Never is safety and integrity of a product more necessary than when talking about pharmaceutical products. The wrong dose, the wrong medicine or a counterfeit product can lead to expensive recalls or even have deadly outcomes. Luckily, the industry is tightening up on processes and packaging to ensure that these types of incidences occur less and less.
According to the report, “Anti-Counterfeiting Packaging Market by Technology (Authentication & Anti-Tempering, and Track & Trace), by Application (Food & Beverage, Pharmaceuticals, and Others)—Global Trends & Forecast to 2019,” by MarketsandMarkets (marketsandmarkets.com), the global anti-tampering, authentication and anti-counterfeit packaging market is projected to grow at a Compound Annual Growth Rate (CAGR) of 14.1% between 2014 and 2019. Authentication technologies are projected to grow at the highest CAGR of 16.3%, because of the increasing awareness about counterfeit products.
Anti-counterfeit technologies (such as holograms, inks and dyes and watermarks) are used to curtail the use of counterfeit products in the food and pharmaceutical markets among numerous other sectors. According to the report, North America was identified as the largest market supporting anti-counterfeit, anti-tampering and authentication technologies in 2014, followed by Europe.
Track & trace technologies, like RFID and bar codes, are critical to authenticating pharmaceutical products. Barcodes are used in numerous applications globally and account for over 60% of the track & trace technologies market in 2013. RFID is projected to grow at a CAGR of more than 20%, to reach $35.2 billion by 2019. There are more measures in place than ever before to stop counterfeit drugs from making their way to consumers.
Prescription drug packaging
According to GS1’s website, counterfeit drugs have become an increasing global threat over the last few decades and more and more regulatory authorities, including Argentina, Brazil, India, South Korea, Saudi Arabia and the EU, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialization in order to protect the supply chain.
In the U.S for example, the Drug Quality and Security Act (DQSA) was signed into law on November 27, 2013 to ensure that a consistent, standardized approach is taken by the pharmaceutical industry to tackle counterfeiting, theft and diversion, and to share critical information across the supply chain. It outlines critical steps to build an electronic, interoperable system for identification and traceability of prescription drugs as they are distributed in the U.S. The new law supersedes any states requirements.
The requirements are designed to become effective over time and are split into three main phases:
April 2015: paper or electronic chain of ownership. Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies beginning July 1, 2015) in the drug supply chain will provide information about a drug and who handled it each time it is sold in the U.S. market
November 2017: item serialization
November 2023: full track-and-trace down to item level
This new system will enable verification of the legitimacy of the drug product identifier down to the item level, enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls — a win-win-win for packagers, pharmacists and patients alike.
The FDA’s decision to require prescription drugs be traceable throughout the supply chain is spurring the development of product identifiers. Product identifiers, which are an FDA requirement, on each prescription drug package hold valuable information that tells doctors, pharmacists and end-users its chain of custody. This identifier can be in the form of a data matrix code containing key information such as standardized numerical identifier, lot number and expiration date and must be readable to the human eye, as well as a machine. Product identifiers will be mandated on all pharmaceutical packaging starting November 27, 2017.
So what does this mean for packaging? The short answer, everything. According to Siobhan O’Bara, senior vice president of Industry Engagement for GS1 US, it all starts with the packaging.
“The packaging has the capability to show everything there is to know about the product and where it has been throughout the supply chain. It must clearly and consistently display the proper information for authentication and track and track efforts to succeed,” states O’Bara.
Medical device packaging
It isn’t just pharmaceuticals that are requiring strict labeling. September 24, 2014 marked the start of the FDA requiring all medical devices, starting with Class 3 devices, be labeled with a unique device identifier (UDI). UDIs contain imperative information about the device (version, model, etc.), as well as the production (lot batch, serial number, expiration date and date of manufacture) and must be readable to the human eye and machine readable. GS1 was named a UDI issuing agency in 2013.
O’Bara says that many drugs and devices are made outside of the U.S, further emphasizing the needs for traceability and authentication. The goal of GS1 and proper labeling is to improve the information on hand about the product and its journey through the supply chain.
The industry, through the GS1 Healthcare US Initiative, is collaborating to create a global standard for the flow of information with the ultimate goal of patient safety. Product identifiers and UDIs simply put, offer that information in a globally recognized format. Machine readable data matrix codes provide all of this with no room for human error such as jotting down the wrong number, the wrong date, or missing something altogether.
A set of standards is critical for tracing, as well as assisting with recalls. Without this data, it is nearly impossible to pinpoint where the product failed across the chain. It is also difficult to pinpoint which providers are using this recalled product. These global data standards will change this, saving manufacturers and packagers money along the way, while improving patient safety.
It’s all about the package
Features within the packaging can help with anti-counterfeiting and track and trace efforts, as long as we know what to look for.
“Packaging allows for inclusion of multiple layers of anti-counterfeiting features both covert and overt. Some features are intended to allow investigators to determine whether a package is real (primarily covert features) and some can aid pharmacists, doctors and patients in determining if the package they have is legitimate (mostly overt features). The challenge is and will continue to be teaching the public what those overt features are and how to recognize them,” says Walter Berghahn, executive director, Healthcare Compliance Packaging Council.
According to the GS1 website, healthcare is by nature a global sector, with supply chains that often cross borders. A global standardized system for traceability, from product manufacture to patient treatment, is imperative to comply with the increasing legal requirements for product traceability around the world. In cases of cross border trading, a global trade item number (GTIN) can be used to identify that product in any country without any restrictions or errors.
With new authenticating and track and trace elements in place for the healthcare market, and new items planned for the next few years, supply chains are tightening up their processes for less error. The more knowledge the public has and more checkpoints in place for packagers and pharmacists alike, the better off all parties involved will be. The ultimate goal is a safer future and that future is now.
How diamond can help companies track and trace products and fight counterfeiting
By: Dr. Andrew S. Janoff, founder and CEO. Taaneh, Inc (taaneh.com).
For products ranging from electronics to fragrances, fashion accessories and pharmaceuticals, counterfeiting is a global threat and costs hundreds of billions of dollars in lost revenues annually. In order to prevent losses related to counterfeit goods, manufacturers often use security measures including package serialization and bar code authentication, but these options have significant limitations, particularly in cases where a product becomes separated from its packaging or labeling. As methods of counterfeiting and forgery become more advanced, manufacturers will need to adopt more effective technologies capable of tracking and tracing products and their packages through every phase of a supply chain from production to consumer. And they will have to provide this information in real time with mobile and readily available technologies that cannot be easily copied or decoded.
Recently, companies have begun to explore the use of diamond powder to confirm a product’s authenticity and combat counterfeiting. The unique molecular structure of diamond allows it to exhibit a wide range of distinct spectral signatures that are virtually impossible to replicate. The presence of diamond in a product, even in trace amounts, makes it possible to confirm a product’s authenticity using a handheld scanner. Importantly, this process can confirm authenticity even in cases where the product has become separated from its packaging. Diamond can also be added to both products and labeling or ink without disrupting existing manufacturing processes or timelines.
Tamper-proof sealing offers security
ITW Pillar Technologies (pillartech.com), a leading manufacturer of advanced surface treatment and induction cap sealing systems, has formed an alliance with Applied DNA Sciences, a provider of DNA-based anti-counterfeiting technology, supply chain and product authentication solutions, to provide traceable, tamper-proof induction sealing solutions that can be used to protect products from contamination and counterfeiting.
ITW Pillar Technologies’ systems easily incorporate a unique SigNature® DNA taggant, supplied by Applied DNA Sciences, to mark products and allow for forensic authentication on the seal itself. This value-added solution has the benefit of protecting the tamper-proof seals on original packaging, and offers scientific proof that the quality and integrity of the product has not compromised.
“Traceable and tamper-proof induction sealing solutions help to protect products, such as pharmaceuticals and agrochemicals, that may be subjected to regular audits, inspections or product authentication,” states MeiLin Wan, executive director, project development, Applied DNA Sciences.
Please mark your calendars to join ITW Pillar Technologies’ upcoming webinar titled, “New Innovations in Closures and Induction Sealing.” This free webinar is September 10.