{"doc_desc":{"title":"Etude transversale sur la surveillance des ordonnances suspectes indicateur d'abus possible","idno":"FRESH-PEF73059-fr","producers":[{"name":"Maryse LAPEYRE-MESTRE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73059-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73059"},{"agency":"FReSH","code":"FRESH-PEF73059"}]},"title":"Etude transversale sur la surveillance des ordonnances suspectes indicateur d'abus possible","alternate_title":"OSIAP"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Maryse;LAPEYRE-MESTRE","firstname":"Maryse","lastname":"LAPEYRE-MESTRE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"organisation id"},{"title":"SIREN","uri":"263100125","role":"organisation id"}],"email":"maryse.lapeyre-mestre@univ-tlse3.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","PILabo":"CHU Toulouse \/ Medical and clinical pharmacology","isContact":true}],"oth_id":[{"name":"EMCDDA (6 pays dont la France est le coordinateur du projet); R\u00e9seau fran\u00e7ais d'addictovigilance (syst\u00e8me fran\u00e7ais d'\u00e9valuation de la pharmacod\u00e9pendance)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"INTERMINISTERIEL"}]},"distribution_statement":{"contact":[{"name":"Maryse;LAPEYRE-MESTRE","lastname":"LAPEYRE-MESTRE","firstname":"Maryse","type":"contact","email":"maryse.lapeyre-mestre@univ-tlse3.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"ordonnance"},{"keyword":"officine"},{"keyword":"indicateur d'abus"},{"keyword":"surveillance"},{"keyword":"m\u00e9dicaments"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addictologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"Troubles dus \u00e0 l'utilisation de substances psychoactives inconnues ou non pr\u00e9cis\u00e9es","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1414319298","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Identifier les m\u00e9dicaments d\u00e9tourn\u00e9s \u00e0 partir d\u2019ordonnances modifi\u00e9es ou falsifi\u00e9es pr\u00e9sent\u00e9es en pharmacie d\u2019officine. Elle permet aussi de classer les m\u00e9dicaments les plus d\u00e9tourn\u00e9s au niveau r\u00e9gional et national par rapport aux donn\u00e9es de vente.","abstract":"","coll_dates":[{"start":"1991-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Toutes les ordonnances suspectes (provenant des pharmacies des r\u00e9seaux des CEIP)  pendant le mois d\u2019\u00e9tude, enregistr\u00e9es sur un bordereau de recueil comportant, pour chaque ordonnance, les caract\u00e9ristiques d\u00e9mographiques du demandeur (sexe, \u00e2ge), le nom du ou des m\u00e9dicaments concern\u00e9s et les crit\u00e8res de suspicion de l\u2019ordonnance. La d\u00e9finition du terme \u00ab ordonnance suspecte \u00bb correspond \u00e0 une ordonnance qui n\u2019est pas la traduction d\u2019une prescription m\u00e9dicamenteuse selon les crit\u00e8res r\u00e9glementairement admis. Elle inclut donc :      les ordonnances r\u00e9dig\u00e9es \u00e0 partir d\u2019une ordonnance vol\u00e9e, les ordonnances photocopi\u00e9es, scann\u00e9es, fabriqu\u00e9es sur PC ;     les ordonnances modifi\u00e9es proprement dites, c\u2019est-\u00e0-dire les ordonnances valides, secondairement modifi\u00e9es (par adjonction d\u2019un m\u00e9dicament ne figurant pas initialement, ou par modification de la posologie ou de la dur\u00e9e du traitement) ;     les prescriptions manifestement anormales ne rentrant pas dans les deux premi\u00e8res situations.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"['Classification ATC pour l\\'enregistrement des m\u00e9dicaments']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":">= 20000 individus","response_rate":"600-800"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Base de donn\u00e9es accessible dans le cadre des activit\u00e9s r\u00e9glementaires d'addictovigilance pilot\u00e9es par l'ANSM. Pas d'acc\u00e8s direct \u00e0 la base de donn\u00e9es. Possibilit\u00e9 de collaboration dans le cadre d'un travail de recherche (contact responsable scientifique)","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"04-05-2015","lastUpdatedAuto":null,"lastUpdatedManual":"12-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.addictovigilance.fr\/osiap"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Le recueil des Ordonnances Suspectes Indicateur d\u2019Abus Possible (OSIAP) est organis\u00e9 en 2 p\u00e9riodes d\u2019enqu\u00eate exhaustive de 4 semaines (mai et novembre). Les pharmacies des r\u00e9seaux des CEIP sont invit\u00e9es \u00e0 participer en identifiant toutes les ordonnances suspectes pendant le mois d\u2019\u00e9tude","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}