ArticleDrug safety2008
Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.
Article in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.
- Impact of safety-related regulatory action on clinical practice: a systematic review.Drug safety · 2012Pooled it
- Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.Drugs in R&D · 2025Article
- Analysis of adverse events with ruxolitinib using real-world datasets and drug-interaction networks.SAGE open medicine · 2025Article
- Nonsteroidal anti-inflammatory drug use by patients: Impact of modular educational training on pharmacists' questioning, counselling and risk assessments.Exploratory research in clinical and social pharmacy · 2024Article
- Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis.Rheumatology and therapy · 2023Article
- Analysis of Drug-Induced Gastrointestinal Obstruction and Perforation Using the Japanese Adverse Drug Event Report Database.Frontiers in pharmacology · 2021Article
- Increase of Adverse Events After Intravenous Injection of Gentamicin in Horses Between 2015 and 2017-From Marketing Authorization Holder's Point of View.Frontiers in veterinary science · 2021Article
- Adverse Events Associated With Radium-223 in Metastatic Prostate Cancer: Disproportionality Analysis of FDA Data Reflecting Worldwide Utilization.Clinical genitourinary cancer · 2020Article
- Assessment of Reye's syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis.SAGE open medicine · 2020Article
- Predicting the Reasons of Customer Complaints: A First Step Toward Anticipating Quality Issues of In Vitro Diagnostics Assays with Machine Learning.JMIR medical informatics · 2018Article
- Article
- Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.British journal of clinical pharmacology · 2017Article
- Analysis of polypharmacy effects in older patients using Japanese Adverse Drug Event Report database.PloS one · 2017Article
- An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies.Drug safety · 2016Article
- Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO Adverse Drug Reaction Database.CNS drugs · 2015Article
- Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).Drug safety · 2014Article
- Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.Drug safety · 2014Review
- Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region).European journal of clinical pharmacology · 2013Article
- Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents.European journal of clinical pharmacology · 2010Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe reporting of adverse drug reactions (ADRs) is the mainstay of post-marketing surveillance systems. Under-reporting and selective reporting are considered the main limitations of a spontaneous reporting-based pharmacovigilance system. However, excessive reporting induced by external events may also impair signal detection by increasing the noise level.
objectiveThe aim of this study was to examine the influence of regulatory measures and other external factors on the rate of ADR reporting in Italy, focusing on four situations occurring in the last 10 years: ACE inhibitor-induced cough; HMG-CoA reductase inhibitors ('statins') and rhabdomyolysis; nimesulide and hepatic toxicity; and cyclo-oxygenase (COX)-2 selective inhibitors ('coxibs') and increase in cardiovascular risk.
methodsThe study was based on data from spontaneous reporting in six Italian regions collected from January 1995 to December 2005. We analysed a 10-year period as a reasonable time interval around the four situations of interest, highlighting the influence of regulatory measures on the rate of ADR reporting (number of reports per million inhabitants). Chi-squared tests were used to assess the statistical significance of any changes in ADR reporting. Drug sales data were also studied to examine possible changes in drug use. Sales data were expressed as daily defined dose per 1000 inhabitants per day.
resultsACE inhibitors: a 5-fold increase in the reporting rate of ACE inhibitor-induced cough was observed in 1998 and 1999 following a restriction on reimbursement for angiotensin receptor blockers introduced in 1998 and removed at the end of 1999. Statins: after the withdrawal of cerivastatin in 2001, the ADR reporting rate increased more than 4-fold, with musculoskeletal ADRs representing about 60% of all the ADRs reported in that year, and progressively decreased in the following years. Nimesulide: an increase in hepatic ADR reporting was observed after withdrawal of the drug from the Finnish and Spanish markets in 2002. Coxibs: no important changes in the rate of cardiovascular events reporting in the period 2000-4 were observed. In 2005, after the withdrawal of rofecoxib in September 2004, both the ADR reporting rate and sales of the drug decreased drastically.
conclusionOur data suggest that spontaneous ADR reporting can be influenced in different ways by external events. Our data emphasize the need for educational initiatives aimed at increasing the doctor's and patient's awareness of the usefulness and the limitations of spontaneous reporting in the pharmacovigilance system. Such initiatives should use appropriate risk communication strategies in order to avoid unnecessary alarm, which could cause unjustified interruption of therapies or misplaced confidence in new drugs.
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