Determining and Reporting Adverse Events vs. Product Complaints

Transcription

1 Determining and Reporting Adverse Events vs. Product Complaints Pharma Perspective: Jacqueline Grissinger Director, Office of Consumer Medical Safety Johnson & Johnson Medical Device Perspective: Lisa Withers Manager, Business Process Complaints Johnson & Johnson June

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Johnson & Johnson, their affiliates or respective officers, directors, employees its directors, officers, employees, volunteers, members, chapters, councils or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. 2

3 Objectives Provide guiding principles to help navigate the complexities of Adverse Event(AE) and Product Quality Complaint(PQC) reporting Potential roles and process design to mitigate risks of noncompliance Understand the existing challenges of reporting decisions related to PQC and AE Reporting Offer best practices for ensuring global requirements are met 3

4 Guiding Principles What are your organization guiding principles for evaluating a product quality complaint and/or an adverse event? Global Regulations Patient Safety Risk Assessment Company Values Efficiencies/Costs 4

5 Guiding Principles Global regulatory authorities define and enforce all medical device, drug and biologic policies for the country/region under their jurisdiction. Each complaint should be evaluated to determine whether the complaint represents an event which is required to be reported to any regulatory authority. Determination if a complaint may be possibly reportable to applicable regulatory authorities based on product type, event location and where the product is marketed. Each complaint identified as potentially reportable must be reviewed with a final determination made with appropriate regulatory reports filed.. North America EMEA ASPAC LatAm 5

6 Guiding Principles: Global Regulations Example: Adverse Event Reporting for Drugs Country United States Adverse Event Reporting Requirement NDA 15 Day: Serious and unexpected adverse experiences from all sources. PADER: Spontaneously reported adverse experiences that occur domestically and that are: Serious and expected; Nonserious and unexpected; Nonserious and expected Monograph Any report received of a serious adverse event associated with such drug when used in the United States European Union 15 Day Serious valid individual case safety reports 90 Day Non-serious valid individual case safety reports (Interim reporting currently and not all EU countries require non-serious reports) 6

7 Guiding Principles: Global Regulations Example: Product Quality Complaint Reporting for Drugs Country United States Product Quality Complaint Reporting Requirement 3 Day Field Alert Any incident that causes the drug product or its labeling to be mistaken for or applied to another article, Bacterial contamination, A significant chemical, physical, or other change, Deterioration in the distributed drug product, and Failure of one or more distributed batches of the drug product to meet the specifications established in its application. European Union The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination. Recall criteria: If a medicinal product proves to be harmful under normal conditions of use If a medicinal product is lacking in therapeutic efficacy If the qualitative and quantitative composition of the product is not as declared The controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled. 7

8 Guiding Principles: Global Regulations Example: Manufacturer Reporting for Devices Country United States Product Quality Complaint Reporting Requirement 30 Day: Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction. 5 Day: Submit reports of individual adverse events no later than 5 work days after the day that you become aware of: A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health, or A reportable event for which FDA has made a written request. Submit supplemental reports if you obtain information that you did not submit in an initial report. European Union 2 Day: Serious public health threat: IMMEDIATELY (without any delay that could not be justified) but not later than 2 calendar days after awareness by the MANUFACTURER of this threat. 10 Day: Death or UNANTICIPATED serious deterioration in state of health: IMMEDIATELY (without any delay that could not be justified) after the MANUFACTURER established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness of the event. 30 Day: Others: IMMEDIATELY (without any delay that could not be justified) after the MANUFACTURER established a link between the device and the event but not later than 30 elapsed calendar days following the date of awareness of the event. If after becoming aware of a potentially reportable INCIDENT there is still uncertainty about whether the event is reportable, the MANUFACTURER must submit a report within the timeframe required for that type of INCIDENT. 8

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10 Guiding Principles: Patient/Consumer Safety and Risk Assessment Safety/Risk Assessment Evaluation Who is the population at risk? What conditions may exacerbate the risk of its occurrence? Is the risk known? Is the risk associated with the product under conditions of use (as labeled)? What is the likelihood of the risk occurring in the future? 10

11 Guiding Principles: Company Values to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. 11

12 Guiding Principles: Company Values and Efficiencies/Costs Values Evaluation Even though it may not be a regulatory requirement, what is the right thing to do? How will this impact customer satisfaction? What will be gained? Is there a more cost effective way to obtain the same results? 12

13 What are your existing challenges?? IDENTIFICATION OF ALL APPLICABLE REGULATORY AUTHORITIES PER EVENT STANDARD OF QUALITY VARIATIONS IN REGULATIONS BY REGULATORY AUTHORITY??? END-TO-END OWNERSHIP OF EVENT DETERMINATION WITHIN THE COMPLAINT HANDLING PROCESS 13

14 Identifying and Defining Roles and Responsibilities Each manufacturer must have sufficient personnel with the necessary background, training, and experience. It must have established procedures for identifying training needs and ensuring that employees are adequately trained to perform their jobs. Training should be documented. CFR Accountability Complaint Quality Management Initial reportability determination Determine and coordinate any necessary regulatory determination updates Medical Safety / Surveillance Review of Adverse Event reportability determinations 14

15 Process Design 1. Receive complaint information 2. Complaint file creation 3. Enter Complaint Information 4. Intake Completed 5. Product Return Status 6. Order Escalation to Medical Safety 7. Review complaint 8. Complete follow-up as needed 9. Review Completed 10. Initial reportability determination 11. Product received 12. Investigation Conducted Reportable Not Reportable 13.Subbmit Reg. report 14. Communicate to customer & close 15

16 Escalation/Triage approach Issue Escalation Objectives Define criteria to filter complaints to the appropriate individuals Ensure there is a clear path to identify and escalate complaints Create dedicated teams to support the various complaint levels Free up capacity for the Company to handle complaints that require specialized skills 16

17 Escalation/Triage approach Complaint Quality Management Receive Case & Triage Duplicate Search Event Data Entry and Coding Medical Safety / Surveillance Review Medical Details and Coding Labeling Assessment Risk Documentation Review 17

18 Process Design - Best Practices Event Tracking Correct identification of identifying type of complaint to ensure correct processing Ability to identify classification type per country Reportability identification early in process Automated logic to determine time lines Visible workflow between Complaint Quality Management and Medical Safety Organizations Change control for new information that can impact reportability; interface of relevant information between Complaint Quality Management and Medical Safety Organizations Change in lot number Results of manufacturing evaluation Upgrade of adverse event to serious/medically important 18

19 Reporting Challenges Historical Challenges Different timeframes and formats Inconsistent interpretation of regulatory requirements Registration occurs locally and gaps in communication of marketing status/obligations Reporting in local language 19

20 Reporting Evaluation and Reporting What determines if an event is a Product Quality Complaint or an Adverse Event? Product Classification? Where the Event occurred? Device: Caused or contributed to a death? Caused or contributed to a serious injury or illness? May cause or contribute to a death or serious injury? Drug: Is it a spontaneous or solicited report? Is the report serious? Expected per the package insert? What is reporting timeline? What type of reporting format is required (electronic transfer, local form, entry to local database)? Periodic vs. Individual? Is translation needed? 20

21 Reporting Evaluation - Product Complaint vs Adverse Event US FDA DRUG/BIOLOGICS DECISION TREE Question 1: Did the individual case safety report contain all of the following: 1)an identifiable patient 2) an identifiable reporter 3) a suspect drug or biological product 4)An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product Yes Was the event Solicited (such as individual cases or findings derived from a study) or Spontaneous (communication from a HCP, consumer etc)? Solicited Solicited Spontaneous System Action: Reportability: Not Reportable *Listing of all cases (15 day) based on aggregate rules No Did the event result in a Serious Adverse Drug Experience? Death Life-threatening adverse experience Initial Prolongation of hospitalization Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus); Important medical events, based upon appropriate medical judgment, that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above. **Listing of all cases based on aggregate rules Yes No System Action: Reportability: Serious, Expected Adverse Experience Create Regulatory Report Record with: Due Date = <Awareness Date> + 30 Days Report Type = Individual electronic to CDER(xml) with Periodic Aggregate(Periodic) Report System Action: Does the Event Country = United States? No Yes Was the experience expected per the US package insert? Yes No Aggregate(Periodic) Report** What is the due date of the report? Aggregate(Periodic) Report** What is the due date of the report? System Action: Reportability: Nonserious, Expected Adverse Experience Create Regulatory Report Record with: Due Date = date user entered Report Type = Periodic 3500A System Action: Reportability: Nonserious, Unexpected Adverse Experience Create Regulatory Report Record with: Due Date = date user entered Report Type = Periodic 3500A System Action: Reportability: Serious Unexpected Adverse Drug Experience Create Regulatory Report Record with: Due Date = <Awareness Date> + 15 Days Report Type = Individual electronic to CDER(xml) No Was the experience expected per the US package insert? Yes What is is the due date of the report? Yes System Action: Does the Event Country = United States? No System Action: Reportability: Not Reportable Reportability values: Not Reportable Serious, Unexpected Adverse Experience Serious, Expected Adverse Experience Nonserious, Expected Adverse Experience Nonserious, Unexpected Adverse Experience Aggregate(Periodic) Report User enters due date((quarterly intervals, for 3 years from the date of approval of the application, and then at annual intervals.) 21

22 Best Practices for Regulatory Reporting Structured Decision Trees Global Regulatory Database to include product classification, registration Locally based associates (CoE s) Regulatory intelligence gathering to ensure correct interpretation of regulations 22

23 Determining and Reporting Adverse Events vs. Product Complaints Q&A Pharma Perspective: Jacqueline Grissinger Director, Office of Consumer Medical Safety Johnson & Johnson Medical Device Perspective: Lisa Withers Manager, Business Process Complaints Johnson & Johnson 23