How and where do I report side effects of my medication?

The timely reporting of adverse drug reactions (ADRs) or side effects is crucial for monitoring the safety of medications on the market. This process helps regulatory agencies identify potential safety concerns and take necessary actions to ensure patient safety. Here, we delve into the procedures for reporting side effects of medications in the UK and US.

Reporting side effects in the UK

In the United Kingdom, the primary system for reporting side effects is the Yellow Card Scheme, managed by the Medicines and Healthcare products Regulatory Agency (MHRA).

What is the Yellow Card Scheme?

The Yellow Card Scheme is a system for collecting and monitoring information on suspected adverse drug reactions (ADRs) to medicines.

Who can report?

Everyone can report side effects – this includes health professionals (like doctors and pharmacists) as well as the general public.

How to report using the Yellow Card Scheme:

• Online: Visit the Yellow Card Scheme website.
• Mobile App: Download the Yellow Card app from the App Store or Google Play.
• Now Paient App: You can report side effects conveniently from the nowpatient.com App
• Paper forms: Available from the MHRA or in the back of the British National Formulary (BNF). Once filled out, they can be mailed to the address provided.

What to include in the report:

• Details about the person experiencing the side effect.
• Information about the medicine or product causing the side effect.
• A description of the side effect or reaction.

Reporting side effects in the US

In the United States, the Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of medications. To report side effects, the FDA encourages the use of the MedWatch program.

What is MedWatch?

MedWatch is the FDA’s system for reporting adverse events and product complaints about drugs, medical devices, and other health products.

Who can report side effects?

Similar to the UK, both health professionals and consumers can report side effects to MedWatch.

How to report using MedWatch:

• Online: Use the online reporting form available at the MedWatch Online Voluntary Reporting Form.
• Fax: Download the pre-addressed, postage-paid form (FDA Form 3500) from the FDA website and fax it to the number provided.
• Now Paient App: You can report US side effects to the FDA conveniently from the nowpatient.com App
• Mail: Similarly, download the FDA Form 3500 and mail it to the address given on the form.

What to include in your report:

• Patient information.
• A detailed description of the adverse event or product problem.
• Information about the suspect product.
• Information about the person submitting the report (this can be anonymous).

Why Reporting is Important:

Both the Yellow Card Scheme and MedWatch provide essential data that helps in the ongoing safety monitoring of health products. This data:

– Alerts regulators to new, unusual, or rare side effects.
– Supports further investigations if needed.
– Can lead to changes in how a product is used or even its removal from the market.

While many side effects are already known and documented when a medicine gets approved, some rare or long-term side effects might only emerge when larger populations or specific groups of patients use the medicine. Reporting side effects, no matter how minor they might seem, contributes to a safer healthcare environment for everyone.

Always remember: if you or someone you know experiences a side effect from a medication, it’s essential to report it. Your input can help ensure the ongoing safety and effectiveness of medicines for everyone.

Sources

• FDA
• MHRA