Pharmacovigilance intake formalised for direct reports
Ergopharm has published a structured intake route for suspected adverse reactions and product quality defects reported directly to the company, alongside the existing routes through distribution partners.
Reports arrive from many directions — a pharmacist, a prescriber, a patient, a partner's quality unit — and the value of a report depends on capturing the same core information regardless of the door it comes through. The intake form captures the four elements that make a case valid for assessment: an identifiable reporter, an identifiable patient, a suspect product and a suspect reaction.
“The report you can act on is the one that arrived with the four things you need.”
Reports are acknowledged with a reference, triaged, coded, assessed for seriousness and expectedness, and followed up where information is missing. Where the product is supplied under a partner's marketing authorisation, the report is transmitted under the safety data exchange agreement with that partner.
The published route makes clear that reporters may also report to their national scheme, and that doing so does not replace or duplicate telling their own prescriber.
Key facts
- Captures
- Reporter, patient, suspect product, suspect reaction
- Process
- Acknowledge, triage, code, assess, follow up
- Partners
- Transmitted under the safety data exchange agreement
- Also available
- National reporting schemes
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.