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Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior (MEGADOSE)

2020년 7월 17일 업데이트: 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

연구 개요

상세 설명

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).

연구 유형

관찰

등록 (예상)

10000000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Marseille, 프랑스, 13354
        • 모병
        • Assistance Publique Hopitaux de Marseille
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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),

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
psychoactive drug misuse
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 12월 20일

기본 완료 (실제)

2018년 5월 20일

연구 완료 (예상)

2020년 12월 20일

연구 등록 날짜

최초 제출

2017년 8월 16일

QC 기준을 충족하는 최초 제출

2017년 8월 16일

처음 게시됨 (실제)

2017년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 7월 17일

마지막으로 확인됨

2020년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2016-50

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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