Medicines Under Additional Monitoring

In the dynamic world of pharmaceuticals, it's imperative for pharmaceutical companies to remain informed about new developments that prioritize patient safety and promote responsible medication use. Today, we're shedding light on "The List of Medicines Under Additional Monitoring," which was last updated in October 2023.

What's Behind "The List of Medicines Under Additional Monitoring"?

Well, it's all about keeping a closer eye on certain medicines. If you spot a black inverted triangle (▼) on their package leaflet or Summary of Product Characteristics (SmPC), it means they're getting some extra attention from regulatory authorities.

Now, this extra scrutiny doesn't mean these medicines are unsafe. It's simply because there might be less information available about them, especially if they're new to the market or lack extensive long-term data. It's all part of "additional monitoring" to ensure the safe and effective use of these medicines, ultimately benefiting patients worldwide.

The purpose of additional monitoring is to enhance the reporting of suspected adverse drug reactions, especially for medicines with a less comprehensive clinical evidence base. Its primary objectives are to gather data as early as possible, thereby enriching our knowledge of how to use these medications safely and effectively. This includes gaining insights into their safety profiles, potential side effects, and benefits when applied in routine medical practice.

So, which medicines make it onto this list?

Generally, you'll find newly approved drugs, products with limited post-market data, or those with complex risk-benefit profiles. These are the meds that healthcare professionals, patients, and regulators need to keep a close watch on.

The list includes centrally and nationally authorised medicines in the following categories:

  • medicines that contain a new active substance that was not contained in any authorised medicine in the EU on 1 January 2011;
  • biological medicines authorised after 1 January 2011;
  • medicines requiring post-authorisation safety studies (PASS);
  • medicines given conditional approval or authorised under exceptional circumstances and medicines authorised with specific obligations on the recording or monitoring of suspected adverse drug reactions.

A medicine can join the list when it's first approved or at any point during its lifecycle, and it stays there for five years or until the European Medicines Agency's PRAC decides to remove it.

You can find the up-to-date list on the EMA's website: List of medicines under additional monitoring

Why medicines are monitored after obtaining their marketing authorization?

Ever wondered why we monitor medicines after they're authorized? It's all about making sure the benefits of a medicine outweigh the risks. Clinical trials give us an initial glimpse, but real-world scenarios are different. A diverse group of patients with various conditions and medications might use the medicine, and some less common side effects may only emerge after extensive use. This is why continuous monitoring is vital to keep patients safe.

And here's why it's significant:

  • Improved Patient Safety: By identifying and tracking potential risks associated with certain medications, regulatory bodies can swiftly act to protect patients.
  • Informed Decision-Making: Healthcare professionals, researchers, and patients can make more informed choices about treatment options, balancing potential benefits against potential risks.
  • Advancing Drug Development: The insights gained from this monitoring contribute to the development of safer and more effective medications.

👉 Don't forget, if you experience any suspected side effects to medicines, please report them. Your input is valuable for continuous improvement.

At AxeRegel, we understand the importance of pharmacovigilance services. We're here to support pharmaceutical companies in fulfilling their responsibilities, from monitoring to reporting, and beyond.

Let's team up to prioritize patient safety and contribute to the ongoing progress of the pharmaceutical industry. Reach out to us to learn how we can assist you in this critical mission.