Will you be ready?
In preparation for deadlines fast approaching under DQSA and its Title II counterpart DSCSA, companies should be assessing how they can meet their compliance requirements with enough time to spare for successful implementation. Successful implementation will require assessment in a number of areas, including relationships with trading partners, technical solutions and business processes.
Waiting until November 1st to start implementing a solution is way to late. Here at TrackTraceRx we are pretty quick at setting up your DSCSA portal to start managing your T3 transactional data. The problem is, your trading partners are getting bombarded to get integrated to automatically receive or send EDI 865 ASN transactions. Some trading partners are taking weeks to get integrated due to a back log, as every hospital, pharmacy and dispensing facility is rushing to get up and integrated.If you are considering a DSCSA solution, the time is now to get started.
“If your business is hoping for effective implementation of any technical or transactional changes, you need to form a strong communication plan with your trading partners – both upstream and downstream.”
DSCSA changes the game when it comes to relationships between suppliers in the pharmaceutical chain. Since collaboration will be needed across the industry in order for everybody to meet regulations and ensure compliance, it means that trading partner relationships are that much more critical going forward.
If your business is hoping for effective implementation of any technical or transactional changes, you need to form a strong communication plan with your trading partners – both upstream and downstream. The plan has to meet DSCSA requirements while also meeting the requirements set down by your trading partners themselves, though it’s important to note that your business must align with every trading partners in the chain, not just the big names. Compliance plans have been shared by several major wholesalers and pharmacy chains using mediums like letters, websites, vendor services, calls and videos, and opening channels for feedback on them. And when it comes to implementing the DSCSA, the FDA has also shown that it recognizes the value of feedback, having opened several public dockets since the DQSA’s enactment to gauge how realistic the expectations set forth are.
However, no matter how much planning and analysis is done by your organization you will never know if a proposed solution is going to work until it is tried and tested, which is what many in the industry have already done. It’s a move that’s allowed them to gather feedback in between and be able to change components and reallocate resources where needed.
Testing out solutions will be doubly important when it comes to complying before the deadline. Any wrong decision made is likely to result in a lot of expenditure and could put a halt on long-term implementation plans. For this reason, a lot of big companies over the last several years have already launched programs to test out technologies, and the feedback loop they’ve kept open has been vital to their success.
There is currently nothing in DSCSA that dictates one technical solution for traceability over the others. The FDA has left that decision up to the industry, so it’s important to figure out which option is going to work best not only for you, but for your suppliers and the industry in the long-term. It is, of course, tempting to stay with your current method, because then there’s no need for a time, money, and resource investment. But there are multiple ways at present to exchange information that meet DSCSA requirements, including electronic Advance Shipment Notices (ASNs), the Electronic Product Code Information Service (EPCIS), Drug Pedigree Messaging Standard (DPMS), invoices – both paper and electronic – and packing slips.
So a question you should ask yourself is: is this method cost effective and sustainable in the long-term? For example, consider your T3 documentation. Paper is considered a valid – and more “traditional” method of storing the traceability data you have to collect. However, it takes up a lot of physical space and it’s expensive – every year, the printing of T3 documents costs an estimated $3500 of paper per mid-sized business. And then, of course, you also have to have a dedicated staff to file it correctly, and records become difficult to obtain for requests within the FDA’s 2-day time limit.
Practically everybody in the pharmaceutical community that dispenses drug product – hospitals, doctor’s clinics, private physicians, pharmacies – all face new requirements for compliance under DSCSA. Everyone, from dispensers to wholesaler distributors to manufacturers and repackagers – all four distinct segments of the supply chain outlined in DSCSA – is looking for ways to implement these requirements simply, as there is 40 pages of complex regulations and now everyone is facing complicated data management, exchange, and process challenges, including (as noted by Becker’s Hospital Review):
- Capturing and managing large volumes of “T3” documentation in diverse formats from suppliers
- Verifying received product from suppliers while minimizing impact to pharmacy efficiency
- Managing central receiving and direct to pharmacy shipments
- Preparing for verification or inspection inquires
- Enabling compliant resale, loan or borrowing of prescription drugs
- Appropriately tracking consignment inventory stored at hospital locations
- Managing emergency drop shipments directly from manufacturers
But how to comply, and how to do it simply?
The phases of DSCSA compliance can be broken down into three parts:
2015: Lot-level traceability as well as verification of products and transactions during investigations of suspect or illegitimate product
2017-2020: Serialization of drug product and enhanced verification of serialized product identity
2023: Unit-level traceability
As a refresher, the key requirements for dispensers include:
- Receiving Lot-Level Compliance Documentation for Purchases – Dispensers must be able to receive the lot-level Transaction History (TH), Transaction Information (TI) and Transaction Statement (TS), aka T3 documentation, for every product they purchase.
- Verifying T3 Documentation – Dispensers must verify T3 documentation against the drug product their suppliers shipped to them, and must quarantine any product they determine to be suspect or illegitimate. However, DSCSA does not define how dispensers should verify T3 documentation, it was a decision left up to the industry, so different organizations will all have different methods of doing this.
- Archiving T3 Documentation – Dispensers must store the T3 documentation that comes with every shipment they receive for at least six years from the date of transaction. This documentation needs to be stored carefully, as it could need to be accessed at a moment’s notice in a variety of situations, and there is no time to waste sorting through a complicated and unorganized system.
- Providing T3 Documentation for Sales – Dispensers must provide T3 documentation to another pharmacy or hospital if they are selling or loaning the product through a change of ownership. This requirement does not apply to dispensers that are owned under the same umbrella company, i.e. a hospital owning a pharmacy sending drug product to that pharmacy, or a wholesaler that also dispenses product itself.
- Retrieving and Responding to Requests for Information – If the FDA or any federal or state official issues a Request for Information (RFI) in regard to a suspect product investigation or in the case of a product recall, the dispenser involved must reply with compliance data within a two-day window.
- Responding to Verification Inquiries – Dispensers are required to conduct an investigation if they make the determination that any drug product they receive might be suspect or illegitimate. The product must be quarantined, and then there should be a request for verification from the FDA. Every investigation should be conducted in coordination with trading partners and will include validating any applicable T3 documentation.
As well as these requirements, in 2020 when serialization regulations phase in, there will be mandates requiring that only drug products encoded with a barcode containing a unique standardized numerical identifier (SNI), which includes a serial number can be purchased and onsold by dispensers. Enhanced verification processes involving the SNI will also begin in 2020.
So dispensers have a complicated set of DSCSA requirements to meet, and while the FDA has been lenient and not enforced requirements so dispensers can perfect their compliance systems, the law is in effect today and there is not a lot of time left to simplify compliance.
The most important things to remember when it comes to simplifying the organization and automation of DSCSA’s requirements is being cost-effective; expecting the unexpected – having contingency plans before they’re needed – as well as collaborating with trading partners to figure out the best way to exchange information and product, and maintaining communication within your organization in order to streamline processes and make sure nothing is overlooked.
And of course, the top priority for any company should be patient safety, and it’s worth remembering that while these regulations are complex and possibly costly up-front, the long-term benefits will affect the drug supply chain on a global scale.
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