Are Communication Tools Effective in Increasing Reporting Rate of Acute Hemolytic Reactions (AHR) In ITP Patients Treated with Rh (D) Immune Globulin?
Notice bibliographique
Résumé
Abstract Abstract 4677 BACKGROUND: Acute Hemolytic Reactions (AHR) associated with administration of Rh(D) Immune Globulin (WinRho® SDF, Cangene Corporation, Winnipeg, MB, Canada) have been infrequently reported during the last 15 years. AHR's as defined were any case reporting hemoglobin decrease, haptoglobin decrease, elevation of bilirubin occurring within hours to number ofdays after WinRho® SDF treatment irrespective of the degree of change from baseline. AHR's where plasma or urinary hemoglobin were positive were categorized as cases of Intravascular Hemolysis (IVH). AIMS/PURPOSE: To determine if communication tools such as publication of Case series (Gaines), Dear Doctor Letters and label changes stimulated reporting of AHR's and IVH. METHODS: Cangene's WinRho® SDF safety database from USA. was reviewed and analysed for the period 1995–2009. The reporting rate of AHR and IVH were calculated based on cases submitted by year and estimates of number of doses distributed in USA for ITP. These rates were trended to determine if the communication of safety risk was effective in stimulating reporting and decreasing rates of AHR or IVH cases. RESULTS: Gaines published 15 cases of IVH after WinRho® SDF in April 2000. Label changes and Dear Healthcare Professional (DHCP) letters were issued in 2000. Gaines reported 6 cases of disseminated intravascular coagulation with IVH in September 2005 and label was changed with Dear Healthcare Professional letters issued in Dec 2005. Reporting rate of IVH was not affected by these warnings. Increase in reporting rate of AHR's was seen after publications and warning letters in 2000 and 2005. CONCLUSION: The overall reporting rate of AHR (including IVH) was estimated as infrequent (0.12%) while IVH reporting frequency was rare (0.03%). Despite significant communication through FDA publications, medical education efforts and DHCP letters, there has been no appreciable change in reporting frequency of hemolytic events following Rh (D) Immune Globulin administration. This suggests that the initial estimate of IVH occurring at approximately 1:1000 doses (Gaines 2000) is still appropriate. Disclosures: Guirgis: Cangene Corporation: Employment. Muller:Cangene Corporation: Employment. Little:Cangene Corporation: Employment. Sinclair:Cangene Corporation: Employment. Genereux:Cangene Corporation: Employment.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
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