Many hospitals struggle to achieve optimal compliance with the Drug Supply Chain Security Act (DSCSA). The challenge to comply seems to come from an incomplete or inaccurate understanding of the regulations, which is understandable given the Act’s complexity. DSCSA was put in place to protect consumers from harmful drugs, such as those that are stolen or contaminated. The Act outlines steps to build an electronic, interoperable system to identify and trace certain human prescription drugs as they are distributed throughout the U.S. DSCSA also helps protect the drug supply chain and establish national licensure standards and annual reporting requirements to the FDA for wholesalers and third-party logistics providers.
Here are 6 best practices that can help achieve optimal compliance with DSCSA:
Each time a drug transfers ownership it must transmit T3 documentation (Transaction information, Transaction history, and a Transaction statement). T3 documentation must be securely stored for six years. Storing it in a single format and centralized location saves money and time through improved accessibility and efficiency. It’s important to consider a system that will convert paper documentation into electronic files, which is especially helpful to manage drop shipments. Electronic access can be extremely helpful to access information quickly, especially if an audit occurs, and the right system will have the capability to combine advance ship notices (ASN) formats, of which there are approximately 200, and paper formats.
Hospitals should implement a dedicated solution to store their own T3 documentation. While careful selection of wholesalers and other authorized trading partners is important, it is not prudent to solely rely upon them to store your data and adhere to DSCSA compliance standards. DSCSA is clear that the hospital, known in the Act as “dispensers”, bears the ultimate responsibility for compliance. While maintaining clear and open communication with authorized trading partners is always important, managing your own solution means greater control over your data as well as ease of accessibility.
Responding to requests for information from regulatory agencies, such as the FDA or state officials, is a critical responsibility. DSCSA requires a response be made within two days, which means key information, such as traceability data, must be searchable. This is yet another area where having an electronic system is of the utmost importance and extremely helpful. In addition to searchability, the system should offer validation and verification of T3 data in real-time to support verification against the physical shipment when it is received.
Under DSCSA, it is incumbent upon dispensers to investigate any “suspect” products received. Dispensers are expected to define action steps if suspect drugs are discovered or they risk federal prosecution. For this reason, it is essential that the action steps developed address quarantining of the product and immediately notifying trading partners of the discovery to begin the investigation process. The FDA should be notified immediately once a suspected product is determined to be “illegitimate.” For more information, reference the FDA guidance on this subject.
As of late last year, all manufacturers and repackagers across the pharmaceutical supply chain must be able to affix or imprint a product identifier on an individual unit or case, with the exception of products packaged by the manufacturer or repackager before November 27, 2018. While this deadline predominately affects manufacturers, medication dispensers must adhere to current regulatory requirements, including capturing, maintaining, and storing a T3 document; validation and verification of the T3 data; and a process to identify and manage potential suspect or illegitimate product. Dispensers must work with the manufacturer if a suspect product is identified and follow steps outlined in the DSCSA. Failure to adhere to these regulations could create supply chain gaps and could violate the law.
New regulations for dispensers concerning receiving, scanning, and reading 2D product barcodes are set for 2020. In preparation for their phase 2 serialization requirements, hospital pharmacies must observe and learn from early pilots and implement an enterprise platform that provides secure storage, and immediate verification of products, including transaction information, transaction histories, and transaction statements.
The Bottom Line
At Visante, we continually seek to find ways to improve safety and efficiency in hospital pharmacy operations, always striving to help our clients achieve optimal compliance with regulations. DSCSA is an important set of regulatory requirements that help protect the drug supply chain and consumers, and we hope these best practices help you to improve your organization’s compliance. With regard to choosing an electronic solution, it’s important to select a system that addresses the key considerations listed above. Visante has identified ConsortiEX as an innovative provider of these types of services to our clients in this market space.
Make sure to follow us on Twitter and LinkedIn to stay up to date on all things DSCSA.