ReviewJournal of pharmacology & pharmacotherapeutics2013
Pharmacovigilance in Italy: An overview.
Review in Journal of pharmacology & pharmacotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
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
40 citing papers in PubMed.
- Article
- Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database.Hematology reports · 2025Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- A bibliometric analysis of research progress on pharmacovigilance and cancer from 2002 to 2021.Frontiers in oncology · 2023Review
- The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study.Journal of clinical medicine · 2022Article
- Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy.Drug safety · 2022Review
- Underreporting and Triggering Factors for Reporting ADRs of Two Ophthalmic Drugs: A Comparison between Spontaneous Reports and Active Pharmacovigilance Databases.Healthcare (Basel, Switzerland) · 2022Article
- Patterns of adverse drug reactions (ADRs) in Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022Article
- The Safety Profile of General and Local Anaesthetic Agents: Data Collected during 20 Years of Spontaneous Reporting Activities in the Campania Region (Southern Italy).Pharmaceuticals (Basel, Switzerland) · 2021Article
- A New Tool for an Awareness Plan Concerning Critical Issues, Needs and Attitudes of Citizens on the Use of Medicines.Healthcare (Basel, Switzerland) · 2021Article
- The Role of Cost-Effectiveness Analysis in Patient-Centered Cancer Care in the Era of Precision Medicine.Cancers · 2021Article
- Analysis of fatal adverse drug events recorded in several Italian emergency departments (the MEREAFaPS study).Internal and emergency medicine · 2021Article
- Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug-drug interactions.Internal and emergency medicine · 2021Observational
- PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.Drug safety · 2021Article
- Reduced risk for hospitalization due to hyponatraemia in lithium treated patients: A Swedish population-based case-control study.Journal of psychopharmacology (Oxford, England) · 2021Article
- Associations Between Antihypertensive Medications and Severe Hyponatremia: A Swedish Population-Based Case-Control Study.The Journal of clinical endocrinology and metabolism · 2020Article
- An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme.Pharmacology research & perspectives · 2020Article
- Risk of hospitalisation associated with benzodiazepines and z-drugs in Italy: a nationwide multicentre study in emergency departments.Internal and emergency medicine · 2020Article
- Safe Drugs Versus Innovative Drugs (Can We Have Both?).Advanced pharmaceutical bulletin · 2020Article
- Inverse association between glucose-lowering medications and severe hyponatremia: a Swedish population-based case-control study.Endocrine · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSpontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy. MATERIALS AND
methodsThe information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).
resultsThe pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs.
conclusionA greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.
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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.