Pharmaceutical labelling errors have generated many global headlines. They are the leading cause of product recalls in the pharmaceutical industry.
In the United States, Dr Reddy’s has recalled 2,770 bags of an epilepsy drug because of a labelling error. The ingredient amount was incorrectly printed on the primary packaging. This caused a nationwide Class-I recall drive. Class-IT recall is for products that may cause serious health problems.
Similarly, there are many such cases across the pharmaceutical industry. The pharmaceutical industry is strictly regulated all over the world. Inaccurate pharmaceutical labelling leads to spreads the wrong information. Sometimes, consuming an incorrect dosage might make patients ill. In a few drastic cases, the consequences might also lead to deaths.
In India, the Central Drugs Standard Control Organization (CDSCO) and the Drug and Cosmetics Act (DCA) regulates pharmaceutical products.
Brands like Cipla, GlaxoSmithKline, Biocon, Sun Pharmaceuticals and more fall under this category. CDSCO also has an elaborate set of rules for pharmaceutical packaging and labelling. The organization handles everything from distributing manufacturer’s license to enforcing quality control.
5 Common Errors in Pharmaceutical Labelling
Pharmaceutical labels contain a lot of information such as ingredients, expiry dates, warnings and more.
In the artwork development process, human errors can creep in. Even an incorrectly placed decimal point on the product label can cause problems. Other instances such as mistakes in language translation or inconsistency in colours can happen too. As a result, brands would have to recall their products.
Let’s understand in detail 5 commonly occurring errors in pharmaceutical labelling and how to overcome them.
1. The Problem – Compliance Risks
As mentioned before, pharmaceutical brands are under constant scrutiny. Hence, it’s important they adhere to safety regulations for all their products. Local regulations are often complex and brands need to be fluent in the requirements.
Depending on the category of medicines, pharmaceutical brands have to follow other mandatory regulations. As the number of regulations increase, so does the difficulty to stay in compliance. Errors on packaging can creep in if it’s not accurately reviewed in the artwork approval process.
Online Artwork Proofing Tools are a great way to reduce compliance risks. Proofing is generally the task of multiple teams. These online tools include a PDF comparison tool, a tool to verify artwork fonts and colours, and a tool to measure dimensions of graphical elements. Contributors can use these free tools to find even the slightest errors.
2. The Problem – Outdated Procedures
Manual proofing of pharmaceutical labelling is a time-consuming job. Sometimes, developing labelling artwork involves many teams from different locations. Often, the volume of the artwork is also quite large. Orchestrating all the activities and integrating different processes creates more difficulties.
Automating the proofing process makes it faster and error-free. While proofing pharmaceutical labels, use free online tools to review the artwork. These tools can help to accurately review labelling artwork in a short span of time.
3. The Problem – Recalls Due to Incorrect Information
If a pharmaceutical product has incorrect information on the labelling, it puts patient safety at risk. Medicine recalls are expensive and can certainly damage the reputation of the manufacturer.
For example, Endo Pharmaceuticals in Ireland had to recall two batches of Robaxin® 750mg Tablets 100. This was due to a labelling error. The dosage was stated as “two to four tablets four times daily” instead of “two tablets three times daily.”
In UAE, JulpharGulf Pharmaceutical Industries had to recall Laxocodyl because of labelling issues. The manufacturers had incorrectly marked them as children’s medicines even though they were for adults. This could have led to twice the dosage in children, causing drastic side effects.
When it comes to product recalls, labelling errors are often the primary reason. Without proper proofing tools, it can be easy to overlook errors in the labelling artwork. An online artwork comparison tool can be a great way to see changes in a revised label. It can find even the smallest changes in text and highlight the revised part.
4. The Problem – Quality Issues
Quality issues may persist throughout the entire artwork development and proofing process. Furthermore, it may lead to inconsistent product packaging. These problems are not extreme enough to result in a recall.
However, quality issues can damage a brand’s reputation. Quality issues can include misplaced or distorted graphics. There may be inconsistency in colours and fonts across the labelling. This can make a product look as if it’s a counterfeit. In certain pharmaceutical products such as inhalers, colour codes on the packaging determine the class of medicine used.
An efficient way to address quality quibbles is by making use of online proofing tools. The font finder can show the font names used. The colour extractor tool can show the exact colour codes present. This helps in easy identification of the product. An artwork comparison tool can be used to check such inconsistencies with the artwork.
5. The Problem – Translation Errors
Pharmaceutical industries have limited time to get a product out in the market and in the hands of those who need it. Often medicines are imported from other countries. In such cases, language plays an important role. Pharmaceutical labelling needs to be in a language that people can read. It can be either in a language native to a country or in universal languages.
Proofing translated labels are a major task undertaken by professional translators. Any errors in the language can cause bottlenecks, delaying the product’s release.
Translation errors can happen due to manual proofing. Local translators might review the pharmaceutical labelling by eye. This might cause them to miss any mistakes.
To reduce the risk of such errors, translators can use an online proofing tool. Once the translator has given his/her feedback, they can easily track the changes in the revised labelling artwork.
The pharmaceutical industry is stringent and over 50% of product recalls are due to errors in labelling. Pharmaceutical brands need to be sure of their labelling artwork or risk public safety. Artwork Proofing Tools help in curbing these errors by simplifying the review process.