ICSR Workflow & Management_Katalyst HLS
Download as PPTX, PDF18 likes8,681 views
This document outlines the workflow and management of Individual Case Safety Reports (ICSR) in pharmacovigilance, detailing the criteria for identifying adverse events, serious versus non-serious reports, and roles involved in the process. It establishes minimum reporting requirements, emphasizes the importance of healthcare professional confirmations, and describes the case processing workflow. The document also highlights queries and actions taken during the report assessment.
ICSR Workflow & Management_Katalyst HLS
- 1. ICSR Workflow and Management 1 Katalyst Healthcares & Life Sciences
- 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. Katalyst Healthcares & Life Sciences
- 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. 3 Katalyst Healthcares & Life Sciences
- 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. 4 Katalyst Healthcares & Life Sciences
- 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. 5 Katalyst Healthcares & Life Sciences
- 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. 6 Katalyst Healthcares & Life Sciences
- 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) 7 Katalyst Healthcares & Life Sciences
- 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 8 Katalyst Healthcares & Life Sciences
- 9. MedDRA Preferred-(Critical)-Terms 9 Katalyst Healthcares & Life Sciences
- 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 10 Katalyst Healthcares & Life Sciences
- 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) 11 Katalyst Healthcares & Life Sciences
- 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 12 Katalyst Healthcares & Life Sciences
- 13. Case processing and assessment workflow process 13 Katalyst Healthcares & Life Sciences
- 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 14 Katalyst Healthcares & Life Sciences
- 15. 15 Katalyst Healthcares & Life Sciences