Embed Size (px)
Citation preview
Basic Pharmacovigilance TrainingBasic Pharmacovigilance Trainingprovided by
BayerPharma AG
Muellerstr. 178, D-13353 Berlin, Germany
2
Purpose of the training
Consumer, patients and healthcare professionals Consumer, patients and healthcare professionals play an important roleplay an important role in the reporting process of in the reporting process of safety related information.safety related information.
To enable Bayer to provide up-to-date safety To enable Bayer to provide up-to-date safety information on Bayer products, your support is information on Bayer products, your support is pivotal to pivotal to continued patient and drug safetycontinued patient and drug safety..
3
Definitions
??Definitions
4
Definitions
Adverse Drug Reaction (ADR)Adverse Drug Reaction (ADR)
An adverse drug reaction (ADR) is An adverse drug reaction (ADR) is any any untoward medical occurrenceuntoward medical occurrence in a patient in a patient
administered a pharmaceutical product, administered a pharmaceutical product, which is suspected to have a causal which is suspected to have a causal relationship with this treatment.relationship with this treatment.
Spontaneous reports from consumers and Spontaneous reports from consumers and healthcare professionals should be regarded healthcare professionals should be regarded as as suspected ADRssuspected ADRs..
5
Definitions
Lack of Efficacy (Lack of Drug Effect)Lack of Efficacy (Lack of Drug Effect)
Failure to produce the expected Failure to produce the expected pharmacological action for an approved pharmacological action for an approved
indication.indication.
Example:Example: A patient received an oral contraceptive and became A patient received an oral contraceptive and became
pregnant.pregnant.
6
??Central questions
WhatWhat informationinformation should be reported ? should be reported ?
HowHow is the information reported ? is the information reported ?
To whomTo whom should I report ? should I report ?
7
??WhatWhat informationinformation should be should be
reported ?reported ?
8
What information should be reported ?
Any informationAny information
on an on an ADR or lack of efficacyADR or lack of efficacy connected with connected with the use of a Bayer product.the use of a Bayer product.
9
What information should be reported ?
Any informationAny information
on ADRs occurringon ADRs occurring
– in the in the course of the usecourse of the use of a drug of a drug – from drug from drug overdoseoverdose whether accidental or intentional whether accidental or intentional– from drug from drug abuse / misuse / non-approved useabuse / misuse / non-approved use– from drug from drug withdrawalwithdrawal– in the infant of a in the infant of a nursingnursing mother mother– possibly as a result of exposure of the mother or the fetus possibly as a result of exposure of the mother or the fetus
during pregnancyduring pregnancy..
10
What information should be reported ?
Any informationAny information
even if no ADReven if no ADR has been observed, has been observed,
– from drug from drug overdoseoverdose whether accidental or intentional whether accidental or intentional– from drug from drug abuse / misuse / non-approved useabuse / misuse / non-approved use– from drug administration from drug administration during pregnancy.during pregnancy.
11
What information should be reported ?
results in deathresults in death is life-threateningis life-threatening requires inpatient hospitalization or prolongation of requires inpatient hospitalization or prolongation of
existing existing hospitalizationhospitalization results in persistent or significant disability/incapacity results in persistent or significant disability/incapacity is a congenital anomaly/birth defectis a congenital anomaly/birth defect is an important medical event.is an important medical event.
Serious ADRsSerious ADRs
Any ADR occurring at any dose which fulfills one Any ADR occurring at any dose which fulfills one of the following criteria:of the following criteria:
12
What information should be reported ?
Minimum informationMinimum information required for a case: required for a case:
An identifiable patientAn identifiable patient
An identifiable reporterAn identifiable reporter
A suspect drugA suspect drug
A suspect ADRA suspect ADR
““Identifiable”Identifiable”
Patient/reporter does not need to be Patient/reporter does not need to be
identified at time of report but is identifiableidentified at time of report but is identifiable
if some effort is taken.if some effort is taken.
13
What information should be reported ?
Product Technical ComplaintsProduct Technical Complaints
Please also report any information regarding the Please also report any information regarding the product qualityproduct quality of a Bayer product you of a Bayer product you
become become aware of.aware of.
Examples areExamples are wrong product (label and contents are different products) wrong product (label and contents are different products) correct product but wrong strengthcorrect product but wrong strength faulty packaging, e.g. wrong or missing batch number or faulty packaging, e.g. wrong or missing batch number or
expiry date.expiry date.
14
HowHow is the information is the information reported ?reported ?
??
15
How is the information reported ?
Adverse EventsAdverse Events
Document any Adverse Event on the Document any Adverse Event on the
ADR Short Report Form.ADR Short Report Form.
16
How is the information reported ?
PregnancyPregnancy
Inform about Inform about
any exposure to a Bayer product during any exposure to a Bayer product during pregnancy.pregnancy.
17
DRUG
PATIENT
EVENT
REPORTER
How is the information reported ?
ADR Short Report FormADR Short Report Form
Who has experiencedWho has experienced the event ? the event ?
What event What event has the patient experienced ?has the patient experienced ?
Which Bayer drugs Which Bayer drugs were involved ?were involved ?
Who has reported Who has reported the eventthe event ??
18
How is the information reported ?
ADR Short Report FormADR Short Report Form
20 June 2004
19
To whomTo whom should I report ? should I report ?
??
20
Global Pharmacovigilance
Global Pharmacovigilance
To whom should I report ?
Report at your earliest Report at your earliest convenience to:convenience to:
Names:Names: Bayer Pharma AG Bayer Pharma AG Global Pharmacovigilance,Global Pharmacovigilance,Muellerstr. 178, D-13353 Berlin, GermanyMuellerstr. 178, D-13353 Berlin, Germany
Fax:Fax: +49 30 468 96765+49 30 468 96765 E-mail:E-mail: [email protected]@bayer.com
