Should pharmaceutical warning labels be standardised?

Pharmaceutical regulators have recently been questioning whether standardised pharmaceutical warning labels can assist healthcare providers to better comprehend risks and benefits.

This is already something that has been applied in the United States, where all product labels look identical down to the font and font size. This is because America’s FDA (Food and Drug Administration) enforces this standardisation, and regulates all pharmaceutical labelling. The end result is that all pharmaceutical warning labels are simple for everyone to read and understand.

When looking at a pharmaceutical label the recipient should easily be able to discern:

  • How to take the medication, including dosages and any additional advice and information
  • Easily understood terminology, all wording should be clear to comprehend
  • How to store the medication e.g. refrigerated, what temperature
  • Company information, including contact details
  • Expiration dates and regulatory information

This basic list demonstrates the need for provision of information that tells the patient or healthcare provider more than just the name of the product. It may also be necessary to print this information in more than one language, if the product is distributed in multiple countries.

However, issues can arise when individual countries require different information provided in line with their government requirements. This can be limiting for a sponsor for many reasons, for instance if they have planned a clinical trial customising the label for each country would be a laborious process. This would also require the sponsor or manufacturer to be fully aware and fluent in the regulatory requirements of each country, which many argue is just not realistic.

If the wording used on pharmaceutical warning labels were to be standardised this could help to avoid any confusion. There should also be a universal agreement on the unit of temperature used to inform people how to store the medicine, for example using either fahrenheit or celsius.

The NHS offers advice for choosing advisory phrases to be used on pharmaceutical warning labels. It suggests using the phrases without modification to avoid miscommunication of the message. If wording is altered the NHS recommends taking care to retain the sense of the original phrase. You can view the recommended label wording here.

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