ID

37617

Beskrivning

Der UAW-Meldebogen des Bundesinstituts für Arzneimittel und Medizinprodukte. https://www.bfarm.de/SharedDocs/Formulare/DE/Arzneimittel/Pharmakovigilanz/aa-uaw-melde-bogen.html The english translation of the german form is not an official state-approved version, but a translation by the researchers at the institute for medical informatics. Das Bundesinstitut für Arzneimittel und Medizinprodukte bittet Sie, Meldungen über unerwünschte Arzneimittelwirkungen auf dem vorliegenden Berichtsbogen BfArM 643 zu erstatten, damit eine rasche Auswertung und EDV-mäßige Bearbeitung gewährleistet ist. Je vollständiger der Berichtsbogen ausgefüllt wird, um so sicherer wird die Auswertung und Abschätzungeines Arzneimittelrisikos sein können. Unvollständige Daten sollten jedoch kein Hinderungsgrund für eine Meldung sein. Um auch bisher unbekannte Arzneimittelrisiken erfassen zu können, ist es notwendig,auch in Verdachtsfällen und beim Auftreten unerwünschter Wirkungen, die bisher nicht mit den verabreichten Arzneimitteln in Verbindung gebracht wurden, einen Berichtsbogen auszufüllen. Dem Berichtsbogen können alle Ihnen zu dieser unerwünschten Arzneimittelwirkung, insbesondere über die Symptomatik und den Verlauf zur Verfügung stehende Unterlagen (z.B. Untersuchungsbefunde,Labordaten, Sektionsprotokolle) in Kopie beigelegt werden. Füllen Sie die Angaben zur Person des Patienten bitte so vollständig wie möglich aus, da hierdurch doppelt gemeldete unerwünschte Wirkungen erkannt werden können. Geben Sie die Initialen des Patienten bitte in der Reihenfolge Name - Vorname an. Die Daten zu den verabreichten Arzneimitteln sollten so genau wie möglich, d.h. unter Berücksichtigungder vollständigen Bezeichnung (z.B. retard, forte), der Darreichungsform, der Stärke, der Dosierung und der Art der Anwendung (z.B. p.o., i.v., i.m.) angegeben werden. Das Arzneimittel, das vermutlich die unerwünschte Wirkung ausgelöst hat, sollte entsprechend gekennzeichnet werden. Alle auf dem Berichtsbogen angegebenen patienten- und arztbezogenen Daten werden den Bestimmungen des Bundesdatenschutzgesetzes entsprechend vertraulich behandelt. Weitere Vordrucke des Berichtsbogens sind beim Bundesinstitut für Arzneimittel und Medizinprodukte,Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn erhältlich.

Länk

https://www.bfarm.de/SharedDocs/Formulare/DE/Arzneimittel/Pharmakovigilanz/aa-uaw-melde-bogen.html

Nyckelord

  1. 2019-08-11 2019-08-11 -
Rättsinnehavare

Bundesinstitut für Arzneimittel und Medizinprodkte

Uppladdad den

11 augusti 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Bfarm Pharmacovigilance

Report about an adverse Drug Reaction (BERICHT ÜBER UNERWÜNSCHTE ARZNEIMITTELWIRKUNGEN)

Basic Data
Beskrivning

Basic Data

Alias
UMLS CUI-1
C1320722
Patient Initials Surname
Beskrivning

Patient Initials Surname

Datatyp

text

Alias
UMLS CUI [1,1]
C0421448
UMLS CUI [1,2]
C2986440
Patient initials forename
Beskrivning

Patient initials forename

Datatyp

text

Alias
UMLS CUI [1,1]
C0421447
UMLS CUI [1,2]
C2986440
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Height
Beskrivning

Height

Datatyp

float

Alias
UMLS CUI [1]
C0005890
Weight
Beskrivning

Weight

Datatyp

float

Alias
UMLS CUI [1]
C0005910
Weeks pregnant
Beskrivning

Leave empty if not pregnant

Datatyp

float

Alias
UMLS CUI [1]
C1135241
Observed adverse drug reaction
Beskrivning

Observed adverse drug reaction

Alias
UMLS CUI-1
C1441672
UMLS CUI-2
C0041755
Observed adverse drug reaction
Beskrivning

Please fill in all observed symptoms here

Datatyp

text

Alias
UMLS CUI [1,1]
C1441672
UMLS CUI [1,2]
C0041755
Occured on
Beskrivning

Occured on

Datatyp

date

Alias
UMLS CUI [1,1]
C1441672
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0011008
Duration
Beskrivning

Duration

Datatyp

text

Alias
UMLS CUI [1,1]
C1441672
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0449238
Involved Drugs
Beskrivning

Involved Drugs

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1314939
Medication/Preparation
Beskrivning

Please fill in the batch number

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3641829
Daily Dose
Beskrivning

Daily Dose

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
Application
Beskrivning

Application

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0185125
Given from
Beskrivning

Given from

Datatyp

date

Alias
UMLS CUI [1,1]
C2348343
UMLS CUI [1,2]
C1517320
Given until
Beskrivning

Given until

Datatyp

date

Alias
UMLS CUI [1,1]
C2348343
UMLS CUI [1,2]
C1720302
Indication
Beskrivning

Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Suspected Drug
Beskrivning

Suspected Drug

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1314939
Suspected Connection with drug number:
Beskrivning

Suspected Connection with drug number:

Datatyp

integer

Alias
UMLS CUI [1,1]
C0750491
UMLS CUI [1,2]
C0449379
UMLS CUI [1,3]
C0013227
Drug administered previously
Beskrivning

Drug administered previously

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0806914
UMLS CUI [1,2]
C0332152
Drug Tolerated
Beskrivning

Drug Tolerated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013220
UMLS CUI [1,2]
C0332152
Possible re-exposition
Beskrivning

Possible re-exposition

Datatyp

integer

Alias
UMLS CUI [1,1]
C0743284
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0332149
Diseases
Beskrivning

Diseases

Alias
UMLS CUI-1
C0012634
Primary Disease
Beskrivning

Primary Disease

Datatyp

text

Alias
UMLS CUI [1]
C0277554
Comorbidity
Beskrivning

Comorbidity

Datatyp

text

Alias
UMLS CUI [1]
C0009488
Anamnestic Specifics
Beskrivning

Anamnestic Specifics

Alias
UMLS CUI-1
C1521970
UMLS CUI-2
C0262926
Nicotine
Beskrivning

Nicotine

Datatyp

boolean

Alias
UMLS CUI [1]
C0028040
Alcohol
Beskrivning

Alcohol

Datatyp

boolean

Alias
UMLS CUI [1]
C0001962
Contraceptives
Beskrivning

Contraceptives

Datatyp

boolean

Alias
UMLS CUI [1]
C0009871
Pacemaker
Beskrivning

Pacemaker

Datatyp

boolean

Alias
UMLS CUI [1]
C0810633
Implants
Beskrivning

Implants

Datatyp

boolean

Alias
UMLS CUI [1]
C0021102
Radiation therapy
Beskrivning

Radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
Physical therapy
Beskrivning

Physical therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0949766
Diet
Beskrivning

Diet

Datatyp

boolean

Alias
UMLS CUI [1]
C0012155
Allergies
Beskrivning

Allergies

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
Metabolic defects
Beskrivning

Metabolic defects

Datatyp

boolean

Alias
UMLS CUI [1]
C0025517
(Medical) Drug Abuse
Beskrivning

(Medical) Drug Abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0260268
Other specifics
Beskrivning

Other specifics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521970
UMLS CUI [1,2]
C0205394
Further explanations
Beskrivning

Further explanations

Datatyp

text

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C0681841
Clinical Laboratory Tests
Beskrivning

Clinical Laboratory Tests

Alias
UMLS CUI-1
C0260877
Changes of Laboratory parameters along with the adverse drug reaction
Beskrivning

append results if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C1707520
UMLS CUI [1,4]
C0041755
Therapy of adverse drug reaction
Beskrivning

Therapy of adverse drug reaction

Alias
UMLS CUI-1
C0041755
UMLS CUI-2
C0087111
Course of the therapy of the adverse drug reaction
Beskrivning

Course of the therapy of the adverse drug reaction

Datatyp

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0087111
Life-threatening
Beskrivning

Life-threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C2826244
Outcome of the adverse drug reaction
Beskrivning

Outcome of the adverse drug reaction

Alias
UMLS CUI-1
C0041755
UMLS CUI-2
C1274040
Outcome of the adverse drug reaction
Beskrivning

Outcome of the adverse drug reaction

Datatyp

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C1274040
Autopsy
Beskrivning

append results if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0004398
Cause of death
Beskrivning

Cause of death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Causality
Beskrivning

Causality

Alias
UMLS CUI-1
C4684583
Assessment of causality
Beskrivning

Assessment of causality

Datatyp

integer

Alias
UMLS CUI [1]
C4684583
Further comments
Beskrivning

Further comments

Datatyp

text

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C0947611
Informed entities
Beskrivning

Informed entities

Alias
UMLS CUI-1
C0678367
UMLS CUI-2
C1522154
Was the BfarM informed?
Beskrivning

BfArM informed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522154
UMLS CUI [1,2]
C0162696
UMLS CUI [1,3]
C0678367
Was the Manufacturer informed?
Beskrivning

Manufacturer informed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522154
UMLS CUI [1,2]
C0947322
Were the Drug comission doctors informed?
Beskrivning

Drug comission doctors informed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522154
UMLS CUI [1,2]
C2986529
Who was informed Others
Beskrivning

Who was informed Others

Datatyp

text

Alias
UMLS CUI [1,1]
C1522154
UMLS CUI [1,2]
C0205394
Signatory Data
Beskrivning

Signatory Data

Alias
UMLS CUI-1
C1511726
UMLS CUI-2
C4288222
Name of the doctor
Beskrivning

Name of the doctor

Datatyp

text

Alias
UMLS CUI [1]
C2361125
Specialty
Beskrivning

Specialty

Datatyp

text

Alias
UMLS CUI [1]
C0037778
Postal Code
Beskrivning

Postal Code

Datatyp

float

Alias
UMLS CUI [1]
C1514254
Clinic
Beskrivning

Clinic

Datatyp

boolean

Alias
UMLS CUI [1]
C0442592
Seal
Beskrivning

possibly, not necessarily

Datatyp

text

Alias
UMLS CUI [1,1]
C1708936
UMLS CUI [1,2]
C0018704
Manufacturer
Beskrivning

Manufacturer

Alias
UMLS CUI-1
C0947322
Manufacturer
Beskrivning

Manufacturer

Datatyp

text

Alias
UMLS CUI [1]
C0947322
Signature
Beskrivning

Signature

Alias
UMLS CUI-1
C1519316
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316

Similar models

Report about an adverse Drug Reaction (BERICHT ÜBER UNERWÜNSCHTE ARZNEIMITTELWIRKUNGEN)

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Basic Data
C1320722 (UMLS CUI-1)
Patient Initials Surname
Item
Patient Initials Surname
text
C0421448 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Patient initials forename
Item
Patient initials forename
text
C0421447 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
m (1)
CL Item
f (2)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Weeks pregnant
Item
Weeks pregnant
float
C1135241 (UMLS CUI [1])
Item Group
Observed adverse drug reaction
C1441672 (UMLS CUI-1)
C0041755 (UMLS CUI-2)
Observed adverse drug reaction
Item
Observed adverse drug reaction
text
C1441672 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Occured on
Item
Occured on
date
C1441672 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Duration
Item
Duration
text
C1441672 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Item Group
Involved Drugs
C0013227 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
Medication
Item
Medication/Preparation
text
C0013227 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
Daily Dose
Item
Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Application
Item
Application
text
C0013227 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
Given from
Item
Given from
date
C2348343 (UMLS CUI [1,1])
C1517320 (UMLS CUI [1,2])
Given until
Item
Given until
date
C2348343 (UMLS CUI [1,1])
C1720302 (UMLS CUI [1,2])
Indication
Item
Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item Group
Suspected Drug
C0013227 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
Item
Suspected Connection with drug number:
integer
C0750491 (UMLS CUI [1,1])
C0449379 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Suspected Connection with drug number:
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Drug administered previously
Item
Drug administered previously
boolean
C0806914 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Drug Tolerated
Item
Drug Tolerated
boolean
C0013220 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Item
Possible re-exposition
integer
C0743284 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
Code List
Possible re-exposition
CL Item
neg. (1)
CL Item
pos. (2)
Item Group
Diseases
C0012634 (UMLS CUI-1)
Primary Disease
Item
Primary Disease
text
C0277554 (UMLS CUI [1])
Comorbidity
Item
Comorbidity
text
C0009488 (UMLS CUI [1])
Item Group
Anamnestic Specifics
C1521970 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Nicotine
Item
Nicotine
boolean
C0028040 (UMLS CUI [1])
Alcohol
Item
Alcohol
boolean
C0001962 (UMLS CUI [1])
Contraceptives
Item
Contraceptives
boolean
C0009871 (UMLS CUI [1])
Pacemaker
Item
Pacemaker
boolean
C0810633 (UMLS CUI [1])
Implants
Item
Implants
boolean
C0021102 (UMLS CUI [1])
Radiation therapy
Item
Radiation therapy
boolean
C1522449 (UMLS CUI [1])
Physical therapy
Item
Physical therapy
boolean
C0949766 (UMLS CUI [1])
Diet
Item
Diet
boolean
C0012155 (UMLS CUI [1])
Allergies
Item
Allergies
boolean
C0020517 (UMLS CUI [1])
Metabolic defects
Item
Metabolic defects
boolean
C0025517 (UMLS CUI [1])
(Medical) Drug Abuse
Item
(Medical) Drug Abuse
boolean
C0260268 (UMLS CUI [1])
Other specifics
Item
Other specifics
boolean
C1521970 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Further explanations
Item
Further explanations
text
C1517331 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
Item Group
Clinical Laboratory Tests
C0260877 (UMLS CUI-1)
Changes of Laboratory parameters along with the adverse drug reaction
Item
Changes of Laboratory parameters along with the adverse drug reaction
text
C0392747 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C1707520 (UMLS CUI [1,3])
C0041755 (UMLS CUI [1,4])
Item Group
Therapy of adverse drug reaction
C0041755 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Course of the therapy of the adverse drug reaction
Item
Course of the therapy of the adverse drug reaction
text
C0750729 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Life-threatening
Item
Life-threatening
boolean
C0041755 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Item Group
Outcome of the adverse drug reaction
C0041755 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Outcome of the adverse drug reaction
integer
C0041755 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Outcome of the adverse drug reaction
CL Item
Restituted (1)
CL Item
Permanent Damages (2)
CL Item
Not yet restituted (3)
CL Item
Unkown (4)
CL Item
Lethal Exit (5)
Autopsy
Item
Autopsy
boolean
C0004398 (UMLS CUI [1])
Cause of death
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Item Group
Causality
C4684583 (UMLS CUI-1)
Item
Assessment of causality
integer
C4684583 (UMLS CUI [1])
Code List
Assessment of causality
CL Item
ensured (1)
CL Item
likely (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not assessed (5)
CL Item
not assessible (6)
Further comments
Item
Further comments
text
C1517331 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Informed entities
C0678367 (UMLS CUI-1)
C1522154 (UMLS CUI-2)
BfArM informed
Item
Was the BfarM informed?
boolean
C1522154 (UMLS CUI [1,1])
C0162696 (UMLS CUI [1,2])
C0678367 (UMLS CUI [1,3])
Manufacturer informed
Item
Was the Manufacturer informed?
boolean
C1522154 (UMLS CUI [1,1])
C0947322 (UMLS CUI [1,2])
Drug comission doctors informed
Item
Were the Drug comission doctors informed?
boolean
C1522154 (UMLS CUI [1,1])
C2986529 (UMLS CUI [1,2])
Who was informed Others
Item
Who was informed Others
text
C1522154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Signatory Data
C1511726 (UMLS CUI-1)
C4288222 (UMLS CUI-2)
Name of the doctor
Item
Name of the doctor
text
C2361125 (UMLS CUI [1])
Specialty
Item
Specialty
text
C0037778 (UMLS CUI [1])
Postal Code
Item
Postal Code
float
C1514254 (UMLS CUI [1])
Clinic
Item
Clinic
boolean
C0442592 (UMLS CUI [1])
Seal
Item
Seal
text
C1708936 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Item Group
Manufacturer
C0947322 (UMLS CUI-1)
Manufacturer
Item
Manufacturer
text
C0947322 (UMLS CUI [1])
Item Group
Signature
C1519316 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])

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