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Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?

ABSTRACT: Zolpidem is one of the most prescribed hypnotic drugs. In 2001, the World Health Organization alerted a risk of pharmacodependence associated with zolpidem. The French health authority decided in 2017 to enforce security on the prescription of zolpidem to reduce those risks. The aim of our study was to evaluate the impact of regulatory framework implementation, secure prescription pad, on the prevalence and incidence of prescriptions of zolpidem according to the age. This study was based on an observational study using the French healthcare data system. Two age categories were defined: "younger" and "older" (<65 years, ≥65 years); in order to study the evolution of prevalence and incidence of zolpidem use in our two groups, two periods were defined, before and after the implementation of the measure. The prevalence decreased in the younger population by 51% (4012 vs. 7948 consumers), while that of the older population decreased by 42% (4151 vs. 7282). This difference in our two groups, with a greater decrease in the younger people, is statistically significant compared to the older people. Our study showed that regulatory framework implementation and mandatory secure prescription pad is more effective for decreasing prevalence of zolpidem prescription for younger people compared to older people.

SUBMITTER: Jobert A

PROVIDER: S-EPMC8619144 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?

Jobert Alexandra A Istvan Marion M Laforgue Edouard-Jules EJ Schreck Benoit B Victorri-Vigneau Caroline C

International journal of environmental research and public health 20211118 22

<h4>Background</h4>Zolpidem is one of the most prescribed hypnotic drugs. In 2001, the World Health Organization alerted a risk of pharmacodependence associated with zolpidem. The French health authority decided in 2017 to enforce security on the prescription of zolpidem to reduce those risks. The aim of our study was to evaluate the impact of regulatory framework implementation, secure prescription pad, on the prevalence and incidence of prescriptions of zolpidem according to the age.<h4>Method ...[more]

PMID: 34831853

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Project description:BackgroundOlder people are the highest users of health services but are less likely to use a patient portal than younger people.ObjectiveThis scoping review aimed to identify and synthesize the literature on contextual factors that impact the implementation of patient portals in acute care hospitals and among older people.MethodsA scoping review was conducted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. The following databases were searched from 2010 to June 2020: MEDLINE and Embase via the Ovid platform, CINAHL and PsycINFO via the EBSCO platform, and the Cochrane Library. Eligible reviews were published in English; focused on the implementation of tethered patient portals; included patients, health care professionals, managers, and budget holders; and aimed at identifying the contextual factors (ie, barriers and facilitators) that impact the implementation of patient portals. Review titles and abstracts and full-text publications were screened in duplicate. The study characteristics were charted by one author and checked for accuracy by a second author. The NASSS (Non-adoption, Abandonment, Scale-up, Spread, and Sustainability) framework was used to synthesize the findings.ResultsIn total, 10 systematic reviews published between 2015 and 2020 were included in the study. Of these, 3 (30%) reviews addressed patient portals in acute care hospitals, and 2 (20%) reviews addressed the implementation of patient portals among older people in multiple settings (including acute care hospitals). To maximize the inclusion of the literature on patient portal implementation, we also included 5 reviews of systematic reviews that examined patient portals in multiple care settings (including acute care hospitals). Contextual factors influencing patient portal implementation tended to cluster in specific NASSS domains, namely the condition, technology, and value proposition. Certain aspects within these domains received more coverage than others, such as sociocultural factors and comorbidities, the usability and functionality aspects of the technology, and the demand-side value. There are gaps in the literature pertinent to the consideration of the provision of patient portals for older people in acute care hospitals, including the lack of consideration of the diversity of older adults and their needs, the question of interoperability between systems (likely to be important where care involves multiple services), the involvement of lay caregivers, and looking beyond short-term implementation to ways in which portal use can be sustained.ConclusionsWe identified important contextual factors that impact patient portal implementation and key gaps in the literature. Future research should focus on evaluating strategies that address disparities in use and promote engagement with patient portals among older people in acute care settings.

Project description:INTRODUCTION:In recent years, data collected by the French Addictovigilance Network have shown the potential for abuse and addiction associated with zolpidem (the most sold hypnotic drug in France). Since 10 April 2017, new regulations have come into force that require zolpidem to be prescribed on special secure prescription pads, in order to reduce the risk of abuse or misuse. This measure has far-reaching repercussions that are not only limited to the consumption of zolpidem but also extend to the usage of sedative medication on a whole. The objective of the ZOlpidem and the Reinforcement of the Regulation of prescription Orders (ZORRO) study is to evaluate the overall impact of the new regulatory framework requiring zolpidem to be prescribed on special secure prescription pads. Three axes will be evaluated: the number of consumers, the type of consumption (chronic use versus occasional use, problematic consumption versus non-problematic use) and the consumption of other sedative molecules.The study has been registered in the Protocol Registration and Results System under the number NCT03584542 at stage "Pre-results". METHODS AND ANALYSIS:The ZORRO study is an epidemiological, observational, national multicentre, non-controlled, prospective research project supported by the French National Agency for Medicines and Health Products Safety. The evaluation of the impact of the regulatory framework change relative to zolpidem will be done according to two axes: via an epidemiological study of the French National Health Insurance database and by the implementation of field studies of prescribers and consumers of zolpidem. ETHICS AND DISSEMINATION:The Nantes Research Ethics Committee (Groupe Nantais d'Ethique dans le Domaine de la Santé), the Committee for the Protection of the Population and the Committee of Expertise in Research, Studies and Evaluations in the Field of Health approved this study. Results will be presented in national and international conferences and submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03584542; Pre-results.

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Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?

Publications

Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?

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