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Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior (MEGADOSE)

17 de julho de 2020 atualizado por: Assistance Publique Hopitaux De Marseille

Prescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of medication in Europe. A single source of information is rarely sufficient to measure such a complex phenomenon. This project entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete efficiently the available data from the addictovigilance centres allowing the health authorities (French Drug Agency) to answer to the main general questions (What are the main prescription drug abused in France? What are the national trends in prescription drug abuse? What is the impact of a public health measure on prescription drug abuse). This project constitutes the opportunity of "extending" the application of our tool (the DS method) on a French national database with a minimal risk since this method has already been validated and applied on different geographic areas, on different drugs and at different levels of analysis. The project would also be integrated in routinely as a useful tool included in the addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of policy and practice interventions implemented by the French Drug Agency.

The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM related to drug misuse in particular: development and identification of systems and tools able to detect earlier misuse phenomenon; analysis of the impact of communications, guidelines, decisions to health authorities and patients

Visão geral do estudo

Status

Desconhecido

Condições

Descrição detalhada

Medicines such as analgesics, opioids substitution drugs, sedatives, hypnotics are increasingly being misuse to induce psychoactive effects or to alter the effects of other consumed drugs, potentially resulting in abuse and dependence (24). Awareness of medicine misuse, especially prescription drugs misuse has been increasing in the past few years and organizations such as the United Nation's International Narcotics Control Board predict that worldwide misuse of prescription drugs will exceed illicit drug use. A major potential part of psychoactive drug misuse is related to drug abuse. Assessment of misuse, abuse and diversion of prescription drugs must address its occult nature and involves fundamentally different monitoring methods compared to other pharmaceutical products. Current best practice is to use multiple detection systems to assess misuse, abuse, and diversion of CNS active drugs by various populations in a timely, sensitive and specific manner (20). In order to detect earlier the prescription drug abuse related to misuse, the investigators have developed a specific method, the doctor shopping method, at the regional level. Doctor shopping is a well-known behavior defined as obtaining prescriptions from several physicians for the same medication at the same time. By cumulating the prescriptions of different physicians during the same period of time, doctor shopping enables patients to be delivered a daily dose superior to that prescribed by each physician on an individual basis. Doctor shopping behavior is regarded as not only a means of obtaining high-dose prescriptions but as the principal method of diversion of prescription medications to street markets.

Using health Insurance Database, the investigators have developed and validated a specific method "the doctor shopping method" providing two indicators: the DSI (Doctor Shopping Indicator expressed in %) and the DSQ (Doctor Shopping Quantity expressed in DDD), reflecting respectively the risk of abuse and the extent of abuse. This previous large work, based along ten years of development and validation through several different studies, has i) been always performed at the regional level on SNIIR-AM (several French areas - Paca Corse, Rhône Alpes, Midi Pyrenées), ii) focused on one product (buprenorphine, clonazepam, methylphenidate) or on one pharmacological class (opioids, benzodiazepines) iii) measured the impact of national prescription monitoring programme (buprenorphine). More recently the investigators have performed a global overview of the extent and risk of abuse of more than 100 psychoactive medications among 11.7 million inhabitants according the doctor shopping method, used as a proxy of drug abuse. Based on this experience, and because there is a need to measure prescription drug abuse, to understand trends over the time and to compare abuse of one product to another, the aim of this project is to provide an up-to-date and nationally consolidated estimation of the risk and the extent of abuse associated with more of 100 psychoactive drugs in the French population, using doctor shopping method on National SNIIR-AM, covering the entire French population (65 million inhabitants). To increase the accuracy of its estimation and its description, the study will take into account relevant factors and determinants of drugs abuse such as i) formulation (dosage, extended or immediate release, route of administration) ii) geographical level iii) time factor (trends analysis between 2010 and 2015).

Prescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of psychoactive medications in Europe. A single source of information is rarely sufficient to measure such a complex phenomenon. This project entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete efficiently the available data from the addictovigilance centres allowing the health authorities (French Drug Agency) to answer to the main general questions (What are the main prescription drug abused in France? What are the national trends in prescription drug abuse? What is the impact of a public health measures on prescription drug abuse).

Tipo de estudo

Observacional

Inscrição (Antecipado)

10000000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Marseille, França, 13354
        • Recrutamento
        • Assistance Publique Hopitaux de Marseille
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

The target population is the whole French population. The SNIIR-AM will be used as the source population. The SNIIR-AM (Systeme National d'Information Inter-Régime de l'Assurance Maladie) is the information system of the French National Health Insurance Scheme, containing individualized, anonymous, and exhaustive data on all health spending reimbursements of the overall French insured population (almost 65 million inhabitants).

The information contained in this database covers the health care services reimbursed including:

  • Characteristics of medication dispensed (name, formulation, dates of prescription, date of dispensing, quantity dispensed and cost)
  • Patients characteristics including age, gender, area of residence, type of affiliation, dependency on the universal health care coverage or CMU (Couverture Médicale Universelle Complémentaire, CMUC, which is attributed to the unemployed and low income insurees, and which can be used as a proxy of the income level),

Descrição

Inclusion Criteria:

  • patients registered in the SNIIR-AM with at least one reimbursement of psychoactive drugs during the study period.

Exclusion Criteria:

  • French population not benefiting from social security

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
psychoactive drug misuse
Prazo: 2 years

the doctor shopping method,to assess medication availability and the extent and risk of abuse of all psychoactive reimbursed drugs at a national level according to the doctor shopping method.

All psychoactive drugs will be ranked according to their DSQ (used as a proxy of the extent of abuse) and their DSI (used as a proxy of abuse potential

2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de dezembro de 2017

Conclusão Primária (Real)

20 de maio de 2018

Conclusão do estudo (Antecipado)

20 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

16 de agosto de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de agosto de 2017

Primeira postagem (Real)

18 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de julho de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2020

Última verificação

1 de julho de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2016-50

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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