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Record W1992505090 · doi:10.1310/hpj4401-47

Quarter Watch: 2008 Quarter 1 : QUARTER WATCH PROJECT TEAM

2009· article· en· W1992505090 on OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueHospital Pharmacy · 2009
Typearticle
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmacovigilance and Adverse Drug Reactions
Canadian institutionsnot available
Fundersnot available
KeywordsQuarter (Canadian coin)MedicineHistory

Abstract

fetched live from OpenAlex

EXECUTIVE SUMMARY A record number of deaths and serious injuries associated with drug therapy were reported to the US Food and Drug Administration (FDA) in the first quarter of 2008. Serious injuries associated with drug therapy reached a total of 20,745 new cases; there were a total of 4,824 reported deaths, a 2.6-fold increase from the previous quarter. In addition, varenicline (Chantix, Champix), an aid to smoking cessation, accounted for more reported serious injuries than any other prescription drug for a second quarter, with a total of 1,001 new cases and including 50 additional deaths. Varenicline was the subject of a previ ous Quarter Watch Special Report and a separate FDA Public Health Alert about psychiatric adverse events. Ranked second in reported serious injuries was heparin, a drug that helps prevent injury from blood clots. Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received reports of 779 cases of serious injury in which heparin was the principal suspect drug. These findings come from a program being developed by the Institute for Safe Medication Practices (ISMP) for improvement of patient safety through increasing understanding of how and why drugrelated injuries and medication errors occur. The results are from analyses of new adverse drug event reports submitted to the FDA. The agency releases computer excerpts of these reports for research use after personal-identifying information has been removed. However, the results of this monitoring program should be interpreted with caution because of the known limitations of these data and the nature of the overall system through which adverse events are monitored in the United States. Because reporting is voluntary, only a small fraction of adverse drug events that occur are ever reported to the FDA or to drug manufacturers who then investigate and forward reports to the agency. Although the sum totals of reported adverse event reports usually provide an accurate overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described. Trends in Reported Cases Serious injuries and deaths associated with drug therapy were reported for a record total of 20,745 persons in the first quarter of 2008. The total was 38% higher than the average for the previous 4 quarters and the highest for any quarter. Reported deaths totaled 4,824 cases, a 2.6-fold increase over the previous quarter and the highest number of deaths in a calendar quarter since 2004. Fatal cases also accounted for a larger share of all serious cases, 23% of those in the first quarter of 2008 compared with an historical average of 16%. Identifiable medication errors accounted for 7.1% (1,464) of all cases of serious injury. The largest numbers of cases were divided evenly between errors of administration (wrong drug, wrong dose, or wrong route of administration) and overdoses (both accidental and intentional). Most drugs in medical use produced only a small number of reports of serious injury or death. One-half the 773 identifiable drugs tracked in the most recent quarter had 6 or fewer serious adverse events reported. Only 50 drugs accounted for 100 or more reported serious injuries. Hospital Pharmacy Volume 44, Number 1, pp 47–56 2009 Wolters Kluwer Health, Inc.

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.

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesInsufficient payload (model declined to judge)
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.163
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.001
Science and technology studies0.0010.000
Scholarly communication0.0000.001
Open science0.0010.000
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0030.004

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.

Opus teacher head0.069
GPT teacher head0.427
Teacher spread0.358 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it