ID

37617

Description

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.

Link

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

Keywords

Versions (1)
  1. 8/11/19 8/11/19 -
Copyright Holder

Bundesinstitut für Arzneimittel und Medizinprodkte

Uploaded on

August 11, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Bfarm Pharmacovigilance

German English

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

1 forms  
Basic Data
Description

Basic Data

Alias
UMLS CUI-1
C1320722
Patient Initials Surname
Description

Patient Initials Surname

Data type

text

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

Patient initials forename

Data type

text

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

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Height
Description

Height

Data type

float

Alias
UMLS CUI [1]
C0005890
Weight
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Weeks pregnant
Description

Leave empty if not pregnant

Data type

float

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

Observed adverse drug reaction

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

Please fill in all observed symptoms here

Data type

text

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

Occured on

Data type

date

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

Duration

Data type

text

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

Involved Drugs

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

Please fill in the batch number

Data type

text

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

Daily Dose

Data type

text

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

Application

Data type

text

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

Given from

Data type

date

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

Given until

Data type

date

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

Indication

Data type

text

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

Suspected Drug

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

Suspected Connection with drug number:

Data type

integer

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

Drug administered previously

Data type

boolean

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

Drug Tolerated

Data type

boolean

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

Possible re-exposition

Data type

integer

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

Diseases

Alias
UMLS CUI-1
C0012634
Primary Disease
Description

Primary Disease

Data type

text

Alias
UMLS CUI [1]
C0277554
Comorbidity
Description

Comorbidity

Data type

text

Alias
UMLS CUI [1]
C0009488
Anamnestic Specifics
Description

Anamnestic Specifics

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

Nicotine

Data type

boolean

Alias
UMLS CUI [1]
C0028040
Alcohol
Description

Alcohol

Data type

boolean

Alias
UMLS CUI [1]
C0001962
Contraceptives
Description

Contraceptives

Data type

boolean

Alias
UMLS CUI [1]
C0009871
Pacemaker
Description

Pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0810633
Implants
Description

Implants

Data type

boolean

Alias
UMLS CUI [1]
C0021102
Radiation therapy
Description

Radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
Physical therapy
Description

Physical therapy

Data type

boolean

Alias
UMLS CUI [1]
C0949766
Diet
Description

Diet

Data type

boolean

Alias
UMLS CUI [1]
C0012155
Allergies
Description

Allergies

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Metabolic defects
Description

Metabolic defects

Data type

boolean

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

(Medical) Drug Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0260268
Other specifics
Description

Other specifics

Data type

boolean

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

Further explanations

Data type

text

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

Clinical Laboratory Tests

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

append results if applicable

Data type

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
Description

Therapy of adverse drug reaction

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

Course of the therapy of the adverse drug reaction

Data type

text

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

Life-threatening

Data type

boolean

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

Outcome of the adverse drug reaction

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

Outcome of the adverse drug reaction

Data type

integer

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

append results if applicable

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Cause of death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Causality
Description

Causality

Alias
UMLS CUI-1
C4684583
Assessment of causality
Description

Assessment of causality

Data type

integer

Alias
UMLS CUI [1]
C4684583
Further comments
Description

Further comments

Data type

text

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

Informed entities

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

BfArM informed

Data type

boolean

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

Manufacturer informed

Data type

boolean

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

Drug comission doctors informed

Data type

boolean

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

Who was informed Others

Data type

text

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

Signatory Data

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

Name of the doctor

Data type

text

Alias
UMLS CUI [1]
C2361125
Specialty
Description

Specialty

Data type

text

Alias
UMLS CUI [1]
C0037778
Postal Code
Description

Postal Code

Data type

float

Alias
UMLS CUI [1]
C1514254
Clinic
Description

Clinic

Data type

boolean

Alias
UMLS CUI [1]
C0442592
Seal
Description

possibly, not necessarily

Data type

text

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

Manufacturer

Alias
UMLS CUI-1
C0947322
Manufacturer
Description

Manufacturer

Data type

text

Alias
UMLS CUI [1]
C0947322
Signature
Description

Signature

Alias
UMLS CUI-1
C1519316
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Gender
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])
Suspected Connection with drug number:
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])
Possible re-exposition
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])
Outcome of the adverse drug reaction
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])
Assessment of causality
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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