Misspelling or incorrect language use in product labeling or packaging may not have serious consequences in some industries, but in the pharmaceutical and medical device sectors, where accurate and error-free information is crucial, the implications can be significant. Medical errors due to spelling can be lethal!
Spelling errors, missing information and language mistakes can lead to medical errors that put patient health at risk. Additionally, such errors can result in misprints, CAPA’s and product recalls. Moreover, the perception of the product and the company’s reputation are likely to suffer.
Spelling errors simply do not belong on labels and packaging
We are particularly prone to making spelling mistakes with so-called homophones – words that sound the same but have entirely different meanings. Arguably, in a world of instant messaging and social media, where we generally write in a register of the spoken language, we are even more susceptible to mistakes of this kind.
Spelling errors also commonly occur with new words, and this is especially the case for brands names, the names of new equipment, and new medical terms.
Along with spelling, it is important that punctuation and grammar are correct, thus avoiding ambiguities in labeling and packaging that might result in medical errors. In some languages, there is the additional complexity that numerals are grouped in thousands with commas, while others use dots; decimal points (e.g. 1.5 mg) appear as commas (1,5 mg). It is one of the most common number errors in translated documents in some countries, adding to the risk that numbers are reversed or otherwise transcribed incorrectly.
Abbreviations
We know that “mg” refers to the dosage “milligram”, and the abbreviation is so generally accepted that not only would writing it out be unnecessary, a patient might even be momentarily distracted if it were. This can have a snowball effect. Distraction increases the risk that a patient misreads, misunderstands or overlooks other parts of the instructions. Of course, the same applies to spelling errors in general.
Regulatory authorities provide guidance on use of abbreviations and acronyms. In Instructions for Use (IFU), for instance, “… FDA recommends avoiding abbreviations in the IFU because they may be misinterpreted, which could result in medication errors that may harm a patient”[1], but “mg” is accepted as standard, as is the abbreviation “IFU” itself on the FDA website, and the guidelines point Regulatory Affairs (RA) professionals to a website with a list of error-prone abbreviations.[2] It is important to have a clear understanding of when to abbreviate and when to spell out a word. Less-known abbreviations need to be spelled out on first use.
Understanding medical terminology
Terminology exists not for its own sake but in order to create clarity and a common understanding. It helps us to reduce ambiguities through a standardized language, especially for healthcare providers. Using correct terminology also helps us to communicate with greater consistency throughout a labeling and packaging document. It saves time and space, because plain-language explanations can be imprecise, and ultimately medical errors can be reduced through better communication and the mutual understanding created through proper use of terminology.
What’s the best way to reduce errors?
First and foremost, a good understanding of regulatory requirements, language and terminology is essential for creating a high-quality, approved document that will be used to create subsequent labeling and packaging versions downstream.
Automated proofreading
Manual proofreading (the old fashioned way- using human eyes only going line by line, item by item) is simply not up to the challenges of labeling and packaging in the regulated pharmaceutical industry.
Automated proofreading, on the other hand, offers the potential to compare any two documents (e.g. a master MS Word file with artwork in PDF format) within seconds, highlighting any deviations between the approved master document and the labeling and packaging version. It is fast, minimizes the risk of human error, and the best of these allow integration easily into workflows and information management systems.
Additionally, an automated proofreading (or document comparison) tool should have the ability to verify spelling and handle complex medical terminology.
This is especially important as a manuscript progresses through the workflow. Most original manuscripts are first created in MS Word. As work progresses, the format generally changes to other formats that do not necessarily include spell-check functions or spellcheck functions that are sufficiently powerful or precise.
A further question to ask when choosing an automated proofreading solution is whether it can check terminology and spell-check technical and proprietary terms. Useful, if not essential for this, is the integration of a medical dictionary and customized dictionaries.
Spelling Verification for Regulated Industries
Let’s look at a few of the advantages of TVT Spelling, a spell-check built to be compatible with regulated documents.
At a glance:
- TVT Spelling includes multiple dictionaries supporting all major EU languages.
- It can be used with Stedman’s® Medical Dictionary to support the spell-checking of medical terminology and accepted abbreviations.
- TVT Spelling comes with a custom dictionary function to check brand and products names, and this can be easily expanded, stored and shared.
- TVT Spelling is fully integrated – one tool can be used to run checks, producing a comprehensive report.
- TVT can be integrated with any information management system for a seamless workflow.
Further information
Find out more about TVT Spelling:
https://www.schlafenderhase.com/tvt-software/tvtspelling/
