Health Canada Mandatory Reporting for Hospitals Your Role in Patient Safety

1. Health CanadaMandatory Reporting for HospitalsYour Role in Patient Safety Medical Devices Operations Section Health Products Surveillance and Epidemiology Bureau Ottawa, ON

2. Presentation Objectives • Provide information on: • The proposed regulations requiring the mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) by hospitals. • Health Canada’s commitment to improve the reporting of SADRs and MDIs. • Outreach, education, and feedback activities. 2

3. Protecting Canadians from Unsafe Drugs (and devices) The Protecting Canadians from Unsafe Drugs Act is known as Vanessa's Law in honour of a 15-year-old woman who died in 2000 of a cardiac arrhythmia after being prescribed cisapride (Prepulsid) for a stomach disorder. The U.S. FDA had advised against prescribing the medication to patients who had eating disorders or electrolyte imbalances. When Vanessa died, Health Canada was in the process of reviewing the drug but only had a few adverse event reports compared to the U.S. FDA. A patient safety advocate’s campaign for increased regulation of therapeutic products has paved the road towards giving Health Canada greater power to request data from hospitals and industry about medication and devices in the marketplace. 3

4. Vanessa’s Law – Objectives Amends the Food and Drugs Act to improve Health Canada’s ability to: Collect post-market safety information; Take appropriate action when a serious risk to health is identified; and Promote greater confidence in the oversight of therapeutic products by increasing transparency. 4

5. Vanessa’s Law – Objectives (cont.) The amendments to the Food and Drugs Act include: Power to compel information, tests/studies, and reassessments Power to compel a label change Power to recall unsafe therapeutic products Tougher measures for those that do not comply Ability to incorporate by reference Mandatory reporting by healthcare institutions • serious adverse drug reactions (ADRs); and • medical device incidents (MDIs). This new measure should improve the quality and increase the quantity of incident reporting. 5

6. Mandatory Reporting by Hospitals The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) amends the Food & Drugs Act to introduce the ability to make regulations regarding the reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) by Canadian hospitals. Why? To improve the quality and increase the quantity of reporting on serious ADRs and MDIs that are reported to Health Canada to optimize detection of potential health product safety issues. 6

7. Multi-pronged Approach to Improving the Reporting of Serious ADRs and MDIs 7

8. Consultations and Regulatory Process for Mandatory Reporting 8

9. Regulations for Mandatory Reporting- Who? The proposed regulations apply to: All hospitals regulated through provincial or territorial legislation, as well as to those operated by the federal government which provide health services to persons who are in-patients. The proposed regulations define a hospital as a facility which: • is licensed, approved, or designated as a hospital by a province or territory, in accordance with the laws of the province or territory, to provide care or treatment to persons suffering from any form of disease or illness; or • is operated by the Government of Canada and provides health services to in-patients. Hospitals are only required to report serious ADRs and MDIs that are documented within the hospital. 9

10. The proposed regulations would require hospitals to report all documented serious ADRs as well as all documented MDIs, including MDIs with the potential to cause harm if they reoccur, where the required information is within the control of the hospital. Serious ADR: a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life- threatening, or results in death. Medical device incident (MDI):an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur. • A serious deterioration in the state of health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. Regulations for Mandatory Reporting- What? 10

11. A serious ADR or MDI that is identified in a patient’s clinical/medical record. • A serious ADR or MDI that is identified in a separate report form (electronic or hard copy) that has been completed by a health care professional, for example: • ADR form as per internal hospital policy; • product complaint form (MDIs); • pathology report; • report in the incident/ patient safety learning database; • computerized prescription recording system. Examples of serious ADR and MDI documentation in a hospital setting 11

12. Regulations for Mandatory Reporting- Products Vanessa’s Law defines a “therapeutic product” as “a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.” The proposed mandatory reporting requirements for hospitals apply to therapeutic products, including: Pharmaceuticals (prescription and non-prescription) Biologic drugs (excluding vaccines administered under a routine immunization program of a province or territory) Radiopharmaceutical drugs (Schedule C to the Food and Drugs Act) Disinfectants Medical devices (Section 1 of the Medical Devices Regulations) 12

13. Medical devices are classified into Classes I to IV, by means of the classification rules set out in Schedule 1 of the Medical Devices Regulations, where Class I represents the lowest risk and Class IV represents the highest risk. Examples of medical devices, by class, can include: • Class I- hospital beds, • Class II- infusion sets, • Class III- infusion pumps, • Class IV-certain pacemakers/ defibrillators. All classes of medical devices are within the scope of mandatory reporting by hospitals. Medical Devices Included 13

14. Regulations for Mandatory Reporting- Requirements Hospitals are required to report serious ADRs and MDIs if the information is in control of the hospital. The information requirements for serious ADRs and MDIs differ from one another; this is due to the differences in the required information for the monitoring of these two types of products.   If the hospital has more information than those listed below as required information for a serious ADR or MDI, Health Canada encourages the hospital to include this information in the reports sent to us in order to ensure the highest quality reports possible. 14

15. What does it mean for information to be ‘in the control’ of the hospital? Information that is ‘in the control’ of the hospital is information that would be reasonably accessible within the hospital. Those who document the serious ADR/ MDI are encouraged to take all reasonable steps to retrieve the information required by the proposed regulations. There is no requirement to do further investigation in order to obtain the pieces of information should they not be reasonably accessible. 15

16. Regulations for Mandatory Reporting- Data Elements 16

17. Regulations for Mandatory Reporting- Timelines Hospitals are required to report serious ADRs and MDIs to Health Canada in writing within 30 calendar daysof first documentation of the reaction or incident within the hospital. If the report is completed earlier than the 30 days, Health Canada encourages hospitals to report sooner. 17

18. An infusion pump stopped, due to a malfunction, but failed to give an alarm. The patient received an under-infusion of antibiotics, causing septic shock and a required stay in the hospital’s intensive care unit to correct. The premature revision of an orthopaedic implant due to loosening. No cause yet determined. The patient has the potential of having serious permanent harm caused by this loosening. During patient examination, the C-arm on an X-ray vascular system had uncontrolled motion. The patient was hit by the image intensifier and was permanently and severely injured. The system was installed, maintained, and used according to manufacturer’s instructions. Sterile, single-use implantable device packaging was labelled with the caution, “Do not use if package is opened or damaged”. By incorrect design, the label is placed on the inner packaging. The device was subsequently stored only in the inner packaging, which did not offer a sufficient sterile barrier. The outer package was removed, but the device was not used during the procedure. There is a potential for serious harm because of potential sepsis. The loss of sensing after a pacemaker has reached “end of life”. The elective replacement indicator did not show up in due time, although it should have according to device specifications. This has a potential for serious harm. Examples of MDIs 18

19. Patients undergoing endometrial ablation of the uterus suffered burns to adjacent organs. Burns of adjacent organs due to thin uterine walls were an unanticipated side effect of ablation. The manufacturer does not change the label of the ablation device, and fails to warn users of this side effect which may be produced when the device is working within specification. A health care professional reported that during the implant of a heart valve, the sewing cuff was discovered to be defective. The valve was abandoned, a new valve was implanted and pumping time during surgery was extended. This had the potential to cause serious harm. During the use of an external defibrillator on a patient, the defibrillator failed to deliver the programmed level of energy due to a malfunction. The patient was not revived. Note: If the patient was revived, this would be considered a near incident and would also be reportable. A batch of out-of-specification blood glucose test strips is released by a manufacturer. The patient uses strips according to instructions, but readings provide incorrect values leading to incorrect insulin dosage, resulting in hypoglycemic shock and hospitalization. A user reported that there were insufficient details in the instructions for use regarding cleaning methods for reusable surgical instruments used in brain surgery, despite the risk of variant Creutzfeldt-Jakob Disease (vCJD) transmission. Examples of MDIs (cont’d.) 19

20. Reports not meeting these criteria: • of being a medical device, • (suspected) defect/failure of device, • causing serious harm/potential for serious harm. Deficiency of a device ALWAYS found by the user prior to patient use • A user performed an inflation test prior to inserting the balloon catheter in the patient as required in the instructions for use accompanying the device. A malfunction on inflation was detected and another balloon was used. Incident caused solely by a patient's condition • A patient died after dialysis treatment. The patient had end-stage renal disease and died of renal failure. Malfunction protection operated correctly • After a malfunction of an infusion pump that was not related to a manufacturing defect, the pump gives an appropriate alarm and stops. There was no harm to the patient. What is Not Reportable? 20

21. Manufacturers and importers are required to report MDIs • Within 10 days: if an incident leads to death or a serious deterioration of health. • Within 30 days: if an incident were to recur, could end in death or serious deterioration of health. All other types of reports from industry and all reports from public/health care facilities(other than hospitals)/professionals/third party are considered voluntary reports. • Health Product Complaint Form (FRM-0317) Who Else Has to Report to HC? 21

22. Industry/ vendor reporting to HC and to hospital • Need to report to HC but not to hospital Hospital reporting to industry/ vendor • Not required by HC, considered voluntary • Prompt voluntary reporting from hospitals to manufacturer and importer enables manufacturers/importers to conduct investigations to determine root cause and corrective actions in a timely manner Hospital to patients • HC does not require this but some provinces do (disclosure) Shared purchasing company reporting to hospital and to HC • HC does not require 3rd parties to report to HC or the hospitals. Communication within all parties is an effective mechanism to ensure product improvement and patient safety. Other Reporting Requirements 22

23. Clinical impact statements, changes priority of reports Your stories/perspectives are different • Industry tells us “Tubing leaked’ • You tell us “Chemotherapy medications spilled, disrupted schedule of drug delivery to patient, thousands of dollars in medications were lost, pregnant nurse exposed to chemotherapy medications, etc.” Your story completes the picture! Why do we need YOUR reports? 23

24. The Bedrail Story… NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on FL14E Rose Bed There is a risk for the side rail to unexpectedly collapse as it appears to be latched in the upright position when it is not fully locked in place. This can result in bruises and/or lacerations to patients. Also, the side rail may not adequately prevent a patient from rolling or falling off of the bed. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28927a-eng.php One report can make a difference 24

25. Health Canada is committed to improve the reporting of ADRs and MDIs in Canada, with the aim to more rapidly identify safety issues and to better share safety information with Canadians and decision makers for action. This will be done in three ways: Implement Mandatory Reporting of ADRs and MDIs from Hospitals Improve Reporting of ADRs and MDIs from Other Health Care Settings Optimize the Timely Analysis and Sharing of Information with Health System Partners Improving Reporting of ADRs and MDIs in Canada 25

26. Health Canada has engaged a contractor, the Institute for Safe Medication Practices Canada (ISMP) in a Joint Venture with the Health Standards Organization (HSO) and the Canadian Patient Safety Institute (CPSI) to: • assess the needs of impacted hospitals in implementing the regulations • develop training materials to support hospitals in their identification and reporting of serious ADRs and MDIs Health Canada is carrying out engagement activities to raise awareness about mandatory reporting and developing knowledge translation products to provide reporter specific feedback Supporting Implementation of the Regulations: Outreach and Education 26

27. Key Milestones for Outreach, Education and Feedback Project start date: December 1, 2017 Project end date: November 1, 2019 Following the project, Health Canada intends to continue to support outreach, education and feedback. 27

28. While most serious ADRs and MDIs will be transferred and treated in hospital, some will not. Given this, Health Canada will undertake two activities to improve reporting from non hospital based health care settings. Expand Existing Canadian Medical Devices Sentinel Network (CMDSNet) • Since 2009, Health Canada has supported the creation of, and sought medical device incident reports through the Canadian Medical Devices Sentinel Network (CMDSNet). • This network currently covers 18 healthcare organizations, representing more than 260 hospitals and facilities across the country. • Health Canada will aim to expand the scope of the CMDSNet to include facilities outside the hospital setting including long term care facilities and private clinics. Outreach and Education: • Health Canada will develop outreach and education aimed at non-hospital settings such as private clinics and long term care facilities. This program will aim to: • Improve the understanding of Canada’s health product safety regime and the critical role non hospital settings and their health care providers play in this regime by reporting reactions and incidents • Outline how information gathered through this reporting system is and will be shared back to Canada’s healthcare community. • Baseline data will help to determine if this education approach is sufficient to improve non hospital reporting. If not, consideration will be given to expanding the mandatory reporting regulations to sites other than hospitals. Improving Reporting of ADRs and MDIs from Other Health Care Settings 28

29. In addition to increasing reporting of ADRs & MDIs, Health Canada will optimize the use of this data. • The quantity and quality of ADR and MDI reports received by Health Canada will be influenced by our ability to demonstrate the benefits of reporting to Canadians, reporting institutions and health care providers. Currently, Health Canada makes all ADR and MDI data available online, produces an annual report and publishes risk communications to providers through a number of forums. Optimizing the Timely Analysis and Sharing of Information with Health System Partners 29

30. Health Canada will improve its analysis and knowledge translation (KT) related to ADR and MDI, ensuring health system partners have timely access to key information by undertaking two activities: Optimize Data Analytics • Health Canada is investing in IT tools that will better support the timely, appropriate analysis of the ADR and MDI data, streamlining the identification of potential safety signals Optimize Sharing of Information with Partners • Through consultation with key stakeholders, Health Canada will identify the content, frequency and format of ADR and MDI products that will be of most use for health system partners thereby getting the right information to the right people in the right formats for uptake; a KT Plan for ADR and MDI information will be developed and implemented as a result • Part of the Health Canada KT Plan will include optimizing our Annual ADR and MDI Report to better meet the needs of clients, and the launch of a webinar series • The webinar series will aim to provide a quarterly and as needed venue for timely discussions on specific ADR and/or MDI issue with target audiences Optimizing the Timely Analysis and Sharing of Information with Health System Partners (cont’d.) 30

31. Resources For full text of the Bill C-17 amendments, see Parliament website (November 2014): http://www.parl.ca/DocumentViewer/en/41-2/bill/C-17/royal-assent Issue Identification Paper (May 2016): https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medeffect-canada/issue-identification-paper-mandatory-reporting-serious-adverse-drug-reactions-medical-device-incidents-healthcare-institutions.html Consultation Paper – “Toward Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions” (June 2017): https://www.canada.ca/en/health-canada/programs/consultation-reporting-serious-adverse-drug-reactions-medical-device-incidents/document.html “What we heard” report (December 2017): https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/responses-public-consultation-toward-mandatory-reporting-serious-adverse-drug-reactions-medical-device-incidents-health-care-institutions.html Proposed regulations published in Canada Gazette, Part I, and RIAS (June 2018): http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/index-eng.html http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/reg6-eng.html Draft Guidance for ADR/MDI hospital reporting (July 2018): https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medeffect-canada/consultation-draft-guidance-hospital-mandatory-reporting-regulations.html 31

32. Please forward any questions or comments to: HC.canada.vigilance.sc@canada.ca Questions and Comments 32