The Impact of Serialization on Drug Recalls

Understanding the impact of serialization on drug recalls

The impact of serialization on drug recalls has been substantial in the recent history of the pharmaceutical field. As new serialization requirements take hold under directives such as the DSCSA or the EU FMD, companies are seeing the benefits of adhering to these standards more and more. To understand the profound impact this has on the practice of recalling medicines, we will first take a look at what problems medicine recall poses today and then see how serialization helps alleviate those issues.


The issues with how drug recall is normally performed

Generally, manufacturers send recall notices to the FDA, recall alert manager services, and direct distribution partners of recalled products. They simultaneously send out a press release, a letter to the media, and product alert services as part of a mass communication. The information is then distributed to all of the dispensers by the distribution partners and recall alert manager services. Pharmacies expend a lot of work processing recalls that might not directly affect them or their patients because they do this whether or not the pharmacy has acquired the product.

As a result, pharmacies could receive up to ten alerts for just one recall of a product they may or may not have purchased, from the manufacturer, wholesaler, recall alert management services, etc. The impact of serialization on drug recalls is precisely that it eliminates the need for such time-consuming guesswork, but we will get to that soon.

For now, the important thing to keep in mind is that all of these notifications take considerable time to process, from logging the initial recall notice and determining whether or not they have purchased said product in the first place to disposing of it, all the while documenting the entire process.

Responding to a single recall typically takes five hours, and the labour and missed productivity costs come out to $100 per hour. With 456 recalls annually, 2,280 man-hours are devoted to recalls, resulting in labour and lost productivity costs of $228,000. Recalls cost the average pharmacy 2,280 man-hours annually, not to mention $228,000 in personnel costs and wasted productivity.

dietary supplement serialization in Russia


The patient safety hazard

The inability of hospitals and pharmacies to instantly ascertain whether they purchased a recalled product has ramifications beyond mere operational efficiency. It might also have an effect on patient safety. Pharmacy employees may take longer to address a recall for a product they purchased and may have dispensed, which could have a significant impact on patient health depending on the recall’s severity or class. This is in addition to monitoring shelves for products they may never have purchased.


The good news about the impact of serialization on drug recalls

Finally, we get to the main part of this article’s topic. We have a lot of articles discussing what serialization is exactly and exploring different aspects of it, so if you are new to the concept it might help to check those out. In this section, we will list all of the ways in which serialization revolutionizes the process of recalling faulty or dangerous medicines.

A scannable 2D barcode on a serialized pharmaceutical product contains useful data such as the national drug code, the drug’s serial number as well as its lot number, alongside an expiration date. Of course, there might be other elements, but this main set of data allows for the following changes in the way drug recall is managed:

  • It enables companies to immediately check the status of any given product to see if it has been already recalled, allowing protective measures to be taken before it enters inventory and is distributed to patients.
  • Companies will no longer receive multiple alerts for a single recall due to a centralized repository of recall notifications that target specific sets of serialized data.
  • A recall for serialized products currently on the market notifies companies that they were given a recalled lot and product at a specific place on a specific date.
  • When a product is returned to the manufacturer, they can be electronically notified about the exact serial numbers you are sending back.
  • Finally, there are benefits for larger pharmacies. If you purchase 500 bottles, for instance, and distribute them into groups of 20 bottles for each location, you may utilize the unique identifier on each bottle to locate each recalled bottle and remove those bottles alone from the shelves instead of having to go over every item on the shelves in every location.

Utilizing the impact of serialization on drug recall

Now that you are aware of these incredible advantages that serialization holds for recalling faulty medicines, you have another non-legal reason to pursue it. It is inevitable that mistakes will happen in the manufacturing and distribution of medicine so having robust systems which simplify drug recall is crucial. If you would like to bolster the serialization practices of your own business, look no further than our informative blog articles. For a more practical approach, feel free to get in touch with us for hands-on help with growing your pharma business.

Share with your contact

Scroll to Top