What we heard - Responses to the public consultation paper entitled Toward mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions

Introduction

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) makes several amendments to the Food and Drugs Act (F&DA), including a new requirement in section 21.8 of the F&DA for certain health care institutions to provide Health Canada with information on serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs). Currently, only the manufacturers are required to report to Health Canada. The central objective of this new authority is to improve the quality and increase the quantity of serious ADR and MDI reports, thereby ensuring that there is sufficient data to detect safety problems. Improving the knowledge base on product safety will empower Canadians along with their health care providers to make better, more informed decisions regarding their medical treatment and support overall patient safety. Although Vanessa’s Law received Royal Assent in November 2014, this requirement will come into effect when accompanying changes are made to both the Food and Drug Regulations and the Medical Devices Regulations.

Health Canada sought feedback from health care institutions, health care professionals, patient advocacy groups, provinces and territories, other stakeholders and any interested members of the public regarding the proposed regulatory amendments, as outlined in Toward Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions: A Consultation Paper to inform the design of the regulations. The consultation paper was posted to Health Canada’s website and available for comment for 45 days from June 28, 2017, to August 11, 2017. The paper described various policy options and sought advice and input from stakeholders in 5 areas:

• which kinds of health care institutions should report;
• what types of serious ADRs and MDIs should be reported;
• which health products should be reported on;
• what information should be included in the report; and,
• what timelines for reporting should be in place.

Feedback was also requested on suggested non-regulatory approaches to improve serious ADR and MDI reporting in an institutional setting, including:

• outreach and education; and,
• the provision of meaningful feedback back to reporting institutions.

Who provided feedback?

Health Canada received a total of 71 responses: 48 via its online form and 23 via email. The breakdown of responses by stakeholder group is shown in Table 1.

Regulatory questions: What did the stakeholders say?

The consultation paper proposed that reporting requirements apply only to hospitals that provide acute care services. The rationale for this was that hospitals that provide acute care services are considered to be more likely to treat patients with serious ADRs and MDIs, and are therefore well-positioned to make and report these observations. Hospitals are also more likely to have the infrastructure and multi-disciplinary teams to effectively support the documentation of complete information for a report.

There was strong support for this position with 59% of respondents agreeing with Health Canada’s proposal in the consultation paper. There was strong support for this position among health care institutions and health care professionals. Approximately a third of stakeholders (37%) recommended broadening the scope beyond hospitals that provide acute care, now or as part of a future amendment. While acute care hospitals would be the most likely institution to treat serious ADRs/MDIs, this may also occur at chronic care and extended care hospitals. It was also suggested that mental health facilities and long-term/ palliative care facilities be included. Some stakeholders noted a lack of clarity about what constitutes ‘acute care’.

Types of reportable ADRs and MDIs

The consultation paper proposed that ADR reporting be limited to reactions that are both serious and unexpected, while MDI reporting would encompass all serious incidents. The proposal to only require the reporting of serious and unexpected ADRs was meant to focus on events that are the highest priority targets for product safety monitoring. Conversely, the mandatory reporting of all serious adverse drug reactions could present a significant operational burden to institutions.

There was strong support (58%) across stakeholder groups for including serious and unexpected ADRs, though there was also notable support (29%) for broadening mandatory reporting to encompass all serious ADRs, not just those that are unexpected, now or in a future regulatory amendment. A small number of respondents felt that the definitions of ‘unexpected’ and ‘in control of the institution’ were unclear in the proposal, and that these may cause confusion. There was strong support (71%) for the proposal to report all serious MDIs. As no subsets were proposed for MDIs in the previous feedback that Health Canada received, it was proposed in this consultation that health care institutions be required to provide Health Canada with information about all serious MDIs in their control, and this would include MDIs with the potential to cause harm if they were to recur.

Scope of health products

The consultation paper proposed to limit the scope of the mandatory reporting requirements to information about pharmaceuticals (prescription and non-prescription), biologic drugs (excluding vaccines), radiopharmaceuticals, disinfectants and medical devices. Certain therapeutic products were excluded from the proposed mandatory reporting requirements as these products are already subject to adverse event reporting requirements by either health facilities or health care professionals. It was explained in the discussion paper that natural health products cannot be included within the scope of this regulatory proposal as a “therapeutic product” was defined under Vanessa’s Law to be “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”.

There was notable support for this position with 45% of respondents providing support to the proposed approach. However, there were also many respondents (53%) who supported the proposed approach but felt that the scope should be broader, and extended to include natural health products (NHPs) and/or vaccines.

In a subsequent question, 80% of respondents indicated that they did not support the alternative approach of limiting the reporting requirements to a targeted subset of higher priority products. Frequent comments among those opposed to this alternative approach included: that this proposal could result in important ADRs/MDIs being missed; and, that verifying whether a product is reportable would be time-consuming.

Mandatory information to include in the report

The consultation paper proposed to require both a minimum set of information data fields and a set of additional data fields ‘required to be completed, if the information is known’. This option may have the potential to encourage more complete reports. It is anticipated that by requiring the completion of additional data fields, if the information is known, this could improve the quality of reports received which would better support product safety monitoring activities. Prescribed minimum data fields would effectively screen out the reports that are not sufficiently complete. It is likely that the adoption of a higher number of minimum data fields may improve the quality of reports received which would better support product safety monitoring activities. However, a higher number of minimum required data fields could potentially lead to fewer reports being submitted by institutions to Health Canada than that which would otherwise be provided with a lower threshold. 

There was significant support for this position with 84% of respondents agreeing with Health Canada’s proposal, although another 10% of respondents felt that the additional data fields (required if known) should be included as minimum required data fields.

Timelines for reporting

The consultation paper proposed to set the reporting timelines for institutions at 30 days for both ADR and MDI reporting. Under this option, a 30 day target may allow sufficient time for institutions to provide reports to Health Canada and may better avoid unnecessary burdens on health care institutions when reporting adverse drug reactions. It is anticipated that the 30 day timeframe would be a period of time that is proportionate to the respective efforts of health care institutions in completing, validating and vetting reports of acceptable quality.

There was significant support for this position with 79% respondents agreeing that 30 days was an appropriate timeframe for reporting these events. Many industry respondents commented that reporting timelines for institutions should align with the 15 day reporting timelines that exist now for manufacturers under the Food and Drug Regulations. A minority of stakeholders (15%), mostly consumers and patients, felt that the timeline should be shorter than 30 days, while a very small number of respondents (6%) thought it should be longer than 30 days.

Non-regulatory questions: What did the stakeholders say?

In addition to the regulatory questions detailed above, Health Canada also asked a series of questions on proposed non-regulatory approaches for outreach and education, as well as how meaningful feedback can be provided back to reporting institutions.

Outreach and education

The majority of respondents (69%) across all stakeholder groups chose the Internet as their preferred method for receiving education tools specific to ADR/ MDI reporting, while smaller numbers chose conferences (28%), in person training (28%) or webinars (13%). It is worth noting that respondents were allowed to choose multiple answers for this question.

With regards to who should be targeted by the education and outreach efforts, there was strong support (66%) for including all professionals working in an institution, while 34% of respondents suggested that these efforts should concentrate only on specific groups of health care professionals (e.g. physicians, pharmacists and nurses). Despite this difference, there was general agreement among all respondents that education and outreach should be available to all health care professionals responsible for ADR/ MDI reporting. Among those who felt that education and outreach should concentrate on specific groups of health care professionals, some thought that focusing on frontline staff would be the most beneficial because they are likely to be the ones treating patients affected by ADRs/ MDIs. Other respondents stated that efforts would be better spent on administrative staff who may often be called upon to prepare and submit the ADR/ MDI reports as well as to develop reporting policies for their institutions.

A majority of respondents (68%) answered that education efforts in professional teaching institutions would be considered ‘very important’. There was notable support for this position among health care professionals, institutions, consumers/ patients and the pharmaceutical industry. A smaller proportion of respondents (28%) felt that this issue was ‘somewhat important’, while very few (4%) thought it was ‘not important at all’.

Providing meaningful feedback to reporting institutions

Most respondents (93%) supported Health Canada’s proposal to provide aggregate information to the broader health care community about ADR/ MDI reports received. Comments in support of this proposal suggested that it could help to improve patient safety and care, promote reporting and transparency, as well as allow external stakeholders to assess trends independently of Health Canada. Some stakeholders indicated that existing tools at Health Canada (e.g. MedEffect, Health Product InfoWatch) could be adapted and used for disseminating information. However, there was some concern that this proposal would not solve the problem of reporters looking for feedback on the specific reports they have filed. Respondents stated that their preferred methods for receiving aggregate information were online, emails, the MedEffect website, newsletters or through existing networks such as The Institute for Safe Medication Practices (ISMP), the Patient Learning System in British Columbia, and professional associations.

Next steps – continued engagement & regulatory development

We would like to thank all respondents for providing comments on this proposal. Feedback received will inform the development of draft regulations, internal operational processes, and relevant guidance documents.

Health Canada is also developing plans to continue external engagement with stakeholders and subject matter experts regarding education and outreach efforts for mandatory ADR/ MDI reporting and how existing information management systems in institutions can be leveraged to facilitate reporting to Health Canada.   

Contact Us

Policy and International Affairs Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9

Email: MHPD-DPSC.VL-LV@hc-sc.gc.ca