharmacists scholarships to help defray some of their pharmacy education expenses. This year, MPF will award a $2,500 scholarship to a current P2, P3, or P4 student pharmacist from each of the colleges of pharmacy. 

In addition, MPF awards the Larry Wagenknecht Leadership Scholarship in honor of his 37 years of dedication to the practice of pharmacy, including serving as MPA's CEO from 1994-2021. This $3,000 scholarship is awarded to a student who has demonstrated exceptional leadership abilities. 

MPF encourages pharmacy professionals to reach out to student pharmacists and encourage them to apply. Student MPA members can apply at: MichiganPharmacists.org/foundation/scholarships.

MPF looks forward to announcing the scholarship winners on Feb. 24, 2024, at the MPA Annual Convention and Exposition (ACE) at the Detroit Renaissance Center.

Questions and applications may be submitted to MPF Executive Director Rick Drabek by email or phone at (517) 377-0227, or mailed to: Michigan Pharmacy Foundation, Attn: Rick Drabek, 408 Kalamazoo Plaza, Lansing, MI 48933.

It's Time to Renew Your Membership

There are many benefits to renewing your membership with 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 the MPA Annual Convention & 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.

Coming Soon: Vote in MPA Elections

MPA will open voting for its 2023 elections beginning Tuesday, Oct. 17. MPA members will have until Tuesday, Oct. 31 to vote.

Look for ballots to be emailed next week.

Register for MSHP Annual Meeting Oct. 27

Registration is open for the Michigan Society of Health-System Pharmacists (MSHP) Annual Meeting, which will be held Friday, Oct. 27, at the Crowne Plaza Lansing West, 925 S. Creyts Road in Lansing.

Held each fall, the MSHP Annual Meeting offers up to six hours of live continuing education credit. Programming is geared toward health-system pharmacists, residents, pharmacy technicians and student pharmacists. The MSHP Annual Meeting focuses on clinical, leadership management and residency topics as well as other general areas of pharmacy practice.

In addition to continuing education programs, the event offers the annual MSHP Town Hall Meeting to install new MSHP Board of Directors members into office officially, recognize volunteers and award recipients, a clinical skills competition for students and an exhibit hall to provide attendees with a chance to exchange ideas and learn about new products and services.

More Upcoming MPA CE Offerings

Pharmacy Technician Immunization Administration

Live Session and Self Study

(Next Live Webinar: Oct. 21, 10-11:30 a.m.)

Implicit Bias 2.0:

Education, Practice and Teams

Oct. 24, 4-6 p.m.

NASPA Pharmacy-Based Point-of-Care Test and Treat National Certificate Program

Nov. 9, 9 a.m.-1 p.m.

Michigan Pharmacy Law and Ethics Update, Quarter 4

Dec. 4, Noon-1 p.m.

APhA Pharmacy-Based

Immunization Training

Dec. 6, 9-11 a.m.

Implicit Bias 2.0:

Education, Practice and Teams

Dec. 11, 4-6 p.m.

IBT Home Study

Can't make it to one of our upcoming implicit bias training (IBT) sessions? Not to worry, our IBT home study could be right for you! This course is based on MPA's original IBT offering and meets all current Michigan licensing requirements. Click the button below to get started!

Looking for Something Else? Try MPA's Home Studies.

In addition to our other programs, MPA offers home study pharmacy CE that can be accessed 24/7/365 on our website. Click the button below to view our catalog of programs.

MDHHS Fall 2023 Immunization Conferences

A message from the Michigan Department of Health and Human Services (MDHHS):

Find out what is new in immunizations!

These conferences have been offered annually for more than 20 years and they have consistently received high ratings from attendees. Their primary goal is to update healthcare providers on immunization issues that affect people of all ages – from the very young to the very old. The conferences will provide participants with a variety of practice-management tools, techniques and information that will help assure that all their patients are fully immunized.

The conferences are appropriate for physicians, nurses, nurse practitioners, medical assistants, public health staff, pharmacists, physicians, physician assistants, medical and nursing students, and anyone interested in learning more about current immunization practice in Michigan.

For a list of conference dates, locations and how to register, please click the button below.

10 U.S. Drugmakers Agree to Participate

in Price Negotiations with Medicare

Ten U.S. drug manufacturers have agreed to participate in the initial round of the first-ever pricing negotiations between Medicare and the nation's pharmaceutical giants, the Biden administration announced Tuesday.

The highly anticipated Medicare Drug Price Negotiation Program was set to enter its next phase after the Centers for Medicare & Medicaid Services invited the drugmakers to voluntarily join the program in August.

The move comes as President Joe Biden seeks to fulfill a campaign promise to make prescription medicines more affordable for millions of aging Americans.

The drugs on the list are among the most commonly used to treat everything from heart failure, blood clots, diabetes, arthritis, and Crohn's disease, however, average Americans often cannot afford to buy the drugs, Biden said in August when the drug cost reform effort kicked off.

Previously, the White House said the drugs are among the top 50 prescription medications that seniors fill the most at retail pharmacies under Medicare Part D.

The companies electing to participate include Bristol Myers Squibb, Boehringer Ingelheim, Janssen Pharmaceuticals, Merck Sharp Dohme, AstraZeneca, Novartis, Immunex, Pharmacyclics LLC, Jannsen Biotech and Novo Nordisk.

U.S. Approves Updated Novavax Shot

as Another Option For COVID-19

U.S. regulators on Tuesday authorized another option for fall COVID-19 vaccination, updated shots made by Novavax.

Updated vaccines from Pfizer and Moderna began rolling out last month, intended for adults and children as young as age 6 months. Now the U.S. Food and Drug Administration has added another choice – reformulated Novavax shots open to anyone age 12 and older.

The Centers for Disease Control and Prevention already has urged most Americans to get a fall COVID-19 vaccination, shots tweaked to protect against a newer coronavirus strain. Novavax said shots will be available “in the coming days.”

Novavax makes a protein-based vaccine mixed with an immune-boosting chemical, a different technology than the so-called mRNA vaccines made by Pfizer and Moderna.

FDA Advisers Vote Against Experimental ALS Treatment

Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrig’s disease at a Sept. 27 meeting prompted by years of patient efforts seeking access to the unproven therapy.

The panel of U.S Food and Drug Administration (FDA) experts voted 17-1 that drugmaker Brainstorm’s stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease known as ALS, or amyotrophic lateral sclerosis. One panel member abstained from voting.

While the FDA is not bound by the vote, it largely aligns with the agency’s own strikingly negative review, in which staff scientists described Brainstorm’s application as “scientifically incomplete” and “grossly deficient.”

“Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic,” said Lisa Lee, a bioethics and research integrity expert from Virginia Tech, who voted against the treatment. The lone positive vote came from a panel member representing patients.

Brainstorm’s single 200-patient study failed to show that NurOwn extended life, slowed disease or improved patient mobility. But FDA agreed to convene the panel of outside advisers after ALS patients and advocates submitted a 30,000-signature petition seeking a public meeting.

In the last year, the FDA has approved two new drugs for ALS, after a nearly 20-year drought of new options. The approvals followed intense lobbying by advocacy groups.

ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. Most people die within three to five years of their first symptoms.

Pharmacies Face Staffing Shortages Entering Busy Season

A dose of patience may come in handy at the pharmacy counter this fall.

Drug and staffing shortages haven’t gone away. Stores are starting their busiest time of year as customers look for help with colds and the flu. And this fall, pharmacists are dealing with a new RSV vaccine and the start of insurance coverage for COVID-19 shots.

Some drugstores have addressed their challenges by adding employees at busy hours. But experts say many pharmacies, particularly the big chains, still don’t have enough workers behind the counter.

In recent years, drugstores have struggled to fill open pharmacist and pharmacy technician positions, even as many have raised pay and dangled signing bonuses.

Larger drugstore chains often operate stores with only one pharmacist on duty per shift, said Richard Dang, an assistant professor of clinical pharmacy at the University of Southern California. That kind of thin staffing can make it hard to recruit employees.

“I think that many pharmacists in the profession are hesitant to work for a company where they don’t feel supported,” said Dang, a former president of the California Pharmacists Association.

Educational Webinars: Pfizer RSV Vaccine

Pfizer’s Vaccines US Medical Affairs team is providing brief educational webinars entitled Pfizer RSV Vaccine – A New Maternal Indication. These live sessions are conducted on Tuesdays, Wednesdays and Thursdays. Additional live sessions may be added, so check the website for the latest schedule. On demand content will be available soon.

Session topics include RSV burden of disease in infants; mechanism of maternal immunization; ACIP recommendations and clinical considerations; clinical trial data: safety and efficacy; and a question and answer session.

Click on the following link for the live schedule and other educational resources:

RSV Vaccine Educational Webinars led by Pfizer Vaccines US Medical Affairs

NOTE: Continuing education credit is not available with these seminars.

 MDHHS Additional 2023-2024 COVID-19 Vaccine Allocations

The Michigan Department of Health and Human Services (MDHHS) is asking all providers to review the following COVID-19 vaccine update on additional ordering allocations. 

3 Key Updates:

• Additional ordering allocations have been received for VFC and MI-AVP/Bridge Access providers and ordering is open for all providers
• Vaccine allocations remain limited, with minimum and maximum order requirements listed below
• The 2023-2024 updated Novavax, adjuvanted vaccine has been authorized by FDA. The Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is NO LONGER authorized for use in the United States.

The MDHHS recently sent communication to all providers on the changes to COVID-19 vaccine ordering amidst the authorization of the updated vaccine and transition to the commercial market. This notification is to inform you that additional allocations (though limited) of vaccine are open to order for all VFC providers and MI-AVP providers in Michigan. It is important to note that with commercialization of COVID-19 vaccines, the state of Michigan will only have federal vaccine allocations for the Vaccines for Children (VFC) program and through the Bridge Access Program to MI-AVP providers. Providers should place all private vaccine orders for COVID-19 vaccine directly through the manufacturer.

Allocations of the 2023-2024 updated COVID-19 vaccine continue to be limited and based on product availability. Because of the limited allocations, MDHHS asks that providers continue to place a minimum dose order, based on your patient population. Orders will only be processed up to the ordering maximums listed below. Orders requested over the maximum amount will not be backfilled. Ordering will be based on a first come, first served basis.

FOR LHD PROVIDERS

• VFC: Please keep orders to a minimum of 10 doses and a maximum of 120 doses.
• MI-AVP/BRIDGE PROGRAM: Please keep orders to a minimum of 10 doses and a maximum of 30 doses.

FOR ALL OTHER PROVIDERS

• VFC: Please keep orders to a minimum of 10 doses and a maximum of 30 doses.
• MI-AVP/BRIDGE PROGRAM: Please keep orders to a minimum of 10 doses and a maximum of 30 doses.

The Centers for Disease Control and Prevention (CDC) will continue to conduct weekly monitoring of ordering to determine future allocations. This will be based on Michigan’s ordering history and continued availability of additional doses. Again, providers have the following options available to them for ordering the newly commercialized COVID-19 vaccine.  

• Directly from the manufacturers to obtain private COVID-19 vaccine supply, as they do with other ACIP recommended vaccines.  
• Through a new temporary program called the Bridge Access Program. This program consists of two components: 
• The first component utilizes existing public health infrastructure including state immunization programs, local health departments, and HRSA-supported health centers to provide COVID-19 vaccines to uninsured and underinsured adults. Michigan Bridge Access providers are current MI-AVP providers. Ordering of Bridge COVID-19 vaccine will be placed through MCIR E-ordering.  
• FOR PHARMACIES: The second component will be implemented through pharmacies. This will enable them to continue offering free COVID-19 vaccinations to the uninsured and underinsured. Pharmacies interested in joining this program can reach out to eTrueNorth to learn more.
• Through the existing Vaccines for Children (VFC) program.  
• Michigan VFC providers will order VFC COVID-19 vaccine through MCIR E-ordering.

ORDERING SPECIFICATIONS 

• Moderna, COVID-19;(12y+);SDV;10-pk, NDC 80777-0102-95
• Moderna, COVID-19;(6m-11y);SDV;10-pk, NDC 80777-0287-92 
• Pfizer, COVID-19;(12y+);SDV;10-pk, NDC 00069-2362-10 
• Pfizer, COVID-19(Pfizer);(5-11y);SDV;10-pk, NDC 59267-4331-02 
• Pfizer, COVID-19(Pfizer);(6m-4y);MDV3;10-pk, NDC 59267-4315-02 (3-dose vials with 30 doses/10 vials) 
• On Oct.3, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the 2023-2024 formula. The Novavax COVID-19 Vaccine, Adjuvanted (original monovalent) is no longer authorized for use in the United States. Additional information on allocations, ordering and clinical guidance will be forthcoming as it is received by our Federal Partners. 
• Orders are no longer placed through the MCIR outbreak module.
• Order VFC and Bridge Access (MI-AVP) COVID-19 vaccines per normal processes through MCIR e-ordering (see image below).
• VFC Program

STORAGE AND HANDLING REQUIREMENTS TO GUIDE VACCINE ORDERING

The Emergency Use Authorization Fact Sheets (EUA) for Healthcare Professionals and for Recipients and Caregivers have been updated for both Pfizer and Moderna for persons aged 6 months through 11 years of age. At this time, there is no EUA for persons 12 years and older. Comirnaty and Spikevax are approved by the FDA and are not under EUA. The CDC does not currently have a timeline for availability of a Vaccine Information Statement (VIS) for these COVID-19 vaccines. Until a VIS is available, a provider should use the manufacturer’s package insert to inform patients about the benefits and risks of that vaccine. Once a VIS is available it should be used. It’s important to note that providers should not delay use of a vaccine because of the absence of a VIS.  

As a reminder, all VFC enrolled providers are expected to carry all ACIP recommended immunizations for the population they serve, including the COVID-19 vaccine. However, due to the limited number of doses Michigan has on hand, all VFC providers may not be able to order vaccine immediately and should only order the number of doses they expect to use within the next few weeks. MDHHS in collaboration with LHDs, will work alongside the VFC providers as we all navigate this change and what this transition means for each office. 

For questions or assistance, please email: checcimms@michigan.gov