ArticleRevista peruana de medicina experimental y salud publica2026
Characterization of the safety notes of pharmaceutical products issued by two regulatory authorities from Latin America.
Article in Revista peruana de medicina experimental y salud publica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmaceutical product safety notes (PPSNs) are regulatory communications that disseminate updated information on the risks of pharmaceutical products (PPs). This study characterized the PPSNs issued by the Direccion General de Medicamentos, Insumos y Drogas (Peru) and the Instituto de Salud Publica de Chile (ISP) between 2014 and 2023. A retrospective analysis of PPSNs published on their websites was conducted. Those describing adverse drug reactions (ADRs) were included. Data were extracted on the type of ADRs, regulatory actions, sources of evidence, and reasons for issuance. Of 746 PPSNs identified, 153 met the criteria (100 Peru, 53 Chile), with a monthly average of 0.83 and 0.44, respectively. Differences in content and PPs were observed. Both agencies based their PPSNs mainly on alerts from the U.S. Food and Drug Administration. The most frequent action was the modification of the technical data sheet; the ISP additionally implemented monitoring and restrictions. In conclusion, PPSNs depend on external alerts, which evidences the need to strengthen local pharmacovigilance and evaluate their impact on the safety of PPs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.