Hamacher Resource Group Inc. and Providence Health Technologies have completed a six-month pilot study as part of Food and Drug Administration’s (FDA) DSCSA pilot project program. The pilot study focused on identifying the ability of small dispensers to comply with recent Drug Supply Chain Security Act (DSCSA) requirements. The study focused on those pharmacies operating in the retail, hospital, long-term care, and specialty markets.
PHT, a software services company that specializes in healthcare and pharmaceutical platforms, created a framework allowing small dispensers the ability to compare barcode and label compliance with DSCSA requirements. Additionally, an application program interface (API) and Graphical User Interface (GUI) were created to leverage the power of partner organization’s Advasur 360 platform and examines DSCSA compliance throughout the drug supply chain.
Because small dispensers — defined as those with 25 or fewer full-time employees — are critical in delivering patient care, the study participants tested the ability to collect and exchange data within the timeframe specified in the DSCSA. PHT and HRG sought to:
- Understand the level of awareness among dispensers of the DSCSA requirements.
- Identify workflow changes necessary to accommodate compliance
- Estimate additional costs that might be incurred.
- Determine accuracy and type of data received from suppliers.
- Measure data present on products shipped and data quality to find indicators of the time needed to achieve compliance benchmarks.
“Most small dispensers do not have any of the infrastructure in place to comply with FDA DSCSA requirements,” says Todd Barrett, RPh, president of PHT. “Additionally, as a critical compliance mandate, it’s essential to implement affordable technology and remove administrative burdens anywhere possible. As the last link in the U.S. pharmaceutical distribution chain, dispensers carry a tremendous burden for patient safety and must have support from other supply chain partners to continue to deliver safe medications.”
Dawn Vogelsang, HRG’s president and majority owner, adds: “Although we found that compliance with DSCSA requirements will be costly both in labor and equipment expenses, the small dispensers in our pilot study were willing to make the investment. They modified their workflow, implemented procedures to meet the federal requirements, and implemented our solutions to help streamline the new processes. Many small dispensing pharmacies are relatively low-margin businesses and don’t have the economies of scale that larger organizations can take advantage of, so it will be important that they find cost-effective solutions from trusted partners.”
Key findings from the pilot include:
- Much education about DSCSA and potential consequences of non-compliance is still needed within the pharmacy community.
- Small dispensers should see increases in annual technology and resource costs to identify and verify each serialized product.
- Average number of suppliers per participant category were discovered to be: (a) Independent Pharmacy: 3.9; (b) Small Specialty Pharmacy: 10.5; (c) Small Long-Term Care Pharmacy: 3.3; (d) Small Hospital: 1.5.
- Dispensing pharmacies must mainstream scanning of received drug orders to establish a comprehensive serialized tracking system.
- The industry should continue standardization of data formats, including serialization and adherence to quality data submission, to maintain meaningful interoperability.