A provider of healthcare services that serves patients with chronic diseases such as type 2 diabetes, heart disease, and arthritis relies on TraceLink to meet DSCSA requirements and ensure that products from its suppliers can be securely tracked. If the product can’t be traced back to a legitimate source, the company won’t allow it to be sold by its network of retail pharmacies. This focus on DSCSA compliance and patient safety is essential to the company’s brand and to the people and communities that rely on the pharmacy network.

The Challenge of DSCSA for Pharmacy Operations

Under DSCSA, pharmacies must be able to provide lot-level transaction information, histories, and statements, or “T3s,” to the FDA for all prescription medications that they purchase. When the company stepped in to help manage their pharmacies’ DSCSA compliance requirements, they quickly saw inconsistencies, errors, and omissions in the documentation that was being maintained by its pharmacies.

“About 60% of our pharmacists today still send us paper transactions,” noted the director of pharmacy compliance and implementation. “The big challenge is missing information. We’ll see that a pharmacist didn’t put the T3 in there, or simply wrote that the T3 was verified. Or there will be a UPS tracking number—but no T3.”

The company recognized the importance of its partnership with TraceLink in helping its pharmacies meet the guidelines of DSCSA. Managing an avalanche of paper-based documentation and reconciling the data to meet compliance guidelines represented a serious challenge in terms of time and resources. A primary concern was the time it would take to prepare for an FDA audit, and the underlying quality and accuracy of the T3 documentation.

Putting a Paper-to-Digital Solution “on Autopilot”

Prior to the director’s appointment, the company had implemented the Product Track solution from TraceLink to satisfy lot-level compliance. When TraceLink introduced its End-to-End Administration Services in July 2017, the company quickly saw its potential for streamlining the process for managing wholesaler paperwork that their pharmacies were sending to its compliance team, as well as managing drop shipments to pharmacies directly from the manufacturers.

“We started using the Product Track End-to-End Administration Services right when it came out as a way to get transaction data into the system quickly: we put in an invoice and it was on autopilot. The TraceLink team alerts us if there is any T3 information missing.”

Having accurate data at their fingertips also gave the company visibility into “what’s on the shelves.” When faced with an audit that needed to identify products that were subject to regulation and over-the-counter products that were exempt, such as diabetic testing strips, the team was able generate a full report from the TraceLink platform in about 15 seconds:

“It was an epiphany,” said the director. “I needed that report and it was there because we had done everything right. Had we not done that, our whole week would’ve been blown up.”

TraceLink enables certification and competitive advantages

Looking ahead, the company is evaluating its business development in terms of the value of being a fully compliant service provider and working towards certification by the Utilization Review Accreditation Commission, or URAC, a national organization that helps promote healthcare quality through the accreditation of organizations involved in medical care services. URAC accreditation will enable the company to qualify for preferred contracts and to offer mail-order prescription services.

“It takes about one and a half years to complete the training for [URAC] certification. Having a proven, recognized solution like TraceLink Product Track with End-to-End Administration gives us a distinct advantage. It shows an organization like URAC that we are doing everything possible to be compliant.”

Though DSCSA serialization requirements for pharmacies are still two years away, the company is already considering the time and resources needed to prepare for serialization at the pharmacy level. By leveraging TraceLink as the foundation for all its DSCSA processes, the company is well poised to take advantage of serialization data as it begins to move through its system. Access to product master data at the unit level will provide even greater visibility into ‘on the shelf’ products, make it easier to avert product shortages and expedite product recalls, and provide even greater levels of security and safety to the organization’s patients, partners, and communities.

From the company’s perspective, “As we transform our processes to meet DSCSA requirements and prepare for serialization, we need to get all our pharmacies on the same page. With TraceLink, we are able to have one process, one conversation.”