Review of National Spontaneous Reporting Schemes: Strengths and Weaknesses
Bibliographic record
Abstract
Objective: To investigate and compare the operation of different national spontaneous reporting schemes for adverse drug reactions. \n \nDesign: Drug safety agencies in 18 countries were contacted by letter to request information about their spontaneous reporting scheme for adverse drug reactions. This information related to the background of the scheme, operational aspects of the scheme and numbers of reports received. \n \nResults: Replies were received from 12 countries. Many differences were found between the schemes operating in different countries. Some schemes had been in operation for over 30 years, while others were more recently established. While most schemes rely on voluntary reports, in two countries (France and Spain), reporting is a legal requirement for healthcare professionals. Reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. There were also differences in the types of reactions for which reports are requested, and the products covered by the schemes. In some countries (e.g. Denmark) reports of all reactions are sought, while other countries focus on only serious reactions or reactions to newly marketed products. In Australia, there is a separate scheme for drug-induced congenital malformations and Canada, South Africa and the US run separate schemes for reactions to vaccines. However, other countries include these reactions in the general spontaneous reporting schemes. The numbers of reports received by the countries also varies considerably - from a few hundred each year in South Africa to over 20 000 in the US. \n \nConclusions: While the schemes all operate on the basic principle of collecting reports of adverse reactions to identify potential hazards, they showed many different approaches to the spontaneous reporting of adverse drug reactions. Features of one scheme may serve to improve reporting rates for another. In addition, all 12 countries participate in the World Health Organization International Drug Monitoring Programme, thus helping to inform the whole international community of drug safety problems.
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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".