May 2020 - rfxcel.com
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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.

 

rfxcel Working to Reduce Supply Chain Issues

Reno, Nevada, April 30, 2020, KTVN Channel 2 News. A Reno company is using its cloud-based technology to improve inefficiencies in the supply chain. As raw materials and goods make their way from one place to another, rfxcel Corporation uses Integrated Monitoring, or RIM, to track its delivery.

“It helps avoid counterfeits, helps to avoid out-of-stocks, and helps ensure that your ingredients and raw materials are going to be there at the plant when you need them,” Glenn Abood, Founder and CEO of rfxcel Corporation said.

The technology is similar to what people use to track online orders as they’re delivered. Each item has a serial number or lot code that gets scanned along its delivery route.

“We, today, deal with pharmaceutical companies, manufacturers, wholesalers, dispensers, we also deal with food and beverage manufacturers,” Abood said.

Abood says the transportation industry is doing a good job of keeping up with demand but that there are other problems with the supply chain.

“The challenge has been that, in the supply chain, there are outages,” Abood said. “There are certain parts of the supply chain that aren’t functioning as well as they should.”

The company uses RIM to track finished goods as they go from the manufacturer to distribution centers and eventually to the market. For the past few months, the bigger focus has been on raw materials that travel from their origins to the manufacturers. He says that is even more important in a global market.

“They might know who they bought it from, directly, but where did that company get the product from?” Abood said. “Was it impacted by what’s going on in China? Was it impacted by other global shortages?”

He says the tracking helps everyone from start to finish. Manufacturers are better-equipped to handle inventory issues and they can make changes to who their suppliers are, if necessary. He says that can help prevent counterfeit products. That is something that can give consumers more confidence.

“If we go to a drug store and by the medicine that we need, that that medicine is in fact genuine,” Abood said.

rfxcel moved its headquarters to Reno in November, 2018. Part of the city’s appeal was the quality of life, proximity to the Bay Area and the University of Nevada. Since then, it has grown but Abood says that has slowed down since the COVID-19 pandemic began. The company has about 100 employees around the world, including more than a dozen in Reno. Many of those are homegrown.

“It’s always a challenge to find the right people and we’re very selective but we have found some great people in the Reno area and we’re really excited about being here,” Abood said.

The company and its employees are also adjusting to the emergency. Most of its workers are doing their jobs, remotely.

“Because we’re a cloud-based company anyway, our software, our applications, our customers use the product in the cloud and therefore, for us it’s not been too difficult to work from home,” Abood said.

Dispensers, the DSCSA, and the “3Ts”

The next DSCSA deadline for dispensers is just months away. Our white paper gets into the specifics of what dispensers will have to do to verify and authenticate drugs this November and what they’ve had to do in previous years. rfxcel has committed itself to creating educational materials about dispensers’ responsibilities under the DSCSA, including Web pages, flyers, webinars, and this white paper. If you want more information about your specific needs, please contact us today.

New GS1 Guidance for Product Identifiers in the DSCSA Saleable Returns Verification Requirement

On March 31, GS1 released new guidance concerning product identifiers (PIs) in the DSCSA Saleable Returns Verification Requirement. The 60-page document describes different scenarios for how pharma supply chain stakeholders can treat the PI status of a returned serialized product in the Verification Router Service (VRS).

Let’s take a look at what new GS1 guidance says about dealing with PIs.

The Basics of the DSCSA Saleable Returns Verification Requirement

The DSCSA Saleable Returns Verification Requirement says that wholesale distributors must verify the PIs on sealed homogeneous cases or packages before they can resell a returned product. This went into effect on November 27, 2019. However, as we reported last September, the FDA delayed enforcement by one year to allow additional time for industry readiness.

The PI contains a Global Trade Item Number (GTIN), a serial number, a lot ID, and an expiration date (for the lot).

In a nutshell, the VRS has requestors and responders. A requestor, often a wholesale distributor, sends a verification request to a responder, usually a manufacturer. The VRS routes the request to the appropriate responder for verification of the PI against its repository. The responder returns the following values:

    • Response status: Do all four components of the PI match?
    • Failure reason: If they don’t match, why?
    • Other information about the PI status: This can be used to identify concerns about the product (e.g., if it has been recalled or is suspect).

A strict interpretation of the DSCSA provides a verification “pass” or “fail” based only on matching all four PI elements. In other words, the DSCSA does not require a responder to consider the PI status as part of its verification. However, many manufacturers believe the PI status must be considered. This is why GS1 developed its new guidance for PIs in the DSCSA Saleable Returns Verification Requirement.

What the GS1 Guidance Says

The guidance describes seven scenarios for saleable return responses, summarized below. For full details, contact us and review the GS1 guidance.

SCENARIO A: The PI matches the manufacturer’s repository and there is no information to indicate that the product is unfit for distribution. The product is verified for resale.

SCENARIO B1: The PI matches. However, the manufacturer has reason to believe the product is recalled/withdrawn or expired. The product DOES pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO B2: Same as B1, but the product DOES NOT pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO C1: The PI matches, but the manufacturer has reason to believe the product is suspect. The product DOES NOT pass verification for resale and the manufacturer provides “Not_for_re-distribution” as a reason for the failure with “Suspect” as additional information in the Output Response.

SCENARIO C2: The PI matches, but the manufacturer has reason to believe the product is unfit for distribution. The product DOES NOT pass verification for resale and the manufacturer provides “Manufacturer_policy” as a reason for the failure without additional information in the Output Response.

SCENARIO D: The PI DOES NOT match. The product DOES NOT pass verification for resale and the manufacturer provides “No_reason_provided” as a reason for the failure.

SCENARIO E: The PI DOES NOT match. The product DOES NOT pass verification for resale. In addition to “No_reason_provided,” there are four other possible reasons the manufacturer can give for the PI mismatch in the Output Response:

    1. “No_match_GTIN_Serial”
    2. “No_match_GTIN_Serial_Lot_Expiry”
    3. “No_match_GTIN_Serial_Lot”
    4. “No_match_GTIN_Serial_Expiry”

Final thoughts

As of May 6, 2020, rfxcel is the only VRS provider to comply with the updated GS1 specifications and fully support all of its scenarios and response options. We also implemented the FDA’s VRS pilot. When you work with us, you’ll know you’re working with the industry’s foremost authority on VRS and the DSCSA Saleable Returns Verification Requirement.

Contact us today to speak with one of our supply chain experts. We can help you understand the intricacies of VRS and the DSCSA, how they might affect your business, and how to be fully prepared for compliance now and always.

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!