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What Does the EU COVID-19 Vaccine Distribution Plan Look Like?

The EU announced its COVID-19 vaccine strategy on June 17, 2020. Among other things, it called for ensuring the quality, safety, and efficacy of vaccines, securing quick access to vaccines, and ensuring equitable access to an affordable vaccine as early as possible. It also called for adapting the EU’s regulatory framework and taking advantage of regulatory flexibility to address the urgent need.

Let’s take a look at what the EU has said about its COVID-19 vaccine distribution plan and answer some frequently asked questions about its vaccine administration.

What vaccines are being used in the EU?

The European Commission says it wants to “build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA.”

The EU authorized the BioNTech-Pfizer COVID-19 vaccine on December 21, 2020, and the Moderna vaccine on January 6, 2021. It did this after the European Medicines Agency (EMA) assessed their safety, quality, and efficacy.

On January 8, the Commission reported that it had concluded contracts for 600 million doses of the BioNTech-Pfizer vaccine and 160 million doses of Moderna’s vaccine. It also reported securing contracts for millions of doses from AstraZeneca, Sanofi-GSK, Johnson and Johnson, and CureVac, and that it had concluded “exploratory talks” with Novavax and Valneva.

Then, on January 29, the Commission announced that AstraZeneca agreed to publish the redacted contract it signed on August 27, 2020, and that CureVac agreed to publish the Advance Purchase Agreement with the EU.

The Commission says it has secured more than 2.3 billion doses of COVID-19 vaccines, adding that if all the vaccine candidates are found to be safe and effective, EU Member States could donate part of their doses to lower- and middle-income countries.

Who will receive the vaccine and when?

As of January 8, the EU said that all Member States would have access to COVID-19 vaccines at the same time, based on the size of their population. On January 29, the Commission enacted a measure requiring Member States to authorize vaccine exports, stating this will “ensure timely access to COVID-19 vaccines for all EU citizens and … tackle the current lack of transparency of vaccine exports outside the EU.”

The Commission says the number of doses will be limited during the initial stages the immunization effort and before production can be ramped up. As in other countries, authorities have said that there will not be enough doses to vaccinate everybody right away; it will take time.

Most members have defined who will get the vaccine first and are further refining sub-groups to assign priority. Frontline healthcare professionals and people over 80 years old top the lists. For more insight about the rollout, see this December 2020 report from the European Centre for Disease Prevention and Control about preparedness in the EU, the European Economic Area, and the UK. The Centre also has a useful “Situation Update” page that tracks the pandemic in the EU.

Vaccine supplies will increase over time, the Commission says, and all adults should be able to get vaccinated during 2021. It predicts that at least 80 percent of people over the age of 80 and 80 percent of health and social care professionals should be vaccinated by March 2021. By this summer, the Commission says 70 percent of the EU’s adult population should be vaccinated. These projections, however, are probably optimistic, as the rollout has been slow and fewer doses than expected have been delivered.

Final thoughts

As we said in our blog post about COVID-19 vaccine distribution in the United States, the world is in an “all hands on deck” situation. We like to think we’ve been part of the effort since the pandemic began.

In April 2020, we joined the COVID-19 Healthcare Coalition, offering our Accurate Immunization Management (AIM) and rfxcel Integrated Monitoring (rIM) solutions. rIM is a real-time environmental monitoring solution that uses Internet of Things (IoT)-enabled devices to monitor products while they’re in transit; it’s a powerful, ideal solution for the pharma cold chain, which is vital to vaccine distribution.

AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Furthermore, our signature rfxcel Traceability System has proven itself in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting. Contact us today to learn more our solutions and how we can help you secure your supply chain, no matter what industry you’re in or where you do business.

How the COVID-19 Vaccine Track and Trace Systems Work in the United States

On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization for a COVID-19 vaccine in the United States. The Pfizer vaccine was the first vaccine made available to the public, followed by Moderna’s vaccine.

There are many challenges for U.S. track and trace systems monitoring COVID-19 vaccine shipments. There’s also the additional challenge of keeping tabs on who receives the vaccine and when, especially as the program is being conducted through both state and federal data networks.

Let’s take a look at how the United States is implementing its track and trace systems and address the unique challenges of vaccine distribution.

What track and trace systems are the United States using?

The United States is using federal immune registry systems and connecting them with a new project called the Immunization Gateway, or IZ Gateway. Put simply, the system enables providers, consumers, and other stakeholders to exchange immunization data. It’s sponsored by the Centers for Disease Control and Prevention’s Immunization Information Systems Support Branch and led by the U.S. Department of Health and Human Services (HHS) Office of the Chief Technology Officer.

IZ Gateway connects 64 Immunization Information Systems (IIS), which consolidate and “deduplicate” immunization information. IIS also have forecasting algorithms that can help people stay current on their vaccines. The IZ Gateway’s centralized technical infrastructure facilitates data exchange through an intelligent message router that connects the IIS to one another, connects large multi-jurisdictional provider organizations to the IIS, and connects the IIS to consumers.

The HHS says the IZ Gateway “aims to increase the availability and volume of complete and accurate immunization data stored within IIS and available to providers and consumers regardless of their jurisdictional boundaries.” Prisons and veteran’s affairs hospitals are also connected to the system.

The main challenge to the U.S. track and trace system

As we know, tracking and tracing the COVID-19 vaccine isn’t an easy task. There have been a variety of concerns, including securing pharma cold chain infrastructure and providing track and trace technology with real-time environmental monitoring, such as our rfxcel Integrated Monitoring solution.

However, two challenges have remained at the forefront of the conversation: the sheer scale of the immunization effort and the two-dose requirement. Although the IZ Gateway creates a nationwide network that can track if a person has received more than one dose, government, providers, and every other vested stakeholder should anticipate mistakes and inaccuracies and do everything within their power to optimize vaccine distribution and administration.

rfxcel’s Accurate Immunization Management (AIM) is one solution that can help. AIM is an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain. It seamlessly integrates with IIS, Electronic Health Records (EHRs), Allscripts, Nextgen, Urochart, Meridian, and iSalus, adding another layer of track and trace protection to vaccine distribution.

Final thoughts

COVID-19 vaccine distribution is an “all hands on deck” situation. Our signature rfxcel Traceability System has proven itself time and again in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting.

Now, AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Contact us today to learn more about AIM, our rfxcel Traceability System and rfxcel Integrated Monitoring, and our other supply chain solutions.

rfxcel Responds to Unprecedented Cold Chain Requirements and Logistics Challenges as COVID-19 Vaccine Distribution Nears

Reno, Nevada, Dec. 2, 2020. rfxcel, the global leader in digital supply chain traceability solutions, continues to address cold chain and logistical challenges it anticipates will arise from the first widespread distribution of COVID-19 vaccines. The company has been preparing for a “vaccine surge” since the pandemic began to ensure it can respond to customer and industry needs when distribution begins to exert pressure on supply chains.

“The pandemic has revealed shortcomings in every supply chain, and we’ve seen increased competition for resources,” said rfxcel CEO and Co-Founder Glenn Abood. “We’ve worked with our global customers in pharma/life sciences, food and beverage, consumer goods, and government to keep their operations responsive and nimble. Now, we’re prepared to address additional stresses distribution of COVID-19 vaccines could create as the call for ‘all hands on deck’ commences and already scarce resources are redirected for the effort.”

rfxcel has provided traceability solutions since 2003. Its rfxcel Traceability System comprises discrete solutions that work in concert to harmonize, optimize, automate, and monitor supply chain operations, including serialization, compliance, environmental monitoring, raw materials traceability, and data analytics.

The company’s Integrated Monitoring (rIM) solution uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, location, humidity, light, and shock. It can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements.

rfxcel has also developed Accurate Immunization Management (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines. It seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

“We want to provide foolproof traceability,” Abood said. “Today, it’s more important than ever to be able to question, examine, and control every part of the supply chain, which is what our rfxcel Traceability System platform provides with solutions such as rIM and AIM.”

For more information about rfxcel’s Traceability System, rIM, AIM, and other solutions, contact Herb Wong, vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

Supply Chain Visibility Can Fight Fraud in the Time of COVID-19

Earlier this month, the U.S. Food and Drug Administration (FDA) posted an update about actions it’s taking to keep fraudulent COVID-19 treatments off the market. The examples of fraud the Agency gave illustrate why all industries — not just the pharmaceutical industry — need to embrace supply chain visibility. Let’s take a look at what the FDA said and why supply chain visibility is a panacea for the problem.

Consumer vulnerability, scammers, and unproven and potentially dangerous products

The FDA’s update addressed “the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.”

This statement reveals one reason fraud exists: consumer vulnerability. When people are confronted with a problem, especially one they feel they cannot control (such as a pandemic), some may tend to seek solutions without pausing to think them through. Peddlers of fake and substandard products are always ready to exploit this situation.

Which brings us to the scammers, many of whom use the internet to sell their bogus goods. Today, the FDA says, unscrupulous actors are claiming their products “mitigate, prevent, treat, diagnose, or cure COVID-19.” With the pandemic dominating headlines and weighing heavily on people’s minds, these quacks are only more than happy to offer unproven and potentially dangerous products.

What is the FDA doing, exactly?

The Agency has launched Operation Quack Hack to find and stop scammers. It’s located scores of phony products online, including fraudulent drugs, COVID-19 testing kits, and personal protective equipment. The FDA has issued 42 warning letters to companies making false COVID-19 claims and has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, most of which have voluntarily removed the offending product pages.

One of the warning letters went to an organization selling fraudulent chlorine dioxide products as a COVID-19 treatment. When it refused to cease and desist sales of its so-called Miracle Mineral Solution, or “MMS,” a federal court issued a preliminary injunction requiring it to immediately stop distributing the product. The FDA characterizes chlorine dioxide as the equivalent of industrial bleach and since 2010 has been warning consumers about MMS and other products with names such as Master Mineral Solution, Chlorine Dioxide Protocol, and Water Purification Solution (WPS).

The FDA also intercepted and investigated a case of mislabeled COVID-19 “treatment kits” that someone was trying to import into the United States. Also, an FDA investigation led to a U.S. Department of Justice criminal complaint against a British man “who sought to profit from [the] pandemic and jeopardize public health.”

How supply chain visibility can fight fraud

Visibility means using data to gain insight into how a supply chain is functioning and to take steps to make it run more efficiently. The goal is to see everything.

A company must have systems that can gather and report data from one end of the supply chain to the other. Data should be as “rich” as possible; today, that means a digital supply chain with real-time access to unit-level data about everything from ingredients to temperature.

Here’s a rundown of how supply chain visibility can fight fraud. We’re using the pharma industry in our example, but the tenets apply to any product in any industry.

    • You know the origin of your ingredients. Supply chain visibility allows a manufacturer to verify that all the ingredients of a drug are legitimate. It can track every ingredient up until the time they’re combined to make the drug.
    • You can follow the drug’s every move: Part 1. After the drug has been manufactured, bottled, and packed into cases, you can see everywhere those cases go after they leave the plant — warehouses, stores, pharmacies, hospitals, etc. — and you can track their movements in real time. With supply chain visibility, you can anticipate traffic bottlenecks and reroute the delivery vehicle, keeping the shipment on time. You’ll also know if the delivery vehicle has been diverted from its prescribed route, which could indicate theft.
    • You know if the drug has been harmed or compromised. Supply chain visibility means you’ll be alerted if there’s a problem with the shipment. For example, if there’s been a change in temperature, light, or humidity that can affect the drug’s efficacy, or if the cases have been dropped or jolted in a way that might have damaged the bottles, packets, or vials inside. And we’ve already mentioned route diversion and theft.
    • You can follow the drug’s every move: Part 2. When the cases are separated (e.g., taken off a pallet), you can follow each one; when a case is opened, supply chain visibility lets you follow the individual bottles or packets all the way to check-out at the cash register or stocking at a pharmacy or hospital.

Final thoughts

Supply chain visibility creates an “airtight” supply chain that leaves virtually no room for unproven, potentially dangerous, fake, or otherwise fraudulent products to sneak in. And if such a product does appear, supply chain visibility means you can remove it faster. After all, when you can see everything, it’s easier to spot imposters and get rid of them.

rfxcel can provide supply chain visibility in any industry. Our signature rfxcel Traceability System (rTS) is a full-stack visibility and track and trace platform that comprises solutions that empower end-to-end supply chain visibility, including:

    • rfxcel Integrated Monitoring (rIM) is an award-winning solution that uses Internet of Things (IoT)-enabled devices to provide real-time data about 12+ environmental conditions (e.g., location, temperature, shock) of products anywhere in the world.
    • rfxcel MobileTraceability brings the power of an rTS digital supply chain to your smartphone, tablet, or other mobile device.

As FDA Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin said, “It is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health.” Supply chain visibility is the way to do this. Contact us today to find out how we can help you.

COVID-19: Now Is the Time for Food Supply Chain Transparency

The novel coronavirus pandemic has exposed vulnerabilities in food supply chains around the world. It’s also pushed the conversation about food supply chain transparency into the public square. Indeed, it’s likely that more people are thinking about supply chains today than at any other time in history.

However, it’s prudent to point out that the industry has resisted full end-to-end transparency. In light of the pandemic — and with the U.S. food supply chain in the news in recent weeks — we might have approached what’s commonly referred to as a teachable moment. The question is, will stakeholders finally realize that food supply chain transparency is in everybody’s best interest?

Why is there industry resistance to food supply chain transparency?

The main reason for resistance is that the industry views food supply chain transparency as a cost instead of an investment. As we pointed out in our “Seafood Supply Chain Traceability Trilogy,” it takes money — sometimes a lot of money — to implement the necessary systems.

Resistance also stems from the fact that supply chains weren’t really designed to be transparent. Companies see their supply chains as things to be guarded, proprietary infrastructure that’s nobody’s business but their own. Why should they “give away” information that could jeopardize their market position or possibly harm their reputation?

Another facet of this built-in opaqueness is that companies can’t always keep tabs on what their trading partners are doing. If an upstream or downstream partner is bending or breaking the law or otherwise doing something they shouldn’t, how can the company know? The gist of this problem is data: If it’s collected at all, it may be incomplete or just plain wrong.

And one final thought: Does the resistance mean the industry actually doesn’t want to be held accountable? Though some companies say that they care and want to held accountable, if they don’t embrace food supply chain transparency, this amounts to an empty promise and deflecting accountability to their trading partners.

Why we need food supply chain transparency in the time of COVID-19 — and beyond

The benefits of food supply chain transparency are not contingent upon world events (though transparency helps companies stay steady when events bring risk and uncertainty). They are what they are, no matter the circumstances. But the pandemic has illuminated the benefits, like a lightbulb going off over the collective head of the industry. Specifically, we need food supply chain transparency now for several key reasons:

    • It decreases risk. Food supply chain transparency helps companies identify problems and risks before they escalate into a crisis (or crises). If all trading partners adhere to the same clear standards and can be held accountable for their actions, they’re more likely to self-govern to avoid trouble. Furthermore, with everybody “on the same team,” it’s significantly easier to solve a problem.
    • It boosts efficiency. As we just said, food supply chain transparency gets everybody on the same team. And with teamwork comes efficiency. Stakeholders keep each another informed, enabling upstream and downstream trading partners to make better decisions, take pre-emptive action when needed (instead of waiting to react to a problem after the fact), and keep the supply chain moving.
    • It helps increase the volume of actionable data. Transparency means being open about what you’re doing — which means sharing data about your operations with your partners, customers/consumers, regulatory agencies, and other stakeholders. With more high-quality data flowing inside and outside of the supply chain, every aspect of your operations can be improved.
    • It encourages cooperation. When trading partners have seen their risks lowered and efficiency increased, they’ll be motivated, if not inspired, to cooperate more. Cooperation is great when things are going well; it’s even better if a problem arises. For example, if there’s a recall, everyone will know how to work together to get the product out of the supply chain.
    • It increases supply chain resiliency. Transparency means you can know what’s going on in your supply chain, share information with your trading partners, put it in the context of events, and execute course corrections quickly. For example, if a factory closes due to a natural disaster, political unrest, or a pandemic, transparency intel empowers you assess the situation, see the real and potential impacts on your operations, and make necessary changes. All of this makes your organization more agile and the supply chain stronger.
    • It inspires trust. The ultimate result of food supply chain transparency is trust among all supply chain stakeholders, from manufacturers all the way to consumers. Without trust, systems can break down. That’s the last thing you want to happen during a crises.

Final thoughts

rfxcel is committed to transparency in every supply chain — food and beverage, pharmaceuticals, consumer goods, and government. As we’ve shown, it’s an indispensable tool that’s more important today than ever before.

When external factors such as the current pandemic affect supply chains, transparency helps ensure products are delivered on time, safely, and to exactly the right location and/or person. It helps vital supply chains keep moving. It helps guarantee a product’s authenticity (i.e., no food fraud or counterfeit drugs). It helps protect the public health and safety.

For food supply chain transparency, our signature rfxcel Traceability System (rTS) offers the most complete and flexible raw materials and finished goods traceability solution for the industry. Our rfxcel MobileTraceability app heightens transparency even further, able to track any batch, movement, and handler at any location. And our rfxcel Integrated Monitoring (rIM) solution lets all stakeholders see their products in real time and mine rich unit-level data about more than a dozen environmental conditions.

Learn more about these and our other solutions for food and beverage here and contact us to start a conversation about transparency in your supply chain.

 

FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency

On April 30, the U.S. Food and Drug Administration (FDA) issued guidance for “flexibility” pertaining to certain transaction and wholesale distribution activities under the Drug Supply Chain Security Act (DSCSA). This was a direct response to the COVID-19 public health emergency. Here’s what the FDA DSCSA guidance says.

Legal Basis for the FDA DSCSA Guidance

Public health emergencies in the United States are provided for under Section 319 of the Public Health Service Act (PHS Act). When an emergency is declared, two statutory provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) are automatically triggered:

    1. The exemption of certain product distribution activities from the definition of transaction under the FD&C Act section 581(24)
    2. The exclusion of certain product distribution activities from the definition of wholesale distribution under the FD&C Act section 503(e)(4)

What the FDA DSCSA Guidance Says

The transaction exemption and wholesale distribution exclusion provisions mean that two DSCSA requirements do not apply to some distribution activities during the COVID-19 public health emergency:

1. Distribution of “covered COVID-19 products” to address the public health emergency. The transaction exemption and wholesale distribution exclusion apply to the following:

    • The distribution of prescription drug products that have been issued an Emergency Use Authorization (EAU) by the FDA. To date, this includes hydroxychloroquine sulfate, chloroquine phosphate, and, as of today, May 1, remdesivir. An EAU designation does not mean the FDA has approved a drug for a specific use; to date, the FDA has not approved any product to treat COVID-19.
    • FDA-approved products to diagnose, cure, mitigate, treat, or prevent COVID-19. According to the FDA website, this includes in vitro diagnostic products; high complexity molecular-based laboratory developed tests; personal protective equipment and related devices; ventilators and other medical devices; and therapeutics.

The FDA says that companies involved in the distribution of covered COVID-19 products should “maintain the security of the supply chain as these products are distributed to address the urgent public health need.” If possible, companies should continue to fully comply with the DSCSA regulations if doing so isn’t “a barrier to timely distribution of covered COVID-19 products.”

2. Distribution of other products affected by the COVID-19 public health emergency. The transaction exemption and wholesale distribution exclusion also extend to the distribution of “other affected products in certain circumstances.” For COVID-19, these circumstances exist when:

    • The distribution activities are directly affected by the COVID-19 public health emergency.
    • The distribution activities are for emergency medical reasons, such as treating symptoms of COVID-19.

The FDA gives three examples of when the COVID-19 public health emergency could directly affect distribution of these other products:

    • Distribution to an area where product availability is limited and there is higher demand.
    • Distribution by an authorized trading partner that needs to establish a new, temporary facility for distribution.
    • Dispenser-to-dispenser transfers of products that are needed, regardless of whether there is a specific patient need.

3. There are a few other parameters for the FDA DSCSA Guidance: 

    • They apply only to products distributed to address the COVID-19 public health emergency.
    • They apply to products that were already in the supply chain when the COVID-19 public health emergency was first declared.
    • They do not apply to a drug shortage unless it is caused by the public health emergency.
    • They are in effect only as long as the COVID-19 public health emergency is in effect.

Final thoughts

For the record, the U.S. COVID-19 public health emergency first went into effect on January 27, 2020. A 90-day renewal took effect on April 26. And as we all know, it’s had a huge impact on people’s lives and the global economy.

rfxcel is committed to being part of the solution. We recently released our Accurate Immunization Management Solution (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain — including potential COVID-19 vaccines. We’ve joined the COVID-19 Healthcare Coalition. We are open and operating at full capacity. Contact us today if you have any questions about our supply chain visibility solutions or our work during the COVID-19 public health emergency.

 

rfxcel CEO Glenn Abood Talks Supply Chain Visibility, Improving Supply Chain Efficiency

rfxcel Co-Founder and CEO Glenn Abood spoke yesterday with Channel 2 News at our headquarters in Reno, Nevada. He fielded questions about supply chain visibility, improving supply chain efficiency, and our rfxcel Integrated Monitoring (rIM) solution. Glenn last spoke with Channel 2 in November 2018, right after we announced that we were moving our headquarters to Reno.

Here’s a recap of yesterday’s conversation.

The power of rIM for supply chain visibility

Glenn explained how rIM improves supply chain visibility by tracking raw materials and finished products in real time as they are transported to their final destinations. rIM helps avoid counterfeits and out-of-stocks, and helps ensure that items get where they need to be, safely and on time.

State of the supply chain

Glenn said the transportation industry was doing a good job of keeping up with demand. There are, however, some problems. “There are certain parts of the supply chain that aren’t functioning as well as they should,” he said. There are also outages along the supply chain.

The key is supply chain visibility. With rIM and other rfxcel solutions, companies can know where everything in their supply chain came from, where it is right now, where it is going and when it gets there. For example, they can find out if an ingredient or raw material sourced from abroad is being delayed due things such as shortages and bottlenecks — whether related to COVID-19 or not.

The benefits of supply chain visibility

Glenn said supply chain visibility benefits everyone, from industry stakeholders all the way to consumers. Manufacturers are empowered to manage inventory issues more effectively. Counterfeit products are targeted and eliminated from the supply chain, resulting in greater consumer confidence.

Final thoughts

It would be impossible to explain rIM and our other supply chain visibility solutions in a 2-minute interview on the evening news. But Glenn did a great job summarizing what we do. It’s all about supply chain visibility. Contact us today to learn more about our solutions and how they can optimize your supply chain, no matter what industry you’re in.

And be sure to check out Glenn’s interview!

rfxcel Joins the COVID-19 Healthcare Coalition, Offers rIM and AIM Solutions

rfxcel has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

Members of the COVID-19 Healthcare Coalition include a “Who’s Who” of American healthcare and business, including the Mayo Clinic, Pfizer, athenahealth, and Amazon Web Services. (See the most recently updated list here.) Each will bring its unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic.

rfxcel is happy to offer two of our cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the coalition. More on this below.

More about the COVID-19 Healthcare Coalition: Goals, Principles

The goal of the COVID-19 Healthcare Coalition is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles. Quoted from its website, they are:

    • Everyone participates for the benefit of the country only — no preferential advantage to any one organization.
    • Everyone cooperates and openly shares their plans.
    • Nobody will get paid for coalition work – without exception. Everyone brings their own resources – no money is exchanged.
    • Verbal agreements will suffice to get us started.
    • Agree to these terms and conditions and you are in.

As of April 7, the coalition said it was organizing around five priorities as it “urgently [tries] to work at the speed of the pandemic”:

    • Connecting personal protective equipment (PPE) suppliers worldwide to healthcare organizations with immediate needs for N95 masks, ventilators, and protective gowns
    • Connecting government COVID-19 initiatives to startups to rapidly accelerate ventilator supplies
    • Connecting the best protocols for treating COVID-19 from across the nation and sharing them online for the public good
    • Connecting an ecosystem of private sector capabilities to accelerate telehealth, home care, and alternative options to reduce load at hospitals
    • Connecting the best sources of information from around the world to provide data, analytics, and insights to all

rfxcel’s contribution to the COVID-19 Healthcare Coalition

Our Washington, D.C.-based Worldwide Government Group is leading our efforts in the coalition’s fight against COVID-19. This team of government and supply chain experts focuses on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. It will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring rIM and AIM to coalition members.

Here’s how our powerful solutions will contribute to the coalition’s goals:

    • rIM is award-winning solution that uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

 

    • AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Final thoughts

rfxcel is proud to be a member of the COVID-19 Healthcare Coalition. As Greg Moulthrop, vice president of our Worldwide Government Group, said, “We care about protecting the public … With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

Our CEO, Glenn Abood, added, “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact our Worldwide Government Group at publicservices@rfxcel.com or visit rfxgov.com. To learn more about all our supply chain solutions, contact Vice President of Marketing Herb Wong at hwong@rfxcel.com and take a look around our website.

India Limits Drug Exports, Launches iVEDA Portal, Moves Regulatory Deadline Amid COVID-19 Lockdown

In recent weeks, India has made major changes to its exporting policies, launched its new iVEDA portal, and postponed pharmaceutical regulations. The timing — in the midst of the COVID-19 pandemic and a 21-day lockdown of the country’s 1.3 billion people — raised eyebrows in both industry and government circles. Let’s take a look at what’s been happening.

Restrictions on the export of active pharmaceutical ingredients (APIs) and medicines

India is the world’s primary source of generic drugs, so its announcement last month that it was restricting the export of 13 APIs and 13 associated medicines was unwelcome news in many quarters. Indian drug manufacturers must get government permission to ship any of these APIs or medicines overseas, including:

    • Paracetamol (a.k.a. acetaminophen), which is used in Tylenol
    • Acyclovir, an antiviral used to treat shingles
    • Antibiotics, including neomycin, clindamycin salts (i.e., hydrochloride), tinidazole, metronidazole, and chloramphenicol
    • Progesterone, a hormone supplement found in birth control pills
    • Vitamins, including B-12

India manufactures at least 20 percent of the world’s generic drugs; the restricted items account for about 10 percent of the country’s pharma exports. According to the FDA, in 2018, 24 percent of medicines and 31 percent of medicine ingredients imported into the United States came from India. The U.S. and Indian governments are currently holding discussions to ease the restrictions.

There has been pushback from India’s pharma sector. For example, it’s been reported that the Pharmaceuticals Export Promotion Council of India (Pharmexcil) wrote India’s Directorate General of Foreign Trade (DGFT) to protest that the restrictions will cause Indian drug companies to lose money and could harm their “credibility and reputation in the international market.”

Generic drug manufacturers in India had talked of shortages if COVID-19 continued in China, the source of many APIs for the Indian market. The Indian government has said the restrictions would be temporary. We will continue monitoring this supply chain story and provide updates when needed. Check back often.

The new national iVEDA portal for drug authentication and track and trace

On April 1, India officially replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA). The iVEDA portal is a repository database that will be used for archiving serialized batch data; it’s key objective is not to track and trace India’s drug supply.

Manufacturers and exporters had complained of technical snafus with DAVA, including problems uploading data encoded on the 2D barcodes required on secondary and tertiary drug packaging and maintaining the parent-child relationship of these packaging levels. In response, the Department of Commerce convened a committee to consult with supply chain stakeholders, ultimately deciding to scrap DAVA and create an entirely portal for validation and authentication of drugs for export.

The iVEDA portal was developed by the Centre for Development of Advanced Computing (C-DAC), “the premier R&D organization of the Ministry of Electronics and Information Technology for carrying out R&D in IT, electronics, and associated areas.” Pharmexcil held testing workshops in Mumbai, Ahmedabad, Hyderabad, and Chandigarh on February 10, February 11, March 3, March 5, respectively, to give stakeholders an opportunity to use the portal and give feedback.

Big change to a regulatory deadline

Just before iVEDA launched, India’s Directorate General of Foreign Trade announced a deadline change for the implementation of the track and trace system for drug exports, particularly as it applies to the parent-child relationship of drug packaging.

On March 31, Public Notice No. 66/2015-2020 extended the date for compliance from April 1, 2020, to October 1, ,2020:

The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal has been extended up to October 1 this year.

The extension makes sense given the problems manufacturers and exporters had maintaining the parent-child relationship of secondary and tertiary drug packaging in DAVA and the newness of iVEDA.

The change applies to both small-scale industry (SSI) drugs and non-SSI drugs. Manufacturers and exporters must still print 2D barcodes for different packaging levels (i.e., primary, secondary, and tertiary) and upload the data to iVEDA, but they do not have to maintain the parent-child relationship between secondary and tertiary packaging until October 1. These stakeholders must also have a manufacturer code and product code allotted by GS1 India, though codes from C-DAC will apparently suffice. They are also responsible for the correctness and completeness of data and ensuring its timely upload to iVEDA, but according to some reports may shift this burden to an adjacent supply chain trading partner, such as a wholesaler, distributor, or retailer.

Final thoughts

rfxcel has worked in the Indian pharma market for many years. We understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive. Contact us today to see how we can maximize your impact in India. And keep an eye on our blog for more information about how COVID-19 is affecting global supply chains. Stay safe!

rfxcel Joins the COVID-19 Healthcare Coalition

Washington, D.C., April 6, 2020. rfxcel, the global leader in digital supply chain traceability solutions, today announced that it has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

The coalition’s goal is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles:

    • All members participate for the benefit of the country only. No organization will be given preferential advantage.
    • All members cooperate and openly share their plans.
    • Members will not be paid for working with the coalition. Each member brings its own resources; no money is exchanged.
    • Verbal agreements will suffice to get the coalition’s work started.
    • If an organization agrees to these terms and conditions, it can join the coalition.

rfxcel has been developing industry-leading track and trace software since 2003, longer than any company serving the life sciences and the business of government. Keeping with the coalition’s wish for members to bring their unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic, the company is offering two of its cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the COVID-19 Healthcare Coalition.

rfxcel Integrated Monitoring (rIM)

rIM uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Accurate Immunization Management (AIM)

AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, and his Washington, D.C.-based team of government and supply chain experts are leading the company’s efforts to bring rIM and AIM to the coalition’s fight against COVID-19. rfxcel will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring its technology to coalition members. Working across government and in partnership with industry, MITRE and its public-private partnerships and federally funded R&D centers tackle challenges to the safety, stability, and well-being of the country.

“We are proud to be a member of the COVID-19 Healthcare Coalition and donate our time and resources to addressing this public health crisis,” Moulthrop said. “rfxcel’s Worldwide Government Group is focused on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. We care about protecting the public; in this case, we must protect the health and well-being of people across the country — across the world — against COVID-19, which is revealing how much we rely on robust, secure supply chains. With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

rfxcel CEO Glenn Abood said the company was honored to join the coalition and was eager to get to work. “We had been considering how we could do more to help defeat COVID-19,” he said. “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.

“rIM is an award-winning environmental monitoring solution that’s proved itself over and over in the pharma industry,” Abood continued, “so it was a logical choice to share with the coalition. And AIM, which we released late last month, was a no-brainer. We had been working on it for a while and successfully tested it with some of our major customers. We were excited about releasing it, but we couldn’t have imagined the timing would coincide with COVID-19. We hope deploying it to the coalition will make a difference.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, at publicservices@rfxcel.com or visit rfxgov.com.

To learn more about rfxcel and its supply chain solutions, contact Vice President of Marketing Herb Wong at 925-824-0300 or hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies manage every aspect of their supply chains, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as traceability, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the EU, Britain, Latin America, Russia, the Middle East, India, Japan, and the Asia-Pacific region.