Adverse Drug Event Report
An encrypted adverse drug event (AE/ADR) report for Swissmedic pharmacovigilance. Covers patient demographics, suspected product details, event description, severity, outcome and reporter information. Compliant with HMG Art. 59, ICH E2A and WHO-UMC guidelines.
A pharmacovigilance report is only a report once it has four things: an identifiable patient, an identifiable reporter, a suspect product and an event. Below that threshold it is an enquiry, and it does not enter the safety database. Most of the design of an intake form for adverse events is about reaching those four elements on the first attempt.
The four elements that make a valid case
A valid adverse event report requires at minimum: (1) an identifiable reporter, (2) an identifiable patient, (3) a suspected product, and (4) an adverse event. This template captures all four elements. Additional detail — causality assessment, medical history, concomitant medications — improves the signal-detection value of the report and should be included where available.
What the form collects
- Patient age group and gender (no name required)
- Suspected medicinal product — name, lot number, expiry date
- Event description and onset date
- Event severity classification (mild / moderate / severe / life-threatening / fatal)
- Clinical outcome at time of reporting
- Causality assessment (certain / probable / possible / unlikely)
- Concomitant medications and relevant medical history
- Reporter identification and professional category (HCP or consumer)
Seriousness, and what it changes
An adverse event is serious under ICH E2A if it: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event that may jeopardise the patient. Serious adverse events must be reported to Swissmedic within 15 calendar days of the MAH becoming aware.
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product, regardless of causality. An adverse drug reaction (ADR) is an AE for which a causal relationship between the drug and the event is at least reasonably possible. For spontaneous (post-marketing) reports, all events are assumed to have at least a possible causal relationship by default — the reporter does not need to establish causality to submit a valid report.
ICH E2A and WHO-UMC causality terminology
ICH E2A defines the minimum data elements for expedited case reports. The WHO-UMC causality assessment scale (certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable) is the standard terminology used by Swissmedic and international partners in the VigiBase signal detection network. Using standardised causality terminology maximises the value of your reports for international signal detection.
Reporter obligations: HCPs and consumers
Healthcare professionals (HCPs) — physicians, pharmacists, nurses — have a professional and in some cases legal obligation to report suspected adverse reactions. In Switzerland, the HMG and cantonal professional regulations establish this duty. Consumer reports (from patients or caregivers) are equally valued by Swissmedic from a signal-detection perspective and should be encouraged by marketing authorisation holders through patient information materials.
Pharmacovigilance duties under the HMG
Switzerland's Heilmittelgesetz (HMG) Article 59 establishes a comprehensive pharmacovigilance obligation for marketing authorisation holders. Any individual or company placing a medicinal product on the Swiss market must establish a pharmacovigilance system, maintain qualified personnel, and report suspected adverse reactions to Swissmedic. The European Union's Good Pharmacovigilance Practices (GVP) Module VI, which Swissmedic largely adopts, specifies the technical requirements for case reporting, including the minimum information required for a valid case.
Receiving reports
Use this template
Copy it into your dashboard — the patient, product, event and reporter sections are already structured.
Add your company or site details
Update the form description with the MAH (Marketing Authorisation Holder) name and the reporting contact for Swissmedic.
Configure routing
Route submissions to your pharmacovigilance team inbox. Ensure the team has the decryption key.
Integrate with your safety database
Export encrypted responses and import into your validated safety database (Argus, ARISg, etc.) according to your data management procedure.
Questions reporters ask
Can this form be used for clinical trial adverse event reporting?
This form is designed for spontaneous post-marketing adverse event reports. Clinical trial adverse events (including SUSARs) have different reporting requirements under HFG, ICH E6 and EU CT Regulation and should be reported through the designated clinical trial safety reporting pathway. Consult your CRO or sponsor safety team.