One of the significant changes on the horizon for pharmacies across the country is the implementation of the Drug Supply Chain Security Act (DSCSA), effective November 27, 2024. In this blog post, we'll delve into the details of what these changes entail and how pharmacies can prepare for seamless adaptation.
Package Level Verification:
One of the fundamental shifts with DSCSA is the transition to package level verification. Previously, pharmacies primarily focused on verifying information provided by vendors at a document level. However, with the advent of DSCSA, every product now carries a unique serial number, necessitating thorough validation and verification by pharmacies. This means ensuring that the serial numbers provided by vendors align accurately with the received products, thereby enhancing transparency and security within the supply chain.
Inoperable Package Details and EPCIS:
Additionally, wholesalers will be required to provide inoperable package details, facilitating comprehensive tracking and traceability. This data, slated for availability by November 27, 2024, will enable pharmacies to gain insights into the contents of cases or non-homogenous packages, further streamlining verification processes. The integration of Electronic Product Code Information Services (EPCIS) into receiving components will ensure seamless matching of serial numbers and lot numbers, bolstering compliance efforts.
Documentation Overhaul:
DSCSA brings about a significant overhaul in documentation requirements, transitioning from the existing Transaction History to a new standard termed EPCIS. This entails a shift from the traditional three Ts (Transaction Information, Transaction History, Transaction Summary) to the simplified T2 (Transaction Information and Transaction Statement). Pharmacies must meticulously ensure the accuracy of transaction information, paving the way for more efficient record-keeping and compliance management.
Challenges and Workflow Impact:
As pharmacies gear up for DSCSA implementation, they must anticipate challenges in adapting to new requirements. Workflow adjustments are inevitable, necessitating seamless integration of compliance measures into existing processes. Partnering with providers offering tailored solutions that align with pharmacy workflows is paramount. Streamlining package level verification through automated processes, such as mobile scanning technologies, can mitigate workflow disruptions and enhance efficiency.
Vendor and Manufacturer Readiness:
While pharmacies gear up for DSCSA compliance, questions loom regarding the readiness of vendors and manufacturers. The transition to electronic documentation remains a work in progress, with ongoing efforts to ensure seamless data flow and accuracy. Pharmacy-vendor relationships may witness shifts, with heightened emphasis on product authenticity and stricter return policies. Pharmacies can play a proactive role in fostering collaboration and ensuring mutual readiness for compliance obligations.
How SureCost Helps Pharmacies Adapt and Succeed:
To navigate the complexities of DSCSA, pharmacies must proactively select DSCSA providers and establish standardized operating procedures. Timely implementation of compliance measures is crucial, allowing sufficient time for training and adaptation. SureCost streamlines your verification processes, offering real-time feedback and integration capabilities. We help pharmacies establish a culture of compliance and readiness so they can navigate DSCSA transitions effectively and uphold patient safety standards.
The impending implementation of DSCSA heralds a new era of accountability and transparency in the pharmaceutical supply chain. The key to DSCSA success is preparing your pharmacy early. It’s imperative that pharmacies embrace these changes proactively, and leverage technology and strategic partnerships to ensure seamless compliance.
