October 22, 2020

October 22, 2020

COVID-19 Vaccine Rollout Planning with Pharmacy Partners: Phase 1 – Ruth Link-Gelles (CDC) and Phase 2 – Angela Guao (CDC)

Ruth began the presentation with an overview of CDC’s long-term care facility (LTCF) planning, followed by Angela who reviewed general pharmacy planning.

CDC’s strategy is based on certain key planning facts and assumptions. Specifically, the plan assumes two doses of vaccine (separated by >21 or >28 days) will be needed for immunity, both doses will need to be the same product, and tracking/patient reminders will be needed. In addition, cold chain requirements will range from 2–8oC to -20oC (frozen) to -80oC (ultra-cold), depending on the vaccine. Surveys have shown that LTCFs do not have frozen cold storage capacity. Finally, it is understood that reconstitution requirements vary by vaccine, resulting in different training needs.

During Phase 1, vaccine dose availability is expected to be limited and will be targeted to specific populations. Vaccine supply should increase relatively quickly, allowing broader vaccination. Phase 1 vaccination will be broken into Phase 1-A (for healthcare personnel [HCP], including LTCF staff), and Phase 1-B, for other essential workers and people at higher risk, including LTCF residents.

During Phase 1A, pharmacy partners will receive vaccine only to support LTCF vaccination efforts. CDC is partnering with CVS and Walgreens to provide vaccination services to residents. Jurisdictions can reach out to pharmacy partners that provide specific services needed for Phase 1 efforts. LTCFs can choose between on-site vaccination provided by CVS/Walgreens via direct federal allocations of vaccine or through facility/provider-administered vaccine from the state allocation. Sign-up is currently ongoing through the end of October. (In response to a question, Ruth noted that, due to immunization program variations, it is difficult for CDC to determine if a LTCF will receive vaccine later if they choose to work with the jurisdiction rather than the CVS/Walgreens approach.) Skilled nursing facilities that report via CDC’s National Healthcare Safety Network (NHSN) will see an alert about this signup within their NHSN reporting. Assisted Living Facilities can use their REDCap program. During November, CVS/Walgreens will coordinate directly with facilities for scheduling. Jurisdictions will receive information about which LTCFs have signed up/received/declined services from CVS/Walgreens, as well as those who signed up but can’t be served by these pharmacies due to issues such as being “too rural.”

Angela continued the presentation with a discussion of pharmacy partnerships in Phase 2, when the vaccine supply should be sufficient to meet demand. At this point, the goal shifts to increasing access. During this period, pharmacy partners offer convenience and ease access, helping to increase coverage. Importantly, more than 86% of people in the U.S. live within a 5-mile radius of a pharmacy, and pharmacies typically offer increased hours for all persons, including high risk populations, to receive vaccination services. Pharmacies have been longstanding immunization partners, including during H1N1 vaccination in 2009. CDC recognizes they will need to make decisions about when to shift from Phase 1 to Phase 2, as well provide guidance on how to recognize prioritized groups for vaccination. Pharmacy scope of practice laws, which vary across states, also must be taken into consideration. In addition, CDC must work with both retail pharmacy chains and independent/community pharmacies.

Pharmacy partners selected to receive federal direct allocation of COVID vaccine are those which have a single entity legally able to sign provider agreements on behalf of all stores, a single point of ordering, and which can be responsible for proper vaccine storage and reporting. Partners that cannot meet these requirements are encouraged to work directly with their jurisdictions to obtain vaccine. For pharmacies receiving direct federal allocation, most vaccine will be distributed directly to individual stores. Some partners may prefer to have an intervening warehouse/wholesaler, but vaccine handling and costs associated with this decision would be the responsibility of the partner.

CDC will share lists of pharmacy partners with jurisdictions, as well as the number of doses distributed/administered at each location. Pharmacy partners must report to state immunization information systems (IIS) whenever the system is capable of receiving this information.

CDC has established email boxes for questions on the long-term care pharmacy strategy and other pharmacy partnership questions.

One Summit partner asked how vaccine going to LTCFs will affect state allocations, and whether adjustments will be made for highly rural states that don’t have access to services from CVS/Walgreens. Ruth responded that this is still being determined and may be affected by the type of vaccines available, as well as the number of LTCFs that sign up.

An additional question was asked about whether veterans could use this LTCF option or receive services through the Veterans Administration (VA) or state programs. Ruth noted that this also is being finalized.

Update on CDC Vaccine Tracking Plan – LaTreace Harris (CDC)

LaTreace provided an overview of how various data elements were chosen for reporting of COVID-19 vaccination. In addition to typical reporting of vaccinations, CDC also recognizes the importance of prioritizing populations, particularly in the early stages of the vaccine campaign, and monitoring vaccine distribution. With this foundation, it also is critical to monitor/track/report vaccine supply, determine vaccine uptake, use, and coverage (including key data points such as geography, demographics, comorbidities, and high risk populations), and continually monitor/report on possible vaccine adverse events and vaccine effectiveness. It also will be important to be able to track COVID-19 vaccine second dose uptake. LaTreace emphasized that the focus of her presentation was on the information that an IIS should communicate to participating providers.

Not all IIS have the capability to provide all information needed for robust COVID-19 vaccine tracking. For example, not all systems report in real-time, and some systems have incomplete data due to state policy limitations and consent requirements. In addition, cross-jurisdictional data sharing is difficult, and some systems do not include robust mass vaccination capability. Most importantly, a national snapshot cannot be generated. With this in mind, the vaccine administration data requirements were based on the need for near-real-time, national data about the individuals and groups receiving COVID-19 vaccine. In addition, data consistency from multiple platforms is needed.

Based on this analysis, CDC coordinated with stakeholders to develop required vs optional data reporting elements. Required elements for all providers (whether or not reporting through the IIS) include recipient demographics and vaccine administration data, such as what is routinely collected from any vaccination. Optional data elements include comorbidity status, serology results, and patient information on missing an appointment or refusing vaccination.  Although it would be helpful for deduplication, CDC recognizes that some jurisdictions and providers will be unable/unwilling to report identifiable data. In addition, the “required” race/ethnicity data element will include an option for choosing that this information was not collected.

Finally, LaTreace noted that data will be submitted to CDC through the Immunization Data Clearinghouse. Some organizations not currently connected to an IIS (e.g., federal entities such as DOD, VA, and IHS) will also be asked to report to the Clearinghouse. All entities will report daily (within 24 hours.)

One Summit partner asked if CDC is concerned about the possible impact if some people choose not to be vaccinated if they are aware identifiable information is being collected. LaTreace agreed that this is a potential point of concern.

In response to a final question, LaTreace pointed out that vaccine inventory reporting will primarily occur via VaccineFinder, as is required in the current vaccine provider agreement. In addition, vaccine ordering data will be available through VTrckS. LaTreace acknowledged that nearly all IIS already manage their vaccine ordering and inventory with VTrckS through the VTrckS EXIS integrated interface. She suggested that additional questions in this area might best be answered by CDC’s Jeanne Santoli.

Announcements – L.J Tan (IAC)

Summit calls are held each Thursday at 3 pm ET, unless cancelled. The call scheduled for next Thursday, October 29, is cancelled because it conflicts with the ACIP meeting. The next Summit call, scheduled for November 5, will include highlights of the ACIP and VRBPAC meetings. Summit partners wishing to provide announcements on upcoming calls should contact L.J Tan or Joanna Hill to be added to the agenda.

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