Notification on Hospitals’ Obligatory Reporting of Significant Adverse Drug Reactions Linked to Biocides

Discover the implications of the new Biocides Regulations on hospitals’ reporting duties.

Introduction to new biocide regulations

Health Canada has unveiled a fresh set of regulations under the Food and Drugs Act (FDA) to enhance the regulation of substances or mixtures intended for sanitizing or disinfecting non-living and non-liquid surfaces.

The newly introduced Biocides Regulations will consolidate three categories of products under a unified legal structure:

surface disinfectants that were earlier regulated under the Food and Drug Regulations (FDR)
surface sanitizers previously governed by the Pest Control Products Act (PCPA)
surface sanitizers utilized in food premises that were once regulated under the FDA

Once these regulations take effect, hospitals will be obligated to report any serious adverse drug reactions (ADRs) linked to biocides, as mandated by section 21.8 of the FDA.

We will later update our guidance regarding mandatory reporting to include the specifics of these new regulations.

Find our guidance on mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals here.

Key points on mandatory reporting and biocides

This section outlines essential information hospitals must understand regarding the new obligations for mandatory reporting of serious ADRs connected to biocides.

Understanding biocides

A biocide is recognized as a drug developed, marketed, or represented for the purpose of eradicating or neutralizing microorganisms on non-living and non-liquid surfaces.

Essentially, biocides encompass surface disinfectants and sanitizers.

However, biocides exclude products intended for the following uses:

in air or water
on contact lenses
on invasive or indirectly invasive medical devices or
exclusively on the surface of food

Similar to drugs under the FDR, biocides regulated under these new provisions will receive a drug identification number (DIN).

Serious ADRs concerning biocides

We have redefined the term “serious adverse drug reaction” specifically for the Biocides Regulations to align regulatory terminology more appropriately with biocide products. Nevertheless, the criteria for defining the seriousness of the adverse reaction remain consistent with the standards established in the FDR for other drug products.

A serious ADR arising from a biocide includes reactions that:

lead to hospitalization or extended hospital stays for the patient
cause congenital malformations or significant, chronic disabilities or incapacities or
are life-threatening or result in fatalities

Note: Serious ADRs associated with biocides encompass critical medical incidents comparably to serious ADRs linked to pharmaceutical drugs.

Assessing reportability

To ascertain whether an incident involving a biocide is reportable, hospitals should evaluate the following:

Is the product classified as a biocide?

Note: Only biocide products assigned an 8-digit DIN fall under the mandatory reporting requirements of the new regulations.

Is there a suspicion that the biocide caused a serious ADR?
Has the ADR been documented in the hospital’s records?

Required information in hospital reports

The language used in the FDR has been revised to stipulate the information hospitals need to present in their reports concerning biocide products. This information matches current protocols outlined in the FDR.

For serious ADRs associated with biocides, hospitals are required to submit the following details:

the hospital’s name and address along with the contact details of a hospital representative
the brand name and identification number of the biocide involved in the adverse reaction, if known
the age and sex of the patient impacted by the reaction
a detailed account of the reaction
the date of the patient’s exposure to the biocide, if available
the date the reaction initially occurred, if recorded
the date when the reaction was first logged in the hospital’s records
the date on which the patient’s health returned to its pre-reaction state, if applicable
the patient’s medical condition relating to the reaction
any additional factors that may have contributed to the reaction

When detailing the description of the reaction, it is important to outline how the serious ADR affected the patient’s health. Examples include:

fatal
unknown
not recovered
fully recovered
currently recovering
recovered with complications

Note: If the sole available information indicates that the patient was only discharged without additional details about their status, the outcome should be classified as unspecified and reported as unknown.

Additional reporting mandates for biocides

The timeline for reporting a serious ADR remains 30 days, mirroring the time frame established in the FDR.

To learn more about the mandatory reporting guidelines for hospitals and the procedure for reporting serious ADRs, please refer to the following guidance document:

We will refresh the serious ADR reporting form for hospitals to encompass biocides prior to the regulations taking effect.

Implementation timeline

The Biocides Regulations will come into effect one year post-registration. The requirement for hospitals to report serious ADRs tied to biocides will initiate at that time.

Manufacturers of surface disinfectants (under the FDR) and registrants of surface sanitizers (under the PCPA) will have a transition period of four years following the implementation of the Biocides Regulations. Those producing surface sanitizers intended for use in food establishments will benefit from a six-year transitional period.

This transition window allows manufacturers ample time to transfer their products to comply with the new regulations. Throughout the transition, products will continue to be permitted under both the FDR and the PCPA, along with the Biocides Regulations.

During this transition, hospitals may be uncertain whether a serious adverse drug reaction falls under mandatory reporting. Any product with an 8-digit DIN will be subject to compulsory reporting. If there is any doubt, hospitals are highly recommended to report it, irrespective of the product’s classification as a sanitizer or disinfectant.

Reach out to us

If you have inquiries regarding mandatory reporting, please reach out to the Canada Vigilance Program via: