A Complete Guide: There’s Only One Way to Tackle T3 Information with First Responders
SummaryFirst Responders may not be direct partners in the pharmaceutical supply chain, but they are equally responsible for the safety and security of drugs. There are ways to identify that the first responder is using the drugs legally and correctly. From T3 transactions to tracking first responders or dispensers, this article explores the exit point of the supply chain in details.
A lot is known and understood about the operations of a drug supply chain in the United States, which is transforming to cope with the ever-changing requirements of the DSCSA and the drug industry in the country. While everything that the DSCSA says and the participants do root in eliminating the counterfeit drug marketing in the US, compliance standards have evolved into something more prolific than just maintaining product visibility; It has, in fact, grown above and beyond mere regulations, addressing the age-old issues of delayed timelines, complex operational infrastructure and archaic drug manufacturing methodologies, to form a more conducive environment for a fast, profitable and effective Business. But, in that process we cannot forget the main aim of implementing the DSCSA standards- for a greater human good and for that very sake we will be discussing probably the most unsupervised and vulnerable point of the supply chain- the First Responders.
While we have discussed the role of each of the stakeholders in the drug supply chain and the way they are expected to function in a fragile yet versatile environment like that of the drug supply chain, we are yet to discuss the most crucial point of the chain- the point where drugs exit from the supply chain to reach to the end users, sometimes through the First Responders.
Who are they and what the DSCSA has to say about them?
As per the FDA, the First Responder is a person who is authorized by law to administer a product in accordance with Section 503 (b)(1) of the FD&C Act and is responsible for the emergency treatment of ill or injured persons. The responder is also authorized to provide emergency treatment of ill and injured persons outside of a health facility. First responders may include employees of the Federal, State, and local law enforcement, and governmental and non-governmental fire/rescue and ambulance services.
Now, here comes the twist. Although considered a part of the supply chain, a First Responder is not required to provide T3 documents or details of the medicine administered or passed on because of lack of scope, unlike their counterparts upstream. The dispensers such as hospital pharmacies also cannot provide T3 information to the First Responders due to the lack of scope and knowledge.
Here’s what FDA has to say for them:
“…..FDA recognizes the fact that first responders may lack the resources to comply with certain requirements under Section 582(d) of the FD&C Act, including receipt, capture, and maintenance of product tracing information and verification. To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders.”
[Read the full report here]
Thus unattended, doesn’t it risk the supply chain as a whole?
- Exchange of product tracing information
- Conducting businesses with authorized trading partners
- The right verification in place
There’s a way out
- Capturing product data
It works out both ways- the dispenser, a part of its protocol, captures and maintains the details of the transactions it has with the First Responder, including the creation of a product tracing information, prior to or at the time of the transaction or after the same. The information should be stored for 6 years as required by the DSCSA. The drug details are produced to the first responder on request, not before 2 days from the date of transaction.
While this is not an ideal situation because the ‘First responder’ is not considered an authorized dispenser, such situations might arise accidentally and cannot be ignored, but responded to immediately.
Given the provision, the responders should also demand for the details of the drugs and the T3 information from the dispenser to be on the safe side and avoiding punishment and penalties if the medicine is found to be fake. If the responder believes that the medicine given to him is a counterfeit, FDA encourages him to protect patients from receiving the illegitimate medicines, which includes quarantining and investigating the product, contacting appropriate authorities and working with the previous owner to stop the distribution of such products.
- Determining trading partners under DSCSA
It is not possible on the part of First Responders to determine the authentication of a trading partner during an emergency situation. However, they can keep a track of the registration number or the license number of the dispensers or the trading partner, as directed by the DSCSA, from whom they are purchasing the medicine.
How can technology help?
Although systems are already in place when drugs change hands between stakeholders in a pharmaceutical supply chain, the end line from the dispenser to the user need stronger reinforcements. Drug counterfeiters are smart and they know how to penetrate a fortress from a vulnerable point. Medicine transfer, especially through a third-party, can risk displacement of original products if not supervised properly. Furthermore, there are thousands, if not millions of First Responders approaching dispensers for medicines every day and keeping a track of them is no small task.
So, when we are talking volumes, the capturing and storing of data should be fast and effective. Engaging manual verification or deploying a single scanner could be one way, but then dispensers have to be prepared for human error or slow turnaround times, leading to financial pressure and delayed services, which cannot be afforded in a service related to emergency care.
The solution? Dispensers, from their end, can engage AR-enabled multiscanners to capture data about the medicine that is being sent out to the end user, in this case, the first responder. A traceability portal or suite could be customized to add data of the buyer-his/her licenses, registration and contact information-to enable engagement or investigation as and when required. The Traceability portal can store important information related to the person buying the medicine and the same can be deployed by the First Responder to track the origin of the medicines he has bought. The traceability suite is linked with a centralized data repository, storing all the information captured to be provided to stakeholders or government bodies during audits or investigations.
The road to complete security of drugs in a supply chain is difficult, but worth trying, given the lives, money and time it can save. Nevertheless, if you have come this long, you are 99% convinced about the need to fortify the end line of the supply chain. You just have to make that last choice of choosing the right vendor to do it for you. So, our advice would be to look for a vendor who has decades of experience in providing all the above-mentioned solutions at an affordable price. However, before that get your basics clear about the DSCSA regulations and what it expects from the dispensers. Ensure that the vendor knows about it and uses DSCSA-guided solutions to meet your requirements.
Compliance at any level of the supply chain is a one-time investment. But the benefits that follow are recurrent and ever-lasting. So, what are you waiting for?