Mandatory reporting by hospitals of serious adverse drug reactions related to biocides: Notice
Learn how the new Biocides Regulations will change mandatory reporting obligations for hospitals.
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New regulations for biocides
Health Canada has introduced a new set of regulations under the Food and Drugs Act (FDA) to regulate substances or mixtures of substances that sanitize or disinfect non-living and non-liquid surfaces more effectively.
The new Biocides Regulations will bring 3 lines of products under a single legal framework:
- surface disinfectants, previously regulated under the Food and Drug Regulations (FDR)
- surface sanitizers, previously regulated under the Pest Control Products Act (PCPA) and
- surface sanitizers for use in food premises, previously regulated under the FDA
When the new regulations come into force, hospitals will be required to report serious adverse drug reactions (ADRs) related to biocides. This requirement stems from section 21.8 of the FDA.
We will be updating the guidance on mandatory reporting by hospitals later to include information on mandatory reporting under the new regulations.
About mandatory reporting and biocides
This section highlights what hospitals need to know about the new requirements for mandatory reporting of serious ADRs related to biocides.
Biocides
A biocide is a drug that's manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface.
In other words, biocides are surface disinfectants and surface sanitizers.
Biocides do not include products for use as follows:
- in air or water
- on contact lenses
- on invasive or indirectly invasive medical devices or
- exclusively on the surface of food
Like drugs under the FDR, biocides authorized under the new regulations will be issued a drug identification number (DIN).
Serious ADRs and biocides
We modified the definition of "serious adverse drug reaction" for the Biocides Regulations to update the regulatory language and to better reflect biocide products. However, the qualifying level of seriousness of the adverse reaction is the same as the level outlined in the FDR for other drug products.
A serious ADR from a biocide is one that:
- results in in-patient hospitalization or prolongs existing hospitalization
- results in congenital malformation or chronic or significant disability or incapacity or
- is life-threatening or results in death
Note: Serious ADRs related to biocides include important medical events in the same manner as serious ADRs related to drugs.
How to determine reportability
To determine if a scenario involving a biocide is reportable, hospitals should consider the following:
- Is the product a biocide?
- Note: Only biocide products with an 8-digit DIN are subject to mandatory reporting under the new regulations.
- Is the biocide suspected to have caused a serious ADR?
- Was the ADR documented in the hospital?
Information to be provided in hospital reports
We adapted language from the FDR to describe the information that hospitals must provide in their reports for biocide products. This information is comparable to existing requirements in the FDR.
For serious ADRs related to biocides, hospitals must provide the following information:
- name and civic address of the hospital and name and contact information of a representative of the hospital
- brand name and identification number of the biocide involved in the reaction, if known
- age and sex of the patient who experienced the reaction
- description of the reaction
- date on which the patient was exposed to the biocide, if known
- date on which the reaction first occurred, if known
- date on which the reaction was first documented in the hospital
- date on which the patient's health was restored to its state before the reaction, if applicable
- patient's medical condition that directly relates to the reaction
- any other factor that may have contributed to the reaction
When providing information on the description of the reaction, include the effect of the serious ADR on the patient's health. Examples:
- fatal
- unknown
- not recovered
- fully recovered
- currently recovering
- recovered with sequelae
Note: If the only information available is that the patient was discharged from the hospital, without any indication on their status, the outcome should be considered unspecified and reported as unknown.
Other reporting requirements for biocides
The reporting timeline for a serious ADR is 30 days, the same as the timeline outlined in the FDR.
For more information on mandatory reporting requirements for hospitals and how to report a serious ADR, consult the following guidance document:
We will be updating the hospital serious ADR reporting form to include biocides before the new regulations come into force.
Coming into force
The Biocides Regulations will come into force 1 year after their registration. Mandatory reporting by hospitals of serious ADRs related to biocides will come into effect at that time.
Manufacturers of surface disinfectants (under the FDR) and registrants of surface sanitizers (under the PCPA) have a 4-year transition period after the Biocides Regulations come into force. Manufacturers of surface sanitizers for use in food premises have a 6-year transition period.
These transition periods will give them time to transfer their products to these new regulations. Until the end of the transition periods, products will continue to be authorized under the FDR and the PCPA as well as the Biocides Regulations.
During this transition period, hospitals may not know whether the serious adverse drug reaction is subject to mandatory reporting. All products with an 8-digit DIN will be subject to mandatory reporting. When in doubt, hospitals are strongly encouraged to report it, regardless of whether the product is a sanitizer or a disinfectant.
Contact us
If you have questions about mandatory reporting, you may contact the Canada Vigilance Program by:
- Email: canadavigilance@hc-sc.gc.ca
- Toll-free telephone: 1-866-234-2345
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