Simpel Interaktion

Følgende er et tænkt, hypotetisk eksempel, der viser indholdet af en

bivirkningsindberetning forårsaget af en interaktion mellem 2 lægemidler, Letigen og Panodil, samt 2 lægemidler der ikke mistænkes for bivirkninger (Metoprolol og Pulmicort).

Patienten er en kvinde, initialer ”OJ”, født 23. April 1982, (personnummer ukendt) med astma. Patienten dør af bivirkningen. Der blev foretaget laboratorieprøver og obduktion.

Indberetteren er læge på en afdeling på Herlev sygehus.

<?xml version="1.0" encoding="UTF-8"?>

<DrugAdverseEventRegistration xmlns="http://www.dkma.dk/drugadverseevent/xml.schema/2009/05/15"

xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"

xsi:schemaLocation="http://www.dkma.dk/drugadverseevent/xml.schema/2009/05/15

http://testcenter.medcom.dk/xsd/www.dkma.dk/drugadverseevent/xml.schema/2009/05/15/DKMA_DrugAdverseEventRegistration.x sd">

<SuspectedInteractingDrug>

<SuspectedTreatmentDrug>

<Drug>

<CompanyName>Nycomed</CompanyName>

<DrugStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DrugName>Letigen</DrugName>

<IndicationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2009/01/01">

<IndicationFreeText>Fedme</IndicationFreeText>

</IndicationStructure>

<DrugAdministrationStartDate>

<DrugAdministrationStartYear>2005</DrugAdministrationStartYear>

</DrugAdministrationStartDate>

<DrugConsideredAsAdministered>false</DrugConsideredAsAdministered>

</SuspectedTreatmentDrug>

</SuspectedInteractingDrug>

<SuspectedInteractingDrug>

<SuspectedTreatmentDrug>

<Drug>

<CompanyName>Parapharma</CompanyName>

<DrugStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DrugIdentifier>28100636073</DrugIdentifier>

<DosageQuantityStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DosageQuantityValue>1</DosageQuantityValue>

</DosageQuantityStructure>

<DosageQuantityUnitText

xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">stk</DosageQuantityUnitText>

</AverageDailyDosage>

<RouteOfAdministrationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<RouteOfAdministrationCode>OR</RouteOfAdministrationCode>

</RouteOfAdministrationStructure>

</Drug>

<IndicationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2009/01/01">

<IndicationFreeText>Ledsmerter</IndicationFreeText>

</IndicationStructure>

<DrugAdministrationStartDate>

<DrugAdministrationStartFullDate>2005-04-13</DrugAdministrationStartFullDate>

</DrugAdministrationStartDate>

<DrugWithdrawn>true</DrugWithdrawn>

<DrugWithdrawnDate>

<DrugWithdrawnFullDate>2009-05-26</DrugWithdrawnFullDate>

</DrugWithdrawnDate>

<DrugWithdrawnBecauseOfReaction>false</DrugWithdrawnBecauseOfReaction>

<DrugReadministration>false</DrugReadministration>

<DrugConsideredAsAdministered>false</DrugConsideredAsAdministered>

</SuspectedTreatmentDrug>

</SuspectedInteractingDrug>

<NonSuspectedDrug>

<NonSuspectedTreatmentDrug>

<Drug>

<CompanyName>Hexal</CompanyName>

<DrugStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DrugName>Metoprolol</DrugName>

<DrugFormStructure>

<DrugFormCode>TBL</DrugFormCode>

</DrugFormStructure>

</DrugStructure>

<RouteOfAdministrationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<RouteOfAdministrationCode>OR</RouteOfAdministrationCode>

</RouteOfAdministrationStructure>

</Drug>

<IndicationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2009/01/01">

<IndicationFreeText>For højt blodtryk</IndicationFreeText>

</IndicationStructure>

</NonSuspectedTreatmentDrug>

</NonSuspectedDrug>

<NonSuspectedDrug>

<NonSuspectedTreatmentDrug>

<Drug>

<CompanyName>AstraZeneca</CompanyName>

<DrugStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DrugName>Pulmicort</DrugName>

<DosageQuantityStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<DosageQuantityValue>1</DosageQuantityValue>

</DosageQuantityStructure>

<DosageQuantityUnitText

xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">pust</DosageQuantityUnitText>

</AverageDailyDosage>

<RouteOfAdministrationStructure xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">

<RouteOfAdministrationCode>OR</RouteOfAdministrationCode>

</RouteOfAdministrationStructure>

<DrugWithdrawn>true</DrugWithdrawn>

<DrugWithdrawnDate>

<DrugWithdrawnFullDate>2009-05-26</DrugWithdrawnFullDate>

</DrugWithdrawnDate>

</NonSuspectedTreatmentDrug>

</NonSuspectedDrug>

<ReactionSeriousness>

<PatientDeath>

<PatientDeathDate>

<PatientDeathFullDate>2009-05-26</PatientDeathFullDate>

</PatientDeathDate>

<CauseOfDeath>Hjertestop</CauseOfDeath>

<PatientDeathCausedByAdverseReaction>yes</PatientDeathCausedByAdverseReaction>

<AutopsyPerformed>true</AutopsyPerformed>

</PatientDeath>

<LifeThreatening>true</LifeThreatening>

<Hospitalization>true</Hospitalization>

<Disabling>false</Disabling>

<NoneOfAbove>false</NoneOfAbove>

</ReactionSeriousness>

<Reaction>

<ReactionDescription>Hovedpine, mavesmerter, ledsmerter og udslet på højre arm</ReactionDescription>

<ReactionStartDate>

<ReactionStartFullDate>2008-03-11</ReactionStartFullDate>

</ReactionStartDate>

<ReactionOutcome>notRecovered</ReactionOutcome>

<ReactionEndDate>

<ReactionEndFullDate>2009-05-13</ReactionEndFullDate>

</ReactionEndDate>

</Reaction>

<MedicallyConfirmed>true</MedicallyConfirmed>

<TestsPerformed>true</TestsPerformed>

<ResultOfTests>Patienten havde det ikke godt. Særligt ikke på det sidste.</ResultOfTests>

<Patient>

<NameInitials>OJ</NameInitials>

<BirthDate xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2005/03/15/">1982-04-23</BirthDate>

<PersonGenderCode xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2006/01/23/">female</PersonGenderCode>

<MedicalCondition>

<MedicalConditionDescription>Astma</MedicalConditionDescription>

<MedicalConditionContinuing>yes</MedicalConditionContinuing>

</MedicalCondition>

<Height>168</Height>

<Weight>64.0</Weight>

</Patient>

<Reporter>

<PersonNameStructure xmlns="http://rep.oio.dk/itst.dk/xml/schemas/2006/01/17/">

<PersonGivenName xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2003/02/13/">Test</PersonGivenName>

<PersonSurnameName xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2003/02/13/">Testesen</PersonSurnameName>

</PersonNameStructure>

<AuthorisationIdentifier

xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">1TSTS</AuthorisationIdentifier>

<DoctorOrganisationIdentifier

xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">123456</DoctorOrganisationIdentifier>

<Qualification>1</Qualification>

<Department>

<DepartmentName>Herlev Sygehus</DepartmentName>

<DepartmentCode>sygehusafdelingsnummer</DepartmentCode>

<HospitalOrganisationIdentifier

xmlns="http://www.dkma.dk/medicinecard/xml.schema/2008/06/01">151631</HospitalOrganisationIdentifier>

</Department>

<AddressPostal xmlns="http://rep.oio.dk/xkom.dk/xml/schemas/2006/01/06/">

<StreetName xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2005/03/15/">Herlev Ringvej</StreetName>

<StreetBuildingIdentifier xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2003/02/13/">75</StreetBuildingIdentifier>

<PostCodeIdentifier xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2005/03/15/">2730</PostCodeIdentifier>

<DistrictName xmlns="http://rep.oio.dk/ebxml/xml/schemas/dkcc/2005/03/15/">Herlev</DistrictName>

</AddressPostal>

<PhoneMailContactStructure xmlns="http://rep.oio.dk/glrchr.dk/eih/xml/schemas/2005/03/01/">

<TelephoneNumberIdentifier

xmlns="http://rep.oio.dk/itst.dk/xml/schemas/2005/01/10/">+4535555566</TelephoneNumberIdentifier>

<EmailAddressIdentifier

xmlns="http://rep.oio.dk/xkom.dk/xml/schemas/2005/03/15/">agr@dkma.dk</EmailAddressIdentifier>

</PhoneMailContactStructure>

<EAN13Identifier xmlns="http://rep.oio.dk/ean/xml/schemas/2005/01/10/">5790000155811</EAN13Identifier>

</Reporter>

</DrugAdverseEventRegistration>

In document Den Gode Bivirkningsindberetning (Sider 23-27)