Risk management plans and drug safety in Canada: A cross-sectional study
Bibliographic record
Abstract
BackgroundHealth Canada uses risk management plans (RMPs) to identify and monitor risks associated with drugs in the postmarket phase but does not make the contents of these RMPs public.ObjectiveTo identify information about RMPs that is available in other Health Canada documents and to analyze extent of the information.MethodsA list of new active substances (NAS) approved by Health Canada between July 1, 2015 and May 5, 2025 was generated. These drugs were searched on the Summary Basis of Decision website and any information about the contents of the RMPs was copied verbatim. The information was read iteratively and grouped into themes.ResultsThere were 385 NAS approved and 381 had RMPs. For 301 the only information was that they had been reviewed by Health Canada and found to be acceptable. The information about the other 80 was typically vague and revealed little about how the information that they generated would be used to enhance safety.ConclusionHealth Canada needs to make RMPs publicly available, should explain how their implementation will be monitored and evaluated, how the information they generate will be used to enhance drug safety and should publish updates to them as necessary.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".