Pharmacovigilance

What is it about?

According to the Therapeutic Products Act (Art. 59 TPA) and the Medicinal Products Ordinance (Art. 63 VAM), healthcare professionals are obliged to report the occurrence of a serious or previously unknown adverse drug reaction (ADR) or one that is insufficiently mentioned in the information for healthcare professionals of the medication in question.

Even if a drug has actually caused an ADR, the causal relationship often cannot be reliably proven formally. In order to be able to identify potential safety risks in the healthcare system with a high degree of sensitivity, a report must therefore also be made if an ADR is suspected.

Since 2021, Swissmedic has been the central office for receiving all ADR reports. Swissmedic’s National Pharmacovigilance Center receives and processes reports of adverse drug reactions from healthcare professionals. The national pharmacovigilance center is supported by five regional centers, which are affiliated to a department of clinical pharmacology and which process reports from healthcare professionals with a high signal value. This also includes the regional Pharmacovigilance Center Zurich, which is affiliated to the Clinic for Clinical Pharmacology and Toxicology at the USZ.

Who reports?

All healthcare professionals who are authorized to dispense, use or prescribe medicinal products are obliged to register.

What must be reported?

Even if there is only a suspicion of a drug-related cause of an adverse event, the event must be reported. Serious or previously unknown adverse drug reactions or those not sufficiently mentioned in the prescribing information of the drug in question, as well as other important adverse medical reactions, must be reported.

Serious undesirable effects are as follows,

• which are fatal,
• are life-threatening,
• lead to hospitalization or its prolongation,
• cause serious or permanent damage,
• are otherwise considered medically important (e.g. if one of the above-mentioned situations could have been avoided by timely medical intervention).

When to report?

• As soon as possible
• Serious ADRs should be reported within 15 days of becoming known, non-serious ADRs within 60 days.
• ADRs that occurred some time ago should also be reported.

How to report?

Adverse drug reactions should preferably be reported directly to Swissmedic electronically via the ElViS online portal. Alternatively, a form can be used.

More information

• The Zurich Regional Pharmacovigilance Center also provides medical advice in cases of suspected ADRs. Within the scope of this function, reports do not have to be anonymized. Only when the reports are forwarded to Swissmedic are they anonymized by the regional center. This approach facilitates clinical collaboration between the regional center and the primary physicians in the interest of the patients.
• The reports with a high signal value (including previously unknown ADRs or ADRs for substances under special monitoring (black triangle)) are evaluated in the regional centers. The primary reporting person receives a written evaluation, including a formal causality assessment, upon receipt of the report.
• For its part, Swissmedic forwards all notifications to the
  Program for International Drug Monitoring of the WHO in Sweden.
• Swissmedic’s pharmacovigilance team carefully checks the reports received for new risks. If it identifies any, it determines the need for action and initiates the appropriate measures.
• Further information at Swissmedic

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