Swissmedic Vigilance News

Statistical review 2022
Pharmacovigilance: Human medicinal products
Swissmedic evaluates safety signals associated with
medicinal products and vaccines on the basis of reports
of adverse drug reactions (ADRs) from within
Switzerland. If its investigations confirm a new
risk, Swissmedic initiates the necessary actions (for
example amending the medicinal product information),
often after first consulting its international
partner authorities. As part of the pharmacovigilance
network, all reports from medical professionals
and, in increasing numbers, patients are
entered in the national database and evaluated by
specialists. Some are also assessed on Swissmedic’s
behalf at six regional pharmacovigilance centres
(RPVCs). Pharmaceutical companies also submit a
large number of reports of adverse reactions from
within Switzerland to Swissmedic.
Activities
Once again, surveillance activities centred on
COVID-19 vaccines. However, the number of reports
of suspected ADRs declined substantially on
the previous year (Figure 1).
The VigilanceONE Ultimate database used to process
ADR reports from Switzerland was upgraded
so that it can perform specialised analyses to detect
new safety signals. The new tool launched in
2022 to enable patients to report ADRs themselves
has proven valuable in practice.
A new tender for pharmacovigilance services for
the 2023–2027 period was issued, a heavy focus being
placed on specific specialised medical skills.
Close collaboration with other countries’ authorities
and in multinational specialist organisations
continued, for example as part of a regular dialogue
on safety signals. Swissmedic regularly briefed the
public on reports connected with COVID vaccines
and the findings obtained. By the end of 2022, it
had published 28 COVID-19 reports as well as other
associated information and answered a large number
of enquiries from the public and the media.
2020 2,802 11,992 14,794
2021
12,685 11,305 23,990
2022
7,845 13856 21,701
0 5,000 10,000 15,000 20,000 25,000
RPVC/Swissmedic
MAH
Figure 1: Number of ADR reports (initial and follow-ups) in Switzerland per primary recipient
Swissmedic Vigilance News | Edition 31 – November 2023
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