Increased AER reporting welcomed by Health Canada

By Mike Stones

- Last updated on GMT

National public health association Health Canada has backed a report which recommends closer monitoring of adverse reactions to Herbal Medicinal Products (HMP).

The report, published earlier this month in the journal Toxicology and Applied Pharmacology​, suggests that as HMPs become more popular, adverse event reactions (AER) to them are increasingly under-reported. It also claims that product quality may be less than ideal and there is lack of information on the toxicity of medicinal herbs or their constituents.

Although the public perceives the risk from HMPs to be low, potential harm can arise from an inherent toxicity of herbs, warns the report. It also highlights dangers associated with contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs.

Benefits and risks

Despite being written by Health Canada​ staff from its Marketed Health Products Directorate and the Natural Health Products Directorate, it does not represent the body’s official position, a spokesperson told NutraIngredientsUSA.com. But he acknowledged that: “The use of Natural Health Products (NHPs) by Canadians is rising, making it increasingly important to have as much accurate information as possible about the benefits and risks associated with the use of NHPs​.”

He also confirmed that the report has helped to: “….increase the knowledge base on NHP assessment methods and makes recommendations aimed at improving both the quantity and quality of information about the potential toxicity of, and adverse reactions to, NHPs​.”

Safety assessment

The report, recommends five actions to protect public health including:

  • Using Poison Control Centre data to augment available reports suspected to be linked to HMPs.
  • Educating consumers, health care practitioners and the industry about potential adverse reactions.
  • Encouraging authors of scientific publications on HMP adverse reactions or toxicity information to provide more information.
  • Using omics and predictive toxicology in the toxicological assessment of HMPs to provide integrated assessments.
  • New active surveillance methods such as community-based surveillance by pharmacies, hospitals, retailers to detect safety signals related to HMPs.

Health Canada has pledged to consider exploring the potential for collection of data from poison control centers.

The association has also advised on reporting practices for adverse reactions. It recently held information sessions on adverse reaction reporting requirements for industry stakeholders across Canada.
The report, Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment​, was written by Scott Jordan, David Cunningham and Robin Marles.

Related topics: Regulation, GMPs, QA & QC, Polyphenols

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