Reporting adverse drug reactions for healthcare professionals
The reporting of suspected adverse drug reactions by healthcare professionals is one of the key pillars of drug safety. These reports play a vital role in the detection of potential drug risks at an early stage and the continuous monitoring of the benefit/risk profile of all available medicines. This particularly applies to reports of serious and/or previously unknown ADRs which, according to Art. 59 of the Therapeutic Products Act (TPA), are subject to mandatory notification.
Healthcare professionals can report directly to Swissmedic. The reports are processed and assessed in close cooperation with the regional pharmacovigilance centres in Basel, Geneva, Lausanne, Zurich and Lugano.
When filling in the data entry screens or form, please pay particular attention to the following points:
- The description of the adverse reactions with their symptoms and findings should be as precise as possible.
- The temporal relationship between the administration of the medicine and the onset of the reaction should be highlighted.
- The outcome – whether or not the symptoms resolved or improved after stopping the therapy – should be reported.
- Details of all medicines administered, including start and end date of therapy, should be given.
- Details of the differential diagnosis and non-drug-related factors that may influence the clinical picture should be listed. In the case of liver damage, for example, alcohol consumption, biliary tract pathology, viral serology, etc. should be mentioned.
- When reporting reactions concerning vaccines, blood products or suspected quality issues, providing the lot number has proved to be very useful.
Please use the Electronic Vigilance System ElViS for the reporting of suspected adverse drug reactions.
Reporting of ADRs by healthcare professionals
ElViS Hotline for technical support only
+41 58 462 06 00
Mon-Fri from 07:30 - 17:30
Swissmedic is responsible for monitoring the safety of medicinal products. This involves receiving and evaluating reports on side effects of medicines and vaccines, including COVID vaccines. However, Swissmedic does not answer questions about individual therapies or vaccination issues, nor does it make any recommendations regarding them.
Important information for doctors / pharmacists reporting adverse drug reactions in a pharmaceutical company function:
Please do not register for an individual ElViS profile. Contact the responsible administrator in your company.
Electronic reports via the ElViS portal
Reporting via ElViS is the preferred route for healthcare professionals. ElViS can also be used to submit case-related documents, such as laboratory reports or hospital discharge reports. Once their report has been successfully sent, users can save the report and acknowledgement of receipt locally on their computer for their own records. Data protection and security satisfy the most stringent requirements.
Self-registration process
You need to register before using ElViS, but this only takes a few minutes. It is important for you to make a one-off decision on whether to log in with a HIN identity or use the CH-LOGIN. The use of two identities and switching between these accesses is not recommended, since reports can be viewed and processed only via the respective login.
- Healthcare professionals with a HIN identity (login)
- Healthcare professionals without a HIN identity (login)
FAQ
Why should I use ElViS to report adverse reactions?
Electronic reporting offers a large number of advantages. Your data are recorded in a structured fashion and checked to ensure they are complete and plausible before they are submitted. Furthermore, you can attach important documents such as laboratory reports, hospital letters, etc. to your report. Your report is imported directly into Swissmedic's drug safety database, where it can be processed immediately by the National Pharmacovigilance Centre. This means that risks are identified earlier and more accurately. Further advantages include data security and the fact that all documents are electronically archived.
Why can I only store one unfinalised report in ElViS?
ElViS is primarily a reporting platform, not a database. That's why submitted reports are only stored in ElViS for a limited period of time. However, you can resume work on any unfinalised report that you store in ElViS whenever you want.
How long will reports that I submit be stored in ElViS?
No more than 6 weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer.
Are my data really secure?
ElViS satisfies the most stringent data protection and security requirements.
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Recommended browsers
For the ELVIS application we recommend the following browsers: Microsoft Edge und Mozilla Firefox
Whom do I contact if I have questions or problems?
Please contact the ElViS hotline by e-mailing it@swissmedic.ch or by calling +41 58 462 06 00. The hotline is open from 7.30 a.m. to 5.30 p.m., Monday to Friday.
Why do I have to register?
Once-only registration is required before you can use ElViS. This is to ensure that the data you submit are transmitted securely and to unequivocally link senders to reports. Registration doesn't take long and all the information you provide will be treated in strict confidence.
Where do I register?
You need to register before using ElViS, but this only takes a few minutes. It is important for you to make a one-off decision on whether to log in with a HIN identity or use the CH-LOGIN. The use of two identities and switching between these accesses is not recommended, since reports can be viewed and processed only via the respective login.
- Healthcare professionals with a HIN identity (login)
- Healthcare professionals without a HIN identity (login)
What's the difference between a "direct insert" and a "file upload"?
If you want to type your report into an online entry mask, choose "direct insert". This is the standard option for most users. If you have an electronic system capable of generating E2B files and you want to upload these files to ElViS, choose "file upload". ElViS can only be used with the E2B-R2 format. This option will normally only be available in specialised centres. You will have to contact the ElViS hotline before you can start a file upload. The same applies if you have chosen a file but then want to change it.
I've forgotten my password. What should I do?
You can reset your password yourself. Click the "Forgotten password" link on the login screen.
What's the quickest way to get to the ElViS login page?
Go to the Swissmedic website and click "Log in ElViS" at the top right of the screen. Alternatively, you can add the login page to your favourites/bookmarks.
Do I have to enter data in a particular order?
No. ElViS will suggest a predefined order, but you can choose which screen you want to enter data on simply by clicking in the menu bar on the left-hand edge of the screen.
What should I do if I don't know the patient's exact date of birth or precisely when an ADR began, for example?
Enter the full date or birth or leave the field empty.
What's the difference between "Designation of the ADR" and "Description of the ADR"?
As the designation, enter a symptom or diagnosis, e.g. headache or rash. You can then describe the diagnoses, symptoms, findings, treatment and course in detail in the description section.
How do I save the data I have entered?
You can save any data you have entered without submitting it if you click the drop-down menu (i.e. the small white triangle) to the right of the "Next" button and click "Save". Please note that you can only save one report in ElViS and will therefore have to save that report on your own computer before you can start to enter another one.
What do I do if I want to resume work on a report I've saved?
If you have saved your report in ElViS, click "Edit" under "Continue report saved in ElViS". If you have saved your report on your own computer, click "Continue a locally saved report", choose the appropriate file and upload it to ElViS.
What does "Add attachments" mean?
If you have test results (e.g. lab reports) or other documents (e.g. hospital letters) that are relevant to a report, you can send them with your report. You can add one or more attachments in any file format.
Will I receive confirmation that my report has been sent?
If your report has been successfully received by the National Pharmacovigilance Centre and imported into Swissmedic's drug safety database, you will initially receive an e-mail. This e-mail will contain a link that you can click to download further documents, including a confirmation of receipt.
I've clicked the link in the e-mail, but get a "Documents not found" error message.
You've probably already downloaded your report and associated documents. These are automatically deleted 24 hours after they have been downloaded and the link will cease to work.
There's a "Valid until" date with the reports I have sent and accompanying documents. What does that mean?
Reports and accompanying documents are stored in ElViS for six weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer. Reports and documents are automatically deleted 24 hours after they have been downloaded. If you have not yet downloaded the relevant files, you will receive an e-mail about one week before the six-week deadline expires.
Submitting follow-up reports
Receiving messages and answering queries
What happens when once a report is filed?
Reports from healthcare professionals are evaluated in the Swissmedic National Pharmacovigilance Centre and, in some cases, in the regional centres. The primary reporter receives a confirmation of receipt of the report and a written evaluation if the report was forwarded to a regional centre for processing.
All evaluated reports are completely anonymised and entered in the national database. If reports are incomplete, it might be necessary to get back to the primary reporter via the regional centre. The pharmaceutical industry forwards any reports it receives directly to Swissmedic.
Swissmedic, in turn, forwards all reports to the international centre for drug safety at the World Health Organization (WHO) as it is an active member of the Programme for International Drug Monitoring.
The Swissmedic pharmacovigilance team carefully screens all incoming reports for new risks. If a new risk is identified, the need for action is evaluated and appropriate measures are taken in collaboration with the Swissmedic department responsible for the drug concerned.
How do I know if there are any messages or queries for me?
You will receive e-mail notification if there are messages or queries concerning a report that you have submitted. You will see them under “Received messages” or “Queries” when you log into ElViS.
What exactly is the difference between a message and a query?
A message from the National Pharmacovigilance Centre contains information on a report you have submitted. There is no need for any action on your part. If you receive a query, however, you will be asked to respond by downloading the relevant document to your own computer, processing it there and then uploading it once again to ElViS.
Can I also reply to queries by phone?
Yes, this is possible. The National Pharmacovigilance Centre or a regional centre may well contact you by phone. However, if you prefer to use e-mail, please remember that e-mail is not a secure way of transmitting sensitive data.