In spite of the current far-reaching tests to which a medicine must be subjected before authorisation, exceptionally risks may only be identified after the market launch when the product is in widespread application and everyday use. The cataloguing of spontaneous reports is still the best way to discover such problems early on.
From 1 January 2021, healthcare professionals should report adverse drug reactions directly to Swissmedic. Further information can be found here.
From 01 July 2021, only electronic reports of adverse drug reactions will be accepted from marketing authorisation holders either via a gateway connection or via the ElViS portal (Electronic Vigilance System). Further information can be found here.
All the important information about the reporting of adverse drug reactions is provided below:
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 Swissmedic National Pharmacovigilance Centre accepts and processes reports of adverse drug reactions from professionals. The National Pharmacovigilance Centre is supported by five 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.
In accordance with the new Therapeutic Products Act, which entered into force on 1 January 2019, all serious adverse reactions or those 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:
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.
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, consumers 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.
You can find information on the reporting/submission of suspected adverse drug reactions by patients here.
Adverse drug reactions should preferably be reported electronically via the online ElViS (Electronic Vigilance System) portal. Alternatively, a form can be used.
You can find information on the reporting/submission of suspected adverse drug reactions by healthcare professionals here.
Pharmaceutical companies
You can find information on the reporting/submission of suspected adverse drug reactions by pharmaceutical companies here.
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.
