Proper labeling of pharmaceutical products is crucial at every stage of manufacturing – whether it is during the process of transporting raw chemicals from one manufacturing unit to another or for the final product that customers purchase. The label is the first point of contact (along with the packaging) between a health product and a healthcare professional or patient, and it conveys crucial information about the safe and proper use of health products, serving as important aids in product identification, selection, and administration. Any misinformation can have serious repercussions and can even put people’s lives at risk. That’s why there are stringent rules and regulations on what information must be included on pharmaceutical labels, along with how they should be formatted. With a lot at stake, it’s important to get every aspect of your labeling right. Read on for some of the most important considerations while labelling pharmaceutical products.
- Do Think About the End User and Their Environment
Medication is taken or administered in a variety of scenarios – it may be taken by an elderly person with visual impairments, be administered by a paramedic under tumultuous circumstances, or used in a dimly lit hospital room. Try and avoid ‘look-alike’ labeling and packaging that can lead to human errors in administration in such situations and make sure that the information on the label is clear and legible.
- Don’t Use Bright Colors
While bright colored backgrounds can certainly make your product stand out on a shelf, they also pique children’s curiosity – which is a big no-no in the pharma industry. Additionally, bright colors can make the text and the graphic symbols difficult to read and cause eye strain or fatigue due to poor legibility. This lack of clarity while reading can also create confusion or misinterpretation of the information like the strength or the dosage of the product. Light colors like white, light blue or grey make great backgrounds. Make sure you incorporate enough white space into your label design so that information is easy to read.
- Do Focus on Conveying the Right Information
Ensure you follow all the rules and regulations regarding product information. Health Canada states that in addition to regulatory requirements, labels should contain eight key elements including:
- brand name
- non-proprietary name (proper or common name)
- strength, with or without total amount per total volume
- dosage form
- route of administration (other than for oral solids, such as tablets)
- critical warnings
- population (e.g., pediatric)
- storage instructions
Proofread your labels and proofread them again. Have multiple different team members check them out or use proofreading software designed for the medical industry. A misplaced decimal point can have lethal consequences.
- Don’t Use Fancy or Tiny Fonts
Leave Comic Sans to the entertainment industry. Chose your fonts carefully, avoiding stylized lettering, as they can affect the readability and comprehension of the information you need to convey. Sans serif fonts, like Helvetica or Arial for example, are clear, simple, and distinct. Similarly, fonts that are too small can also cause errors or mistakes in the identification or the administration of the product.
- Do Include Cautions and Warnings
Cautions or warnings should be prominent, conspicuous, and easily noticeable on the packaging. Cautions or warnings should also be written in simple, concise, and understandable language. Avoid writing them in all caps as this can affect legibility. Some examples of cautions or warnings are:
- Keep out of reach of children.
- For external use only.
- Do not use after the expiration date.
- Consult your doctor before using this product if you are pregnant, breastfeeding, or have any medical conditions.
- Keep refrigerated.
- Don’t Use Abbreviations, Acronyms, or Symbols That Are Not Standardized or Recognized
Minimize the use of abbreviations, symbols, and dose designations as much as possible. Abbreviations, acronyms, or symbols that are not standardized or recognized can cause confusion, misunderstanding, or miscommunication of the information. The Institute for Safe Medication Practices Canada (ISMP Canada) has a Do Not Use list that is extremely helpful for this.
- Do Think About Anti-Counterfeiting Measures
“Although it’s not mandatory in Canada, using automated identification systems (like RFID) can help make health products safer and more efficient. They can be used at different stages of the product-use process including procurement, inventory management, storage, and dispensation. Anti-counterfeiting measures can also include the use of specialty inks on labels.
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