During this late, spooky time of year, we can look back at some real-life scenarios where clinical supply created something scary out of something that should have been helpful. Hopefully by hearing about these tales from industry experts, your mind will be primed for problem solving your own clinical trial supply snafus.
Culling from the most grotesque, we begin with 'bulging bottles'. The name alone is concerning enough to strike fear into the strongest Supply Managers! There were complaints from sites regarding a handful of bottles that had bulging bottoms and wobbled on the shelf. There were concerns of contamination or a defect in the bottle itself. To troubleshoot, shipments went out at different temperatures (controlled ambient, non-controlled ambient, refrigerated), and no pattern emerged. As more complaints came in, the bottles were quarantined and there were grave concerns of a stockout because the new shipment of bottles might bulge too. Extensive testing was done on the bulging bottles to confirm that the product within was stable and safe, and many spreadsheets and reports were analyzed. Have you worked it out yet?
It turns out the sites nearest to the depot were delivered by truck and maintained a steady altitude. Meanwhile, the sites who were airmailed supplies, or existed at high-altitude locations like Colorado, received bulging bottles. After this was identified, the depot could include a form letting recipients know although the bottles might arrive bulging they were absolutely safe to use. Phew!
Here’s another shipment nightmare: 'ants on a plane'. Forget snakes, ants are scarier! Upon landing in Brazil to begin the customs clearance process, a high value and high quantity (kit packaged) depot drug shipment was identified as being part of the cargo on a plane infested with ants. If you have experience with the time it takes to get an import permit and to ship to Brazil, you’ll surely appreciate the heartache that went into needing to quarantine that shipment until further notice.
Ever been faced with ‘mysterious missing medicine’? We’ve heard so many stories of dropping kits into toilets, leaving them behind on the bus, or once a delivery driver was held up at gunpoint and robbed…of a placebo shipment! Sometimes the cause is truly mysterious and can feel like navigating a house of mirrors. Imagine a site that received a shipment, and signed for it, but the site staff say it never arrived. Our 4G colleague went in loops with the clinic, and finally convinced them to take a look around. So what happened? A passing ‘helpful’ person who had nothing to do with the study received the shipment and stuck it on a shelf, and then went on their merry way. Sounds like a case of Tell Tale Delivery!
Sometimes the horror comes from 'labyrinthian label requirements'. Some countries that don't use Fahrenheit want their own label because they refuse to have "XX degrees F" on their label. Tough luck if you want to share bottles across countries and reduce waste. Another colleague had a special packaging and labeling design for a country that wanted to provide compassionate use medication. It took so long, and had so many specific requirements, that once it was finally released and shipped just a couple of bottles were used.
How about some disfigured drug? Apparently, a common problem that gives the shivers to our colleagues with experience in manufacturing is the specter of “black specs”. They showed up in a bulk batch and were written off as debris. Everything had to just start over again, and no cause was ever found.
Another colleague had pills that looked just fine, but in an entire barrel of blue pills there was one single orange pill. No one knew where it came from, but that one 'changeling pill' was enough of a concern that the entire barrel had to be thrown out.
But 'the Frankenpill' wins the prize for disfigured drug. A patient returned their remaining capsules and during the drug accountability review the site coordinator noticed one of the 4 remaining capsules were visually smaller than the others. The smaller capsule looked identical in every other way – color, texture, etc. This product complaint put the entire drug batch at risk, putting that batch on hold across the globe until an investigation was completed. You can only imagine the number of around the clock hours required to move quickly to address this product complaint! In the end, the capsule in question was identified (and tested) to be a supplement the patient was also taking that somehow made its way back into the investigational drug bottle. If only that had been realized by the patient up front!
Crazy as it may sound, these are all true stories. So what do you do when it feels like the supply chain is delivering tricks? If there’s a sweet treat at the center of these rotten apples, it’s to familiarize yourself with your SMEs so you can pull them in when appropriate. No matter what level you’re at, even the experts have their experts at the ready. And who doesn’t love hearing a seriously spooky supply story?
BLOG POST CONTRIBUTORS:
Sr. Director of Product Development, Infinity Pharmaceuticals
Karen is a Senior Director of Product Development at Infinity Pharmaceuticals. Karen Ellis is the Product Development lead at Infinity Pharmaceuticals which includes clinical supplies responsibilities. Karen has worked in the biotech/ pharma industry for 17 years.
Forecasting Services Lead, 4G Clinical
Mohib is a Forecasting Services Lead who has more than 15 years of experience working in the clinical trial industry. His past experience includes building and supporting studies in IRT systems on top of forecasting, packaging and distribution as a Clinical Supplies Lead at GSK.
Forecasting and Resupply Operations Lead, 4G Clinical
Nicolas Biber, Forecasting and Resupply Operations Lead at 4G Clinical, has extensive knowledge of clinical trial forecasting theory and leading forecasting applications from ten years experience in the subject matter. He has consulted clinical supply operations through forecasting, supported the Prancer RTSM® forecasting module, trained internal and client teams on forecasting theory and application, and driven forecasting service development. Nicolas has a PhD in Marine Studies from the University of Plymouth (UK).
Sr. Forecasting Services Lead, 4G Clinical
Laurel is a Senior Forecasting Services Lead at 4G Clinical. She has over 16 years of experience in Clinical Supply Management and Forecasting, holding various positions in Packaging & Distribution Management, RTSM Build & Maintenance, and Clinical Supply Forecasting.
Sr. Manager, Business Development for 4C Supply®, 4G Clinical
Casey Ferrier brings 14+ years of experience in the clinical trial supply industry to 4G Clinical. He has implemented and led supply chain strategies to deliver solutions that support packaging, distribution, and logistics requirements for clinical trials for Pharma, Biotech, and CRO organizations.