Do Patients Take Medications on Holidays?

All Situation Room examples are constructed and not descriptions of actual events.

Published on: December 7, 2022
Walter Routh
Categories: The Situation Room
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What is the stability situation?

The intervals for my in-use study are being disrupted by holidays. I've been running a 10-week in-use study for a weekly-dose injectable product. It is labeled for refrigerated storage with instructions to bring it to room temperature before injection, so at each interval, vials will be brought to room temperature, product removed and then refrigerated again. We’ll test the material midway and at the end. The problem is that our start date of October 27th requires critical pulls on both Thanksgiving and our end-of-year shutdown.

Packaging for the stability batches started on 25-Oct which means that 27-Oct was the earliest we could start the study in order for our R&D group to include the data in their early 2023 filing. Unfortunately, labor contract rules leave us with no trained lab technicians available to pull or test samples for two of the three key test intervals, including the last interval of the study.

We had no choice but to pull the Thanksgiving sample two days early and plan to pull the New Year’s sample four days late, but this seems like a significant departure from normal use since it’s very unlikely a patient would miss a dose by more than a day.

For clarity, here is the schedule as it stands, now:

27-Oct Start: Pull 1 (Test)
03-Nov: Pull 2 (Dispense and discard)
10-Nov: Pull 3 (Dispense and discard)
17-Nov: Pull 4 (Dispense and discard)
24-Nov: Pull 5 (Test) (Moved to 22-Nov)
01-Dec: Pull 6 (Dispense and discard)
08-Dec: Pull 7 (Dispense and discard)
15-Dec: Pull 8 (Dispense and discard)
22-Dec: Pull 9 (Dispense and discard)
29-Dec: Pull 10 (Test) (Will be 02-Jan)

Will this impact the validity of the data in the filing?

How should this be resolved?

Although this actually represents a worse case since it's pulling the final interval farther out, the real issue could be that this shows lack control within the stability program, meaning these "disruptions" should've been anticipated and included in the pre-approved protocol. Changing the study after the fact should involve some justification documentation included with the data. What thoughts would you like to contribute to this situation?

We Want to Hear Your Thoughts!

  • October 5, 2024

    Packaging is being changed late in development while also trying to shortcut around quality checks and balances that Stability is intended for. How does a quality representative explain to upper management the risk they are taking on?

  • September 7, 2024

    What are some ways we could finish cooking this half-baked digitalization process and make our digitized data even more accessible and user friendly?

  • August 10, 2024

    What career path should I take and how can I balance my work and personal life if I choose the difficult stability career path option?

Share your questions and experiences

A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!

A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!