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, Bern, 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.

Last modification 27.05.2024

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