To help prevent counterfeiting and to minimize medical dispensing errors around the world, auto-ID standards need harmonizing.
Automatic identification technologies involving bar codes and RFID are being looked at as powerful weapons in the fight against counterfeiting, diversion, and medical errors. FDA in particular has mandated bar codes for drugs supplied to hospitals and is pursuing RFID to develop an electronic drug pedigree.
But given the global nature of the pharmaceutical industry as well as the worldwide threats of counterfeiting and diversion, FDA’s work may not be enough. Global standards shared throughout the healthcare industry may be the key to identifying and authenticating products.
The GS1 global Healthcare User Group (HUG; www.gs1.org/hug) is a voluntary group of specialists who have come together to develop automatic identification standards specific to the needs of the healthcare industry. In this exclusive roundtable discussion with PMP News editor Daphne Allen, several of the GS1 HUG leadership team members and work team leaders discuss the group and its hopes to unify automatic identification standards throughout the world.
Participants include Steve Hess, senior director of packaging technology for Merck; Rich Hollander, senior director of packaging services for Pfizer; Ulrike Kreysa, group manager, healthcare solutions, GS1 Solutions, GS1 Global Office; Peter Tomicki, global packaging project manager for Baxter; and Mark Walchak, senior manager, global package technology and testing, for Pfizer.
Can you explain a little bit about GS1 HUG and what are some of the current tasks at hand?
Hollander: The GS1 HUG was formed about a year ago to help bring together the medical device and pharmaceutical product communities to understand how to best apply automatic identification tools to address issues involving patient safety. When we talk about patient safety, we are talking about everything from prevention of dispensing errors to serialization to enable the authentication, tracking, and tracing of high-risk products subject to counterfeiting. In the past year, we have met three times formally—once each in Brussels, Princeton, and Rome. During that time we have worked to understand the specific requirements for patient safety around the world. Not just from a user perspective—that is the product manufacturer—but also from the rest of the supply chain.
Are you taking the framework that was already established by the Uniform Code Council Inc. (UCC) and EAN International and developing it into global standards?
Kreysa: EAN International and UCC came together 11¼2 years ago and formed the new organization GS1, which is a really global organization. Before, there were different member organizations around the world in more than 100 countries, all with different names. The biggest ones were UCC and some member organizations in Europe and Japan. They all have decided to form one global organization called GS1.
Hess: One thing that attracted me to this organization was the approach of trying to leverage the entire portfolio of GS1 technologies. The HUG was not focused solely on using a single technology to solve all problems. Also, there are lots of other initiatives that are very U.S.-centric, but I was attracted to the HUG’s global approach. I think that is just so powerful.
Does this mean that there will be one harmonized approach to bar coding or electronic product coding for healthcare products?
Walchak: One of the things that we are trying to do is to have a standardized system for assigning numbers that will be used from a unit-dose aspirin all the way up to an MRI machine. It would cover any OTC or prescription drug and all medical devices. We will have a standardized system that can be used universally.
Tomicki: The scope of the HUG is really across all industries within healthcare—devices, pharmaceuticals, biologics, vaccines, and all the subindustries within those. I think it is across all of healthcare and it is in concert with the GS1, which is across all other industries as well. It makes sense to align healthcare as one industry as best as we can so that it is not regional or technology specific.
Can you give an example of what standard already exists and how you will be adapting it?
Walchak: There are already global trade item number (GTIN) allocation rules that GS1 has published for consumer goods. We will be taking those rules and modifying them to take in the unique requirements of the healthcare industry. For example, we need a unit of use that would be taken to the patient’s bedside in a hospital. That unit needs to be scanned and recorded. To do this, we have taken the National Drug Code (NDC) and incorporated it into the GTIN, which is now a unique number that is recognized worldwide.
Tomicki: In essence, FDA created the NDC structure in the United States to ensure that manufacturers’ products can be identified. The power of the GTIN is that it identifies products uniquely for a company. Currently, the NDC is inside the GTIN, so it aligns well in that respect. However, GTINs that contain NDCs are U.S. specific, and elsewhere GTINs contain other country-specific codes or are assigned by the companies and managed accordingly within those companies.
Will there be any particular challenges to that system?
Tomicki: I think there will be, potentially, as the world goes towards GTINs. I think the NDC structure makes a whole lot of sense for the U.S. market, and in terms of a global market, it is similar to any other national code. Managing country-specific codes does present programming challenges, though, in global inventory management systems. In terms of the GTIN being a product identifier, if countries allow companies to assign GTINs for their product without embedding country codes, we would manage the GTINs within our own systems and according to the healthcare industry GTIN allocation rules. This would enable global GTIN standards and infrastructure to take care of them, minimizing regional exceptions.
Walchak: There are different countries that have different ways of assigning the numbers that are to be used for healthcare items. In the ideal world, the way they assign those numbers would fit into the GTIN system. Some of them do not, and we will have two different numbers, one that will be country specific to meet their regulatory requirements and one that is a GTIN. But I think that most countries will be aligned.
Are there any particular healthcare products that will be a challenge to get into this system?
Walchak: One of the biggest issues we face is the medical device area. There is such a broad range of items, and we have a committee that is trying to come up with a system.
Tomicki: The GTIN allocation for devices is going to be one of the most significant challenges. There are many different permutations and possibilities or scenarios for assigning rules for how to assign GTINs to those types of products. That working team will generate rules that make sense and that are manageable within our infrastructure.
Walchak: Examples of some of the issues we face are for the same product—you might have different languages, voltages, or software. A key question arising in GTIN allocation in the medical device area is whether you assign GTINs based on form/fit/function or based on the commercial unit.
What data structure may evolve for the medical device field?
Walchak: EAN13 codes and UPCs that exist for most items can be converted into a GTIN.
What are some of the GS1 HUG work teams?
Hess: I can touch base on the vaccines work team. Vaccine containers are pretty small, so space is an issue. In addition, while FDA has issued a compliance guide that describes its intent to exercise enforcement discretion for Rx and OTC drugs to pilot RFID, we do not yet have that same clearance for biological and protein-based products. FDA is asking for data on RFID’s possible effects on biologicals and proteins. Again, HUG’s approach involves looking at the full portfolio of GS1 technologies and trying to identify the right technology for each product area, not trying to force-fit a unique technology across the board. At this point we are identifying what our problem areas are. We are trying to also identify as much as possible where we can harmonize with pharmaceuticals, because that is really what we want to do. But there are going to be some unique requirements for vaccines, such as the size and the cold-chain requirements.
Tomicki: The biologics and vaccines team was created because it is a high-need area for auto-ID in healthcare. There are certain countries like Canada that are moving really quickly toward trying to get either mandates or guidances in place to effectively manage biologicals and vaccines in their regions or countries. We want to create one harmonized approach for all of healthcare if we can, including devices, pharma, biologics, vaccines, and all subcomponents or subindustries.
Now, in certain cases, there may be some unique features of that particular subindustry that warrant some special attention, and that is what we are looking at with vaccines and biologics. We want to see where there are commonalities and differences and address those differences so that we can basically build upon this harmonized healthcare standard.
Hess: Harmonization is really the key. If we can get a harmonized approach, we are going to increase the rate of adoption, and we are going to have good benefits in the end in terms of patient safety and reduced errors.
Kreysa: There are eight work teams in total. These include Standards Implementation/Regulatory Affairs, Business Case, Membership, Communication and Coordination, Vaccines and Biologicals, Instruments and Implants, Standards Development, and GTIN Allocation Rules. The most central one is the Standards Implementation/Regulatory Affairs team, which is looking at maintaining a central database of all the regulatory requirements and autoidentification policies around the world. They are also looking at the issues around the world and will define global guidelines.
Tomicki: The standards development working team will optimize the existing GS1 standards process for healthcare. Healthcare has been a silent user of GS1 standards for a long time, when it was known as UCC/EAN. With the HUG we are looking to have a firm presence in the GS1 so that we can take a look at their existing process and see whether it makes sense that there should be some changes specific to healthcare needs. The working team is also forecasting future needs in healthcare, which is an ongoing process that will be cyclical or periodic. We will review existing standards and predict what standards we may need so that we can properly queue up our submissions to the GS1 to create new standards for healthcare needs. Some working teams, vaccines and biologics, for example, have identified the gaps, and we are addressing them.
Can you tell me how you will fight counterfeiting, diversion, and medical errors?
Hollander: The HUG was formed to develop global standards in the healthcare industry when it comes to automatic identification and act as the leading voice for the healthcare industry. As such, we needed to have a reason for doing it. Ultimately, for those three focus areas we want to use the work teams to help us define the appropriate data elements such as the GTIN or the electronic product code (EPC), the appropriate data structure, application identifiers, and ultimately the appropriate data carrier. Should it be a Code 128 linear bar code? Should be it a 2-D Data Matrix? Should it be the RFID tags themselves for EPC for non-line-of-sight applications? These aforementioned work teams are focused on defining these standards.
Many of the standards required already exist, but there are a multitude to choose from. Multinational companies are struggling to keep up with individual market needs that keep being put out there in the form of regulations that are divergent from one another to address the same business issue, be it dispensing errors, diversion, or anticounterfeiting. Individual markets, such as the United States, Italy, Japan, Portugal, Spain, Greece, Belgium, and now France, are all defining their own automatic identification approach. Most of them are at least using GS1 standards, but they are using them differently, and that is part of the problem.
Kreysa: It is not easy to define a global standard for all healthcare products. In the last 11 months, HUG has gone quite a long way to getting the right members involved. We are working on getting more attention from regulatory bodies; this cannot be enough. We are now really working hard to get standards and guidelines written and agreed on.
I think that the team’s existence is already holding up the release of other regulatory requirements from different countries or different bodies. We have achieved this, even if we have not yet released standards. But our work on it makes others think.
A lot of ministries of health are already participating. At our last meeting in Rome we were welcomed by the Italian Ministry of Health and others. The WHO participated, and it plans to include the HUG in reviews of its documents on fighting counterfeits.
Hollander: We communicate quite regularly with FDA. FDA actually came to our meeting in Brussels, presented its business requirements, including some of its work toward serialization via RFID and/or bar codes. They will attend our June conference in Minneapolis. In addition, one of our guiding principles is to continue to stay closely aligned with the EPCglobal Healthcare and Life Sciences (HLS) business action group (BAG). The trichairs from the HLS BAG attend our HUG meetings regularly, and the HUG leadership attends HLS BAG meetings regularly.
We are looking at establishing global standards for the healthcare industry. Your readership largely comprises of users, supply-chain participants, or manufacturers that produce equipment and software for the healthcare industry. We would very much welcome people who are interested in actively working in the HUG to help establish these standards. We need people to join our work teams and commit to doing work to help establish these standards. We will invite in third-party vendors as appropriate once we understand the standards needed to support existing business issues.
Tomicki: To identify stakeholders, we are looking specifically at global manufacturers, but we are also welcoming all manufacturers, channel partners, and end-users. We are trying to identify all of the stakeholders in the channel who would like to play a role and welcome them to the HUG.