Track and Trace: What Pharmacists Need to Know
Illegitimate drugs are a public health issue. An estimated 10% of global pharmaceutical commerce is attributed to counterfeit drugs, according to the World Health Organization (WHO). Many times these drug products are sold directly to patients online, but other times they may end up in the drug supply chain and dispensed to the patient through a pharmacy or clinic.
These issues tend to be more prevalent in developing countries, but approximately 1% of the world’s counterfeit drugs are sold in the United States. In addition to counterfeit drugs, illegitimate drugs also include drugs that have been diverted, are part of a fraudulent transaction, or are unfit for distribution.
In November of 2013, Congress enacted the Drug Quality and Security Act (DQSA), which included the Drug Supply Chain Security Act (DSCSA), otherwise known as “track and trace”. This provision outlines, in 3 phases, the steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they make their way through supply chains in the United States, improving the detection and removal of potentially dangerous drugs. Requirements started as early as 2014 and will continue to be phased in through 2023.
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So what responsibility do pharmacy professionals have to uphold these legal requirements? Read on to find out.
What does track and trace involve?
The DSCSA impacts all parties involved in the drug supply chain, including:
Manufacturers
Repackagers
Wholesale distributors
Third-party logistics (3PL) providers
Dispensers (pharmacies)
As the final step before a patient receives a prescription drug product, pharmacies play an important role in ensuring that the drug being dispensed is not counterfeit, stolen, contaminated, or otherwise harmful. Here we’ll review what you need to know about DSCSA and when to expect these changes to go into effect. The FDA has issued several guidance documents to help you prepare for and understand the requirements under DSCSA.
First, there are a few terms that you need to know, including:
Authorized trading partner
Transaction
Transaction statement
Transaction information
Transaction history
Authorized trading partners include manufacturers, wholesalers, repackagers, 3PL providers, and dispensers with valid registrations and licenses are required by state and federal law. Pharmacies, for example, may be multiple types of trading partners since they can be licensed or registered as both dispensers and wholesalers.
A transaction is a transfer of product between authorized trading partners as it moves through the supply chain. When you dispense a drug to a patient, or if you distribute a small amount of drugs to a practitioner for office use, these situations would not be considered transactions under DSCSA.
When a transaction occurs, there is a paper or electronic transaction statement that contains the required transaction information, including:
Product name
Strength
Dosage form
National Drug Code (NDC)
Container size
Number of containers
Transaction date
Shipment date
Name and address of seller and buyer
Lot number
As each transaction occurs, from manufacturer to dispenser, the transaction information is recorded to create a transaction history, showing each prior transaction information.
Does my packing slip or invoice count as a transaction statement? Well, it depends on the information provided. DSCSA offers flexibility in terms of how the information is exchanged, whether it is by paper, email, electronic, or accessed through a web portal. Hopefully, the way trading partners exchange transaction information will become more uniform as systems are put into place.
Chances are that you are probably purchasing most of your drug products through a large wholesaler, such as McKesson or AmerisourceBergen, and may be relying on them for product tracing. If this is the case, you need to have a copy of the written agreement.
Implementing the track and trace system
The implementation of the track and trace system involves a phased approach.
Phase 1: Lot-level traceability and trading partner verification
Phase 1, which is already in place, requires pharmacies to only accept drug products if the transaction history, transaction information, and transaction statement (the “3 Ts”) are provided, and that you retain this information for 6 years from the transaction date. There are some exemptions in place due to COVID-19, which we’ll discuss later.
You also need to have a system in place to be able to verify and handle a suspect or illegitimate product, which includes product quarantine, investigation, and providing notification to the FDA and immediate trading partners if an illegitimate product is found, and if or when a suspect product has been cleared.
In the event of an official investigation of a recall, or upon request from FDA, you need to be able to provide the transaction information, transaction statement, and transaction history from the previous trading partner within 2 business days, so it is important that this information is easily retrievable.
Pharmacies also need to verify trading partners to make sure that they have valid registration and licensure, as applicable. You can validate FDA registration of wholesale distributors and 3PL providers here, as well as manufacturers and repackagers here. You’ll need to check with your respective state for tools available to verify state licensure and registration of trading partners.
Phase 2: Product identifier
Changes to comply with Phase 2 have already started. As of November 2018, all manufacturers and repackagers should be putting product identifiers encoded in a 2D data matrix barcode format on each drug product unit or case. You can see an example of what a 2D data matrix barcode looks like here. These barcodes look different from the linear barcodes you are used to seeing, and they may require new scanning guns to read the new format. Certain products still require linear barcodes too, so it won’t be unusual to see packages that have both types of barcodes.
Save the date: Effective November 27, 2020, pharmacies are to only accept products if there is a product identifier on the unit or case, unless the product was packaged before November 27, 2018.
Pharmacies are also required to follow appropriate steps to investigate and document a potentially suspect product. If you think that a product is potentially counterfeit, stolen, or contaminated, or that something just seems wrong, investigate it.
What are some signs that a product is suspect and should be investigated? A few things to consider:
Is the product potentially counterfeit, diverted, part of a fraudulent transaction, and/or unfit for distribution?
Do the lot numbers and product identifiers correlate with the specific product?
Are there any issues or inconsistencies with the transaction history and/or transaction information?
Has one of your trading partners notified you that the product is potentially illegitimate?
All suspect products should be quarantined from your regular stock as you conduct your investigation. If you and your trading partners find that the product is illegitimate, you’ll need to:
Provide notification to the FDA and all immediate trading partners within 24 hours.
Along with your trading partners, have a process to dispose of illegitimate products.
Keep an adequate sample for further testing.
If your investigation concludes that the suspect product is not illegitimate, you will also need to have a process for clearing the product for distribution and/or dispensing. Any prior notification to the FDA and trading partners about the suspect product needs to be terminated.
Additional information on notification requirements and procedures can be found here.
Phase 3: Enhanced drug distribution security
Starting in 2019, the FDA launched a DSCSA Pilot Project Program with 20 supply chain stakeholders, including wholesalers, manufacturers, technology companies, and health systems to explore ways to develop the systems needed to enhance the safety and security of the drug supply chain, and ultimately achieve the goal of DSCSA. The information gathered from the pilot program is intended to inform efforts that will support the enhanced requirements for 2023. Once the program concludes, a final report will be available on the FDA website.
According to FDA’s implementation plan, they are targeting the following dates:
November 27, 2021 for regulations that establish an enhanced drug distribution security system for interoperable electronic tracing of a product at the package level
November 27, 2022 for guidance on the standards for interoperable data exchange and system attributes necessary to enable secure tracing at the package level
Current COVID-19 exemptions
Certain exemptions have been granted due to the COVID-19 pandemic, specifically related to product tracing and wholesale distribution requirements. These exemptions apply as long as the COVID-19 public health emergency declaration exists, and can be extended by 90-day intervals at a time.
First, trading partners distributing covered COVID-19 products or participating in distribution that is directly impacted by COVID-19 do not need to comply with the product tracing and product identification requirements.
Examples of covered COVID-19 products include:
Drug products issued an emergency use authorization (EUA) by the FDA for use against COVID-19
Drug products that have been FDA-approved to treat or prevent COVID-19
Examples of distribution that is directly impacted by COVID-19 may include:
Drug products that treat symptoms of COVID-19 or provide supportive care to severe cases in an area of low availability and high demand
Authorized trading partners that need to set up a new, temporary facility due to the impact of COVID-19 on the original facility
Dispenser-to-dispenser transfers that are needed as a result of COVID-19, whether or not there is a specific patient need
DSCSA requirements related to wholesale distribution and authorized trading partners do not apply to activities described above, specifically DSCSA’s licensure provisions, and the reporting and wholesale distributor requirements under sections 503(e) and 582(c) of the Food, Drug, and Cosmetic Act (FDCA). Trading partners that are not authorized solely because of the COVID-19 public emergency must work with and/or be permitted to operate during this time by state authorities. Entities engaging in activities outside of the scope of the public health emergency still need to comply with the requirements under DSCSA.
Takeaways
What we’ve covered is not all-inclusive of all scenarios and requirements. You’ll want to review DSCSA and the guidance documents to make sure that you are in compliance. It is also important to keep up-to-date on any changes and deadlines that may impact your pharmacy.
Check credentials
Make sure that you are verifying the credentials of your trading partners such that they have proper registration and licensure.
Do business with trusted partners
Make sure that you are doing business with trusted partners and that all required product tracing information is being exchanged.
Especially during the COVID-19 exemptions, there may be entities looking to take advantage of the opportunity so be cautious of illegally marketed products, false claims, and illegitimate partners.
Know what is required for when you accept drug products
Only accept drug products that come with the transaction information, transaction history, and transaction statement. Keep this information on file and easily retrievable for at least 6 years from the transaction date.
Only accept drug products with a compliant product identifier.
Know the steps for how to identify and investigate suspect products
Ensure that pharmacy staff are trained on how to identify a potentially suspect product, as well as what steps are taken to properly investigate. Be sure to keep investigation documents in an easily retrievable format for at least 6 years.
Work with your trading partners in identifying, investigating, reporting, and removing illegitimate drug products from distribution.
Keep up to date
Stay updated on the latest requirements and guidance related to DSCSA to make sure that your pharmacy is compliant, and that you can anticipate any necessary changes to meet future deadlines.
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