Mandatory Reporting of Serious Adverse Drug Reactions and ... · 6. Drug identification number assigned for the drug, if applicable 7. Date on which the patient first used the drug

Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device

Incidents by Hospitals

Educational Support for Vanessa’s Law

Module 3: ADR and MDI Reporting Processes

Draft for Pilot Test Only

Goals of the Education Approach

• Support the implementation of Vanessa's Law by providing hospitals with information on Health Canada's new regulatory requirements for serious adverse drug reaction (serious ADR) and medical device incident (MDI) reporting

• Provide strategies for healthcare leadership and healthcare providers to promote and support reporting of serious ADR and MDI documented within hospitals

• Describe Health Canada’s assessment and feedback mechanisms


Components of the Education Approach

• The Education Approach provides core content about ADR and MDI reporting that can be used by healthcare leadership, healthcare providers, patients and families, and educators.

• These educational materials are designed to be building blocks (either as an individual slide or an entire module) for you to integrate into your own learning or to incorporate into orientation, continuing education and other education activities.

• There are 5 PowerPoint modules:Module 1 – Overview of Vanessa’s Law and Reporting RequirementsModule 2 – Culture of SafetyModule 3 – ADR and MDI Reporting ProcessesModule 4 – System Supports for Reporting and LearningModule 5 – Health Canada’s Review and Communication of Safety Findings

Module 3

ADR and MDI Reporting Processes


Learning Outcomes

Completion of Module 3 will enable you to:

• Be familiar with ADR and MDI reporting systems available in hospitals• Describe ADR and MDI reporting systems available from Health Canada• Identify the required information for mandatory reporting of serious ADRs and MDIs • Differentiate between mandatory reporting of serious ADRs or MDIs and voluntary

reporting of ADRs or MDIs


Module 3 Outline – ADR and MDI Reporting Processes

1. Reporting Systems in Hospitals (with Examples) o ADR and MDI reporting systems in hospitals o Leadership considerations for mandatory reporting by hospitalso Healthcare provider considerations for mandatory reporting by hospitals

2. Submitting Reports to Health Canada o Methods for submitting serious ADR and MDI reports to Health Canadao New form for mandatory reporting of serious ADRs o New form for mandatory reporting of MDIs

3. Frequently Asked Questions (FAQs)4. Case Examples 5. Voluntary ADR and MDI Reporting Systems6. Key Points to Remember7. Abbreviations


Reporting Systems in Hospitals (with Examples)

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ADR and MDI Reporting Systems in Hospitals

• Systems and/or processes in hospitals for documenting harms experienced by patients may vary by hospital and province.

• Hospital systems, processes, policies, procedures, and forms may need to be updated to reflect requirements for mandatory reporting of serious ADRs and MDIs to Health Canada.


Leadership Considerations for Mandatory Reporting by Hospitals

• Develop and maintain internal policies and procedures and provide staff training in order to comply with the regulatory requirement to report all serious ADRs and MDIs that are documented within the hospital to Health Canada

• Procedures should provide for a standard process to identify reportable events in a timely fashion and be effective in compiling the information necessary for a complete report

• Determine clear internal roles and responsibilities for staff in meeting the mandatory reporting obligations

Note: The mandatory reporting requirement applies to the hospital and not to the individual healthcare providers working in the hospital. However, healthcare providers will have an important role in recognizing and documenting serious ADR and MDI.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medeffect-canada/consultation-draft-guidance-hospital-mandatory-reporting-regulations/guidance-document.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medeffect-canada/consultation-draft-guidance-hospital-mandatory-reporting-regulations/guidance-document.html


Healthcare Provider Considerations for Mandatory Reporting by Hospitals

• All healthcare providers have a role in identifying and reporting serious ADR and MDI, in accordance with hospital-defined processes.

• It is mandatory for hospitals to report a serious ADR or MDI.

• It is helpful to report a suspected serious ADR or MDI, even if: ◦ its association with the drug and/or medical device is

only suspected; ◦ causality is not confirmed; and/or◦ all the details are not known.


EXAMPLE 1: Hospital Reporting System for Serious ADR and MDI -Alberta Health Services (AHS)

• A centralized provincial approach is being developed for serious ADR reporting and being improved for MDI reporting.

○ Provincial Task Force is in place to coordinate the initiative○ Includes centralized process to receive, review and further report

• Alberta is implementing a province-wide clinical information system○ All sites will use a single electronic health record (Epic software)○ Phased roll out across the province over five years○ Serious ADR reporting will be integrated into the electronic health record (Epic software)○ MDI reporting will be linked from the electronic health record, as well as from the AHS intranet

Source: Alberta Health Services


EXAMPLE 1a: Hospital Reporting System for Serious ADR -Alberta Health Services (AHS)

Sites that have implemented the new electronic health record

(Epic software)

Sites that have not yet implementedthe new electronic health record

(Epic software)

ADR reporting functionality will be fully integrated into the electronic health record

The existing online provincial reporting and learning system will be used

Source: Alberta Health Services.


EXAMPLE 1b: Hospital Reporting System for MDI -Alberta Health Services (AHS)

• There are centralized Medical Device Safety (MDS) support teams that have been in place for more than 10 years, to:◦ receive ‘feedback’ forms and review incident reports;◦ assess, investigate, and action 2000-3000

reports/year; and◦ track and trend for early detection of larger-scale

issues.• A single MDIP* report form will replace the current

Product & Equipment Feedback forms

• There will be a link to the MDIP report form in the electronic health record and the AHS intranet.

Link to MDIP Form in Electronic Health Record

Improved MDIP Reporting Form

*Medical Device Incident or Problem Source: Alberta Health Services; Applies to AHS, Covenant Health, and Subsidiaries


EXAMPLE 2: Hospital Reporting System for ADR -British Columbia Patient Safety & Learning System (BCPSLS)

Source: British Columbia Patient Safety and Learning System.

The BCPSLS is a Provincial Online Reporting System


Submitting Reports to Health Canada

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Submitting Serious ADR and MDI Reports to Health Canada

• Health Canada is open to accepting different formats for reports of serious ADRs and MDIs, recognizing that hospital systems vary.

• Health Canada is exploring the opportunity to transfer report information through system to system methods and File Transfer Protocol (FTP).

• Health Canada is in the process of improving online tools for reporting, such as those available from MedEffect at: www.healthcanada.gc.ca/medeffect.

• The reporting forms for serious ADRs and MDIs, together with instructions, will be available on the Health Canada website in June 2019.

http://www.healthcanada.gc.ca/medeffect


Methods for Submitting Serious ADR and MDI Reports to Health Canada

From a Hospital System DatabaseIf you are interested in submitting reports electronically to Health Canada using hospital databases, please email the Canada Vigilance Program at [email protected].

Directly OnlineThe new reporting forms for serious ADR and MDI, together with instructions, will be available on the Health Canada website in June 2019.

Fax or MailDownload, print, and complete the applicable form and send by fax or by mail to the Canada Vigilance Office.

Fax to: 613-957-0335 Mail to: Canada Vigilance ProgramMarketed Health Products DirectorateHealth Products and Food BranchHealth CanadaAddress Locator 1908COttawa, Ontario K1A 0K9

Note: Do not send by email, as secure transfer of personal information is not ensured.

mailto:[email protected]


New Form for Mandatory Reporting of Serious ADR - DRAFT

The new reporting form for serious ADR, together with instructions, will be available on the Health Canada website in June 2019.


Required Data Elements when Hospitals Report a Serious ADR1. Name of the hospital and contact information of the representative of that hospital2. Drug’s brand name, proper name or common name 3. In the case of a drug imported under Division 10 of the Regulations (Access to Drugs in

Exceptional Circumstances), the identifying number or code of the drug 4. Patient’s age and sex 5. Description of the serious adverse drug reaction 6. Drug identification number assigned for the drug, if applicable 7. Date on which the patient first used the drug and, if applicable, the date on which the

patient stopped using the drug 8. Date on which the serious adverse drug reaction first occurred and, if applicable, the date

on which the patient’s health was restored to its state prior to the adverse drug reaction 9. Any medical condition of the patient that directly relates to the serious adverse drug

reaction 10. Any concomitant therapeutic products used by the patient 11. Result of the serious adverse drug reaction on the patient’s health


New Form for Mandatory Reporting of MDI - DRAFT

The new reporting form for MDI, together with instructions, will be available on the Health Canada website in June 2019.


Required Data Elements when Hospitals Report an MDI

1. Name of the hospital and contact information of the representative of that hospital2. Name of the device and its identifier 3. Name of the manufacturer of the device 4. Description of the medical device incident5. Lot number of the device or its serial number 6. Any contributing factors to the medical device incident, including any medical condition(s)

of the patient that directly relates to it7. Result of the medical device incident on the patient’s health


Contact Information for Canada Vigilance -Mandatory Reporting

• If you have technical questions about submitting reports electronically to Health Canada using hospital databases, email the Canada Vigilance Program at [email protected].

• You can contact Health Canada if you have any questions about reporting a serious ADR or MDI by emailing [email protected].




Frequently Asked Questions (FAQs)

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FAQ - Mandatory Reporting of Serious ADRs

1. What are the criteria for determining if an ADR is a serious ADR?

• Response: To determine if an ADR is a serious ADR, consider if the ADR:o requires in-patient hospitalization or prolongation of existing hospitalization,o causes congenital malformation,o results in persistent or significant disability or incapacity, oro is life-threatening¥ or results in death.

When in doubt of the seriousness of the ADR, Health Canada encourages hospitals to report.

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¥ The term “life-threatening” in the definition of “serious” refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction which hypothetically might have caused death if it were more severe.



2. What are the requirements for a hospital to report a serious ADR to Health Canada?

• Response: Hospitals are required to report serious ADRs to Health Canada within 30 calendar days of first documentation of the reaction within the hospital.

o Serious ADR documentation within the hospital includes: a serious ADR that is identified in a patient’s clinical/medical record; a serious ADR that is identified in a separate report form (electronic or hard copy) that has

been completed by a healthcare professional; and a serious ADR that has been documented in an ADR form as per internal hospital policy, a

pathology report, an incident/patient safety learning database, or a computerized prescription recording system.

o In the event that several patients have experienced the same serious ADR, separate reports should be submitted to Health Canada.



3. Is the hospital required to report a serious ADR that occurred in the community and led to the patient’s hospitalization?

• Response: If the serious ADR was documented within the hospital, the hospital would be required to report it to Health Canada.

4. Is the hospital required to report a serious ADR that occurred in the community and the patient was treated in the hospital’s emergency room, but was not admitted as an inpatient?

• Response: If the serious ADR was documented within the hospital, the hospital should report it to Health Canada, regardless of the specific service area (including the emergency department).

5. Is the hospital required to report a serious ADR that occurred at another hospital before the patient was transferred?

• Response: If the serious ADR was documented at both hospitals, both hospitals are required to report it to Health Canada. If the serious ADR was only documented at one hospital, then that hospital is required to report it to Health Canada.


FAQ - Mandatory Reporting of MDIs

1. What are the requirements for a hospital to report an MDI to Health Canada?

• Response: Hospitals are required to report an MDI to Health Canada within 30 calendar days of first documentation of the incident within the hospital. o MDI documentation within the hospital includes:

an MDI that is identified in a patient’s clinical/medical record; an MDI that is identified in a report form (electronic or hard copy) completed by a

healthcare professional; and an MDI that has been documented in a product complaint form (MDI) per internal hospital

policy, a pathology report, an incident/patient safety learning database, or a computerized prescription recording system.

o In the event an MDI affected several patients, either a separate report for each patient or one report for all patients should be submitted to Health Canada.


FAQ - Mandatory Reporting of MDIs

2. How do hospitals report multiple incidents with the same device? • Response: In the case of a medical device such as an automated chemistry analyzer, an incident

concerning a particular run or rack of analyses (containing samples from multiple patients) can be submitted in one report to Health Canada.

3. Do hospitals need to report MDIs to both Health Canada and manufacturers?• Response: Vanessa’s Law mandates hospitals to report MDIs to Health Canada. However, Health

Canada encourages hospitals to continue to report MDIs to manufacturers and importers for opportunities to improve safety.

4. What if it is unclear which of several concurrently used medical devices caused the MDI?

• Response: If the MDI occurred during the use of several concurrent medical devices, and the cause could not be determined, the report should identify all suspected medical devices.


FAQ - Mandatory Reporting of MDI

5. What are other considerations when an MDI is identified?

• Response: For a thorough assessment of the MDI, all components of the medical device should be considered.

○ Medical device components may include: Medical consumables Applied parts Ancillary components Accessories

◦ Hospital policies, procedures, and processes can ensure that a medical device is sequestered (removed from use) whenever possible following an MDI.


Case Examples

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ADR Case Example: Is the Hospital Required to Report?

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RATIONALE

Resulted in in-patient

hospitalization

ADR meets the criteria of

“serious”Life-threatening

condition

A patient had been taking warfarin, among other medications, and presented to the emergency department with a life-threatening gastrointestinal (gut) bleed. The patient required hospitalization in order to be stabilized.

and/or


ADR Case Example: Is the Hospital Required to Report?

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Note: This ADR would need to be reported if the patient developed febrile neutropenia and required in-patient hospitalization and treatment with antimicrobials to prevent infectious complications.

While the patient may be at increased risk for potentially fatal infections, the ADR is notimmediately life-threatening.

A patient was being treated with doxorubicin and cyclophosphamide and developed neutropenia. After assessing the severity of the neutropenia, a decision was made to continue with chemotherapy at a reduced dose with growth factor support.

RATIONALE


MDI Case Example: Is the Hospital Required to Report?

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Reportable MDISerious deterioration in the state of health of a patient

An infusion pump stopped, due to a malfunction, but failed to give an alarm. The patient received an under-infusion of antibiotics; septic shock occurred and required the patient to stay longer in the hospital’s intensive care unit.

RATIONALE


MDI Case Example: Is The Hospital Required to Report?

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During the use of an external defibrillator on a patient, the defibrillator failed to give the programmed level of energy due to a malfunction. The patient was not revived.

Note: This MDI would still need to be reported if the patient had been revived because the MDI would have had the potential to lead to death or serious deterioration in the state of health of the patient.

Reportable MDIDeath or serious deterioration in the state of health of a patient

RATIONALE


Voluntary ADR and MDI Reporting Systems

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Voluntary Reporting of ADRs and MDIs to Health Canada

• Voluntary reporting programs for ADRs and MDIs are available to all Canadians and can be accessed through the Canada Vigilance Program.

• Both ADR and MDI reporting are accessed by clicking on “Report an Adverse Reaction” to reach the Adverse Reaction and Medical Device Problem Reporting web page.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html


Voluntary Reporting of ADRs and MDIs to Health Canada

• Consumers and health professionals can access the online forms for voluntary ADR and MDI reporting.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html


• The minimum data elements needed for an ADR report are:

o Patient information o Adverse reaction descriptiono Name of the health product(s)o Reporter contact information (in case Health Canada requires additional information)

Voluntary Reporting of an ADR - Minimum Data Elements


• The minimum data elements needed for an MDI report are:

o Medical device information o Description of the complaint / defect in detail o Authorization to release contents of the report to others (e.g., manufacturer)

Voluntary Reporting of an MDI - Minimum Data Elements


Contact Information for Canada Vigilance –Voluntary Reporting

The Canada Vigilance Program is a national post-market monitoring program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada.

Reporting for Health Products (except Medical Devices)• Online: www.healthcanada.gc.ca/medeffect• Telephone: 1-866-234-2345 (toll-free)• Fax or Mail: Download, print and complete the Side Effect Reporting Form (please read the

instructions before completing the form).○ Fax: 1-866-678-6789 (toll-free)○ Mail: Canada Vigilance Office (using the postage paid label)

Reporting for Medical Devices• Online: www.healthcanada.gc.ca/medeffect for the Health Product Complaint Form (FRM-0317)




Key Points to Remember

• Hospital reporting systems, procedures and forms (online/paper) may need to be updated to include serious ADR and MDI reporting to Health Canada.

• Hospitals are required to report serious ADRs and MDIs to Health Canada within 30 calendar days of first documentation of the reaction or incident within the hospital.

• When completing a serious ADR or MDI report, provide as much information as possible to facilitate the assessment process.

• Consider sequestering medical devices involved in MDIs, along with relevant medical consumables, applied parts, ancillary components, and accessories whenever possible.

• Voluntary reporting programs for ADR and MDI are available to all Canadians through the Canada Vigilance Program.


Abbreviations

ADR: Adverse Drug ReactionAHS: Alberta Health ServicesBCPSLS: British Columbia Provincial Patient Safety and Learning SystemFAQ: Frequently Asked QuestionFRM-0317: Online Form for Medical Devices OnlyFTP: File Transfer Protocol MDI: Medical Device IncidentMDS: Medical Device SafetyMDIP: Medical Device Incident and Problem

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The educational materials (either as individual slides or entire modules) can be used to explain, describe or promote ADR and MDI reporting.

The educational approach was developed by the Institute for Safe Medication PracticesCanada (ISMP Canada), in a Joint Venture with Health Standards Organization (HSO) andthe Canadian Patient Safety Institute (CPSI), to assist Health Canada with outreach,education and feedback regarding the Protecting Canadians from Unsafe Drugs Act(Vanessa’s Law).

Disclaimer: The information is shared without warranty or representation of any kind (express, implied orstatutory). The responsibility for the interpretation and use of the information provided hereby lies with the reader.

Use of PowerPoint Slides and Education Modules


Your Thoughts are Welcome

As we continue to provide this education content we welcome your feedback:

ISMP Canada: [email protected]

HSO: https://healthstandards.org/contact/

CPSI: [email protected]


https://healthstandards.org/contact/


Documents

Mandatory Reporting of Serious Adverse Drug Reactions and ... · 6. Drug identification number assigned for the drug, if applicable 7. Date on which the patient first used the drug