Overview:

Eleven retailers from around the UK were asked to recall certain batches of cold and flu capsules due to a mistake on the leaflet and carton that states children aged 12 to 15 years can take a maximum of up to 12 capsules (3.6 grams of paracetamol per day) in any 24 hours. This labelling is correct for adults aged 16 years and over, but not for children aged 12 to 15 years old. This case, where mislabeled packaging could have led to overdoses, serves as a stark reminder of the vulnerabilities in pharmaceutical labelling processes and the potential impact of human error.

Recently, a leading pharmaceutical company in India recalled a batch of its popular thyroid disorder drug with 88mcg tablets having an incorrect 25mcg label. Well, mislabeling does pose a significant risk to patient safety and can land companies in huge revenue drawbacks apart from the reputation because when it comes to healthcare, even the smallest detail can have the biggest impact. Missing information, incorrect and inconsistent text, wrong translations, and a lot more can be avoided. Let’s see how.
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Source: FDA
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3 Common Reasons for Pharmaceutical Recalls:

The major reason for pharmaceutical recalls is labelling or packaging errors. Failure to mention medical compounds, mislabeled packages regarding compound quantity, and under or over-dosage instructions can cause serious problems and put patient safety in trouble. The following are the most common error occurrences:

1. Labelling Errors: These happen when label artwork omits important details. When regulatory standards change and the manufacturer neglects to update the package artwork by the new guidelines, this kind of error most frequently happens. For instance, missing essential information, inconsistencies in context and meaning, content errors, and technical flaws such as illegible barcodes.
   

2. Compliance Errors: Compliance errors arise due to violations of regulatory standards or guidelines set by health authorities. According to the FDA, failure to meet manufacturing standards, improper storage conditions, or inadequate documentation results in compliance issues and poses risks to patient safety.  
   

3. Non or Inaccurate drug declarations: Non or inaccurate drug declarations occur when pharmaceutical companies provide incomplete or incorrect information about the composition, potency, or ingredients of a medication. Patients may end up obtaining medications that don't match their prescription specifications which could result in negative side effects or inadequate treatment. For instance, recently, Arize Herbal Dietary Supplement recalled its one lot of capsules on the consumer level that contain an undeclared component resulting in the unapproved new drug.
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Addressing these common reasons for pharmaceutical recalls requires stringent quality control measures, adherence to regulatory guidelines, and continuous monitoring of manufacturing processes to ensure the safety and efficacy of medications.

What might the mistakes cost you?

1. Compromise on the patient’s safety: Labelling errors can prove hazardous to patient’s health and safety causing serious side effects and risking their well-being. This damages trust in the brand and reduces its value and reputation.
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2. Regulatory compliance issues: It is important to meet the regulatory practices failing which can lead to paying hefty fines and penalties, including recalls. Regulatory practices should be meticulously met to avoid putting at costly repercussions.
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3. Financial and reputational damage: The company’s reputation and core values face an unfavorable impact resulting in a decline in sales and brand image. Recalls and other corrective actions also result in significant financial losses if the recalls result from the consumer level as seen above in the case of Arize.
   
   

How does ManageArtworks Copy Manager help you reduce labelling errors?
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1. Centralized copy management: Multiple files and not sure which is the updated version? Well, it can be tiring to switch to and fro from Excel files and confirm with every stakeholder for approvals. A lot of information can be missed and so can the deadlines to release the product. The copy manager assists you with creating copy lists for easy approval with all the stakeholders on board facilitating easy content collation and collaboration across teams and less time to market.
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2. Copy and Design Components: Multiple components and elements can be segregated and made available on a single dashboard such as specifying what should go on front, side, and back labels. This simplifies the designer’s task by reducing the need for multiple approval processes. Copy content is easily accessible with ManageArtworks Adobe Illustrator or InDesign Plugin making it convenient for the design teams facilitating smooth export.
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3. Version Controlled: Every change made in the labels is tracked to ensure the right version gets approved. The copy manager facilitates defined approval workflows that require sign-off from designated personnel before finalizing labels to reduce the risk of unauthorized modifications. Detailed audit trails of all activity are maintained for thorough investigation and identification of potential errors before the production stage.
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4. Reduce Rework: A direct comparison of the artwork and the content in the copy sheet is shown in the comparison report. Copy manager not only enables you to reuse copy elements in the sheets but also allows you to create a new one from the old enabling efficient time usage and rework reductions.

Labelling errors in pharmaceutical products has wide-ranging implications, affecting patient safety, regulatory compliance, internal team dynamics, and the company's financial standing and reputation. Though the errors seem obvious they are often ignored by the businesses leading to product recalls and enormous fines. It is of utmost importance to exercise rigorous quality control and adhere to regulatory standards in pharmaceutical labelling processes.
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Check out here how Copy Manager can help you stay updated with your copy game.
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^{About ManageArtworks:}

ManageArtworks has over a decade of experience in providing Artwork management solutions for large enterprises across industries. It enables better collaboration, drives efficiency and helps you get to market faster. Stay updated and keep track of the latest developments in the packaging artwork for a quick turnaround of your Artwork workflow.  

To know how it can aid your artwork management process, click here for a FREE DEMO.