Pharmacovigilance and technovigilance: what nurses report
- Safe practice
Nurses report suspected problems with medicines (pharmacovigilance) and with medical devices (technovigilance) so INVIMA can detect risks and act.
What it is
Pharmacovigilance is the work of detecting, assessing, understanding and preventing adverse effects and other problems related to medicines. Technovigilance does the same for medical devices: it identifies and classifies adverse events and incidents linked to their use. In Colombia both national programmes are run by INVIMA, and institutions take part through their own programme lead. Nurses are often the first to see a problem: a reaction after a medicine, a medication error, a medicine that does not work, a product that looks altered, an event after vaccination, or a device that fails. Their job is to make the patient safe, record what happened and report it through the institution's channel, which sends it on to INVIMA. A report is a suspicion, not proof: the patient does not have to be harmed for a report to be useful, and reports are handled confidentially.
What it requires
- Know who leads pharmacovigilance and technovigilance in your institution and how to reach them.
- Know the institution's reporting form or system and where to find it on every shift.
- Keep the product: the medicine or device involved, its packaging, batch or lot and serial number, if safe to do so.
- Record the facts in the clinical record without blame.
- Patients and the public may also report directly to INVIMA through its online forms.
Components
- Pharmacovigilance: medicines, including vaccines; INVIMA's Programa Nacional de Farmacovigilancia and its national network.
- Technovigilance: medical devices; INVIMA's Programa Nacional de Tecnovigilancia (Resolución 4816 de 2008) and its national network.
- Institutional level: a programme lead who receives, analyses and sends the reports.
- National level: INVIMA analyses reports, issues safety alerts and can order measures on products.
How it is applied (and why)
- Make the patient safe first: stop the infusion or the device if needed and call the nurse in charge or the doctor.
- Record what happened, when, the product involved and what was done, in objective words: a clear record supports the analysis.
- Keep the medicine or device, its packaging and its batch, lot or serial number, if safe: INVIMA may need to trace the product.
- Decide what kind of problem it is (reaction, error, therapeutic failure, quality problem, device event or incident): it guides the right report.
- Report it to the institution's pharmacovigilance or technovigilance lead using the institutional form, on the same shift.
- Flag serious cases at once: a serious device event or incident must reach INVIMA within 72 hours.
- Tell the patient or family what happened, following the institution's disclosure policy: transparency is part of safe care.
- Take part in the analysis and apply the actions agreed: reporting is useful only if the system learns from it.
What to report and to which programme
| Programme | Type of problem | Bedside example |
|---|---|---|
| Pharmacovigilance | Suspected adverse reaction | A rash and itching start soon after a new antibiotic is given |
| Pharmacovigilance | Medication error | A medicine is given to the wrong patient, or at the wrong time or route |
| Pharmacovigilance | Therapeutic failure or quality problem | A medicine has no expected effect, or its vial looks cloudy or its label looks altered |
| Pharmacovigilance | Event after vaccination | Fainting or a high fever after a vaccine (serious if it endangers life or needs hospital care) |
| Technovigilance | Device adverse event or incident (serious or non-serious) | A pump delivers too fast and harms the patient (event), or an alarm fails but is caught in time (incident) |
In nursing practice
- INVIMA classes device problems as serious when they could have caused death or a serious deterioration of health, such as a threat to life, permanent damage or hospital admission.
- Health institutions report to INVIMA through the national pharmacovigilance network; patients, caregivers and independent professionals can use INVIMA's online forms.
- Events after vaccination are monitored as part of the immunisation programme: a serious event is one that causes death, endangers life, needs admission or a longer stay, or causes lasting disability.
- Most medication errors are preventable: reporting where in the process they happen helps fix the system, not blame the person.
Common mistakes
- Not reporting because the patient was not harmed or the error was caught in time.
- Throwing away the device or the vial before recording its batch or serial number.
- Waiting until the end of the week to report a serious device event.
- Writing blame or opinions in the clinical record instead of facts.
- Assuming someone else on the team already reported it.
Test yourself
Think of the answer, then tap the question to see it.
What is the difference between an adverse event and an adverse incident in technovigilance?
An adverse event caused unintended harm. An adverse incident could have caused harm but did not, because of chance, a professional's action or a safety barrier.
Within how long must a serious device event or incident reach INVIMA?
Within 72 hours of its occurrence (Resolución 4816 de 2008). Non-serious events and incidents go in a quarterly report.
Which four kinds of medicine-related problems may a nurse report to pharmacovigilance?
Suspected adverse reactions, medication errors, therapeutic failure and quality problems; events after vaccination are also reported.
Connections
Educational content for students; it does not replace your institution's protocols, supervised clinical training or a prescriber's order. Dose-calculation examples use made-up numbers: they are educational, not a clinical order.
Sources: Farmacovigilancia (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2026); Programa Nacional de Tecnovigilancia (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, 2026); Boletín Farmaseguridad 2024, volumen 16 (Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Grupo de Farmacovigilancia, 2024).
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Representative model, for educational purposes only.