AE reporting through the Yellow Card System – how well does it work?

How is the Yellow Card System in the UK's NHS working? I started thinking about this while I was analysing results from a poll that we did at last year's World Drug Safety Congress Europe, looking at ways to improve risk communication and adverse event reporting. The poll asked the audience to rate innovative and effective systems and the yellow card system came out near the bottom of the rank. It got me thinking what is good about the system and why does our mainly pharma and biotech audience not rate it highly? Is there something lacking in the system?

What is the system?

It's a system for the early detection of potential drug safety signals and routine monitoring for all authorized medicines. Suspected adverse reactions are reported to the NHS and MHRA. It encourages the patient to engage in safety reporting which was traditionally the job of the professional.

What information are patients asked to provide?

  • the suspected side effect
  • the person who had the suspected side effect (even if you prefer not to give a name)
  • the medicine that might have caused the side effect
  • any other medicines being taken at the same time

What are the potential challenges of the system from pharma's perspective?

  • making patients aware of the system
  • making patients take the effort to report the potential AEs
  • making patients aware of the importance of reporting potential AEs
  • ensuring detailed, relevant information is collected

Surely a system that encourages patients to prioritise AE reporting when an reaction occurs is great for pharma? The problem may lie with making sure it is a common place system that patients know of and go out of their way to engage with and making sure the information is quality led. What are the strong points and weaknesses of the system as it currently stands?

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