FDA RFID Drug Pilot Planned This Summer

The U.S. Food and Drug Administration has signed on to a six-month project with a technology firm, as well as drug companies and hospitals, to study the value of data captured from UHF RFID-tagged injectable drugs as they move from the point of manufacture to a patient.
Published: July 30, 2019

The U.S. Food and Drug Administration (FDA) plans to launch a pilot in August 2019, managed by a group of technology, drug and health-care companies, to measure the effectiveness of using RFID technology to improve drug traceability and verification in the supply chain. Pharmaceutical traceability technology firm Kit Check recommended the pilot to the FDA and is providing the testing of UHF RFID tag reads, as well as related data, in partnership with the Hackensack University Medical Center,
Coral Gables Hospital, Nephron Pharmaceuticals and Novartis.

The six-month pilot will test an alternative technology for meeting the requirements of the FDA’s Drug Supply Chain Security Act (DSCSA)—namely, RFID—with UHF tags applied to the packaging of drugs, which are read as they move through the supply chain and are compared against traditional 2D barcodes. The pilot will leverage both the 2D barcode monitoring technology commonly in use, as well as RFID, so both methods can be evaluated, compared and analyzed. The goal is to identify whether RFID could provide use cases for greater drug supply chain visibility, according to Kevin MacDonald, Kit Check’s CEO and co-founder.

Kit Check’s Kevin MacDonald

In 2013, the FDA (which has not responded to a request for comment) released the DSCSA to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. In this effort, the DSCSA requires the serialization of each drug as it is manufactured and then traced from that site to the drug dispenser, with a unit-level traceability mandate slated for 2023. To date, electronic data exchange for the drug industry has been largely provided by barcodes. In fact, the DSCSA does not mandate or recommend RFID as a form of technology to track pharmaceuticals, but only 2D barcodes.

“With RFID,” MacDonald says, “we’re doing this at a more detailed level than 2023 regulations required.” For instance, with barcodes, companies typically track goods by the case, scanning the barcode on each case as it is transported to a hospital and is provided to patients. However, that provides no item-level traceability, he notes. “With RFID, we’re tracking every single vial, every step of the way.”

The test consists of attaching adhesive UHF RFID labels, provided by Avery Dennison, to vials of a variety of injectable drugs, as well as pre-filled syringes, according to the FDA’s requirements. The labels will be attached at the point of manufacture and will then be read at multiple points along the supply chain, through the distribution center and to the hospital. The readers used to read the tags before the product reaches the latter will be a combination of off-the-shelf devices, MacDonald says, while Kit Check’s own RFID-enabled scanning stations will be deployed at hospitals.

Each tag’s unique ID number will be linked to the drug’s batch and lot numbers, as well as to its date of manufacture and expiration date, and this information will be stored in Kit Check’s software. The tag will be read at the point of shipping and again at the receiving hospital. At the same time, barcode scans will be collected and stored as part of the electronic data exchange.

Kit Check predicts the RFID-based data could provide more granular details regarding products and their history, as well as prove their authenticity. For instance, MacDonald says, with the unique ID captured and linked to a particular lot number and other related data, in the event that a drug is recalled, the software will enable supply chain members to identify where each vial of a recalled product is located. It will also allow an alert to be sent to the hospital that may have that vial onsite, so that it will not be administered to a patient.

As the tag is read at the hospital, users could identify if an item has been recalled, whether its expiration data is approaching and whether it is counterfeit; if the tag cannot be read or does not match the product’s printed label, it is likely a counterfeit. Kit Check intends to create some “fake” counterfeits to determine whether they can be identified in the supply chain via an RFID tag read. Once the pilot is under way, MacDonald says, the tags are expected to be read at approximately six sites.

The participating hospitals have already been testing or deploying RFID technology for their own purposes, while some pharmaceutical companies may be tagging their products for the first time during this pilot. Drug maker Sandoz, which already utilizes Kit Check’s solution, plans to participate in the pilot, using RFID and a central repository to capture and manage data, according to Anthony J. Wallace, Sandoz’s head of sales.

Sandoz’s Anthony J. Wallace

Sandoz has been working with Kit Check to develop a system to automatically identify details about the medicines it produces and sells, including each medication’s National Drug Code (NDC), lot number and expiration date. The goal, Wallace explains, is to save time for hospital personnel and reduce the risk of medical errors. “As a result,” he states, “the pharmacy can see the product’s journey from inventory to the point of administration in real time.” This technology is expected to reach more than 500 hospitals throughout the United States and Canada.

“We believe this pilot will show that RFID, a non-line-of-sight technology, can reduce aggregation errors in the supply chain for serialization,” Wallace says, as well as “provide efficiency on the product flow in the supply chain and assist hospitals with utilizing DSCSA-required data in recall situations.” Sandoz’s goal, he adds, is to better understand how its medicines are used at hospitals, optimize the supply chain, and track recalls and expiration dates.

“We expect one of the outcomes [of the FDA pilot] will be giving people a better knowledge of what RFID can accomplish,” MacDonald predicts. “What we’re hoping is that the pilot shows RFID is a viable and acceptable data carrier.” Based on that result, he conjectures, the pilot could open up the Food and Drug Administration to recommending interoperability of RFID with the DSCSA electronic records that are captured and shared among supply chain members and the FDA.

“What we’re trying to do is open everyone’s eyes about what’s already out there,” Wallace states. “People think RFID is a ‘maybe someday’ technology.” Far from that, he argues, the technology has been deployed by Kit Check at 500 hospitals to date—with around 100 new hospitals launching the company’s RFID solution each year—and RFID tags have been applied to between 65 million and 70 million drugs so far. Most tags are still being applied at the hospital rather than by the pharmaceutical companies. Kit Check finds that compounders are the first drug companies to begin deploying RFID.

The pilot will focus on three audiences, MacDonald says: the FDA, the general public and the pharmaceutical industry. The agency intends to make the final reports public alongside other DSCSA 2023 participants’ findings, with the hope that all supply chain stakeholders will benefit from the data.