PrimeRx and InfiniTrax Help Pharmacies Prepare for DSCSA Compliance

November 27, 2023, should be a date pharmacists have circled in red on their calendars.  That’s the date when key provisions of the Drug Supply Chain Security Act (DSCSA) – often referred to as the “track-and-trace” law – are scheduled to take effect.

The federal legislation, which became law in 2013, seeks to ensure the safety of the nation’s prescription drugs by creating a “closed and secure supply chain,” as described by the U.S. Food and Drug Administration (FDA).  A cornerstone of the law is the creation of a single electronic system, implemented nationwide, through which “authorized trading partners” exchange verified product information.  The law established a ten-year timeline for building the system, with a set deadline of November 2023.  When implemented, the national system will preempt all state networks.

Pharmacies are already well aware of the DSCSA, since several provisions have already taken effect that directly affect dispensers.  Those provisions are rooted in technology as well, and pharmacies that rely on the PrimeRx technology management system have been able to utilize system capabilities to assist with compliance.

PrimeRx has enhanced its DSCSA compliance efforts through a recently-announced partnership with InfiniTrax, a leading provider of solutions targeted at DSCSA requirements.

First though, it’s helpful to review key tenets of the law, and provisions that directly impact pharmacies.

Purpose of the DSCSA

According to the FDA, the purpose of the law is to protect the nation’s drug supply by creating “a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.”

To do this, the law sets out several pharmacy-specific requirements, many of which should already be in place.

Pharmacy Provisions Currently in Effect

According to the American Society of Health-System Pharmacists (ASHP), provisions of the law already in effect include:

1. Pharmacists are assumed to only engage with licensed, registered trading partners:
   1. Manufacturers and repackagers are required to hold current registrations.
   2. Wholesale distributors and third-party logistics providers are required to be licensed.
2. The law requires drugs to be traced as they move through the supply chain, and pharmacies must:
   1. Only accept prescription drugs that are accompanied by three pieces of product tracing documentation. Together, these items are called “the 3Ts,” and they include:
      1. Transaction Information (TI)
      2. Transaction History (TH) (scheduled to expire in late 2023)

• Transaction Statement. (TS)

1. Have a process in place to store product tracing information – in paper or electronic format – for six years.
2. Generate and provide all product tracing documentation with the transaction if a prescription drug is sold to a trading partner. (This information does NOT have to be provided to a patient OR if product is sold to another pharmacy for dispensing to a specific patient.)

3. Investigate and properly handle suspect or illegitimate product. This includes quarantining product until its legitimacy can be determined.
   1. Pharmacies must have a process in place to investigate and handle suspect and illegitimate prescription drugs. This includes drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.  Required steps include:
      1. A process to quarantine and investigate suspect prescription drugs to determine if they are illegitimate.
      2. If a drug is determined to be illegitimate, the pharmacy must work with the manufacturer to ensure patients do not receive the drug. The pharmacy must also notify the FDA and trading partners from whom the drug was bought and/or sold.

November 2023: Additional Pharmacy Requirements

According to ASHP, beginning this year, pharmacies must have policies and procedures in place that allow for unit-level traceability as follows:

1. A secure, interoperable electronic system must be in place that allows trading partners to exchange TI and TS information.
2. The ability to check for inclusion of a package identifier (PI) to identify the prescription pharmaceutical product at the package level. According to the FDA, a package identifier refers to a “standardized graphic (i.e., bar code) that includes the product’s standardized numerical identifier (composed of the NDC and a unique alphanumeric number), lot number, and expiration date.”  The product identifier must be presented in a 2-dimensional data matrix barcode for packages, and in a linear 2-dimensional data matrix barcode for homogenous cases.
3. The ability to verify the product identifier on a package or sealed case via a secure, interoperable electronic system.
4. The ability to ensure that trading partners can provide TI and TS information via a secure, interoperable electronic system when requested by authorized agents.
5. The ability to ensure that its secure, interoperable system allows for the prompt production of TI for each transaction going back to the manufacturer.
6. Capability for its electronic system to address returns by ensuring that TI and TS information accompanies a product sent back through the supply chain.

Facilitating Compliance with PrimeRx and InfiniTrax

In a late-2022 webinar offered by the FDA as a way to help stakeholders understand DSCSA compliance requirements, Dr. Patricia Kavzoni, director of the agency’s Center for Drug Evaluation and Research (CDER) noted that the DSCSA’s goal of creating a secure pharmaceutical supply chain is “a very, very important part of our work.”

To accomplish this, she continued, “EVERY LINK of that chain must be secure from the moment drugs leave the manufacturing facility to final delivery to pharmacies or healthcare professionals’ offices where prescription medicines are ultimately given to patients.”

Pharmacists, of course, have a key role in ensuring the success of the nation’s drug supply chain.  And most pharmacists recognize the importance of technology in these efforts.  Not surprisingly, certain pharmacy technology providers have responded with functionality that allows pharmacies to meet DSCSA compliance requirements.

Micro Merchant Systems, developer of the innovative PrimeRx pharmacy management system, has been a leader in identifying DSCSA-related solutions.  Most notably, the company announced a partnership with InfiniTrak, which has been at the forefront in developing DSCSA-specific solutions.  Key InfiniTrax capabilities include:

• 2D Barcoding Functionality.
• Easy capture of critical data elements including Drug Lot/Expiration Numbers, GTIN Numbers, and Serial Numbers.
• Real time verification of prescriber licensing authority.
• Workflows that support the identification and verification of suspicious products, product quarantines, and guidance for notifying the Food and Drug Administration.
• Ability to search for products by date, supplier, description, NDC, invoice number, lot, status, and type.
• Ability to coordinate global location numbers (GLN) for interoperability.
• Ability to store – and easily access – DSCSA compliance reviews and inspection documentation as needed.

Each of these capabilities addresses a specific pharmacy requirement of the new drug supply chain law.  PrimeRx pharmacies now have direct access to the InfiniTrax suite of solutions, which integrate directly with the PrimeRx system.

Beyond its partnership with InfiniTrax, PrimeRx offers core capabilities that facilitate DSCSA compliance.  Those capabilities include:

Access to National Drug Code and other databases.  The system enables direct access to FDA and NDC databases as a way to quickly verify medications and validate trading partners’ licensing and certification.

Recordkeeping.  PrimeRx offers extensive recordkeeping capabilities that allow pharmacy managers to efficiently store documentation and information about all aspects of pharmacy operations.  With regard to DSCSA compliance, the system can seamlessly process and store mandated transaction documents.  Should those documents need to be transmitted to another pharmacy or trade partner, the system can automatically send the required materials.

Report generation.   In addition to storing this information, PrimeRx allows the pharmacy manager to generate detailed reports on a wide range of patient, inventory and operations topics.  This includes reports to satisfy FDA information requests regarding specific transactions, or drug investigations.  Should a pharmacy determine that a drug is illegitimate, PrimeRx can facilitate compliance with all FDA reporting requirements.

Bar Code Scanning.  Since the DSCSA requires all product identifiers to be available in 2-D format, it’s essential for a pharmacy technology system to be able to easily import that information.  PrimeRx offers the required scanning capability and allows for information to be quickly and accurately loaded and filed.

Clearly, pharmacists must have a full understanding of their DSCSA obligations, and processes in place to ensure compliance.  For some pharmacists, this will present a significant challenge, and yet one more compliance mandate to add to an already over-loaded regulatory burden.  For others though, that already prioritize the role of technology in improving pharmacy operations, DSCSA compliance can be a relatively seamless experience.

Regardless of your pharmacy’s state of “DSCSA-readiness,” PrimeRx is here to help.