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2. Guide de la Haute autorité de santé (HAS) : les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes) : principes et méthodes

Author

Auquier, Pascal, Baumelou, Elisabeth, de Bels, Frédéric, Bene, Marie-Christine, Bernard, Alain, Boissel, Jean-Pierre, Carrere, Marie-Odile, Czernichow, Pierre, Dervaux, Benoit, Eschwege, Eveline, Fabbro-Peray, Pascale, Falissard, Bruno, Fourrier, Annie, Guillemot, Didier, Lacoin, François, Lapeyre-Mestre, Maryse, Maison, Patrick, Massol, Jacques, Oger, Emmanuel, Roudot-Thoraval, Françoise, Trouiller, Patrice, Vray, Muriel, Zureik, Mahmoud, Stamenkovic, Sophie, Solesse, Anne, Zanetti, Laura, and Zagury, Pascale

Published
2012
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4. Facteurs associés à une consommation régulière de cannabis chez les étudiants de la cohorte i-Share

Author

Perino, Justine, primary, Tournier, Marie, additional, Matthieu, Clément, additional, Letinier, Louis, additional, Peyré, Alexandre, additional, Miremont, Ghada, additional, Qchicach, Sarah, additional, Fourrier, Annie, additional, Pollet, Clothilde, additional, Fatseas, Mélina, additional, Tzourio, Christophe, additional, and Daveluy, Amélie, additional

Published
2021
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8. Vaccinations and multiple sclerosis

Author

Begaud, Bernard, Alperovitch, Annick, Hanslik, Thomas, Viboud, Cecile, Flahault, Antoine, Gout, Olivier, Sturkenboom, Miriam C.J.M., Fourrier, Annie, Buttinelli, Carla, Salvetti, Marco, Ristori, Giovanni, Hostetler, Larry, Ascherio, Alberto, Zhang, Shumin M., Walker, Alexander M., Confavreux, Christian, Suissa, Samy, and Saddier, Patricia

Subjects
Hepatitis B vaccine -- Adverse and side effects, Multiple sclerosis -- Risk factors
Published
2001

22. Inappropriate medication use and risk of falls – A prospective study in a large community-dwelling elderly cohort

Author

Fourrier Annie, Dartigues Jean-François, Bertrand Marion, Berdot Sarah, Tavernier Béatrice, Ritchie Karen, and Alpérovitch Annick

Subjects
Geriatrics, RC952-954.6
Abstract

Abstract Background Explicit criteria for determining potentially inappropriate medication consumption in elderly were elaborated by Beers et al. These lists have been used worldwide to evaluate medical prescriptions but there is little epidemiologic evidence demonstrating negative consequences of inappropriate medication use. It has been reported that some drugs could increase the risk of falls, which are a frequent and serious problem in elderly population. We aimed to evaluate the association between the use of potentially inappropriate medications and the risk of falls. Methods The 3C Study is a multicentre prospective cohort study conducted in France with 4 years of follow-up. Non-institutionalized men and women aged 65 years or over (N = 6343) were randomly selected from electoral rolls. Data on socio-demographic, medical characteristics and medication use (based on self-reports and data from the national healthcare insurance) were collected. Use of inappropriate medication for elderly was defined from established criteria. Data about falls were collected at the two follow-up examinations (2 years and 4 years after baseline). The association between the exposure to inappropriate medications and the risk of falls was evaluated using multivariate models (Cox model and logistic regression). Results 32% of subjects reported inappropriate medication use at baseline and 29% at least two of the three examinations; 22% had fallen 2 times or more during follow-up. Overall, inappropriate medication users had an increased risk of falling. This increase was mainly due to the use of long-acting benzodiazepines (adjusted odds ratio (OR) = 1.4, 95% confidence interval: [1.1–1.8], in both occasional and regular users), other inappropriate psychotropics (adjusted OR = 1.7 [1.7–2.7] in regular users), or medication with anticholinergic properties (adjusted OR = 1.6 [1.2–2.1] in regular users). Neither occasional, nor regular use of short- or intermediate-acting benzodiazepines was associated with an increased risk of falling. Further analysis in long-acting benzodiazepines users did not show any dose-effect relation between the number of prescriptions filled over a 3-year period and the risk of falling. Conclusion Our study showed that use of inappropriate medications was associated with an increased risk of falling in elderly persons. This increase was mainly due to long-acting benzodiazepines and other inappropriate psychotropics, and to medications with anticholinergic properties.

Published
2009
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23. Abstracts of papers Rational use of drugs: 18th European Symposium on Clinical Pharmacy

Author

Dukes, M. N. G., Elenbaas, Robert M., Tognoni, G., Smith, Dorothy L., Lunde, Inga, Leufkens, H. G. M., Hekster, Y. A., Bakker, A., Ostino, G., Petri, H., Sturmans, F., Banta, H. D., Rutten, F. F. H., Martens, L. L., Noyce, P. R., Merkus, F. W. H. M., de Jong-v.d.Berg, Lolkje, Haaijer-Ruskamp, Flora, Dukes, Graham, Vidgren, B. -M., Vidgren, S., Martini, N., Sala, M. L., Scroccaro, G., Olivencia, P., McLcod, D. C., Coln, W. G., Hartzcma, A. G., Thaver, C. F., Rodriguez-Sasiain, J. M., Sangroniz, B., Mauleon, M. D., Wood, M. A., Martinez, M. J., Leinebø, O., Saugen, J. N., Marini, P., Olivato, R., Alberola, C., Cruz-Martos, E., Cruz, T., Marfagon, N., de Tejada, A. Herreros, Denig, P., Haaijer-Ruskamp, F. M., Wesseling, H., Versluis, A., Gascón, M. P., Horne, Robert, Hough, Jane, Klazinga, N. S., van Everdingen, J. J. -E., van den Broek, P. J., Roberts, D. K., Veitch, G. B. A., Tan K. K. C., Holland D. A., Allwood M. C., Nicholls, A., Astobieta, A., Calvo, R., Rodriquez-Sasiain, J. M., Barriquand, D., Pochon, C., Aulagner, G., Vial, A., Dumarest, C., Maire, P. H., Jelliffe, R. W., Brouwers, J. R. B. J., Cramer, K., Gulyas, J., vd Kam, H. J., Sijtsma, J., Donadio, C., Tramonti, G., Garcea, G., Costagli, M., Lucchetti, A., Giordani, R., Paizis, G., Pierotti, R., Falcone, G., Bianchi, C., Gallastegui C., Farré R., Jiménez I., Mangues M. A., Guasch E., Ginovart G., Sagrera X., Raspall F., Queralto J. M., Kovarik, J. M., Rademaker, C. M. A., Verhoef, J., Silvestri, L., Caputo, M., Andrew, M., Toverud, E. -L., Jimenez I., Castro I., Alvarez E., Altimiras J., van de Leur, J. J. J. P. M., Muller, N. F., Van Turnhout, J. M., Mendizabal, L., Sasiain, J. M. Rodriguez, Morana, G., Ofstad, K. Moss, Timenes, A. -M., Vroom, J. K. F., de Jong-van den Berg, L. T. W., van den Berg, P. B., de Gier, J. J., Ferres J., Recoder O., Sanchez Rio T., Garcia M. P., Julia A., Balet A., Farre R., Manques M. A., Berod, T., Dufay, E., Naveau, C., Combe, M., Sauvageon, A., Hansen, Erik Wind, Christensen, Jens Dencker, Lie-A-Huen, L., Kinqma, J. H., Meijer, D. K. P., Le Meur, F., Isoard, P., Salek, M. S., Finlay, A. Y., Khan, G. K., Luscombe, D. K., Stuurman, A., Boidin, M. P., Wallenius, K., Ojala, R., Kariluoto, A., Ikonen, M., Paes, A. H. P., Blom, A. Th. G., Bakker, A., Wallenius, S., Enlund, H., Vainio, K., Codina, C., Roca, M., Sardà, P., Corominas, N., Massó, J., Ribas, J., Kentra, K., Myllyntausta, M., Saarenpää, M., Airaksinen, M. S. A., Mendarte, L., Rimola, A., Meisters, R., Hekster, Y., Janssen, W., Cox, A., Kempen, R., Aerdts, S. J. A., van Dalen, R., Clasener, H. A. L., Festen, J., Schjphorst, PP, Benraad, HB, van Asten, P., de Wit, R., Muller, N. F., Limbeek, R. J. G., Nagel, H. G. M., Mgyboom, R. H. B., Stricker, B. H. C., van den Berg, B. A. M., Nelen, T. H. A., Tijssen, T. A. G., Wassink, P., Wassink-L'Ortije, M. J. E., Gascón, P., Selva, C., Bassons, T., Pardo, C., Mas, M. P., Saqalés, M., Sánchez, F., Mercade, V., Pujol, R., Agustí, C., Cano, M., Gurrera, T., Gorchs, M., Fabregas, X., Murgui, L. L., Verdaguer, A., Witjes, W. P. J., Vollaard, E. J., Crul, B. J. P., Limpens, C., Ahonen, K., Klaukka, T., Vohlonen, I., Martikainen, J., Goldenberg, Daniel, Brodsky, Andres, Aparici, Ines, Argeri, Cecilia, Goldenberg D., Saidman C., Sevinski L., Allevato N., Mujico B., Ubogui J., Dorfman P., Rodriguez Lupo L., Varela M., Higa J., Fourrier, Annie, Larrouturou, Philippe, Samarran, Claire, Huchet, Jacqueline, Barber, N. D., Party, N., Wilson, P., Eide, Grethe, Horvei, Kari, Kruse-Jensen, Angelika, Wold, Ingrid, Møark, Turid, Barrett, C. W., Tugwell, A. C., Søndergaard, B., Rasmussen, M., Davidsen, F., Hey, H., Kierkeby, L., Riis, L., Korhonen, M., Vidgren, P., Ojanen, T., Vidqren, M., Ferrés J., Sanchez T., Gallastequi C., Julià A., Herings, R. M. C., Stricker, B. H. Ch., Janssen, A. J. H. H., Dinter, Heike, Janssen, A. J. H. M., Barbaut, X., Proust, S., Amlagner, G., Eskens, F. A. L. M., Clasener, H. A. L., Vollaard, E. J., Arnoldussen, E., Sieradzki, E., Wanat-Słupska, E., Zlółkowska, M., Pankowska, I., Mazur, R., Ksiazkiewicz, B., Jankowski, A., Marzec, A., Marzec, C., Marzec, M. O., Marzec, J. P., Marzec, A., Mungall, D. R., Portnoy, Lynne, Lucas, F., Kadir, F., Pijpers, A., Vulto, A., Zuidema, J., Tan, K. K. C., Sutton, P., Samu, Antal, Murphy, John E., Chapman, Ronnie, Wieringa, Nicolien, de Gier, J. J., Rolloos, J., Voesten, M. T. P. J., de Meijer, P. J. J., de Koning, G. H. P., Salek, S., Reerink, E., Mungall, D. R., Farrow, L., Raskob G., Rosenbloom D., Hull R., Ferres J., Torras A., Farre R., Recorder O., Garcia M. P., Torras C., Cubellsl J., Font, M., Madridejos, R., Catalán, A., Huguet, M., Franquesa, N., Gratacós, J., Martinez, M., Saltó, A., van der Kleijn, E., ter Wee, R. J. M., Holmberg, N., and Brenninkmeijer, R. F.

Published
1989
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25. Guide de la Haute autorité de santé (HAS) : les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes) : principes et méthodes

Author

Stamenkovic, Sophie, primary, Solesse, Anne, additional, Zanetti, Laura, additional, Zagury, Pascale, additional, Vray, Muriel, additional, Auquier, Pascal, additional, Baumelou, Elisabeth, additional, de Bels, Frédéric, additional, Bene, Marie-Christine, additional, Bernard, Alain, additional, Boissel, Jean-Pierre, additional, Carrere, Marie-Odile, additional, Czernichow, Pierre, additional, Dervaux, Benoit, additional, Eschwege, Eveline, additional, Fabbro-Peray, Pascale, additional, Falissard, Bruno, additional, Fourrier, Annie, additional, Guillemot, Didier, additional, Lacoin, François, additional, Lapeyre-Mestre, Maryse, additional, Maison, Patrick, additional, Massol, Jacques, additional, Oger, Emmanuel, additional, Roudot-Thoraval, Françoise, additional, Trouiller, Patrice, additional, and Zureik, Mahmoud, additional

Published
2012
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32. Evaluation of Statistical Association Measures for the Automatic Signal Generation in Pharmacovigilance.

Author

Roux, Emmanuel, Thiessard, Frantz, Fourrier, Annie, Bégaud, Bernard, and Tubert-Bitter, Pascale

Subjects
DRUG side effects, INFORMATION storage & retrieval systems, INFORMATION resources management, KNOWLEDGE management, DATA mining, DRUGS
Abstract

Pharmacovigilance aims at detecting tile adverse effects of marketed drugs. It is generally based on the spontaneous reporting of events thought to be the adverse effects of drugs. Spontaneous Reporting Systems (SRSs) supply huge databases that pharmacovigilance experts cannot exhaustively exploit without data mining tools. Data mining methods; i.e., statistical association measures in conjunction with signal generation criteria, have been proposed in the literature but there is no consensus regarding their applicability and efficiency, especially since such methods are difficult to evaluate on the basis of actual data. The objective of this paper is to evaluate association measures on simulated datasets obtained with SRS modeling. We compared association measures using the percentage of false positive signals among a given number of the most highly ranked drug-event combinations according to the values of the association measures. By considering 150 drugs and 100 adverse events, these percentages of false positives, among the 500 most highly ranked drug-event couples, vary from 1.1% to 53.4% (averages over 1000 simulated datasets). As the measures led to very different results, we could identify which measures appeared to be the most relevant for pharmacovigilance. [ABSTRACT FROM AUTHOR]

Published
2005
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33. The delusion of reducing sample size.

Author

Bégaud, Bernard, Fourrier, Annie, Moore, Nicholas, and Moride, Yola

Subjects
*LETTERS to the editor, *CLINICAL trials
Abstract

Presents a letter to the editor about the delusion of reducing sample size in clinical trials.

Published
2003
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34. Évaluation de la performance du système de pharmacovigilance au Sud-Sud du Nigéria

Author

Olowofela, Abimbola, Fourrier, Annie, Isah, Ambrose O., Ozolua, Ray, Bateman, Nicholas, Edwards, I. Ralph, Moore, Nicholas D., Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Bordeaux, Annie Fourrier, Ambrose O. Isah, and STAR, ABES

Subjects
Professionnels de la santé, Système de pharmacovigilance, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Indicateurs de pharmacovigilance, Adverse drug reactions, Nigeria, Educational intervention, Pharmacovigilance, Healthcare professionals, Connaissances sur la santé, Health knowledge and attitudes, Pharmacovigilance system, Pharmacovigilance Indicators, Intervention éducative, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Effets indésirables du médicament
Abstract

The evolution of the pharmacovigilance system in Nigeria has been associated with modest growth and teaching hospitals have been identified as important partners in the pharmacovigilance mechanism. However, there have been no studies evaluating the performance of the pharmacovigilance system in Nigerian Teaching hospitals prior to this time. This study set out to evaluate the state of pharmacovigilance specifically adverse drug reactions in South-South Nigeria. The pharmacovigilance system as well as the prescribing pattern of medicines was evaluated using the WHO Core Pharmacovigilance indicators and WHO Core Prescribing indicators respectively. This was followed by an educational intervention with text messages sent via the Short Messaging System (SMS) to improve the knowledge, attitude and practice of pharmacovigilance amongst healthcare professionals. The number, quality and profile of Adverse Drug Reactions (ADRs) were also assessed before and after the intervention. Factors likely to contribute to poor reporting of pharmacovigilance issues were sought by conducting knowledge, awareness, and practice survey of healthcare professionals working in the zone.The findings showed that of the six teaching hospitals assessed, only three could be described as functional or partly functional although all had some structures in place for pharmacovigilance activities. The process and outcome/impact indicators revealed weak health systems and overall insufficient attention to pharmacovigilance in the hospitals as only one centre had committed their ADR reports to the National Pharmacovigilance Centre and there were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 admissions. It further showed that although a modest knowledge and fair perception of pharmacovigilance existed among the group, practice was poor as only 12% of the 811 healthcare Professionals had ever used the national ADR reporting form and there were few adverse drug reaction reports in the local hospital databases. These were attributed to insufficient awareness of pharmacovigilance on what can be reported, poor reporting processes, wrong beliefs that their reporting will not make a difference and difficulty in determining what to report. There was an improvement in the knowledge and practice of pharmacovigilance, with a 31.6% increase in the number of adverse drug reaction reports following an educational intervention. This study also highlighted the ADR profile to commonly used medicines in the zone and the inherent problems associated with spontaneous reporting. It further highlights that the growing discipline of pharmacovigilance can be improved through frequent assessments of the system, training of the healthcare professionals and general strengthening of the Nigerian healthcare system. More in-depth studies would be required to further evaluate the safety of medicines in the Nigerian population., L’évolution du système de pharmacovigilance au Nigéria a été associée à une croissance modeste et les hôpitaux universitaires ont été identifiés comme des partenaires importants du système de pharmacovigilance. Cependant, aucune étude n'a encore été réalisée sur les performances du système de pharmacovigilance dans les hôpitaux universitaires nigérians. Cette étude visait à évaluer l'état de la pharmacovigilance, en particulier les réactions indésirables aux médicaments dans le sud et le sud du Nigéria, en se référant à des médicaments sélectionnés. Le système de pharmacovigilance ainsi que le schéma posologique des médicaments ont été évalués à l'aide des indicateurs de pharmacovigilance de base de l'OMS et des indicateurs de prescription de base de l'OMS, respectivement. Cela a été suivi d'une intervention éducative avec des messages texte envoyés via le système de messagerie courte (SMS) pour améliorer les connaissances, l'attitude et la pratique de la pharmacovigilance parmi les professionnels de la santé. Le nombre, la qualité et le profil des effets indésirables du médicament ont également été évalués avant et après l'intervention. Les facteurs probables susceptibles de contribuer à une mauvaise notification des problèmes de pharmacovigilance ont été recherchés en effectuant une enquête sur les connaissances, la sensibilisation et les pratiques des professionnels de la santé travaillant dans la zone. Ces faiblesses de la pharmacovigilance étaient essentiellement. Les résultats ont montré que des structures étaient en place pour les activités de pharmacovigilance, même si certaines étaient peu fonctionnelles. Les indicateurs de processus et de résultat / impact ont révélé des systèmes de santé faibles et une attention générale insuffisante à la pharmacovigilance dans les hôpitaux. Il a également montré que, même si le groupe possédait une connaissance modeste et une perception juste de la pharmacovigilance, la pratique était médiocre et peu de réactions indésirables au médicament étaient répertoriées dans les bases de données des hôpitaux locaux. Celles-ci ont été attribuées à une connaissance insuffisante de la pharmacovigilance sur ce qui peut être signalé, à des processus de notification médiocres, à de fausses croyances selon lesquelles leur notification ne fera aucune différence et à la difficulté de déterminer les éléments à signaler. Une perception insuffisante de l’intérêt de la notification des effets indésirables. Les connaissances et les pratiques en matière de pharmacovigilance se sont améliorées, de même que le nombre de déclarations d'effets indésirables au médicament suite à une intervention éducative. Cette étude a également mis en évidence le profil des effets indésirables associés aux médicaments couramment utilisés dans la zone et les problèmes inhérents à la notification spontanée. Il souligne également que la pharmacovigilance, discipline en pleine croissance, peut être améliorée par des évaluations fréquentes du système, la formation des professionnels de la santé et le renforcement général du système de santé nigérian. Des études plus approfondies seraient nécessaires pour mieux évaluer la sécurité des médicaments dans cette population noire homogène.

36. [Antidepressant adverse effects in the elderly: analysis of spontaneous reports in France].

Author

Daurel-Receveur M, Miremont-Salamé G, Fourrier A, Auriche P, Moore N, Bégaud B, and Haramburu F

Subjects
Adverse Drug Reaction Reporting Systems, Aged statistics & numerical data, Cardiovascular Diseases chemically induced, Cardiovascular Diseases epidemiology, France epidemiology, Humans, Metabolism drug effects, Aged physiology, Antidepressive Agents adverse effects
Abstract

The prescription of antidepressants in the elderly has changed since the marketing of new antidepressants such as selective serotonin reuptake inhibitors (SSRIs). We analysed the adverse effects associated with antidepressants in subjects aged > or =75 years reported to the pharmacovigilance centres in France. Among the 2381 cases recorded between 1985 and 2001, the distribution of adverse effects may reflect sales figures: 1040 for SSRIs (44%), 586 for tricyclic and related antidepressants (25%), 46 for monoamine oxidase inhibitors (2%) and 654 for other antidepressants (27%). Adverse effect patterns differed according to antidepressant class. For SSRIs, hyponatraemia was predominant (30%), followed by psychiatric (13%) and nervous system (10%) effects. For tricyclic antidepressants, psychiatric effects (confusion, agitation) [21%] were the most frequent followed by cardiovascular effects (15%). However, the consequences of adverse effects such as hyponatraemia are far from negligible in the elderly.

Published
2005
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