Reporting of suspected adverse drug reactions by patients
Under the Swiss Therapeutic Products Act, consumers, patients and their organisations and interested third parties can report adverse drug reactions and incidents to Swissmedic.
Please be aware that you should still talk to your doctor or chemist if you are worried about suspected adverse reactions or an incident.
Reports of suspected side-effects of COVID-19 vaccines
To report suspected side-effects of a COVID-19 vaccine, please use this specific form:
In case of technical problems with the PDF form you can use the following form:
Need for pharmacovigilance
Medicines are developed over a period of several years. The efficacy and safety of a new drug are generally studied on a few thousand carefully selected and followed-up trial subjects and patients according to strictly defined criteria. For this reason only very frequent adverse reactions – mainly those depending on the drug's pharmacological properties – can be observed during its clinical development.
Once the product has been placed on the market, a much larger – and also often polymorbid – population will be exposed, which may lead to a change in the drug's hitherto known safety profile. Adverse drug reactions can then be observed more frequently, including those occurring only sporadically and independently of the pharmacological properties of the substance. These adverse reactions of drug treatment observed in daily practice must be reported without delay. If such information is consistently forwarded to the Swissmedic National Pharmacovigilance Centre, hitherto unknown risks can be identified and tackled.
The reporting system in Switzerland
The Swissmedic National Pharmacovigilance Centre accepts and processes reports of adverse drug reactions. The National Pharmacovigilance Centre is supported by six regional centres that are each affiliated to a university department; in particular, these process reports from healthcare professionals that involve an important safety signal. For its part, the pharmaceutical industry forwards reports of adverse reactions that it receives to Swissmedic. The National Pharmacovigilance Centre works closely with the World Health Organization (WHO) international centre for drug safety.
What to report, and when?
In accordance with the new Therapeutic Products Act, which entered into force on 1 January 2019, all serious adverse reactions that are hitherto unknown or insufficiently documented in the product information leaflet of the medicine concerned, as well as any other medically significant adverse reaction, must be reported.
Adverse reactions are considered serious if they:
- result in death
- are life-threatening
- lead to, or prolong, hospitalisation
- involve a persistent disability or incapacity
- are otherwise to be considered medically significant (if, for example, a timely medical intervention prevented one of the above-mentioned outcomes)
These suspected adverse reactions should be reported within 15 days of diagnosis; non-serious reactions should be reported within 60 days.
A causality between a reaction and a medicine need not be proved: suspicion alone is sufficient to justify reporting such events.
Although misuse, dependency and addiction are not covered by the WHO definition of an adverse drug reaction, as they do not relate to normal posology, it is important to report such events as they might affect the safety profile of a drug.
Who should file a report?
Under the Therapeutic Products Act, all professionals who are entitled to distribute, administer or prescribe medicines are obliged to report suspected adverse drug reactions. Pharmaceutical companies that manufacture or distribute ready-to-use medicinal products are also subject to a reporting obligation.
However, patients may also report undesirable side-effects of drug therapy. A consultation with the family doctor leading to a joint report has the advantage of providing relevant medical details such as results of investigations, but this is not compulsory.
How to file reports?
Adverse drug reactions can be reported using a form.
Adverse drug reactions should preferably be reported electronically via the online ElViS (Electronic Vigilance System) portal. Alternatively, a form can be used.
What happens when once a report is filed?
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.
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. For such enquiries, please contact your doctor.
Last modification 26.05.2021