Friday, March 4, 2021

ASSOCIATION NEWS

The Texas Pharmacy Association and Independent Pharmacy Academy Boards of Directors met Thursday to discuss the latest developments related to pharmacy’s legislative priorities for the current Texas legislative session. TPA Chief Executive Officer Debbie Garza and Duane Galligher, one of TPA’s lobbyists, provided updates about the Association’s priorities of meaningful PBM reform, allowing pharmacists to “test and treat” based on positive results from CLIA-waived point-of-care tests, and maintaining the expanded immunization authority granted to pharmacists during the pandemic. The group also discussed other bills TPA is watching regarding issues such as physician dispensing, which could affect the pharmacy profession. TPA's expert lobby team continues to meet weekly to discuss strategy and to track our advocacy efforts.

DSHS Commissioner John Hellerstedt on Wednesday announced immediate prioritization inclusion of those who work in school and child care operations. DSHS received a letter from the U.S. Department of Health and Human Services directing states to expand vaccine eligibility to include “those who work in pre-primary, primary, and secondary schools, as well as Head Start and Early Head Start programs (including teachers, staff, and bus drivers) and those who work as or for licensed child care providers, including center-based and family care providers.” In light of this federal directive, all vaccine providers in Texas should immediately include these personnel in vaccination administration and outreach to ensure they are able to be immunized. This action does not change the other groups prioritized for vaccination in Texas.

Texas can expect nearly 1 million doses next week with the addition of approximately 200,000 doses of the Johnson & Johnson vaccine and the federal FEMA sites, the federal FQHC program, and the Federal Retail Pharmacy Program. The state has prioritized the additional pharmacies to be added to the Federal Retail Pharmacy Program as directed by the CDC. Walgreens is the next federal retail pharmacy partner to be added. Texas will add additional pharmacies, as follows, as additional vaccine becomes available in the federal program: Med Shoppe/Cardinal, Kroger, Albertsons, CPESN, Health Mart, Topco, Costco, and Premier/Innovatix. With more vaccine coming to Texas for state allocations, pharmacies should be sure to keep placing orders in VAOS. There will be a lull in Johnson & Johnson/Janssen vaccine after next week, with more supply toward the end of March.

The FDA has published the following information about the Johnson & Johnson/Janssen vaccine. All Janssen vaccine recipients should receive the Janssen Fact Sheet for Vaccine Recipients and Caregivers.

• Janssen EUA Fact Sheet for Vaccination Providers
• Janssen EUA Fact Sheet for Vaccine Recipients and Caregivers
• Janssen COVID-19 Vaccine Frequently Asked Questions

Providers should store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if vaccine is not used within these times.

The FDA announced last week that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. The FDA published an updated Fact Sheet for Health Care Providers Administering Vaccine (Vaccination Providers) to help front line workers understand the new alternative transportation and storage temperatures.

As a reminder, pharmacists must report adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). Pharmacists are also required to provide all vaccine recipients information about CDC’s v-safe program.

The Texas Pharmacy Association hosted the virtual quarterly meeting of the Texas Pharmacy Congress (TPC) on Friday, February 26. President Michelle Beall, President-Elect Michael Muñiz, and CEO Debbie Garza attended the gathering of leaders from Texas pharmacy schools along with TPA, the Texas Society of Health-System Pharmacists (TSHP), the Texas Federation of Drug Stores (TFDS), and the Texas State Board of Pharmacy (TSBP). Garza began the meeting with an update on pharmacy’s legislative initiatives for the 87th legislative session, with both TSHP and TFDS discussing their priorities as well. The TPC then discussed vaccination efforts by Texas pharmacy schools and student pharmacist vaccination efforts, as well as the role pharmacists are playing across the state, being adaptive to the needs of their communities. Schools reported that despite difficulties with the pandemic and recent weather, pharmacy students across Texas have been involved, engaged with other healthcare professionals, and have become "a living model of team-based care." Reports from member organizations are available online.

The goal of the meeting was to have a better understanding of how the state looks at network adequacy for providers, as we have heard that members who have tried to enroll as a provider in health plan medical benefits are being told there are already enough providers. The discussion also included TDI standards requirements of plans for credentialing providers.

Texas Pharmacy Association CEO Debbie Garza participated Thursday in Health Tech Austin’s online Women’s Health Summit. Garza spoke as part of a panel alongside Dr. James Anderson, a pediatrician with Austin Regional Clinic, about how pharmacy is playing a role in women’s health. “Particularly in light of this current pandemic, pharmacists more than ever are recognized as essential providers,” Garza said. “People are used to utilizing their pharmacist and going to their pharmacies for other services, like vaccinations and point-of-care tests, than what typically you would think of, just picking up a prescription.” Anderson and Garza both discussed the importance and accessibility of pharmacy to women, who are often a family’s primary health care decision-makers. Garza also addressed pharmacy technology trends, from automation to e-prescribing and sharing clinical data through electronic medical records.

STATE NEWS

The Texas Department of State Health Services notified all vaccine providers on Wednesday that they should immediately include school and child care workers in vaccine administration. DSHS received a letter from the U.S. Department of Health and Human Services directing states to expand eligibility to include those groups. This action does not change the other groups prioritized for vaccination in Texas.

Texas Department of State Health Services (March 3, 2021)

Governor Greg Abbott on Tuesday issued an Executive Order (GA-34) lifting the mask mandate in Texas and increasing capacity of all businesses and facilities in the state to 100 percent. Abbott noted that "nearly 5.7 million vaccine shots have been administered to Texans, and the state is now administering almost one million shots each week."

Office of the Texas Governor (March 2, 2021) Abbott, Greg

Houston is the nation’s first city to record every major variant of the novel coronavirus — many of which are more contagious than the original strain. “The numbers of the major variants we have identified in our large sequencing study are disquieting,” said Dr. James Musser, who leads the team of experts at Houston Methodist Hospital behind the new finding.

Houston Chronicle (March 1, 2021) Downen. Robert and Garcia, Julie

NATIONAL NEWS

On Saturday, the FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

U.S. Food and Drug Administration (February 27, 2021)

The CDC’s Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for use of the Janssen COVID-19 vaccine that recently received emergency use authorization. The information comes following a transparent evidence-based review of all available data.

Centers for Disease Control and Prevention (March 2, 2021)

President Biden announced Tuesday that his Administration has helped forge a historic manufacturing collaboration between Merck and Johnson & Johnson (J&J) to expand production of J&J’s COVID-19 vaccine. The collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks.

U.S. Department of Health and Human Services (March 2, 2021)

Dr. Anthony Fauci, the top U.S. infectious disease official, said on Sunday he was encouraging Americans to accept any of the three available COVID-19 vaccines, including the newly approved Johnson & Johnson shot. “All three of them are really quite good, and people should take the one that’s most available to them,” Fauci said.

Reuters (February 28, 2021) Sullivan, Andy

The Biden administration is planning to provide states with estimates of their expected vaccine shipments likely months ahead of time rather than weeks. The longer planning window could address concerns from governors who had complained that limited shipment forecasts affect their ability to plan vaccination clinics and figure out where to steer doses.

Politico (February 25, 2021) Roubein, Rachel

CMS has issued guidance on coverage and reimbursement for COVID-19 diagnostic testing and vaccines. The guidance states that the CARES Act requires plans and issuers to reimburse any provider acting within the scope of their license or authorization for COVID-19 diagnostic testing an amount that equals the negotiated rate, or if the plan or issuer does not have a negotiated rate, the cash rate for the service.

Centers for Medicare and Medicaid Services (February 26, 2021)

CMS published a variety of guidance on COVID-19 vaccines, including FAQs on Medicare fee-for-service billing to administer vaccines, vaccine resources for hard-to-reach patients, and more. During the pandemic, Medicare will cover and pay for the administration of the Janssen vaccine (when furnished consistent with the EUA).

Centers for Medicare and Medicaid Services (March 4, 2021)

USP has updated its toolkit that provides critical information to pharmacists and others involved in handling COVID-19 vaccines. The toolkit includes operational strategies in preparation and labeling; storage, handling, and transport; and waste and disposal.

United States Pharmacopeia (February 2021)

In hearings on the nomination of California Attorney General Xavier Becerra to be Secretary of Health and Human Services, two freshman senators asked Becerra about the role of PBMs and how he would handle their impact on pharmacies and patients. Becerra alluded to the role he played in supporting Rutledge v. PCMA, which gives states more ability to reign in PBM practices, but also noted a need for federal oversight and reform of PBMs.

U.S. Senate Committee on Health, Education, Labor and Pensions (February 23, 2021)

On Feb. 25, NCPA and other compounding pharmacy stakeholders filed an amicus curiae brief in the Wellness Pharmacy, Inc. v. Cochran case. At the center of the litigation is the Oct. 26, 2020, memo of understanding between the FDA and approving states which would govern distribution requirements for compounding pharmacies preparing drugs for interstate patients.

National Community Pharmacists Association (February 26, 2021)

TRENDING NEWS

Significant areas of the country lack brick-and-mortar pharmacies capable of administering COVID-19 vaccines. From 2003 to 2018, 1,231 independent rural pharmacies closed, leaving some 630 rural communities with no retail drugstore. Changing economics in the pharmacy industry did them in, including pharmacy benefit managers eating into small-pharmacy profits.

Kaiser Health News (March 3, 2021) Hawryluk, Markian

A large majority of American adults, 85 percent, prefer to get their prescription drugs from a local pharmacist instead of a mail order service, mainly because of the personal relationship. They say their pharmacist answers questions and provides counsel on how to use the drugs, and some worry their drugs will get lost in the mail, exposed to the elements, or stolen.

National Community Pharmacists Association (March 4, 2021)

Community pharmacies, they argued, can play a critical role in delivering COVID-19 shots, so they're frustrated that they aren’t receiving as many vaccines proportionally as major chains get from the federal, state and local governments. They said their personal relationships with their customers are crucial to a successful vaccine rollout.

USA Today (March 1, 2021) Bomey, Nathan

Many people are wondering which COVID-19 vaccine they should get: Is one better for certain groups of people? Will people have a choice? If so, which vaccine should they choose? All three vaccines have very favorable safety profiles. The trial results should not be compared directly, because the trials were not done as head-to-head comparisons.

CNN (March 2, 2021) Hetter, Katia

More than two-thirds of the 328 pharmacists surveyed by CoverMyMeds said they have taken on new job responsibilities since the COVID-19 pandemic began. The top new responsibilities were patient follow-up calls for refills and adherence, a prescription home delivery program and finding ways to help patients save money. One-third of pharmacists also said they began COVID-19 testing at their pharmacy.

Becker’s Hospital Review (February 16, 2021) Anderson, Maia

The COVID-19 pandemic not only introduced rapid-fire changes to care delivery, but it also exposed the health care system’s weak links. Frontline pharmacy staff and leaders were forced to navigate new medication and supply shortages as well as rapidly adapt. New technology and interdisciplinary teams can ensure compliance and medication safety.

Drug Topics (February 26, 2021) Lambert, Annie

Patients who used statins prior to COVID-19 hospitalization were almost 50% less likely to experience 30-day in-hospital mortality compared with those that didn't, according to a retrospective study. Statins are drugs meant to reduce blood fat for conditions such as high cholesterol, and, as such, they have anti-inflammatory and anti-clotting properties.

Nature Communications (February 26, 2021) Gupta, Aakriti, et al

The drug industry is warning of shortages and delays if the FDA does not work quickly to clear a backlog of pharmaceutical plant inspections. The FDA has completed significantly fewer than average drug and biologic product facility inspections since last March, and is considering using video and other methods for virtual inspections.

Politico (March 2, 2021) Smalley, Suzanne

As an increasing number of COVID-19 vaccine vials are shipped in coming weeks, the concern about shortages may well shift to human capital: the vaccinators themselves. With the recent expanded liability protections, those qualifying include pharmacy interns and recently retired doctors and nurses, as well as physicians, nurses and pharmacists.

Kaiser Health News (February 23, 2021) Appleby, Julie

Demographics play a significant role in who is staying current with health care during the pandemic and who is letting things slide. Lower income Americans appear to be doing a better job of looking after themselves than higher-earners. Still, a survey shows 78% of respondents reporting that they have put off at least some medical services during the past three months of pandemic, and 27% missed annual physical check-ups.

Time (February 23, 2021) Kluger, Jeffrey

Texas Pharmacy Today
Editor: Brian Sparks, Division Director, Communications and Marketing
(512) 615-9140 • bsparks@texaspharmacy.org

Texas Pharmacy Association
Debbie Garza, R.Ph., Chief Executive Officer
(512) 615-9170