Adverse event reporting

1. What we must report

Medicine and device manufacturers must track the safety of their products. Market researchers working for them must pass on safety information they hear, under the law and the BHBIA and EphMRA codes. There are three kinds:

• Adverse events: any side effect or unwanted change in health while someone is using a medicine or device, whether or not it was caused by it.
• Product complaints: a problem with the product itself, such as damaged packaging, a strange taste or a device that does not work.
• Special situations: use in pregnancy or breastfeeding, taking too much, misuse, use for something it is not approved for, medication errors, or the medicine not working.

2. When it applies

It applies to studies funded by a manufacturer that ask about its medicines or devices. When a study carries this duty, we tell you before you start, and you confirm you understand. It covers anything you mention in an answer, an interview or a message to our support team, even if the question was about something else.

Professionals are asked about clinical patterns, not individual patients. Please do not give us anything that could identify a patient.

3. What happens

Our trained safety team logs the report and sends it to the manufacturer's drug safety team within 24 hours of when we learned about it. The manufacturer may in turn report it to regulators such as the US Food and Drug Administration. Taking part in the study carries on as normal; it never counts against you.

4. Your name and contact details

We pass on what was said, the product and whether the person was a patient, a carer or a professional. We only share your name and contact details if you agree, so the manufacturer can ask follow-up questions. If you say no, the report is sent without them.

5. Reporting something yourself

Members can report a side effect or product problem at any time, from their account. You can also report directly to the manufacturer, or to the FDA through MedWatch.

6. If you need medical help

Reporting to us is not a way to get medical advice. If you or someone else is unwell, contact a doctor or pharmacist. In an emergency, call 911.