From: Mitchel C. Rothholz, RPh, MBA, Chief of Governance & State Affiliates and Executive Director, APhA Foundation, American Pharmacists Association

The Food & Drug Administration authorized an extension of the shelf life for the Johnson & Johnson’s Janssen COVID-19 vaccine from 4.5 months to 6 months (an additional 45 days). The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 6 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

https://vaxcheck.jnj

Vaccine providers should visit https://vaxcheck.jnj/ to confirm the latest expiration dates of vaccine, including those currently available for administration throughout the U.S. This extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer’s storage conditions.

 COVID-19 vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates can be extended as we get more stability data.  Always be sure to check the manufacturer’s website to obtain the most up-to-date expiration dates for COVID-19 vaccines you have on hand. 

• Position: Executive Director, Retail Pharmacy Network
• Link to apply: https://social.icims.com/job/Executive-Director-Retail-Pharmacy-Job-US-GA-Marietta-30508167.html?isd_source=web&isd_pub=2588307
• Contact for more information: Teresa Waters teresa.waters@wellstar.org
• Job description

Renewal of Determination That A Public Health Emergency Exists

The U.S. Department of Health & Human Services formally made a declaration effective July 20, 2021, that a public health emergency exists and has existed since January 27, 2020. 

https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx

CliffNotes: The pandemic is not over. 

From the Georgia DPH and CDC

Today we received additional guidance from CDC about expiring COVID vaccine.

Please see below:

Expiring COVID-19 Vaccine

In July and August, some lots of Pfizer, Moderna, and J&J/Janssen vaccines are set to expire. In order to minimize the number of unused expired doses and manage expiring doses correctly, we encourage providers to:

• Monitor expiration dates weekly, rotate stock as needed, and follow a “first in, first out” strategy to manage inventory.

• If nearing expiration, check posted manufacturer information for the most up to date expiration/extension information for vaccine lots.

How to handle expired or expiring COVID vaccine supply:

• Upon expiration, providers who are able to safely quarantine expired doses in the appropriate storage unit environment, should:

• Quarantine doses, marked Do Not Use.
• Place vaccine in a storage unit where the risk of inadvertently administering an expired dose can be avoided

• If the provider is unable to safely quarantine expired doses, the provider should:

• Based on the latest expiration information, REMOVE expired vaccine from the storage unit IMMEDIATELY. Do not give staff opportunity to administer expired vaccine.

• If expired vaccine is inadvertently is administered, it is considered a vaccine administration error and requires remediation including a VAERS report, contacting the recipient to inform them of the error, and may or may not require revaccination based on the manufacturers’ guidance. Guidance on vaccine administration errors can be found in Appendix A of the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.

Report Expired Vaccine

• Please promptly report any expired vaccine. This helps CDC and DPH accurately monitor the amount of vaccine in the field. Keep in mind that there are no negative consequences for reporting waste, and it will not negatively impact future vaccine shipments. CDC recognizes that unused expired vaccine is a normal part of any vaccination program, especially one of this scope and size.

NEWS RELEASE

ALEXANDRIA, Va. (July 1, 2021) — As part of what the Federal Trade Commission said will be the first in a series of monthly meetings opening its work to the public, National Community Pharmacists Association General Counsel Matthew Seiler, RN, Esq., spoke to the commission at today’s open meeting about pharmacy benefit managers and their anticompetitive practices harming patients and neighborhood pharmacies. Each speaker was allowed one minute to make their remarks. Seiler’s are excerpted below and linked here as prepared for delivery: 

“The PBMs are systematically driving community pharmacies out of business through anticompetitive practices such as below-cost reimbursement and patient steering to PBM-preferred networks. This has led to pharmacy deserts. One in three neighborhoods in the 30 most populous cities are pharmacy deserts. NCPA urges this body to take immediate action to curb the PBMs’ anticompetitive conduct and the effects of consolidation and vertical integration in the pharmacy industry.” 

Participating in today’s open meeting is the latest in NCPA’s ongoing efforts to press the FTC, other regulators, and policymakers on antitrust enforcement and anticompetitive issues in the prescription drug supply chain. Just last week NCPA urged FTC Chair Lina Khan and an affiliated multilateral task force to more fully scrutinize and develop enforcement and policy efforts. 

NCPA CEO B. Douglas Hoey, pharmacist, MBA, says, “FTC rulings can have profound consequences for the public, particularly with health care, so it’s critical that decisionmakers be open to receiving input on the effects of those choices. Marketplace competition should allow consumers the freedom to choose but in health care, the largest players have often been permitted to manipulate the system and rob patients of choice. We’re grateful to Chair Khan and the commission for the opportunity to share concerns about PBMs’ anticompetitive behaviors and are eager partners in the work to help restore fairness and balance for patients and their trusted small business pharmacies.”

Video of the meeting can be found here.

April 26, 2021

Dear Colleague: 

After a thorough safety review, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the use of Janssen (J&J) COVID vaccine should resume in the United States. As such, the Georgia Department of Public Health (DPH) COVID Vaccine Program will again offer J&J vaccine to Georgians aged 18 and older. 
 
A warning will be added to the J&J vaccine about the potential for very rare, but severe blood clots associated with the vaccine. Vaccine providers administering the J&J vaccine should review the Janssen COVID-19 Vaccine Fact Sheet. Vaccine recipients and/or their caregivers should be provided with the Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers. Both fact sheets now include information about thrombosis and thrombocytopenia syndrome which have occurred in a very small number of people who have received the J&J vaccine. 

ATLANTA, Georgia (WRBL) – The Georgia Department of Public Health, following the guidance of the Centers for Disease Control and Prevention and the Food and Drug Administration, paused all Johnson & Johnson vaccines in the state, according to a news release.

DPH said they are pausing the vaccine while CDC and FDA investigate data involving six reported cases of a “rare and severe type of blood clot” that occurs 6 to 13 days after vaccination.

DPH said it would issue additional information about appointments and rescheduling soon.

https://www.wrbl.com/news/health/coronavirus/georgia-dph-pauses-all-johnson-johnson-vaccines/

The Georgia Department of Public Health (DPH) has been alerted of a possible cluster of overdoses related to counterfeit pills which may be sold as Xanax or Percocet and contain fentanyl. These counterfeit pills may be driving increased overdoses in Richmond County, the Coastal Health District, and the Northwest Health District.

If you are seeing unusual overdose activity or suspect the presence of possible counterfeit pills in your area, please call the Georgia Poison Center at 1-800-222-1222 or contact the Drug Surveillance Unit at ga.opioidprogram@dph.ga.gov.

Read notice from Georgia DPH, April 5, 2021

Here are a few resources with multilingual information about COVID-19 Vaccines for recipients, caregivers and healthcare providers.

CDC Multilingual resources:

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/communication-toolkit.html

Moderna Multilingual Fact Sheet:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine

Pfizer Multilingual Fact Sheet:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine

J&J Multilingual Fact Sheet:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine

FDA COVID Multilingual Took Kit:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/multilingual-covid-19-resources

From Bob Coleman on March 25, 2021

If you have patients on the Indy Health plan, please review the three files below. The first  is being sent to member/beneficiaries by the company’s mail vendor.  The second is the script for the Robocalls which will start this evening or in the morning.  The third is the notice to pharmacists which will be pushed last night.  The member/beneficiary and pharmacy notices will also be posted to the Indy Health website.

Medicare drug plan with Indy Health Insurance Company ended on March 23, 2021 announcement

Robo Call Script

FAQ  Indy Health Insurance Network Pharmacies

Important information about Indy Health

Arkansas Medicare Part D pharmacy benefits insurer Indy Health is under an order of rehabilitation (effective March 18). As part of that order, the Arkansas insurance commissioner has taken control of Indy Health.

Click here to read the full news release from the Arkansas Insurance Department. Click here for a FAQ document from Indy Health.

Click here for the Direct Member Reimbursement Form

LI-NET will accept Indy Health Medicare part D claims effective March 1–31 through the LI-NET program for transition coverage of prescription drugs. Indy Health claims will pay through LINET (Humana transition claims for Medicare D). GPhA members wanting additional information, please contact the Arkansas Department of Insurance, visit the GPhA website, or check your email for the latest information.

Part D members with questions and/or concerns should call 1-800-799-0927 or email customercare@indyhealthinc.com. Customers may also contact the Arkansas Insurance Department Consumer Services Division at 1-800-852-5494.

Indy Health claims will pay through LINET (Humana transition claims for Medicare D)

ID is Medicare number

Bin 015599

No group

PCN 05440000

Frances Grice Lipscomb, August 29, 1931 – February 26, 2021

Frances Grice Lipscomb, age 89, of Dahlonega, Georgia passed away on February 26, 2021. She was the daughter of Charles and Gladys Grice and was born in Geneva, Alabama on August 29, 1931. Frances graduated from the University of Georgia College of Pharmacy in 1953 and was one of three women in her graduating class. While at UGA, she served as the President of Zeta Tau Alpha sorority. After graduation, she initially worked in a local Dahlonega drug store (Lipscomb Drug Company) that her father-in-law, Doc Lipscomb, owned and operated with her then-husband, George. Frances later moved to Atlanta to help establish the Georgia Medicaid program. She spent the rest of her career working to expand Medicaid and presided over the Pharmacy Division until her retirement in 1995. Frances was also the first female president of the Georgia Pharmaceutical Association (GPhA). She was a member of Epworth United Methodist Church where she was active with the Suzie Bowen Circle, the Food for Friends Ministry, the Adult Choir, and the Suzanna Wesley Sunday School class. She was also a volunteer at the Good Samaritan Center in Jesup, Georgia.

Frances was preceded in death by her parents, Charles and Gladys Grice, and her younger sister, Mary Ann Pollard. She is survived by her four daughters, Laura (Larry) McKinley, Melinda Lipscomb, Nancy Lipscomb and Lisa Lipscomb, as well as her grandson, Brent (Milly) Cole and her granddaughter, Alex (Travis) Harrison. Additional survivors include her three great-grandchildren; Randi, Sam, and Willa.

A private service will be held at a later date. In lieu of flowers, memorial donations may be made to Epworth United Methodist Church at 675 South Third Street, Jesup, Georgia 31545.

To share a memory of Mrs. Lipscomb or a condolence with the family visit andersonunderwood.com.

Anderson-Underwood Funeral Home, 2068 Hwy 19 N, Dahlonega, GA 30533

https://www.andersonunderwood.com/obituary/frances-lypscomb?lud=BBFF45CC6153D5C48F44413B83E226A6

To plant Memorial Trees in memory of Frances Lipscomb, please click here to visit the Sympathy Store.

THE GPHA BOARD NAMES JONATHAN SINYARD AS PRESIDENT ELECT

ATLANTA (February 11, 2021) The Georgia Pharmacy Association (GPhA) Board of Directors elected Jonathan Sinyard, PharmD, as President Elect, with his installation occurring at the Georgia Pharmacy Convention in June 2021. He will replace Mahlon Davidson as President Elect, who will assume the board presidency. Sinyard has served on several committees and graduated from LeadershipGPhA in the 2015 inaugural class. He was elected to an at-large board of director seat in 2016 and again in 2019. Sinyard is a graduate of University of Georgia College of Pharmacy (2009). He hails from Cordele, Georgia, where his lives with his wife Michelle and their two daughters, Caitlin and Bailey Grace.

When asked why he chose the profession of pharmacy, Sinyard said, “I’ve always been very interested in the field of healthcare. I began working in a pharmacy during the summer after my first year of college and loved it. I thoroughly enjoyed the face to face interactions with patients and being able to help them. The relationships that we build with our patients as we serve them is what keeps me engaged in retail pharmacy even to this day.”

Sinyard works at Adams Drug Store, Cordele, GA. He began working during the summer of 2004, continued as an intern through pharmacy school, and was hired as a full-time pharmacist upon graduating in 2009. He later purchased the pharmacy in 2019. “My store has been in business for 70 years and we’ve got second and third generation patients that we serve. It is such a blessing to be able to serve our community with state-of-the-art pharmacy services, while still retaining the level of service that they have come to expect,” he shared.

When asked why he is passionate about GPhA leadership, Sinyard said, “I love the networking and advocacy that GPhA offers. It’s always great to go to GPhA events, because it feels more like catching up with old friends rather than a “work meeting.”  It’s great to have those relationships in the pharmacy world, because when I have a question, 9 times out of 10, there’s a GPhA member that’s got the answer I’m looking for. I also can’t say enough about the advocacy work that GPhA does on behalf of its members. The world of pharmacy is an ever-changing landscape, and it’s great to know that we have someone on our side fighting for ALL pharmacists in Georgia.”

When he first got involved with GPhA as a student in college, it was for the networking with other students and practicing pharmacists. Over time, he said, “it has blossomed into so much more than that.”

###

The Georgia Pharmacy Association represents Georgia’s pharmacists, pharmacy technicians, and their patients. We fight for pharmacists at the capitol. We provide education, networking, and resources to improve pharmacy practice every day. For more information and the latest pharmacy news, visit GPhA.org.

Media Contact:

Michelle Turkington, Director of Marketing and Communications

Georgia Pharmacy Association

mturkington@gpha.org

678-640-4313

THE GPHA BOARD NAMES MAHLON DAVIDSON AS PRESIDENT

 ATLANTA (February 11, 2021) The Georgia Pharmacy Association (GPhA) Board of Directors named Mahlon Davidson, RPh, as president, with his installation occurring at the Georgia Pharmacy Convention in June 2021. He will replace Wes Chapman, RPh, as GPhA Board President. Davidson grew up in Camilla, Georgia and graduated from the University of Georgia College of Pharmacy in 1982, with a specialty in diabetes management. Davidson has been practicing in Conyers/Covington area for the past 33 years (Big B Drugs and Kroger). He is a UGA preceptor and enjoys working with students. He resides in Oxford, Georgia, with Peaches the cat. He has two sons, Nick (an attorney) and Blake (a geologist). His second love after pharmacy is fishing.

Davidson has been an active member of GPhA since 1985 and has a long list of achievements. In 1997, Davidson served on the Pharmacy Practice Act Revision Commission, representing employee pharmacists. Davidson was instrumental in founding the Academy of Employee Pharmacists, serving as chairman from 2002-2003. He was named Employee Pharmacist of the Year in 2003. He has served two terms as Georgia Fifth Region President and was recognized as the Mal T Anderson Outstanding Region President in 2004. He chaired the Pharmacy Membership Linkage Committee 2016-2017. Davidson is a gold-level contributor to PharmPAC and was formerly chairman of its board from 2019-2020. “GPhA offered me the ability to shape my future. It gave me the chance to sit around with pharmacists from different work settings and discuss what changes were needed in our profession,” said Davidson.

We asked Davidson why he went into pharmacy and he shared that his mother was a type 1 diabetic and because of it, he had many interactions with their local pharmacy. Through his frequent encounters, he realized the importance of the relationship to his mother’s care and well-being. “Our small-town pharmacy was the first-line entry to our local healthcare system,” he said. “I wanted to be that important piece of my own patient’s healthcare system. I get up every day with the intent to make a positive impact.”

###

The Georgia Pharmacy Association represents Georgia’s pharmacists, pharmacy technicians, and their patients. We fight for pharmacists at the capitol. We provide education, networking, and resources to improve pharmacy practice every day. For more information and the latest pharmacy news, visit GPhA.org.

Media Contact:

Michelle Turkington, Director of Marketing and Communications

Georgia Pharmacy Association

mturkington@gpha.org

678-640-4313

The Georgia DPH has let GPhA know that they are experiencing “significant” weather delays on vaccine shipments. They do not have arrival status at this time. We will do our best to keep you informed. Stay warm.

URGENT! 
Time Sensitive – We need your help NOW!

 Senate Bill 46 that expands the vaccines pharmacists can administer via protocol to all ACIP recommended vaccines for adults, including the Covid-19 vaccine, is being heard in a Senate HHS committee meeting this afternoon at 2 PM.
 
It has come to our attention that there is an organized effort to oppose this legislation.  
 
Please reach out to the senators on the HHS committee this morning via phone or email and
 
1:  Tell them that by empowering pharmacists, SB 46  will increase patient access to needed vaccines and improve health outcomes for Georgians; and 
 
2: Ask for their support and vote in support of SB 46.
 
Committee Members
 
Watson, Ben Chairman
ben.watson@senate.ga.gov
(404) 656-7880
 
Dolezal, Greg Secretary
greg.dolezal@senate.ga.gov
(404) 656-7127
 
Kennedy, John F. Ex-Officio
john.kennedy@senate.ga.gov
(404) 656-0045
 
Walker, III, Larry Ex-Officio
larry.walker@senate.ga.gov
(404) 656-0095
 
Au, Michelle Member
michelle.au@senate.ga.gov
(404) 463-1562
 
Butler, Gloria S. Member
gloria.butler@senate.ga.gov
(404) 656-0075
 
Cowsert, Bill Member
bill.cowsert@senate.ga.gov
(404) 463-1366
 
Halpern, Sonya Member
sonya.halpern@senate.ga.gov
(404) 463-1351
 
 Hatchett, Bo Member
bo.hatchett@senate.ga.gov
(404) 656-7454
 
Hufstetler, Chuck Member
chuck.hufstetler@senate.ga.gov
(404) 656-0034
 
Jackson, Lester G. Member
lester.jackson@senate.ga.gov
(404) 463-5261
 
Kirkpatrick, Kay Member
kay.kirkpatrick@senate.ga.gov
(404) 656-3932
 
Orrock, Nan Member
nan.orrock@senate.ga.gov
(404) 463-8054
 
Time is short. Please call or email the committee members today. Your action on this important topic can make the difference. 

 Let your voice be heard. 

Thank you,

Bob Coleman
CEO Georgia Pharmacy Association

Greg Reybold
Vice President of Public Affairs