How Missing Traceability Data Could Affect Pharmacy Patients

There are a number of obstacles related to distributors’ compliance with the requirements of the Drug Supply Chain Security Act (DSCSA), including:

  • They don’t have much time left to set up data exchange systems
  • Some smaller or less connected players may ignore the requirements and the need to prepare
  • The costs of implementing traceability systems can be prohibitive, especially without a way to recover funds directly

The 2022 HDA Traceability Seminar this week in Washington DC highlighted the efforts of the distributor (pharmacy) community. During a panel on distributor data flow, an audience member asked how data exceptions could affect patients in real time. In the scenario he described, a pharmacy tells a patient to come in at 10 a.m. when his prescription needs to be filled, but he discovers while trying to fill that he has not received traceability data for this product and he cannot fill the prescription.

[Editor’s note: Panelists spoke on this topic during the Q&A portion from the audience. As such, their statements were made off-the-cuff. They may include conjecture and do not necessarily reflect official policies.]

Leon Nevers is the Director, Sourcing and Business Development at HEB. He explained that when a pharmacist runs out of an item, there are usually opportunities to refill other items, whether by offering an over-the-counter drug or sourcing from a DSP. [distance selling pharmacy] according to customer needs. “As for the labor impact, I have a pharmacist who would just have to dispense a prescription to the customer any way they want. It’s a dissatisfaction for the customer when they don’t receive this, so that’s the first step. The second step is that the pharmacist now needs to go and counsel that customer and probably walk them down the OTC aisle or explain to them what their options are and now is the time,” he said.

If a given vendor causes these kinds of outages frequently, Nevers said he might have to consider moving that vendor’s product until he can get his data in shape and prove he can ship it. properly.

Lisa Schwartz, PharmD, RPh, senior manager, professional affairs, National Community Pharmacists, echoed that sentiment, adding that it would likely be treated as a “sold out” — although the product is in the facility, it cannot be distributed in a conforming manner. “You end up having to do an assessment of doing business with a business partner at some point,” she said. She also noted that at some point a pharmacy owner can be an example if they take the risk of dispensing a product without having tracing data.



Ian Cannell, practice lead consultant/DSCSA project manager at Kaiser Permanente, said that was the elephant in the room. “The question is, how not to grope on the one-yard line?” He agreed with the other panelists about getting supplies from another pharmacy or finding alternatives: “Can we place an overnight or emergency order? Can we choose another SKU? Is there another choice that can be used? I think your original question was largely about policy and procedure. Every organization needs to take a cold look at their compliance and legal department when it comes to whether you have a worst-case scenario, whether it’s compliance versus the reality of a critical business need. ‘a patient…it comes down to trying to mitigate those risks in advance.”

Cannell also noted that distributors have limited resources and limited serialization vendors. To avoid bottlenecks, the best practice is to try to move forward and identify trading partners with data issues ahead of time to try to mitigate these scenarios. But some partners can lose business if they put distributors at risk by not providing the correct product data.

Nevers added that precise upstream operations should help alleviate the problem. “So [product] arrives and we receive at the warehouse. If our employees scan and find “no data”, your data will not go any further and we will not pay you for it. It defeats the purpose of what we are working on together. He concluded that he did not intend to put his customers or pharmacists at risk by moving the product from the warehouse to stores when they have no data on where it came from.

About Donnie R. Losey

Check Also

New rules loom as baseball pushes for better product in 2023

In other words, a lot of the game is spent waiting for something to happen …