Marie-Caroline Husson | PubMed Health

PubMed2005

Infovigilance: reporting errors in official drug information sources.

INTRODUCTION: The 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). METHOD: The 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. RESULTS: 2.7% (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. CONCLUSIONS: Our efforts to improve the quality of drug information sources through a continuous "infovigilance" process need to be continued and extended to other information sources.

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[ATC and EphMRA classifications: evolution from 1996 to 2003 and comparative analysis].

In their daily practice, health practitioners use one or more pharmacotherapeutic classifications. This diversity of classifications impairs the exchange of drug information, while the use of international or European classifications facilitates this diffusion. The "Hospital National Center of Drugs Information" (CNHIM) has integrated ATC (Anatomical Therapeutic Chemical) and EphMRA (European Pharmaceutical Marketing Research Association) classifications into its "Thériaque" database and has given the ATC official status in France by publishing a French translation. The objective of this article was to analyse the evolution of these two classification systems between 1996 and 2003, and to compare their allocations (of codes) with those for the drugs present in Thériaque in January 2002. The ATC comprises 14 principal groups and five levels of hierarchy, while the EphMRA comprises 16 principal groups and three to four levels. In Thériaque, the ATC is linked to active substances and drugs, and the EphMRA to drugs. Data-processing requests have made it possible to make a comparative analysis. Each year, the two classification systems evolve in terms of addition, suppression, modification and subdivision. Two principal differences are evident in the allocations in Thériaque (class EphMRA K "Hospital solutions" versus class ATC B "Blood and blood forming organ"; class EphMRA T "Diagnostic agents" versus class ATC V "Various"). Classifications evolve in parallel or independently, and although they are closely related to one another, they retain their specificities in terms of structure and uses.

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