Preparing for a Recall Armageddon

Recalls aren’t actually the end of the world, but they can seem that way to a pharmaceutical company. After going through the trouble of investing so much in research, clinical studies and marketing, the drug finally hits the market. You start to see your investment pay off both financially and by helping patients improve their quality of life. Then the unthinkable happens — there’s a problem. And it’s bad enough that you have to recall all the product that you worked so hard to get out into the market.

If you’re lucky, you wake up and realize that your pharma nightmare was literally a nightmare and your drug is just fine. If you’re not so lucky, you pinch yourself and realize the proverbial nightmare is your new reality.

Preparing to Armageddon It

How you deal with that new reality depends on how you’ve prepared for it. You can lower the cost and time needed for a recall by planning your recall process out now. The U.S. Food and Drug Administration (FDA) just came out with new guidance to help companies with this preparation.¹ Their three biggest points involve training, record keeping and procedures.

Training

When Armageddon hits, the supplies that you’ve stockpiled won’t be any good if you don’t know how to use them. The same is true of a recall. Even the best standard operating procedure (SOP) for recalls has no practical use if employees aren’t trained on it. To train employees you must first identify which ones will be involved, establish a recall communications plan, and identify FDA reporting requirements.

Record Keeping

This isn’t quite as important for actual Armageddon, but for this recall version accurate and thorough record keeping is essential. This is one area of the guidance where pharma companies are already well prepared. Being able to trace the product being recalled involves proper coding and maintaining records to track the drug down.

Procedures

Preparing for Armageddon involves having a plan and recording it. This is where the aforementioned SOP comes in. Employee training should be based on the SOP, which needs to include who will do what when. It needs to address when you’ll initiate a recall and how the drugs will be removed from the market. The more well-written the procedure is, the quicker the recall can be completed with the least disruption to the company.

The Practical Side of Armageddon

A recall might seem like the end of your pharma world, but even with the FDA’s guidance you’re probably not feeling fine. That might have something to do with the siloed nature of training, documents and SOPs in most organizations. It’s clear from the language of the guidance that surviving recall Armageddon requires these three to work together. Avoiding recall fallout means doing business in a more connected way and that means digitization and automation.

The right software solutions will connect your training to your SOPs. It will alert your employees when the recall SOP changes and will automatically prompted them to take an exam to prove proficiency in the new procedure. There are also solutions that provide document control that centralizes your record keeping in such a way that records are easily tracked and located when needed.

Adhering to the guidance from the FDA and choosing an integrated software solution will help pharma and other FDA-regulated companies face the daunting task of a recall. A company that is properly prepared can tackle the event quickly and efficiently without compromising the rest of its business processes.

References:

1. U.S. Food and Drug Administration. “Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls.” April 23, 2019. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-fda-associate-commissioner-regulatory-affairs-melinda-k-plaisier-agencys-new-steps?utm_campaign=4-23-2019-recalls&utm_medium=email&utm_source=Eloqua