adr monitoring
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Adverse Drug Reaction(s)
Adverse Event -Any untoward medical occurrence in a
patient or clinical investigation subject
administered a pharmaceutical product and
which does not necessarily have to have a causal
relationship with this treatment.Adverse Drug ReactionsAre events, thought to be a
response of which is both due to the drug and
considered noxious and un intended.
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SAE
Serious Adverse Event or reaction - is any untoward
medical occurrence that at any dose: Results in death,
Is life threatening,
Requires inpatient hospitalization or prolongation ofexisting hospitalization.
Results in persistent or significant
disability/incapacity.
Results in a congenital anomaly/birth defect
Results in other medically important conditions
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ADRs are always under reported
ADRs are the 4th-6th largest cause formortality
ADRs account for approximately 10% ofhospital admissions
ADRs increase the length of hospital stayand medical costs
15-20% of hospital budget may be spentdealing with drug complications
Incidence of ADRs
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Possible Causes of Adverse Reactions
Intrinsic factors of the drug
Pharmacological Idiosyncratic
Carcinogenicity, Mutagenicity
Teratogenicity
Extrinsic factors
Adulterants
Contamination
Underlying medical conditions Interactions
Wrong usage
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HOW KNOWLEDGE ABOUT ADRs IS CREATED
Animal experiments
Clinical trials
Epidemiological
methods
Observational studies
Case reports
Case series
Post-Marketing
Surveillance (PMS)
Prescription event
monitoring
Cohort studies Intensive hospital
monitoring
Case-control studies
Record-linkage
Meta-analysis
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Limitations of Clinical Trials
Too few - Normally < than 1500 patients
Too simple - Use patients without
complications, other medical
conditions
Too narrow - Limited indications
Too brief - Limited time
Too median - Very old/very young patients,pregnant women not included
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Identify the suspected drug Identify factors that contributed to the
occurrence of the adverse reaction
such as:
Multiple drug therapy,
Drug-drug interactions
Drug-herbal interactions
Drugfood interactions Excipients, colouring agents
Aim of Surveillance of Drug Related Adverse Reactions
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Increase information on use in at-risk population
Identify unlabeled, rare, delayed adverse reactions Identify abuse potential
Follow-up cases where drugs prescribed intentionally
during pregnancy
Monitor outcome of pregnancy
Effect of drug to the foetus/baby
MAKE CHANGES TO PRODUCT INFORMATION
BASED ON NEW FINDINGS
Aim of Surveillance of Drug Related Adverse Reactions
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How to Recognize ADRs
Since ADRs may act through the same
physiological and pathological pathways asdifferent disease, they are difficult and
sometimes impossible to distinguish
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Drug administered
Pt develops a new condition/symptoms
Drug suspected?
Yes
Check literature
Documented ? (for the productor similar class of products)
Yes
Highly suggestive of ADR
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Not documented in literature
Drug continued Drug discontinued
Worsening ofsymptoms Symptoms improve(+ve dechallenge)
Drug restarted
Symptoms recur(+ve rechallenge)
Any other possible causes? Concomitant therapy Underlyingconditions
I t it f E t
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Intensity of Events
Mild events: Mild events are those, which are easily
tolerated.
Moderate events: Moderate events are those, which
cause sufficient discomfort to the
subject which interferes with dailyactivity and/or require a simple dose
of medication, e.g. analgesics or
antiemetics.
Severe events: Severe events are those, which
incapacitate or prevent usual activity or
require complex medication or
hospitalisation.
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Severe vs Serious
The term "severe" is often used to describe the intensity
(severity) of a specific event (as in mild, moderate, orsevere myocardial infarction); the event itself, however,
may be of relatively minor medical significance (such as
severe headache).
This is not the same as "serious," which is based onpatient/event outcome or action criteria usually
associated with events that pose a threat to a patient's life
or functioning.
Seriousness (not severity) serves as a guide for defining
regulatory reporting obligations.
C l R l ti hi
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Causal RelationshipAdverse events can be classified as :
HIGHLY PROBABLE: The event follows a reasonable temporal sequence
from administration of the drug and is confirmed by positive dechallenge andpositive rechallenge.
PROBABLE: The event follows a reasonable temporal sequence from
administration of the drug is confirmed by dechallenge and is not reasonably
explained by the known characterization of patients clinical state.
POSSIBLE: The event follows a reasonable temporal sequence from
administration of the drug and follows a known response pattern to the
suspected drug but could have been produced by the patients clinical state or
other modes of therapy administered to the patient.
REMOTE: Any event that does not meet the above criteria especially if the
event has no temporal association with use of the drug.
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Product Safety Update Report (PSUR)
The Periodic Safety Update Report (PSUR) is required as part of the
Post Marketing Drug Risk Assessment (PMDRA) program.
The PSUR report is evolving with the ICH initiatives and the
February 2004 FDA Guidance for industry.
The PSUR software is designed to track the submission of Periodic
Safety Update Reports by marketed product and country.
The PSUR is a practical mechanism for summarizing interval safetydata covering short periods of time and for conducting and overall
safety evaluation.
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Product Safety Update Report (PSUR) PSUR tracks basic information such as International Birth Date (IBD),
Product license number and renewal date, and the date range of the
report.
Information on all indications, dosage forms, and regimens for the
active substance can also be tracked as well as the affiliate requesting
the report. PSUR tracks the initiation date for requests for information and thereceipt of that information from the various corporate departments that
contribute to the PSUR report.
Besides the dates, provision is made to link the various documents andcomponents to the PSUR tracking records for immediate retrieval of
that report component.
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AE Reporting Form
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