In 2018, a pharmaceutical labeling error caused babies in Spain to be dosed with medication for hair loss. As a result, they developed hypertrichosis (werewolf syndrome) which caused them to grow thick and dense hair.
To keep the situation under control, the Spanish Health Ministry recalled batches of the medicine and closed the factory where the drug was produced.
This incident shows the grave consequences of pharmaceutical labeling errors and how they negatively impact the brand reputation and trust that consumers have placed on companies.
That’s why it’s important to tackle these errors early on to maintain the brand’s reputation and escape hefty fines and recalls.
So, in this article, we’ll look at the most common errors in pharmaceutical labeling and how to reduce these labeling errors.
Let’s start with the most common pharmaceutical errors and their causes.
56 lots of asthma treatments sold in US retail outlets were recalled because they failed to include information on when the consumer should stop taking medicine and consult a doctor.
A Spanish company recalled products because it omitted the word “not”, which could put lives at risk. The product’s leaflet stated that “pseudoephedrine is excreted in breastmilk, so this product should be taken during breastfeeding” instead of “should not be taken during breastfeeding.” (Source: Schlafender Hase)
You’ll see plenty of pharmaceutical labeling errors like this with far-reaching consequences, so you’ve got to have a good understanding of the different types of errors you should be on the lookout for. Here are a few types:
Now that we’ve looked at the different types of errors, let’s take a closer look at their implication for patients and the company.
Proofreaders are “the air traffic controllers of pharmaceutical labeling and packaging. They have to get it right, because the consequences can be far-reaching,” says Dr. Jutta Hohenhoerst, Regional Sales Director, Schlafender Hase.
Dr. Hohenhoerst’s right because consumers and healthcare professionals look to the label for information and instructions on its safe and effective use. So, any error in the artwork or label contents will have far-reaching implications like:
But to avoid these errors and the harmful impacts, let’s take a closer look at the factors that cause these errors.
Most pharmaceutical errors occur due to the following reasons:
The causes mentioned above seem obvious, but you’ll be surprised at how many companies don’t pay attention to them and end up paying hefty fines and dealing with product recalls.
And the best way to eliminate these causes is to use a standard operating procedure and adhere to a lean label management process, both of which can be easily established with an online pharma artwork management tool.
This helps the teams stay on track, reduce revisions, and finish the artwork label before the deadline. It also helps them make swift changes to artwork designs if a new regulatory requirement is introduced. So, next, let’s look at how an online artwork management tool makes the drug labeling process easier.
An online label software helps you streamline your labeling process and avoid errors which cause serious implications. Here’s how:
An online artwork management tool like Artwork Flow has workflows and checklists that helps you establish an SOP and get everyone on your team on the same page regarding the whole process.
It also injects accountability and traceability into the process, so the project manager knows which team member is responsible for a specific task.
For example, with Artwork Flow, a pharmaceutical labeling project can be split into multiple stages like briefing, design, and review. And each of these stages can have tasks which the project manager can assign to different team members.
This helps locate the error sources quickly, evens out the workload distribution, and helps members understand priorities. As a result, stress-related and decision making errors are eliminated completely.
You can no longer be reliant on manual proofing as your proofreaders are subject to constant stress and fatigue, especially when they’re working on multiple projects that are similar in nature.
That’s why you need an online label management software like Artwork Flow which has a set of proofing tools like the ones below to identify the different types of labeling errors.
Regulations aren’t limited to just identifying spelling errors that can cause grave consequences. According to the FDA’s 21 CFR Part 11, companies are required to maintain an audit trail to show everyone who worked on the label and signed off on it.
And if you have an artwork management system like Artwork Flow, this process becomes a breeze.
As mentioned earlier, the workflow feature helps maintain a record of everyone who worked on the project. And the Artwork Flow library, which also doubles as a Digital Asset Management (DAM) tool, maintains a record of all the changes made to the artwork.
With the collective data from these tools, it’s easy to create an audit trail with all the tasks, the changes made to the artwork, and the members who worked on it.
Pharmaceutical labeling errors have far-reaching consequences that go beyond product recalls and fines.
Companies have to deal with lawsuits, backlash from the medical community and patients, and spend millions of dollars trying to rebrand their image and earn back consumers’ trust.
The best way to prevent these serious mishaps and nip these errors in the bud is to invest in an artwork management tool like Artwork Flow which has a set of proofing tools and other features which help you stay compliant.
For example, Ashish Life Sciences, manufacturers of animal health and veterinary products used Artwork Flow to eliminate labeling errors, stay on top of regulation, and improve their go-to market time.
If you want to join the bandwagon and learn how Artwork Flow can help eliminate instances of recalls and errors that cause dire consequences, get a demo right away.