Drug safety;
pharmacovigilance;
side effect;
spontaneous reporting system;
underreporting;
PHARMACOVIGILANCE;
CHALLENGES;
PHYSICIANS;
SYSTEMS;
D O I:
10.1080/14740338.2021.1933430
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
Background: Interventions for improving reporting and management of adverse drug reactions (ADRs) need regular evaluations of attitude and knowledge of health care professionals regarding pharmacovigilance. Research design and methods: An exploratory survey among general practitioners in Germany was conducted. Results: We interviewed 302 individuals (participation rate 34.3%; mean age 54 yrs; 37.1% female). Underreporting was prevalent in the sample (only 16.6% had reported an ADR in 2015; average total number of ADR-reports was 5). We found awareness of the importance of pharmacovigilance and ADRs, information deficits (43% were not aware of the obligation to report ADRs), and several uncertainties regarding the detection and reporting of ADRs. The participants rated the German ADR reporting system as satisfactory (mean grade 3.7 +/- 1.2) and criticized the expenditure of time (63.6%) and the overall complexity (47.4%). To increase the motivation to report ADRs, the majority requested the possibility to report by telephone (61.3%), feedback after reporting (49.3%), telephone consultations (47.4%), and more education and training in pharmacovigilance (31.1%), also during medical school (25.8%). Conclusions: We found evidence of objective and subjective need for further (mandatory) education and training in pharmacovigilance, already during medical school. Our results point to some shortcomings of the German pharmacovigilance system.
机构:
Univ Cape Town, Fac Hlth Sci, Div Nursing & Midwifery, Anzio Rd, ZA-7925 Cape Town, South AfricaUniv Cape Town, Fac Hlth Sci, Div Nursing & Midwifery, Anzio Rd, ZA-7925 Cape Town, South Africa
Afolalu, Olamide O.
Jordan, Sue
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h-index: 0
机构:
Swansea Univ, Sch Human & Hlth Sci, Swansea, W Glam, WalesUniv Cape Town, Fac Hlth Sci, Div Nursing & Midwifery, Anzio Rd, ZA-7925 Cape Town, South Africa
Jordan, Sue
Kyriacos, Una
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机构:
Univ Cape Town, Fac Hlth Sci, Div Nursing & Midwifery, Anzio Rd, ZA-7925 Cape Town, South AfricaUniv Cape Town, Fac Hlth Sci, Div Nursing & Midwifery, Anzio Rd, ZA-7925 Cape Town, South Africa
机构:
Univ Tokyo, Grad Sch Frontier Sci, Dept Computat Biol & Med Sci, Minato Ku, 4-6-1 Shirokanedai, Tokyo 1088639, JapanUniv Tokyo, Grad Sch Frontier Sci, Dept Computat Biol & Med Sci, Minato Ku, 4-6-1 Shirokanedai, Tokyo 1088639, Japan
Kitabayashi, Aki
Inoue, Yusuke
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机构:
Univ Tokyo, Inst Med Sci, Dept Publ Policy, Minato Ku, 4-6-1 Shirokanedai, Tokyo 1088639, JapanUniv Tokyo, Grad Sch Frontier Sci, Dept Computat Biol & Med Sci, Minato Ku, 4-6-1 Shirokanedai, Tokyo 1088639, Japan
机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Feng, Jing
Jiang, Heng
论文数: 0引用数: 0
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机构:
La Trobe Univ, Sch Psychol & Publ Hlth, Ctr Alcohol Policy Res, Melbourne, Vic, Australia
Univ Melbourne, Ctr Hlth Equ, Melbourne Sch Populat & Global Hlth, Melbourne, Vic, AustraliaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Jiang, Heng
Shen, Xin
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Shen, Xin
Lei, Zihui
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Lei, Zihui
Li, Liqing
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机构:
Jiangxi Sci & Technol Normal Univ, Sch Econ & Management, Dept Management Sci & Engineer, Nanchang, Jiangxi, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Li, Liqing
Zhu, Yi
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Zhu, Yi
Zhang, Mingye
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h-index: 0
机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Zhang, Mingye
Yang, Tingting
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机构:
Henan Prov Peoples Hosp, Dept Nutr, Zhengzhou, Henan, Peoples R China
Zhengzhou Univ, Peoples Hosp, Zhengzhou, Henan, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Yang, Tingting
Meng, Xin
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h-index: 0
机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Meng, Xin
Di, Hongkun
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Di, Hongkun
Xia, Wenqi
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Xia, Wenqi
Lu, Zuxun
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
Lu, Zuxun
Gan, Yong
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机构:
Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R ChinaHuazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Social Med & Hlth Management, Wuhan, Hubei, Peoples R China
机构:
Univ Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Univ Limoges, EA HAVAE 6310, F-87025 Limoges, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Merle, Louis
Kreft-Jais, Carmen
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h-index: 0
机构:
AFSSaPS, F-93285 St Denis, France
INPES, F-93203 St Denis, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Kreft-Jais, Carmen
Castot-Villepelet, Anne
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h-index: 0
机构:
AFSSaPS, F-93285 St Denis, France
Agence Reg Sante ARS Ile de France, F-75935 Paris, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Castot-Villepelet, Anne
Durrieu, Genevieve
论文数: 0引用数: 0
h-index: 0
机构:
Univ Hosp, Pharmacol Pharmacovigilance & Pharmacoepidemiol D, F-31000 Toulouse, France
Univ Toulouse, INSERM, U1027, F-31000 Toulouse, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Durrieu, Genevieve
Gras, Valerie
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h-index: 0
机构:
Univ Hosp, Reg Ctr Pharmacovigilance, F-80054 Amiens, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Gras, Valerie
Guy, Claire
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h-index: 0
机构:
Univ Hosp, Reg Ctr Pharmacovigilance, F-42055 St Etienne, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Guy, Claire
Jean-Pastor, Marie-Josephe
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机构:
Univ Hosp, AP HP, Reg Ctr Pharmacovigilance, F-13009 Marseille, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Jean-Pastor, Marie-Josephe
Jonville-Bera, Annie-Pierre
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机构:
Univ Hosp, Reg Ctr Pharmacovigilance, Clin Pharmacol Unit, F-37044 Tours, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Jonville-Bera, Annie-Pierre
Merlet-Chicoine, Isabelle
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机构:
Univ Hosp, Dept Geriatr, F-86021 Poitiers, France
Univ Hosp, Memory Ctr CM2R, F-86021 Poitiers, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Merlet-Chicoine, Isabelle
Miremont-Salame, Ghada
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h-index: 0
机构:
Univ Hosp, Reg Ctr Pharmacovigilance, F-33076 Bordeaux, France
Univ Bordeaux, INSERM, U657, F-33000 Bordeaux, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Miremont-Salame, Ghada
Nourhashemi, Fati
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h-index: 0
机构:
Univ Hosp, Dept Internal Med & Geriatr, Gerontopole, F-31059 Toulouse, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France
Nourhashemi, Fati
Charmes, Jean-Pierre
论文数: 0引用数: 0
h-index: 0
机构:
ALURAD, Ctr Dialysis, F-87038 Limoges, FranceUniv Hosp, Reg Ctr Pharmacovigilance, Pharmacol Toxicol Pharmacovigilance Unit, F-87042 Limoges, France