Co-Chairs’ Update from the Joint HC/CBS/PTBLC/NAC Working Group re: Sentinel Event Communication Wendy Peppel Lead Senior Manager National Blood File Dr. Angela Tonary Senior Scientific Evaluator, Health Canada April 28, 2016

Background / Context The Joint HC/CBS/PTBLC/NAC WG has met twice: First telecon was December 15, 2015 Second telecon was April 8, 2016 Hypersensitivity adverse reactions (ARs) with lots of IGIVnex in 2014 and 2015 were duly reported to the manufacturer but clustering was not identified at those times. Concern was expressed regarding: the practice of some manufacturers to downgrade the seriousness of a reaction; and the inability to capture the volume of minor reactions which could signal a more serious sequelae. Hospital reporting is challenging at the present time, and is voluntary in some jurisdictions. Vanessa’s Law will be helpful but is not yet implemented.

Background / Context – con’d Clinicians need early information in order to act as soon as possible. Interest was expressed in having a more timely, robust identification, reporting and fan out of communication/alert across Canada. HC provided input on the Ontario TTISS algorithm for reporting ARs to blood products, and identified a need to educate and clarify the roles and responsibilities of HC versus PHAC. There is a strong desire for education to appropriate clinicians. WG members were very supportive of education sessions at the next Canadian Society for Transfusion Medicine Conference (May 2016 in Vancouver, BC). HC suggested getting started using the new MHPD.Blood@hc-sc.gc.ca listserv that had been created for stakeholder communications about AR clusters. Dr. Pavenski says she sent an email to the listserv but it didn’t work.

Actions from first telecon Manitoba group will develop Key Messages, with input from HC, to be provided for WG members in enhancing awareness. HC will follow up with their IT department to get the new listserv fixed. HC will provide a summary of a potential presentation for the CSTM, as Dr. Pavenski has kindly agreed to contact the organizing committee to ask for time on the agenda. Each WG member is to seek out opportunities to educate/enhance awareness around identifying and reporting potential clusters at hospitals.

3 Documents Prepared for Educational Outreach Key Messages – Sentinel Event Communication and Reporting 2. QA Sentinel Event Communication and Reporting 3. QA Vanessa’s Law

Key Messages- Sentinel Event Communication and Reporting Purpose- The purpose of the key messages is to assist and encourage health care professionals in meeting the adverse reaction reporting requirements for blood and blood products to Health Canada. Reporting adverse reactions to Canada Vigilance (required by law) versus reporting to TTISS (voluntary). Some information on adverse reactions to IVIG infusion. The minimum reporting information (e.g., AR description, name and lot number). The adverse reaction reporting mechanisms to the Canada Vigilance Program, including Health Canada’s new listserv: Transfusion Medicine stakeholders can send a heads-up email to: MHPD.Blood@hc-sc.gc.ca about lot-associated issues, particularly potential clusters of serious and non-serious reactions. Safety signals can be identified by Health Canada using the Canada Vigilance Adverse Reaction Database.

Benefits of Health Canada’s new listserv Use of the listserv will minimize the gap: Manufacturers have 15 days to report serious ARs and they are not required to report non-serious ARs, and blood establishments have 15 days to report non-fatal serious and unexpected ARs, impacting timely identification of clusters. MHPD will be able to quickly follow up with the Inspectorate, who will contact the manufacturer to act. Patient safety will be improved. Listserv members include: the Health Canada WG members; additional MHPD evaluators (scientific and medical) involved with AR assessment; and key personnel from the Canada Vigilance Program.

QA Sentinel Event Communication and Reporting - What is the Canada Vigilance Program? - What is the MedEffect™ Canada Initiative? - How does the Canada Vigilance Program collaborate with the Transfusion Transmitted Injury Surveillance System (TTISS)? - Are there any gaps in the current adverse event reporting systems? - What is Intravenous Immune Globulin (IVIG)? - Is IVIG safe to use? - What are adverse reactions? - What is a serious adverse drug reaction? - What is a serious unexpected adverse reaction? - Are there product-specific differences in the rate of adverse reactions? - Why is it important to report serious and serious unexpected adverse reactions? - What are Health Canada’s future considerations for adverse reaction reporting systems?

QA Vanessa’s Law - What is Vanessa’s Law? - What do the amendments apply to? - When will the amendments be effective? - Under Vanessa’s Law, who will be required to report adverse reactions? - What are the implications of these future reporting requirements for health care professionals? - What are the key elements of the amendments to the Food and Drugs Act? - What new regulations are in progress? - Will there be a user-friendly reference for these amendments? - What is the position of the Canadian Medical Association on these changes to reporting adverse events?

Identified opportunities to educate/enhance awareness CSTM Conference, May 11-16, 2016. The presentation by HC will be given by the Inspectorate and will include information on the Blood Regulations. Canadian Blood Coordinating Program Collaborative meeting, May 10, 2016. HC is applying for travel approval to give a presentation in person. Provincial/Territorial Blood Liaison Committee meetings. NAC, suggestion to put links to documents on website. Other Transfusion Medicine stakeholder meetings.