[Use of the capture-recapture method to assess the frequency of "serious" adverse drug reactions: experience of Toulouse University Hospital]. / Utilisation de la méthode capture-recapture pour l'évaluation de la fréquence des effets indésirables "graves" médicamenteux: l'expérience du CHU de Toulouse.

There is evidence that the methods classically used to identify and quantify adverse drug reactions (ADRs), based on spontaneous reporting or computerized medical databases, are not exhaustive. Spontaneous notifications to regional pharmacovigilance centers suffer from under-reporting Combining different sources could improve our knowledge of ADR frequency. The aim of this study was to estimate the incidence of serious ADRs handled in medical wards of a French university hospital, using data from the Programme de Medicalisation des Systemes d'Information (PMSI) and spontaneous reports recorded in the French Pharmaco Vigilance Database. The study period was the first 6 months of 2001. From the PMSI, we selected all hospitalization summaries that included an ICD-10 code related to a potential ADR. From the French Pharmaco Vigilance Database, we selected all serious ADRs that occurred during the study period and were reported by physicians working in the University Hospital. After identifying cases recorded in both sources, we applied the capture-recapture method in order to estimate the real number of ADRs. From the PMSI, we identified 274 different hospital stays involving an ADR. Out of 241 reports selected from the French Pharmaco Vigilance Database, we retained 151 ADRs for analysis. Fifty-two ADRs were found in both databases, giving an estimated total of 796 serious ADRs [95% confidence interval (CI) 638, 954], corresponding to 2.9% of inpatients (95% CI 2.3, 3.5) during the first half of 2001. This study confirms the lack of exhaustiveness of ADR reporting, whatever the data source, and underlines the value of merging data from different databases.

[Patterns of non steroidal anti-inflammatory drug use in ambulatory care]. / Profil des utilisateurs d'anti-inflammatoires non stéroïdiens.

The aim of this study was to discuss the patterns of non steroidal anti-inflammatory drug (NSAID) use in general population. We identified NSAID's users from the French Health Insurance System claims database covering more of the population in the Midi-Pyrenees area (southwest of France), if they have received at least one NSAID in June 2003. We discussed this population according to the NSAID used, to their demographic characteristics and to other drugs delivered in the period. Our study shows different patterns of use according to each NSAID. For example, users of ibuprofen or tiaprofenic acid were younger and less frequently exposed to "gastroprotective" drugs, users of coxibs were older and more frequently exposed to drugs increasing the risk of bleeding. This study confirms the wide use of NSAIDs and describes their target population. It underlines the interest of Health Insurance System Database for better knowledge of drug use in ambulatory care in France.

Using a capture-recapture method to assess the frequency of adverse drug reactions in a French university hospital.

AIMS: There is evidence that different methods used to identify and quantify adverse drug reactions (ADR) in hospitals are not exhaustive (spontaneous reporting or computerized medical databases). The combination of these different sources of data could improve knowledge about ADR frequency in hospitals. The aim of this study was to estimate the incidence of serious ADRs handled in medical wards of a French university hospital using data from the Programme de Medicalization des Systemes d'Information (PMSI) and spontaneous reports recorded in the French Pharmacovigilance Database. METHODS: The study period was the first semester of 2001. RESULTS: From PMSI, all hospitalization summaries including an ICD-10th code related to a potential ADR were selected. From the French Pharmacovigilance Database, all serious ADRs which occurred during the study period and were reported by physicians working in the University Hospital were collected. After identification of common cases, the capture-recapture method was applied in order to estimate the real number of ADRs occurring during the first semester of 2001. From PMSI, we identified 274 different hospital stays related to an ADR. Out of 241 reports selected from the French Pharmacovigilance Database, we retained 151 ADRs for analysis. Fifty-two ADRs were common in the two databases, giving an estimated number of serious ADRs of 796 [95% confidence interval (CI) 638, 954], corresponding to 2.9% of inpatients (95% CI 2.3, 3.5). CONCLUSIONS: This study shows the lack of exhaustiveness of ADR reporting whatever the sources of data and underlines the interest of merging data from different databases to identify fully the real impact of ADR in hospitals.

[Coxibs, which real therapeutic advance?: Recent pharmacoepidemiological data]. / Coxibs, quel réel progrès thérapeutique?: données pharmacoépidémiologiques récentes.

Therapeutic advance is defined by an improvement in effectiveness, safety and/or convenience. In this article, these three criteria were applied to currently marketed coxibs (celecoxib, rofecoxib), using data from clinical trials and pharmacoepidemiological studies. Risk of adverse drug reactions to coxibs, as evaluated by clinical trials, differs from that observed in real medical practice. Rofecoxib and celecoxib exhibit the same profile of adverse drug reactions as the other classical nonsteroidal anti-inflammatory drugs. Coxibs are currently prescribed and too often used outside the studied and approved indications, which clearly increases their cost (already high for society). Currently marketed coxibs do not appear to meet the previously defined criteria for therapeutic advance.

Music perception in adult cochlear implant recipients.

OBJECTIVE: To evaluate musical perception in adult cochlear implant (CI) recipients, i.e. perceptual accuracy for pitch, timbre, rhythmic patterns and song identification. MATERIAL AND METHODS: Twenty-nine adult patients were included in this transverse single-center study. Evaluative measures included tests assessing ability to discriminate pitch, rhythm and timbre and to identify nursery songs with and without verbal cues. Performance scores were correlated with duration of deafness, duration of implantation, speech discrimination and musical perception skills. RESULTS: A total of 38% of patients reported that they did not enjoy listening to music with their device and 86% presented lower scores of listening habits after implantation. We found positive correlations between musical background and pitch identification and identification of nursery songs played by piano. We also found positive correlations between speech discrimination and rhythm, timbre and identification of nursery songs with verbal cues. CONCLUSION: Trends in the patterns of correlation between speech and music perception suggest that music patterns are differentially accessible to CI users. New processing strategies may improve this.