- Anyone can report side effects or issues with medicines, vaccines, or devices to the Therapeutic Goods Administration (TGA), including people with MS and their carers.
- Reports to the TGA helps to identify safety concerns and can lead to updates, warnings, or changes in how treatments are used.
- Even minor or suspected reactions should be reported. Every report helps keep the MS community safe.
What Are Adverse Events?
Adverse events are unintended and sometimes harmful occurrences associated with the use of therapeutic goods, including medicines, vaccines, or medical devices. These can include side effects, reactions, or other problems. Reporting these events helps the Therapeutic Goods Administration (TGA) monitor the safety of therapeutic goods and act when necessary.
Report Every Concern. No Matter How Small
Even if a reaction seems minor or uncertain, it is worth reporting. The TGA encourages all reports; suspicions are enough. You don’t need to be sure a product caused the issue. If in doubt, report it.
What Can Be Reported?
You can report any issue related to:
- Prescription or over-the-counter medicines
- Complementary medicines (e.g., herbal remedies, vitamin supplements)
- Vaccines
- Medical devices (e.g., bandages, infusion pumps, implants)
- Suspected drug interactions
- Unusual or unexpected reactions, even if they’re not listed on the label.
Who Can Report?
Anyone can report an adverse event, including:
- People who experience an adverse event
- Family members or carers
- Health professionals, including doctors, pharmacists, nurses, and allied health workers
- Sponsors or manufacturers
What to Include in a Report
When reporting an adverse event, provide as much information as possible, including:
- Your contact details
- A description of the adverse event
- Details of the medicine, vaccine, or medical device involved.
If you don’t have all the information, don’t worry, just report what you know. If possible, keep the medicine labels and packaging, as it can help with follow-up. The TGA may follow up if more details are needed. Personal information is kept confidential.
Important: Seek medical advice first for any urgent health concerns. Reporting is important, but your health comes first.
How to Report
There are several ways to report an adverse event:
- Online: Use the Adverse Event Management System (AEMS) to submit a report.
- Phone: Call the 1300 MEDICINE line at 1300 633 424 (Monday to Friday, 9am to 5pm AEST, closed on NSW public holidays) to speak with a registered pharmacist.
- Email or Fax: You can also report via email or fax. Visit the TGA’s Reporting Problems page for more details.
What Happens After Reporting
Your report will be added to a national database and the TGA may contact you for further details. Reports are de-identified and published in the Database of Adverse Event Notifications (DAEN).
The TGA reviews each report to identify potential safety concerns. If a risk is identified, they may take regulatory action. For example, they may update safety information, issue warnings or safety alerts, request label changes, or withdraw products from the market.
What Does This Mean for People with MS?
People living with MS often rely on a combination of therapies to manage their condition. Some therapies may be new, specialised, or be used off-label. By reporting even minor or suspected adverse events, you can contribute to a safer treatment landscape, not just for yourself, but for the entire MS community.
Your experiences matter. Whether it’s a side effect, an unusual reaction, or an issue with a device, sharing what you notice can make a real difference.
By reporting adverse events, you play a vital role in ensuring MS treatments remain as safe and effective as possible for the MS community and the broader public. Your vigilance helps maintain the integrity of therapeutic goods in Australia.
