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In This Issue:
MPA CEO Perspective
MPA News
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Jan./Feb./Mar. Edition of Michigan Pharmacist Published
Member Updates
- MPA Member Receives National Recognition
- MPA Career Center- Featured Job Opportunities
- Participate in this Year's MPA Adopt-a-Student Program at ACE
- MPF 2023 Golf Classic- Save the Date
CE Events
- Register Today: MPA Annual Convention & Exposition
- More Upcoming CE Opportunities
Legislative and Regulatory News
- Abortion-Related Bills Introduced into Michigan Legislature
- Michigan Bureau of Professional Licensing Update
- FDA Approves SUNLECA for the Treatment of HIV-1 in Adults with Limited Treatment Options
- What Happens When COVID-19 Emergency Declarations End?
- DEA Announces Important Change to Registration Requirement
COVID-19 Updates
- Evusheld Not Currently Authorized for Emergency Use in Any U.S. Region
Professional Practice
- PTCB Relaunches Online Testing Delivery for Assessment-Based Certificates
- MDHHS Urges Vaccination Against HPV
Advertisements
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The calendar changing over to February can only mean one thing – our Annual Convention & Exposition (ACE) is just around the corner. There’s still plenty of time for you to register if you haven’t already for this year’s event Feb. 24-26, 2023 at the Detroit Marriott Renaissance Center.
We’ve assembled a great program, including Friday’s Opening Keynote Session featuring Al Carter, executive director of the National Association of Boards of Pharmacy, and MPA Past Chair Charlie Mollien, who also is the immediate past chair of the Michigan Board of Pharmacy.
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Saturday’s Keynote Session will feature a heavy-hitting legislative panel comprised of national pharmacy leaders and advocates from all sections of pharmacy, including MPA member and current interim CEO for the American Pharmacists Association, Ilisa Bernstein.
Best of all, if you attend every keynote and a session at each breakout offering, you can acquire up to 15 hours of live continuing education credit at this year’s ACE. That’s a great deal!
Register for ACE today and join your friends and colleagues for great programming, unparalleled networking and the opportunity to source new products and services on the exposition floor. And, if you’re looking to exhibit, please sign up today before space is gone!
Can’t wait to see everybody at ACE!
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Michigan Pharmacist Published | |
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The Michigan Pharmacist Jan./Feb./Mar. 2023 journal features:
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Cover Story: The MPA Annual Convention & Exposition (ACE) returns Feb. 24-26 at the Detroit Marriott Renaissance Center.
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President's Platform: MPA President Hope Broxterman reflects on the association's accomplishments in 2022 and looks forward to the year ahead.
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From the Foundation: The MPF celebrates its 30th anniversary and outlines its vision for 2023.
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Advocacy Update: "The Year of Pharmacy" was extended for an entire legislative session as MPA was able to advocate for major wins in the Michigan Legislature. MPA also debuts its Legislator Scorecard to see how lawmakers aligned with MPA positions on legislation.
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Professional Affairs: The COVID-19 pandemic demonstrated how pharmacists can play a bigger role with other public health concerns.
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Legal Insights: Julie Janeway breaks down the Corporate Transparency Act of 2020.
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CE Homestudy: Earn free continuing education credit on the topic of "Health Equity in the Pharmacy."
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CSPM Focus: CSPM President Matthew McTaggart delves in to the treatment of COVID-19 in cancer patients. Also, the CSPM Board of Directors looks at the section's strategic priorities for 2023 and how it can enhance member services and benefits.
Please note: The Michigan Pharmacist will be available in digital format only. Printed copies may be requested via email at MPA@MichiganPharmacists.org.
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MPA Member Receives National Recognition | |
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BETHESDA, Md. — Stan Kent, RPh, MS, CPEL, FASHP, chief pharmacy officer, Michigan Medicine, was one of 20 pharmacy leaders who recently received the inaugural Certified Pharmacy Executive Leader (CPELSM) credential from the American Society of Health-System Pharmacists (ASHP). The CPELSM recognizes commitment to achieving and maintaining excellence in professionalism, leading people, leading the pharmacy enterprise and leading within and across complex healthcare systems.
Launched in 2021 and the first of its kind in pharmacy leadership, the CPELSM acknowledges the unique expertise of pharmacy executive leaders. To be recognized, pharmacists must have a minimum of five years of progressive and sustained leadership experience, including significant managerial oversight in a healthcare organization resulting in advancing pharmacy practice and positive patient outcomes.
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Participate in this Year's MPA Adopt-a-Student Program at ACE | |
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Each year, the Michigan Pharmacy Foundation (MPF) hosts the “Adopt-a-Student” program at the Michigan Pharmacists Association's Annual Convention & Exposition (ACE) to promote the advancement of the profession of pharmacy by connecting student pharmacists with seasoned pharmacy professionals to help guide their future.
If you are a student pharmacist or a pharmacy professional wishing to participate in the program, please click below for more information.
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Cabrini Clinic Seeks Volunteers
The Cabrini Clinic, 1234 Porter St. in Detroit, is always in need of motivated volunteers to support its mission. If you are a physician, physician assistant, nurse, nurse practitioner, pharmacist or medical assistant interested in donating your time, please complete the volunteer form or contact the clinic directly at (313) 961-7863 to learn more about volunteer opportunities at Cabrini Clinic.
Experience in primary care is unnecessary; Cabrini Clinic welcomes providers of all specialties. A commitment of at least one clinical session a month is preferred.
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Michigan Pharmacy Foundation Golf Classic | |
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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! More information about registration, sponsorships and more can be found here.
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Annual Convention & Exposition (ACE) | |
More Continuing Education Opportunities | |
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Pharmacy Technician Advanced Immunization Training
home study
Live session April 18
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Pharmacy-Based Immunization Training
4 p.m. March 22
Registration closes March 17
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Implicit Bias Training
More details will be revealed at a later date.
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Legislative & Regulatory News | |
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Third Circuit Court of Appeals Rules in Favor of
Drugmakers in 340B Contract Pharmacy Case
The United States Court of Appeals for the Third Circuit ruled yesterday in favor of Sanofi, Novo Nordisk and AstraZeneca in a case regarding 340B contract pharmacies. The drugmakers sued the Department of Health and Human Services (HHS) following attempts by the Health Resources and Services Administration to enforce requirements that the manufacturers honor 340B contract pharmacy arrangements.
Similar cases are pending in two other appellate courts in the District of Columbia and Seventh Circuit. Should those courts find in HHS’s favor, the circuit split would have to be resolved by appeal to the U.S. Supreme Court. At present, this means that the contract pharmacy issue has not been fully decided.
“We are disappointed in the Third Circuit decision, but we believe that the other courts will side with HHS and protect the expanded access provided by contract pharmacy agreements,” said Tom Kraus, the American Society of Health-System Pharmacists (ASHP) vice president of government relations. “In the interim, we will continue to push back aggressively against manufacturer attempts to unlawfully limit the 340B Drug Pricing Program.”
ASHP said it remains committed to safeguarding the 340B program. ASHP filed an amicus brief supporting HHS in this case, as well as a separate case brought by Eli Lilly against HHS over the 340B program. In addition to litigation efforts, ASHP and its partners undertook a joint national advocacy effort to safeguard the 340B program, including a digital campaign opposing pharmaceutical manufacturers’ actions that threaten to undermine the program. ASHP also mobilized its members to write to their federal legislators urging them to protect the program.
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Abortion-Related Bills Introduced into Michigan Legislature | |
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The following bills have been introduced into the Michigan Legislature regarding abortion and removing/repealing administration clauses from the Michigan Public Health Code (MPHC).
SB 37 (click to read full bill): Removes reference to crime of administering drugs to procure miscarriage to reflect repeal. To amend 1927 PA 175 by amending section 16a of chapter XVII (MCL 777.16a), as amended by 2010 PA 97.
SB 38 (click to read full bill): Removes reference to crime of administering drugs to procure miscarriage to reflect repeal. Tie-barred to SB 39.
SB 39 (click to read full bill): Repeals penalty for administering with intent to procure miscarriage. It amends 1931 PA 328 by repealing section 14 (MCL 750.14).
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Michigan Bureau of Professional Licensing Update | |
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The U.S. Food and Drug Administration recently updated its Risk Evaluation and Mitigation Strategy to use mifepristone to allow it to be dispensed to patients directly from a pharmacy under certain conditions.
Additional information, including about the steps to obtain certification to dispense this medication, can be viewed using the following links:
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FDA Approves SUNLECA (Lenacapavir) for the
Treatment of HIV-1 in Adults with Limited Treatment Options
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On Dec. 22, 2022, the U.S. Food and Drug Administration (FDA) approved SUNLENCA (lenacapavir), in combination with other antiretroviral(s), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
The approved recommended regimen of SUNLENCA consists of two initiation dosing options followed by maintenance dosing:
Initiation (two options):
- Option 1: 927 mg subcutaneous (SC) injection and 600 mg orally on Day 1, then 600 mg orally on Day 2
- Option 2: 600 mg orally on Day 1, 600 mg orally on Day 2, 300 mg orally on Day 8, then 927 mg SC injection on Day 15
Maintenance
- 927 mg SC injection every six months (26 weeks) from the date of the last injection +/-2 weeks
Full prescribing information is available here.
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What Happens When COVID-19 Emergency Declarations End? Implications for Coverage, Costs, and Access
On Jan. 30, the Biden Administration announced its intent to end the national and public health emergency declarations on May 1 related to the COVID-19 pandemic. These emergency declarations have been in place since early 2020 and gave the federal government flexibility to waive or modify certain requirements in a range of areas, including in the Medicare, Medicaid and CHIP programs and private health insurance, as well as to allow for the authorization of medical countermeasures and to provide liability immunity to providers who administer services. In addition, Congress also enacted legislation — including the Families First Coronavirus Response Act (FFCRA), the Coronavirus Aid, Relief, the Economic Security (CARES) Act, the American Rescue Plan Act (ARPA), the Inflation Reduction Act (IRA) and the Consolidated Appropriations Act of 2023 (CAA) — that provided additional flexibilities tied to one or more of these emergency declarations, and as such, they too are scheduled to expire when (or at a specified time after) the emergency period(s) expires.
This brief provides an overview of the major health-related COVID-19 federal emergency declarations that have been made and summarizes the flexibilities triggered by each.
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DEA Announces Important Change to DATA-Waiver Registration Requirements | |
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With the signing of the Consolidated Appropriations Act of 2023 (the Act) on Dec. 29, 2022, Congress eliminated the “DATA-Waiver Program.” The Drug Enforcement Administration (DEA) fully supports this significant policy reform. At this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA’s top priority is doing everything in its power to save lives. The DEA stated that its goal is simple, which is for opioid use disorder to be readily and safely available to anyone in the country who needs it. Eliminating the X-Waiver will increase access to buprenorphine for those in need.
All DEA registrants should be aware of the following:
- A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
- Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
- There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
- The Act does not impact existing state laws or regulations that may be applicable.
Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance. Significantly, these new requirements do not impact the changes related to eliminating the DATA-Waiver Program described above.
For information regarding DEA’s Diversion Control Division, please visit https://www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division Policy Section at ODLP@dea.gov if you seek additional assistance regarding this or any other matter.
See original signed document. Please visit SAMSHA for additional information. MPA is working with the Board of Pharmacy and LARA on any additional requirements.
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Evusheld Not Currently Authorized
for Emergency Use in Any U.S. Region
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The U.S. Food and Drug Administration (FDA) announced Jan. 26, 2023, that the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) has been revised. Based on this revision, Evusheld is not currently authorized for use in the U.S. because it is unlikely to be active against more than 90 percent of the SARS-CoV-2 variants currently circulating in the U.S. based on the latest Centers for Disease Control (CDC) data. However, people who have used Evusheld still have options to increase their protection against the most serious consequences of COVID-19, including hospitalization and death.
According to the most recent CDC Nowcast data, certain SARS-CoV-2 variants are projected to make up more than 90 percent of the variants currently circulating in the U.S. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants. Given that a COVID-19 infection is likely to be caused by one of these non-susceptible variants and consistent with the terms and conditions of the Letter of Authorization, Evusheld is not currently authorized for emergency use in any U.S. region at this time. The Department of Health and Human Services (HHS) and AstraZeneca have paused the distribution of Evusheld until further notice by the Agency.
More details about these and other treatment options that are expected to retain activity against COVID-19 can be found here and below:
- Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
- Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 6.5 pounds) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
- COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.
Individuals for whom COVID-19 vaccination is recommended should consider getting vaccinated with the primary series and an updated vaccine when eligible to increase protection against the most serious consequences of COVID-19.
Please visit Michigan.gov/covidtherapy, the FDA’s website or view ASPR’s information sheet for additional details.
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PTCB Relaunches Online Testing Delivery
for Assessment-Based Certificates
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WASHINGTON, D.C. – The Pharmacy Technician Certification Board (PTCB) is kicking off 2023 with new opportunities for Certified Pharmacy Technicians (CPhTs) to demonstrate their knowledge and earn advanced and specialty certificates. PTCB is relaunching OnVUE, an online proctored testing platform, allowing PTCB CPhTs to earn advanced credentials more conveniently.
“Following an evaluation period of our initial launch in 2020, we are excited to move forward with this expanded testing option for our certificates,” said Khunteang Pa, Senior Director of Certification Operations. “Relaunching online proctored delivery of PTCB’s Assessment-Based Certificate Exams empowers pharmacy technicians to pursue career advancement with more flexibility.”
Administered on a secure platform using artificial intelligence combined with live virtual proctor supervision and monitoring, online exams are the same as those administered at a test center. To take their exam online, candidates need a computer with a webcam, a reliable internet connection, and a quiet space where they can spend a few uninterrupted hours. In-person testing is still available at Pearson VUE testing centers for all PTCB exams.
PTCB offers a growing suite of advanced and specialty credentials for pharmacy technicians to invest in their careers as their responsibilities expand. With almost 60 percent of PTCB-certified technicians considering the profession their long-term career, technicians must have the opportunity to grow and demonstrate their knowledge and skills. Certified pharmacy technicians reported higher wages than non-certified technicians, according to the 2022 PTCB Workforce Survey, which received responses from over 20,000 technicians.
PTCB currently offers ten Assessment-Based Certificate Programs–such as Regulatory Compliance, Point-of-Care Testing, and Supply Chain and Inventory Management–that open doors for technicians to demonstrate their knowledge, receive recognition, and grow in their careers. For a complete list and more information, please visit PTCB.org/credentials.
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MDHHS Urges Vaccination Against HPV | |
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January was Cervical Health Awareness Month and the Michigan Department of Health and Human Services (MDHHS) is encouraging you to protect your patients with an on-time HPV vaccination. Cervical cancer was once a leading cause of cancer death for women in the United States. Today, HPV vaccines and cervical cancer screening have made it one of the most preventable cancers. Still, according to the National Cancer Institute, nearly 14,100 women in the U.S. received a diagnosis of cervical cancer and nearly 4,300 died from the disease last year alone.
More than 9 of every 10 cases of cervical cancer are caused by HPV. Almost all cervical cancer can be prevented by HPV vaccination. HPV vaccination is recommended at age 11 or 12 but can begin at 9. While on-time vaccination of HPV vaccine by age 13 provides the best protection, everyone through age 26 years should get an HPV vaccine if they were not fully vaccinated already. Further, some adults aged 27 through 45 years who were not already vaccinated might choose to get HPV vaccine after speaking with their doctor about their risk for new HPV infections and the possible benefits of vaccination for them.
HPV vaccination provides safe, effective, and long-lasting protection against HPV cancers. To learn more, visit cdc.gov/hpv. You may also visit the MDHHS website on HPV for more information.
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