Prior FDA Investigation Spurs Hospital to Find DSCSA Solution
The advent of FDA enforcement for dispensers came and went on March 1 with no major headlines, but that doesn’t mean that hospitals are necessarily flying under the Drug Supply Chain Security Act (DSCSA) radar. We caught up with one small Wisconsin hospital to learn what key factors—such as past lessons learned when federal investigators unexpectedly showed up at their door—led them to seek a full-scale compliance solution.
Preparing for DSCSA
Aspirus Langlade Hospital is located in Antigo, Wisconsin, and comprises two dispenser locations: the hospital and an adjacent cancer center. The pharmacies conduct direct and indirect business and drop-shipments with 13 trade partners. Aspirus Langlade Pharmacy Manager Stacy Brownell prepared herself for DSCSA by attending a number of webinars offered by TraceLink and Vizient, the hospital’s group purchasing organization (GPO). “It was those two companies, and links to all the guidances that had been published by the FDA, that really spurred my research,” she says. Brownell discovered that the scope and complexity of DSCSA requirements has the potential to place unheralded demands on hospital staff. “Anything that comes from the government is complex,” Brownell continues. “With serialization, the regulations will change every year until 2023.
Ruling out a “do nothing” or homegrown approach
Looking at a box full of unsorted packaging slips last October, Brownell determined that a homegrown solution wouldn’t be adequate for storing, archiving, and accessing all the data required by the DSCSA. “It would still be a manual process and I knew it wasn’t going to be searchable like I needed it to be. It would be far too labor intensive for our small pharmacy to handle it with the number of people we have,” she said.
Other hospitals that Brownell spoke to seemed less concerned about DSCSA compliance. “When I asked what they were going to do, there was no reply.” Brownell was concerned, in part, with protecting her own license and reputation. “My name is on the license with the state. I’m not willing to put my license and my hospital pharmacy license on the line,” she says. “I would have to answer to the FDA if they chose to come visit us. There isn’t anybody else in the hospital that is responsible for compliance. I can’t pass the buck—it’s all on me.”
Talks between the hospital’s leadership team and business partners like Vizient made it clear that a third-party solution would deliver a scalable model that an internal system could not. “In the future, how will you comply with lot-level recalls and serialization?” she asks. “I don’t know how a homegrown system would ensure everything you need to have.”
Expecting the FDA
Aspirus Langlade staff is well aware that an inspection can happen to any business of any size in the supply chain, which is the other reason that “doing nothing” wasn’t an option for them. “The FDA has already been in our hospital once,” Brownell says.
In 2013, the FDA was investigating one of Aspirus’ upstream suppliers due to a concern that some of the drugs they provided were counterfeit. “The FDA wanted to know how we knew they are not counterfeit,” Brownell says. In addition to drug product, investigators wanted to see documentation. “They asked us to show them what was on our shelves, our invoices, and where we purchased from.” Brownell says the hospital was caught off guard. “They showed up unexpectedly,” she says. That experience of feeling caught unprepared is not one that pharmacy staff is eager to repeat.
Choosing a provider
When it came to selecting a provider, Brownell explains that searchability and price were both “huge decision factors.” Searching by drug and national drug code (NDC) was an important advantage that TraceLink offered. TraceLink was also less expensive than the other third-party solution she considered. Plus, Vizient had recommended TraceLink.
Tapping into TraceLink’s established network of trade partners meant that most of Aspirus Langlade’s suppliers were just a single connection away, significantly reducing system integration and project implementation efforts. “Implementation timeframe was important because I waited until the last minute,” Brownell says.
“The TraceLink network is key. It’s been beneficial because I’ve had to do very little work in setting up the relationships with my suppliers. All I had to do was provide company names and account numbers. That took maybe half an hour.” In addition, the conversations she had with the TraceLink Services team have helped her feel like she made the right decision. “I feel very comfortable based on the many conversations I’ve had with Sarah and the implementation teams.”