Why pharmacovigilance is needed

"Swissmedic is responsible for monitoring the safety of medicines. Pharmaceutical companies and healthcare professionals, for example doctors or pharmacists who dispense or administer therapeutic products, are legally required to report to Swissmedic. But pharmacovigilance is important not just from the legal standpoint, but also for ethical reasons: Reporting improves our knowledge of the safety profile of a medicine, so that we can then better protect future patients from the negative consequences of a treatment. It is essential, therefore, that serious and previously unknown adverse drug reactions, in particular, should be reported. Unfortunately, the number of reactions that go unreported is still very high. We suspect that there are various reasons for this: Uncertainty about the existing reporting system and statutory reporting requirements, a guilty conscience about having prescribed or dispensed a medicine with side effects, the additional administrative workload, concerns about legal consequences, etc. It is vital that all professionals working in the medical field should contribute towards drug safety. In previous years, we have worked hard to inform those concerned and to raise awareness among healthcare professionals with publications on the duty to report – but even greater commitment is needed from all sides."

How the reporting system works in Switzerland

“The reporting system for healthcare professionals has been updated as of 1 January 2021. Up to the end of 2020, they submitted reports of side effects to the regional pharmacovigilance centres in the university hospitals in the cantons of Geneva, Vaud, Bern, Basel-Stadt, Zurich and Ticino, where they were first reviewed and processed in detail before being forwarded to us by the clinical pharmacology departments. Since the start of this year doctors, pharmacists, and patients as well, have been reporting adverse drug reactions directly to Swissmedic. Our interdisciplinary expert team checks the reports and decides which of them need to be followed up externally and then entrusts this task to the aforementioned regional pharmacovigilance centres. Thanks to this triage by our division, there is a greater focus on those reports that could provide new insights. A report on a skin rash as an adverse reaction to an antibiotic, for example, hardly indicates a new risk. Nothing has changed in the new year as regards the reporting route for the pharmaceutical industry, which has already been reporting to us directly."

"Drug safety focuses on finding new risks rather than the management of known side effects."

When a report is accepted

"For a report from healthcare professionals or patients to be followed up by us requires the existence of four key elements: the name of the medicine is known; information about the patient is available (for example, age group, gender); at least one specific adverse drug reaction has occurred (for example, rash, diarrhoea), and information about the reporting individual is available. It is important to bear in mind that a causal connection between the event and the medicine does not need to be proved – just the suspicion is enough to submit a report."

A specific example

"At the end of 2018, we received a warning, in the context of international collaboration, that a known diuretic – a medicine for promoting urination – may cause non-melanoma skin cancer. Although such forms of skin cancer are less dangerous than melanoma, for example, they still need to be taken very seriously. But diuretics are also effective against high blood pressure and are therefore included in numerous antihypertensive medicines. In this case, therefore, a warning letter was sent to all doctors, and the product information was revised accordingly and now refers to the increased risk of skin cancers associated with the administration of drugs containing this diuretic. It also recommends more frequent check-ups by the doctor, or switching to other blood-pressure lowering medicines."

Why international information-sharing is important

"We share information with partner authorities in other countries via e-mail and regular telephone conferences. This prompt sharing is especially important if a new safety risk is suspected – sometimes we in Switzerland are one step ahead, and occasionally other countries are quicker. If an adverse drug reaction occurs in a country, the manufacturer is obliged to enter this report in the WHO database. Despite differing national circumstances, a harmonisation of reporting systems has taken place in recent years. From the European standpoint, the cooperation within the EU and the common database of the European Medicines Agency have further improved the sharing of information."

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