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.