Reporting adverse reactions as a healthcare professional
As a healthcare professional you have a duty under Art. 59 TPA to report serious suspected cases and reactions that were previously unknown or are insufficiently described in the product information. Serious within 15 days, non-serious within 60, through ElViS or a regional pharmacovigilance centre.
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Which cases are reportable?
Not every side effect has to be reported. The duty covers what is serious, what was previously unknown and what is insufficiently covered by the product information. Add to that suspected interactions, abuse, medication errors with harm and quality defects. Everything else may be reported and is scientifically welcome.
- Serious reactions: death, life threatening events, hospitalisation, persistent disability, congenital anomaly
- Previously unknown reactions, whatever their severity
- Reactions absent from the product information, or clearly more frequent or more severe than described
- Suspicion of a clinically relevant interaction
- Medication errors with harm, abuse, dependence
- Lack of effect in critical indications such as antibiotics, anticoagulants and oncology
Causality is not your job
You do not have to prove an association. Suspicion is enough. Causality assessment is done by the regional centre and Swissmedic. A report is not an allegation and not an incident report.
The deadlines and where they start
The 15 day deadline applies to serious suspected cases and the 60 day deadline to non-serious, previously unknown ones. Counting starts on the day you become aware of the case, so usually at the consultation or when the laboratory report that raises the suspicion arrives.
| Case | Deadline | Channel |
|---|---|---|
| Serious suspected case | 15 days | ElViS or a regional centre |
| Non-serious, previously unknown | 60 days | ElViS or a regional centre |
| Quality defect without a health risk | Without delay | Marketing authorisation holder |
| Quality defect with a health risk | Immediately | Swissmedic market surveillance |
| Medical device incident | Without delay | Manufacturer or CH-REP and Swissmedic |
ElViS or a regional centre?
Both routes are valid. ElViS is the direct electronic route to Swissmedic and suits a fully documented case. The five regional pharmacovigilance centres at the university hospitals also take reports, assess them clinically, ask follow-up questions and advise you on stopping, switching or re-exposure. If you want a clinical opinion, go through the centre.
What a good report contains
The four minimum elements make a report valid but not usable. What makes it usable is the timeline, the dose, the concomitant medication and the outcome. One report with a clear chronology and the course after withdrawal is worth more to signal assessment than ten incomplete ones.
- Patient data: initials, year of birth, sex, and weight in children and oncology cases.
- Suspect medication with brand name, dose, route, start and stop dates, and the batch number for biologicals and vaccines.
- The reaction with onset, course, diagnosis and the relevant laboratory values.
- Outcome and action taken: withdrawn, reduced, continued unchanged, re-exposed with the result.
- Concomitant medication, pre-existing conditions and the alternative explanations you considered.
Biologicals and vaccines: give the batch number
For biological medicines and vaccines the batch number is required for traceability and is often the only way to tell a product-specific signal from a class effect.
Reporting and professional secrecy
Reporting to Swissmedic is provided for by law and does not breach professional secrecy. What is transmitted is pseudonymised: initials, year of birth and sex instead of name and address. Patient consent is not required for the legal duty, although mentioning the report to the patient is good practice.
Practice organisation: who reports in a team?
In hospitals and group practices the duty usually fails on ownership rather than knowledge. Name one person per unit to collect and submit cases, do not tie the ElViS access to a single individual, and put the deadline into the internal process. Hospital pharmacies tend to carry this role most reliably.
Frequently asked questions
Do I have to report a reaction that is in the product information?
For serious reactions yes, even where they are known and described. For non-serious reactions that are already adequately described there is no duty. The exception is a reaction that occurs clearly more often or more severely than described.
Who reports when several professionals are involved?
One report is enough. Duplicates are not a problem because Swissmedic detects and merges them, but within a team the ownership should be settled so that the case does not sit unnoticed.
Do pharmacists have to report, or only the prescribing doctor?
The duty covers every healthcare professional who prescribes, dispenses or administers medicines. Pharmacists carry it as much as doctors, and in self-medication they are often the only ones who see the case at all.
How do I report a case from a clinical trial?
Cases from clinical trials do not go through routine pharmacovigilance but through the sponsor, who reports to Swissmedic and the ethics committee. As an investigator you report serious adverse events to the sponsor within 24 hours.
Is a lack of effect reportable?
Lack of effect is reportable where it is clinically relevant, for example with antibiotics, anticoagulants, antiepileptics, oncology treatments or contraceptives. It may point to a quality defect or to resistance.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.