Scarce Resource (Vaccine and Therapeutic) Centralized Distribution and Tracking Program
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Therapeutics used to treat, and vaccines used to prevent COVID-19 or Monkeypox are considered extremely scarce resources and supply is tightly controlled by government organizations such as the Centers for Disease Control (CDC) and Department of Health and Human Services (HHS).
Due to regulations and supply limitations, these agencies have strict data tracking requirements which must be implemented for continued eligibility to procure and utilize these lifesaving products.
The process ensures efficiency by removing the burden from facilities and VISNs from developing multiple disparate systems, having a single set of data and definitions is helpful to provide consistency in an ever-changing landscape
The success of this process serves as a proof of concept to show how the VA can adapt and provides a model for future endeavors with similar requirements. A program like this can be developed locally, regionally, or nationally to help track future Emergency Use Authorization (EUA) or critical drugs or other clinical products that are in short supply.
Origin:
December 2020, Edward Hines Junior Hospital
Adoptions:
173 successful
Partners:
Pharmacy Benefits Management Services
Recent Updates
Overview
The problem
The COVID-19 pandemic (and now Monkeypox) has created many unprecedented challenges. One such challenge was the need to rapidly develop and deploy a system that tracks and equitably distributes scarce resources used under emergency use authorization (EUA) for the Veterans and employees we serve.
There are over 20 products including drugs and vaccines use ... The COVID-19 pandemic (and now Monkeypox) has created many unprecedented challenges. One such challenge was the need to rapidly develop and deploy a system that tracks and equitably distributes scarce resources used under emergency use authorization (EUA) for the Veterans and employees we serve.
There are over 20 products including drugs and vaccines used under EUA for the treatment or prevention of COVID-19 and Monkeypox. Before the pandemics, an EUA was an extremely rare event. Because an EUA only authorizes products for emergency use and does not constitute an official Food and Drug Administration (FDA) approval, these agents come with stringent requirements that facilities must comply with.
Additionally, these agents are considered extremely scarce resources and supply is tightly controlled by government organizations such as the Centers for Disease Control (CDC) and Department of Health and Human Services (HHS). Due to this scarcity, a method needed to be developed to distribute vaccine and therapeutic product efficiently and equitably across the entire VA health system.
Due to regulations and supply limitations, federal agencies have strict data tracking requirements for continued eligibility to procure and utilize these lifesaving products. These requirements must be met and implemented with consistency across all facilities in the VA, and data accuracy must be ensured in order for the VA to continue to be eligible to receive these products. See more
There are over 20 products including drugs and vaccines use ... The COVID-19 pandemic (and now Monkeypox) has created many unprecedented challenges. One such challenge was the need to rapidly develop and deploy a system that tracks and equitably distributes scarce resources used under emergency use authorization (EUA) for the Veterans and employees we serve.
There are over 20 products including drugs and vaccines used under EUA for the treatment or prevention of COVID-19 and Monkeypox. Before the pandemics, an EUA was an extremely rare event. Because an EUA only authorizes products for emergency use and does not constitute an official Food and Drug Administration (FDA) approval, these agents come with stringent requirements that facilities must comply with.
Additionally, these agents are considered extremely scarce resources and supply is tightly controlled by government organizations such as the Centers for Disease Control (CDC) and Department of Health and Human Services (HHS). Due to this scarcity, a method needed to be developed to distribute vaccine and therapeutic product efficiently and equitably across the entire VA health system.
Due to regulations and supply limitations, federal agencies have strict data tracking requirements for continued eligibility to procure and utilize these lifesaving products. These requirements must be met and implemented with consistency across all facilities in the VA, and data accuracy must be ensured in order for the VA to continue to be eligible to receive these products. See more
Links
- Sample file shows Data Use Agreement from CDC for COVID-19 Data SAMPLE: CDC Data Use Agreement
- Landing page at Food and Drug Administration (FDA) covering products used under Emergency Use Authorization (EUA) FDA EUA Landing Page
The solution
To meet these reporting requirements, VA Pharmacy Benefits Management (PBM) Services developed a centralized process to track and collect necessary data in a timely and accurate manner. This removed the burden from individual sites and equipped leadership to make informed decisions on allocations and overall pandemic planning. Collected data are analyzed and
...
To meet these reporting requirements, VA Pharmacy Benefits Management (PBM) Services developed a centralized process to track and collect necessary data in a timely and accurate manner. This removed the burden from individual sites and equipped leadership to make informed decisions on allocations and overall pandemic planning. Collected data are analyzed and used nationally to ensure fair and equitable distribution across the system.
See
more
Images
Above:
Simplified COVID-19 EUA Therapeutics Workflow
Links
- Internal to VA link, main landing page for all things COVID-19 vaccine related including updates, tracking tools, and dashboards. COVID-19 Vaccine PBM SharePoint Homepage
- Internal to VA link, main landing page for all things COVID-19 therapeutics related including updates, tracking tools, and dashboards. COVID-19 EUA Therapeutics PBM SharePoint Homepage
- Internal to VA link, main landing page for all things Monkeypox Vaccine & Therapeutics related including updates, tracking tools, and dashboards. Monkeypox Vaccine & Therapeutics PBM SharePoint Homepage
The results
Data from this program are summarized and shared as appropriate on a local facility, VISN, and national level to other organizations. Data are also used in retrospective and real-time medication use evaluations (MUEs) to identify safety signals and assess appropriate use. Data are also used by government agencies such as CDC and HHS, as well as VA leadership
...
Data from this program are summarized and shared as appropriate on a local facility, VISN, and national level to other organizations. Data are also used in retrospective and real-time medication use evaluations (MUEs) to identify safety signals and assess appropriate use. Data are also used by government agencies such as CDC and HHS, as well as VA leadership to drive critical decisions for the VA and the rest of the country in pandemic planning.
A system like this has not existed before in the VA and is considered a best practice by CDC and HHS. This program is a proof of concept, and a similar model can be developed at other systems nationally, regionally, or locally to track future EUA therapies or other clinical resources. See more
A system like this has not existed before in the VA and is considered a best practice by CDC and HHS. This program is a proof of concept, and a similar model can be developed at other systems nationally, regionally, or locally to track future EUA therapies or other clinical resources. See more
Metrics
- 535 locations (including VAMCs and CBOCs) registered and tracked data in COVID-19 Vaccine and Therapeutics Trackers
- Over 8.6M doses of COVID-19 vaccine ordered and delivered
- Over 1.5 years of data tracked
- Approx 90,000 doses/courses of COVID-19 Therapeutic EUA products shipped
- Approx 65,000 requests for COVID-19 Therapeutic EUA products entered and adjudicated
- Over 3,600 users registered
Diffusion tracker
Does not include Clinical Resource Hubs (CRH)
Implementation
Timeline
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Preparation: Determine goals and regulatory requirements of implementation
Work with internal and external stakeholders to determine the goals for the project. Determine what products will be tracked and what type of data will need to be tracked.Identify goals are for the project – these can be based on regulatory requirement(s) as well as internal leadership requests. For example can ask certain questions such as: Is it intended to be a workflow to approve requests? Is the goal to only track inventory? Is patient level data needed; if so, what kind? Are there any special requirements that leadership may want to look at?Based on answers to these questions, a determination can be made on the scope and which tools are best to be used to achieve these goals most efficiently. Once tools are determined, staff should make every effort to reach out to experts and seek out additional training.For this project, specifications were largely provided by CDC, HHS, and VACO, which provided the foundation for the tracking application. -
Preparation: Determine scale and scope of project
Based on the information from the previous step, determine the scale of the project and develop a registration tool to create clearly defined locations. On a national or VISN scale a location can be a VAMC, a clinic, or a VISN center. On a local facility scale, a location can be a clinic or a unit.Determine if there are any considerations needed with security. This can be important if your tool contains PHI/PII. This can also be helpful to prevent users from one location from accidently modifying data for the wrong location. -
Preparation: Create a “One-Stop-Shop” page for users
It is important to provide a positive and easy to navigate user experience. Using SharePoint resources, a “one-stop-shop” page can be built to point users in the right direction.This page can provide a lot of valuable information for end users including basic training, how-to/ getting started guides, and quick access to tracking links. This page can also show users the reason/background for why the implementation is needed, relevant internal/external resources, news/peer-reviewed articles, and a summary of all recent announcements/changes to the program. -
Development: Begin development of tool
Using information gathered in the preparation steps above, the tool can now be developed and may include forms, workflows, and notification systems. Based on the goals, requirements, size, and scope of the project, this process can vary in time needed to complete, from 1-2 weeks to 1-2 months. This is also intended to be an iterative process. -
Maintenance: Support users and continually improve to stay relevant and provide a positive user experience
As time goes on, requirements may change, feedback will be given, and new ideas may arise. It is important to stay agile and open to these changes to provide the best possible experience for users.It is important to provide customer support for end-users as questions come up and as new minor or major features are implemented, as such it is important to continually test to ensure a frictionless user experience. -
Reporting: Process collected data based on requirements and report out to customers
As data is collected it is helpful to provide users with the results of their hard work. Data can be transferred to a SQL database for easier analysis. From here, data can be share via multiple methods: exports to internal/external groups, DOEx (in the event that CDW databases are used), and PowerBI reports/dashboards.Reports can be made available at every level (facility, VISN, national) as appropriate to capture a wide audience. -
Quality Assurance: Review data and provide tools for users to have the most accurate data possible
Data accuracy is critical when live data are being used to make real-time decisions, however, mistakes happen. It is important to build a system which continually reviews submitted data for potential internal discrepancies and notifies users that intervention/correction is needed. -
Rinse and Repeat
As new requirements, new technologies, and new limitations come out, this process may need to be repeated.
Departments
- Emergency care
- Pharmacy
- Logistics
- Critical care
- Administration
- Purchasing and supplies
- Central supply
- Infectious disease
- Information management
Core Resources
| Resource type | Resource description |
|---|---|
PEOPLE |
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PROCESSES |
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TOOLS |
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Optional Resources
| Resource type | Resource description |
|---|---|
PEOPLE |
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PROCESSES |
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TOOLS |
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Links
- This link is to the VA SharePoint Community of Practice Teams home page which has a wealth of knowledge to help both beginner and advanced users work with PowerPlatform tools and SharePoint. Highly recommended to join and participate in weekly office hours calls, the community includes VA subject matter experts and key personnel from Microsoft and is very active and helpful. [Internal to VA] SharePoint Community of Practice Page
- This link is to the VA Microsoft Power Platform CoE home page which provides a tremendous amount of useful information for those starting out with Microsoft Power Platform at VA. There are a lot of resources including office hours, training calls, recordings, code samples, and many other guides that are helpful for beginners and experts. Additionally, this page contains information for those wishing to move forward with a premium solution. The Power Platform CoE has staff that will review specific use-cases to determine if premium licensing is necessary and will help to navigate the complexities of licensing. Participation with this group is highly encouraged, especially for more complex projects. This community includes VA subject matter experts and key personnel from Microsoft. [Internal to VA] VA Microsoft Power Platform CoE
Risks and mitigations
| Risk | Mitigation |
|---|---|
| Data quality issues due to user-reported data | Real-time Quality Assurance (QA) processes can be developed to continually review and correct data. Processes can be automated (e.g data discrepancy checks that would email stakeholders) or policy based/periodic manual touch points |
| Downtime planning | Typically free cloud resources (SharePoint, PowerPlatform, etc) are not rated for 100% uptime. If there is the potential for delays in care or if process has low tolerance for downtime, a back up system or process should be developed as a contingency |
| PHI/PII security |
If PHI/PII is being stored, there are several considerations: - Ensure your system does not violate any VA policy regarding the system of record - Ensure your system follows all protocols when storing PHI/PII in SharePoint to avoid potentially inappropriate exposure (e.g row-level security) |
About
Origin story
The COVID-19 pandemic created many unprecedented challenges (as well as new opportunities to serve our Veterans).
The main challenge we faced was the need to rapidly develop and deploy a system that tracks and equitably distributes scarce resources used under emergency use authorization (EUA) for the Veterans and employees we serve. Rising to the challen
...
The COVID-19 pandemic created many unprecedented challenges (as well as new opportunities to serve our Veterans).
The main challenge we faced was the need to rapidly develop and deploy a system that tracks and equitably distributes scarce resources used under emergency use authorization (EUA) for the Veterans and employees we serve. Rising to the challenge was a must in order to ensure that VA can receive COVID-19 vaccine and therapeutic agents (and eventually Monkeypox products).
PBM was responsible for centrally ordering, distributing, and tracking COVID-19 Vaccine, Therapeutics, and eventually Monkeypox product for the entire VA with a very small FTEE (fewer than 5). Based on this necessity, the tool was born to automate and validate as much as possible to ensure efficient, fair, and equitable distribution.
Original team
Jennifer Martin, PharmD
Deputy Chief Consultant for Pharmacy Benefits Management Services
Fran Cunningham, PharmD
Director, VA Center for Medication Safety
Ashir Shumunov, PharmD
Clinical Informatics and Quality Assurance Pharmacist
Alexis Barrett, PharmD
Research Health Science Pharmacist
Terry Smith, PharmD
Informatics Pharmacist
Comment
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