Supporting Access to Critical Medical Countermeasures

Published:

The Joint Product Manager for CBRN Medical National Stock Number Sponsorship

By Ms. Melissa Myers, JPM CBRN Medical Strategic Communications, USA

As recent pandemics have shown, a significant health threat can appear at any moment. The outbreak of COVID-19 in 2019 highlighted just how important procurement processes and infrastructure are to a nation’s ability to effectively respond to and combat a public health emergency. Given the vastness of the U.S. federal government – comprised of hundreds of different agencies, departments, and units – organization is key to streamlining and standardizing procurement processes. Without standardizing how the U.S. government obtains lifesaving supplies, medicines, and devices, delays in response could cost lives. This is where National Stock Numbers (NSNs) come into play.

The importance of NSNs

Similar to having a unique 10-digit cell phone number, NSNs are unique 13-digit codes for items the Defense Department (DoD), and other federal agencies, repeatedly use, buy, stock, and distribute. NSNs centralize essential information on all items managed within the DoD and are a crucial component of the federal procurement and national logistics supply chain, streamlining the procurement process and logistics for government agencies all around the world, and making it easier for those agencies to get the items they need in a timely manner.

Since the beginning of the current global pandemic, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) has played a critical role in facilitating the assignment of NSNs to relevant medical countermeasures (MCMs), resulting in increased access to protective medicines for our nation’s service members. The JPM CBRN Medical’s focus has been to identify products with supporting data from the COVID response or other approved products, which demonstrate how the product can be used as a MCM against CBRN threats.

Of the 28 JPM CBRN Medical-sponsored NSNs assigned in recent years, 14 were for items specifically targeting COVID-19, and valuable during the global pandemic:

· Remdesivir (NSN 6505-01-688-2270)

· Seracare Life Sciences SARS-CoV-2 Reference (ECM) Material Kit (NSN 6550-01-687-8878)

· BioFire Defense Coronavirus Test Kit (NSN 6550-01-687-2996)

· BioFire Defense Coronavirus Detection Kit (NSN 6550-01-687-3020)

· BioFire Defense Coronavirus Test ECM Kit (NSN 6550-01-687-8878)

· Abbott Laboratories Coronavirus Test Kit (NSN 6550-01-687-8122)

· Cepheid Coronavirus Test Kit (NSN 6550-01-688-2739)

· OLUMIANT® (baricitinib) (NSN 6505-01-688-4626)

· HUMIRA® (adalimumab) (NSN 6505-01-691-4533)

· Young Innovations Nasopharyngeal Swab (NSN 6515-01-691-2298)

· Pfizer COVID vaccine (tozinameran) (NSN 6505-01-692-4172)

· Moderna COVID vaccine (mRNA-1273) (NSN 6505-01-692-5287)

· TAVALISSE® (fostamatinib) (NSN 6505-01-692-3286)

· Accuviral Nasopharyngeal Sample Collection Kit (NSN 6550-01-691-2786)

The reality is, it takes a lot of supplies, and many types of equipment, to fight a global pandemic. For the DoD and other government partners, the Defense Logistics Agency Troop Support (DLA TS) provides this type of materiel by delivering supply chain solutions in support of national defense, humanitarian assistance, and disaster relief. For medical materiel and pharmaceuticals, DLA TS works with the U.S. Army Medical Materiel Agency (USAMMA) and the Defense Health Agency (DHA) Medical Logistics (MED LOG). JPM CBRN Medical is a contributor to this team, identifying and sponsoring specific MCMs, and every member of this team is integral and assists in accomplishing the mission. The DoD global supply chain would not be optimal without the synergy among all of these team members. Specific to the pandemic, by sponsoring these NSN items, JPM CBRN Medical members of this global team facilitate the ordering of materials to continue battling this virus.

As an example, on May 1, 2020, the U.S. Food and Drug Administration (FDA) authorized remdesivir under an emergency use authorization (EUA) for the treatment of COVID-19. JPM CBRN Medical sponsored the NSN for remdesivir, and worked with the DHA MED LOG and the USAMMA to champion the product and provide essential elements of information to the DLA TS. On May 8, 2020, the DLA TS assigned the NSN, and this product entered the global U.S. government database: Federal Logistics Information System (FLIS). At that point in time, government organizations all over the world had the information necessary to facilitate ordering this treatment and battle COVID.

On October 22, 2020, the FDA approved remdesivir for the treatment of COVID-19, the first treatment for COVID-19 to receive FDA approval. As of the writing of this article, it continues to be one of the two FDA-approved treatments for COVID-19. The only other approved treatment is Olumiant® (baricitinib), which happens to be another product sponsored by the JPM CBRN Medical. There are EUAs for several other COVID-19 treatments, and the JPM CBRN Medical monitors their clinical activity closely. Without NSNs and the FLIS, our DoD customers would not have essential information in a standardized format to assist them in ordering medical treatments.

The JPM CBRN Medical’s core program efforts are dedicated to the development and acquisition of safe, effective, and innovative medical solutions to combat chemical, biological, radiological, and nuclear (CBRN) threats. While supporting the U.S. whole-of-government response to the COVID-19 crisis, the JPM CBRN Medical team has concurrently continued to deliver traditional CBRN MCMs to the warfighter. Since the onset of the pandemic, the JPM CBRN Medical has also sponsored 14 NSNs unrelated to COVID-19:

· TPOXX® (tecovirimat) (NSN 6505-01-684-9538)

· JYNNEOS (smallpox vaccine) (NSN 6505-01-684-4091)

· TEMBEXA® (brincidofovir) (NSN 6505-01-696-1752)

· INMAZEB® (Ebola treatment) (NSN 6505-01-693-8769)

· ERVEBO® (Ebola vaccine) (NSN 6505-01-694-6755)

· FIRDAPSE® (amifampridine) (NSN 6505-01-693-4057),

· Heptavalent Botulism Anti-Toxin (HBAT) (NSN 6505-01-684-9483)

· Ruzurgi (botulinum neurotoxin treatment) (NSN 6505-01-686-6357)

· EVZIO (naloxone autoinjector) (NSN 6505-01-684-9014)

· Bag Valve Mask with Filter (BVM-F) (6515-01-690-7226)

· Omadacycline (anthrax treatment) (6505-01-685-8977/8964/8990/9011)

· Raxibacumab (anthrax treatment) (NSN 6505-01-686-9526)

· Ribavirin (Crimean Congo Hemorrhagic Fever treatment) (NSN 6505-01-686-2538)

· XOFLUZA® (baloxavir marboxil) (NSN 6505-01-693-3211)

Smallpox, Ebola, and botulism, to name a few, may not be on the average U.S. citizen’s list of pressing concerns, but they are still diseases of interest from a world-view threat perspective.

For instance, smallpox, a serious infectious disease caused by the variola virus, was successfully eradicated in the 20th century; however, the naturally-occurring variola virus still has the potential to be used in an intentional, biological attack. Many seemingly “harmless” biological agents that exist in the world today have the very real potential of being weaponized by adversaries, and the JPM CBRN Medical team is dedicated to preparedness. Even a single, confirmed case of smallpox today would be considered a major public health emergency, and currently, there are only two antiviral drugs approved by the FDA to treat smallpox – tecovirimat (TPOXX®) and brincidofovir (TEMBEXA) – as well as one vaccine (JYNNEOS), all of which the NSN’s were sponsored by the JPM CBRN Medical.

The Ebola virus is another virus many Americans may be familiar with, thanks to blockbuster movie representations like “Outbreak,” which touts an exceptionally high 70-90 percent mortality rate. Despite the risk of contracting Ebola in the U.S. being relatively low, an outbreak has the potential to be devastating. If this virus were weaponized, the outcome could be catastrophic. In response, the JPM CBRN Medical has already sponsored NSN assignments of both an Ebola vaccine (ERVEBO®) and an Ebola treatment (INMAZEB®) to combat infection caused by Zaire ebolavirus, enabling the ordering process for the federal government.

Even lesser-known diseases, like clostridium botulinum (botulism), are viable threats that the JPM CBRN Medical monitors for the safety of the warfighter and nation. Botulinum toxin, derived from the spore-forming bacteria clostridium botulinum, and one of the most toxic poisons known, has always been on the list of top bioweapon candidate agents, due to its extremely high toxicity: it is 50-100 times more toxic orally than cyanide. The toxin’s lethality, combined with its potential for bioterrorist attack on the nation’s food and water supplies, make it a formidable threat. It is imperative that the JPM CBRN Medical continues to support sponsoring NSNs for developing treatments – like Heptavalent Botulism Anti-Toxin (indicated for the treatment of botulism), FIRDAPSE®, and Ruzurgi (treatment to assist breathing in the event of botulinum neurotoxin exposure) – to combat it.

Assignment of NSNs gets the logistics support information of a product into the system. At that point, the product becomes visible to our customers at DoD medical treatment facilities. But, this is not the end of JPM CBRN Medical’s effort to reach all of its customers. U.S. service members deploy with medical assemblages that are supported logistically, and all assemblages must be standardized, up to date, and ready to deploy. To get MCMs out to the customers that deploy, the JPM CBRN Medical must focus efforts on enabling product addition to those medical assemblages.

MCMs that are listed in the Joint Deployment Formulary (JDF) are considered for standardization and incorporation into military medical assemblages. The JDF is the database of DoD-approved pharmaceutical items required for theater-level care for the first 30 days of contingency operations. The DHA Clinical Advisory Committee approves additions to the JDF based on clinical practice guidelines (CPGs). The JPM CBRN Medical works closely with members of the DHA committee on CPGs, and the products that support them. Once the product is added to the JDF, the JPM CBRN Medical works closely with the DHA medical assemblage managers at the U.S. Army Futures Command, Naval Medical Logistics Command, and Air Force Medical Logistics Office to support the incorporation of the item into the appropriate medical assemblages.

“These JPM CBRN Medical efforts are an integral part of this organization’s overall mission to provide an integrated and layered chemical, biological, radiological, and nuclear defense capability to the Joint Force,” said Col. Ryan Eckmeier, Joint Project Manager for the JPM CBRN Medical. “Sponsoring NSNs allows us to do our part in delivering products not only in support of our deployed forces, but public health at large. NSN assignment facilitates MCMs being easily ordered and potentially prepositioned at strategic locations around the globe, ultimately ensuring timely access to products in regions where these unique threats are encountered.”

Today, NSNs are used to identify and manage over seven million active products in the FLIS, and over six billion in the federal supply chain. Nevertheless, even with the pandemic and general turmoil in the world, the JPM CBRN Medical continues to add to that lengthy list, and will deliver even more NSNs as the need arises.

Author: Bio

Ms. Melissa Myers is a Strategic Communications Specialist supporting the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical).

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