Publications by authors named "Elisabetta Poluzzi"

Introduction: Impulsivity induced by dopaminergic agents, like pramipexole and aripiprazole, can lead to behavioral addictions that impact on social functioning and quality of life of patients and families (e.g., resulting in unemployment, marital problems, anxiety).

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The growing complexity of geriatric pharmacotherapy necessitates effective tools for mitigating the risks associated with polypharmacy. The Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP)/Screening Tool to Alert doctors to Right Treatment (START) criteria have been instrumental in optimizing medication management among older adults. Despite their large adoption for improving the reduction of potentially inappropriate medications (PIM) and patient outcomes, the implementation of STOPP/START criteria faces notable challenges.

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Introduction: From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing questions about optimal implementation and significance of disproportionality analyses, leading to the development of Good Signal Detection Practices. The ensuing period witnessed the independent exploration of research paths proposed by IMI PROTECT, accumulating valuable experience and insights that have yet to be seamlessly integrated.

Areas Covered: This state-of-the-art review integrates IMI PROTECT recommendations with recent acquisitions and evolving challenges.

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Aims: The aims of this study were to measure the prevalence of polypharmacy and describe the prescribing of selected medications known for overuse in older people with polypharmacy in primary care.

Methods: This was a multinational retrospective cohort study across six countries: Belgium, France, Germany, Italy, Spain and the UK. We used anonymized longitudinal patient-level information from general practice databases hosted by IQVIA.

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Article Synopsis
  • Disproportionality analyses in pharmacovigilance are essential for detecting safety signals from individual case safety reports, but there are no clear guidelines for publishing these analyses, leading to potential misunderstandings.
  • The READUS-PV statement was created to address these concerns by providing a set of 14 guidelines aimed at improving the transparency and comprehensiveness of disproportionality studies.
  • By promoting better reporting standards, the READUS-PV guidelines aim to enhance the accuracy of drug safety data interpretation and support evidence-based decision-making in pharmacovigilance.
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Article Synopsis
  • Disproportionality analyses are key for detecting drug safety signals but are often poorly reported, prompting the creation of new guidelines called READUS-PV for better reporting practices.
  • A panel of 34 international experts developed these guidelines through surveys and consensus meetings, resulting in a checklist of 32 recommendations for reporting in main articles and 12 for abstracts.
  • The implementation of READUS-PV aims to enhance transparency and improve the quality of publications related to drug safety signals.
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Aims: In this reflection paper, the authors, based on their experience as teachers and students of the courses of Pharmacology at the University of Bologna, reflect on their specific roles towards innovation in the teaching of Clinical Pharmacology.

Methods: Strengths, weaknesses and challenges are presented as identified during the teaching and learning experience in the currently evolving medical degree programmes of the University in light of current trends in medical education.

Results: Keeping in mind the identified challenges together with the features proposed for the model prescriber (knowledgeable, contemporary, communicative and safe), we indicate some ways to improve the students' experience and make sure they develop up-to-date skills in Clinical Pharmacology taking advantage of recent ongoing collaborations at European level.

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Introduction: In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of different event definitions, drug definition is often overlooked. The US FDA Adverse Event Reporting System (FAERS) records drug names as free text, necessitating mapping to active ingredients.

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Purpose: Communication atypicalities are considered promising markers of a broad range of clinical conditions. However, little is known about the mechanisms and confounders underlying them. Medications might have a crucial, relatively unknown role both as potential confounders and offering an insight on the mechanisms at work.

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Background And Aim: Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about potential adverse drug reactions: the so-called disproportionality signals. We aim to map the methods used by researchers to assess and increase the validity of their published disproportionality signals.

Methods: From a systematic literature search of published disproportionality analyses up until 1 January 2020, we randomly selected and analyzed 100 studies.

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Traditionally, the effects of drugs and of environmental factors on health have been studied independently. Recently, several research groups have started to broaden the view and consider potential overlaps and interactions between environmental exposures and drug use. In Italy, regardless the strong competencies in environmental and pharmaco-epidemiology and the availability of detailed data, to date research in the fields of pharmacoepidemiology and environmental epidemiology is mainly being conducted in silos, but time has come to dedicate attention to possible convergence and integration between the two disciplines.

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Pharmaceuticals can reach the environment at all stages of their lifecycle and accumulate in the ecosystem, potentially reaching toxic levels for animals and plants. In recent years, efforts have been made to map and control this hazard. Assessing country-specific environmental risks could drive regulatory actions towards eco-friendlier drug utilization and disposal practices.

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Objective: Due to significant risks to the offspring after intrauterine exposure, the European Medicines Agency issued recommendations in 2014 and 2018 restricting the use of valproate (VPA) in women of childbearing age (WOCA). We aimed to evaluate their impact in the Emilia-Romagna region (ERR) of Northern Italy.

Methods: Using administrative databases, we identified all the ERR residents who received antiseizure medication (ASM) prescriptions from 2010 to 2020.

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Introduction: Impulse control disorders (e.g. pathological gambling, hypersexuality) may develop as adverse reactions to drugs.

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Aims: Impulse control disorders (ICDs) are iatrogenic and idiopathic conditions with psychosocial and economic consequences for the affected individuals and their families (e.g. bankruptcy and divorce).

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