ComputerTalk Publisher Bill Lockwood sat down with Randy Hoggle, B.Pharm., D.Ph., M.B.A., managing director of Advasur’s DSCSA Compliance Services Resource Center to hear about Advasur’s solution for DSCSA (Drug Supply Chain Security Act)compliance. This is the year for compliance.
ComputerTalk: Let’s start with how Advasur’s experience with DSCSA can specifically help pharmacies be DSCSA compliant.
Randy Hoggle: Advasur provides three systems and 12 comprehensive services related to DSCSA compliance.
CT: And when faced with an inspection?
Hoggle: One of our services is assisting the pharmacy when they are audited for DSCSA compliance. Advasur has a 14-point DSCSA compliance SOP [standard operating procedure] specific for inspections by the federal government, state government, or PBM [pharmacy benefit manager] prescription claim clawback requiring DSCSA compliance data.
CT: Would you mind sharing what the cost is for your service?
Hoggle: Advasur started building a DSCSA compliance system and services in 2013 based on the initial requirements and those subsequently added. Advasur has never charged a setup fee, as is common with other SaaS [software as a service] vendors. Additionally, Advasur has never increased our price as we have moved from three services up to 12 services today.
Advasur has instead decreased our pricing periodically, as we have gained economies of scale and as our dispenser client base has expanded. As you know from our previous discussions, Advasur’s 360 system was built by pharmacists for pharmacists. To speak directly to the question of cost, it is less than $100 per month per location for our smallest client and a couple of hundred dollars per month per location for our large-volume clients. For specialty, long-term care, and health-systems pharmacies the cost is a couple hundred dollars per month based on size of practice.
CT: How do the DSCSA requirements differ for each segment of pharmacies — retail, specialty, long-term care, and hospitals?
Hoggle: The DSCSA compliance requirements are the same for all types of pharmacies. However, complexities can be introduced as pharmacies assume additional lines of business. For example, a pharmacy performing 340B-contract services for a covered entity takes possession of the entity’s products without taking ownership.
The Health Resources and Services Administration [HRSA] may decide to request access to the DSCSA compliance data from the 340B-covered entity, which presumably will require the pharmacy’s DSCSA compliance data to be defended during an audit.
CT: What are the supplier issues that you have encountered?
Hoggle: The most common issues to date are related to the four characteristics of the product — name, strength, form, and container size. Advasur frequently has to collaborate with the supplier to correct these issues for future shipments.
Based on my personal experience in building two contracting systems, I think one of the newer issues suppliers and group purchasing organizations [GPOs] will face is authorized trading partner [ATP] credentialing. Suppliers may require GPOs to validate their members’ GS1 Global Location Numbers [GLNs], since the migration to EPCIS [Electronic Product Code Information Services] for data transmissions requires that identifier.
CT: I hear a lot about interoperability. How does this play out with DSCSA compliance?
Hoggle: Until the manufacturers have more experience testing EPCIS with their authorized distributors of record [ADRs] and for pharmacies receiving direct shipments from that manufacturer, there will be enhanced drug distribution security discovery of EPCIS exceptions and data exchange deficiencies that will be discovered and must be addressed before Nov. 27, 2023.
SAP conversions by many manufacturers and wholesalers during the period since the DQSA [Drug Quality and Security Act] was approved will be the most important interoperability challenge between manufacturers and their ADRs to address in the first half of 2023.
As EPCIS transmissions replace ASN as the standard DSCSA compliance data transmission format, every ATP needs to develop EPCIS exception-handling procedures. Since many ATP suppliers have yet to standardize their procedures, Advasur stepped into the void to recognize the procedures being recognized by the Healthcare Distribution Alliance and Partnership for DSCSA Governance group to refine and standardize for our current 5,000 dispensers and 15,000 more dispensers scheduled to use our service in the first half of 2023.
CT: It certainly sounds like you have a playbook that can help pharmacies with DSCSA compliance. Any closing comments?
Hoggle: Advasur focused on the dispenser as our initial client base because we knew it would be hardest for them to comply without the needed DSCSA-related policy and regulatory experience. We saw that without compliance systems and staff in place, dispensers became vulnerable to potential fines and civil penalties, license suspension or revocation, and even imprisonment. Pharmacies need to be able to focus on patient care, and time spent dealing with regulatory compliance is a distraction from that mission.
Thus, Advasur started the way we will finish, offering dispensing pharmacies turnkey solutions to provide compliance tracking, data evaluation, and comprehensive analytic and reporting capabilities so that pharmacies can focus on pharmacy. CT