ArticlePharmacy world & science : PWS2005
Infovigilance: reporting errors in official drug information sources.
Article in Pharmacy world & science : PWS, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Differences in the information about procedures after cold chain disruption provided by pharmaceutical industry to hospital and community pharmacies.European journal of hospital pharmacy : science and practice · 2016Article
- Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment.European journal of clinical pharmacology · 2013Article
- Drugs and Birth Defects: a knowledge database providing risk assessments based on national health registers.European journal of clinical pharmacology · 2013Article
- Advice on drug safety in pregnancy: are there differences between commonly used sources of information?Drug safety · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe French drug database Thériaque (http://www.theriaque.org) developed by the (Centre National Hospitalier d'Information sur le Médicament) (CNHIM), is responsible for the dissemination of independent information about all drugs available in France. Each month the CNHIM pharmacists report problems due to inaccuracies in these sources to the French drug agency. In daily practice we devised the term "infovigilance": "Activity of error or inaccuracy notification in information sources which could be responsible for medication errors". The aim of this study was to evaluate the impact of CNHIM infovigilance on the contents of the Summary of Product Characteristics (SPCs).
methodThe study was a prospective study from 09/11/2001 to 31/12/2002. The problems related to the quality of information were classified into four types (inaccuracy/confusion, error/lack of information, discordance between SPC sections and discordance between generic SPCs).
main outcome measures(1) Number of notifications and number of SPCs integrated into the database during the study period. (2) Percentage of notifications for each type: with or without potential patient impact, with or without later correction of the SPC, per section.
results2.7% (85/3151) of SPCs integrated into the database were concerned by a notification of a problem. Notifications according to type of problem were inaccuracy/confusion (32%), error/lack of information (13%), discordance between SPC sections (27%) and discordance between generic SPCs (28%). 55% of problems were evaluated as 'likely to have an impact on the patient' and 45% as 'unlikely to have an impact on the patient'. 22 of problems which have been reported to the French drug agency were corrected and new updated SPCs were published with the corrections.
conclusionsOur efforts to improve the quality of drug information sources through a continuous "infovigilance" process need to be continued and extended to other information sources.
Indexed as
Identifiers
16096882What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.