| アブストラクト | PURPOSE: Many published guidelines are available for health care providers describing the best way to manage patient's adverse drug reactions (ADRs). However, there is a lack of guidance on the best way to promote and manage ADR reporting within hospitals. The goal of this study was to develop good pharmacovigilance reporting practices (GPRPs). METHODS: This descriptive study used a modified Delphi method. The research team developed 41 statements, according to a modified Specific Measurable Attainable Realistic Timely (SMART) method and grouped them in six categories: organization (n = 12 statements), pharmacovigilance committee (n = 4), database (n = 5), training (n = 5), tools (n = 3), and quality (n = 12). The Delphi consultation (two online rounds, conducted in 2018) involved directors of pharmacy in Quebec hospitals. RESULTS: Of 30 directors of pharmacy invited to participate in the first round, 27 (90%) did so. Following this round, the wording of five statements was modified according to pre-established rules. Twenty-five (93%) of the original 27 participants responded during the second round. Of the initial 41 statements, 37 were selected (average score >/= 7); the other four were eliminated. Of the 37 statements selected, 22 had a "must do" formulation, 12 had a "should do" formulation, and three had a "may do" formulation. CONCLUSION: Using a modified Delphi method, we established a set of GPRPs for hospital pharmacy based on 37 statements. To our knowledge, these are the first GPRPs published in the hospital pharmacy literature. |
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| ジャーナル名 | Pharmacoepidemiology and drug safety |
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| 投稿日 | 2019/6/11 |
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| 投稿者 | Rault, Pauline; Megroureche, Emilie; Labarre, Jean-Simon; Pettersen-Coulombe, Flavie; Lebel, Denis; Bussieres, Jean-Francois |
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| 組織名 | Research Unit in Pharmaceutical Practice, Sainte-Justine University Hospital;Center, Montreal, Quebec, Canada.;Faculty of Pharmacy, University of Rennes I, Rennes I University Hospital Center,;Rennes, Bretagne, France.;Department of Pharmacy and Research Unit in Pharmaceutical Practice,;Sainte-Justine University Hospital Center, Montreal, Quebec, Canada.;Faculty of Pharmacy, University of Montreal, Pavillon Jean-Coutu, Montreal,;Quebec, Canada. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31179606/ |
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