Fake Drugs Raising Track and Trace Questions

The appearance of fake versions of the ADHD drug Adderall is raising concerns about track and trace laws and how pharmaceuticals need to be monitored to ensure public safety.  The story, reported in numerous media outlets (click here), follows on a similar problem earlier this year with the appearance of counterfeit versions the drug Avastin and coincides with Congressional review on the topic of traceability and counterfeiting. The risks associated with this problem are significant as patients may unwittingly take counterfeit medicines that can do more harm than good.  New FDA regulations, according to the article, could pose a danger to both sides as the government tries to balance public safety against increasing regulations that could stifle innovation.

Real or Fake? Can Technology Improve Authenticity?

The article states that the US House and Senate versions of the FDA re-authorization bill include language that would set up more stringent tracking of drugs to help prevent counterfeiting, but the details have yet to be set. (Citing Reuters)  The FDA wants a nationwide program that includes and tracks identifiers on individual containers. The plan put up by an industry coalition would put unique serial numbers on individual drug packages but require scanning drugs only in “lots” when they get to distributors. They have argued that to expect individual tracking from truck to warehouse to distributor to pharmacies is unworkable, at least for now.

Europe will start requiring unique identifiers on all drug packages starting in 2016.

This has been an ongoing issue for the industry.  California has twice postponed its ePedigree initiatives that are now slated to go into effect commencing in 2015 because of the technical challenge of tracking and tracing pharmaceuticals at the item level.  Yet, as more counterfeit drugs show up on the market, consumers (and ultimately the government) will increase their pressure on the industry.

We think Intelleflex can help with the solution.  Intelleflex temperature monitoring tags can store a complete record of the serial numbers of the individual items within the carton and also a secure e-Pedigree all in the tag memory.  This makes it easier to associate the information about the items with the container that they’re shipped in. And, by using our readers with Zest Data Services, it’s possible to keep track of the drugs no matter where they may go and set secure waypoints at each location.  To learn more about Intelleflex solutions for the pharmaceutical industry, click here.  To read an Intelleflex article on serialization and inference, click here.

Kevin Payne

Senior Director of Marketing

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Mix One Part Pharma, One Part Food…

As noted in an earlier post, recently I was able to attend the 2012 Georgia Tech Academic Cold Chain Forum.  Unlike most of the trade shows and conferences I attend which focus on one industry, this event was designed to bring together corporate leaders in both the food and pharmaceutical cold chains in an academic setting where they could share ideas and engage in candid discussions.

Sharing knowledge was the focus of the Forum

Held at the Georgia Tech Research Institute in Atlanta, the event was moderated by Dr. Jean-Pierre Emond, one of the most noted academics studying the cold chain.  This was the first time that the Forum included representatives from both food and pharmaceutical companies.  Executives from produce growers, shipping companies, restaurants and food service providers, and pharmaceutical manufacturers and retailers were in attendance.  This made for some very interesting discussions. While both food and pharma companies deal with the cold chain on a daily basis, their perspectives on the topic were quite different and they were often amazed to learn about the separate – though related – worlds that each industry lived in.

After the event concluded, I was fortunate to be able to interview Dr. Emond and also Melissa Germain, the host of the event.  In the interview, they share what they found to be key trends identified at the Forum, the weakest link in the cold chain and how the two industries could benefit by working together and sharing knowledge.  You can read the interview by clicking here.

I’m looking forward to the 2013 Forum and my thanks to Dr. Emond and Ms. Germain for organizing the event and taking the time for the interview.

Kevin Payne

Senior Director of Marketing

…And Speaking of Intelligent Pallets (and RTIs)…

Maybe you don’t think about pallets that often.  If you’re not in the logistics industry, the word “pallet” probably conjures up images of beaten up pieces of wood on a loading dock behind a store. But, if you’re into logistics, there’s a whole lot more going on.

A recent article on PalletEnterprise.comspeaks about trends in the logistics of the pallet industry. The author, Rick LeBlanc, discusses a number of logistics challenges and opportunities for 2012 including palletization in emerging nations, unit load tracking, supply chain optimization, sustainability, and sanitation concerns. One thing in particular, however, struck me: the increasing need for intelligent pallets – and I would add into that returnable transport items (RTIs) such as totes, bins and containers as well.

Will Wooden Pallets Go the Route of the Dinosaur?

LeBlanc writes: With global supply chains, the importance of accurately projecting demand, and coordinating it with supply continues to be of huge importance, as is flexibility. With respect to flexibility of managing inventory en route, tracking and monitoring technology will play an increasingly important role. [Italicized references are my added emphasis.] Whether or not such technology will be increasingly embedded in pallets or just attached or in the vicinity of unit loads, is yet to be determined.

Another point that LeBlanc raises relates to risks and costs associated with bioterrorism, cargo theft, and food safety. He cites a recent presentation by Dr. Paul Singh, professor emeritus of Michigan State University, and Michael McCartney, principal of QLM Consulting, at the United Fresh produce conference in Dallas about the Food Safety Act and the FDA’s ability to enforce the law. Referencing the United Fresh presentation LeBlanc writes: Depending upon how aggressive the enforcement, we should see an escalating emphasis on proper handling of pallets to keep them clean and dry, as well as more tracking technology to monitor not only the location of the load, but also tampering, load temperature, vibration and other information that could influence load condition. Whether this technology will be embedded in the pallet or somewhere else in the vicinity, Singh and McCartney are suggesting a future where a trailer load of fresh produce will be a high tech mobile warehouse.

LeBlanc then summarizes that the logistics industry will be looking for “safer pallets, greener pallets and possibly smarter pallets”.

I agree.  We’re seeing increasing demand for smarter, intelligent pallets and RTIs.  Producers, retailers and food service providers in particular are looking to intelligent RTIs that include the ability to locate where the RTI is as well as report on the condition of the cargo – specifically the temperature.  RTIs with embedded condition monitoring tags built in can significantly enhance food safety and quality by capturing and sharing both the temperature and waypoint information providing the ability to ensure the product has been handled correctly in the supply chain as well as providing an electronic traceability record. These capabilities, combined with advances in RTIs, could help to revolutionize logistics and enable a more intelligent supply chain.  You can learn about how XC3 Technology can help by clicking here.

Kevin Payne

Senior Director of Marketing

ABC News Story: Are Doctors Improperly Storing Vaccines?

If you have children who are receiving vaccines to prevent illnesses, a recent story on ABC’s Good Morning America should give you cause for concern.  The story references a study by the U.S. Department of  Health and Human Services regarding the Vaccines for Children (VFC) program.

The story said:

Although the majority of storage temperatures we independently measured during a 2 week period were within the required ranges, VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation.

According to the story, the investigation found that the 76 percent of the providers referenced in the study stored the vaccines at temperatures that were either too hot or too cold. They also found that 13 providers stored expired vaccines along with nonexpired vaccines. In addition, they said they found that none of the providers properly managed the vaccines according to VFC program requirements.

The story continues by saying “As a result, the 20,252 VFC vaccine doses that we [HHS] observed during site visits may not provide children with maximum protection against preventable diseases and may be vulnerable to fraud, waste and abuse,” according to the report. “These doses were worth approximately $800,000.”

Temperature Monitoring is Critical

The story references Dr. William Schaffner, chair of preventive medicine at Vanderbilt University Medical Center who said that “The temperature [of vaccines] has to be monitored throughout the entire time, from the time it leaves the manufacturer to the time it spends in transit to the time it’s delivered to the clinic and it’s used in the clinic. We want every dose given to every child to provide the optimum protection as it’s intended.”

Dwayne Grant, the regional inspector general for the Office of Inspector General in Atlanta commented that “We want them [The Centers for Disease Control] to work with the grantees and providers to make sure that they’re storing vaccines properly, then put in better inventory control mechanisms so there’s less inventory on hand so that creates less chances that vaccines can expire.”

This particular report was specifically related to vaccines offered under the VFC program, doctors say the government’s investigation is an important reminder to all clinicians about the need to properly and carefully store all vaccines.

“We have vaccines delivered probably every week, and vaccines come in these large Styrofoam containers, and that is to keep them cold or frozen depending on the particular vaccine,” said Dr. Promise Ahlstrom, a pediatrician.

As a parent or patient, how do you know if the vaccine you”re receiving is still effective?  You can’t…you have to trust that your health care provider is taking proper care in refrigeration, storage and handling of vaccines.  The best bet today, if you’re concerned, is to speak with your physician about the vaccines and how they’ve been stored and manage in the office or at a clinic.

Ahlstrom, the pediatrician, also said parents shouldn’t worry too much about it, but said if they are worried, they should ask questions. “I think that it is probably good for them to address it with their doctors so that they can feel that their mind is put at rest,” Ahlstrom said.

The increase in the number and usage of temperature sensitive pharmaceutical products may require new methods for monitoring and managing the transportation and storage of these items.  We think RFID solutions can help by making it easier to identify potential alarm conditions before they occur and provide doctors and patients with documented proof of the quality and efficacy of the vaccines that they’re dispensing.  You can learn more about this by reading our white paper.

Kevin Payne

Senior Director of Marketing

Tracking the Clues

Many of us remember playing “Clue” a popular board game from Parker Brothers.  We had to determine who, what and where something happened by a process of elimination.  For me, at least, it wasn’t easy. It was hard to keep track of all of the players and locations and who was where when.

Tracking and Tracing the Clues Can be Difficult

When it comes to food safety and recalls, it can be even more complicated as contamination issues need to be tracked to the source and then traced through distribution to a myriad of retailers and ultimately to consumers in order to stop the spread of tainted product.  And, unfortunately, there seems to have been an increase in the number of recalls with one grower having just now issued its third recall in two weeks time. We should applaud their proactive approach to removing potentially contaminated produce from the supply chain as quickly as possible.

What can we do to improve the traceability process?  Trying to sort the clues using paper-based systems be a time consuming and complex process fraught with dire consequences.  The Food Safety Modernization Act (FSMA) is designed to help remedy this problem and RFID-based track and trace systems can be a big part of the solution because they have the ability to capture and digitize information for more rapid analysis. Pallet-level temperature monitoring RFID tags not only helps to improve shelf-life management but also can store way point data about the product as it moves through distribution.   Having an electronic – rather than paper-based system –  can help speed the search to the source of the problem and then more quickly identify who has received and distributed the product, potentially shaving days or weeks off the recall process.

Not only does this help to ensure public safety, it also helps protect the growers, packers, shippers and distributors by enabling them to better manage their supply chains in the event of a recall.  We have a short white paper on the impacts and benefits of the FSMA which you can find here.

Kevin Payne

Senior Director of Marketing