Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods. Contact: "Katalyst Healthcares & Life Sciences" South Plainfield, NJ, USA info@KatalystHLS.com

1. ICSR Workflow
and
Management
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2. 2
Agenda
1. Identify the minimum criteria for ICSR.
2. Distinguish between serious and non-serious reports.
3. Identify HCP reports.
4. Determine medically confirmed reports
5. Define non-ICSR.
6. Describe the case processing and assessment workflow
process.
7. List the roles and associated responsibilities of persons
involved in PV workflow.
8. Explain the query process.
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3. What is an “Adverse Event” (AE)?
 An adverse event is any untoward medical occurrence in a
patient, clinical investigation subject or consumer
administered a product or medical device.
 The event need not necessarily have a causal relationship with
the treatment or usage of the product or medical device.
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4. Adverse Reaction: WHO technical report:
A response to a drug which is noxious and unintended and which
occurs at doses normally used in humans for the prophylaxis, diagnosis
or therapy of disease or for the modification of physiological function
Adverse Event Vs Adverse Reaction:
Adverse event time relationship with drug is positive and causal
relationship with drug is negative.
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5. What is the minimum criteria
that an Adverse Event report must contain?
Identifiable Patient: A specific individual or a known number of specific
individuals is involved. At least one of the following characteristics must be
available: Age, age group, gender, birth date, or patient ID number.
Suspect Product: Clearly refers to or names a drug, biologic, medical device,
over-the-counter (OTC) product, or blinded therapy unless the event occurs in
a clinical trial during a non-treatment period.
Adverse Event: A description of at least one event such as a sign, symptom,
diagnosis or of a circumstance leading up to an increased risk of an event, for
example, EIU, overdose, misuse.
Identifiable Reporting Source: The reporter is clearly identified establishing
that there was first-hand knowledge of the identifiable
patient/subject/consumer.
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6. Non Valid cases:
 For non-valid cases every attempt should be made to follow-up
the case to obtain the minimum information that constitutes a
valid ICSR. The same process and time frames mentioned above
for spontaneous reports will be applied.
 Non valid cases are still entered in to safety database.
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7. SERIOUSNESS CRITERIA
 Death
 Life-threatening
 Results in inpatient or prolonged hospitalization
 Results in persistent or significant disability/incapacity
 Results in congenital anomaly/birth defect
 Important medical event (IME) – Medical and scientific judgment
determines that the event may jeopardize the patient and/or may require
intervention to prevent one of the outcomes listed above (Examples:
intensive treatment in an emergency room or at home for allergic
bronchospasm, blood dyscrasias, drug abuse)
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8. Exceptions to Hospitalization as SAEs
 In the absence of a medical adverse event
 Admission for treatment of a pre-existing condition not associated with the
development of a new AE or with a worsening of a pre-existing condition
 Social admission
 Administrative admission
 Protocol-specified admission during the study
 Optional admission not associated with a precipitating medical AE
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9. MedDRA Preferred-(Critical)-Terms
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10. CONFIRMATION OF CASE SERIOUSNESS
 No changes are made to the seriousness classification of a
case if:
 The case is received as serious from an HCP.
 The case is received from a license partner or a regulatory
authority/registry
 A clinical trial case is reported as serious, for which no event
terms appear to meet seriousness criteria and no clarification
can be obtained from the investigator in due time.
 IME list
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11. Healthcare Professional (HCP) Reports
 Physicians
 Dentists
 Pharmacists
 Nurses
 Coroners
 Employees of a physician or other HCP who contact Pfizer on behalf of the physician
 Other health professionals specified by local regulations, e.g. Physician’s Assistant in US,
psychologist in Germany
 Literature reports from medical and scientific journals
 Clinical study reports (Exception: Reports in which a clinical study patient/subject is
reporting on himself/herself)
 Regulatory agency reports except where the reporter to the regulatory agency is
identified not to be an HCP (e.g. a consumer)
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12. What is a medically confirmed report?
A report in which an HCP confirms the occurrence of one or more of the AEs
reported and does not deny the relationship of the confirmed AEs to the
comp any product.
Determination of whether an adverse event report is medically confirmed is
necessary when:
 The initial case was received from a non-HCP source
 The case did not originate from a clinical study
 Follow-up information is received from an HCP source
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13. Case processing and assessment workflow process 13
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14. Query Overview
 Queries are captured on the ‘Activities’ tab as individual ‘Action Items’
 Queries can be entered / revised during any step of case processing
 E.g. Data Entry, QC, Medical Review
 The individual query is to be entered as an individual action item
 Do NOT enter multiple queries in one action item
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