Lauren Biscaldi is the Managing Editor of Drug Topics. 

Lauren Biscaldi, Managing Editor

The Total Pharmacy Solutions Summit is back and better than ever: On October 22, join community pharmacy thought leaders online for a day of education, conversation, and insights centered around the theme of 

From 9 AM to 3 PM, join this virtual Summit and tune into sessions where attendees will learn tips and tricks in areas such as innovative test-to-treat strategies, the ins and outs of AI optimized pricing, and the latest updates on COVID-19 booster vaccines and treatments. Attendees who participate in the live event on October 22 are also eligible to earn 3 live CE credits via 3 accredited sessions, including one on avoiding medication errors and another covering best practices around controlled substances. Both of these CE sessions are accredited by 

Pharmacists, pharmacy support staff, and owners and operators across the independent and community pharmacy space—as well as pharmacy professionals interested in independent pharmacy—are all encouraged to attend.

most recent Total Pharmacy Solutions Summit

 took place on April 30, 2022. Speakers from across the industry came together to share their insights on the latest topics affecting independent pharmacy practitioners across the country and included Paige Clark, RPh, vice president of pharmacy programs and policy at Prescryptive Health; Lisa Faast, PharmD, founder and CEO of DiversifyRx; and Steven F. Moore, PharmD, vice president of Condo Pharmacy, who delivered the day’s Keynote Address.

Please join us for the Total Pharmacy Solutions Summit on Saturday, October 22, 2022 from 9 AM to 3 PM EST. Visit the 

 today to pre-register and secure your spot at the event.

Articles

Extend Care and Expand Revenue at the Total Pharmacy Solutions Summit

From business education programming and innovative CE sessions to jam-packed General Sessions, this year’s National Community Pharmacists Association (NCPA) Annual Convention and Expo is an event that independent pharmacists and pharmacy owners simply won’t want to miss. The conference kicks off on Saturday, October 1 in Kansas City, Missouri at the Kansas City Convention Center through Tuesday, October 4.

Are you ready to embrace this year’s theme and 

? Read on for some of our top highlights and notable events taking place at the 2022 NCPA Annual Convention and Expo.

This year’s Annual Convention features two General Session events: Sunday, October 2 and Monday, October 3, both at 9:30 AM. The first of these sessions features keynote speaker Mike Abrashoff, former commander of the USS Benfold, who will share a story from his time in the Navy to demonstrate why leadership matters and why culture is everything.

On October 3, the second General Session kicks off with Lina M. Kahn, chair of the Federal Trade Commission (FTC). Kahn will join NCPA CEO B. Douglas Hoey, RPh, MBA for a fireside chat and Q&A session. “As FTC Chair, Khan has been receptive to hearing the concerns of independent pharmacists, and this is a great opportunity to get her thoughts about issues in our industry and talk about the important work her agency does on behalf of consumers,” said Hoey in a press release.

Finally, ophthalmologist Will Flanary, MD will take the stage as the day’s second keynote speaker. Perhaps better known by his social media handle of Dr Glaucomflecken, Flanary has more than 2.5 million followers across social platforms. With a keen eye for observational humor and biting satire, Flanary provides commentary on everything from “the perils of Visine to the horrors of health insurance”

 for audiences across the health care industry with the help of his 

"As a pharmacist, the most important thing is taking time to provide the best care possible for your patients, but pharmacists don't always lean on technology for the solution," Paige Clark, RPh, vice president of pharmacy programs and policy at Prescryptive Health, told 

 from Prescryptive Health, independent pharmacists said they spend an average of 2 to 6 hours a week reviewing drug pricing. That is up to roughly 312 hours a year spent reviewing pricing that could be focused back on patient care." 

"Intelligent pricing solutions driven by artificial intelligence can put this precious time back into pharmacy practitioners' hands, so they can do more of what they love: helping patients," Clark added. 

Led by Clark, Prescryptive Health will be presenting 2 sessions in the Exhibit Hall. The first—focusing on the ways in which pharmacies can use technology to remain competitive and boost their bottom line—will take place on Sunday, October 2 from 12:30 to 1:00 PM. During the session, Clark will present a case study detailing how one multi-location pharmacy was able to sustainably grow profits while keeping consumer prices affordable.

Between 3 and 3:30 PM on Monday, October 3, Clark will be joined by Brad Gallagher, partner at Barclay Damon in Albany, New York, for a CE session combining legal and pharmacy education to raise awareness of cybercrime in pharmacy. With personal health information selling for $250 per record on the black market—compared with 50 cents for a credit card number—this session is can’t-miss.

This 4-day event will also feature numerous business education sessions, many of which provide the opportunity to earn CE credits. On Saturday, October 1, learn more about the 

 and how pharmacists can use point-of-care testing services to grow their bottom line. On Sunday, October 2, a session hosted by NCPA senior director of professional affairs Lisa Schwartz will educate attendees on 

—to comply with the Drug Supply Chain Security Act, which goes into effect in November 23. And on Monday, October 3, Blueberry Pharmacy owner Kyle McCormick will answer pharmacists’ 

For attendees who are too excited to wait to start their NCPA Annual Convention experience, 3 days of 

—running September 29 through Noon on October 1—will be covering a wide range of topics, including a pharmacy ownership workshop, a guide to creating a pharmacist-led lifestyle and weight management program, and the ever-popular NCPA 

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

The Exhibit Hall will be open from Sunday, October 2 at 12 PM through 5 PM on Monday, October 3. Don’t forget to visit 

 at booth 931: Grab a copy of our latest issue, sign up for our eNewsletters, and chat with our team to learn more about how you can stay up to date on everything independent pharmacy.

Drug Topics’ coverage of the 2022 NCPA Annual Convention and Expo is sponsored Prescryptive Health.

FTC Chair speaking at NCPA Annual Convention in October. News release. National Community Pharmacists Association. September 12, 2022. Accessed September 19, 2022. 

https://ncpa.org/newsroom/news-releases/2022/09/12/ftc-chair-speaking-ncpa-annual-convention-october

Keynote speakers. National Community Pharmacists Association. Accessed September 19, 2022. 

Rewriting the script: Independent pharmacy trends. 2022 research report. Prescryptive Health. Accessed September 19, 2022. 

https://prescryptive.com/2022-pharmacy-study/

The meeting will take place in Kansas City, Missouri, from October 1 through October 4.

Conference Preview: NCPA Annual Convention and Expo 

The last year has included a number of legislative and regulatory advancements and wins for the pharmacy industry: The Centers for Medicare and Medicaid Services (CMS) finalized their Medicare Part D rule,

 set to require Part D plans to include pharmacy price concessions (commonly referred to as direct and indirect remuneration (DIR) fees) in negotiated price at point of sale, and that is scheduled to take effect in 2024. The bipartisan Pharmacy Benefit Manager Transparency Act of 2022

 was introduced by United States Senators Maria Cantwell (D-WA) and Chuck Grassley (R-IA). But perhaps most important for the future of the pharmacy profession was the introduction of the bipartisan HR 7213, the Equitable Community Access to Pharmacist Services Act.

have come together with peers across the industry, “working collaboratively to establish and craft new legislation to permanently recognize pharmacists as providers to be reimbursed through Medicare for clinical services related to COVID-19 and other respiratory illnesses,” explained Beth Mitchell, senior director of government affairs at AmerisourceBergen. “Having this bill introduced is a notable legislative development.”

HR 7213 was introduced on March 24, 2022 by United States Representatives Ron Kind (D-WI), David B. McKinley (R-WV), Earl L. “Buddy” Carter (R-GA), and Nanette Diaz Barragán (D-CA).

 The goal of the bill is simple: to “ensure patients’ continued access to pandemic-related care services provided by pharmacists, including services to keep communities safe from COVID-19 and future public health crises.” To date, Mitchell said, there are more than 40 bipartisan Members of Congress who have cosponsored the bill. For those not yet engaged, Mitchell, AB’s public affairs group and the Future of Pharmacy Care Coalition are working to educate Members of Congress, federal agencies and the Administration to garner support for the legislation.

In addition to 42 bipartisan United States Representatives, HR 7213 is supported by organizations from the American Red Cross and the National Association of Black Nurses to the National Community Pharmacists Association, the National Association of Chain Drug Stores, the American Pharmacists Association, and state pharmacy groups. More than 80 organizations representing patients, seniors and rural Americans support HR 7213.

“As healthcare evolves, pharmacists are going to be an integral piece of providing clinical patient services,” Mitchell explained. “COVID-19 has shown pharmacists are accessible and more than capable of providing this level of clinical care to their communities.”

“With the flexibilities that the COVID-19 Public Health Emergency and the PREP Act declarations have afforded pharmacists, we [AmerisourceBergen and 

] have pharmacy customers who are currently providing COVID-19 vaccines, tests, and treatment, such as monoclonal antibodies and antivirals used to treat COVID-19. Now, we’re also seeing some of our stores get tapped by their local healthcare jurisdictions to help roll out Monkeypox vaccines,” she added. “We’ve administered more than 6 million doses of COVID-19 vaccine shipped to nearly 1700 Good Neighbor Pharmacies across the country; without pharmacists, we would not be where we are in terms of the country’s response to this pandemic.”

Once the COVID-19 public health emergency ends and the PREP Act declarations ultimately expire, the flexibilities currently afforded to pharmacists are “at risk of going away,” Mitchell said. To avoid that, it’s crucial to have legislation introduced and enacted at the federal level ensuring that pharmacists are recognized as health care providers with the ability to provide critical clinical care and receive Medicare reimbursement for services related to testing, immunizations, and treatment for COVID-19, influenza, strep throat, and RSV.

One additional benefit of HR 7213? If enacted, the bill would also “give the Secretary of Health and Human Services the ability to, if a future public health emergency comes to fruition, call on pharmacists, again,” said Mitchell, enabling them to provide critical timely support.

“That’s what the bill is seeking to do,” said Mitchell. “Give pharmacists the permanent ability to provide clinical care services related to COVID-19 and other respiratory illnesses, and then to be reimbursed by Medicare for those services. All of that ultimately leads to improving health equity and making sure patients have access to care at their pharmacy in an effective and timely way.”

Although the COVID-19 pandemic brought to light the importance of health care providers across the practice spectrum, a bright light has been cast on independent pharmacists, a group that rolled up their collective sleeves and went above and beyond to continue caring for patients in their communities. This spotlight, Mitchell said, has led to a number of regulatory changes that have directly impacted the way independent pharmacists practice.

At the height of the pandemic, a slate of bipartisan Congressional COVID-19 response bills, including the Coronavirus Aid, Relief, and Economic Security (CARES) Act,

 were passed and signed into law; these federal laws included significant provisions to make funding available at CMS to reimburse pharmacists for care provided. Put together with regulatory actions like the PREP Act and its subsequent amendments,

 independent pharmacists found themselves providing more care and services than ever before.

But, Mitchell said, “We need Congress to advance impactful bills such as HR 7213. I think a lot of people are having COVID-19 fatigue, including Members of Congress and key officials and federal agencies,” she explained. “Regardless of that, we must continue to advocate for long-needed and permanent changes, and remind lawmakers of the patient care that pharmacists continue to carry out in their communities.”

One way to encourage this Congressional action is by capitalizing on the momentum surrounding each legislative and regulatory victory.

“It’s important for citizens, pharmacists, pharmacy technicians, store managers, [and] patients…to be a part of the process and to be involved,” Mitchell explained. “I love what I do, because I get to be an advocate for our customers and for our company, but meaningful change happens when people and groups come together to advocate on a common issue of importance.”

For pharmacists and pharmacy technicians, that might look like inviting their member of Congress to visit their pharmacy, showing them in real time how independent pharmacists help their communities. Mitchell also encourages pharmacists to learn more about HR 7213 and to ask their Member of Congress to cosponsor the legislation; AmerisourceBergen’s 

 platform is one available resource, she noted, which includes a 

 page that facilitates pharmacists contacting their member of Congress.

Jennifer Shannon, PharmD, BCPS, owner of Lily’s Pharmacy in Johns Creek, Georgia and a member of the 

 network, never thought she’d be an advocate for anything. “When we opened our pharmacy, someone told me, ‘You’ll be at the table very quickly when your patients can’t access medicine,’” she said. Shannon took the stage during General Session at ThoughtSpot 2022 to discuss the future of pharmacy in the context of legislative advocacy work.

“Each of us building local relationships will ultimately help expand our scope [of practice],” Shannon said. “Federally, we are working on getting provider status. I really feel that working in your own communities – reaching out to our local and state legislators – will be the key to expanding our collective scope. It is incredibly important and will continue to help demonstrate what we’re doing [to lawmakers].”

Mitchell also underscored the urgency and importance of pharmacists achieving provider status and how that will improve health equity. “Once the current assortment of federal and state pandemic response flexibilities expire, the last thing anyone would want is for a patient to walk into a pharmacy and not be able to get the care they need from their pharmacist, such as a COVID-19 test,” she said. “That precedent has already been set, and that’s part of our message too. You can’t just turn the lights off.”

For her part, Shannon is optimistic about the potential passage of HR 7213 and looking forward to the ways its enactment will improve pharmacy practice for the better.

“There are a lot of things that were ‘if’s’ a few short years ago that became ‘now’s—our new reality” she explained. “It wasn’t too long ago that pharmacists couldn’t give vaccinations; it wasn’t too long ago that nobody knew what a PBM was.

“I always worry what would happen [to the people we take care of] if we weren’t here,” she added, “but I know we’ll be here because there are so many people advocating on our behalf, when some of us have trouble saying what we need or communicating what we do. We all have to work to share our voice and our story, and to not be afraid.”

To learn more about AmerisourceBergen’s commitment to advocacy on behalf of independent pharmacies across the United States, visit 

AmerisourceBergen commends the introduction of S. 1909 & H.R. 3554, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, in Congress. AmerisourceBergen. Published June 8, 2021. Accessed August 12, 2022. 

https://www.amerisourcebergen.com/newsroom/media-statements/amerisourcebergen-commends-the-introduction

Key U.S. Senators introduce PBM legislation requiring transparency and prohibiting deceptive practices. Our Independent Voice. Published May 27, 2022. Accessed August 12, 2022. 

https://www.ourindependentvoice.com/latest-updates/news-item/2022/05/27/key-u.s.-senators-introduce-pbm-legislation-requiring-transparency-and-prohibiting-deceptive-practices

H.R 7213 - Equitable Community Access to Pharmacist Services Act. 117th Congress (2021-2022). Accessed August 12, 2022. 

https://www.congress.gov/bill/117th-congress/house-bill/7213

Media statement and quotes on the Equitable Community Access to Pharmacist Services Act. AmerisourceBergen. Published March 25, 2022. Accessed August 12, 2022. 

https://www.amerisourcebergen.com/newsroom/media-statements/media-statement-and-quotes-on-the-introduction-of-hr-7213

S.3548 – CARES Act. 116th Congress (2019-2020). Accessed August 12, 2022. 

https://www.congress.gov/bill/116th-congress/senate-bill/3548/text

Seventh amendment to declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. Public Health Emergency. Reviewed March 12, 2021. Accessed August 12, 2022. 

https://www.phe.gov/Preparedness/legal/prepact/Pages/PREP-Act-Guidance.aspx

Continued advocacy work is the key to seeing state and federal legislative action come to fruition. 

As Health Care Providers, Pharmacists Must Advocate for What They Need and What Patients Deserve

The current emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 vaccines have been amended by the FDA, the agency announced, to authorize the bivalent formulations of each vaccine “for use as a single booster dose at least 2 months following primary or booster vaccination.”

These bivalent or “updated” boosters, the news release noted, contain 2 mRNA components of the SARS-CoV-2 virus: one, the original SARS-CoV-2 strain, and the other, the common strain in the BA.4 and BA.5 lineages of the omicron variant.

Currently, the BA.4 and BA.5 lineages of the omicron variant are the cause of most cases of COVID-19 in the United States; these lineages are also predicted to be the primary lineages circulating throughout the fall and winter.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” said Peter Marks, MD, PHD, director of the FDA Center for Biologics Evaluation and Research, adding that the agency sought input from outside experts on the inclusion of the omicron component in COVID-19 booster vaccines.

“We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently,” Marks continued. “The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations.”

These updates come after a June meeting of the Vaccines and Related Biological Products Advisory Committee, where a vote was “overwhelmingly” in favor of including an omicron component in booster vaccines. The final decision for each vaccine made by the FDA was based “on the totality of available evidence,” which included extensive safety and effectiveness data of the monovalent vaccines; safety and immunogenicity data from the bivalent COVID-19 vaccine containing mRNA from omicron variant BA.1; and nonclinical data from a bivalent COVID-19 vaccine containing mRNA of the original strain and mRNA in common from the BA.4 and BA.5 omicron lineages.

The agency anticipates that the bivalent vaccine will provide increased protection against the current omicron variant in circulation. Of note, the EUA updates do not authorize monovalent vaccines as booster doses for individuals aged 12 and older.

Currently, individuals aged 18 or older are eligible to receive a single booster dose of the bivalent Moderna COVID-19 vaccine if it has been 2 months since completion of their primary vaccination series or since they received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Individuals aged 12 and older are eligible for a single booster dose of the bivalent Pfizer-BioNTech COVID-19 vaccine if it has been at least 2 months since completion of their primary vaccination series or since they have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as booster dose. News release. FDA. August 31, 2022. Accessed August 31, 2022. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

These bivalent formulations include an mRNA component common to the BA.4 and BA.5 Omicron variant. 

FDA Updates Moderna, Pfizer-BioNTech EUA to Include Use of Bivalent Vaccine as Booster Dose

The Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV237) has received an expansion of the emergency use authorization (EUA) from the FDA, the company announced today. The expanded EUA allows the vaccine to be used as a 2-dose primary series for adolescents aged 12 through 17.

The decision is based on data from the ongoing Phase 3 PREVENT-19 clinical trial (

). In an ongoing pediatric expansion, investigators are evaluating the safety and effectiveness of the Novavax COVID-19 vaccine in 2247 adolescent participants across 75 US sites. According to recent data, “the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI, 37.55%-92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.”

“Having more vaccine options for use in both adults and adolescents…will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season,” said Stanley C. Erick, president and CEO of Novavax.

In addition to effectiveness data, safety data from the pediatric expansion showed the Novavax vaccine to be “generally well-tolerated.” Rates of serious and severe adverse reactions were low, and both local and systemic reactogenicity was “generally lower than or similar to adults after the first and second dose.”

The EUA update follows the initial EUA granted by the FDA in July 2022, which allowed the vaccine to be used as a 2-dose primary series in adults aged 18 and older. This initial EUA was followed by a recommendation from the Advisory Committee on Immunization Practices (ACIP) and endorsement by the CDC.

U.S. FDA grants emergency use authorization for Novavax COVID-19 Vaccine, Adjuvanted for adolescents aged 12 through 17. News release. Novavax. August 19, 2022. Accessed August 22, 2022. 

https://ir.novavax.com/2022-08-19-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-for-Adolescents-Aged-12-Through-17

The vaccine was previously authorized under an EUA for adults aged 18 and older. 

FDA Expands Novavax EUA for Use in Adolescents Aged 12 to 17

Tables 1 and 2 are accurate as of publication by the CDC on July 23, 2022. The COVID-19 vaccination schedules are accurate as of July 21, 2022.

On June 17, 2022, the FDA authorized the Moderna and Pfizer-BioNTech COVID-19 vaccines for use in children 6 months to 5 years of age,

 and many parents and caregivers across the country breathed a sigh of relief. Endorsement by the Advisory Committee on Immunization Practices (ACIP) and the CDC followed,

 and distribution of these vaccines across the United States began immediately.

The authorization of the vaccine for this final group means that COVID-19 immunizations are available for individuals age 6 months and older. This month, 

® is providing an overview of the latest interim guidance, direct from the CDC, on administering these vaccines.

Table 1 - Immunization Schedule for Individuals 18 Years of Age

* Complete the primary series with same product. If the vaccine product previously administered cannot be determined or is no longer available, any age-appropriate mRNA COVID-19 vaccine product may be administered at least 28 days after the first dose. Any COVID-19 vaccine product (age appropriate) may be administered for a booster dose. It does not need to be the same product used for the primary series. An mRNA COVID-19 vaccine is preferred.

† Persons with a recent SARS-CoV-2 infection may consider delaying a primary series or booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic).

‡ Some studies in adolescents and adults have shown the small risk of myocarditis associated with mRNA COVID-19 vaccines might be reduced and peak antibody responses and vaccine effectiveness may be increased with an interval longer than 4 weeks. An 8-week interval may be optimal for people who are not moderately or severely immunocompromised and ages 6 months–64 years, especially for males ages 12–39 years.

§ Age-appropriate mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for all vaccine doses for all vaccine-eligible people 18 years of age and older. Janssen COVID-19 vaccine should only be used in limited situations. See: 

www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

** People ages 18-49 years: Those who received Janssen COVID-19 vaccine as both their primary series dose and booster dose may receive a second booster dose using an mRNA COVID-19 vaccine at least 4 months after the Janssen booster dose.

Table 2 - Immunization Schedule for Children 6 Months Through 17 Years of Age

* Complete the primary series with same product. If the vaccine product previously administered cannot be determined or is no longer available, any age-appropriate mRNA COVID-19 vaccine product may be administered at least 28 days after the first dose. Any COVID-19 vaccine product (age appropriate) may be administered for a booster dose. It does not need to be the same product used for the primary series. 

COVID-19 Vaccination Schedule for Most People

COVID-19 Vaccination Schedule for People Who Are Moderately or Severely Immunocompromised

1. Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age. News release. FDA. June 17, 2022. Accessed July 19, 2022 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

2. CDC recommends COVID-19 vaccines for young children. News release. CDC. June 18, 2022. Accessed July 19, 2022. 

https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html

3. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. CDC. Reviewed June 30, 2022. Accessed July 12, 2022. 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html

The latest guidance for when to administer the COVID-19 vaccine to patients aged 6 months and older.