PharmacovigilanceOfficial

SÚKL joins record #MedSafetyWeek drive urging adverse reaction reports

🇨🇿 SÚKL · Mon 02 Nov 2026

The Czech regulator is backing the Uppsala Monitoring Centre campaign, running 2–8 November, which encourages patients and health professionals to report suspected adverse drug reactions.

The Czech State Institute for Drug Control (SÚKL) has joined this year's global #MedSafetyWeek campaign, which runs from 2 to 8 November. The campaign is led by the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring. Its message is that suspected adverse reactions should not be ignored, and that reporting them helps protect other people from harm.

According to SÚKL, this is the largest edition so far. More than 140 organisations in over 130 countries will share the message in more than 61 languages. WHO and members of the International Coalition of Medicines Regulatory Authorities (ICMRA) are among the supporters.

SÚKL director Tomáš Boráň said reactions can be more likely soon after a new medicine is started, or after a change of dose or dosage form. They may also occur when a medicine is taken with others, or after long-term use. He advised reading the package leaflet and asking health professionals about known side effects and interaction risks.

The regulator asks for reports of suspected serious or unexpected reactions, suspected interactions, teratogenic effects and lack of efficacy. It also wants reports of misuse, overdose, and preparation or administration errors linked to an adverse reaction. Patients are asked to report especially when symptoms affect daily life, are serious or are not listed in the leaflet.

Under the Czech medicines act, health professionals must report serious or unexpected adverse reactions to SÚKL. Patients have no such duty, but SÚKL encourages them to tell their doctor or pharmacist, or to use the online form at nezadouciucinky.sukl.cz. The campaign introduces no new regulatory requirements.

What it means for your team

  • No new obligations: existing Czech requirements for health professionals to report serious or unexpected reactions to SÚKL are unchanged.
  • Pharmacovigilance teams may see more spontaneous reports, including from patients, during and after the campaign week.
  • SÚKL's list of reportable events, including medication errors linked to a reaction, misuse and lack of efficacy, is a useful reference for training reporters.
  • Marketing authorisation holders can point patients and health professionals to the national reporting form in Czech-market communications.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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