Health Product InfoWatch: February 2025
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 240000
Contents
- Announcement
- Monthly recap of health product safety information
- Scope
- Reporting Adverse Reactions
- Helpful links
- Contact us
Announcement
Canadian Clinical Drug Data Set: Standardizing drug terminology for digital health systems
Healthcare is continuously evolving, and digital health is a key part of this transformation. Electronic (e)-prescriptions, electronic medical records, e-referrals, and e-consults have become a part of most Canadians' experiences when interacting with the healthcare community.
Health Canada's Office of Submissions and Intellectual Property (OSIP), along with data scientists from the Business Facilitation and Modernization Directorate, have collaborated with Canada Health Infoway to develop a standardized terminology and coding system: the Canadian Clinical Drug Data Set (CCDD). This free tool, enables the interchange of standardized drug and medical device information between diverse digital health systems. It does so by providing a consistent approach to the identification and naming of medications and a limited number of medical devices. Originally developed to support e-prescribing in Canada, the CCDD can also be leveraged for medication records, medication reconciliation, and analytics.
The data source for the CCDD is the Drug Product Database, which contains information on drugs authorized by Health Canada. The CCDD data model follows the CCDD's Editorial Guidelines, which take into consideration international terminology standards.
In the CCDD, authorized drugs that are marketed in Canada are broken down into 3 concept classes (see Table 1).
| Model class | Definition and description | Example |
|---|---|---|
| Therapeutic Moiety (TM) | The functional and clinically significant part of the active ingredient substance(s) present in a medicinal product. | amlodipine |
| Non-proprietary Therapeutic Product (NTP) | An NTP is described by the set of active ingredient substance(s) (both the precise active ingredient substance and the basis of strength substance, if different),their strength(s), the dosage form, and, for some products, their unit of presentation. | amlodipine (amlodipine besylate) 2.5 mg oral tablet |
| Manufactured Product (MP) | A brand specific drug that is or, within the lifetime of the CCDD, has been available for prescribing and dispensing in Canada. | ACT AMLODIPINE (amlodipine (amlodipine besylate) 2.5 mg oral tablet) ACTAVIS PHARMA COMPANY |
In addition, the CCDD has a Special Groupings file which allows CCDD concepts to be grouped together based on public policies. It can be used to identify "groups" of products (such as controlled substances) as needed by healthcare professionals or research communities.
The CCDD can be accessed on Infoway's Terminology Gateway, where registration and login are required, or on the Government of Canada's Open Government Portal.
For more information, contact the CCDD unit in OSIP at: drug.terminology-terminologies.des.medicaments@hc-sc.gc.ca
Did you know?
Online platforms for e-prescription services can be supported by the CCDD. Integration of the CCDD into digital health solutions allows healthcare professionals to complete electronic prescriptions in one software and transmit prescriptions electronically directly to a community or hospital pharmacy that may be using software from a different vendor. This eliminates the need for handwritten prescriptions and faxes, which may be unreliable, difficult to understand, or slow.
Healthcare professionals are encouraged to check if their pharmacy or clinic is using the CCDD in their online platforms to improve patient safety and clinical workflows.
Monthly recap of health product safety information
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in January 2025 by Health Canada.
APO-Quetiapine XR and Quetiapine XR
Affected lots of APO-Quetiapine XR and Quetiapine XR have been recalled as they may have exceeded the established acceptable intake limit for N-nitroso-desalkyl-quetiapine (NNAP).
Unauthorized Health Products
Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.
Scope
This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.
Reporting Adverse Reactions
Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada
For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.
Helpful links
- MedEffectTM Canada
- Recalls and Safety Alerts Database
- New Safety and Effectiveness Reviews
- Canada Vigilance Adverse Reaction Online Database
- Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database
- Drug Product Database
- Medical Devices Active Licence Listing
- Licensed Natural Health Products Database
- The Drug and Health Product Portal
- Drug Shortages Canada
- Medical Device Shortages
- COVID-19 Vaccines and Treatments Portal
Contact us
Your comments are important to us. Let us know what you think by reaching us at: infowatch-infovigilance@hc-sc.gc.ca
Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9
Reference
- Footnote 1
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Government of Canada. Canadian Clinical Drug Data Set (CCDD) - Editorial Guidelines. Published November 14, 2023.
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