VaccineXpress: Installment 1
Anya Aggarwal, Johns Hopkins University
Vaccines are one of the great population Health tools developed to prevent a number of diseases. The diseases that vaccines can prevent range from measles, mumps, polio, flu, hepatitis, to certain types of cancer. While vaccines are great population health management tools, the management and administration of vaccines can be a challenge for manufacturers, providers, health systems and the government.
When people hear the word “vaccines” they normally think of huge, painful needles that look like something out of their nightmares. To a patient, the nurses or doctors bring the dreaded needle into the room seemingly out of nowhere, already prepped and ready to be administered. But actually, the process of getting the vaccine from creation to a patient is quite intricate and meticulous.
The VaccineXpress articles will be released as a series explaining the process by which the CDC manages distribution of vaccines by interacting with vaccine providers and a whole chain of other key players in the healthcare industry. This first installment will provide a foundation by discussing the basic structure of the vaccine database and explaining key components of vaccine labeling.
Some History on Vaccine Inventory Management by the CDC:
The so-called “life cycle” of a vaccine includes very important but often unrecognized processes: data management and regulation. Much like the way a grocery store logs inventory of its produce, or a shipping warehouse does of its products, the CDC (Center for Disease Control and Prevention) and vaccine manufacturers work together to maintain a detailed log of every vaccine created and administered. It is important to note that the CDC manages public vaccines that are provided at no cost to patients who are part of the Vaccines for Children (VFC) program, or who do not have insurance and receive vaccines through public health programs. Other private vaccines are purchased by health systems, providers, and pharmacies, administered to patients, and are then billed to the patient or their insurance company by the owning entity.
In the 90’s, the technological infrastructure that managed and distributed vaccines was made of multiple stand-alone systems that made regulation and response to public health crises relatively difficult. Today, a more sophisticated central system for managing and distributing vaccines exists. The system, referred to as VTrcks (Vaccine Tracking System), encompasses a database of information about the publicly-funded vaccine supply chain allowing maintenance and regulation of purchasing, ordering and distribution. VTrcks creates a detailed timeline of actions by state, local, and territorial health departments (called “awardees”) and health care providers, regarding vaccines. VTrcks’s capabilities prove effective in managing and distributing vaccines as it streamlines vaccine order tracking, improves inventory transparency, provides public funding and dosage accountability, and works to increase public safety responses. One of the system’s functionalities that makes it so efficient is its consolidation of and user-friendly approach to vaccine orders. It allows health care providers to order online, and these orders are then evaluated against guidelines set by the CDC and awardees. By ordering online through an external information system (ExIS), there is more transparency regarding how public funding is spent, and the health care providers benefit from decreased administrative costs. The integrated VTrcks system also benefits awardees and vaccine providers by reducing their need for manual data entry. For example, instead of logging vaccine orders by hand, awardees can quickly export orders through ExIS to VTrcks, thereby saving administrative costs and communicating higher inventory and shipping status visibility to the CDC’s centralized distributor. Both the awardees and health care providers benefit from the optimized system’s reduction of administrative efforts, incentivizing them to use the system, while improving the CDC’s ability to regulate the creation and distribution of vaccines through increased transparency. Future articles will provide a more in-depth view into the specifics of how data is updated and communicated to the database.
Components within the CDC Vaccine Databases:
When there are multiple players and numerous pieces of data like in the VTrcks system, it is important that the process of reporting and recognizing the vaccine data is normalized. In this way, the system, the awardees, and the healthcare providers can all communicate information about vaccines in the same “language”. The CDC has set guidelines regarding specific codes that each vaccine must have to universalize the way each and every vaccine is processed. These “tags” include the vaccine name, NDC number, CVX code, CPT code, and VIS sheet.
The vaccine name is quite self-explanatory as it ensures that each player knows exactly which vaccine is being referred to in creation, orders, administration, and immunization records. It provides an easy identifier that can be used in basic communication about the vaccine without requiring memorization of numerical codes. It is also helpful in indicating which disease the vaccine is meant to be administered for. (Example: Meningococcal – Meningitis B)
The National Drug Code, or NDC number, is a three-part unique numerical product identifier for drugs. Since 2017, there are both UoS (Unit of Sale) and UoU (Unit of Use) NDC numbers, some of which may not be the same as their counterpart. In order to keep track of the vaccines, immunization providers are required to record administered vaccines using either the UoS or the UoU NDC number depending on the established clinical workflow. Certain providers may choose to use technology that scans and captures the NDC number from 2D barcodes on the vials or syringes (ex. VaccineXpress technology). This information is normally transmitted through an EMR system in the 5-3-2 format. The first section is a labeler code assigned by the FDA that denotes which firm manufactured or distributed the vaccine. The second section is the product code which relays a specific strength, dosage form, and formula. The third section is the package code that identifies package size assigned by the immunization firm. (Example: Infanrix vaccine – a package of 10 single-dose vials : 58160 -810 -11).
CVX codes are numerical strings that indicate the type of product used and identifies which vaccine was administered. CVX codes are standardized and are the same for a given product regardless of the recipient. The codes are assigned based on the product’s formulation, concentration, manufacturing process, and route of administration. When combined with the MVX code ( alphabetic code that identifies vaccine manufacturer), it indicates the vaccine’s “trade name”. (Example: 43 MSD = Hepatitis B, adult formulation by Merck).
Current Procedural Terminology, or CPT codes, are produced by the American Medical Association and are used to report medical procedures and services. The CDC provides a table that cross-references CPT codes to corresponding CVX codes to support efficient communication of immunization data. (Example: CPT – 90476 + CVX – 54 = Adenovirus type 4, live, for oral use).
VIS sheets (Vaccine Information Statements) are documents procured by the CDC that inform vaccine recipients, their parents, or their legal representatives, of the possible benefits and risks of the vaccine they are receiving. It is required by the National Vaccine Childhood Injury Act that all vaccine providers give patients the appropriate VIS prior to vaccine administration and prior to each dose in a multi-dose series, regardless of the recipient’s age. VISs try to offer the most current information about vaccines and are sometimes updated and newly released. According to the CDC, the latest change was released on October 12, 2018 noting a minor update to the Hepatitis B VIS indicating a 2-dose series is now available.
The CDC databases are a central framework for details related to vaccines provided from each Vaccine Manufacturer. These details include vaccine manufacturer name, vaccine name, dose, lot number, expiration date and current date of VIS sheet for each vaccine. Health Information technology firms should leverage this information to enhance the management of vaccines in the supply chain. Ideally, the vaccine inventory tools should provide the capabilities for Healthcare providers to record the detail vaccine information administered to a patient into a patient vaccine record with minimal manual data entry.