{"doc_desc":{"title":"Cross-sectional study of surveillance of suspicious prescriptions, indicators of possible abuse","idno":"FRESH-PEF73059-en","producers":[{"name":"Maryse LAPEYRE-MESTRE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73059-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73059"},{"agency":"FReSH","code":"FRESH-PEF73059"}]},"title":"Cross-sectional study of surveillance of suspicious prescriptions, indicators of possible abuse","alternate_title":"OSIAP"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Maryse;LAPEYRE-MESTRE","PILabo":"CHU Toulouse \/ Medical and clinical pharmacology","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ORCID","uri":"0000-0002-5494-5873","role":"pi id"},{"title":"IdRef","uri":"057940118","role":"pi id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"maryse.lapeyre-mestre@univ-tlse3.fr","isContact":"Yes"}],"oth_id":[{"name":"EMCDDA (6 countries, for which France is the project coordinator); R\u00e9seau fran\u00e7ais d'addictovigilance (French drug dependence assessment system)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Maryse;LAPEYRE-MESTRE","email":"maryse.lapeyre-mestre@univ-tlse3.fr","type":"contact","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":"pharmacy"},{"keyword":"abuse indicator"},{"keyword":"prescription"},{"keyword":"surveillance"},{"keyword":"medicines"}],"topics":[{"topic":"General medicine","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":"Psychiatry","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":"Addiction medicine","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":"Disorders due to use of unknown or unspecified psychoactive substances","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1414319298","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To identify medicines diverted using modified or falsified prescriptions presented at the pharmacy. It also allows for the classification of the most diverted medicines at the regional and national level in relation to the sales data.","abstract":"","coll_dates":[{"start":"1991-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"All suspicious prescriptions (coming from CEIP network pharmacies) during the month of the study, registered on a collection form that includes, for each prescription, the demographic characteristics of the requester (sex, age), the name of the medicine(s) involved and the suspicious prescription criteria. The definition of the term \\\"suspicious prescription\\\" corresponds to a prescription that is not the translation of a medical prescription according to the accepted regulatory criteria.   It therefore includes:  - prescriptions written from a stolen prescription, prescriptions that are photocopied, scanned, prepared on a PC;  - prescriptions that have been modified, i.e. valid prescriptions that have subsequently been modified (by addition of a medicine not initially included, or by modification of the dosage or duration of the treatment);  - clearly abnormal prescriptions that are not included in the first two situations.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"['ATC classification for the registration of medicines']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"600-800"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Database accessible as part of regulatory activities related to drug abuse and dependence monitoring overseen by ANSM. No direct access to the database. Possibility of collaboration as part of a research project (contact scientific supervisor)","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"04-05-2015","lastUpdatedAuto":null,"lastUpdatedManual":"12-09-2017","isContributorPI":"No","contributorName":"Maryse LAPEYRE-MESTRE","contributorAffiliation":"UNIVERSITE DE TOULOUSE","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":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"The data collection on Suspicious Prescriptions, Indicators of Possible Abuse (OSIAP) is organised into two 4-week periods of exhaustive research (May and November). CEIP network pharmacies were invited to participate by identifying all suspicious prescriptions for the month of the study.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}