In This Issue:

MPA CEO Perspective

MPA News

• Michigan Pharmacist Journal Published
• MPA Welcomes Students for Month of May
• Promote with the MPA Social Media Form
• Save the Date: MSHP Annual Meeting Oct. 27
• Law Books Available for Purchase

MPA Member Updates

• Now Accepting MPA Executive Board and Practice Section Board Nominations
• MPF 2023 Golf Classic — Register Today

CE Events

• Upcoming CE Opportunities

Upcoming Events

• Pink Book Registration Now Open

Professional Practice

• Lilly: Experimental Drug Slows Worsening of Alzheimer's
• Lilly: Tirzepatide Achieved Up to 15.7% Weight Loss in Adults With Obesity or Overweight and Type-2 Diabetes

National Association News

• PTCB Launches Nonsterile Compounding Certificate

Legislative and Regulatory News

• What Pharmacies Need to Know as PHE Ends May 11
• Senate Documents Indicate PBM Reform Won't Take Effect Until Late 2025
• CE Broker Communication Not Issued on Behalf of LARA
• FDA Approves Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children
• Notice of Public Hearing for Pharmacy – General Rules Issued
• MCIR COVID-19 Vaccine Ordering Update

COVID-19 Updates

• CDC Simplifies COVID-19 Vaccine Recommendations, Allows Additional Bivalent Booster for Certain Individuals

Keeping Busy With Congressional Fly-in, Commencements

It’s been a busy few weeks attending the National Community Pharmacists Association (NCPA) Congressional Fly-in in Washington, D.C. and commencement events for all three of Michigan’s colleges of pharmacy. We’ve been keeping you up to date on these activities on MPA social media, including the MPA Facebook page, but it’s nothing like being there.

Michigan was tied with Georgia for having the largest delegation (18) to attend the Congressional Fly-in, the first since 2019 due to COVID-19 and subsequent Capitol Hill visiting restrictions. I’d like to thank the AAPA and Executive Director Sammy Salem for encouraging their independent pharmacists to participate in the fly-in. Together, we had visits with eight members of Congress and/or their legislative staffs to discuss pharmacy benefit manager (PBM) reform and provider status legislation on Capitol Hill. Advocacy at this level is critically important to such pharmacy legislation and, as one legislative staffer put it, “It’s a bad time to be a PBM on Capitol Hill.”

This is also such a great time of year with commencement activities happening at our three colleges of pharmacy. These visits energize me as I get to welcome our student pharmacists to the profession and encourage them to belong to state and national pharmacy associations. Not only will they gain experience and knowledge, which will enhance their professional development, but they will develop relationships that will last a lifetime. I also tell them as I look out over the audience that I’m no doubt looking at a future president of the MPA or even one of the national pharmacy associations. And, I can’t wait to see that day!

Michigan Pharmacist Journal Published

The April/May/June 2023 edition of the Michigan Pharmacist Journal is now available online! Click the cover image to the right to read about the following topics:

• MPA Members Stack Up Awards: At home and nationally, MPA members bring home hardware.
• President's Platform: MPA President Hope Broxterman looks at opportunities ahead for pharmacists.
• From the Foundation: Don't take a mulligan on the annual MPF Golf Classic June 21.
• Advocacy Update: Read up on how you can promote pharmacy priorities at the state and federal levels.
• MSCP Focus: MSCP President Brooke Roe gives pharmacists some phrases to live by, while Thomas Burns looks at how pharmacists can help women have greater access to hormonal contraception.
• New program: Wayne State professors and students give a glimpse of the school's new ambulatory care concentration.
• Free CE for Members: Lessons Learned Across Ambulatory Care Telehealth Practices in Michigan. See page 9 for more details.

Please note: The Michigan Pharmacist will be available in digital format only. Printed copies may be requested via email at MPA@MichiganPharmacists.org.

MPA Welcomes Residents for Month of May

The Michigan Pharmacists Association would like to welcome two new guests on rotation for the month of May.

Anas Ali is originally from Toronto, Canada, and graduated in 2021 from the Albany College of Pharmacy in Colchester, Vermont. Ali enjoys hiking, playing music and spending time with friends and family. He started his career at McLaren Greater Lansing (MGL) as a pharmacist and is currently in the home stretch of completing a PGY1 pharmacy residency at MGL.

His clinical areas of interest include emergency medicine and critical care. He plans to begin his professional pharmacy career in August at Memorial Hospital in South Bend, Indiana, as a clinical pharmacist.

Riley Eichenauer also joins MPA on a month-long rotation as a pharmacy resident. She is originally from the South Bend, Indiana, area and graduated from Manchester University in Fort Wayne, Indiana, in May 2022. After graduation, Eichenauer moved to Lansing and started at McLaren Greater Lansing in July 2022 as part of its inaugural residency class.

Her passions in the pharmacy field include chronic disease state management. In her free time, Eichenauer enjoys being outdoors and watching Michigan State University sporting events. After residency, she plans to begin her pharmacy career as a faculty member at her alma mater, Manchester University.

Save the Date: MSHP Annual Meeting Oct. 27

Promote with the MPA Social Media Form

Have something you think is worth sharing on MPA social media channels? The MPA Social Media Request Form may be right for you!

This form, available on the MPA website here, allows members to potentially promote events or resources, recognize member accomplishments, or share other messages and information. Submitting this form does not guarantee your content will be shared, but you will be contacted if MPA is unable to post your content.

To get started, fill out the form and return it to MPA Communications Manager Ryan Weiss at rweiss@MichiganPharmacists.org.

Fourth Edition Pharmacy Law Books Available to Purchase

The fourth edition of the 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.

Now Accepting MPA Executive Board

and Practice Section Board Nominations

The Michigan Pharmacists Association (MPA) is successful because of the volunteer efforts of engaged pharmacy professionals. MPA is guided by the leadership of its Executive Board as well as practice section and affiliated chapter leadership.

Learn more about each Board and the election process.

Please note that the deadline for MSHP Board nominations is May 15, 2023.

Submissions for the Executive Board and other practice sections are due June 1, 2023.

Michigan Pharmacy Foundation Golf Classic

Register Below!

Pharmacy Technician Advanced Immunization Training Home Study



Live session May 16;

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

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

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 and Prevention (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.

PTCB Launches Nonsterile Compounding Certificate

The Pharmacy Technician Certification Board (PTCB) has launched its Nonsterile Compounding Certificate. This new, specialized credential recognizes pharmacy technicians in community settings creating customized formulations for patients requiring medications or dosage forms that are not commercially available.

“We are pleased to offer technicians this new opportunity to advance their careers,” PTCB Executive Director and CEO William Schimmel said. “Not only will this certificate benefit technicians, but it also expands the ability of community pharmacies to safely provide medication formulations tailored to each patient’s unique needs.”

Technicians who pursue this specialty will "gain the critical knowledge and skills required to address the risks involved with compounded medications, ensuring the quality of the product and protecting their patients," PTCB said in a press release. The certificate complements PTCB’s Certified Compounded Sterile Preparation Technician (CSPT) Program, which assesses technicians’ knowledge and skills to prepare medications in sterile environments such as hospitals, home infusions centers and other compounding facilities to prevent contamination. 

Lilly: Experimental Drug Slows Worsening of Alzheimer's

Eli Lilly and Co. says its experimental Alzheimer’s drug appeared to slow the worsening of the mind-robbing disease in a large study.

In the 18-month trial, people in the early stages of Alzheimer’s who received infusions of donanemab showed 35 percent less decline in thinking skills compared to those given a placebo, Lilly announced in a press release.

The drug is designed to target and clear away a sticky protein called beta-amyloid that builds up into brain-clogging plaques that are one hallmark of Alzheimer’s.

Donanemab also comes with risk. Lilly said in its study the brain side effects caused the deaths of two participants and a third also died after a serious case.

Lilly: Tirzepatide Achieved Up to 15.7 Percent Weight Loss

in Adults With Obesity or Overweight and Type-2 Diabetes

Eli Lilly announced on April 27, 2023, that tirzepatide (10 and 15 milligrams) achieved superior weight loss compared to placebo at 72 weeks of treatment in results from SURMOUNT-2. The study met both co-primary objectives and all key secondary objectives for tirzepatide compared to placebo for both estimands. Those taking tirzepatide lost up to 15.7 percent (34.4 pounds) of body weight for the efficacy estimand. SURMOUNT-2 is the second global phase 3 clinical trial that evaluated the efficacy and safety of tirzepatide for chronic weight management. The trial evaluated 938 adult participants with obesity or overweight and type 2 diabetes.

For the efficacy estimand, participants taking tirzepatide achieved average weight reductions of 13.4 percent (29.8 pounds) on 10 milligrams and 15.7 percent (34.4 pounds) on 15 milligrams compared to placebo (3.3 percent, 7.0 pounds). Additionally, 81.6 percent (10 milligrams) and 86.4 percent (15 milligrams) of people taking tirzepatide achieved at least 5 percent body weight reduction, the other co-primary endpoint, compared to 30.5% of those taking placebo.

Tirzepatide also met all key secondary objectives, which included a reduction in A1C and other cardiometabolic parameters. 41.4 percent (10 milligrams) and 51.8 percent (15 milligrams) of people taking tirzepatide achieved at least 15 percent body weight reduction compared to 2.6 percent of those taking placebo. Reduction in A1C compared to placebo was similar to the SURPASS trials in adults with type 2 diabetes. Study participants had a mean baseline body weight of 222 pounds) and baseline A1C of 8.0.

What Pharmacies Need to Know as PHE Ends May 11

On Thursday, May 11, the Public Health Emergency (PHE) related to the COVID-19 pandemic comes to an end. With it, certain authorities granted by the Public Readiness and Emergency Preparedness (PREP) Act also come to an end. Here is how this will affect your pharmacy practice:

Certain provisions will continue after May 11

The U.S. Department of Health and Human Services (HHS) has extended some, but not all, of the authorities granted under the PREP Act. This includes the authority to continue to administer COVID-19 tests and vaccines. Pharmacy personnel also retain the authority to administer seasonal influenza vaccines to children ages 3 and up. These privileges may be continued through Dec. 2024, provided that HHS does not elect to sunset them sooner.

Additionally, the provisions addressing coverage of COVID-19 tests and vaccinations for patients are being continued through Dec. 2024.

Which provisions will sunset?

Administration of childhood vaccines by pharmacy personnel will no longer be covered as of May 11. Provisions that allowed for the participation of non-traditional providers (such as retirees) also expire. Flexibilities granted by PREP allowing professionals licensed in one state to provide COVID-19 vaccines in a jurisdiction where they are not licensed will also expire.

How can pharmacies continue to provide essential services to patients after the expiration of these provisions?

Fortunately, Michigan’s delegation doctrine for health care services remains broad. This means that vaccination and testing services that are not continuing after May 11 may continue to be conducted under a collaborative practice agreement with a licensed Doctor of Medicine or Doctor of Osteopathic Medicine and Surgery. Meanwhile, Michigan Pharmacists Association continues to work with state agencies, legislators, and on codifying components of the PREP Act that enhance patient access to these critical pharmacy services.

— Information compiled by MPA Director of Government Affairs Eric Roath and PGY1 residents Anas Ali and Riley Eichenauer

Senate Documents Indicate PBM Reform

Won't Take Effect Until Late 2025

New documents indicate that senators involved in proposing pharmacy benefit manager (PBM) reforms are postponing their effective date by at least 10 months. PBM reforms scheduled to take effect under the PBM Reform Act by Jan. 1, 2025, have been revised to take effect 30 months after the law is passed, no earlier than Nov. 2025, according to revised legislation prepared for a markup May 2 by the Senate health committee.

As a result, the actual effective date is expected to be further delayed because the bill still needs to pass the Senate and the Republican-led House, then be signed by President Joe Biden. The PBM measure calls for greater clarity for plans that use PBMs and would require PBMs to pass 100 percent of the rebates they collect from pharmaceutical companies on to the plans that hire them. In addition, the measure would prohibit spread pricing and would change how medications are paid for in the private insurance market.

The PBM reform package was sponsored by Senate health committee chair Bernie Sanders, I-Vt., ranking member Bill Cassidy, R-La., Sen. Patty Murray, D-Wash., and Sen. Roger Marshall, R-Kan.

A number of senators filed amendments to the PBM bill for consideration, according to documents. For instance, Sen. Mike Braun, R-Ind., wants to make hospitals that serve uninsured and underinsured patients disclose how they use discounts that drug companies are required to provide, while Sen. Lisa Murkowski, R-Alaska, proposed a way to make it easier for patients to avoid step therapy. Read More (May Require Paid Subscription)

CE Broker Communication Not Issued on Behalf of LARA

The Michigan Pharmacists Association (MPA) has received many inquiries regarding CE Broker’s communication to licensees stating that the recipient's pharmacist license is about to expire. MPA would like to stress that the communication was not sent on behalf of the Michigan Department of Licensing and Affairs (LARA). If audited, a licensee must provide proof of meeting the requirements outlined in the Board of Pharmacy Pharmacist Continuing Education Rules.

CE Broker is LARA's official partner, however, use of the system by licensees is optional. All communication from BPL regarding CE Broker has stated it is optional for licensees.

For additional questions, please contact MPA Director of Professional Development Farah Jalloul or visit the BPL website. 

A sample of the CE Broker email communication is pictured at left.

FDA Approves Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

The U.S. Food and Drug Administration (FDA) has approved Pfizer's pneumococcal conjugate vaccine (Prevnar 20) for the prevention of invasive pneumococcal disease (IPD) caused by 20 Streptococcus pneumoniae serotypes in infants and children aged 6 weeks to 17 years, and for the prevention of otitis media in infants aged 6 weeks to 5 years caused by the seven serotypes contained in the company's original pneumococcal conjugate vaccine (Prevnar).

The new vaccine expands on Pfizer's approved Prevnar 13 vaccine, and includes seven additional serotypes — 8, 10A, 11A, 12F, 15B, 22F and 33 — that have been found to be associated with greater disease severity, prevalence, invasiveness and antibiotic resistance in pediatric pneumococcal cases. A study revealed that these seven additional serotypes caused an estimated 37% of IPD cases in U.S. children younger than age 5 years. 

The FDA’s decision is based on results from the Phase 2 and Phase 3 clinical trial programs for the pediatric indication for PREVNAR 20.

Notice of Public Hearing for Pharmacy – General Rules Issued

A notice of public hearing for the Pharmacy – General Rules has been issued. The Michigan Pharmacists Association (MPA) will be submitting comments on behalf of membership.

Members are encouraged to submit comments to MPA Director of Professional Development Farah Jalloul. 

DEA Extends Telemedicine Option

for Prescribing Controlled Medications

The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration said Tuesday they will allow healthcare providers to continue using telemedicine to prescribe certain medications for opioid use disorder, pain and anxiety. The agencies will extend for six months the greater flexibility established during the COVID-19 pandemic emergency.

The agencies made the announcement just two days before the telemedicine flexibilities were set to expire on May 11. The ability to prescribe controlled medications remotely will last through November 11, 2023. However, that deadline can be extended if providers have already formed a telemedicine relationship with patients. In that situation, providers can continue to prescribe medications virtually through November 11, 2024. The extension will enable DEA officials to assess feedback the agency received after it proposed resuming stricter rules for prescribing certain controlled substances as officials establish a permanent rule.

The controlled medications include drugs such as amphetamine/dextroamphetamine, oxycodone, and buprenorphine. Advocates of using telemedicine say there is no evidence indicating that the remote prescription of buprenorphine has led to more of the drug being diverted to the streets or an increase in overdose deaths involving the drug. Read more (May Require Paid Subscription)

MCIR COVID-19 Vaccine Ordering Update

The Michigan Department of Health and Human Services (MDHHS) is warning that a bug in the MCIR is causing monovalent Moderna and Pfizer COVID-19 vaccines to display as available on the ordering screen. Attempting to order the vaccines will result in an error message. Please review vaccine selections and confirm the correct National Drug Code (NDC) prior to ordering to make sure you have selected the appropriate bivalent Pfizer or Moderna vaccines. Novavax is also still available to order in the five-dose per vial presentation.

The monovalent vaccine NDCs are listed below:

Pfizer

• 59267-0078-04
• 59267-1000-02
• 59267-1000-03
• 59267-1025-03
• 59267-1025-04
• 59267-1055-04

Moderna

• 80777-273-98/15
• 80777-273-99/10
• 80777-275-99/05
• 80777-279-99/05
• 
  

Contact Kelsey Napier with any questions.

CDC Simplifies COVID-19 Vaccine Recommendations, Allows Additional Bivalent Booster for Certain Individuals

Following action from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) has revised the COVID-19 immunization schedule as follows:

• Individuals who have not yet received a bivalent booster dose may receive a single dose of a bivalent vaccine. This guidance remains unchanged.
• Individuals 65 and older who have received a bivalent booster dose may receive one additional bivalent dose at least four months after the administration of the first bivalent dose.
• Individuals with immunocompromising conditions who have received a bivalent booster dose may receive one additional bivalent dose at least two months after the administration of the first bivalent dose. Additional bivalent doses may be administered at the discretion of the healthcare provider. Eligibility for immunocompromised individuals 6 months through 4 years of age will depend on the vaccine previously administered.
• Other individuals who have received a bivalent booster dose are not eligible for an additional bivalent dose at this time. 
• Young children should still receive multiple doses. Guidance varies by age, manufacturer, and vaccines previously administered.

Additionally, the immunization schedule for unvaccinated individuals has been simplified:

• The updated bivalent vaccine is now the only FDA-approved vaccine. The original, monovalent vaccines are no longer authorized for use. Unvaccinated individuals should receive one dose of the bivalent vaccine, rather than multiple doses of the monovalent vaccines.

Alternatives to mRNA vaccines such as the Novavax and Johnson & Johnson vaccines remain available. The guidelines for their administration remains the same.

For more information, see the CDC’s media release here.