Inês Guerra Tavares
Research Assistant / Safety Manager, Pharmacovigilance Unit of Coimbra @ AIBILI - Association for Innovation and Biomedical Research on Light and Image
In Portugal's decentralised pharmacovigilance system, regional units work close to the people who report. Experience from Coimbra suggests that this can improve ADR reporting.
On a quiet Friday morning at a regional pharmacovigilance unit in Coimbra, Portugal, the telephone rings. On the other end of the line is a nurse who recently attended a training session on spontaneous reporting. She has just witnessed what may be an adverse drug reaction (ADR), and she is not sure whether it is worth reporting. But she knows exactly who to ask.
Portugal's National Pharmacovigilance System is coordinated by INFARMED, the national medicines authority, and includes ten regional pharmacovigilance units: eight on the mainland and one each in the Azores and Madeira. Anyone, whether a healthcare professional or a patient, can report a suspected ADR through a single, user-friendly national website, Portal RAM. The system then assigns each report, based on the reporter's location, to the regional unit responsible for that area. The unit processes the report before sending it to EudraVigilance, the European database, and then to VigiBase, the WHO global database. In a country of just over ten million people, one might ask: why divide the work between regions at all? Why not have one, centralised, reporting system?
Reporting an ADR is, at its core, an act of altruism. The reporter gains nothing directly; the benefit goes to future patients. For people to keep reporting, they need to trust the process and understand how their information can help prevent harm to others. Trust, the Coimbra team has found, is easier to build when the people processing reports are easy to reach by telephone or email. More than ten years of processing reports at the Coimbra unit have shown that people have different preferences: healthcare professionals tend to favour email, while patients, especially older people, are more comfortable reporting over the phone.
Proximity helps on two other fronts: quantity and quality. When a report is missing key details, such as when the reaction started, how it evolved or which other medicines were being taken, the regional unit, which has already been in contact with the reporter, can easily contact them again to complete it. Most reporters are happy to help.
Reporters also value feedback in any form, from an automatic email confirming the receipt of a report to the outcome of the causality assessment. Feedback closes the loop, and it encourages reporting behaviour. Reporters who have had a positive experience with their regional unit tend to talk about it with colleagues, spreading the message that detecting and reporting ADRs matters. Professionals themselves have described this word-of-mouth effect in the closing discussions in the unit's training sessions.
Decentralisation also makes targeted training possible. When the Coimbra unit noticed that one hospital was reporting less than others nearby, it offered a dedicated training session, free of charge, to the hospital's staff. The unit's sessions have reached audiences as diverse as hospital pharmacists, nursing students, and even patient associations.
Good training is more than theory. Each session is adapted to the institution and to the trainees' scientific background and health literacy. Fictional ADR scenarios, discussed together, have proved one of the best ways to keep an audience engaged. Sessions end by walking through how an example case is reported, step by step, on Portal RAM, so that a first report no longer feels like a step into the unknown. There is an unexpected bonus from this personalised training: when reporters link the trainer they met to the name on a follow-up request, they are more willing to reply.
However, proximity has its limits. Healthcare professionals work under heavy pressure, and at the end of a long shift, reporting is rarely a priority. In the unit's experience, professionals know that reporting is important, but their first concern is, naturally, to manage and resolve the reaction rather than to document it. This is why a simple national entry point such as Portal RAM matters: the easier the first step, the more likely it is to be taken. The Portuguese model combines both: one door for reporting, and a regional team on the other side to collect the data and move it on in the pharmacovigilance cycle.
Back to that Friday morning. By the end of the call, the nurse had her answer: when in doubt, report. She also knew there was someone she could turn to next time. That is the value of Portugal’s regional approach: a single national entry point makes reporting accessible, while local teams turn it into a relationship. Personal contact, feedback and tailored training help build trust, encourage reporting and fill gaps in reports. The lesson for more centralised systems not necessarily to redraw the map, but to put a name, and a responsive person, on the other end of the line.
Read more:
Uppsala Reports connects you with the people behind pharmacovigilance and the lessons they’ve learned along the way. Subscribe to get their stories straight to your inbox.
Subscribe
Inês Guerra Tavares
Research Assistant / Safety Manager, Pharmacovigilance Unit of Coimbra @ AIBILI - Association for Innovation and Biomedical Research on Light and Image
Mexico's new pharmaceutical waste framework puts One Health into practice, from hazardous-waste handling in hospitals to expired pills in the kitchen drawer.
27 August 2026
By building adverse drug reaction reporting directly into clinicians' existing patient records system, two Sydney hospitals turned years of near-silence into over 1,600 reports.
13 August 2026
A review of PBRERs assessed between 2023 and 2025 reflects how the SFDA has gradually refined its approach to monitoring medicine safety.
10 July 2026