Top 10 DSCSA Decision Drivers for Hospitals & Pharmacies
DSCSA is fully in effect for dispensers so if you haven’t implemented a solution, then you are out of compliance. The only advantage of being late to the table is that you have the benefit of learning what criteria other pharmacy directors and pharmacy buyers have been using when selecting a cost-effective compliance solution that offers operational efficiencies. Based on our experience in helping hundreds of hospitals and pharmacies, we’ve produced this top 10 list of decision drivers that have guided other pharmacy leaders.
1. “Future-proofing” saves time and resources from the outset.
Industry guidance on how to comply with government regulations is constantly evolving. Staying on top of diverse issues like FDA first responder guidance, 340B Program treatment, and upcoming serialization requirements is challenging and time-consuming. Partnering with a DSCSA solution provider lays the groundwork for future success and ensures that you:
- Get the latest in evolving government guidance.
- Tap into regulatory updates through your product and workflow.
- Partner with an expert for the more complex serialization requirements coming in 2020.
2. Centralization drives pharmacy efficiency.
Different supply partners invariably send different forms of paper and electronic compliance documentation. A flexible solution enables you to consolidate, store, and search disparate Transaction History, Information, and Statement (T3) data in one central repository, simplifying the required task of managing data for six years. Your pharmacy staff can quickly locate any DSCSA information required, which is especially important during an inspection where your license could be on the line.
3. Having an optimal receiving process is critical.
Using a defined, technology-enabled workflow process for managing product and T3 receipts reduces risk. When discrepancies such as overages happen, an electronic system helps your staff identify exceptions where T3 records are at odds with physical inventory so that you can update compliance documents accordingly.
4. Supplier portal dependence has hidden costs.
A critical consideration for many pharmacy administrators when approaching DSCSA is the ownership of data. Having efficient, dependable control over data gives you flexibility with your suppliers. While many will offer portal access, having to manage multiple logins, interfaces, and processes increases the time your staff must spend on DSCSA compliance. In addition, what kind of guarantee do you have that your suppliers will store your data for the required six years? And what happens to the documentation if you stop doing business with them?
5. Tracking a growing number of electronic data formats is cumbersome.
DSCSA does not specify a standard format for data exchange, and thus, there are more than 200 different ASN types and over 30 different document exchange scenarios to consider for compliance. This results in an overwhelming IT requirement, especially as DSCSA requires drug manufacturers to move away from paper and towards electronic exchange. Using a dedicated solution provider to manage all your supplier connections allows you to outsource data exchange complexities.
6. Secondary distribution requires a standardized workflow.
Many hospitals and pharmacies have reached a critical inflection point where they must define their policies regarding reselling and loaning drug product. When considering a solution that supports secondary distribution, ask yourself:
- What types of data does my compliance system allow me to send?
- Does it allow me to manually enter missing lot numbers during product receipt?
- Does it produce outbound transaction history (TH) documentation?
7. Downstream paper TH volumes will rapidly decrease.
Paper TH will become increasingly harder to use as the November 1, 2017, electronic deadline for manufacturers approaches. Here are a few reasons why more pharmacies and hospitals are moving away from paper records:
Price tag: Pharmacy managers find paper more difficult when it comes to exception management and tracking things like shipment errors. The typical independent pharmacy will dedicate valuable staff time each day and spend $3,500 each year on paper.
Paper fees: Some suppliers are evaluating the potential to charge you if you require paper TH.
Storage: If your solution can’t transform paper into electronic T3s, you have the burden of storing each physical record for six years.
8. Every shipped product is accompanied by master data.
Master data includes things like product names, price lists, and government drug codes. Now that data accompanies every product shipment, your peers have realized that keeping all that data in sync with your suppliers is a significant challenge that a compliance partner can support.
9. Regulatory inspections travel up and down the supply chain.
Inspections can occur at random and without notice. DSCSA was created to provide transparency into the ownership of drug product movements. As one of our customers learned recently, no hospital or pharmacy is so small that they can fly under the radar. An FDA regulatory review of T3 data and compliance processes can begin anywhere in the supply chain, often pulling in multiple businesses. The potential consequences include fines and penalties that can impact your reputation with your suppliers and patients.
10. A community of trusted peers increases compliance confidence.
Pharmacies and hospitals are consulting with each other on a wide range of topics, from FDA enforcement to data management to who they trust for DSCSA compliance. Like them, you want a proven solution partner that brings together a large group of your peers who are all tackling the same compliance questions.
To learn more about the DSCSA requirements for dispensers, schedule a free consultation with one of our compliance experts.