In This Issue:

MPA CEO Perspective

MPA News

• Jalloul, Farris Honored at APhA Annual Meeting
• Register Today for NCPA Congressional Pharmacy Fly-In April 26-27
• Law Books Available for Purchase

MPA Member Updates

• Renew Your MPA Membership Now
• MPF 2023 Golf Classic — Register Today

CE Events

• Upcoming CE Opportunities

Legislative and Regulatory News

• More Than 190 Groups Applaud Bipartisan Legislation to Ensure Senior Access to Essential Pharmacist Services
• FDA Approves First OTC Naloxone Nasal Spray
• FDA to Discuss OTC Birth Control Pill in May
• Inflation Reduction Act and Prescription Drug Price
• Bipartisan Federal Legislation Reintroduced to Require Fair Reimbursements and Ban Spread Pricing in Medicaid 
• ASHP Releases Model MOUD Prescribing Legislation, State Protocol
• FDA Approves IM Administration as an Option for M-M-R II from Merck
• FDA Clarifies Pharmacist Recommendations in Buprenorphine for Opioid Dependence REMS
• LARA Issues Reminder on Required Inventory for Controlled Substances
• Michigan Dispensing Law Changes

COVID-19 Updates

• Updated Interim Clinical Considerations for Use of COVID-19 Vaccines
• MDHHS Issues Proposed Medicaid Policy

Pharmacy Education

• U-M, Wayne State Make Becker's Top 10 Pharmacy Schools by NAPLEX Pass Rates

Professional Practice

• MDHHS and MPA Cobranded Letter for Electronic Prescribing of Expedited Partner Therapy (EPT) and Sample EPT Script
• Pharmacy Fraternity Hosting 5K Run/Walk to Raise Funds for Project HOPE

I'm fresh off attending the American Pharmacists Association (APhA) Annual Meeting and Exposition in Phoenix. I hope you’ve been able to experience our Michigan highlights through MPA's Facebook, LinkedIn, Instagram and Twitter pages if you did not have the opportunity to attend.

I couldn’t be more proud of our Michigan award recipients on the national stage. Karen Farris, from the University of Michigan, was the recipient of the Tyler Prize for Stimulation of Research and MPA Director of Professional Development Farah Jalloul received the Hubert H. Humphrey Award. Congratulations to both for representing Michigan and MPA so well!

We had more than 70 MPA members and guests join us Saturday evening for the Michigan Reception. I was so appreciative of MPA member and APhA Interim CEO Ilisa Bernstein, who took time from her busy schedule to attend our event. I also want to thank our cohosts for the evening: Ferris State University College of Pharmacy, University of Michigan College of Pharmacy and Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences.

Representing MPA at the House of Delegates were President Hope Broxterman, Past President Heather Rickle, CSPM President Matt McTaggart, MSCP Board member Brittany Stewart and Jalloul. Thanks to them all for carving out five-plus hours over two days to serve as delegates.

On a personal note, I was re-elected to the board of the National Alliance of State Pharmacy Associations (NASPA). I look forward to serving again on the board and interacting with my peers from across the country in support of pharmacy.

Save the date now to attend the 2024 APhA Annual Meeting and Exposition March 22-25 in Orlando. Hope to see you there!

Jalloul, Farris Honored at APhA Annual Meeting

Farah Jalloul, MPA's director of professional development, and MPA member Karen Farris were both honored with awards at the American Pharmacists Association (APhA) Annual Meeting March 24-27 in Phoenix.

Jalloul was bestowed with the Hubert H. Humphrey Award, which is named after the former United States vice president and senator, who also was a pharmacist and a longtime APhA member. The Humphrey Award was established in 1978 "to recognize APhA members who have made major contributions in government and legislative service."

Farris, of the University of Michigan College of Pharmacy, was given the Tyler Prize for Stimulation of Research, which is awarded every three years. The Tyler Prize "recognizes an individual(s) for encouraging research by peers, students, fellows, residents, and others via publications or by directing research, serving as a preceptor, or mentoring in any discipline of the pharmaceutical sciences," according to the APhA.

The University of Michigan's Karen Farris, middle, and MPA's Farah Jalloul, right, are pictured with MPA CEO Mark Glasper at the APhA Annual Meeting in Phoenix.

Register Today for the NCPA Congressional

Pharmacy Fly-In April 26-27

Registration is still open for the National Community Pharmacists Association's 2023 Congressional Pharmacy Fly-In April 26-27.

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’s 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.

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.

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, life 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 the end of today, 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 final edition of PRN you receive.

Michigan Pharmacy Foundation Golf Classic

Register Below!

Implicit Bias Training

4-6 p.m. virtual session

April 10

Pharmacy Technician Advanced Immunization Training Home Study



Virtual session April 18 with home self-study

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

2-3 p.m. virtual session April 25

Implicit Bias Training

4-6 p.m. virtual session

June 15

MPJE Pharmacy Law Review 2023

9 a.m.-noon virtual session May 20

APhA Pharmacy-Based Immunization Training

9-11 a.m. virtual session July 19

More than 190 Groups Applaud Bipartisan Federal Legislation

to Ensure Senior Access to Essential Pharmacist Services

The Michigan Pharmacists Association is among the more than 190 organizations — including the American Pharmacists Association (APhA), rural and senior advocacy groups, physician and provider groups, patient advocacy organizations, pharmacists, health systems and others — that are praising House Resolution 1770, the Equitable Community Access to Pharmacist Services Act. The bipartisan legislation ensures that Medicare beneficiaries can obtain essential services from pharmacists for COVID-19, influenza, respiratory syncytial virus (RSV) and strep throat. The legislation recognizes pharmacists and their role in improving healthcare access by establishing Medicare Part B direct reimbursement for certain pharmacist services.

"We commend bipartisan lawmakers for introducing federal legislation to protect the role pharmacists play to deliver essential care and services to America's seniors," said Ilisa Bernstein, Interim CEO at APhA, and Paul W. Abramowitz, CEO at the American Society of Health-System Pharmacists (ASHP). "Pharmacists in all settings, including rural communities, hospitals, clinics, and health centers, are on the frontlines and have supported Americans through the worst health emergency in a generation. H.R. 1770 would empower older Americans, who are at higher risk of contracting infectious diseases and needing hospitalization, to continue to rely on services provided by pharmacists in their local communities. While Americans with private insurance, Medicaid beneficiaries, and federal employees may be covered, America's seniors will be left behind if Congress doesn't act to ensure access to essential pharmacist services in Medicare."

The Future of Pharmacy Care Coalition, which represents pharmacists and community pharmacies of all sizes serving millions of patients in the United States every day, supports H.R. 1770. Coalition members supporting the legislation include APhA, ASHP, Abbott, AmerisourceBergen, Cardinal Health, CVS Health, Good Neighbor Pharmacy, Health Mart, Kroger, McKesson, Medicine Shoppe, the National Association of Chain Drug Stores, Walgreens, and Walmart.

FDA approves First OTC Naloxone Nasal Spray

The U.S. Food and Drug Administration (FDA) approved Wednesday, March 29, Narcan, a 4-milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use – the first naloxone product approved for use without a prescription.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The approval paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

The timeline for the availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.



“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Inflation Reduction Act and Prescription Drug Prices 

On March 15, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), announced 27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. CMS has released information about these 27 Part B drugs and biological products in the quarterly ASP public file, available here. A fact sheet is available here.

Lower Part B coinsurance will go into effect Saturday, April 1, 2023. This coinsurance adjustment applies to certain drugs and biologicals covered under Medicare Part B. The Part B drugs impacted by this coinsurance adjustment may change quarterly. 

See the initial guidance detailing the requirements and procedures for the Medicare Prescription Drug Inflation Rebate Program here.

Bipartisan Federal Legislation Reintroduced to Require Fair Reimbursements and Ban Spread Pricing in Medicaid 

Reps. Buddy Carter, R-Georgia., Vicente Gonzalez, D-Texas, Rick Allen, R-Georgia, Jake Auchincloss, D-Massachussetts, Elise Stefanik, R-New York, and Deborah Ross, D-North Carolina, reintroduced H.R. 1613 on March 17, 2023, the Drug Transparency in Medicaid Act.

This legislation would improve transparency and prevent the use of spread pricing in Medicaid managed care programs. A broad ban on Medicaid-managed care spread pricing and a move to fair and transparent pharmacy reimbursement would save the federal government more than $1 billion over the next 10 years. Additionally, this bill would also require pharmacy reimbursements in all state Medicaid-managed care programs to be at a rate of pharmacy’s average acquisition costs based on the National Average Drug Acquisition Cost survey plus the state’s Medicaid fee for service dispensing fee.

The American Pharmacists Association is among the groups applauding the reintroduction of the bill.

"APhA strongly supports this legislation to eliminate one of PBMs’ harmful business practices that is increasing drug costs at the expense of Medicaid patients and creating ‘pharmacy deserts’ in minority and underserved communities, where the neighborhood pharmacy may be the only health care provider for miles,” said APhA Interim Executive Vice President and CEO Ilisa BG Bernstein, Pharm.D., J.D., FAPhA. “It’s way past time to put patients over PBM profits and Congressional action is overdue.

The National Community Pharmacists Association (NCPA) is encouraging people to contact their legislators and urge them to support the legislation.

ASHP Releases Model MOUD Prescribing Legislation,

State Protocol

The American Society of Health-System Pharmacists (ASHP) has released model legislation and a model protocol for pharmacists prescribing medications for opioid use disorder (MOUD). 

Congress recently eliminated the X-waiver, a federal barrier to pharmacists prescribing MOUD. States can now use pharmacists to improve access to MOUD. ASHP has developed these models to encourage states to leverage pharmacists as part of the care team to curb the opioid crisis in their communities. 

The model legislation: 

• Provides clear authority for pharmacists to initiate MOUD
• Establishes a timeline for board of pharmacy action
• Ensures pharmacists comply with federal registration and training requirements
• Removes any pre-existing state barriers to MOUD prescribing
• Creates mechanisms for both Medicaid and commercial insurance to pay for these services
• The model protocol similarly empowers pharmacists to initiate, modify, discontinue, and administer medications approved by the Food and Drug Administration for treatment of opioid use disorder.

The release of these models follows ASHP’s sustained advocacy on opioid use disorder last year, which resulted in the elimination of the X-waiver, along with continued efforts this year to expand access to MOUD. ASHP’s CEO Paul W. Abramowitz recently sent a letter to President Biden urging the federal government to utilize pharmacists to expand access to MOUD. ASHP will continue to advocate for and keep our members informed on this important issue.

For more advocacy resources and information, visit ashp.org/opioids. 

FDA Approves IM Administration

as an Option for M-M-R II from Merck

On March 6th, 2023, Merck announced that the U.S. Food and Drug Administration (FDA) approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV (measles-mumps-rubella-varicella) family of vaccines: M-M-R®II (measles-mumps-rubella vaccine), VARIVAX® (varicella vaccine), and ProQuad®(measles-mumps-rubella-varicella vaccine). Previously, these vaccines were only licensed for subcutaneous administration. They are now approved for either IM or subcutaneous administration.

Two brands of MMR vaccine are distributed in the United States. Only Merck’s brand is licensed for either IM or subcutaneous administration. Priorix from GSK is licensed for subcutaneous administration only.

Package Insert -- M-M-R-II (fda.gov)

Package Insert -- PORQUAD (fda.gov)

Package Insert -- VARIVAX (fda.gov)

FDA Clarifies Pharmacist Recommendations

in Buprenorphine for Opioid Dependence REMS

The Food and Drug Administration (FDA) is notifying pharmacists of the recommendation in the buprenorphine-containing transmucosal products for opioid dependence (BTOD) Risk Evaluation and Mitigation Strategy (REMS) program for a pharmacist to “verify that the prescription you receive is from a prescriber who is in compliance with the provisions of DATA 2000 (Drug Treatment Act of 2000)” is no longer applicable. Pharmacists can dispense buprenorphine for opioid use disorder (OUD) to patients without such verification. 

The Consolidated Appropriations Act of 2023 amended the Controlled Substances Act to eliminate the DATA 2000 requirement, thus making the BTOD REMS program recommendation to verify DATA 2000 is no longer applicable. DATA 2000 required healthcare practitioners who held a controlled substances registration with the Drug Enforcement Administration to apply for a waiver through the Substance Abuse and Mental Health Services Administration to prescribe buprenorphine for maintenance or detoxification treatment for OUD.

All product labeling for BTOD products is being updated along with modifications to the REMS materials to reflect these changes.

FDA panel to discuss OTC birth control drugs in May

Advisers from the U.S. Food and Drug Administration (FDA) will meet May 9-10 to discuss whether the agency should approve an over-the-counter (OTC) oral contraceptive. If approved, HRA Pharma's Opill — a progestin-only medication also known as a "mini-pill" — would be the first-ever daily birth control available OTC in the United States.

Opill has been available with a prescription since its approval 50 years ago. HRA Pharma submitted an application to switch from prescription to OTC status last July. In October, a previously-scheduled FDA meeting was pushed back to review additional data requested by the company.

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. 

Michigan Dispensing Law Changes

Public Act 80 of 2022 went into effect Wednesday, March 29, 2023. This act allows a pharmacist to dispense a prescription, except a prescription for a controlled substance, written by a prescriber licensed in another state or province of Canada. The act defines “prescriber” as:

• A licensed dentist
• A licensed doctor of medicine
• A licensed doctor of osteopathic medicine and surgery
• A licensed doctor of podiatric medicine and surgery
• A licensed physician’s assistant
• A licensed optometrist
• An advanced practice registered nurse
• A licensed veterinarian
• A nurse anesthetist

A pharmacist who dispenses a prescription written by a prescriber licensed in another state or province of Canada must comply with the requirements of MCL 333.17751. Additionally, a pharmacist who receives a prescription under MCL 333.17751(2) from an advanced practice registered nurse prescriber or physician's assistant prescriber in another state or province of Canada may dispense the drug or device without determining whether the advanced practice registered nurse prescriber or physician's assistant prescriber is authorized under the laws of the other state or province of Canada to issue the prescription.

Pursuant to MCL 333.17763(e), a pharmacist may only dispense a prescription for a controlled substance written by a physician, dentist or veterinarian who is licensed in another state and authorized by law to prescribe controlled substances in that state. 

Should you have any questions, please contact bplhelp@michigan.gov or visit michigan.gov/bpl.

Updated Interim Clinical Considerations

for use of COVID-19 Vaccines

On March 14, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the bivalent Pfizer-BioNTech COVID-19 vaccine to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least two months after completion of primary vaccination, with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 vaccine.

On March 16, 2023, the Centers for Disease Control and Prevention (CDC) issued two important updates to the interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. The updates are outlined below. 

• New recommendation for children ages 6 months through 4 years who previously completed a three-dose monovalent Pfizer-BioNTech primary series to receive one bivalent Pfizer-BioNTech booster dose at least two months after completion of the three-dose monovalent primary series. 

1. Note that since December 2022, children ages 6 months through 4 years of age who received the first two doses with monovalent Pfizer-BioNTech COVID-19 vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 bivalent vaccine. Children in this age group are not eligible for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes. 

• The March 14, 2023, FDA authorization is for those children 6 months through 4 years of age who completed their three-dose primary vaccination series with the monovalent Pfizer-BioNTech COVID-19 Vaccine, before the Pfizer-BioNTech bivalent COVID-19 vaccine was authorized to provide the third dose in the 3-dose primary series. 
• Vaccination providers are now required to report cases of myocarditis and pericarditis after receipt of a Janssen COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS).

COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. CDC recommends that people get up to date with COVID-19 vaccination as soon as feasible.

Proposed Medicaid Policy 2305-F2F

The Michigan Department of Health and Human Services (MDHHS) has issued 2305-F2F: Reversal of Temporary COVID-19 Relaxation of Face-to-Face Requirement Policies and Update of Face-to-Face and In-Person Definitions proposed policy for public comment.



The policy discontinues the temporary COVID-19 relaxation of face-to-face policies at the end of the Public Health Emergency (PHE) – including bulletins MSA 20-12, MSA 20-30 and Telemedicine Coverage section of MSA 20-42. It also updates the definition of face-to-face and in-person language.  

The proposed policy has a proposed effective date of May 12, 2023 (the end of the PHE). Comments on the proposed policy are due on April 18, 2023, and may be forwarded to frankmane@michigan.gov.

Proposed Medicaid policies may be accessed on the MDHHS website.

U-M, Wayne State Make Becker's

Top 10 Pharmacy Schools By NAPLEX Pass Rates

MDHHS and MPA Cobranded Letter for Electronic Prescribing of Expedited Partner Therapy (EPT) and Sample EPT Script 

The attached letter is designated for those providers prescribing or pharmacists dispensing Expedited Partner Therapy (EPT) intended for partners exposed to sexually transmitted infections such as chlamydia, gonorrhea and/or Trichomoniasis. The Michigan Department of Health and Human Services (MDHHS) and Bureau of HIV/STI Programs (BHSP), in conjunction with the Michigan Pharmacists Association (MPA), would like to make providers and pharmacists aware of updates to the Michigan Dispensing Laws and Electronic Scripting of EPT. 

Please share with pertinent staff to spread awareness as it relates to EPT and Electronic Scripting, or E-prescribing. If you have any questions or concerns please contact Bianca Clarke, Partner Health Improvement Coordinator (MDHHS), at (517) 582-4353 or clarkeb3@michigan.gov, or Farah Jalloul, State Pharmacy Emergency Preparedness Coordinator, (MPA) at Farah Jalloul at fjalloul@michiganpharmacists.org.

Pharmacy Fraternity Hosting 5K Walk/Run April 8

to Raise Funds for Project HOPE

The Omicron Chapter of the Lambda Kappa Sigma (LKS) Professional Pharmacy Fraternity is hosting a 5K walk/run at Nankin Mills Recreation Area at Hines Park April 8 to raise funds for Project HOPE.

Tickets are $20, which can be purchased at tinyural.com/hopewalks2023 until March 31.

Project HOPE is an international nonprofit organization working to improve healthcare across the world. It provides healthcare during disasters and health crises, helps to combat infectious and noncommunicable diseases, works to minimize maternal, neonatal and child health disparities, and helps create impactful healthcare policies. 

If you have any questions, please feel free to contact student pharmacist Shannon Habba or the LKS fraternity advisor, Dr. Mary Beth O’Connell.