For over a decade, the EMA has mandated that the product name, and in some cases the strength, pharmaceutical form and intended patient (e.g baby, child or adult) of any medicinal product be expressed in Braille on the folding boxes. This introduced a new set of challenges for proofreaders, since this is another component that needs to be reviewed before going to print.
As you can imagine, we have heard about almost every possible labelling blunder. The following describes a real case story of a Braille misprint:
Situation: Companies using Braille on their documents often have it twice in their PDF. Once on the actual designed folding box which will be printed, and once outside of the printing area on the same PDF (or in some cases on another page). Usually, the Braille that is outside of the printing area includes a “translation” in letters. This allows the reviewer to check that the correct information, such as dosage for example, is inserted. Both of the Braille letters are supposed to be identical, which is why you should verify them, because it is not always the case!
Problem: Proofreading Braille is a well-known issue in the pharmaceutical industry. Employees in the Regulatory Affairs Labelling department are responsible (among many other things) to ensure content accuracy on labelling material including folding boxes. If a text comparator is not used, they must rely solely on their visual skills. When it comes to proofreading something like Braille, it can be challenging since they have likely not learned it. This is like proofreading a language with characters you don’t know. For added complexity, different countries use different Braille systems.
We recently acquired a customer who realised too late that on the same file, the Braille on the box and the Braille outside of the print area were different (different dosage). This resulted in a recall for them. Sometimes the bigger the trap, the easier to fall into it! The Text Verification Tool (TVT) was implemented shortly after that incident.
Solution: Since implementing TVT, they now routinely compare one Braille against the other to ensure it is always correct. They compare the artwork with the text and image comparison capabilities of TVT by simply loading the same PDF twice in TVT and pressing compare. TVT does the rest.
According to an article published by the BBC, less than 1% of the visually impaired people in the UK can actually read Braille. Although this may seem like a very small percentage, this regulation came into effect before the widespread availability of smart phones, which now enables people to have information read aloud to them. Nevertheless, Braille is mandatory on all drug boxes sold in the EU, so it is up to the proofreaders to ensure accuracy and consistency. Luckily TVT can help.
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