Apport de la visite d’assistants de recherche clinique aux cabinets de médecins généralistes sur la notification des effets indésirables médicamenteux

Durrieu, Geneviève; Jacquot, Julien; Baudrin, Dominique; Mège, Mathilde; Rousseau, Vanessa; Bagheri, Haleh; Bondon‐Guitton, Emmanuelle; Abadie, Delphine; Montastruc, François; Bismuth, Michel; Oustric, Stéphane; Montastruc, Jean‐Louis

doi:10.1016/j.therap.2016.09.004

Cited by 10 publications

(3 citation statements)

References 18 publications

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“…The Italian legislation on OL prescriptions was introduced in the wake of the Di Bella case of 1998 [13]. Law n. 94/1998 (Di Bella Law) allows OL prescriptions only: Law n. 244/2007 specifies that physicians cannot prescribe medicines OL unless completed phase II studies show favorable results (Article 2(348)).…”

Section: Italymentioning

confidence: 99%

“…Physicians should inform patients about the OL prescription's risks and benefits [13], although they are not explicitly required to disclose its administrative status (see Table 1). If the patient is younger than 18 years, the physician acquires the parents' IC (Law 219/2017) and considers the minor's will according to their discernment capacity.…”

Section: Italymentioning

confidence: 99%

“…Despite reported examples of judicial proceedings targeting non-compliant OL prescriptions [13], their impact on pediatric practice seems limited.…”

Section: Italymentioning

confidence: 99%

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Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions

et al. 2021

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Section: Italymentioning

confidence: 99%

Section: Italymentioning

confidence: 99%

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Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions

et al. 2021

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Interventions to improve adverse drug reaction reporting: A scoping review

Khalili

Mesgarpour²,

Sharifi

et al. 2020

Pharmacoepidemiology and Drug

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Purpose Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to improve ADR reporting. The aim of this study was to systematically map interventions and strategies to improve ADR reporting among health care professionals. Methods The six‐stage methodological framework of Arksey and O'Malley was used to conduct this scoping review. Ovid MEDLINE, EMBASE, All EBM, and Web of Science were systematically searched from 1999 to February 2019, and the reference lists of the included papers were also searched for gray literature to identify any interventions and strategies that aimed to increase ADR reporting. Two reviewers screened the papers for eligibility based on the inclusion criteria and extracted their key data and analyzed them descriptively. Results Ninety out of 14 501 papers met the selection criteria. Using computerized registration and active surveillance can increase ADR reporting significantly. Educational interventions performed individually or combined with sending reminders and/or feedback, awards, and providing easier reporting channels can improve ADR reporting over a short to medium term. Multiple interventions may have more impact than single‐component interventions. Conclusion Multiple interventions could cause a greater increase in ADR reporting rates than single interventions. Although educational interventions appear to be effective, few studies have reviewed their long‐term effects to ascertain whether the improvements are sustained over time. Studies with a better methodological quality are required on this subject.

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Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study

et al. 2016

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Apport de la visite d’assistants de recherche clinique aux cabinets de médecins généralistes sur la notification des effets indésirables médicamenteux

Cited by 10 publications

References 18 publications

Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions

Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions

Interventions to improve adverse drug reaction reporting: A scoping review

Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study

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