Pharmaceutical Case Study

     |     

Counterfeiters threaten $1 billion pipeline of medicine.

You are your company’s brand protection manager. Counterfeit copies of one of your major pharmaceutical brands turn up in the U.S. market. You have no security measures in place to allow patients or inspectors to tell the real stuff from the fake. Consequently, $1 billion worth of your product, already in the distribution pipeline, can’t be sold—at least not until you come up with some method of allowing patients and retailers to verify that your medicine is actually authentic.

Patient safety, your company’s hard-earned reputation not to mention $1 billion in sales are all under severe threat. Time to send out a SOS.

This is exactly the situation one of our customers found themselves in. And when they came to us for help, Authentix answered the call. Our customer desperately needed a way to instantly authenticate medicines in the field. No problem, we said.

We immediately jumped into action. The customer’s product was repackaged to include a variety of authentication features that could be identified by patients and inspectors, both in the field and in the laboratory. These included:

  • Overt, color-shifting inks can be readily distinguished by patients.
  • Covert, machine-readable inks can be detected in the field by inspection staff with appropriate readers.
  • Forensic markers can only be detected under laboratory analysis.
A happy ending

The Authentix solution to our customer’s counterfeiting problem provided a secure means of instantly identifying authentic from counterfeit medicines. The benefits were immediate and significant:

  • $1 billion worth of product frozen within the supply chain was released for sale
  • The expense of a full product recall was averted
  • The customer was able to mitigate the risk of potential lawsuits
  • And, our customer’s brand protection manager instantly became the organization’s authentication “superhero.”

Most importantly, confidence in the brand was restored among physicians, pharmacists and patients.

Every superhero needs a partner.

What would Batman be without Robin? The Green Hornet without Kato? Not much, if you ask us. If you want to be your company’s authentication superhero, contact us today. In true superhero style, Authentix is the partner with the innovative solution to boost your authentication powers!

Download Blog PDF Here

Case Study: Fast-Moving Consumer Goods

     |     

Brand protection solution to eliminate the diversion of products from legitimate distribution channels

The Challenge

A large, global hair care manufacturer produces category-leading brands with high consumer loyalty and demand. Their products are marketed through exclusive, professional beauty care channels via a complex supply chain with diverse manufacturing systems and multiple distribution outlets.

All of these elements make their products high-value targets for counterfeiters, organized theft rings, and gray market wholesalers. In fact, the manufacturer found they were being negatively impacted by diversion of its products from legitimate distribution channels into gray or retail markets. This situation was creating dissatisfied customers and weakening their market promotional efforts.

The Need

Clearly, the manufacturer needed an anti-diversion authentication solution that would help them maintain brand equity. It was imperative that the solution include the ability to authenticate product and verify its “product genealogy” throughout its life cycle. They also needed the ability to track product throughout their entire supply chain and make sure the right product was always delivered to the right location.

The Solution

The global hair care manufacturer turned to Authentix to implement an authentication solution of serialization and a track-and-trace system that identified product diversion in the brand’s distribution channels. The Authentix solution utilized multiple covert authentication features that allow item-level serialization, full product trace-ability from manufacturing to retail, as well as provisions to track repackaged products. In addition, the track-and-trace system was seamlessly integrated into manufacturing process controls for all of the manufacturer’s 13 production lines.

Itemized serialization was accomplished for over 165 million products, enabling full trace-ability from manufacturing to retail.

The Outcome

      • Successfully identified channel leaks within a complex distribution chain of over 2,500 channel partners and 15 distributors
      • Over 300 million units have been marked since the Authentix solution was implemented
      • 47 percent reduction in product diversion
      • Consequently, product sales increased by $77 million

Contact us if your company is struggling with lost revenue due to illicit activity throughout your supply chain.

Agrochemical Case Study

     |     

Violation of Licensing Agreement Revealed with In-Product Brand Protection Program

The Issue

An agricultural chemical manufacturer suspected that one of its formulators was in violation of a licensing agreement, substituting a generic active ingredient for the licensed component. The formulator also appeared to be diverting the end-product for sale in a region outside of its licensed territory where it had a higher value.

The Solution

The manufacturer turned to Authentix for a solution to ensure the use of their component in the formulator’s end-product. Authentix worked with the manufacturer to incorporate US FDA-compliant in-product markers into the licensed component, ensuring that the markers could endure the harsh synthesis process, become homogenous and remain stable, while not impacting the active ingredient. By adding markers to all of the licensed component, a test of the suspect formulator’s end-product that showed low concentration or no marker presence would indicate that the formulator was replacing the licensed active ingredient with a generic product.

The markers are detectable in the field using a simple qualitative (yes / no) test kit, backed up with a quantitative laboratory test. The layered marker program allows wide-spread and quick field screening, with suspect samples sent to a centralized laboratory for validation and to provide support for corrective action. The manufacturer’s personnel were trained to use the test kits and perform the laboratory analysis, allowing them to monitor the formulator’s end-product for compliance with the licensing agreement.

The Outcome

The agricultural chemical manufacturer determined conclusively that the formulator was in violation of its licensing agreement by testing for and not finding the Authentix markers in the end-product. Field tests were confirmed by precise laboratory testing, delivering proof that enabled enforcement action to be taken.

Case Study: Wine & Spirits

     |     

Addressing Counterfeiting and Adulteration Increases Sales by 25%

 

The Issue

Authentix implemented a program in South America to help address a spirits counterfeiting issue. With annual production of over 60 million bottles of various spirits (approx. 50 million liters), this market provided the largest single source of state government revenue—over $150M in previous years.

The Solution

To solve the issue, the program used a combination of in-product, on-package marking and distribution channel monitoring. For authentication purposes on packaging, an overt feature was added as tamper evidence for consumers and a covert feature was added for official retail inspectors via handheld field verification readers and test kits. In addition, covert features were incorporated into the spirit itself for field verification and forensic lab verification.

The Outcome

  • Within the first year of the program, 75 million liters of spirits had been protected (approx. 100 million bottles).
  • More than 1300 inspectors in 28 states had inspected over 300 retail outlets.
  • Of these, 10% were found to contain counterfeits and 5 retail outlets were investigated resulting in arrests.
  • The brand owner experienced a 25% increase in sales over the same time period.

Is it Worth the Risk?

     |     

As long as you know the risks and can bridge the gaps…

Whether you’re a superhero or a pharmaceutical manufacturer, risk is unavoidable. It can’t be ignored, but it can be managed. One of the biggest risks you face involves counterfeit medicines. They are a $200 billion annual business—that means they are the largest segment of fraudulent goods sold worldwide every year.

One of the major reasons for counterfeit medicines is the complexity of the pharmaceutical supply chain, which can have multiple tiers of suppliers and several geographic destinations. That’s why it is becoming increasing important to ensure the integrity of your pharmaceutical supply chain to close the gap on counterfeit medicines.

It’s true that effective, FDA-accepted technologies exist for both packaging and the pharmaceutical products themselves. But technology by itself is not enough. You also need a comprehensive risk assessment strategy to make the successful leap to prevention, early detection, and effective prosecution.

Proactively identifying which medicines are “at risk” of being counterfeited is the first step in understanding potential threats, and where the gaps are in your supply chain. First understand which of your high-value medicines are at risk, and then rank them according to their risk level. This will provide you the data needed to allocate the proper resources to eliminate those risks.

Authentix can help you manage counterfeit risks with our proven expertise and innovative authentication solutions. We’ve helped our customers mitigate risks to maximize revenues and build a competitive advantage.

Take our Risk Assessment Survey and find out which of your high-value drugs are at risk, and how we can help you protect them.

Download Blog PDF Here

Life is better with the Right Authentication Strategy

     |     

Establish “authentication empowerment” with an end-to-end, customized program that instantly authenticates suspicious medicines, when and where it matters most.

By: Chad Crouch, Vice President of Sales, Authentix, Inc.

If you doubt that the counterfeiting of pharmaceutical medicines is a monumental problem, take a look at these statistics: counterfeit pharmaceuticals are now a $200 billion annual business, and about one million people die each year after taking counterfeit pharmaceuticals.1 It’s a big problem and isn’t going away anytime soon. It’s extremely profitable—that means it has attracted some pretty sharp individuals who can match your product packaging in a blink of an eye. So, if they haven’t hit your company yet, chances are they will try real soon. Be prepared for when that happens.

Without an authentication solution in place, you’ll find that the costs of resolving such an incident are unpredictable and unbudgeted. You won’t have processes in place to deal with counterfeit products that weaken your supply chain and have unclear consequences for your distribution chain. And the various departments within your company will not know how to coordinate efforts to combat the counterfeiters. In a word, you’ll have no checks and balances in place.

The good news is, you and your company don’t have to live that way. If you find the right authentication partner, and together plan and implement an end-to-end, customized solution to deal with counterfeiting, it can be a productive relationship. Instead of reacting to incidents, you’ll be proactive, with a wealth of tools already in place to take on the bad guys:

  • Financial resources will already be allocated
  • Authentication processes will instantly act on suspicious medicines
  • Supply chain will be stronger
  • Distribution chain more transparent
  • Internal departments will be empowered to act in concert and get a handle on the problem

If you make the right move and choose the right authentication partner, then work together to develop and implement the right authentication solution for your company, here’s what you can expect to see moving forward:

  • Improved analysis of suspicious medicines and packaging
  • Rapid matching of samples against your predetermined standard
  • More secure supply chain with process improvements/improved visibility in upstream and downstream directions
  • Internal processes understood and monitored
  • New sources of data developed that fuel ongoing process improvements

Don’t let the pharmaceutical counterfeiters make your company their next victim. By acting instead of reacting, you can stay one step ahead of the bad guys. The best way to act is to implement an end-to-end authentication solution that’s customized to meet the unique demands of your organization. Contact us to become your company’s authentication hero today.

 

  1. Fighting counterfeit pharmaceuticals: New defenses for an underestimated – and growing – menace, Peter Behner, Dr. Marie-Lyn Hecht, Dr. Fabian Wahl, 201

Download Blog PDF Here

Get Instant Authentication of your Pharmaceutical Products

     |     

With the right partner, you can design and implement an end-to-end, customized authentication program and put it to work quickly. Go from zero to hero in weeks. 

By Andrzej Hornostaj, VP Brand Solutions, Authentix, Inc.

If you were part of the pharmaceutical industry in 2002, you will remember the Procrit® counterfeiting case. If you weren’t, here’s a brief recap: Procrit, a clear liquid that at the time cost about $500 an injection, was used to treat severe anemia (often in very sick patients with cancer or AIDS). Its manufacturer was alerted to a suspicious product in the field. While the suspicious product could not be instantly identified in the field, investigation confirmed fairly quickly that it was counterfeit—and much more was to be found in the supply chain.

In one instance, counterfeiters had copied Procrit labels and packaging and had filled vials with water. Some of the vials comprised genuine Procrit containers scavenged from bags of medical waste. In another case, the counterfeiters had relabeled bottles to substitute a weak dosage for a much more expensive, concentrated one. A prosecutor estimated that the switch might have made the counterfeiters a tidy $46 million in profit. Unfortunately, only about 10 percent of the counterfeit medication was ever recovered.1

The Procrit manufacturer responded to the crisis as quickly and efficiently as they could. In 23 days, they were able to authenticate the suspicious medicine in their lab, repackage it with security features and ship. Here’s the timeline for their response:

  • Day 1: Suspicious medicine reported
  • Day 2: Package confirmed as counterfeit
  • Day 3: All Procrit shipments halted, sent back and new security features authorized
  • Day 9: New labels received
  • Day 11: Equipment procured and set up in warehouse
  • Day 23: Procrit with new packaging shipped out

This reaction was considered “world class” at the time—but it still caused massive disruption to the Procrit supply chain and effected over 200 employees. Why? Because the company’s response was reactive, not proactive. The critical factor was this: when the suspicious product was initially discovered, it could not be instantly authenticated in the field.

In the years since the Procrit case, the problem of counterfeit pharmaceuticals has grown exponentially as the “bad guys” devise increasingly sophisticated and hard-to-detect counterfeiting schemes. A proactive solution and instant authentication have to be the goals for any pharmaceutical company that doesn’t want to be at the complete mercy of the counterfeiters in 2018 and beyond.

How close is your company to taking a proactive approach to identifying suspicious medicines in the field?

To answer that question, you must first ask:

  • What do we have in place to authenticate a suspicious medicine when it’s reported in the field?
  • How quick and supply-chain-wide is our response?
  • How much time does it take to authenticate?
  • What security features do we currently lack that would help us authenticate instantly?
  • How complex would such a system need to be?
  • Have the stakeholders in our company bought into the concept of instant authentication?
  • What is the ROI outlook?

It might seem it would take you forever just to answer these questions, much less develop an authentication strategy and implement it. Your options are to find a partner to help you develop the right authentication strategy and implement it or hope that the counterfeiters don’t get around to counterfeiting your products. The only problem is, they will. And when they do, it will be disruptive.

In reality, answering all those questions and developing an instant authentication solution isn’t as difficult as it may seem—if you’re working with the right partner. The right partner will devise an effective strategy and guide you along the way to implementation and beyond. The key point is finding the partner willing to work with you and your third-party vendors to establish a customized program that will make instant authentication a standard operating procedure. To accomplish this, the program must include design, seamless implementation, and operational and ongoing support.

Your ideal partner will have a complete understanding of the pharmaceutical industry in general and your business in particular. They will become an integrated part of your team and extend that support to your third-party vendors. They’ll be agile enough to adapt to your culture, your unique challenges, and your particular processes.

Here’s what the authentication planning/implementation process should look like:

  • Your partner will work with you to create an end-to-end, customized plan and budget.
  • They will demonstrate the ability to print security feature samples for internal demonstration and buy-in.
  • They will be completely independent so they can work with all of your third-party vendors without interruption.
  • They will help you seamlessly implement your authentication plan, which will include:
          • Execution across your entire global supply chain
          • Training and enablement for everyone involved
          • The flexibility to expand and grow with your changing needs

With the right authentication partner by your side, and with the right authentication solution in place, you can make instant authentication a reality. Instead of reacting to incidents, you’ll be in proactive mode. You can go from zero to authentication hero, staying one step ahead of the counterfeiters and thwarting their most villainous schemes.

Contact us today to go from zero to authentication hero in weeks.

Download Blog PDF Here

Andrzej Hornostaj is VP Brand Solutions at Authentix, a leading global authentication and information services company. Authentix assists its customers in many industries, including pharmaceuticals, by combating illicit trade and managing the integrity of their global supply chains. Using comprehensive end-to-end authentication solutions, Authentix safeguards industry leaders worldwide from counterfeiting, product theft, product diversion, and adulteration.

 

1 Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply, Katherine Eban, 2005

Superhero Plan

     |     

They might not want to admit it, but even superheroes need a plan. And let’s face it—they’re people of action, not necessarily the best planners. If they’re lucky, they have a sidekick who can take care of the planning and preparation of things, so their mission is a success.

Think about Green Hornet for a minute. You remember how he was always ready to jump into the thick of it, tangle with the bad guys, and not hesitate for a second? Good thing he had his trusty sidekick, Kato, to come up with an effective plan. It wasn’t always a complex plan—just the right plan for the situation.

If you want to be your company’s authentication superhero, maybe you need a sidekick—with the right plan.

The clock is ticking.

Picture this: a distress signal comes in about a suspicious medicine in the field. You need to know what’s real…and what isn’t. And the clock is ticking. There isn’t enough time for a labor-intensive authentication method. But when is there? Time isn’t on your side and you need a plan to instantly authenticate that product in lightning speed.

Who can be your trusted sidekick? Your planning and preparation expert? Your authentication partner?

So many questions. But just one answer: Authentix!

Authentix can help you customize a plan to start battling the villains and initiate your superhero powers.

Up and running in a month.

Think such as plan would be too hard to implement? Think again. With Authentix as your partner, we can have your empowerment solution up and running within 30 days.

We thrive in complexity.

We know you operate in a very complex environment of global suppliers and distributors. That doesn’t scare us. We’ll tailor your solution and perform a print trial to make sure it works perfectly in your complex world of suppliers and systems.

And 90 percent of the time, jobs are ready to go immediately after the print trial.


Global implementation across the supply chain is followed by training, enablement, ongoing support and the monitoring and interpretation of results. Being the perfect partner, we’ll make it easier than you ever thought possible. (Right, Green Hornet?)

In true superhero style, Authentix is the partner with the right plan to boost your authentication powers!

Watch our video and discover how Authentix can work with you to develop the right plan.

Contact us today to collaborate on the right plan.

Download Blog PDF Here

Discover the Right Authentication Solution that will Save Time, Millions and Lives.

     |     

Time is never on your side when your pharmaceutical product is counterfeited and your brand reputation is at stake.

By: Cheryl Smith-Johnson, Brand Marketing Manager, Authentix, Inc.

The World Health Organization recently passed along some pretty alarming news: it cited statistics claiming that global sales of counterfeit pharmaceutical products could top $75 billion this year. That’s a 90% increase over the last five years! More than likely, your pharmaceutical company is in the process of addressing this growing problem. It’s critical that you adopt effective measures that prevent counterfeiting (below you’ll find a guide to some of the best tools available). The counterfeiters plaguing the pharmaceutical world are resourceful and relentless. Chances are, a counterfeit version of one of your products will eventually make its way into the marketplace. That’s when the ability to react swiftly becomes paramount—to beat the bad guys, you must have the right tools in place to instantly authenticate suspicious packages in the field, where and when it matters most.

You’ve heard the cliché, “Timing is everything”. That certainly holds true in the pharmaceutical world. When the authentication of your product takes too long, it can be extremely damaging to the patients who depend on your products for their health, to your revenue stream, and to your brand reputation. So, what’s the best route to being able to instantly authenticate your products in the field? By choosing the right authentication solution for your company. You have many options—here’s a look at the different tool sets that can assist you in authenticating suspicious packages reported in the field:

Authentication technologies that work

Overt security features are visible to the naked eye, allowing health professionals and patients to easily identify the authenticity of the package. For overt features to be effective in identifying a counterfeit product, health professionals and patients must know what they are looking for when they inspect a package. Consequently, public education and awareness are very important elements of any overt security plan. Solutions commonly employed for overt security include:

  • Optically-variable inks
  • Pearlescent inks
  • Gold and silver inks
  • Anti-tampering technologies (tamper-evident closures and labels)
  • Optical security technologies (holographic seals and labels)

Covert security features utilize an image invisible to the naked eye, often printed with security inks on primary and/or secondary packaging. These security inks can only be detected using a device. Examples of security components and inks include:

  • Heat-activated inks
  • Color-revealing inks
  • Light-activated inks
  • Fugitive inks
  • UV-activated inks

Forensic markers, being covert organic compounds, are not readily recognizable and require special tools for detection and validation. Whereas machine-readable taggants can be detected in the field, forensic markers must often be taken to a laboratory with specialized equipment. The use of forensic markers allow companies like yours to pursue legal actions against counterfeiters, conduct private investigations and cooperate with law enforcement agencies.

Serialization Track and Trace and Anti-Diversion solutions use two-dimensional data matrix codes and radio-frequency identity tagging. Each product is assigned a unique identifying code during the manufacturing process that allows it to be tracked, traced, verified, and recalled if necessary. Serialization “track and trace” methodology provides a basic security coverage, but it is likely to fall short of the overall goal of keeping the pharmaceutical supply chain free and clear of counterfeit drugs. Counterfeiters have access to the best printers and can easily copy unique codes and apply them to their counterfeit products. To combat them and create greater security in your supply chain, you must strengthen your anti-counterfeiting efforts by combining multiple authentication features.

Online monitoring: The Internet is one of the primary avenues counterfeiters use to pass off their counterfeit products to consumers. Keeping ahead of the counterfeiters is becoming more challenging in this space. Implementing a comprehensive online monitoring platform can help you quickly identify sites that are taking advantage of your brand, remove the counterfeit links, provide appropriate enforcement measures and help reduce online abuse.

It’s important to look for an online monitoring system that has internal and external capabilities to monitor dark web and gray web activities related specifically to online pharmacies. A constant review of the data is imperative to understand where breaches are taking place.

Choose an end-to-end authentication platform with “super powers”

Any of the solutions mentioned above will help authenticate a suspicious package reported in the field—but to stay ahead of the bad guys, you’re going to need more. You’re going to need an authentication platform with some serious power.

When you adopt this kind of customized authentication platform, you’re taking a proactive approach that combines the best available technologies—providing you with the “authentication super powers” needed to protect patients and your brand reputation. You’ll have access to an integrated set of software applications designed to enable successful deployment and operation of an authentication program. You’ll be able to act based upon brand insights that are aggregated, analyzed and reported directly to the smartphones, tablets and computers of your team. Best of all, you’ll be able to perform instant, in-field authentication allowing you to take immediate action.

Implementing a multi-layer approach takes you one step closer to successfully combating counterfeit products. This type of approach combines proven authentication tools with accurate data collection and analytics, providing you with authentication empowerment to save the day.

Remember, timing is everything. Having the right customized authentication solution will provide you with a proactive process that will save you time and, quite possibly, lives. When you can identify, and remove counterfeit products quickly, you’re bound to become your company’s authentication hero.

Contact us today and become an authentication hero.

Download Blog PDF Here