Collaboration Between Health-Care Professionals, Patients, and National Competent Authorities Is Crucial for Prevention of Health Risks Linked to the Inappropriate Use of Drugs: A Position Paper of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

Vignot, Stéphane; Daynes, Pascale; Bacon, Trystan; Vial, Thierry; Montagne, Olivier; Albin, Nicolas; Emmerich, Joseph; Ratignier-Carbonneil, Christelle; Martin, Dominique; Maison, Patrick

doi:10.3389/fphar.2021.635841

Cited by 8 publications

(5 citation statements)

References 11 publications

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“…Recently, in France, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) published their position endorsing appropriate drug use on an individual level, especially in frail populations such as children. They highlighted the inappropriate UL/OL use of drugs as one of the main concerns and called for collective actions [38].…”

Section: Implications For Practice and Researchmentioning

confidence: 99%

Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data

Jaberi,

Boussaha,

Dode

et al. 2024

Healthcare

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Background: Unlicensed and off-label (UL/OL) prescriptions have been associated with an increased risk of drug-related problems. Data of their prevalence at hospital discharge remain insufficient. We aimed to describe the prevalence of UL/OL drugs in outpatient prescriptions at discharge in children. Methods: We conducted a retrospective study using the routinely collected health data of children at discharge from 2014 to 2016. The primary reference source for determining licensed labelling was the summaries of product characteristics (SPCs) in a French industry-independent formulary named Thériaque. We described the characteristics of UL/OL prescriptions at discharge and looked for predictors of UL/OL prescriptions. Results: We included 2536 prescriptions of 479 children. Licensed, OL, and UL prescriptions accounted for 58.6% (95% CI: 56.7–60.5), 39.2% (95% CI: 37.3–41.1), and 2.3% (95% CI: 1.7–2.9), respectively. A total of 323 (74%) children received at least one UL/OL drug. Among the licensed drugs, bronchodilators (8.8%) and analgesics (8.6%), and among the OL drugs, antibiotics (2.8%), were the most prescribed. The younger age of the children and higher number of drugs they received increased the probability of UL/OL prescriptions (unadjusted p-value of ≤0.05). Conclusion: The prevalence of UL/OL prescriptions is about 40% at discharge from a pediatric university hospital in France.

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Section: Implications For Practice and Researchmentioning

confidence: 99%

Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data

Jaberi,

Boussaha,

Dode

et al. 2024

Healthcare

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“…There are different profiles of ‘people concerned’ that need to be considered depending on the subject and the regulatory process. All patients have an experience of the use or conditions of use of health products that can contribute to BR assessment21 and some of them have built up specific knowledge from their experience, through continuous training or a reflective process with their peers or within patient organisations. The contribution of the ‘people concerned’ in the BR assessment varies according to their engagements, their motivations14 and the agencies’ expectations, ranging from simple information or consultation to collaboration or coconstruction 13 21 22.…”

Section: Initiatives For Supporting Health Democracy In the Br Assess...mentioning

confidence: 99%

Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Belgodère,

Pougheon Bertrand,

Jaulent

et al. 2023

BMJ Glob Health

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“…On the right, the various situations of misuse are identified with the identification of individuals. Adapted according to [1] , [2] , [24] . MA: marketing authorisation; FR: risk factor; RCP: summary of product characteristics …”

Section: General Contextmentioning

confidence: 99%

Prevention of risks associated with inappropriate use/unnecessary consumption of medicines

Cracowski

Müller

Anglade³

et al. 2022

Therapies

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In the code of public health, misuse is defined as intentional and inappropriate use of a medicine or product, which is not in accordance with the terms of the marketing authorisation or the registration as well as with good practice recommendations. Very often this involves an individual or the interaction of several individuals including the patient, his/her carers, prescriber(s) and/or dispensers. Misuse is common; it is the source of medicinal adverse effects for which a significant part is avoidable. Medicines initially prescribed or dispensed in the context of their marketing authorization (MA) can also be the subject of primary dependency and misappropriation. Companies which develop medicines nationally make declarations to the ANSM (French National Agency for the Safety of Medicines and Health Products) and implement measures to limit non-compliant use of their products. Recently, the coronavirus disease-2019 (COVID-19) pandemic has highlighted the influence and societal impact of drug misuse. The finding of the existence of systemic misuse, the impossibility of proposing simple solutions leads us to propose two main areas for improved information and the training of users and health professionals in medicines in the context of multi-faceted interventions: prevention of misuse on the one hand and its identification and treatment on the other hand.

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Collaboration Between Health-Care Professionals, Patients, and National Competent Authorities Is Crucial for Prevention of Health Risks Linked to the Inappropriate Use of Drugs: A Position Paper of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

Cited by 8 publications

References 11 publications

Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data

Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data

Patient and public involvement in the benefit–risk assessment and decision concerning health products: position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM)

Prevention of risks associated with inappropriate use/unnecessary consumption of medicines

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