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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cross-sectional study of surveillance of suspicious prescriptions, indicators of possible abuse</titl>
      <IDNo>FRESH-PEF73059-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" role="">Maryse LAPEYRE-MESTRE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cross-sectional study of surveillance of suspicious prescriptions, indicators of possible abuse            </titl>
      <altTitl>
                    OSIAP                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73059-en            </IDNo>
      <IDNo agency="PEF">
                    73059                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73059                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Maryse LAPEYRE-MESTRE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)">
        <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
        <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="EMCDDA (6 countries, for which France is the project coordinator) R&#xE9;seau fran&#xE7;ais d&amp;#039 addictovigilance (French drug dependence assessment system)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)                    
                                    </fundAg>
      <fundAg>
                                            INTERMINISTERIEL                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" email="maryse.lapeyre-mestre@univ-tlse3.fr">
                    Maryse;LAPEYRE-MESTRE
                                            <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    pharmacy</keyword>
      <keyword vocab="" vocabURI="">
                    abuse indicator</keyword>
      <keyword vocab="" vocabURI="">
                    prescription</keyword>
      <keyword vocab="" vocabURI="">
                    surveillance</keyword>
      <keyword vocab="" vocabURI="">
                    medicines</keyword>
      <topcClas vocab="health theme">
                        General medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4b9f8efb-68dd-45a1-b04c-d23d457d6898"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D058006"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Psychiatry                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3de50dee-da1c-4791-a386-56bca24a5fed"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D011570"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Addiction medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/42d645e0-f58d-40ed-9917-5b227ff41a92"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000073316"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Disorders due to use of unknown or unspecified psychoactive substances                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1991-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe 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.                    </universe>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>ATC classification for the registration of medicines</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&gt;= 20000 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>600-800</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>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)</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
